Metaanalisis de Disfagia y Aspiracion

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Dysphagia and poor oral health: significant risk factors of aspiration pneumonia in frail older people

Claar D. van der Maarel-Wierink

Dysphagia and poor oral health: significant risk factors of aspiration pneumonia in frail older people

Claar D. van der Maarel-Wierink

Colofon Dysphagia and poor oral health: significant risk factors of aspiration pneumonia in frail older people Thesis, Radboud University Nijmegen Medical Centre, The Netherlands ISBN: 978-90-6464-627-0 Copyright © C.D. van der Maarel-Wierink All rights are reserved. No part of this thesis may be reproduced or transmitted in any form or by any means without permission of the author or the publishers of the included scientific papers. Cover design: by Ron Slagter, RS Enterprises, Voorschoten Printed: by GVO drukkers en vormgevers BV, Ede Publication of this thesis was financially supported by: Zonnehuisgroep Amstelland, Amstelveen; Nederlandse Vereniging van Tandartsen (NVT), Almkerk; Nederlandse Maatschappij tot bevordering der Tandheelkunde (NMT), Nieuwegein; Aemstelgroep Tandartsen, Amstelveen; Verenigd Accountantskantoor voor Medici en Paramedici, Zeist; Verpleeghuis en Revalidatiecentrum Vreugdehof, Amsterdam; Nederlandse Vereniging van Mondhygiënisten (NVM), Nieuwegein; Raadgevers Kuijkhoven, De Bilt; Universitair Medisch Centrum St Radboud, Nijmegen.

Dysphagia and poor oral health: significant risk factors of aspiration pneumonia in frail older people

Proefschrift Ter verkrijging van de graad van doctor aan de Radboud Universiteit Nijmegen op gezag van de rector magnificus, prof. mr. S.C.J.J. Kortmann volgens besluit van het college van decanen in het openbaar te verdedigen op donderdag 21 maart om 10:30 uur precies

door Clara Debora van der Maarel-Wierink geboren op 8 december 1979 te Amsterdam

Promotoren prof. dr. C. de Baat prof. dr. J.M.G.A. Schols (Universiteit Maastricht) prof. dr. J.N.O. Vanobbergen (Universiteit Gent, België) Copromotor dr. G.J. van der Putten Manuscriptcommissie prof. dr. M.G.M. Olde Rikkert prof. dr. N.H.J. Creugers prof. dr. J. Duyck (Katholieke Universiteit Leuven, België)

Paranimfen drs. P.C. Bots-van ‘t Spijker drs. P.J. van Bruggen-van der Linden

Contents

Chapter 1

General introduction

7

Chapter 2 Risk factors for aspiration pneumonia in frail older people: a systematic literature review

17

Chapter 3

59

Meta-analysis of dysphagia and aspiration pneumonia in frail elders

Chapter 4 Oral health care and aspiration pneumonia in frail older people: a systematic literature review

75

Chapter 5

91

Subjective dysphagia in older care home residents in the Netherlands

Chapter 6 Dysphagia in care home residents, assessed by speech therapists, and its feasible risk factors

107

Chapter 7

The effect of daily applying a 0.05% chlorhexidine solution on the incidence of aspiration pneumonia in care home residents: design of a double-blind cluster randomized placebo-controlled trial

121

Chapter 8

General discussion

135

Chapter 9

Summary

147

Chapter 10

Samenvatting

155



Publications and award Dankwoord Curriculum vitae

164 166 171

5

Chapter

General introduction

1

Chapter 1

INTRODUCTION The supervisor of a ward for primarily physically-disabled residents of the care home in which I am working for several years now, requested my advice. A resident with a high spinal cord injury suffered from severe dysphagia and feeding was only possible by a feeding tube, directly into the patient’s stomach (percutaneous endoscopic gastrostomy). The supervisor’s question was ”do I have to clean the patient’s teeth although he is at risk of aspiration?”. No food or drink went into the patient’s mouth, but I presume that every dentist would respond this question positively. However, is there any scientific evidence for this response? Several randomized controlled trials have found evidence for a reduction of the risk of pneumonia in intensive care unit residents, often dependent on mechanical ventilation, through oropharyngeal cleansing with a 0.2% chlorhexidine gluconate solution. However, other studies found controversial evidence. Reviewing the literature on this topic, Scannapieco and Binkley [1] concluded that additional large-scale, multi-centre randomized controlled trials are needed to fully understand the role of oral health care in preventing pneumonia in intensive care unit residents. Tube-fed patients have a very high risk of aspiration (level 1, Dysphagia Outcome and Severity Scale (DOSS) [2]. Langdon et al. [3] found that tube-fed patients with a cerebrovascular disease, who were unlikely to have aspirated anything other than saliva secretions or reflux, showed significantly higher incidence rates of pneumonia than orally-fed patients with a cerebrovascular disease. It was concluded that stringent oral health care and measures to prevent reflux are potentially modifiable aspects in the care of patients with a cerebrovascular disease. The results of this study provide a valuable and evidence based response to the question of the ward supervisor, but is this response also applicable for other care home residents? The literature shows prevalence estimations for dysphagia in care home residents of 50-75% (level 2-6, DOSS) [4-6]. However, exact data on this topic are very scarce. In care home residents, pneumonia is the second most common infection, after urinary tract infections, and the leading cause of death from infection [7]. Therefore, there is an urgent need of scientific evidence on the risk factors of dysphagia and aspiration pneumonia in frail older people and on the role of oral health care in the prevention of aspiration pneumonia in frail older people. Frailty Frail older people may be hospitalized, institutionalized, or remain community-dwelling, whether or not supported by professional or informal care, provided by family members, friends or neighbours. Although frailty is a medically distinct, clinically recognizable syndrome, it is very difficult to provide an exact definition of the term. Recently, an integral conceptual definition has been formulated: “Frailty is a dynamic state affecting an individual who experiences losses in one or more domains of human functioning (physical, 8

General introduction

psychological, social), which is caused by the influence of a range of variables and which increases the risk of adverse outcomes” [8]. When frailty ultimately results in considerable disabilities, admission to a care home is often inevitable. Care homes in the Netherlands Care homes in The Netherlands, offering 24 hour medical and nursing care, have separate wards for residents with primarily physically disabling diseases and for primarily cognitivelyimpaired residents. The medical diagnoses most frequently registered in physically-disabled residents are cerebrovascular diseases, other neurological diseases, status post-hip fracture surgery, other locomotor disabilities, and malignancies. More than 85% of the cognitivelyimpaired residents are suffering from dementia [9,10]. Dysphagia and aspiration pneumonia Dysphagia or swallowing impairment has been described as a symptom which refers to difficulty or discomfort during the progression of the alimentary bolus from the oral cavity to the stomach [11]. Oropharyngeal swallowing composes of three stages: oral preparatory, oral, and pharyngeal. Swallowing disorders can occur at any of the three stages. Residue, laryngeal penetration, and aspiration are symptoms of a swallowing disorder [12]. Aspiration pneumonia, an inflammatory condition of lung parenchyma, is usually initiated by inhalation of colonized oropharyngeal material into the lung alveoli [13,14]. Since frail older people have high levels of functional disability and underlying illnesses, they are at increased risk of acquiring infectious diseases, such as pneumonia. The incidence of pneumonia, commonly caused by Streptococcus pneumoniae (50%), Haemophilus influenza (20%), Chlamydophila pneumonia (13%), and Mycoplasma pneumonia (3%), varies between countries and increases sharply with age. In people aged 75 years or older, the reported incidence increases threefold to fivefold when compared to the general population [13]. In 2009, an incidence of 19.4% was found for pneumonia in care home residents in The Netherlands [15]. For aspiration pneumonia specifically, actual prevalence or incidence figures in care home residents are not available. The mechanism of aspiration pneumonia onset is unknown. Scannapieco [16] described four possible mechanisms for oral bacteria causing respiratory infections. The first mechanism is the colonization of pulmonary pathogens in the oral biofilm and aspiration of these pathogens into the lungs. A second theory is that periodontal disease-associated enzymes in saliva may modify mucosal surfaces and facilitate the adherence of respiratory pathogens which are subsequently aspirated into the lungs. Third, periodontal diseaseassociated enzymes may destroy protective salivary pellicles, such as mucin, resulting in fewer non-specific host defense mechanisms (clearance potential). Fourth, cytokines originating from infected periodontal tissues may alter respiratory epithelium, resulting in respiratory pathogen colonization and an increased risk of infection.

9

Chapter 1

Oral health and aspiration pneumonia Some evidence is available for the association between oral biofilm presence and onset of aspiration pneumonia in frail older people. Since more older people keep their dentition during a longer period of life, the oral biofilm is of increasing importance and may become more virulent as oral health (self)care diminishes in frail older people [17-19]. In a Japanese study, the oral biofilms of 138 frail older people were examined and in 64.5% of cases potential respiratory pathogens colonized in the oral biofilm were found [20]. The predominantly potential respiratory pathogens were Staphylococcus aureus (24.5%), Klebsiella pneumoniae (18.1%), Pseudomonas aerugionosa (18.1%), and Enterobacter cloacae (11.6%). Since potential respiratory pathogens were found in the oral plaque of frail older people, more attention was paid to their oral health care. In one study, nurses or other care providers cleaned the intervention group residents’ mouths using a toothbrush during five minutes after each meal. Dentists or dental hygienists provided professional oral health care once a week. In the control group, residents performed oral health self care once a day or irregularly. In the intervention as well as in the control group, dentures were cleaned with a denture brush every day and with a denture cleanser once a week by care providers. When compared to the control group, the intervention group had statistically significant lower incidences of febrile days, pneumonia, and dying from pneumonia after two years [21]. However, in this study very intensive oral hygiene care was provided. Further information on the effect of oral health and oral hygiene care on the incidence of aspiration pneumonia in care home residents is not available, neither on the efficacy of oral health care interventions in reducing the risk of aspiration pneumonia. Oral health of care home residents Care home residents are often dependent on nurses for daily oral hygiene care, inducing a serious problem since oral hygiene care is generally not prioritized by care home nurses [22-24]. As a consequence, it has been found that care home residents in several countries have poorly cleaned teeth and removable dentures [25]. One strategy to improve oral health and hygiene care in care homes is implementing adequate guidelines and protocols [23,24]. Therefore, the Dutch ‘Oral health care guideline for older people in Long-term care Institutions’ was developed [26]. It is well known that any care guideline needs careful implementation as well as research for assessing its residents’ and care providers’ compliance. Guideline implementation involves the concrete activities and interventions undertaken to turn policies into desired results. With regard to the Dutch ‘Oral health care guideline for older people in Long-term care Institutions’, van der Putten et al. [27] compared a supervised versus a non-supervised implementation. The supervision included: a 1.5-hour informative oral presentation on the guideline by a dental hygienist addressing care home managers and supervisors, a 2-hour lecture and in total 3 hours of practical education for nurses who served as so-called ward oral health care organizers, a 1.5-hour theoretical and executive education session at each ward presented by the ward oral health care organizer, providing oral health care materials and products, and monitoring visits 10

General introduction

of the dental hygienist and an investigator every six weeks. The results showed a statistically significant, but clinically limited beneficial effect of the supervised implementation when compared to the non-supervised implementation. When compared to baseline, a significantly beneficial effect of the intervention was observed, being 30% lower mean dental plaque score and 20% lower mean denture plaque score. However, according to the statistical data analysis, the reduction of mean dental plaque scores could not be explained exclusively by the intervention. The authors concluded that daily oral hygiene care for care home residents still needs more attention. Study rationale Aspiration pneumonia is causing high hospitalization rates, morbidity and often death in frail older people. This thesis might provide awareness to health care providers of the role of dysphagia and poor oral health in the development of aspiration pneumonia. Early recognition and treatment of these risk factors may decrease the incidence of aspiration pneumonia and its serious consequences in frail older people.

11

Chapter 1

AIM, OBJECTIVES, AND MAIN RESEARCH QUESTIONS Aim The overall aim of this thesis is to explore the role of dysphagia and poor oral health, separately or in combination, on the development of aspiration pneumonia in frail older people. Objectives The specific objectives of this thesis are: 1. To systematically review the literature on the risk factors of aspiration pneumonia in frail older people and the contribution of bad oral health among the risk factors. 2. To assess the association of dysphagia with aspiration pneumonia in frail older people. 3. To systematically review the literature on oral health care interventions in frail older people and the effect of these interventions on the incidence of aspiration pneumonia. 4. To assess the prevalence of subjective dysphagia in care home residents in the Netherlands and to assess the associations of subjective dysphagia with feasible risk factors of dysphagia. 5. To determine the prevalence of objective dysphagia in physically-disabled and cognitivelyimpaired care home residents in the Netherlands and to assess the associations of objective dysphagia with feasible risk factors of dysphagia. 6. To develop a study design to assess whether the application of a 0.05% chlorhexidinecontaining solution in addition to usual daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia. Main research questions Related to the objectives formulated, the following main research questions are addressed in this thesis: 1. Which are the risk factors for aspiration pneumonia in frail older people and what is the contribution of bad oral health among the risk factors? 2. What is the association of dysphagia with aspiration pneumonia in frail older people? 3. What kind of oral health care interventions in frail older people have been provided and what was the effect on the incidence of aspiration pneumonia? 4. What is the prevalence of subjective dysphagia in care home residents in the Netherlands? 5. Which are the associations of subjective dysphagia with feasible risk factors of dysphagia in care home residents? 6. What is the prevalence of objective dysphagia in physically-disabled and cognitively-impaired care home residents in the Netherlands? 7. Which are the associations of objective dysphagia with feasible risk factors of dysphagia in care home residents? 8. What is an adequate study design to assess whether a 0.05% chlorhexidine-containing solution in addition to usual daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia? 12

General introduction

OUTLINE The thesis includes the following chapters: Chapter 1 is the general introduction. Chapter 2 describes a systematic literature review on the risk factors of aspiration pneumonia in frail older people and the contribution of bad oral health among the risk factors. In Chapter 3 a meta-analysis assessing the association of dysphagia with aspiration pneumonia in frail older people is presented. Chapter 4 shows a systematic literature review on oral health care interventions in frail older people and their effects on the incidence of aspiration pneumonia. In Chapter 5 the results are presented of a secondary analysis of data of the Dutch National Prevalence Measurement of Care Problems, assessing the prevalence of subjective dysphagia in care home residents in the Netherlands and the associations of subjective dysphagia with feasible risk factors of dysphagia. Chapter 6 presents the results of a study objectively assessing the prevalence of dysphagia in physically-disabled and cognitivelyimpaired care home residents in the Netherlands and the associations of objective dysphagia with feasible risk factors of dysphagia. Chapter 7 describes the study design to assess whether a 0.05% chlorhexidine-containing solution in addition to usual daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia. Chapter 8 involves the general discussion, summarizing the main findings, considerations, and methodological issues of each study. It also provides recommendations for health care providers and recommendations for future research. In Chapter 9 and 10 summaries in English and Dutch are provided respectively.

13

Chapter 1

REFERENCES 1. Scannapieco FA, Binkley CJ. Modest reduction in risk for ventilator-associated pneumonia in critically ill patients receiving mechanical ventilation following topical oral chlorhexidine. J Evid Based Dent Pract 2012;12:103-106. 2. O’Neill KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia 1999;14:139-145. 3. Langdon PC, Lee AH, Binns CW. High incidence of respiratory infections in ‘nil by mouth’ tube-fed acute ischemic stroke patients. Neuroepidemiology 2009;32:107-113. 4. Steele CM, Greenwood C, Ens I, Robertson C, Seidman-Carlson R. Mealtime difficulties in a home for the aged: not just dysphagia. Dysphagia 1997;12:43-50. 5. 5Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clavé P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing 2010;39:39-45. 6. Kayser-Jones J, Pengilly K. Dysphagia among nursing home residents. Geriatr Nurs 1999;20:77-82. 7. Pace CC, McCullough GH. The association between oral microorganisms and aspiration pneumonia in the institutionalized elderly; review and recommendations. Dysphagia 2010;25:307-322. 8. Gobbens RJJ, Luijkx KG, Wijnen-Sponselee MTh, Schols JMGA. In search of an integral conceptual definition of frailty: opinions of experts. J Am Med Dir Assoc 2010;11:338343. 9. Schols JMGA, Crebolder HFJM, van Weel C. Nursing home and nursing home physician: the Dutch experience. J Am Med Dir Assoc 2004;5:207-212. 10. Schols JMGA. Nursing home medicine in The Netherlands. Eur J Gen Pract 2005;11:141-143. 11. Rofes L, Arreola V, Almirall J, et al. Diagnosis and management of oropharyngeal dysphagia and its nutritional and respiratory complications in the elderly. Gastroenterol Res Pract 2011;2011:818979. 12. Logemann JA, Larsen K. Oropharyngeal dysphagia: pathophysiology and diagnosis for the anniversary issue of Diseases of the Esophagus. Dis Esophagus 2012;25:299-304. 13. Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax 2012;67:71-79. 14. Wark P. Viral and bacterial interactions in pneumonia. Expert Rev Respir Med 2010;4:221-228. 15. Veldman-Ariesen MJ, Haenen A, Alblas J, van Benthem BHB. Referentiecijfers basis surveillance 2009. Surveillance Netwerk Infectieziekten Verpleeghuizen. Bilthoven: Rijksinstituut voor Volksgezondheid en Milieu, 2010. 16. Scannapieco FA. Role of oral bacteria in respiratory infection. J Periodontol 1999;70:793-802. 14

General introduction

17. Shay K. Infectious complications of dental and periodontal diseases in the elderly population, Clin Infect Dis 2002;34:1215-1223. 18. Paju S and Scannapieco FA. Oral biofilms, periodontitis, and pulmonary infections, Oral Dis 2007;13:508-512. 19. Abrahamian FM, Deblieux PM, Emerman CL, et al. Health care-associated pneumonia: identification and initial management in the ED. Am J Emerg Med 2008;26:1-11. 20. Sumi Y, Miura H, Michiwaki Y, Nagaosa S, Nagaya M. Colonization of dental plaque by respiratory pathogens in dependent elderly. Arch Gerontol Geriatr 2007;44:119-124. 21. Yoneyama T, Yoshida M, Ohrui T, et al. Oral Care Working Group. Oral care reduces pneumonia in older patients in nursing homes. J Am Geriatr Soc 2002;50:430-433. 22. Young BC, Murray CA, Thomson J. Care home staff knowledge of oral care compared to best practice: a West of Scotland pilot study. Br Dent J 2008;205:E15. 23. de Mello AL, Padilha DM. Oral health care in private and small long-term care facilities: a qualitative study. Gerodontology 2009;26:53-57. 24. Reis SCGB, Marcelo VC, da Silva ET, Leles CR. Oral health of institutionalised elderly: a qualitative study of health caregivers’ perceptions in Brazil. Gerodontology 2011;28:69-75. 25. De Visschere LM, Grooten L, Theuniers G, Vanobbergen JN. Oral hygiene of elderly people in long-term care institutions - a cross-sectional study. Gerodontology 2006;23:195-204. 26. Deerenberg-Kessler W, Nieuwlands T, Vreeburg E, et al. Richtlijn mondzorg voor zorgafhankelijke cliënten in verpleeghuizen. Utrecht: Nederlandse Vereniging van Verpleeghuisartsen, 2007. 27. van der Putten GJ, Mulder J, de Baat C, De Visschere LMJ, Vanobbergen JNO, Schols JMGA. Effectiveness of supervised implementation of an oral health care guideline in care homes; a single-blinded cluster randomized controlled trial. Clin Oral Investig 2012; Epub ahead of print.

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Chapter

2

Risk factors for aspiration pneumonia in frail older people: a systematic literature review Claar D. van der Maarel-Wierink, Jacques N.O. Vanobbergen, Ewald M. Bronkhorst, Jos M.G.A. Schols, Cees de Baat

Published as: van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Risk factors for aspiration pneumonia in frail older people: a systematic literature review. J Am Med Dir Assoc 2011;12:344-354.

Chapter 2

ABSTRACT Objective: To systematically review the risks for aspiration pneumonia in frail older people and the contribution of bad oral health among the risk factors. Design: Systematic literature review. Setting: Pubmed (Medline), Web of Science, Cochrane Library, EMBASE and CINAHL were searched for eligible studies, published in English in the period January 2000 to April 2009. Participants: Frail older people. Measurements: Only publications with regard to hospitalized, institutionalized, or frail homedwelling people of 60 years and older were eligible. Two authors independently assessed the publications for their methodological quality. Unadjusted and adjusted odds ratios and their corresponding 95% confidence intervals for respective risk factors related to aspiration pneumonia were extracted. The results were evaluated according to the levels of evidence of the Oxford Centre for Evidence-based Medicine. Results: A total of 21 publications fulfilled the quality criteria. Evidence level 2a (systematic review with homogeneity of cohort studies) was found for a positive relationship between aspiration pneumonia and age, male gender, lung diseases, dysphagia, and diabetes mellitus; 2b (individual cohort study) for severe dementia, angiotensin I-converting enzyme deletion/ deletion genotype, and bad oral health; 3a (systematic review with homogeneity of casecontrol studies) for malnutrition; 3b (individual case-control study) for Parkinson’s disease and the use of antipsychotic drugs, proton pump inhibitors, and angiotensin-converting enzyme inhibitors. The contribution of bad oral health among the risk factors seems limited. Conclusion: Thirteen significant risk factors were identified: age, male gender, lung diseases, dysphagia, diabetes mellitus, severe dementia, angiotensin I-converting enzyme deletion/ deletion genotype, bad oral health, malnutrition, Parkinson’s disease, and the use of antipsychotic drugs, proton pump inhibitors, and angiotensin-converting enzyme inhibitors. The contribution of bad oral health seems limited.

18

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

INTRODUCTION Because frail older people have high levels of functional disability and underlying illnesses, they are at increased risk of acquiring infectious diseases, such as pneumonia. There is evidence of an association between oral biofilm presence and onset of aspiration pneumonia in frail older people. Because more older people keep their natural dentition for a longer period during life, the oral biofilm is of increasing importance and may become more virulent as oral health (self-) care diminishes in frail older people [1-3]. In a Japanese study, the oral biofilms of 138 frail older people were examined and in 64.5% of cases potential respiratory pathogens colonized in the oral biofilm were found [4]. The predominantly potential respiratory pathogens were Staphylococcus aureus (24.5%), Klebsiella pneumoniae (18.1%), Pseudomonas aerugionosa (18.1%), and Enterobacter cloacae (11.6%). The mechanism of aspiration pneumonia onset is unknown [5]. Aspiration pneumonia is often defined as a pneumonia with preexisting risk factors and demonstrated or suspected aspiration [6,7]. A number of reviews discussed different risk factors for aspiration pneumonia. The current knowledge was reviewed recently [8]; however, a systematic literature review of the various risk factors and their importance for frail older people is lacking. Unknown is also the contribution of bad oral health in the group of risk factors. Therefore, the objectives of this article were to systematically review the literature published between January 2000 and April 2009 on the risk factors of aspiration pneumonia in frail older people and the contribution of bad oral health among the risk factors.

METHODS Data sources and search strategy A comprehensive literature search was carried out. The electronic retrieval systems and databases searched for relevant articles were PubMed (Medline), Web of Science, Cochrane Library, EMBASE, and CINAHL. The keywords (Medical Subject Headings in Medline) used were “aspiration pneumonia” or “pneumonia”, “frail elderly” or “aged”, “nursing homes” or “longterm care” or “geriatric nursing”, “risk factors”, “periodontal disease” and “oral health”, isolated or in different combinations using different Boolean operators. Special attention was paid to the article reference lists and related articles. Selection criteria and quality assessment The search was limited to human studies, studies published in English, and studies published during the period January 2000 to April 2009. Titles and abstracts of publications obtained using the search strategy described were screened. Only publications with regard to hospitalized, institutionalized, or frail home-dwelling older people of 60 years and older were eligible. Subsequently, potentially relevant publications were read in full by the first 2 authors 19

Chapter 2

and independently assessed for their methodological quality. The methodological quality of a publication was assessed on the basis of the criteria defined by the Dutch Cochrane Centre, which were translated from Dutch into English (Table 2.1; www.dcc.cochrane.org). In case of the first two authors’ disagreement and inconsistency concerning inclusion of publications, the opinion of the fourth author was decisive. Data extraction If available, unadjusted and adjusted odds ratios (ORs) and their corresponding 95% confidence intervals (95% CIs) for risk factors related to aspiration pneumonia were extracted from all publications. In case an unadjusted or adjusted odds ratio was not mentioned, the relative risk or the hazard ratio and the corresponding 95% CI were extracted. The risk factors were grouped and the results were assessed for heterogeneity. Clinical heterogeneity was also assessed and, in case of relevance, subgroups were considered. The results of each risk factor were evaluated according to the levels of evidence of the Oxford Centre for Evidence-based Medicine related to “etiology” (Table 2.2) [9]. With regard to risk factors for aspiration pneumonia, evidence level 2a is the best attainable level because randomized controlled trials cannot be carried out for ethical reasons.

20

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Table 2.1 Criteria Related to the Design of Studies for Assessment of the Methodological Quality of Publications (www.dcc.cochrane.org) A.

Quality criteria for assessment of cohort studies

1.

Is there sufficient description of the groups and the distribution of prognostic factors? Are the groups assembled at a similar point in their disease progression?

2.

Can selection bias be excluded?

3.

Is the exposure clearly defined and the method for assessment adequate?

4.

Is the outcome clearly defined and the method for assessment adequate?

5.

Was the outcome assessment blind to exposure status?

6.

Was follow-up long enough for the outcomes to occur?

7.

Were drop-out rates and reasons for drop-out similar across exposed and unexposed groups?

8.

Were the groups comparable on all important confounding factors? Was there adequate adjustment for the effects of these confounding variables?

9.

What is the external validity of the study?

10.

Are the conclusions consistent with the results of the study?

B.

Quality criteria for assessment of case-control studies

1.

Is the case definition explicit? Is the patient group clearly described?

2.

Is the control group clearly described?

3.

Can selection bias be excluded? (comparability of cases and controls)

4.

Is the exposure clearly defined and the method for assessment adequate?

5.

Was outcome assessment clearly defined and blind to exposure status?

6.

Are confounding factors clearly described? Was there adequate adjustment for the effects of these confounding variables?

7.

What is the external validity of the study?

8.

Are the conclusions consistent with the results of the study?

21

Chapter 2

Table 2.2 Oxford Centre for Evidence-based Medicine Levels of Evidence (March 2009) Level Therapy/Prevention, Aetiology/Harm 1a

(SR) (with homogeneity*) of RCT

1b

Individual RCT (with narrow Confidence Interval‡)

1c

All or none§

2a

SR (with homogeneity*) of cohort studies

2b

Individual cohort study (including low-quality RCT; eg, <80% follow-up)

2c

“Outcomes” research; ecological studies

3a

SR (with homogeneity*) of case-control studies

3b

Individual case-control study

4

Case-series (and poor-quality cohort and case-control studies§§)

5

Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”

Note: Users can add a minus-sign “-“ to denote the level of that fails to provide a conclusive answer because: EITHER a single result with a wide confidence interval OR a systematic review with troublesome heterogeneity. Such evidence is inconclusive and only can generate Grade D recommendations. * By homogeneity we mean a systematic review that is free of worrisome variations (heterogeneity) in the directions and degrees of results between individual studies. Not all systematic reviews with statistically significant heterogeneity need be worrisome, and not all worrisome heterogeneity need be statistically significant. As noted above, studies displaying worrisome heterogeneity should be tagged with a “-” at the end of their designated level. SR, systematic review; RCT, randomized controlled trials. ‡ See note above for advice on how to understand, rate, and use trials or other studies with wide confidence intervals. § Met when all patients died before the prescription (Rx) became available, but some now survive on it; or when some patients died before the Rx became available, but none now die on it. §§ By poor-quality cohort study we mean one that failed to clearly define comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both exposed and nonexposed individuals and/or failed to identify or appropriately control known confounders and/or failed to carry out a sufficiently long and complete follow-up of patients. By poor-quality case-control study we mean one that failed to clearly define comparison groups and/or failed to measure exposures and outcomes in the same (preferably blinded), objective way in both cases and controls and/or failed to identify or appropriately control known confounders.

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Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Table 2.3 Publications Excluded after Methodological Quality Assessment Study

Study Design

Exclusion Reason

Taylor et al., 2000 [10]

Review and cross-sectional

Information bias: retrospective data-analysis, additional analyses of a study published previously. Selection bias: inclusion criteria poorly described (not clear how the cohort was extracted from the previously published study). Confounding factors poorly described.

Baine et al., 2001 [11]

Cross-sectional

Information bias: retrospective analysis of insurance data. Confounding factors poorly described.

Imsand et al., 2002 [12]

Cross-sectional

Selection bias: small sample size, one-centre study. Confounding factors poorly described.

Hilker et al., 2003 [13]

Cohort

Selection bias: small sample size, one-centre study. Low external validity.

Madariaga et al., 2003 [14]

Case-control

Selection bias: small sample sizes, one-centre study. Confounding factors poorly described.

Millns et al., 2003 [15]

Cohort

Selection bias: small sample sizes, one-centre study, patient groups difficult to compare. Only 1-year follow up. Confounding factors poorly described.

Carnes et al., 2004 [16]

Cross-sectional

Information bias: retrospective data-analysis. Only 14 days of follow-up. Confounding factors not included in statistical analysis.

Shariatzadeh et al., 2006 [6]

Cohort/ case-control

Selection bias: patient groups hard to compare. Confounding factors poorly described.

Abe et al., 2008 [17]

Cohort

Selection bias: small sample size, only 1-year followup. Confounding factors poorly defined.

Bassim et al., 2008 [18]

Cohort

Selection bias: one-centre study, small sample sizes. Patient groups hard to compare.

Ide et al., 2008 [19]

Cohort

Information bias: self-rated oral symptoms questionnaire, no clinical measurements. Information on oral symptoms only collected at baseline.

Saito et al., 2008 [20]

Cohort

Selection bias: small sample size, one-centre study. Poor external validity.

Sopena et al., 2007 [21]

Cohort

Information bias: retrospective data analysis. Selection bias: one-centre study, small sample size. Confounding factors defined inadequately.

Marciniak et al., 2009 [22]

Case-control

Selection bias: small sample sizes, one-centre study. Poor external validity.

23

Chapter 2

RESULTS The keyword search identified 1802 potentially relevant publications: 613 from PubMed (Medline), 185 from Web of Science, 35 from Cochrane Library, 922 from EMBASE and 47 from CINAHL. Duplicates were excluded. Screening of titles and abstracts revealed that 35 publications were relevant for further review and these publications were read in full text and assessed for their methodological quality. Fourteen publications were excluded after methodological quality assessment (Table 2.3) [6,10-22]. Table 2.4 shows the characteristics of the 21 remaining publications [7,23-42]. The study designs were 1 case-cohort, 12 cohort, 7 case-control and 1 cross-sectional design. Fourteen preliminary risk factors of aspiration pneumonia in frail older people could be identified: age, male gender, severe dementia, Parkinson’s disease, lung diseases, cerebrovascular diseases, diabetes mellitus, malnutrition, heart failure, angiotensin I-converting enzyme deletion/deletion (ACE DD) genotype, specific medication (angiotensin-converting enzyme inhibitors, proton pump inhibitors and antipsychotics), smoking, dysphagia, and bad oral health (Table 2.5). One case-control study showed nonsignificant results concerning higher risk for aspiration pneumonia in frail older people [40]. Five cohort studies and 1 cross-sectional study demonstrated a significant age-related risk for aspiration pneumonia (evidence level 2a) [26,27,30,35,37,38]. Three cohort studies and 1 case-control study showed nonsignificant results concerning the factor gender and the risk for aspiration pneumonia [32,37,38,41]. Eight publications demonstrated a significant gender-related risk for aspiration pneumonia, with men more at risk than women (evidence level 2a) [25,27,29,30,34,35,40,42]. For severe dementia, suggested being a risk factor for aspiration pneumonia, 1 casecontrol study showed nonsignificant results [32]. However, significant results were found in 2 cohort studies and 2 case-control studies (evidence level 2b) [25,27,31,34]. One of the cohort studies included a high number of participants, yielding narrow 95% CIs and a more precise estimate [27]. The other cohort study included only patients with Alzheimer’s disease, resulting in a high odds ratio with a wide 95% CI [25]. The clinical heterogeneity of the populations studied might explain the outcome differences. One case-control study showed a nonsignificant result for Parkinson´s disease as a risk factor for aspiration pneumonia [31]. However, according to 2 publications, Parkinson’s disease might be a risk factor (evidence level 3b) [34,40]. Only one cohort study showed a nonsignificant result concerning the risk for aspiration pneumonia in frail older people with lung diseases [27]. Five publications reporting lung diseases being a significant risk factor are case-control studies [28,31,32,34,40]. One of these publications reported an increased risk in case the patients did not need medication and oxygen, did need medication only, or did need both medication and oxygen, providing some evidence for a dose-response effect. Medications prescribed to treat a low respiratory 24

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

condition were mast cell stabilizers, anticholinergics, bronchodilators, corticosteroids, antitussives, expectorants, or antibiotics [31]. Four cohort studies and 1 case-cohort study, in patients who had had a cerebrovascular accident and nursing home residents, showed lung diseases also being a significant risk factor [7,29,37,41,42]. However, 1 of these cohort studies seemed less precise because of the wide 95% CI [41]. The results of 1 cross-sectional study were in agreement with the other results [26]. Summarized, a positive relationship between lung diseases and aspiration pneumonia could be assessed (evidence level 2a). Five studies on cerebrovascular disease as a risk factor for aspiration pneumonia showed nonsignificant unadjusted odds ratios greater than 1 [7,27,30,31,42]. Two studies showed nonsignificant unadjusted odds ratios less than 1 [32,37]. Two cohort studies and 1 case-control study revealed a significant adjusted odds ratio greater than 1 [25,34,38], although 1 cohort study seemed less precise because of the wide 95% CI [38]. One cohort study reported a significant unadjusted odds ratio greater than 1 [23]. Two case-control studies confirmed these results [34,40]. In contrast, a cross-sectional study, including many participants, showed a significant adjusted odds ratio less than 1 [26]. In conclusion, evidence for cerebrovascular disease being a risk factor for aspiration pneumonia in frail older people is inconclusive. Six studies showed nonsignificant results concerning higher risk for aspiration pneumonia in frail older people with diabetes mellitus [7,27,31,32,35,38]. One cohort and 1 case-cohort study reported a significant adjusted odds ratio greater than 1 [30,42]. One casecontrol study yielded a significant unadjusted odds ratio greater than 1 [40]. Two cohort studies also resulted in a significant unadjusted odds ratio greater than 1, but with wider 95% CIs [37,41]. Sufficient evidence exists for an increased risk of aspiration pneumonia in frail older patients with diabetes mellitus (evidence level 2a). One case-control study showed a nonsignificant result concerning higher risk for aspiration pneumonia in frail older patients with malnutrition [24]. Three case-control studies and 1 cross-sectional study reported a significant adjusted odds ratio greater than 1 [26,28,31,34]. Two of these studies showed the most precise estimates with narrow 95% CIs [26,31]. The only available cohort study reported a significant unadjusted odds ratio greater than 1 [37]. In conclusion, a positive relationship between malnutrition and aspiration pneumonia was found (evidence level 2b). Four studies reported nonsignificant results on heart failure being a risk factor for aspiration pneumonia in frail older patients [7,27,32,37]. One cohort study showed a significant unadjusted odds ratio greater than 1 [30]. One cross-sectional study and 2 case-control studies reported a significant adjusted odds ratio greater than 1 [26,28,31]. Another case-control study mentioned a significant unadjusted odds ratio greater than 1 [40]. In contrast, 1 cohort study showed a significant adjusted odds ratio less than 1 and 1 case-cohort study demonstrated a significant unadjusted odds ratio less than 1 [29,42]. In summary, there is inconclusive evidence for heart failure being a risk factor for aspiration pneumonia. One cohort and 1 case-control study suggested ACE DD genotype being a risk factor for aspiration pneumonia owing to more profound decrease in cough reflex activity resulting 25

Chapter 2

from reduced local levels of bradykinin or substance P or both (evidence level 2b) [27,32]. One cohort study reported nonsignificant results for ACE inhibitors being risk factors for aspiration pneumonia [33]. However, according to a case-control study, the use of this medication could be a protective factor in the onset of aspiration pneumonia, particularly in individuals with the ACE genotypes ID + II (evidence level 3b) [32]. One case-control study demonstrated that using proton pump inhibitors for acidrelated disorders in the upper gastrointestinal tract might be a risk factor for aspiration pneumonia (evidence level 3b) [36]. In 2 case-control studies, a positive relationship was found between antipsychotic drug usage and aspiration pneumonia (evidence level 3b) [34,40]. Six studies reported nonsignificant results for smoking being a risk factor for aspiration pneumonia in frail older people [7,33,34,35,38,42]. One case-control study showed a significant adjusted odds ratio greater than 1 [31]. Another cohort study reported a significant unadjusted odds ratio greater than 1; however, the 95% CI was wide and the sample size rather small [41]. Two cohort studies demonstrated significant unadjusted odds ratios less than 1 [30,37]. Consequently, there is inconclusive evidence for smoking being a risk factor for aspiration pneumonia. Nine studies investigating dysphagia being a feasible risk factor for aspiration pneumonia in frail older people showed a significant adjusted or unadjusted odds ratio greater than 1 [24,26,33,34,35,37,38,41,42]. Of these, the results of 1 case-cohort, 1 cohort, and 1 cross-sectional study are most convincing [26,33,42]. In contrast, the results of 4 of these studies are less precise because of the wide 95% CIs [24,34,35,41]. In conclusion, a positive relationship was found between dysphagia and aspiration pneumonia (evidence level 2a). In 4 cohort studies, various bad oral health factors showed to be risk factors for aspiration pneumonia (evidence level 2b) [7,33,37,39]. Owing to the variety of outcome variables used in the analyses, the studies have to be considered as isolated studies. Table 2.6 summarizes the evidence of the 13 significant risk factors for aspiration pneumonia in frail older people.

26

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Table 2.6 Evidence Level of the 13 Significant Risk Factors for Aspiration Pneumonia in Frail Older People Risk Factor

Evidence Level

Age

2a

Male gender

2a

Lung diseases

2a

Dysphagia

2a

Diabetes mellitus

2a

Severe dementia

2b

ACE DD genotype

2b

Bad oral health

2b

Malnutrition

3a

Parkinson’s disease

3b

Use of antipsychotic drugs

3b

Use of proton pump inhibitors

3b

Use of angiotensin-converting enzyme inhibitors

3b

27

Chapter 2

Table 2.4 Characteristics of Publications Included Publication

Age Group

Participants

Study Design

Nakagawa et al., 2000 [23]

Mean age cases 78.8 ± 6.1 years, controls 80.0 ± 5.9 years

269 community-residing participants of senior day-care centre

Cohort

Terpenning et al., 2001 [7]

58-96 years

358 veterans, 50 subjects with aspiration pneumonia

Cohort

Vergis et al., 2001 [24]

Median age pneumonia patients 75.0 years, control subjects 72.5 years

104 case-control pairs, residents Veterans Affairs long-term care facility (n = 208)

Case-control

Wada et al., 2001 [25]

Mean age 78.2 ± 7.5 years

121 Alzheimer’s disease patients

Cohort

28

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Diagnostic Criteria of (Aspiration) Pneumonia

Investigated Risk Factors for Aspiration Pneumonia

1. new infiltrate on chest radiograph; 2. one of following features: cough, temperature > 37.8°C, subjective dyspnea.

Male gender, age, Barthel index, Mini Mental State Examination score, body mass index, follow-up time; size, location, and vascular territory of silent cerebral infarction.

Positive respiratory fluid cultures, infiltrate on chest radiograph, confirmation by pulmonary physician, body temperature 99.5°F, observed aspiration, white blood cell count ≥ 5.000/mm³, appropriate auscultatory findings, fever with cough, sputum production, dyspnea, pleuritic chest pain.

Age, education, race, smoking, alcohol use, COPD, congestive heart failure, stroke, diabetes mellitus, needs help eating/brushing teeth, number of teeth, functional teeth units, number of decayed teeth, plaque index, gingival bleeding score, P gingivalis in plaque, S sobrinus/ S aureus in saliva, number dental hygiene visits per year.

1. new infiltrate on chest radiograph or documentation of new localized rales; 2. one of following symptoms: temperature > 38.3°C or < 36.1°C, cough, dyspnea, > 24 breaths/min; 3. no cause other than pneumonia.

Age, Activities of daily living Index score, Comorbidity Index score, intermediate care, urinary catheter, pressure sore, other open wound, malnutrition, obesity, antimicrobial therapy, histamine receptor antagonists, antacids, documented aspiration, tranquillizers, antidepressants, narcotics, physical restraints, family visits > 1/week.

1. new infiltrate on chest radiograph; Age, male gender, dementia severity, silent brain 2. one of following features: cough, infarction in basal ganglia, intake neuroleptics/ body temperature > 37.8°C, subjective benzodiazepines. dyspnea.

29

Chapter 2

Continuation Table 2.4 Characteristics of Publications Included Publication

Age Group

Participants

Study Design

Langmore et al., 2002 [26]

49% ≥ 85 years, 51% 65-85 years

102,842 nursing home residents, 3118 subjects with pneumonia

Cross-sectional, with retrospective data analysis

Morimoto et al., 2002 [27]

Mean age 82 ± 7 years

1011 older people in long-term care hospital, 87 pneumonia cases

Cohort

Rothan-Tondeur et al., 2003 [28]

Average age pneumonia patients 87 years, control subjects 85 years

75 pneumonia patients, 150 controls

Case-control

Sund-Levander et al., 2003 [29]

Mean age 84.5 ± 6.7 years

234 nursing home residents, 32 cases of pneumonia.

Cohort

Aslanyan et al., 2004 [30]

Mean age 70 ± 12 years

1455 ischemic stroke patients, subjects of Glycine Antagonist in Neuroprotection (GAIN) International Trial

Cohort

30

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Diagnostic Criteria of (Aspiration) Pneumonia

Investigated Risk Factors for Aspiration Pneumonia

Diagnoses pneumonia in MDS (Minimum Data Set, component of RAI) assessments (ICD-9-CM code 486).

Age, male gender, race, smoking, Alzheimer’s disease, Cognitive Performance scale-severe impairment, coma, delirium indicators deteriorated change in cognitive status/speech clarity/communication, activities of daily living index, arthritis, cancer, congestive heart failure, emphysema/asthma/COPD, stroke, urinary tract infection, breath shortness in last 7 days, ventilator/ respirator, vomiting, Resource Utilization Groups Case mix index, dehydration, eating/swallowing training, feeding restrictions/tube/mechanically altered diet, suctioning, swallowing problem, syringe feeding, tracheotomy care, weight loss, chewing problem, daily cleaning of teeth/ dentures, number of medications 6 or more, occupational therapy, speech therapy.

Criteria of the Centers for Disease Control and Prevention with requirement of an abnormal chest radiograph.

Male gender, dementia, stroke, chronic heart failure, chronic ischemic heart disease, poor nutritional state, diabetes mellitus, lung disease, asthma.

New onset of pneumonia at least 3 days after initial admission, chest x-ray confirming, and at least 2 of following clinical signs: temperature > 38°C, chest pain, crepitating rales/ wheezes/rhonchi, > 20 breaths/min, purulent sputum.

Malnutrition, swallowing disorder, neurological disease, history of pneumonia less than 6 months ago, nasogastric tube, oxygen, COPD, heart failure, active smoking, antibiotic therapy in previous month, corticosteroid therapy, diabetes mellitus, dependency in activities of daily living, pressure ulcers, pneumococcus and influenza immunization.

Cough, sputum production, chest pain, > 20 breaths/min, temperature > 38.0°C, change in cognitive or functional status, worsening chronic disease, anorexia, findings on chest examination, and chest x-ray.

Smoking, COPD, malnutrition, dementia, stroke, heart disease, cancer, influenza vaccination, pneumococcal vaccination, activities of daily living staircase, body mass index.

No definition (Not mentioned in the reference provided.)

Age, Higher baseline National Institute of Health Stroke Scale, male gender, gavestinel treatment, race, previous stroke, atrial fibrillation, hypertension, diabetes mellitus, hypercholesterolemia, smoking, alcohol use > 2 drinks/day, previous myocardial infarction, Oxfordshire Community Stroke Project classification: Lacunar infarct, partial anterior circulation infarction, total anterior circulation infarction, posterior circulation infarction.

31

Chapter 2

Continuation Table 2.4 Characteristics of Publications Included Publication

Age Group

Participants

Study Design

Jackson et al., 2009 [31]

38% 65-74 years, 45% 75-84 years, 17% ≥ 85

1173 cases of community-acquired pneumonia, 2346 controls

Case-control

Takahashi et al., 2005 [32]

Mean age case subjects 82.9 ± 8.2 years, Control subjects 82.7 ± 8.2 years

105 pneumonia patients, 420 control subjects

Case-control

Quagliarello et al., 2005 [33]

Mean age 84.7 years

613 nursing home residents

Cohort

32

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Diagnostic Criteria of (Aspiration) Pneumonia

Investigated Risk Factors for Aspiration Pneumonia

ICD-9 codes 480-487.0 Presumptive outpatient or hospitalized cases validated by reviewing chest radiograph reports or hospitalization records.

Lung disease, smoking, heart disease, diabetes mellitus, dementia, history of stroke, blindness or severe vision impairment, needs assistance: bathing, transferring, dressing, eating, toilet; walks without assistance, with cane, with walker, uses wheelchair or bedridden; number of impairments, weight, current alcoholism, Parkinson’s disease, use of home health services, creatinine ever measured, influenza vaccine.

1. Rales or dullness to percussion on chest examination. 2. Any of the following: new onset of purulent sputum or change in character of sputum; organism isolated from blood culture; isolation of pathogen from specimen obtained by transtracheal aspirate, bronchial brushing, or biopsy; isolation of virus or detection of viral antigen in respiratory secretions; diagnostic single antibody titer (IgM) or fourfold increase in paired serum samples (IgG) for pathogen; histopathologic evidence of pneumonia. 3. Chest radiograph shows new or progressive infiltrate, consolidation, cavitation, or pleural effusion.

Age, male gender, dementia, bedridden state, stroke, ischemic heart disease, congestive heart disease, hypoalbuminemia, diabetes mellitus, lung disease. Angiotensin I-converting enzyme inhibitor use, other antihypertensive agents. ACE gen insertion/deletion (I/D) polymorphism, DD genotype.

Radiographically documented pneumonia and > 2 of the following clinical features: new or increased cough, sputum production, breath shortness, abnormal chest examination findings, pleuritic chest pain, worsening functional status, temperature > 38°C, > 25 breaths/min.

Age, male gender, race, COPD, dementia, stroke, congestive heart failure, diabetes mellitus, cancer, kidney disease, liver disease, degree mobility, activities of daily living, inadequate oral care, swallowing difficulty, lack of influenza vaccination, depression, feeding positioning < 90°, active smoking, use of sedative medication, gastric acid-reducing medication, angiotensin-converting enzyme inhibitor.

33

Chapter 2

Continuation Table 2.4 Characteristics of Publications Included Publication

Age Group

Participants

Study Design

Hennessy et al., 2007 [34]

Median age cases 81 years, controls 75 years

12,004 cases of hospitalization for pneumonia, 48,176 controls. 159 cases of aspiration pneumonia, 636 controls

Case-control study within the General Practice Research Database(GPRD) in the United Kingdom

Kwon et al., 2006 [35]

Mean age: Pneumonia 68.7 ± 13.9, no pneumonia 61.6 ± 12.7

286 stroke patients

Cohort

Gulmez et al., 2007 [36]

All ages, but only results of patients ≥ 60 years included

7642 hospitalized community-acquired pneumonia cases (4529 cases > 60 years), 34,176 controls (20,712 controls > 60 years).

Case-control

Sellars et al., 2007 [37]

Mean age pneumonia patients 75.9 ± 11.4 years, no pneumonia 64.9 ± 13.9 years

412 stroke patients

Cohort

34

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Diagnostic Criteria of (Aspiration) Pneumonia

Investigated Risk Factors for Aspiration Pneumonia

Pneumonia: GPRD-records

Male, alcohol use, smoking, diagnoses ever in past: anterior horn motor neuron disease, anxiety, bipolar disorder, COPD, cerebrovascular disease, depression, dysphagia, herpetic neuralgia/herpes zoster, insomnia, Parkinson’s disease, poor nutritional status, schizophrenic disorders, senile dementia, suicidal ideation; drugs prescribed ever in past/currently: antipsychotic, antiparkinsonian, barbiturate, benzodiazepine, histamine2receptor antagonist, mood stabilizer, opiate, proton pump inhibitor; currently prescribed antidepressant.

At least 1 of the following: auscultatory respiratory crackles and temperature > 37.7°C, radiographic evidence, new purulent sputum.

Age, sex, hypertension, diabetes mellitus, smoking, initial stroke severity, blood pressure, initial body temperature, fasting blood glucose level, high sensitivity C-reactive protein.

Community-acquired pneumonia: ICD-10 codes J13 to J18, including all subcategories.

Exposure to proton pump inhibitors and histamine2receptor antagonists.

3 or more of the following: temperature > 38°C, productive cough with purulent sputum, > 22 breaths/ min, tachycardia, inspiratory crackle, bronchial breathing, abnormal chest radiograph, arterial hypoxemia (PO2 < 70 mm Hg or SpO2 < 94%) and isolation of positive Gram stain and culture.

Age, sex, number of medications, current smoker, prestroke modified Rankin Scale score, prestroke Barthel index, previous stroke, ischemic heart disease, peripheral vascular disease, COPD, congestive heart failure, diabetes mellitus, hypertension, gastroesophageal reflux or peptic ulcer disease, infarct: hemorrhage, Oxfordshire Community Stroke Project total anterior circulation syndrome, heart rate, respiratory rate, SpO2, serum urea, serum albumin, nutritional status, Modified National Institutes of Health Stroke Scale score, modified Rankin Scale score, Abbreviated Mental Test score, dentures, no teeth or dentures, oral health status score, salivary flow rate, oral gram-positive/gram-negative bacteria, failed water swallowing test, Logemann total score/oral-stage disorder/ pharyngeal delay/pharyngeal-stage disorder/ aspiration, Daniels severity of dysphagia, mean/lowest SpO2 during swallow.

35

Chapter 2

Continuation Table 2.4 Characteristics of Publications Included Publication

Age Group

Participants

Study Design

Walter et al., 2007 [38]

Men mean age 67.6 years, women mean age 72.3 years

236 acute ischemic stroke patients

Cohort

Awano et al., 2008 [39]

80 years old

697 older

Cohort

Knol et al., 2008 [40]

Median age 81 years

543 cases of hospitalization for pneumonia, 2163 controls

Case-control

Masiero et al., 2008 [41]

Mean age 72.9 ± 12.2 years

67 patients, 6 months after stroke

Cohort

Skull et al., 2009 [42]

Mean age 78 years

1952 cases with community-acquired pneumonia, 2927 cohort subjects

Case-cohort, cases also eligible for inclusion in the cohort.

ACE, angiotensin-converting enzyme; COPD, chronic obstructive pulmonary disease; DD, deletion/deletion; P gingivalis, Porphyromonas gingivalis; PO², partial pressure of oxygen; SpO², pulse oximeter oxygen saturation; S aureus, Streptococcus aureus; S sobrinus, Streptococcus sobrinus.

36

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Diagnostic Criteria of (Aspiration) Pneumonia

Investigated Risk Factors for Aspiration Pneumonia

Stroke-associated pneumonia: lung auscultation and percussion, fever, purulent tracheal secretion; tracheal specimens, blood cultures; chest x-ray findings.

Age, male gender, diabetes mellitus, malignant tumor, smoking, heavy drinking, infection other than strokeassociated pneumonia, National Institutes of Health Stroke Scale > 10, impaired vigilance, dysphagia, mechanical ventilation, cardioembolism, large-artery atherosclerosis, small-vessel occlusion, dissection, ischemic stroke location.

No definition of pneumonia. “Deaths were classified by trained physicians according to the International Classification of Diseases”

Gender, number of teeth, denture use (partial/full), number teeth with probing depth of at least 4 mm, methyl mercaptan, Candida species, saliva-swallowing test, stroke history, cardiovascular disease, pneumonia, cancer, blood pressure, serum albumin, total cholesterol, glucose, body mass index, self-reported smoking.

Pneumonia: ICD-9 codes 480-486 and 507

Age, male gender, antibiotic use, immunosuppressants, acid-suppressive drugs, drugs with potential extrapyramidal symptoms, benzodiazepines, delirium, cardiovascular disease, Parkinson’s disease, COPD, lung cancer, diabetes mellitus, heart failure, number of hospital admissions, number of drugs.

> 3 of following: temperature > 38°C, productive cough with purulent sputum, > 22 breaths/min, tachycardia, inspiratory crackles, bronchial breathing, abnormal chest radiograph, PO² 70 mm Hg, positive Gram stain and culture.

Age, male gender, lesion side, type of lesion, Aspiration Penetration Scale score on Fiberoptic Endoscopic evaluation of swallowing in patients with pneumonia, Modified Rankin Scale at enrollment, absence of reflex cough after swallow, arterial hypertension, diabetes mellitus, COPD, smoking, consciousness level National Institutes of Health Stroke Scale.

Subjects with ICD-10-AM codes J10-J18. Nosocomial pneumonia excluded (diagnosis > 48 hours after admission).

Male gender, living in own home, diabetes mellitus, immunosuppression, other respiratory disease, renal disease, hematological disease, aspiration, first language English, pneumonia ever, pneumonia past year, excess alcohol intake, increasing doctor visits past year.

37

Chapter 2

Table 2.5 Unadjusted and Adjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) Found in the 21 Publications on the 14 Preliminary Risk Factors for Aspiration Pneumonia of the Systematic Literature Review Publication

Risk Factor

Additional Description Reference

Study Design

Langmore et al. [26]

age

years

cross-sectional

Morimoto et al. [27]

age

5 years

cohort

Aslanyan et al. [30]

age

years

cohort

Kwon et al. [35]

age

≥ 65 years

< 65 years

cohort

Sellars et al. [37]

age

≥ 65 years

30-64 years

cohort

Walter et al. [38]

age

≥ 73 years

<74 years

cohort

Knol et al. [40]

age

75-84 years

65-74 years

case-control

Knol et al. [40]

age

> 85 years

65-74 years

case-control

Wada et al. [25]

male gender

cohort

Morimoto et al. [27]

male gender

cohort

Sund-Levander et al. [29] Aslanyan et al. [30]

male gender

cohort

male gender

cohort

Takahashi et al. [32]

male gender

case-control

Hennessy et al. [34]

male gender

case-control

Kwon et al. [35]

male gender

cohort

Sellars et al. [37]

male gender

cohort

Walter et al. [38]

male gender

cohort

Knol et al. [40]

male gender

case-control

Massiero et al. [41]

male gender

cohort

Skull et al. [42]

male gender

case-cohort

Wada et al. [25]

dementia

Morimoto et al. [27]

dementia

Jackson et al. [31]

dementia

Takahashi et al. [32]

dementia

38

severe dementia (CDR = 3) MMSE ≤ 23

cohort cohort case-control

MMSE ≤ 23

case-control

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Follow up

Number of Participants

Unadjusted OR (95% CI)

Adjusted OR (95% CI)

retrospective

102.842

8 months

1011

3 months

1455

30 days

286

3.18 (1.63-6.18)*

7.96 (2.68-23.64)*

3 months

412

3.9 (2.0-7.5)*

3.310 (P.005)*

1-43 days

236

2.51 (1.47-4.27) RR*

retrospective

2706

1.2 (0.96-1.15)

retrospective

2706

1.1 (0.8-1.4)

retrospective

121

8 months

1011

1.8 (1.1-2.8)*

2.6 (1.6-4.3)*

1 year

234

2.00 (0.94-4.27)

3.2 (1.4-7.8)*

3 months

1455

1.21 (0.89-1.65)

1.71 (1.22-2.39)*

8 months

525

1.00 (0.61-1.65)

retrospective

795

2.26 (1.57-3.23)*

2.57 (1.72-3.84)*

30 days

286

2.33 (1.08-5.05)*

3.73 (1.22-11.37)*

3 months

412

1.32 (0.78-2.23)

1-43 days

236

0.80 (0.49-1.31) RR

retrospective

2706

3.20 (2.63-3.90)*

6 months

67

0.86 (0.20-3.62)

retrospective

4879

1.32 (1.17-1.48)*

retrospective

121

8 months

1011

1.9 (1.2-3.0)*

retrospective

3519

1.72 (1.20-2.47)*

8 months

525

0.84 (0.54-1.30)

1.01 (1.00-1.01)* 1.3 (1.1-1.5)*

1.3 (1.1-1.6)* 1.06 (1.04-1.08)*

4.55 (1.22-20.0)*

1.34 (1.18-1.53)* 6.75 (1.79-25.53)* 2.0 (1.3-3.2)*

39

Chapter 2

Continuation Table 2.5 Unadjusted and Adjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) Found in the 21 Publications on the 14 Preliminary Risk Factors for Aspiration Pneumonia of the Systematic Literature Review Publication

Risk Factor

Additional Description Reference

Study Design

Hennessy et al. [34]

dementia

senile dementia

case-control

Jackson et al. [31]

Terpenning et al. [7]

Parkinson’s disease Parkinson’s disease Parkinson’s disease lung diseases

COPD

cohort

Langmore et al. [26]

lung diseases

COPD

cross-sectional

Morimoto et al. [27]

lung diseases

Rothan-Tondeur et al. [28] Sund-Levander et al. [29] Jackson et al. [31]

lung diseases

prior pneumonia

case-control

lung diseases

COPD

cohort

lung diseases

no medication/oxygen

case-control

Jackson et al. [31]

lung diseases

medication, no oxygen

case-control

Jackson et al. [31]

lung diseases

using oxygen

case-control

Jackson et al. [31]

lung diseases

all together

case-control

Takahashi et al. [32]

lung diseases

Hennessy et al. [34]

lung diseases

COPD

case-control

Sellars et al. [37]

lung diseases

COPD

cohort study

Knol et al. [40]

lung diseases

COPD

case-control

Masiero et al. [41]

lung diseases

COPD

cohort study

Skull et al. [42]

lung diseases

pneumonia ever

case-cohort

Skull et al. [42]

lung diseases

case-cohort

Terpenning et al. [7]

CVA

other respiratory disease stroke

Nakagawa et al. [23]

CVA

cohort

Nakagawa et al. [23]

CVA

Wada et al. [25]

CVA

silent cerebral infarction deep > superficial infarcts silent brain infarction in the basal ganglia

Hennessy et al. [34] Knol et al. [40]

40

case-control case-control case-control

cohort

case-control

cohort

cohort cohort

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Follow up

Number of Participants

Unadjusted OR (95% CI)

Adjusted OR (95% CI)

retrospective

795

5.18 (2.07-12.96)*

3.39 (1.26-9.10)*

retrospective

3519

1.04 (0.51-2.14)

retrospective

795

6.20 (1.68-22.82)*

retrospective

2706

1.8 (1.3-2.6)*

8.5 years

358

1.91 (1.00-3.66)*

retrospective

102.842

8 months

1011

1.5 (0.9-2.5)

1.5 (0.9-2.1)

30 days

225

5.06 (2.46-10.43)*

4.50 (2.17-9.35)*

1 year

234

3.36 (1.25-9.01)*

5.6 (1.8-17.7)*

retrospective

3519

1.52 (1.10-2.10)*

2.0 (1.5-2.7)*

retrospective

3519

2.39 (2.04-2.81)*

2.5 (2.2-3.0)*

retrospective

3519

10.03 (6.30-15.99)*

8.3 (5.5-12.7)*

retrospective

3519

3.29 (2.83-3.83)*

8 months

525

2.15 (1.33-3.47)*

1.91 (1.16-3.14)*

retrospective

795

2.80 (1.68-4.66)*

2.91 (1.66-5.09)*

3 months

412

3.5 (1.6-8.0)*

retrospective

2706

3.24 (2.53-4.14)*

6 months

67

21.88 (3.71-129.10)*

retrospective

4879

2.21 (1.89-2.60)*

2.30 (1.83-2.89)*

retrospective

4879

2.39 (2.11-2.70)*

2.41 (2.10-2.77)*

8.5 years

358

1.09 (0.53-2.24)

2 years

269

4.67 (1.87-11.67)*

2 years

269

5.00 (1.91-13.08)*

retrospective

121

6.91 (1.69-28.3)*

2.5 (1.3-5.0)* 2.49 (2.27-2.72)*

2.50 (1.23-4.90)* 41

Chapter 2

Continuation Table 2.5 Unadjusted and Adjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) Found in the 21 Publications on the 14 Preliminary Risk Factors for Aspiration Pneumonia of the Systematic Literature Review Publication

Risk Factor

Langmore et al. [26]

CVA

Morimoto et al. [27]

CVA

stroke

cohort

Aslanyan et al. [30]

CVA

previous stroke

cohort

Jackson et al. [31]

CVA

history of stroke

case-control

Takahashi et al. [32]

CVA

stroke

case-control

Hennessy et al. [34]

CVA

case-control

Sellars et al. [37]

CVA

cerebrovascular disease previous stroke

Walter et al. [38]

CVA

non-lacunar basalganglia infarction

cohort

Knol et al. [40]

CVA

case-control

Skull et al. [42]

CVA

case-cohort

Terpenning et al. [7]

diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus diabetes mellitus

cohort

Morimoto et al. [27] Aslanyan et al. [30] Jackson et al. [31] Jackson et al. [31] Jackson et al. [31] Takahashi et al. [32] Kwon et al. [35] Sellars et al. [37] Walter et al. [38] Knol et al. [40]

42

Additional Description Reference

Study Design cross-sectional

cohort

cohort cohort without insulin

case-control

with insulin

case-control

together

case-control case-control cohort cohort cohort case-control

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Follow up

Number of Participants

Unadjusted OR (95% CI)

retrospective

102.842

8 months

1011

1.0 (0.6-1.7)

3 months

1455

1.21 (0.80-1.82)

retrospective

3519

1.16 (0.89-1.52)

8 months

525

0.81 (0.50-1.32)

retrospective

795

5.68 (3.77-8.57)*

3 months

412

0.91 (0.53-1.56)

1-43 days

236

retrospective

2706

3.41 (1.85-6.29)*

retrospective

4879

1.07 (0.93-1.24)

8.5 years

358

1.69 (0.87-3.30)

8 months

1011

1.5 (0.8-2.7)

3 months

1455

1.36 (0.94-1.98)

retrospective

3519

0.99 (0.73-1.34)

retrospective

3519

1.25 (0.99-1.58)

retrospective

3519

1.16 (0.95-1.40)

8 months

525

1.73 (0.90-3.32)

30 days

286

1.13 (0.58-2.22)

3 months

412

5.88 (3.02-11.46)*

1-43 days

236

0.90 (0.58-1.39) RR

retrospective

2706

1.53 (1.18-1.98)*

Adjusted OR (95% CI) 0.83 (0.75-0.91)*

5.64 (3.51-9.05)*

28.2 (3.5-229.8)*

1.7 (0.9-3.5)

1.62 (1.09-2.41)*

1.72 (0.87-3.39)

43

Chapter 2

Continuation Table 2.5 Unadjusted and Adjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) Found in the 21 Publications on the 14 Preliminary Risk Factors for Aspiration Pneumonia of the Systematic Literature Review Publication

Risk Factor

Masiero et al. [41]

Vergis et al. [24]

diabetes mellitus diabetes mellitus malnutrition

Langmore et al. [26]

malnutrition

Rothan-Tondeur et al. [28]

Skull et al. [42]

Additional Description Reference

Study Design cohort case-cohort

body weight < 80% of the ideal weight weight loss

case-control

severe malnutrition

body mass index, plasma albumin <30 g/L or prealbumin <150 mg/L

case-control

Jackson et al. [31]

malnutrition

case-control

Hennessy et al. [34]

malnutrition

>10% weight loss during baseline poor nutritional status

Sellars et al. [37]

malnutrition

nutritional status, undernourished (BMI < 20 kg/m2)

cohort

Terpenning et al. [7]

heart failure

congestive heart failure

cohort

Langmore et al. [26]

heart failure

congestive heart failure

cross-sectional

Morimoto et al. [27]

heart failure

ischemic heart disease

cohort

Morimoto et al. [27]

heart failure

congestive heart failure

cohort

Rothan-Tondeur et al. [28] Sund-Levander et al. [29] Aslanyan et al. [30]

heart failure

case-control

heart disease

cohort

Jackson et al. [31]

heart failure

Jackson et al. [31]

heart failure

Jackson et al. [31]

heart failure

Jackson et al. [31] Takahashi et al. [32]

44

heart failure

cross-sectional

case-control

previous myocardial infarction non-CHF heart disease

cohort

case-control

heart failure

mild chronic heart failure severe chronic heart failure heart diseases together

heart failure

ischemic heart disease

case-control

case-control

case-control case-control

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Follow up

Number of Participants

Unadjusted OR (95% CI)

Adjusted OR (95% CI)

6 months

67

5.88 (1.30-26.65)*

retrospective

4879

1.09 (0.95-1.24)

2 years

104

1.40 (0.71-2.74)

retrospective

102.842

30 days

225

5.08 (2.30-11.22)*

4.81 (1.22-20.43)*

retrospective

3519

1.89 (1.43-2.50)*

1.9 (1.3-2.6)*

retrospective

795

14.60 (2.91-73.31)*

13.92 (2.67-72.69)*

3 months

412

2.66 (1.38-5.13)*

8.5 years

358

0.96 (0.35-2.64)

retrospective

102.842

8 months

1011

1.2 (0.7-2.0)

8 months

1011

0.9 (0.5-1.9)

30 days

225

2.58 (1.34-4.96)*

2.57 (1.38-4.19)*

1 year

234

0.38 (0.17-0.82)*

0.3 (0.1-0.7)*

3 months

1455

1.69 (1.14-2.50)*

retrospective

3519

1.00 (0.86-1.16)

1.2 (1.1-1.4)*

retrospective

3519

2.11 (1.61-2.77)*

1.9 (1.5-2.5)*

retrospective

3519

4.26 (2.96-6.14)*

3.3 (2.3-4.7)*

retrospective

3519

1.56 (1.35-1.80)*

8 months

525

0.83 (0.47-1.47)

1.22 (1.05-1.42)*

1.60 (1.47-1.74)*

1.75 (1.61-1.90)*

45

Chapter 2

Continuation Table 2.5 Unadjusted and Adjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) Found in the 21 Publications on the 14 Preliminary Risk Factors for Aspiration Pneumonia of the Systematic Literature Review Publication

Risk Factor

Additional Description Reference

Study Design

Takahashi et al. [32]

heart failure

congestive heart failure

case-control

Sellars et al. [37]

heart failure

ischemic heart disease

cohort

Sellars et al. [37]

heart failure

congestive heart failure

cohort

Knol et al. [40]

heart failure

Skull et al. [42]

heart failure

Morimoto et al. [27]

ACE DD genotype ACE DD genotype angiotensinconverting enzyme inhibitors

cohort

Quagliarello et al. [33] angiotensinconverting enzyme inhibitors

cohort

Gulmez et al. [36]

case-control

Takahashi et al. [32] Takahashi et al. [32]

case-control ischemic heart disease

case-cohort

case-control case-control

Terpenning et al. [7]

proton pump inhibitors antipsychotic drugs antipsychotic drugs smoking

current smoker

cohort

Aslanyan et al. [30]

smoking

current smoker

cohort

Jackson et al. [31]

smoking

former smoker

case-control

Jackson et al. [31]

smoking

current smoker

case-control

Jackson et al. [31]

smoking

case-control

Quagliarello et al. [33] smoking

former and current smokers active smoking

Hennessy et al. [34]

smoking

current smoking

case-control

Kwon et al. [35]

smoking

cohort

Sellars et al. [37]

smoking

current smoker or quit smoking < 5 yrs current smoker

Hennessy et al. [34] Knol et al. [40]

46

case-control case-control

cohort

cohort

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Follow up

Number of Participants

Unadjusted OR (95% CI)

Adjusted OR (95% CI)

8 months

525

0.44 (0.15-1.28)

0.39 (0.13-1.19)

3 months

412

1.03 (0.60-1.77)

3 months

412

1.05 (0.44-2.48)

retrospective

2706

1.61 (1.12-2.34)*

retrospective

4879

0.77 (0.69-0.87)*

8 months

1011

2.6 (1.5-4.3)*

8 months

525

8 months

525

1 year

613

retrospective

25.241

2.4 (2.1-2.6)*

1.5 (1.3-1.7)*

retrospective

795

9.70 (4.69-20.09)*

1.43 (0.64-3.22)

retrospective

2706

1.9 (1.6-2.4)*

1.6 (1.3-2.1)*

8.5 years

358

1.63 (0.84-3.17)

3 months

1455

0.60 (0.39-0.90)*

retrospective

1173

1.43 (1.24-1.66)*

1.3 (1.1-1.5)*

retrospective

1173

1.89 (1.43-2.50)*

1.8 (1.4-2.3)*

retrospective

1173

1.72 (1.48-2.00)*

1 year

613

retrospective

795

1.13 (0.75-1.70)

30 days

286

0.52 (0.25-1.08)

3 months

412

0.40 (0.23-0.70)*

2.9 (1.7-4.8)* 2.05 (1.21-3.48)*

0.45 (0.24-0.88)*

0.46 (0.23-0.91)*

0.71 (0.43-1.19)

0.92 (0.38-2.21) 1.22 (0.76-1.97)

47

Chapter 2

Continuation Table 2.5 Unadjusted and Adjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) Found in the 21 Publications on the 14 Preliminary Risk Factors for Aspiration Pneumonia of the Systematic Literature Review Publication

Risk Factor

Additional Description Reference

Study Design

Masiero et al. [41]

smoking

> 10 cigarettes/day

cohort

Skull et al. [42]

smoking

current smoker

case-cohort

Vergis et al. [24]

dysphagia

documented aspiration

case-control

Langmore et al. [26]

dysphagia

swallowing problem

cross-sectional

Quagliarello et al. [33] dysphagia

swallowing difficulty

cohort

Hennessy et al. [34]

dysphagia

case-control

Kwon et al. [35]

dysphagia

cohort

Sellars et al. [37]

dysphagia

Walter et al. [38]

dysphagia

Masiero et al. [41]

dysphagia

Skull et al. [42]

dysphagia

Risk factors for aspiration pneumonia Terpenning et al. [7] bad oral health Terpenning et al. [7]

bad oral health

Quagliarello et al. [33] bad oral health

Logemann, aspiration

cohort cohort

absence of reflex cough after swallow aspiration

cohort

no. of decayed teeth

cohort

no. of functional dental units inadequate oral care

cohort

cohort

case-cohort

cohort

Sellars et al. [37]

bad oral health

Sellars et al. [37]

bad oral health

oral health status >10/24 dentures

Sellars et al. [37]

bad oral health

no teeth or dentures

cohort

≥10 teeth with a probing depth > 4 mm

cohort

Risk factors for mortality from pneumonia Awano et al. [39] bad oral health

cohort

ACE DD, angiotensin I-converting enzyme deletion/deletion; BMI, body mass index; CDR, clinical dementia rating scale; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CVA, cerebrovascular accident; HR, hazard ratio; MMSE, Mini Mental State Examination; RR, relative risk. *Significant unadjusted and adjusted odds ratios.

48

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

Follow up

Number of Participants

Unadjusted OR (95% CI)

Adjusted OR (95% CI)

6 months

67

14.29 (2.53-80.58)*

retrospective

4.879

1.02 (0.80-1.31)

2 years

208

13.9 (1.7-111.0)*

retrospective

102.842

1.46 (1.31-1.62)*

1 year

613

1.61 (1.02-2.56) HR*

retrospective

795

16.06 (7.02-36.73)*

23.11 (8.30-64.36)*

30 days

286

49.07 (14.67-164.17)*

15.56 (3.84-63.10)*

3 months

412

7.17 (3.69-13.95)*

1- 43 days

236

9.92 (5.28-18.7)*

6 months

67

12.50 (2.51-62.30)*

retrospective

4.879

2.25 (1.39-3.65)*

8.5 years

358

1.2 (1.1-1.4)*

8.5 years

358

1.2 (1.02-1.4)*

1 year

613

1.55 (1.04-2.30) HR*

3 months

412

3.9 (2.3-6.8) *

3 months

412

0.67 (0.39-1.14)

3 months

412

5.66 (2.76-11.59)*

4 years

697

15.7 (5.6-43.7)*

2.19 (1.20-3.99)*

3.9 (1.1-13.9) HR*

49

Chapter 2

DISCUSSION A limitation of this study is the inconsistency of definitions used for the various risk factors. Dysphagia, for example, is defined as aspiration, absence of reflex cough after swallow, Logemann-aspiration, swallowing difficulty, and swallowing disorder. The dysphagia-related factors “mechanically altered diet”, “suctioning use”, and “feeding tube”, although related to dysphagia, were not included because too much heterogeneity would have hindered an appropriate comparison of results. A second limitation is the problem of adequately diagnosing aspiration pneumonia in frail older people. Most studies use as a definition of pneumonia 2 or more of the following symptoms or signs: fever (temperature > 38 °C), cough, sputum production, shortness of breath, pleuritic chest pain, crackles, or consolidation on examination of the chest together with an acute pulmonary infiltrate evident on the chest radiographs compatible with pneumonia. Aspiration pneumonia is defined as clinical presentation consistent with pneumonia associated with a history of witnessed aspiration or risk factors for aspiration [6,7]. In addition, the clinical symptoms of (aspiration) pneumonia are less clear in frail older than in younger people and it is not always possible to make a chest radiograph in frail older people living in long-term care facilities. Therefore, comparing the results of the various studies may not be conclusive. Potential lifestyle confounders, such as smoking and alcohol consumption may play an important role in the gender differences of aspiration pneumonia risk in frail older people. The univariate analysis of a population-based case-control study in the general population, not included in this review, showed for both current and previous smokers as well as for men drinking more than 40 g alcohol daily a higher risk for community-acquired pneumonia [43]. In another population-based case-control study investigating the risk of hospitalization for community-acquired pneumonia in older adults, not included in this review, the multivariable analysis demonstrated a smoking history of more than 100 cigarettes in a lifetime (OR = 2.01; 95% CI = 1.26-3.36) and a history of increased alcohol use during the previous 12 months of 5-g increase monthly (OR = 1.69; 95% CI = 1.08-2.61) [44]. An alternative explanation of higher risk for aspiration pneumonia in men is a history of regular exposure to gases, fumes, or chemicals at work [44]. Exposure to certain environmental factors predisposed workers to occupational respiratory diseases. Contact with dust in the previous month and some interrelated jobs (builders, carpenters, painters) were more frequent variables in cases than in controls, but in the multivariable analysis sudden changes of temperature in the workplace during the last 3 months was the only independent environmental factor for communityacquired pneumonia [43]. In contrast, the authors of a cohort study concluded that reduced short-term and long-term survival in men following community-acquired pneumonia was explained by patterns of inflammatory biomarkers and coagulation factors, suggesting greater fibrinolysis in men than in women, independent from differences in chronic diseases, health behaviour, and quality of care [45]. When compared with patients with mild or moderate Alzheimer’s disease, the mean 50

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

latency of the swallowing reflex was significantly longer in patients with severe dementia. This suggests that dysphagia is a confounding factor in the association of dementia with aspiration pneumonia [25]. In a small case-control study, the breathing and swallowing in patients with Parkinson’s disease was investigated [46]. It was concluded that the increased risk of aspiration pneumonia in Parkinson´s disease may be attributable to an impaired coordination of breathing and swallowing. Dysphagia seems to be a confounding factor. Lung diseases were indicated as significant risk factors for aspiration pneumonia. Two small cohort studies assessing the swallowing reflex of patients with chronic obstructive pulmonary disease (COPD) were not included because pneumonia was not an outcome variable. However, both studies showed an impaired swallowing function in patients with COPD, predisposing to oropharyngeal dysphagia and increased risk of aspiration pneumonia [47,48]. A large retrospective data-analysis study suggested an association between inhaled corticosteroid prescriptions and pneumonia in patients with COPD [49]. The association was confirmed by a recent systematic review with meta-analysis, showing a relative risk of 1.34 (95% CI = 1.03-1.75) for pneumonia with inhaled corticosteroid therapy in patients with COPD [50]. The underlying mechanism is unclear. A feasible explanation is that inhaled corticosteroid therapy may raise pneumonia risk by increasing local airway immune suppression, causing a decreased ability of the innate immune system to defend against aspirated bacteria. Also, malnutrition and loss of respiratory muscle strength in patients with COPD, causing a decreased cough reflex, might play a role. The results reporting an association between cerebrovascular diseases and aspiration pneumonia in frail older people are not consistent. It was found that deep cerebral infarcts were more closely associated with the incidence of pneumonia than superficial infarcts [23]. Therefore, the localization of cerebrovascular diseases in the brain may clarify the inconsistency of results. Dysphagia, often being a complication of cerebrovascular diseases, may be a confounding factor. The relationship between aspiration pneumonia and diabetes mellitus is caused by the increased blood glucose concentrations involving elevated airway glucose levels. Diabetes mellitus may be predisposing for respiratory infections resulting from abnormalities in neutrophil function, such as impaired chemotaxis, phagocytosis, and bacterial killing [51,52]. A population-based case-control study examining whether diabetes mellitus is a risk factor for hospitalization due to pneumonia, showed an increased risk in patients with diabetes mellitus when compared with nondiabetic patients (RR = 1.26; 95% CI = 1.21–1.31) [52]. Explanations for the association of malnutrition with aspiration pneumonia in frail older people could be reduced respiratory muscle strength as well as dysphagia caused by protein-energy malnutrition [53]. Thus, both factors are feasible confounding factors in the association of malnutrition with aspiration pneumonia in frail older people. Inconclusive evidence was found for heart failure being a risk factor for aspiration pneumonia in frail older people. None of the studies included with a significant odds ratio 51

Chapter 2

greater than 1 presented an explanation for the pathogenesis [26,28,30,31,40]. The ACE DD genotype may participate in the development of pneumonia [27,32]. A preventive effect of ACE inhibitor use on aspiration pneumonia was found in older individuals with the ACE ID + II genotypes, but not in those with the ACE DD genotype [32]. Additional research on this feasible risk factor is warranted. Recent initiation of proton pump inhibitor use (0-7 days) showed a significant association with pneumonia, whereas the risk decreased with treatment that had been started much earlier. No dose-response effect could be demonstrated [36]. Additional research is needed. Current use of antipsychotic drugs was associated with an almost 60% increase in the risk of pneumonia in frail older people. The risk was highest during the first week after initiation of an antipsychotic drug. There was no clear dose-response relation [40]. The underlying mechanism remains speculative, a drug-induced dysphagia as a side effect on both the central and peripheral nervous system resulting in aspiration was suggested. The results of a case-control study including patients who used antipsychotic drugs and underwent a videofluoroscopic swallowing study during the course of their hospital care showed that patients using antipsychotic medications scored significantly worse on the Dysphagia Severity Rating Scale when compared with matched subjects. Higher doses of antipsychotic medication were associated with worse swallowing function [54]. Although smoking is a risk factor for lung diseases, inconclusive evidence was found for smoking being a risk factor of aspiration pneumonia in frail older people. Dysphagia might be a confounding factor in the relationship between aspiration pneumonia and severe dementia, Parkinson’s disease, cerebrovascular diseases, malnutrition and the use of antipsychotic drugs. Future research is needed to find out whether dysphagia is always recognized in these patients and whether the risk of aspiration pneumonia in these patients may decrease with, for example, therapy by a speech therapist. Several bad oral health factors seem to play a role in the risk of aspiration pneumonia in frail older people. An oral assessment guide score, assessing the voice, swallow, lips, tongue, saliva, mucous membranes, gingiva and teeth or dentures resulted in an increased risk of aspiration pneumonia [37]. The number of decayed teeth and the number of functional dental units were also found as being risk factors of aspiration pneumonia [7]. Having 10 or more teeth with probing depth greater than 4 mm was even found to be a risk factor for mortality owing to pneumonia [39]. The results of a cohort study in nursing home patients suggested that improving daily oral care might decrease the risk for the onset of aspiration pneumonia [33]. A population-based case-control study identifying risk factors for community-acquired pneumonia showed that visiting a dentist during the past month was an independent protective factor for pneumonia [43]. Two Japanese oral health care intervention studies showed diminished risk of developing aspiration pneumonia and even the risk of dying from aspiration pneumonia in care home residents [18,55].

52

Risk factors for aspiration pneumonia in frail older people: a systematic literature review

In conclusion, on the basis of this systematic literature review, it is not easy to assess the contribution of bad oral health among the risk factors for aspiration pneumonia in frail older people, because of the difficulty of comparing studies and study results. However, the contribution of bad oral health seems limited. Future research is warranted to assess whether improving oral health reduces aspiration pneumonia risk in frail older people.

CONCLUSION Thirteen significant risk factors of aspiration pneumonia in frail older people could be identified. The results showed evidence level 2a (systematic review with homogeneity of cohort studies) for a positive relationship between aspiration pneumonia and the risk factors of age, male gender, lung diseases, dysphagia, and diabetes mellitus. For the risk factors severe dementia, ACE DD genotype and bad oral health evidence level 2b (individual cohort study) was found. The results showed evidence level 3a (systematic review with homogeneity of case-control studies) for a positive relationship between aspiration pneumonia and malnutrition. For the risk factors Parkinson’s disease and the use of antipsychotic drugs and proton pump inhibitors evidence level 3b was found. There is also evidence level 3b (individual case-control study) for the use of ACE inhibitors being a protective factor in the onset of aspiration pneumonia. Inconsistent evidence was found for cerebrovascular diseases, heart failure, and smoking. Dysphagia might be a confounding factor in the relationship between aspiration pneumonia and severe dementia, Parkinson’s disease, cerebrovascular diseases, malnutrition, and the use of antipsychotic drugs. The contribution of bad oral health among the risk factors seems limited.

53

Chapter 2

REFERENCES 1. Shay K. Infectious complications of dental and periodontal diseases in the elderly population. Clin Infect Dis 2002;34:1215-1223. 2. Paju S, Scannapieco FA. Oral biofilms, periodontitis, and pulmonary infections. Oral Dis 2007;13:508-512. 3. Abrahamian FM, Deblieux PM, Emerman CL, et al. Health care-associated pneumonia: Identification and initial management in the ED. Am J Emerg Med 2008;26:1-11. 4. Sumi Y, Miura H, Michiwaki Y, Nagaosa S, Nagaya M. Colonization of dental plaque by respiratory pathogens in dependent elderly. Arch Gerontol Geriatr 2007;44:119-124. 5. Scannapieco FA. Role of oral bacteria in respiratory infection. J Periodontol 1999;70:793-802. 6. Shariatzadeh MR, Huang JQ, Marrie TJ. Differences in the features of aspiration pneumonia according to site of acquisition: Community or continuing care facility. J Am Geriatr Soc 2006;54:296-302. 7. Terpenning MS, Taylor GW, Lopatin DE, Kerr CK, Dominguez BL, Loesche WJ. Aspiration pneumonia: Dental and oral risk factors in an older veteran population. J Am Geriatr Soc 2001;49:557-563. 8. Cabre M. Pneumonia in the elderly. Curr Opin Pulm Med 2009;15:223-229. 9. Oxford Centre for Evidence-based Medicine Levels of Evidence 2009. Available at: http://www.cebm.net/?o=1025. Accessed June 14, 2009. 10. Taylor GW, Loesche WJ, Terpenning MS. Impact of oral diseases on systemic health in the elderly: Diabetes mellitus and aspiration pneumonia. J Public Health Dent 2000;60:313-320. 11. Baine WB, Yu W, Summe JP. Epidemiologic trends in the hospitalization of elderly Medicare patients for pneumonia, 1991-1998. Am J Public Health 2001;91:1121-1123. 12. Imsand M, Janssens JP, Auckenthaler R, Mojon P, Budtz-Jørgensen E. Bronchopneumonia and oral health in hospitalized older patients. A pilot study. Gerodontology 2002;19:66-72. 13. Hilker R, Poetter C, Findeisen N, et al. Nosocomial pneumonia after acute stroke: Implications for neurological intensive care medicine. Stroke 2003;34:975-981. 14. Madariaga MG, Thomas A, Cannady PB Jr. Risk factors for nursing home-acquired pneumonia. Clin Infect Dis 2003;37:148-149. 15. Millns B, Gosney M, Jack CI, Martin MV, Wright AE. Acute stroke predisposes to oral gram-negative bacilli: A cause of aspiration pneumonia? Gerontology 2003;49:173-176. 16. Carnes ML, Sabol DA, DeLegge M. Does the presence of esophagitis prior to PEG placement increase the risk for aspiration pneumonia? Dig Dis Sci 2004;49:1798-1802. 17. Abe S, Ishihara K, Adachi M, Okuda K. Tongue-coating as risk indicator for aspiration pneumonia in edentate elderly. Arch Gerontol Geriatr 2008;47:267-275.

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Risk factors for aspiration pneumonia in frail older people: a systematic literature review

18. Bassim CW, Gibson G, Ward T, Paphides BM, Denucci DJ. Modification of the risk of mortality from pneumonia with oral hygiene care. J Am Geriatr Soc 2008;56:16011607. 19. Ide R, Mizoue T, Fujino Y, et al. Oral symptoms predict mortality: A prospective study in Japan. J Dent Res 2008;87:485-489. 20. Saito T, Oobayashi K, Shimazaki Y, et al. Association of dry tongue to pyrexia in longterm hospitalized patients. Gerontology 2008;54:87-91. 21. Sopena N, Pedro-Botet L, Mateu L, Tolschinsky G, Rey-Joly C, Sabrià M. Communityacquired legionella pneumonia in elderly patients: Characteristics and outcome. J Am Geriatr Soc 2007;55:114-119. 22. Marciniak C, Korutz AW, Lin E, Roth E, Welty L, Lovell L. Examination of selected clinical factors and medication use as risk factors for pneumonia during stroke rehabilitation: A case-control study. Am J Phys Med Rehabil 2009;88:30-38. 23. Nakagawa T, Sekizawa K, Nakajoh K, Tanji H, Arai H, Sasaki H. Silent cerebral infarction: A potential risk for pneumonia in the elderly. J Intern Med 2000;247:255-259. 24. Vergis EN, Brennen C, Wagener M, Muder RR. Pneumonia in long-term care: A prospective case-control study of risk factors and impact on survival. Arch Intern Med 2001;161:2378-2381. 25. Wada H, Nakajoh K, Satoh-Nakagawa T, et al. Risk factors of aspiration pneumonia in Alzheimer’s disease patients. Gerontology 2001;47:271-276. 26. Langmore SE, Skarupski KA, Park PS, Fries BE. Predictors of aspiration pneumonia in nursing home residents. Dysphagia 2002;17:298-307. 27. Morimoto S, Okaishi K, Onishi M, et al. Deletion allele of the angiotensin-converting enzyme gene as a risk factor for pneumonia in elderly patients. Am J Med 2002;112:8994. 28. Rothan-Tondeur M, Meaume S, Girard L, et al. Risk factors for nosocomial pneumonia in a geriatric hospital: A control-case one-center study. J Am Geriatr Soc 2003;51:9971001. 29. Sund-Levander M, Ortqvist A, Grodzinsky E, Klefsgård O, Wahren LK. Morbidity, mortality and clinical presentation of nursing home-acquired pneumonia in a Swedish population. Scand J Infect Dis 2003;35:306-310. 30. Aslanyan S, Weir CJ, Diener HC, Kaste M, Lees KR; GAIN International Steering Committee and Investigators. Pneumonia and urinary tract infection after acute ischaemic stroke: A tertiary analysis of the GAIN International trial. Eur J Neurol 2004;11:49-53. 31. Jackson ML, Nelson JC, Jackson LA. Risk factors for community-acquired pneumonia in immunocompetent seniors. J Am Geriatr Soc 2009;57:882-888. 32. Takahashi T, Morimoto S, Okaishi K, et al. Reduction of pneumonia risk by an angiotensin I-converting enzyme inhibitor in elderly Japanese inpatients according to insertion/deletion polymorphism of the angiotensin I-converting enzyme gene. Am J Hypertens 2005;18:1353-1359. 55

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33. Quagliarello V, Ginter S, Han L, Van Ness P, Allore H, Tinetti M. Modifiable risk factors for nursing home-acquired pneumonia. Clin Infect Dis 2005;40:1-6. 34. Hennessy S, Bilker WB, Leonard CE, et al. Observed association between antidepressant use and pneumonia risk was confounded by comorbidity measures. J Clin Epidemiol 2007;60:911-918. 35. Kwon HM, Jeong SW, Lee SH, Yoon BW. The pneumonia score: A simple grading scale for prediction of pneumonia after acute stroke. Am J Infect Control 2006;34:64-68. 36. Gulmez SE, Holm A, Frederiksen H, Jensen TG, Pedersen C, Hallas J. Use of proton pump inhibitors and the risk of community-acquired pneumonia: A population-based case-control study. Arch Intern Med 2007;167:950-955. 37. Sellars C, Bowie L, Bagg J, et al. Risk factors for chest infection in acute stroke: A prospective cohort study. Stroke 2007;38:2284-2291. 38. Walter U, Knoblich R, Steinhagen V, Donat M, Benecke R, Kloth A. Predictors of pneumonia in acute stroke patients admitted to a neurological intensive care unit. J Neurol 2007;254:1323-1329. 39. Awano S, Ansai T, Takata Y, et al. Oral health and mortality risk from pneumonia in the elderly. J Dent Res 2008;87:334-349. 40. Knol W, van Marum RJ, Jansen PA, Souverein PC, Schobben AF, Egberts AC. Antipsychotic drug use and risk of pneumonia in elderly people. J Am Geriatr Soc 2008;56:661-666. 41. Masiero S, Pierobon R, Previato C, Gomiero E. Pneumonia in stroke patients with oropharyngeal dysphagia: A six-month follow-up study. Neurol Sci 2008;29:139-145. 42. Skull SA, Andrews RM, Byrnes GB, et al. Hospitalized community-acquired pneumonia in the elderly: An Australian case-cohort study. Epidemiol Infect 2009;137:194-202. 43. Almirall J, Bolíbar I, Serra-Prat M, et al. New evidence of risk factors for communityacquired pneumonia: A population-based study. Eur Respir J 2008;31:1274-1284. 44. Loeb M, Neupane B, Walter SD, et al. Environmental risk factors for communityacquired pneumonia hospitalization in older adults. J Am Geriatr Soc 2009;57:10361040. 45. Reade MC, Yende S, D’Angelo G, et al. Differences in immune response may explain lower survival among older men with pneumonia. Crit Care Med 2009;37:1655-1662. 46. Gross RD, Atwood CW Jr, Ross SB, Eichhorn KA, Olszewski JW, Doyle PJ. The coordination of breathing and swallowing in Parkinson’s disease. Dysphagia 2008;23:136-145. 47. Teramoto S, Kume H, Ouchi Y. Altered swallowing physiology and aspiration in COPD. Chest 2002;122:1104-1105. 48. Kobayashi S, Kubo H, Yanai M. Impairment of the swallowing reflex in exacerbations of COPD. Thorax 2007;62:1017. 49. Ernst P, Gonzalez AV, Brassard P, Suissa S. Inhaled corticosteroid use in chronic obstructive pulmonary disease and the risk of hospitalization for pneumonia. Am J Respir Crit Care Med 2007;176:162-166. 56

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50. Drummond MB, Dasenbrook EC, Pitz MW, et al. Inhaled corticosteroids in patients with stable chronic obstructive pulmonary disease: A systematic review and meta-analysis. JAMA 2008;300:2407-2416. 51. Dziedzic T, Slowik A, Pera J, Szczudlik A. Association between hyperglycemia, heart failure and mortality in stroke patients. Eur J Neurol 2009;16:251-256. 52. Kornum JB, Thomsen RW, Riis A, Lervang HH, Schønheyder HC, Sørensen HT. Diabetes, glycemic control, and risk of hospitalization with pneumonia: A population-based casecontrol study. Diabetes Care 2008;31:1541-1545. 53. Hudson HM, Daubert CR, Mills RH. The interdependency of protein-energy malnutrition, aging, and dysphagia. Dysphagia 2000;15:31-38. 54. Rudolph JL, Gardner KF, Gramigna GD, McGlinchey RE. Antipsychotics and oropharyngeal dysphagia in hospitalized older patients. J Clin Psychopharmacol 2008;28:532-535. 55. Yoneyama T, Yoshida M, Ohrui T, et al. Oral care reduces pneumonia in older patients in nursing homes. J Am Geriatr Soc 2002;50:430-433.

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3

Meta-analysis of dysphagia and aspiration pneumonia in frail elders C.D. van der Maarel-Wierink, J. N.O. Vanobbergen, E.M. Bronkhorst, J.M.G.A. Schols and C. de Baat

Published as: van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Metaanalysis of dysphagia and aspiration pneumonia in frail elders. J Dent Res 2011;90:1398-1404.

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ABSTRACT As part of a systematic literature review, a comprehensive literature search was carried out to identify risk factors for aspiration pneumonia in frail older people. A prominent risk factor found was dysphagia with evidence level 2a, according to the Oxford Centre for Evidencebased Medicine Levels of Evidence. Subsequently, a meta-analysis of 4 cohort, 1 case-cohort, and 1 case-control study on dysphagia as a risk factor of aspiration pneumonia in frail older people was performed. Using a random effects model, we found a positive correlation between dysphagia and aspiration pneumonia: OR = 9.84; 95% CI = 4.15 - 23.33 (test for statistical homogeneity: p < 0.001). Then, a subgroup meta-analysis was performed with 4 cohort studies, all including patients with a cerebrovascular disease. Once again, a positive correlation was found between dysphagia and aspiration pneumonia: OR = 12.93; 95% CI = 8.61 - 19.44. The test for statistical homogeneity revealed no statistically significant result (p = 0.15). It was concluded that dysphagia is a serious risk factor for aspiration pneumonia in frail older people, particularly in those suffering from a cerebrovascular disease.

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INTRODUCTION There is evidence of an association of oral biofilm presence with the onset of aspiration pneumonia. Since more older people keep their dentition for a longer period during their lives, the oral biofilm is of increasing importance and may become more virulent as people become frail and oral health (self-)care diminishes [1]. Predominantly, potential respiratory pathogens found in the oral plaque of older people living in residential care homes were Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterobacter cloacae [2]. Frail older people may be hospitalized, institutionalized, or home-dwelling, whether or not supported by professional or family domiciliary care. Although frailty is a medically distinct, clinically recognizable syndrome, it is very difficult to provide an exact definition of the term. Recently, an integral conceptual definition was formulated: “Frailty is a dynamic state affecting an individual who experiences losses in one or more domains of human functioning (physical, psychological, social), which is caused by the influence of a range of variables and which increases the risk of adverse outcomes” [3]. The mechanism of aspiration pneumonia onset is unknown. Scannapieco described 4 possible mechanisms for oral bacteria causing respiratory infections [4]. The first mechanism is the colonization of pulmonary pathogens in the oral biofilm and aspiration of these pathogens into the lungs. A second theory is that periodontal-disease-associated enzymes in saliva may modify mucosal surfaces and facilitate the adherence of respiratory pathogens which are subsequently aspirated into the lungs. Third, periodontal-disease-associated enzymes may destroy protective salivary pellicles, such as mucin, resulting in fewer non-specific host defense mechanisms (clearance potential). Fourth, cytokines originating from infected periodontal tissues may alter respiratory epithelium, resulting in respiratory pathogen colonization and an increased risk of infection. Although the exact pathogenesis is not known, the results of a previously published systematic literature review on the risk factors of aspiration pneumonia in frail older people showed dysphagia being a prominent risk factor, with evidence level 2a; this was a systematic review with homogeneity of cohort studies [5,6]. Dysphagia might play a role in the aspiration of respiratory pathogens colonized in the oral biofilm or adhering to mucosal surfaces, as described by Scannapieco [4] in the first and second theories, because dysphagia increases the risk of aspiration. The results of the systematic review [6] underline both the importance of a metaanalysis to assess an exact estimate of the risk and the need to increase the understanding of the role of dysphagia in the development of aspiration pneumonia in frail older people. Therefore, the objective of the present meta-analysis was to assess the association of dysphagia with aspiration pneumonia in frail older people.

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MATERIALS AND METHODS Data sources and search strategy The methodology of the systematic review and meta-analysis was started with a comprehensive literature search to identify risk factors for aspiration pneumonia in frail older people. The electronic retrieval systems and databases searched for relevant articles were: PubMed (MEDLINE), Web of Science, Cochrane Library, EMBASE, and CINAHL. The key words (Medical Subject Headings in MEDLINE) used were: “aspiration pneumonia” or “pneumonia”, “frail elderly” or “aged”, “nursing homes” or “long-term care” or “geriatric nursing”, “risk factors”, “periodontal disease”, and “oral health”, isolated or in different combinations with different Boolean operators. Special attention was paid to the article reference lists and related articles, in a search for additional relevant publications not found in the initial search. Grey literature, such as unindexed or unpublished conference proceedings, pre-prints, and state-ofthe-art reports, was not included. Selection criteria and quality assessment The search was limited to human studies, studies published in English, and studies published during the period January 2000 to April 2009. Before the year 2000, the majority of publications focused on aspiration pneumonia in patients in intensive care units, often dependent on mechanical ventilation, but not exclusively older people [7]. In preparing a systematic literature review to assess oral health care intervention studies in frail older people and the effect on the incidence of aspiration pneumonia, we concluded that no publications were available of sufficient methodological quality on this subject before the year 2000 [8]. For this reason, we decided to start the literature search for risk factors for aspiration pneumonia in frail older people from that same year. Titles and abstracts of publications obtained with the search strategy described were screened. Only publications with regard to hospitalized, institutionalized, or frail home-dwelling older people of 60 yrs and older were eligible. Subsequently, potentially relevant publications, dealing with evident risk factors for aspiration pneumonia, were read in full by the first and second authors and independently assessed for their methodological quality. The methodological quality of a publication was assessed by checklists initially based on the checklists reported by Straus et al. [9] and available at the Dutch branch of the Cochrane Collaboration (www.dcc.cochrane.org) [6]. We assessed risk of bias by evaluating the following items: risk of selection bias, blindness of outcome assessment, follow-up period, drop-out rates, and reasons for drop-outs. Excluded studies and reasons for exclusion were published in the systematic review [6]. In case of the first and second authors’ disagreement and of inconsistency concerning inclusion of publications, we attempted to resolve the disagreement by consensus. In case of persisting disagreement and inconsistency, the opinion of the fourth author was decisive.

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Data extraction and selection for meta-analysis If available, unadjusted and adjusted odds ratios (ORs) and their corresponding 95% confidence intervals (95% CIs) for risk factors related to aspiration pneumonia in frail older people were extracted from all publications. In case an unadjusted or adjusted odds ratio was not mentioned, the relative risk (RR) or the hazard ratio (HR) and the corresponding 95% confidence interval (95% CI) were extracted. From the 13 risk factors identified for aspiration pneumonia in frail older people, dysphagia seemed to be prominent [6]. Nine of the 21 publications included for the systematic literature review reported dysphagia being a risk factor. Since the multivariate model of each study was adjusted for different possible confounding factors, the unadjusted odds ratios were extracted or calculated. The first author extracted the data from the studies included, calculated unadjusted odds ratios when needed, and corresponded with the authors of the publications to acquire missing data, valuable for the meta-analysis. The second and third authors verified the extracted data and the calculated unadjusted odds ratios. Data were tested for statistical homogeneity by Woolf’s test [10]. In case the studies could be considered homogeneous, the classic Mantel-Haenszel method was used to create an overall estimate of the odds ratio [11]. In case of heterogeneity, the situation was more complex. The presence of various subgroups of studies necessitated an analysis which considered both variation between similar studies and variation between those subgroups while calculating an overall effect. To this end, a random effects model was applied [12].

RESULTS Table 3.1 shows the relevant characteristics of the 9 publications included initially. However, it was not possible to calculate the unadjusted odds ratios for 3 publications. In the study by Vergis et al. [13], there were no cases of documented aspiration in the control group; consequently it was not possible to calculate an unadjusted odds ratio for this factor. A logistic regression model using backward stepwise elimination showed swallowing problems/dysphagia being a significant risk factor for pneumonia in the study by Langmore et al. [14]. However, data to calculate an unadjusted odds ratio were missing. In the study by Quagliarello et al. [15], the total population showed 15% swallowing difficulty, but it was not possible to possible to establish how many people with and without pneumonia had swallowing difficulty. We did not receive any reply to our e-mail, when we requested the authors to provide us with the missing data. Therefore, these 3 publications were excluded from the meta-analysis. For the 6 publications remaining, the unadjusted odds ratios were reported or could be calculated.

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Table 3.1 Characteristics of the Studies Included Study

Age Group

Population (n)

Study design, Evidence level

Vergis et al. [13], Not included in meta-analysis

Median age pneumonia patients 75.0 yrs, control individuals 72.5 yrs

104 case-control pairs, residents Veterans Affairs long-term care facility (n = 208)

Case-control, evidence level 3b

Langmore et al. [14], Not included in meta-analysis

49% ≥ 85 yrs, 51% 65-85 yrs

102,842 nursing residents, 3,118 individuals with pneumonia

Cross-sectional, with retrospective data-analysis, evidence level 3b

Quagliarello et al. [15], Not included in meta-analysis

Mean age 84.7 yrs

613 nursing home residents

Cohort, evidence level 2b

Hennessy et al. [16]

Median age, pneumonia patients 81 yrs, Control individuals 75 yrs

12,004 cases of hospitalization for pneumonia, 48,176 controls. Selected: 159 cases of aspiration pneumonia, 6,636 controls.

Case-control, evidence level 3b

Kwon et al. [17]

Mean age pneumonia patients 68.7 ± 13.9 yrs, no pneumonia 61.6 ± 12.7 yrs

286 cerebrovascular disease patients

Cohort, evidence level 2b

Sellars et al. [18]

Mean age pneumonia patients 75.9 ± 11.4 yrs, no pneumonia 64.9 ± 13.9 yrs

412 cerebrovascular disease patients

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Meta-analysis of dysphagia and aspiration pneumonia in frail elders

Description dysphagia

Diagnostic criteria for (aspiration) pneumonia

Documented aspiration (episode of aspiration that occurred within 14 days before the onset of pneumonia, recorded by a physician or nurse)

(1) New infiltrate on chest radiograph or documentation of new localized rales; (2) one of following symptoms: temperature > 38.3 °C or < 36.1 °C, cough, dyspnea, > 24 breaths/min; (3) no cause other than pneumonia

Diagnoses pneumonia in MDS (Minimum Data Set, Swallowing problem/dysphagia, identified observationally (examples component of RAI) assessments (ICD-9-CM code 486) include frequent choking and coughing when eating or drinking, holding food in mouth for prolonged periods of time, or excessive drooling) Difficulty swallowing (defined as cough during swallowing)

Radiographically documented pneumonia and > 2 of the following clinical features: new or increased cough, sputum production, breath shortness, abnormal chest examination findings, pleuritic chest pain, worsening functional status, temperature > 38°C, > 25 breaths/min

Dysphagia: General Practice Research Pneumonia: General Practice Research Database Database records in the United records in the United Kingdom Kingdom

Dysphagia: positive clinical signs accompanied by pathologic findings with water swallowing or pharyngeal sensation test

At least 1 of the following: auscultatory respiratory crackles and temperature > 37.7°C, radiographic evidence, new purulent sputum

Logemann, aspiration: asymmetric/poor pharyngeal wall contraction on gag, cough/throat clear on trial swallows, reduced laryngeal elevation on trial swallows, gurgly voice on trial swallows, multiple swallows per bolus, more than 5 unsafe ratings on oromotor testing and observations of trial swallows

3 or more of the following: temperature > 38°C, productive cough with purulent sputum, > 22 breaths/min, tachycardia, inspiratory crackle, bronchial breathing, abnormal chest radiograph, arterial hypoxemia (pulse oximetry < 70 mm Hg or oxygen saturation < 94%), and isolation of positive Gram’s stain and culture

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Vervolg Table 3.1 Characteristics of the Studies Included Study

Age Group

Population (n)

Study design, Evidence level

Walter et al. [19]

Men mean age 67.6 yrs, women mean age 72.3 yrs

236 cerebrovascular disease patients

Cohort, evidence level 2b

Masiero et al. [20]

Mean age 72.9 ± 12.2 yrs

67 patients, 6 mos after cerebrovascular accident

Cohort, evidence level 2b

Skull et al. [21]

Mean age pneumonia patients 78.4 yrs, cohort participants 76.1 yrs

1952 cases with community-acquired pneumonia, 2,927 cohort participants

Case-cohort, evidence level 3b

Table 3.2 Unadjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) for Dysphagia as a Risk Factor for Aspiration Pneumonia in Frail Older People, Found in the 6 Publications OR

95% CI

Hennessy et al. [16]

16.06

7.14 - 36.13

Kwon et al. [17]

15.57

6.88 - 35.23

Sellars et al. [18]

7.17

3.74 - 13.77

Walter et al. [19]

22.99

10.33 - 51.15

Masiero et al. [20]

12.50

2.59 - 60.33

2.25

1.40 - 3.62

Skull et al. [21]

Test for statistical homogeneity: χ2 = 38.63 (df = 5; p < 0.001 ). Random effects (DerSimonian-Laird) meta-analysis. Summary OR = 9.84; 95% CI = 4.15 - 23.33.

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Description dysphagia

Diagnostic criteria for (aspiration) pneumonia

Dysphagia: a drop of ≥ 2% in the arterial oxygen saturation within 2 minutes after swallowing

Lung auscultation and percussion, fever, purulent tracheal secretion; tracheal specimens, blood cultures; chest x-ray findings

Absence of reflex cough after swallow

> 3 of following: temperature > 38°C, productive cough with purulent sputum, > 22 breaths/min, tachycardia, inspiratory crackles, bronchial breathing, abnormal chest radiograph, pulse oximetry < 70 mm Hg, positive Gram stain and culture

History of aspiration

Individuals with ICD (International Statistical Classification of Diseases and Related Health Problems)-10-AM codes J10-J18: pneumonia including those due to influenza. Nosocomial pneumonia was excluded (diagnoses > 48 hrs after admission)

Table 3.3 Unadjusted Odds Ratios (OR) and 95% Confidence Intervals (95% CI) for Dysphagia as a Risk Factor for Aspiration Pneumonia in Frail Older People, Found in 4 Publications, Including Patients with a Cerebrovascular Disease OR

95% CI

Kwon et al. [17]

15.57

6.88 - 35.23

Sellars et al. [18]

7.17

3.74 - 13.77

Walter et al. [19]

22.99

10.33 - 51.15

Masiero et al. [20]

12.50

2.59 - 60.33

Test for statistical homogeneity: χ2 = 5.33 (df = 3; p = 0.1494). Fixed effects (Mantel-Haenszel) meta-analysis. Summary OR = 12.93; 95% CI = 8.61-19.44.

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Figure 3.1 Forest Plots of the 2 meta-analyses performed

(A) Forest plot for dysphagia as a risk factor for aspiration pneumonia in frail older people. Squares represent the unadjusted odds ratio (OR) for dysphagia, found in each study. The size of the square is proportional to the size of the study, and error bars represent the 95% confidence intervals (CI). The diamond shape represents the pooled OR, which was OR = 9.84; 95% CI = 4.15 - 23.33. (B) Forest plot for dysphagia as a risk factor for aspiration pneumonia in older patients with a cerebrovascular disease. Squares represent the unadjusted odds ratio (OR) for dysphagia, found in each study. The size of the square is proportional to the size of the study, and error bars represent the 95% confidence intervals (CI). The diamond shape represents the pooled OR, which was OR = 12.93; 95% CI = 8.61- 19.44. (A)

(B)

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The test for statistical homogeneity showed p < 0.001, demonstrating that the studies can be considered as heterogeneous. With a random effects model, a positive correlation was found between dysphagia and aspiration pneumonia, OR = 9.84; 95% CI = 4.15 - 23.33 (Table 3.2, Fig. 3.1). Since the test for statistical homogeneity showed a statistically significant result, a subgroup meta-analysis was performed for the studies by Kwon et al. [17], Sellars et al. [18], Walter et al. [19], and Masiero et al. [20], all including patients with a cerebrovascular disease. The test for statistical homogeneity of this subgroup showed no statistically significant result (p = 0.15). Once again, a positive correlation was found between dysphagia and aspiration pneumonia OR = 12.93; 95% CI = 8.61 - 19.44 (Table 3.3, Fig. 3.1).

DISCUSSION To the best of our knowledge, this is the first meta-analysis assessing dysphagia as a risk factor for aspiration pneumonia in frail older people. The results confirmed that frail older people with dysphagia are at greater risk for aspiration pneumonia when compared with frail older people without dysphagia. Furthermore, the subgroup meta-analysis of 4 cohort studies showed dysphagia being a significant risk factor for aspiration pneumonia in patients suffering from a cerebrovascular disease. Although the effect was studied with relatively low levels of precision, the strength of the association between dysphagia and aspiration pneumonia makes the effect clearly significant. A limitation of the current study was the inconsistency in the descriptions of dysphagia. The term “dysphagia” was used in 3 studies: Hennessy et al. [16] used the General Practice Research Database record for dysphagia; Kwon et al. [17] used positive clinical signs accompanied by pathologic findings with a water-swallowing test or pharyngeal sensation test; and Walter et al. [19] used a water-swallowing test in combination with an arterial oxygen saturation measurement. However, the terms “absence of reflex cough after swallow” [20], “Logemann-aspiration”, which was also diagnosed during a water-swallowing test [18], and “history of aspiration” [21] were used as well. However, it is not likely that this limitation influenced the result of the meta-analysis. A second limitation was the problem of diagnosing aspiration pneumonia adequately in frail and disabled older people. In frail older people, the clinical symptoms of (aspiration) pneumonia are often unclear. Moreover, it is not always possible or even prudent to take a chest radiograph to confirm the diagnosis in frail and/or disabled care home residents [22]. Therefore, a comparison of the results of the various studies might not be conclusive. Third, the literature search for risk factors for aspiration pneumonia in frail older people included publications published from January of the year 2000 onward. Excluding publications published before the year 2000 may have induced bias. However, the potential bias seems limited, because the majority of these publications focused on aspiration pneumonia in patients in intensive care units, often dependent of mechanical ventilation, but not exclusively older people. 69

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There are no recent numbers for the incidence of dysphagia in frail older people, but in a review article the incidence was estimated at 50-75% in care home residents [23]. Tamura et al. [24] investigated 173 dysphagic patients treated at a dysphagia rehabilitation clinic. Fiftythree percent of patients ranged from 0-12 yrs of age, and 24% of them were over 60 yrs of age. Disease of the central nervous system, such as cerebral palsy, was a major diagnosis in the young patients, whereas cerebrovascular disease was predominant in adult and older patients. The results of the systematic literature review showed evidence level 3b (individual casecontrol study) for the correlation between antipsychotic drug usage and aspiration pneumonia [6]. Higher doses of antipsychotic medication were associated with worse swallowing function in the case-control study by Rudolph et al. [25]. The incidence of community-acquired pneumonia varies per country and increases sharply with age. For people aged ≥ 75 yrs, the reported incidence is 3- to 5-fold higher than in the general population [26]. This meta-analysis showed dysphagia being a significant risk factor for aspiration pneumonia in frail older people. Although an exact estimate of the risk of developing aspiration pneumonia in frail older people with dysphagia is available as for now, evidence for the pathogenesis is still lacking. More research is required to find evidence for one or more of the mechanisms described by Scannapieco [4] and to confirm the role of dysphagia in the aspiration of pulmonary pathogens colonized in the oral biofilm or adhering to mucosal surfaces. In contrast to the result of this meta-analysis, in the previously published systematic literature review on the risk factors of aspiration pneumonia, inconsistent evidence was found of a potential correlation between cerebrovascular diseases and aspiration pneumonia [6]. It was suggested that the localization of cerebrovascular diseases could explain the inconsistency of results. Indeed, the study by Nakagawa et al. [27] showed deep cerebral infarcts more closely associated with the incidence of pneumonia than superficial infarcts. Furthermore, GonzalezFernandez et al. [28] found a statistically significant increased risk of dysphagia in individuals with acute ischemic involvement of the internal capsule of the brain. Other supratentorial regions which might be associated with dysphagia include the primary somatosensory, motor, and motor supplementary areas, the orbitofrontal cortex, and the putamen, caudate, and basal ganglia. Recently, a significant interaction between hemisphere and lesion location was identified by Cola et al. [29]. Lesions in the left periventricular white matter of the brain might be more disruptive to swallowing behavior than similar lesions in the right periventricular white matter. They suggested that swallowing deficits involving oral control and transfer might be a sign of subcortical neural axis involvement. Kwon et al. [17] defined a clinical grading scale for the prediction of pneumonia after cerebrovascular disease. The scale consisted of 5 predetermined independent predictors of pneumonia: neurologic deficit as rated on the National Institutes of Health stroke scale (NIHSS ≥ 11), age ≥ 65 yrs, gender, mechanical ventilation, and dysphagia. All components were scored 0 or 1, with a total pneumonia risk score of 0-5 points. The pneumonia risk score appeared to be an accurate predictor of pneumonia development assessed as a 30-day incidence. However, the 70

Meta-analysis of dysphagia and aspiration pneumonia in frail elders

localization of cerebrovascular disease was not represented in the pneumonia score. Since the subgroup meta-analysis showed dysphagia as a significant risk factor for aspiration pneumonia in cerebrovascular disease patients, more research is needed to find out whether dysphagia is also a significant risk factor for aspiration pneumonia in patients suffering from other diseases with dysphagia as complicating factor, such as dementia or Parkinson’s disease, and whether the risk of aspiration pneumonia in these patients may be decreased by supervised feeding, dietary modifications, swallowing therapy (compensatory strategies or exercises to strengthen swallowing musculature), or pharmacologic therapy [23]. In addition, the effect of improving oral health care on the prevention of aspiration pneumonia would be of great interest. The risk of developing pneumonia after aspiration due to dysphagia might be decreased as a result of improved oral health care. Sellars et al. [18] found bad oral health as a significant risk factor for aspiration pneumonia in patients with a cerebrovascular disease. In the study by Ishikawa et al. [30], the quantity of potential respiratory pathogens decreased due to improved oral health care. In the studies by Yoshino et al. [31] and Watando et al. [32], the swallowing reflex, cough reflex sensitivity, and overall functional status were improved after improved oral health care in frail older people. A reduction in the risk of developing aspiration pneumonia was suggested. In conclusion, dysphagia is a serious risk factor for aspiration pneumonia in frail older people, in particular in patients suffering from a cerebrovascular disease.

ACKNOWLEDGEMENTS The authors acknowledge the continuous support from BENECOMO, Flemish-Netherlands Geriatric Oral Research Group, and from the Department of Oral Function and Prosthetic Dentistry, Radboud University Nijmegen Medical Centre, while carrying out this study. The authors declare no potential conflicts of interest with respect to the authorship and/or publication of this article.

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REFERENCES 1. Shay K. Infectious complications of dental and periodontal diseases in the elderly population. Clin Infect Dis 2002;34:1215-1223. 2. Sumi Y, Miura H, Michiwaki Y, Nagaosa S, Nagaya M. Colonization of dental plaque by respiratory pathogens in dependent elderly. Arch Gerontol Geriatr 2007;44:119-124. 3. Gobbens RJJ, Luijkx KG, Wijnen-Sponselee MTh, Schols JMGA. In search of an integral conceptual definition of frailty: opinions of experts. J Am Med Dir Assoc 2010;11:338343. 4. Scannapieco FA. Role of oral bacteria in respiratory infection. J Periodontol 1999;70:793-802. 5. Oxford Centre for Evidence-based Medicine Levels of Evidence (March 2009). Levels of Evidence URL accessed at: http://www.cebm.net/?o=1025 on July 7, 2011. 6. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Risk factors for aspiration pneumonia in frail older people: a systematic literature review. J Am Med Dir Assoc 2011;12:344-354. 7. Scannapieco FA, Bush RB, Paju S. Associations between periodontal disease and risk for nosocomial bacterial pneumonia and chronic obstructive pulmonary disease. A systematic review. Ann Periodontol 2003;8:54-69. 8. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Oral health care and aspiration pneumonia in frail older people: a systematic literature review. Gerodontology 2012 Mar. [Epub ahead of print] 9. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: how to practice and teach EBM. 3rd Edition. Edinburgh: Churchill Livingstone, 2005. 10. Woolf B. The log likelihood ratio test (the G-test); methods and tables for tests of heterogeneity in contingency tables. Ann Hum Genet 1957;21:397-409. 11. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959;22:719-748. 12. Dersimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials 1986;7:177188. 13. Vergis EN, Brennen C, Wagener M, Muder RR. Pneumonia in long-term care: a prospective case-control study of risk factors and impact on survival. Arch Intern Med 2001;161:2378-2381. 14. Langmore SE, Skarupski KA, Park PS, Fries BE. Predictors of aspiration pneumonia in nursing home residents. Dysphagia 2002;17:298-307. 15. Quagliarello V, Ginter S, Han L, Van Ness P, Allore H, Tinetti M. Modifiable risk factors for nursing home-acquired pneumonia. Clin Infect Dis 2005;40:1-6. 16. Hennessy S, Bilker WB, Leonard CE, et al. Observed association between antidepressant use and pneumonia risk was confounded by comorbidity measures. J Clin Epidemiol 2007;60:911-918. 72

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17. Kwon HM, Jeong SW, Lee SH, Yoon BW. The pneumonia score: a simple grading scale for prediction of pneumonia after acute stroke. Am J Infect Control 2006;34:64-68. 18. Sellars C, Bowie L, Bagg J, et al. Risk factors for chest infection in acute stroke: a prospective cohort study. Stroke 2007;38:2284-2291. 19. Walter U, Knoblich R, Steinhagen V, Donat M, Benecke R, Kloth A. Predictors of pneumonia in acute stroke patients admitted to a neurological intensive care unit. J Neurol 2007;254:1323-1329. 20. Masiero S, Pierobon R, Previato C, Gomiero E. Pneumonia in stroke patients with oropharyngeal dysphagia: a six-month follow-up study. Neurol Sci 2008;29:139-145. 21. Skull SA, Andrews RM, Byrnes GB, et al. Hospitalized community-acquired pneumonia in the elderly: an Australian case-cohort study. Epidemiol Infect 2009;137:194-202. 22. Gutiérrez F, Masiá M. Improving outcomes of elderly patients with communityacquired pneumonia. Drug Aging 2008;25:585-610. 23. Marik PE, Kaplan D. Aspiration pneumonia and dysphagia in the elderly. Chest 2003;124:328-336. 24. Tamura F, Ayano R, Haishima H, Ishida R, Mizukami M, Mukai Y. Distribution of causes and treatments of dysphagia at dysphasia/dysphagia rehabilitation clinic of Showa University Dental Hospital: 1999-2002. Int J Orofacial Myology 2004;30:53-62. 25. Rudolph JL, Gardner KF, Gramigna GD, McGlinchey RE. Antipsychotics and oropharyngeal dysphagia in hospitalized older patients. J Clin Psychopharmacol 2008;28:532-535. 26. Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax 2012;67:71-79. 27. Nakagawa T, Sekizawa K, Nakajoh K, Tanji H, Arai H, Sasaki H. Silent cerebral infarction: a potential risk for pneumonia in the elderly, J Intern Med 2000;247:255-259. 28. Gonzalez-Fernandez M, Kleinman JT, Ky PKS, Palmer JB, Hillis AE. Supratentorial regions of acute ischemia associated with clinically important swallowing disorders. A pilot study. Stroke 2008;39:3022-3028. 29. Cola MG, Daniels SK, Corey DM, Lemen LC, Romero M, Foundas AL. Relevance of subcortical stroke in dysphagia. Stroke 2010;41:482-486. 30. Ishikawa A, Yoneyama T, Hirota K, Miyake Y, Miyatake K. Professional oral health care reduces the number of oropharyngeal bacteria. J Dent Res 2008;87:594-598. 31. Yoshino A, Ebihara T, Ebihara S, Fuji H, Sasaki H. Daily oral care and risk factors for pneumonia among elderly nursing home patients. J Am Med Assoc 2001;286:22352236. 32. Watando A, Ebihara S, Ebihara T, et al. Daily oral care and cough reflex sensitivity in elderly nursing home patients. Chest 2004;126:1066-1070.

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Oral health care and aspiration pneumonia in frail older people: a systematic literature review Claar D. van der Maarel-Wierink, Jackie N.O. Vanobbergen, Ewald M. Bronkhorst, Jos M.G.A. Schols and Cees de Baat

Published as: van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Oral health care and aspiration pneumonia in frail older people: a systematic literature review. Gerodontology 2012 [Epub ahead of print]

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ABSTRACT Objective: To systematically review the literature on oral health care interventions in frail older people and the effect on the incidence of aspiration pneumonia. Background: Oral health care seems to play an important role in the prevention of aspiration pneumonia in frail older people. Methods: Pubmed, Web of Science, Cochrane Library, EMBASE and CINAHL were searched for eligible intervention studies. Only publications with regard to hospitalized or institutionalized older people, who were not dependent on mechanical ventilation were eligible. Two authors independently assessed the publications for their methodological quality. Results: Five publications were included and reviewed. Two studies showed that improvement of oral health care diminished the risk of developing aspiration pneumonia and the risk of dying from aspiration pneumonia directly. The three studies remaining showed that adequate oral health care decreased the amount of potential respiratory pathogens and suggested a reduction in the risk of aspiration pneumonia by improving the swallowing reflex and cough reflex sensitivity. Conclusions: According to the results of the current systematic literature review oral health care, consisting of tooth brushing after each meal, cleaning dentures once a day, and professional oral health care once a week, seems the best intervention to reduce the incidence of aspiration pneumonia.

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INTRODUCTION Pneumonia in older people is causing high hospitalization rates, serious morbidity and often death [1]. It is an inflammatory condition of lung parenchyma, usually initiated by the introduction of bacteria into the lung alveoli [2]. The incidence of community-acquired pneumonia varies per country and increases sharply with age. For people aged ≥ 75 years the reported incidence is 3-5 fold higher than in the general population [1]. Furthermore, frail older people living in (residential) care homes have more functional disabilities and diseases and have, consequently, a higher risk of developing aspiration pneumonia than community-dwelling older people [3,4]. Although frailty is a medically distinct, clinically recognizable syndrome, it is very difficult to provide an exact definition of the term. An integral conceptual definition formulated is: ‘Frailty is a dynamic state affecting an individual who experiences losses in one or more domains of human functioning (physical, psychological, social), which is caused by the influence of a range of variables and which increases the risk of adverse outcomes’ [5]. In a large prospective population-based study, 1946 adults admitted to a hospital with pneumonia were stratified by their residence as community dwelling or residing in (residential) care homes [6]. In the group of community-dwelling patients, 155 of 1499 (10%) were diagnosed with aspiration pneumonia. In contrast, 134 of 447 (30%) patients from (residential) care homes were diagnosed with aspiration pneumonia. The mechanism of aspiration pneumonia onset is unknown. Scannapieco described four feasible mechanisms for oral bacteria causing respiratory infections [7]. However, until now there is no evidence for one of these hypotheses. Recently, the literature published in the period January 2000-April 2009 was systematically reviewed on the risk factors of aspiration pneumonia in frail older people [8]. The following risk factors could be identified: age, male gender, lung diseases, dysphagia, diabetes mellitus, severe dementia, ACE DD genotype, bad oral health, malnutrition, Parkinson’s disease and the use of antipsychotic drugs and proton pump inhibitors. Since potential respiratory pathogens were found in the oral plaque of frail older people [9], more attention was paid to oral health care in frail older people. Oral health care seems to play an important role in the prevention of aspiration pneumonia in frail older people. However, it is not clear which oral health care intervention is most efficacious in reducing the risk of aspiration pneumonia. Therefore, the purpose of this study was to systematically review the literature published in the period January 2000-July 2010 on oral health care interventions in frail older people and the effect of these interventions on the incidence of aspiration pneumonia.

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METHODS Data sources and search strategy A comprehensive literature search was carried out. The electronic retrieval systems and databases searched for relevant publications were: Pubmed (Medline), Web of Science, Cochrane Library, EMBASE and CINAHL. The key words (Medical Subject Headings in Medline) used were: ‘aspiration pneumonia’ or ‘pneumonia’, ‘oral health’, ‘oral care’, ‘oral hygiene’, ‘prevention’, ‘intervention’ and ‘reducing risk’, isolated or in different combinations using different Boolean operators. It was decided to use the key words ‘aspiration pneumonia’ as well as ‘pneumonia’, because it is hardly possible to discriminate between these diagnoses clinically, in particular in frail older people [10]. Special attention was paid to the publication reference lists and related publications, searching for additional relevant publications not found in the initial search. Selection criteria and quality assessment The search was limited to human studies, intervention studies, studies published in English and studies published in the period January 2000-July 2010. Before the year 2000, no intervention studies with adequate methodological quality investigating the effect of oral health care on the incidence of aspiration pneumonia in frail older people, have been published [11,12]. Titles and abstracts of publications obtained using the search strategy described, were screened. Only publications with regard to hospitalized or institutionalized people aged ≥ 70 years who were not dependent on mechanical ventilation, were eligible. Subsequently, potentially relevant publications were read in full by the first and second author (CDM-W, JNOV) and independently assessed for their methodological quality. The methodological quality of a publication was assessed using checklists initially based on the checklists reported by Straus et al. [13] and available at the Dutch branch of the Cochrane Collaboration (Table 4.1; http://www.dcc.cochrane.org). In case of the first and second authors’ disagreement and of inconsistency concerning inclusion of publications, it was tried to resolve the disagreement by consensus. In case of persisting disagreement and inconsistency, the opinion of the fourth author (JMGAS) was decisively.

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Table 4.1 Appraisal Checklist of Randomized controlled Trials (http://www.dcc.cochrane.org) 1.

Was the assignment of patients to treatment randomized?

2.

Was randomization concealed?

3.

Were patients kept blind to group assignment?

4.

Were clinicians kept blind to group assignment?

5.

Were outcome assessors kept blind to group assignment?

6. 7.

Were the groups similar in terms of all important confounding factors at the start of the trial? Were there enough patients with long enough follow up in each group?

8.

Were all patients analysed in the groups to which they were randomised?

9.

Were all groups treated equally except for the treatment being studied?

10.

What is the external validity of the study?

11.

What was the size of the treatment effect and how precisely did the study estimate the treatment effect?

RESULTS The key word search identified 177 potentially relevant publications: 32 from Pubmed (Medline), 75 from Web of Science, two from The Cochrane Library, 46 from EMBASE and 22 from CINAHL. Duplicates were excluded. Screening of titles and abstracts revealed that seven publications were relevant for further review and these publications were read in full text and assessed for their methodological quality. Due to selection bias and information bias, two publications were excluded after methodological quality assessment [14,15]. Table 4.2 shows the characteristics of the five remaining publications [16-20]. Only the studies of Yoneyama et al. and Bassim et al. [17,19] reported respectively pneumonia and risk of dying from pneumonia as outcome variable. The three studies remaining had outcome variables influencing the risk of aspiration pneumonia directly, such as salivary substance P which is mediating the swallowing and cough reflex, the cough reflex sensitivity and the levels of oropharyngeal pathogens [16,18,20]. The study of Yoneyama et al. [17] fulfilled all criteria of the appraisal checklist of randomized controlled trials and is consequently of high methodological quality. In the studies of Yoshino et al. and Watando et al. [16,18] the assignment of patients to treatment or control was randomized. However, blindness of clinicians and outcome assessors was not reported. There was no randomization of patient assignment to treatment or control in the studies of Bassim et al. and Ishikawa et al. [19,20], inducing the risk of selection bias and confounding. Moreover, the study of Bassim et al.[19] was based on a retrospective chart review. After discussion, the first and second author decided to include the study, because of the clinical relevance of the assignment of an oral hygiene aid and the relative long follow-up period of 79 weeks. 79

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Table 4.2 Characteristics of the Five Intervention Studies Study

Methodoligical Quality

Age Group

Population (N)

Yoshino et al. [16] (Japan, 2001)

Randomization, no blinding

Mean age intervention group 75 years, control group 76 years

40 CVA-patients with dysphagia, living in a care home

Yoneyama et al. [17] Randomization, (Japan, 2002) blinding of investigators

Mean age intervention group 82.0 ± 7.8 years, control group 82.1 ± 7.5 years

366 care home residents

Watando et al. [18] (Japan, 2004)

Randomization, no blinding

Mean age intervention group 85.0 ± 1.6 years, control group 87.2 ± 0.9 years

59 care home residents

Bassim et al. [19] (USA, 2008)

No randomization

Mean age intervention group 76.56 ± 9.26 years, control group 70.97 ± 11.57 years

143 care home residents

Ishikawa et al. [20] (Japan, 2008)

No randomization

Mean age care home A 79.9 ± 0.9 years, care home B 83.1 ± 0.9 years, care home C 82.5 ± 0.9 years

202 care home residents: care home A n = 72, care home B n = 70, care home C n = 60

ADL, activities of daily living; CI, confidence interval; CVA, cerebrovascular accident; OR, odds ratio; POHC, professional oral health care; RR, relative risk; SP, Salivary substance P.

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Intervention

Results

Tooth brushing by care providers using distilled water after each meal

SP and ADL scores were significantly higher in the intervention group SP: OR = 7.1, 95% CI = 1.3-38.7; ADL: OR = 6.1, 95% CI = 1.5-35.7

5 min tooth brushing after each meal. In case tooth brushing was not effective: povidone iodine 1% was used. POHC once a week

Control group compared with intervention group: febrile days RR = 2.45, 95% CI = 1.77-3.40; pneumonia RR = 1.67, 95% CI = 1.01-2.75; dying from pneumonia RR = 2.40, 95% CI = 1.54-3.74

5 min tooth brushing after each meal. POHC once a week

Significant improvement of cough reflex sensitivity in the intervention group: OR = 5.3, 95% CI = 1.716.0

Specific individual daily oral health care by Multivariate analysis: risk of dying from pneumonia oral hygiene aid in the control group (OR = 3.57; 95% CI = 1.1313.70) was 3-fold when compared to the risk in the intervention group POHC once a week or/and gargling with 0,35% povidone iodine after lunch

Levels of oropharyngeal pathogens decreased or disappeared after weekly POHC. After lunch gargling was less effective than POHC.

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In a study with 40 older care home residents with dysphagia due to cerebrovascular disease, residents were randomly allocated to the intervention or control group [16]. In the intervention group, the teeth and gingiva of the residents were cleaned by care providers with a toothbrush and distilled water after each meal during 1 month. The residents of the control group performed oral health self care. Assistance with oral health care after each meal was associated with significant decreases in swallowing latency time at 3, 10 and 30 days after the intervention was started, when compared to the swallowing latency time of the control group (p < 0.001). Salivary substance P, released from vagal sensory nerves in the pharynx and upper airways mediating both swallowing and cough reflexes, and the scores on a scale for measuring activities of daily living (ADL-scores) were significantly higher in the intervention group when compared to the control group (Salivary substance P: OR = 7.1; 95% CI = 1.3-38.7 and ADL: OR = 6.1; 95% CI = 1.5-35.7). It was concluded that assistance with oral health care after each meal may reduce the risk of aspiration pneumonia due to an improved swallowing reflex. An improvement in overall functional status may also contribute to this reduction in risk. Yoneyama et al. [17] studied oral health care and the incidence of pneumonia in 417 residents in 11 care homes during 2 years. Residents were randomly allocated to the intervention or control group. In the intervention group, nurses or other care providers cleaned the residents’ mouths using a toothbrush during 5 min after each meal. Toothpaste was not used and cleaning the oral tissues included the palatal and mandibular mucosa and the tongue dorsum. In case cleaning the mouth using a toothbrush was not efficient, a solution of 1% povidone iodine was applied. Dentists or dental hygienists provided professional oral health care once a week. In the control group residents performed oral health self care once a day or irregularly. In both groups, dentures were cleaned with a denture brush every day and with denture cleanser once a week by care providers. When compared to the intervention group, the control group had statistically significant higher incidences of febrile days, pneumonia, and dying from pneumonia, respectively RR = 2.45 and 95% CI = 1.77-3.40; RR = 1.67 and 95% CI = 1.01-2.75; RR = 2.40 and 95% CI = 1.54-3.74. To explore the effects of intensive oral health care on impaired cough reflex sensitivity, 60 care home residents were randomly allocated to an intervention or control group [18]. In the intervention group, oral health care was performed as described in the study of Yoneyama et al. [17], except for the use of povidone iodine. In both groups, dentures were cleaned with a denture brush after each meal and with a denture cleanser once a week by care providers. In the intervention group, cough reflex sensitivity at 30 days was significantly higher than at baseline and significantly higher when compared to the control group. In the intervention group, the odds ratio of improvement of cough reflex sensitivity was 5.3 (95% CI = 1.7-16.0). One month of intensive oral health care did not have a significant effect on the salivary substance P concentration, cognitive function, and ADL. It was concluded that intensive oral health care may reduce the incidence of pneumonia due to an improved cough reflex sensitivity. To investigate the associations between the assignment of an oral hygiene aid in 2 of 4 care home wards and risk factors for mortality from pneumonia, a longitudinal analysis of 82

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medical records was performed [19]. The intervention group consisted of a ward for dementia patients and a ward for recovery care and care home residents. The control group consisted of a ward for patients who were disabled walking and also a ward for recovery care and care home residents. The oral health care provided included setting up for, encouraging, and monitoring oral health self care for all residents who were aware and able to participate in self care, including tooth brushing, antiseptic mouthwash use, and oral and denture cleaning for edentulous or partially edentulous residents. For residents who were unwilling or unable to perform oral health self care, the care was provided by the oral hygiene aid. For residents who were belligerent or resistant to care, mouthwash and toothettes were used. Oral health care for residents who were likely to aspirate was performed using suction-assisted toothettes, with tooth brushing and swabbing with dilute hydrogen peroxide. The head of any resident likely to aspirate, was elevated to at least 30° during providing oral health care. Initially, the intervention group, consisting of older and less functionally residents, showed approximately the same incidence of mortality from pneumonia as the control group. But after adjusting the data for the risk factors found to be significant for mortality from pneumonia, the odds ratio of dying from pneumonia in the control group was more than three times the odds ratio of dying in the intervention group (OR = 3.57; 95% CI = 1.13-13.70). Adjustments were carried out for the confounding risk factors age, needing assistance with eating, dementia, needing assistance with ambulation, hygiene ability, needing assistance with oral hygiene, and sore risk. In the study of Ishikawa et al. [20] professional oral health care and/or gargling with a disinfectant solution was performed over a 5-month period in three care homes for dependent older people. In care home A, the residents received professional oral health care once a week. In care home B, the residents did not receive professional oral health care during the first 2 months. During the following 3 months, they received professional oral health care once a week. In care home C, the residents gargled with 0.35% povidone iodine once a day after lunch during the first 2 months. During the subsequent 3 months, they received professional oral health care once a week in addition to gargling. Professional oral health care included tooth brushing, cleaning dentures with a denture brush, ultrasonic irrigation using a denture cleanser, and swabbing the tongue and the oral mucosa with a sponge brush. The levels of potential respiratory pathogens (streptococci, staphylococci, Candida, Pseudomonas, and black-pigmented Bacteroides species) decreased or disappeared after weekly professional oral health care. Gargling after lunch with povidone iodine was less effective than professional oral health care. It was concluded that professional oral health care once a week may be an important strategy to prevent aspiration pneumonia in dependent older people. The conclusions of the five intervention studies are summarized in Table 4.3.

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Table 4.3 Conclusions of the Five Intervention Studies Study

Conclusions

Yoshino et al. [16]

Assistance with oral health care after each meal was associated with significant decreases in swallowing latency time, suggesting a reduction in the risk of aspiration pneumonia.

Yoneyama et al. [17] Cleaning the mouth by care providers during 5 min after each meal and in some cases with the addition of 1% povidone iodine, resulted in significant higher incidences of febrile days, pneumonia, and dying from pneumonia in the control group. Watando et al. [18]

Cleaning the mouth by care providers during 5 min after each meal resulted in significant improvement of cough reflex sensitivity, suggesting a reduction in the risk of aspiration pneumonia.

Bassim et al. [19]

The assignment of an oral hygiene aid in care home wards led to a 3-fold risk reduction for dying from pneumonia when compared to the control group.

Ishikawa et al. [20]

The levels of potential respiratory pathogens decreased or disappeared after weekly professional oral health care. Gargling after lunch with povidone iodine showed to be less effective than professional oral health care.

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DISCUSSION The Healthcare Infection Control Practices Advisory Committee and the Centres for Disease Control and Prevention in the United States of America published a general guideline for preventing health-care-associated pneumonia. The guideline recommends to develop and implement a comprehensive oral hygiene programme, without providing any detailed information. It only suggests to include the use of an antiseptic agent for patients in acute care settings or (residential) care homes [21]. The recommendation to implement a comprehensive oral hygiene programme has been confirmed by the results of the current systematic literature review (Table 4.3) and the previously published systematic literature review of Sjögren et al. [12]. The latter study investigated the effect of oral hygiene on pneumonia and respiratory tract infections in studies published in the period 1996–2007, whereas the current study included only intervention studies investigating oral health care methods to reduce the incidence of pneumonia directly or indirectly, published in the period January 2000–July 2010. The results of the current study showed that improvement of oral health care diminished the risk of developing aspiration pneumonia [17] and even the risk of dying from aspiration pneumonia in care home residents [17,19]. These results are consistent with the results of a meta-analysis of five oral hygiene intervention trials in critically ill patients (not specifically older patients), often dependent on mechanical ventilation [22]. Furthermore, the results of the current systematic literature review showed that adequate oral health care decreased the amount of potential respiratory pathogens [20] and suggested a reduction in the risk of aspiration pneumonia by improving the swallowing reflex and cough reflex sensitivity [16,18]. The question remains which intervention is the most efficacious in reducing the incidence of aspiration pneumonia in frail older people. Yoneyama et al. [17], reporting the study with the best methodological quality, and Watando et al. [18] provided very intensive oral health care by tooth brushing for 5 min after each meal. In the study of Bassim et al. [19] the oral hygiene aid provided specific individual oral health care once a day. And the study of Ishikawa et al. [20] showed decreased levels of potential respiratory pathogens after weekly professional oral health care. Both the study of Yoneyama et al. and the study of Ishikawa et al. [17,20] did not demonstrate a significant effect of the addition of povidone iodine to oral health care. Combining the results of these studies in a meta-analysis is not appropriate due to the fact that the studies used different outcome variables. According to the results of the current systematic literature review, oral health care consisting of tooth brushing after each meal, cleaning dentures once a day, and professional oral health care once a week, seems the best intervention to reduce the incidence of aspiration pneumonia. An individualized approach based on risk assessment of aspiration pneumonia may be the best guide to determine the content of a more intensive oral health care prevention programme. The presence of two or more of the risk factors found in the previous published systematic literature review on risk factors of aspiration pneumonia in frail older people, such 85

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as dysphagia, lung diseases, diabetes mellitus, severe dementia, malnutrition, Parkinson’s disease, and the use of antipsychotic drugs and proton pump inhibitors, could be an indicator for specific preventive oral health care needed [8]. In those cases, the combination of frequent tooth brushing and a pharmacological intervention might be an adequate oral health care intervention. However, results of intervention studies on tooth brushing in combination with a pharmacological intervention in frail older people are not available, except for gargling with povidone iodine. Despite the lack of preliminary statistical significance, the results of using a chlorhexidine containing oral rinse were more promising [23]. This systematic literature review had several limitations. Four of the five studies were carried out in one country, Japan, which may have resulted in some selection bias [16-18,20]. Also, the already in the results section mentioned differences in methodological quality of the studies, might have caused some bias. Furthermore, the studies used different outcome variables, hampering mutual comparison of the results. Consequently, performing a metaanalysis is not conceivable. More randomized controlled trials of high methodological quality, preferably carried out in various countries, are needed to assess the most efficacious oral health care intervention programme in reducing the incidence of aspiration pneumonia in frail older people.

CONCLUSION Only five studies, investigating oral health care interventions in frail older people and the effect on the incidence of aspiration pneumonia directly or indirectly, were of adequate methodological quality. Combining the results of these studies in a meta-analysis is not appropriate due to the fact that the studies used different outcome variables. According to the results of the current systematic literature review oral health care, consisting of tooth brushing after each meal, cleaning dentures once a day, and professional oral health care once a week, seems the best intervention to reduce the incidence of aspiration pneumonia.

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REFERENCES 1. Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax 2012;67:71-79. 2. Wark P. Viral and bacterial interactions in pneumonia. Expert Rev Respir Med 2010;4:221-228. 3. Furman CD, Rayner AV, Tobin EP. Pneumonia in older residents of long-term care facilities. Am Fam Physician 2004;70:1495-1500. 4. Loeb MB. Pneumonia in nursing homes and long-term care facilities. Semin Respir Crit Care Med 2005;26:650-655. 5. Gobbens RJJ, Luijkx KG, Wijnen-Sponselee MT, Schols JM. In search of an integral conceptual definition of frailty: opinions of experts. J Am Med Dir Assoc 2010;11:338343. 6. Shariatzadeh MR, Huang JQ, Marrie TJ. Differences in the features of aspiration pneumonia according to site of acquisition: community or continuing care facility. J Am Geriatr Soc 2006;54:296-302. 7. Scannapieco FA. Role of oral bacteria in respiratory infection. J Periodontol 1999;70:793-802. 8. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JM, de Baat C. Risk factors for aspiration pneumonia in frail older people: a systematic literature review. J Am Med Dir Assoc 2011;12:344-354. 9. Sumi Y, Miura H, Michiwaki Y, Nagaosa S, Nagaya M. Colonization of dental plaque by respiratory pathogens in dependent elderly. Arch Gerontol Geriatr 2007;44:119-124. 10. Mylotte JM, Goodnough S, Gould M. Pneumonia versus aspiration pneumonitis in nursing home residents : prospective application of a clinical algorithm. J Am Geriatr Soc 2005;53:755-761. 11. Loeb MB, Becker M, Eady A, Walker-Dilks C. Interventions to prevent aspiration pneumonia in older adults: a systematic review. J Am Geriatr Soc 2003;51:1018-1022. 12. Sjögren P, Nilsson E, Forsell M, Johansson O, Hoogstraate J. A systematic review of the preventive effect of oral hygiene on pneumonia and respiratory tract infection in elderly people in hospitals and nursing homes: effect estimates and methodological quality of randomized controlled trials. J Am Geriatr Soc 2008;56:2124-2130. 13. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-Based Medicine: how to Practice And Teach EBM. 2005, 3rd Edition. Churchill Livingstone: Edinburgh, Appendix. 14. Adachi M, Ishihara K, Abe S, Okuda K. Professional oral health care by dental hygienists reduced respiratory infections in elderly persons requiring nursing care. Int J Dent Hyg 2007;5:69-74. 15. Quagliarello V, Juthani-Mehta M, Ginter S, Towle V, Allore H, Tinetti M. Pilot testing of intervention protocols to prevent pneumonia in nursing home residents. J Am Geriatr Soc 2009;57:1226-1231. 87

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16. Yoshino A, Ebihara T, Ebihara S, Fuji H, Sasaki H. Daily oral care and risk factors for pneumonia among elderly nursing home patients. JAMA 2001;286:2235-2236. 17. Yoneyama T, Yoshida M, Ohrui T, et al. Oral Care Working Group. Oral care reduces pneumonia in older patients in nursing homes. J Am Geriatr Soc 2002;50:430-433. 18. Watando A, Ebihara S, Ebihara T, et al. Daily oral care and cough reflex sensitivity in elderly nursing home patients. Chest 2004;126:1066-1070. 19. Bassim CW, Gibson G, Ward T, Paphides BM, Denucci DJ. Modification of the risk of mortality from pneumonia with oral hygiene care. J Am Geriatr Soc 2008;56:16011607. 20. Ishikawa A, Yoneyama T, Hirota K, Miyake Y, Miyatake K. Professional oral health care reduces the number of oropharyngeal bacteria. J Dent Res 2008;87:594-598. 21. Tablan OC, Anderson LJ, Besser R, Bridges C, Hajjeh R; CDC; Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-careassociated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep 2004;53:1-36. 22. Scannapieco FA, Bush RB, Paju S. Associations between periodontal disease and risk for nosocomial bacterial pneumonia and chronic obstructive pulmonary disease. A systematic review. Ann Periodontol 2003;8:54-69. 23. Pineda LA, Saliba RG, El Solh AA. Effect of oral decontamination with chlorhexidine on the incidence of nosocomial pneumonia: a meta-analysis. Crit Care 2006;10:R35.

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Subjective dysphagia in older care home residents in the Netherlands Claar D. van der Maarel-Wierink, Judith M.M. Meijers, Luc M.J. De Visschere, Cees de Baat, Ruud J.G. Halfens, Jos M.G.A. Schols

van der Maarel-Wierink CD, Meijers JMM, De Visschere LMJ, de Baat C, Halfens RJG, Schols JMGA. Subjective dysphagia in older care home residents in the Netherlands. Submitted for publication.

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ABSTRACT Objective: first, to assess the prevalence of subjective dysphagia in care home residents in the Netherlands. Second, to assess the associations of subjective dysphagia with feasible risk factors of dysphagia. Methods: A retrospective data analysis of a multi-centre, cross-sectional study was performed. Data of 8,119 care home residents aged 65 years or older were analyzed. Subjective dysphagia was assessed by a resident’s response to a dichotomous question with regard to experiencing swallowing problems. Several residents’ data were collected: gender, age, (number of) diseases, the presence of malnutrition, Care Dependency Scale scores, and the Body Mass Index. Results: Subjective dysphagia was present in 751 (9%) residents. A final prediction model for subjective dysphagia after multivariate backward stepwise regression analysis revealed several significant variables: CDS scores ‘completely dependent’ (OR 42.18; 95% CI 25.80-68.94), ‘to a great extent dependent’ (OR 12.71; 95% CI 7.84-20.63), ‘partially dependent’ (OR 5.30; 95% CI 3.19-8.80), and to a great extent independent (OR 2.24; 95% CI 1.27-4.00), ‘malnutrition’ (OR 1.55; 95% CI 1.28-1.86), ‘comorbidity’ (OR 1.07; 95% CI 1.01-1.14), and the disease clusters ‘nervous system disorder’ (OR = 1.59; 95% CI 1.23-2.05) and ‘cerebrovascular disease/ hemiparesis’ (OR = 1.77; 95% CI 1.47-2.14). Conclusion: It seems justified to conclude that subjective dysphagia is a relevant care problem in older care home residents in the Netherlands. In order of importance (ranged from high to low) lower functional status, nervous system disorders including (the consequences of) cerebrovascular diseases, malnutrition, and comorbidity seem significant predicting factors for subjective dysphagia in care home residents.

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INTRODUCTION In a systematic review with homogeneity of cohort studies, dysphagia has been proven to be a prominent risk factor for aspiration pneumonia in frail older people [1]. Aspiration pneumonia, an inflammatory condition of lung parenchyma usually initiated by the introduction of bacteria into the lung alveoli, is causing high hospitalization rates, morbidity, and often death in frail older people [2]. Therefore, risk factors of aspiration pneumonia, such as dysphagia, should be prevented in frail older people whenever possible. Dysphagia or swallowing impairment has been described as a symptom which refers to difficulty or discomfort during the progression of the alimentary bolus from the oral cavity to the stomach [3]. Actual prevalence or incidence figures of dysphagia in frail older people in the community as well as in care homes are not available. The literature reveals limited evidence for an association of dysphagia with increasing age, diminished functional status, malnutrition, comorbidity, psychological disorders, nervous system disorders, and cerebrovascular disease [4-9]. Each year, many care homes in The Netherlands participate in the Dutch National Prevalence Survey of Care Problems (known as LPZ), with the purpose to create awareness of care problems and to improve the quality of care. Since 2009, subjective dysphagia has been registered as a subdivision of the care problem malnutrition. Better insight in the prevalence of (subjective) dysphagia in frail older people may improve its early recognition and treatment, decreasing the risk of developing aspiration pneumonia. Therefore, the objectives of this survey were to assess the prevalence of subjective dysphagia in care home residents in the Netherlands and to assess the associations of subjective dysphagia with feasible risk factors of dysphagia.

METHODS The LPZ survey design was a cross-sectional, multi-centre point prevalence measurement. Ethical approval was received from the University Hospital Maastricht’s medical ethical committee. Based on literature findings, variables considered as feasible risk factors of dysphagia were gender, age, diminished functional status, malnutrition, comorbidity, and several diseases. Data collection In each participating care home, a coordinator was responsible for collecting and registering the survey data. The coordinators of all participating care homes were educated collectively by members of the LPZ research group in managing the survey within their care home, using a standardized questionnaire and an online data-entry programme. They received a protocol and an education package supporting them to instruct the care providers of their care homes how to complete the questionnaires. Two care providers completed a questionnaire for every resident, one nurse, nurse 93

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assistant, dietician or physician of the resident’s ward and one independent care provider. In case of disagreement, they resolved their disagreement through discussion. Subjective dysphagia was assessed by a resident’s response to a dichotomous question with regard to experiencing swallowing problems. When a resident was not able to response, the question was responded by the ward care provider who registered the resident’s survey data or the resident’s file was consulted for swallowing complaints or dysphagia registered. ‘Diminished functional status’ was determined using the Care Dependency Scale (CDS), which contains 15 care dependency items [10]. With regard to malnutrition, residents’ height and weight were measured for calculating the Body Mass Index (BMI) [11]. Malnutrition was assessed on the basis of: (1) BMI < 18,5 kg/m2 (age 18–65 years) or BMI < 20 kg/m2 (age > 65 years), and/or (2) unintentional weight loss (more than 6 kg in the previous six month or more than 3 kg in the last month) and/or (3) no nutritional intake for three days or reduced intake ten days combined with a BMI between 18,5–20 kg/m2 (age 18–65 years) or between 20–23.9 kg/m2 (age > 65 years) [12,13]. Residents’ gender, age, comorbidity, and (number of) diseases were collected from their files. The diseases were arranged in the following clusters of associated diseases by an expert panel of physicians of the LPZ research group: ‘diabetes mellitus’, ‘psychological disorder other than dementia’, ‘dementia’, ‘nervous system disorder’, ‘cardiovascular disease’, ‘cerebrovascular disease/hemiparesis’, and ‘respiratory disorder/disease’. Statistical analyses Statistical analyses were performed using SPSS version 15.0 (SPSS INC, Chiacago, IL, USA), including descriptive frequency distributions for all variables. Differences between groups were tested using Student’s t-test, the chi-square test or variance analysis according to ANOVA with post-hoc analysis using the Bonferroni method. Additionally, odds ratios (OR) with 95% confidence intervals (95% CI) were calculated. To explore the role of the feasible risk factors of dysphagia on the prevalence of subjective dysphagia, a prediction model was built using multivariate backward stepwise logistic regression analysis. Since residents of care homes clustered in a care home organization could be arranged into groups, indicative variables of the care home organizations were included in the analysis. ORs with 95% CIs were included and p < 0.05 was applied as cut-off value. The Hosmer and Lemeshow value was calculated to explain the fit of the final model: the higher the p-value the better the fit of the model.

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RESULTS In 2010, 119 (33%) out of the total number of 360 care homes in The Netherlands participated in the LPZ survey. Data of 8,119 residents aged 65 years or older were analyzed. Table 5.1 shows the participating residents’ gender, mean age, CDS scores, mean BMI score, as well as the mean number of diseases per resident. Table 5.2 shows that subjective dysphagia was present in 751 (9%) residents. Also, data on gender, age, CDS scores, BMI score, malnutrition, number of diseases per resident, and prevalence of disease clusters are presented in Table 5.2, separately for residents with subjective dysphagia present and not present. Statistically significant results are that residents with dysphagia, when compared to residents without dysphagia, were younger, had higher CDS scores, had lower BMI scores, had a higher prevalence rate of malnutrition, had more diseases per resident, and had higher prevalence rates of the following disease clusters: ‘psychological disorders other than dementia’, ‘dementia’, ‘nervous system disorders excluding cerebrovascular disease’, and ‘cerebrovascular disease/hemiparesis’. The disease clusters ‘diabetes mellitus’ and ‘respiratory disorder/disease’ did not show statistically significant prevalence differences between residents with subjective dysphagia and residents without dysphagia. The disease cluster ‘cardiovascular disease’ showed a statistically significant higher prevalence in residents without subjective dysphagia. Subjective dysphagia prevalence in residents diagnosed with a disease in one of the disease clusters with dysphagia risk was: 11% for ‘psychological disorder other than dementia’, 10.9% for ‘dementia’, 14.6% for ‘nervous system disorders excluding cerebrovascular disease’, and 17.5% for ‘cerebrovascular disease/hemiparesis’. Table 5.3 shows the final prediction model for subjective dysphagia after multivariate backward stepwise regression analysis. The Hosmer and Lemeshow test demonstrated a reasonable good fit for the final model (0.41). Significant variables were CDS cores ‘completely dependent’ (OR 42.18; 95% CI 25.80-68.94), ‘to a great extent dependent’ (OR 12.71; 95% CI 7.84-20.63), ‘partially dependent’ (OR 5.30; 95% CI 3.19-8.80), and ’to a great extent independent’ (OR 2.24; 95% CI 1.27-4.00), ‘malnutrition’ (OR 1.55; 95% CI 1.28-1.86), ‘comorbidity’ (OR 1.07; 95% CI 1.01-1.14) and the disease clusters ‘nervous system disorder’ (OR = 1.59; 95% CI 1.23-2.05) and ‘cerebrovascular disease/hemiparesis’ (OR = 1.77; 95% CI 1.47-2.14).

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Table 5.1 Data on the Participating Residents’ Gender, Age, Care Dependency Scale Scores (CDS), Body Mass Index (BMI), and Number of Diseases per Resident, Presented as Numbers and Percentages or as Mean Scores with Standard Deviation (±)

Women

Number of residents

Percentage

6,003

74%

Age in years

Mean (±)

84.0 ± 7.0

CDS-scores completely dependent

1,327

16.3%

to a great extent dependent

2,001

24.6%

partially dependent

1,612

19.9%

to a great extent independent

1,417

17.5%

completely independent

1,762

21.7%

BMI

25.2 ± 5.1

Number of diseases per resident

2.7 ± 1.5

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Table 5.2 Data on Number, Gender, Age, Care Dependency Scale (CDS), Body Mass Index (BMI), Prevalence of Malnutrition, Number of Diseases per Resident, and the Prevalence of Disease Clusters, Separately for Residents with Subjective Dysphagia Present and Not Present. The Data are Presented as Numbers and Percentages or as Mean Scores and Standard Deviations, Both with p-values of the Statistical Tests Subjective dysphagia Number of residents

Present 751 (9%)

Not present 7,368 (91%)

Gender Women Mean age

0.111** 537 (71.5%)

5,466 (74.2%)

83 ± 7

84 ± 7

Age group 65-75

126 (16.8%)

852 (11.6%)

Age group 76-85

332 (44.2%)

3,016 (40.9%)

Age group >85

293 (39.0%)

3,500 (47.5%)

CDS 377 (50.2%)

950 (12.9%)

to a great extent dependent

234 (31.2%)

1,767 (24.0%)

86 (11.5%)

1,526 (20.7%)

to a great extent independent

34 (4.5%)

1,383 (18.8%)

completely independent

20 (2.7%)

1,742 (23.6%)

BMI

<0.001*

<0.001**

completely dependent

partially dependent

p-value

23.4 ± 4.6

25.3 ± 5.1

<0.001*

224 (29.9%)

1,212 (16.5%)

<0.001**

3.1 ± 1.6

2.7 ± 1.5

<0.001*

‘Diabetes mellitus’

139 (18.5%)

1,366 (18.5%)

0.983**

‘Psychological disorder, other than dementia’ ‘Dementia’

110 (14.6%)

888 (12.1%)

0.039**

379 (50.5%)

3,087 (41.9%)

<0.001**

‘Nervous system disorder, excluding cerebrovascular disease’

113 (15.0%)

602 (8.2%)

<0.001**

‘Cardiovascular disease’

261 (34.8%)

3,066 (41.6%)

<0.001**

’Cerebrovascular disease/ hemiparesis’

296 (39.4%)

1,397 (19.0%)

<0.001**

‘Respiratory disorder/disease’

104 (13.8%)

959 (13.0%)

0.519**

Malnutrition Mean number of diseases per resident Prevalence of disease clusters

* student’s t-test with Bonferroni correction ** chi-square test

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Table 5.3 Final Prediction Model for Subjective Dysphagia after Multivariate Backward Stepwise Regression Analysis, with Regression Coefficient (B), Wald Statistic (Wald), p-value and Odds Ratio (OR) with 95% Confidence Interval (95% CI) B Age group 65-75

Wald 9.335

Age group 76-85

-0.136

1.218

Age > 85

-0.345

7.560

‘Completely independent’

488.540

‘Completely dependent’

3.742

222.741

‘To a great extent dependent’

2.543

106.051

‘Partially dependent’

1.667

41.483

´To a great extent independent´

0.807

7.766

Malnutrition

0.436

21.104

Comorbidity

0.070

5.338

‘Dementia’

-0.639

40.923

0.463

12.867

-0.223

5.109

0.572

35.639

-4.502

304.522

‘Nervous system disorder’ ‘Cardiovascular disease’ ‘Cerebrovascular disease/ hemiparesis’ Constant * Significant result p < 0.05 ** Odds ratio > 1, with p < 0.05

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p-value

OR

CI 95%

0.009* 0.270

0.873

0.686-1.111

0.006*

0.708

0.554-0.906

0.000*

42.177**

25.803-68.943

0.000*

12.715**

7.837-20.630

0.000*

5.296**

3.189-8.796

0.005*

2.242**

1.271-3.955

0.000*

1.547**

1.284-1.863

0.021*

1.073**

1.011-1.139

0.000*

0.528

0.434-0.642

0.000*

1.589**

1.234-2.046

0.024*

0.801

0.660-0.971

0.000*

1.771**

1.468-2.137

0.000*

0.011

0.000*

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DISCUSSION In this survey, the prevalence of subjective dysphagia in care homes residents was 9%. The literature shows prevalence estimations of 50-75% [4,14]. These estimations are based on three cross-sectional surveys, in which the prevalence rates of dysphagia varied from 13.7% to 97.5% [15-17]. It seems reasonably to presume that objectively assessed dysphagia, as diagnosed after a video fluoroscopic swallowing investigation, might have resulted in a higher prevalence rate. The reason for the low subjective dysphagia prevalence rate might be that patients do not always recognize their swallowing problems or consider dysphagia a natural symptom of ageing or an ordinary symptom of their diseases. This presumption is supported by the results of a cross-sectional survey using the M.D. Anderson Dysphagia Inventory (MDADI) in a population of 107 independent older people. According to the MDADI-scores 17 (15.9%) persons had moderate to profound dysphagia. Fifteen per cent reported having difficulties with swallowing and 23.4% thought that dysphagia is a natural part of ageing [18]. Gender was not a variable of importance in the final prediction model for subjective dysphagia in the current survey. This finding is in agreement with the result of a previous crosssectional survey in 40 healthy subjects, not specifically older people [19]. The majority of residents who experienced dysphagia in the current survey, were older than 76 years of age (83.2%). However, the multivariate backward stepwise logistic regression analysis did not indicate age as a predicting factor for subjective dysphagia. It is not clear if age was assessed as a risk factor in the three cross-sectional surveys about the prevalence of dysphagia [15-17]. The final prediction model of the current survey showed that care dependency was a significant variable with respectively a 42 times, 13 times, 5 times and 2 times higher chance for residents who were ‘completely dependent’, ‘to a great extent dependent’, ‘partially dependent’, and ‘to a great extent independent’ when compared to residents who were ‘completely independent’ (Table 5.3). Eating and drinking and maybe body posture, both items of the CDS, may have a direct relationship with dysphagia. Residents who are dependent on others for eating and drinking and who have a bad body posture might have an increased risk of aspiration, which might result in the development of pneumonia. The CDS items ‘dependency on hygiene care’, and more specifically ‘dependency on oral hygiene care’, may also be important in this context and will be described further in this paragraph. However, care dependency and thus ‘lower functional status’ has predictive value for subjective dysphagia. This finding was approved by a prospective cohort study in 134 older people hospitalized because of pneumonia. Fifty-five per cent presented clinical signs of dysphagia with the water swallow test and these people showed lower functional status [4]. In the current survey, 29.9% of the residents with subjective dysphagia suffered from malnutrition ((1) BMI < 20 kg/m2, and/or (2) unintentional weight loss (more than 6 kg in the previous six month or more than 3 kg in the last month) and/or (3) no nutritional intake for three days or reduced intake ten days combined with a BMI between 20–23.9 kg/m2). Another 100

Subjective dysphagia in older care home residents in the Netherlands

large cross-sectional multicentre survey assessed the prevalence of problems which potentially led to decreased nutritional intake and the association between these problems and body mass index in 2,930 hospital patients and 5,521 care home residents. A BMI ≤ 20 kg/m2 was found in 8.5% of the hospital patients and in 16.7% of the care home residents. In the hospital patients as well as in the care home residents, BMI ≤ 20 kg/m2 was significantly associated with swallowing problems (OR = 2.3; 95% CI 1.4-3.6 and OR = 2.3; 95% CI 1.9-2.8) [20]. These results, as well as the results of the before mentioned study of Cabre et al. [4], confirm the high prevalence rate of malnutrition in residents with subjective dysphagia in the current survey. The final prediction model for subjective dysphagia showed that the disease clusters ‘nervous system disorders, excluding cerebrovascular disease’ and ‘cerebrovascular disease/ hemiparesis’ were variables of importance. Fifteen per cent and 39.4% of the residents experiencing dysphagia, suffered from these disease clusters respectively. Swallowing has a multiregional and asymmetrical cerebral representation, which may be damaged by a nervous system disorder or a cerebrovascular disease [9]. A retrospective study of 596 medical files of patients hospitalized due to an ischemic cerebrovascular disease, reported clinically examined dysphagia in 19.6% of the patients [21]. In contrast, in a cohort study of 128 hospital-referred patients with an acute first cerebrovascular disease, 51% showed clinical evidence of a swallowing abnormality [22]. The differences in results of the various studies might be explained by the brain localization of the cerebrovascular diseases or by variations in recognizing and reporting dysphagia. Eleven per cent of the residents with the disease cluster ‘psychological disorder other than dementia’ reported experiencing dysphagia in the present study. This prevalence rate is rather low when compared to a systematic literature review reporting prevalence rates of subjectively or objectively assessed dysphagia ranging from 9-42% in adults with mental illness, not specifically older people [23]. High doses of antipsychotics might explain the high prevalence rate of dysphagia in the population with a severe psychological disorder. ‘Psychological disorder other than dementia’ was not a variable of importance in the final prediction model of the current survey. Remarkably, in the current survey the disease cluster ‘dementia’ was not a variable of importance in the final prediction model for subjective dysphagia. However, the prevalence of ‘dementia’ was significantly higher in residents experiencing dysphagia when compared to residents not experiencing dysphagia. Furthermore, the prevalence of subjective dysphagia was 10.9% in residents with dementia. Explanation of this finding could be that in some care homes a prevention programme for dysphagia was established for demented residents, a usual therapy according to a review assessing feeding difficulties in dementia patients [24]. Another explanation might be that the dementia residents usually consume soft diets, making swallowing easier, and resulting in fewer dysphagia complaints. In addition, it is also possible that dementia residents did not realize they had swallowing complaints or were not able to express their complaints. Care providers might also have problems recognizing swallowing complaints in dementia residents, resulting in underdiagnosing dysphagia. 101

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In other studies, dysphagia and bad oral health have been proven to be significant risk factors for aspiration pneumonia in frail older people [1]. Consequently, in care home residents with dysphagia adequate oral health care may decrease the amount of respiratory pathogens and diminish the risk of aspiration pneumonia [25-27]. Furthermore, improvement of oral health care may improve the swallowing and cough reflex sensitivity [28,29]. The results of the current survey seem to confirm the benefits of an intensive oral health care prevention programme for care home residents with care dependency, malnutrition, comorbidity, and/or a nervous system disorder, including (the consequences of) cerebrovascular diseases. This is the first survey assessing the prevalence of subjective dysphagia in a large group of care home residents (8,119). However, this survey has some limitations. One limitation is the absence of a speech pathologist in the research team for assessing dysphagia objectively in all care home residents. For properly diagnosing objective dysphagia, a video fluoroscopic swallowing investigation is warrented [30]. However, it is usually not possible or even contraindicated to refer older care home residents for such major investigation. For future research, it is recommended to assess dysphagia objectively by a speech pathologist. Furthermore, this survey is a secondary analysis of LPZ data and dysphagia was assessed as a subdivision of the care problem malnutrition. Thus, assessing feasible associations of dysphagia with diseases was not the primary objective of the LPZ survey, making it difficult to draw radical conclusions. A third limitation was that the LPZ survey arranged diseases in associated clusters. Consequently, the diseases of every resident could not be well specified, limiting the statistical analysis.

CONCLUSION Within the limitations of this cross-sectional, multi-centre point prevalence measurement, it seems justified to conclude that subjective dysphagia is a relevant care problem in older care home residents in the Netherlands. In order of importance (ranged from high to low) lower functional status, nervous system disorders including (the consequences of) cerebrovascular diseases, malnutrition, and comorbidity seem significant predicting factors for subjective dysphagia in care home residents.

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REFERENCES 1. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Risk factors for aspiration pneumonia in frail older people: a systematic literature review. J Am Med Dir Assoc 2011;12:344-354. 2. Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax 2012;67:71-79. 3. Rofes L, Arreola V, Almirall J, et al. Diagnosis and management of oropharyngeal dysphagia and its nutritional and respiratory complications in the elderly. Gastroenterol Res Pract 2011;2011:818979. 4. Cabre M, Serra-Prat M, Palomera E, Almirall J, Pallares R, Clavé P. Prevalence and prognostic implications of dysphagia in elderly patients with pneumonia. Age Ageing 2010;39:39-45. 5. Hudson HM, Daubert CR, Mills RH. The interdependency of protein-energy malnutrition, aging, and dysphagia. Dysphagia 2000;15:31-38. 6. Rudolph JL, Gardner KF, Gramigna GD, McGlinchey RE. Antipsychotics and oropharyngeal dysphagia in hospitalized older patients. J Clin Psychopharmacol 2008;28:532-535. 7. Wada H, Nakajoh K, Satoh-Nakagawa T, et al. Risk factors of aspiration pneumonia in Alzheimer’s disease patients. Gerontology 2001;47:271-276. 8. Gross RD, Atwood CW Jr, Ross SB, Eichhorn KA, Olszewski JW, Doyle PJ. The coordination of breathing and swallowing in Parkinson’s disease. Dysphagia 2008;23:136-145. 9. Hamdy S, Rothwell JC, Brooks DJ, Bailey D, Aziz Q, Thompson DG. Identification of the cerebral loci processing human swallowing with H2(15)O PET activation. J Neurophysiol 1999;81:1917-1926. 10. Dijkstra A, Tiesinga LJ, Plantinga L, Veltman G, Dassen TWN. Diagnostic accuracy of the care dependency scale. J Adv Nurs 2005;50:410-416. 11. James WP, Ferro-Luzzi A, Waterlow JC. Definition of chronic energy deficiency in adults. Report of a working party of the International Dietary Energy Consultative Group. Eur J Clin Nutr 1988;42:969-981. 12. Meijers JMM, Halfens RJG, van Bokhorst-de van der Schueren MAE, Dassen T, Schols JMGA. Malnutrition in Dutch health care: Prevalence, prevention, treatment, and quality indicators. Nutrition 2009;25:512-519. 13. Meijers JMM, van Bokhorst-de van der Schueren MA, Schols JMGA, Soeters PB, Halfens RJG. Defining malnutrition: mission or mission impossible? Nutrition 2010;26:432-440. 14. Marik PE, Kaplan D. Aspiration pneumonia and dysphagia in the elderly. Chest 2003;124:328-336. 15. Kayser-Jones J, Pengilly K. Dysphagia among nursing home residents. Geriatr Nurs 1999;20:77-82. 103

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16. Turley R, Cohen S. Impact of voice and swallowing problems in the elderly. Otolaryngol Head Neck Surg 2009;140:33-36. 17. Lin LC, Wu SC, Chen HS, Wang TG, Chen MY. Prevalence of impaired swallowing in institutionalized older people in Taiwan. J Am Geriatr Soc 2002;50:1118-1123. 18. Chen P-H, Golub JS, Hapner ER, Johns MM 3rd. Prevalence of perceived dysphagia and quality-of-life impairment in a geriatric population. Dysphagia 2009;24:1-6. 19. Kim Y, McCullough GH, Asp CW. Temporal measurements of pharyngeal swallowing in normal populations. Dysphagia 2005;20:290-296. 20. Tannen A, Schütz T, Smoliner C, Dassen T, Lahmann N. Care problems and nursing interventions related to oral intake in German Nursing homes and hospitals: A descriptive multicentre study. Int J Nurs Stud 2012;49:378-385. 21. Remesso GC, Fukujima MM, Chiappetta AL, et al. Swallowing disorders after ischemic stroke. Arq Neuropsiquiatr 2011;69:785-789. 22. Mann G, Hankey GJ, Cameron D. Swallowing function after stroke: prognosis and prognostic factors at 6 months. Stroke 1999;30:744-748. 23. Aldridge KJ, Taylor NF. Dysphagia is a common and serious problem for adults with mental illness: A systematic review. Dysphagia 2012;27:124-137. 24. Chang CC, Roberts BL. Feeding difficulty in older adults with dementia. J Clin Nurs 2008;17:2266-2274. 25. Yoneyama T, Yoshida M, Ohrui T, et al. Oral Care Working Group. Oral care reduces pneumonia in older patients in nursing homes. J Am Geriatr Soc 2002;50:430-433. 26. Bassim CW, Gibson G, Ward T, Paphides BM, Denucci DJ. Modification of the risk of mortality from pneumonia with oral hygiene care. J Am Geriatr Soc 2008;56:16011607. 27. Ishikawa A, Yoneyama T, Hirota K, Miyake Y, Myatake K. Professional oral health care reduces the number of oropharyngeal bacteria. J Dent Res 2008;87:594-598. 28. Yoshino A, Ebihara T, Ebihara S, Fuji H, Sasaki H. Daily oral care and risk factors for pneumonia among elderly nursing home patients. JAMA 2001;286:2235-2236. 29. Watando A, Ebihara S, Ebihara T, et al. Daily oral care and cough reflex sensitivity in elderly nursing home patients. Chest 2004; 126: 1066-1070. 30. Logemann JA, Larsen K. Oropharyngeal dysphagia: pathophysiology and diagnosis for the anniversary issue of Diseases of the Esophagus. Dis Esophagus 2012;25:299-304.

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Dysphagia in care home residents, assessed by speech therapists, and its feasible risk factors Claar D. van der Maarel-Wierink, Gert-Jan van der Putten, Luc M.J. De Visschere, Ewald M. Bronkhorst, Cees de Baat and Jos M.G.A. Schols

van der Maarel-Wierink CD, van der Putten GJ, De Visschere LMJ, Bronkhorst EM, de Baat C, Schols JMGA. Dysphagia in care home residents, assessed by speech therapists, and its feasible risk factors. Submitted for publication.

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ABSTRACT Pneumonia is an important cause of death in care home residents. Dysphagia is a significant risk factor for developing aspiration pneumonia. The primary aim of the present study was to determine the prevalence of dysphagia, assessed by speech therapists in physically-disabled and cognitively-impaired care home residents in the Netherlands. A secondary aim was to determine feasible associations of dysphagia with Parkinson’s disease, cerebrovascular disease, dementia, and using antipsychotics, proton pump inhibitors, and ACE-inhibitors. Five experienced speech therapists assessed systematically 115 primarily physically-disabled and 88 primarily cognitively-impaired care home residents aged 60 years or older in the first week after admission to the care home. First, the speech therapists interviewed the residents. Second, a water swallowing observation was performed. Several residents’ data were also collected from the medical records, including age, gender, status of admission ‘primarily physically disabled’ or ‘primarily cognitively impaired’, and registered diagnoses. The speech therapists assessed in 43 (21.2%) residents the presence of dysphagia. The final prediction model for dysphagia, using multivariate logistic regression analysis, showed Parkinson’s disease as a significant factor (OR = 5.11; CI 1.49 … 17.52). It seems justified to conclude that dysphagia, assessed by speech therapists, is a relevant care problem in primarily physically-disabled and also in primarily cognitively-impaired care home residents in the Netherlands. Early diagnosis and therapy of dysphagia might decrease the prevalence of aspiration pneumonia.

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INTRODUCTION Dysphagia or swallowing impairment has been described as a symptom which refers to difficulty or discomfort during the progression of the alimentary bolus from the oral cavity to the stomach [1]. In a systematic literature review with homogeneity of cohort studies, dysphagia was proved to be a prominent risk factor for aspiration pneumonia in frail older people [2]. Aspiration pneumonia, an inflammatory condition of the lung parenchyma usually initiated by the introduction of bacteria into the lung alveoli, is causing high hospitalization rates, morbidity, and often death in frail older people [3,4]. Therefore, risk factors of aspiration pneumonia, such as dysphagia, should be prevented in frail older people whenever possible. A retrospective data-analysis of the Dutch National Prevalence Survey of Care Problems (LPZ), containing data of 8,119 care home residents aged 65 years or older, showed that the prevalence rate of dysphagia in care home residents was 9% [5]. However, in this study dysphagia was assessed subjectively by interviewing the residents on swallowing problems experienced, whereas some authors recommended previously to assess dysphagia objectively [6,7]. The motivation for this recommendation was that subjective assessment is probably less reliable because residents do not always recognize their swallowing problems well. They often consider dysphagia as a natural symptom of ageing or an ordinary symptom of their diseases. A video fluoroscopic swallowing investigation is the most reliable method for investigating swallowing problems [8]. Since video fluoroscopy is rarely possible and feasible in care home residents, a clinical assessment by a speech therapist seems the optimal method to assess dysphagia and, consequently, aspiration risk in care home residents. Until now, actual prevalence or incidence figures of dysphagia in frail older people in the community as well as in care homes are hardly available. The retrospective data-analysis of the Dutch National Prevalence Survey of Care Problems (LPZ) also revealed that the disease clusters ‘nervous system disorders’ (OR = 1.59; 95% CI 1.23-2.05) and ‘cerebrovascular disease’ (OR = 1.77; 95% CI 1.47-2.14) were important factors for predicting subjective dysphagia. In contrast to previous findings [9], the multivariate logistic regression analysis did not show dementia being a predicting factor for (subjective) dysphagia [5]. Additionally, the above mentioned systematic literature review assessing risk factors for aspiration pneumonia showed evidence that using antipsychotics and using proton pump inhibitors are significant risk factors, whereas using angiotensin-converting enzyme (ACE)inhibitors is a significant protective factor [2]. It was suggested that dysphagia might explain the relation between the use of these medications and the onset of aspiration pneumonia, because antipsychotics can cause worse swallowing function and proton pump inhibitors influence gastric acidity, but reduce also acidity of the upper aero-digestive tract, resulting in increased bacterial colonization and high bacterial load with aspiration due to dysphagia [10,11]. The preventive effect of ACE-inhibitors is probably caused by increased substance P concentration, resulting in improved cough reflex [12]. 109

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Care homes in The Netherlands have separate wards for residents with primarily physically disabling diseases respectively residents with primarily cognitive dysfunction. The most frequent medical diagnoses registered in physically-disabled residents are cerebrovascular diseases, other neurological diseases, status post-hip fracture surgery, other locomotor disabilities, and malignancies. More than 85% of the cognitively-impaired residents are suffering from dementia [13,14]. The first objective of this study was to determine the prevalence of dysphagia in physically-disabled and cognitively-impaired care home residents in the Netherlands, assessed by speech therapists. The second objective was to determine feasible associations of dysphagia with Parkinson’s disease (a nervous system disorder), cerebrovascular disease, dementia, and using antipsychotics, proton pump inhibitors, and ACE-inhibitors.

METHODS Five experienced speech therapists assessed systematically, as part of the routine nutritional screening and assessment, all care home residents aged 60 years or older in the first week after admission to one of six care homes of the care home organization Vivre in Maastricht, the Netherlands in the period May 2010-March 2011. First, the speech therapists interviewed the residents with questions based on the previously used self-report symptom inventory for assessing oral-pharyngeal dysphagia [15]. When a resident was not able to respond, the question was answered by the primarily responsible ward nurse. The into the Dutch language translated questions were: 1. Do you ever have a feeling of food getting stuck in the throat when you swallow? 2. Do you ever drool saliva from your mouth? 3. Do you ever lose drinks or food from your mouth? 4. Do you ever cough or choke when swallowing solid foods or liquids? 5. Can you eat: warm/cold/ spicy/crumbly food? 6. Can you drink thin liquids? 7. Can you eat food that needs chewing/ food that needs biting off? Second, unless a resident was suffering from severe dysphagia, the care home residents were requested to drink a glass of water. When the speech therapist suspected dysphagia beforehand, the resident first received a tea spoon with water and when there were no symptoms of dysphagia, the resident got a sip of water and, thereafter the resident drank the glass of water. Ambulatory patients were seating in a chair, bed-bound patients were sitting upright in bed. The speech therapists observed the swallowing phases, the tonus of the swallowing muscles (hypertonic/hypotonic), and the sensibility of the oropharyngeal cavity by inspecting the oral cavity for any residues. This water swallowing test was based on the 3-ounce water swallow test, a widely used method of screening individuals who are at risk for oropharyngeal dysphagia and aspiration. Although the test has a low specificity and high false positive rate, it is a quick and easy screenings instrument. And if the 3-ounce water swallow test is passed, not only thin liquids but other food consistencies 110

Dysphagia in care home residents, assessed by speech therapists, and its feasible risk factors

can be recommended confidently and without further instrumental dysphagia. Criteria for referral for further assessment of swallowing include inability to complete the task, coughing, choking, or a wet-hoarse vocal quality exhibited either during or within 1 minute of test completion [16]. After the interview and the swallowing observation, the speech therapist assessed the presence or absence of dysphagia. The swallowing observation, an objective assessment, was leading for making the final decision. Several residents’ data were also collected from the medical records, including age, gender, status of admission ‘primarily physically disabled’ or ‘primarily cognitively impaired’, registered diagnoses: Parkinson’s disease, cerebrovascular disease and dementia, and actual use of antipsychotics, proton pump inhibitors, and ACE-inhibitors. Statistical analyses were performed using SPSS version 18.0 (SPSS INC, Chiacago, IL, USA), including descriptive frequency distributions for all variables. Differences between groups were tested using Student’s t-test for age and the Fisher’s Exact test for other variables. To explore the role of feasible risk factors of dysphagia and to assess confounding, a prediction model was built using multivariate logistic regression analysis. A p-value of 0.05 was considered statistically significant. Statistical analysis Statistical analyses were performed using SPSS version 18.0 (SPSS INC, Chiacago, IL, USA), including descriptive frequency distributions for all variables. Differences between groups were tested using Student’s t-test for age and the Fisher’s Exact test for other variables. To explore the role of feasible risk factors of dysphagia and to assess confounding, a prediction model was built using multivariate logistic regression analysis. A p-value of 0.05 was considered statistically significant.

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RESULTS Two hundred and three primarily physically-disabled or primarily cognitively-impaired care home residents (117 women, 86 men) aged 60 years or older were systematically assessed for dysphagia by the speech therapists. The mean age of the residents was 82.8 ± 8.3 years. The speech therapists assessed in 43 (21.2%) residents dysphagia and, consequently, aspiration risk. Table 6.1 shows the residents’ gender, mean age, admission status of primarily physical disabled or cognitively impaired, the prevalences of Parkinson’s disease, cerebrovascular disease, and dementia and the prevalences of actual use of antipsychotics, proton pump inhibitors, and ACE-inhibitors separately for the total group, the group of physically-disabled and the group of cognitively-impaired residents . 115 (57%) Residents were primarily physically disabled and 88 (43%) primarily cognitively impaired. The difference in prevalence of dysphagia between physically-disabled residents (26.1%) and cognitivelyimpaired residents (14.8%) was not statistically significant (Fisher’s Exact Test; p = 0.058). Cognitively-impaired residents used statistically significantly more antipsychotics (Fisher’s Exact Test; p < 0.001) and less proton pump inhibitors than physically-disabled residents (Fisher’s Exact Test; p = 0.029). There was no significant difference in the prevalence of using ACE-inhibitors between physically-disabled and cognitively-impaired residents (Fisher’s Exact Test; p = 0.323). Table 6.2 shows the same variables as table 6.1, but separately for residents with dysphagia (n = 43) and residents without dysphagia (n = 160). Residents with dysphagia were significantly younger and had a significantly higher prevalence of Parkinson’s disease when compared to residents without dysphagia (Fisher’s Exact Test; p = 0.02). In contrast, the prevalences of dementia (Fisher’s Exact Test; p = 0.025) and using antipsychotics were significantly lower (Fisher’s Exact Test; p = 0.022) in residents with dysphagia when compared to residents without dysphagia. Dementia, Parkinson’s disease, and the use of antipsychotics were significant variables in the univariate analysis. Cerebrovascular disease had a significant relation with dementia (Fisher’s Exact Test; p = 0.02). These four variables and the variable age were included in the multivariate logistic regression analysis. Since this study showed 43 cases of dysphagia, five variables is the maximum for including in the multivariate logistic regression analysis [16]. The final prediction model for dysphagia, using multivariate logistic regression analysis, showed Parkinson’s disease as a significant factor (OR = 5.11; CI 1.49 … 17.52) (Table 6.3).

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Table 6.1 The Participating Care Home Residents’ Gender, Mean Age, Prevalences of Parkinson’s Disease, Cerebrovascular Disease, and Dementia and Prevalences of Use of Antipsychotics, Proton Pump Inhibitors, and ACE-Inhibitors, and Prevalence of Dysphagia, Separately for the Total Group, the Group of Physically-Disabled and the Group of Cognitively-Impaired Residents (T-test for Age and Fisher’s Exact Test for All Other Variables) Number of residents

Physically disabled

Cognitively impaired

p-value

203

115

88

Women

117 (58%)

67 (58%)

50 (57%)

0.886

Age in years (mean ± standard deviation)

82.8 ± 8.3

81.6 ± 8.8

84.4 ± 7.3

0.015

Parkinson’s disease

15 (7.4%)

12 (10.4%)

3 (3.4%)

0.064

Cerebrovascular disease

37 (18.2%)

29 (25.2%)

8 (9.1%)

0.003

Dementia

98 (48.3%)

13 (11.3%)

85 (96.6%)

<0.001

Antipsychotics

57 (28.1%)

20 (17.4%)

37 (42.0%)

<0.001

Proton pump inhibitors

124 (61.1%)

78 (67.8%)

46 (52.3%)

0.029

ACE-inhibitors

49 (24.1%)

31 (27.0%)

18 (20.4%)

0.323

Dysphagia

43 (21.2%)

30 (26.1%)

13 (14.8%)

0.058

Registered diagnoses:

Medications used:

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Table 6.2 Number of Residents, Residents’ Gender, Mean Age, Prevalences of Parkinson’s Disease, Cerebrovascular Disease, and Dementia and Prevalences of Use of Antipsychotics, Proton Pump Inhibitors, and ACE-Inhibitors, Separately for Residents with and without Dysphagia (T-test for Age and Fisher’s Exact Test for all Other Variables) Dysphagia

With

Without

p-value

Number of residents

43 (21%)

160 (79%)

Women

24 (56%)

93 (58%)

0.862

Mean age ± standard deviation Registered diagnoses:

80.3 ± 8.8

83.5 ± 8.0

0.027

Parkinson’s disease

7 (16.3%)

8 (5.0%)

0.020

Cerebrovascular disease

11 (25.6%)

26 (16.3%)

0.183

Dementia

14 (32.6%)

84 (52.5%)

0.025

Antipsychotics

6 (14.0%)

51 (31.9%)

0.022

Proton pump inhibitors

31 (72.0%)

93 (58.1%)

0.114

ACE-inhibitors

14 (32.6%)

35 (21.9%)

0.162

Medication used:

Table 6.3 Final Prediction Model for Dysphagia (Using Logistic Regression Analysis), p-value and Odds Ratio (OR) with 95% Confidence Interval (95% CI) for Age, Parkinson’s Disease, Cerebrovascular Disease, Dementia, Antipsychotics Used p-value

OR

95% CI for OR

Age

0.098

0.472

0.194 … 1.148

Parkinson’s disease

0.009*

5.114

1.493 … 17.519

Cerebrovascular disease

0.352

1.501

0.639 … 3.526

Dementia

0.383

0.708

0.326 … 1.537

Antipsychotics used

0.033*

0.330

0.119 … 0.917

Constant

0.225

0.586

* Significant result p < 0.05

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DISCUSSION In this study, the overall prevalence of objective dysphagia (21.2%) in care home residents of a Dutch care home organization, assessed by speech therapists, is more than twice the prevalence found for subjective dysphagia in care home residents in the LPZ-study [5]. This result confirms the suggestion that residents might not always recognize their swallowing problems or consider dysphagia as a natural symptom of ageing or an ordinary symptom of their diseases, resulting in underdiagnosing dysphagia when assessed subjectively. In this study as well as in the LPZ-study, gender was not a significant factor. In the final prediction model for dysphagia age was not a significant factor. The group with dysphagia was in this study as well as in the LPZ-study statistically significantly younger than the group without dysphagia. The only significant predicting factor for dysphagia in this study was Parkinson’s disease. This result is in agreement with a recently published meta-analysis of the prevalence of dysphagia in Parkinson’s disease, not specifically older patients. The results showed that the pooled relative risk was 3.2 for both subjective dysphagia (95% CI 2.32 … 4.41) and objective dysphagia (95% CI 2.08 … 4.98). Subjective dysphagia occurred in one third of community-dwelling Parkinson’s disease patients. Objectively measured dysphagia rates were much higher, with 4 out of 5 patients being affected [18]. The LPZ-study reported for the disease cluster ‘nervous system disorders’ an odds ratio for subjective dysphagia of 1.59 (95% CI 1.23 … 2.05) [5]. Cerebrovascular disease was not a significant factor in the final prediction model for dysphagia in this study. This is in contrast with previous findings reporting a relatively high frequency of dysphagia in the acute phase after a cerebrovascular accident [19,20] and with the results of the final prediction model for subjective dysphagia of the LPZ-study, showing the disease cluster ‘CVA/hemiparesis’ to be a significant factor [5]. The systematic literature review by van der Maarel-Wierink et al. also reported inconsistent evidence for cerebrovascular diseases as a risk factor for aspiration pneumonia [2]. Based on literature results, ‘dementia’ was expected to be a significant predicting factor for dysphagia [9,21]. However, in the final prediction model of this study ‘dementia’ was no significant factor. Also the use of antipsychotics was not a significant factor in the final prediction model for dysphagia. Moreover, the prevalence of using antipsychotics was significantly lower in residents with dysphagia when compared to residents without dysphagia. Furthermore, there was no significant difference in the use of proton pump inhibitors between residents with and without dysphagia. Additionally, the study did not present information about the genotype of the residents. However, there was no significant difference in the use of ACE inhibitors between residents with and without dysphagia. In this study, dysphagia was assessed systematically with an interview and swallowing observation by experienced speech therapists. Video fluoroscopic swallowing investigation is the golden standard in diagnosing dysphagia [8]. However, it is not usual to refer older 115

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care home residents for such major investigation, because a referral to the hospital is often considered to be more harmful than beneficial for these residents. Nevertheless, the lack of video fluoroscopic swallowing investigation has to be mentioned as a limitation of this study. A second limitation was that no inter- and intra-reliability tests of the speech therapists’ assessments have been performed. However, the speech therapists were experienced with the swallowing assessment, because the protocol was accurately implemented one year before the start of this study. Within the limitations of this study, it seems justified to conclude that dysphagia, assessed by speech therapists, is a relevant care problem in both primarily physically-disabled and primarily cognitively-impaired care home residents in the Netherlands, particularly in residents with Parkinson’s disease. Health care providers in care homes should be aware of the high incidence of dysphagia (1:5). Therefore, screening for swallowing disorders should be incorporated in the routine nutritional screening and assessment of every care home resident. Maybe the recently validated Modified Mann Assessment of Swallowing Ability, a physician-administered screening tool, originally developed for screening of dysphagia in patients with an acute cerebrovascular disease, might be useful to early recognize dysphagia [22]. Pulse oximetry, using coughing, choking, and voice alteration as endpoints, might be a valuable addition to the water swallowing evaluation for the assessment of dysphagia by speech therapists, increasing the sensitivity of the assessment [23]. Therapy, such as supervised feeding, dietary modifications, swallowing therapy (compensatory strategies or exercises to strengthen swallowing musculature) or pharmacologic therapy may decrease aspiration risk and, consequently, the risk for developing aspiration pneumonia [24]. More research, with validated screening tools, is warranted on the prevalence of dysphagia and the related aspiration risk in care home residents, to confirm the results of this study, and to further assess the risk factors of dysphagia.

ACKNOWLEDGEMENTS We would like to thank the speech therapists Mrs. G.S. Hertogs, Mrs. L.J.M. Daemen, Mrs. B.P.M. Swelsen, Mrs. S. Ubben and Mrs. E.F.A. Hamers of the care home organization Vivre for their important contribution to the study. C.D.v.d.M., C.d.B. and J.M.G.A.S. were responsible for the study design. C.D.v.d.M. and J.M.G.A.S. were responsible for the data collection. E.B. is responsible for the statistical analysis of the research data collected. C.D.v.d.M. wrote the paper. C.D.v.d.M., C.d.B. and J.M.G.A.S. had primary responsibility for the final content. All authors critically reviewed several drafts and approved the final manuscript.

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REFERENCES 1. Rofes L, Arreola V, Almirall J, Icart R, Palomera E, Arreola V, et al. Diagnosis and management of oropharyngeal dysphagia and its nutritional and respiratory complications in the elderly. Gastroenterol Res Pract, published online 26 July 2012, DOI: 10.1183/09031936.00019012. 2. van der Maarel-Wierink CD, Vanobbergen JN, Bronkhorst EM, Schols JM, de Baat C. Risk factors for aspiration pneumonia in frail older people: a systematic literature review. J Am Med Dir Assoc 2011;12:344-354. 3. Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax 2012;67:71-79. 4. Wark P. Viral and bacterial interactions in pneumonia. Expert Rev Respir Med 2010;4:221-228. 5. van der Maarel-Wierink CD, Meijers JM, De Visschere LM, de Baat C, Halfens RJ, Schols JM. Subjective dysphagia in older care home residents in the Netherlands. Submitted for publication. 6. Kayser-Jones J, Pengilly K. Dysphagia among nursing home residents. Geriatr Nurs 1999;20:77-82. 7. Lin LC, Wu SC, Chen HS, Wang TG, Chen MY. Prevalence of impaired swallowing in institutionalized older people in Taiwan. J Am Geriatr Soc 2002;50:1118-1123. 8. Logemann JA, Larsen K. Oropharyngeal dysphagia: pathophysiology and diagnosis for the anniversary issue of Diseases of the Esophagus. Dis Esophagus 2012;25:299-304. 9. Wada H, Nakajoh K, Satoh-Nakagawa T, Suzuki T, Ohrui T, Arai H, et al. Risk factors of aspiration pneumonia in Alzheimer’s disease patients. Gerontology 2011;47:271-276. 10. Rudolph JL, Gardner KF, Gramigna GD, McGlinchey RE. Antipsychotics and oropharyngeal dysphagia in hospitalized older patients. J Clin Psychopharmacol 2008;28:532-535. 11. Eom CS, Jeon CY, Lim JW, Cho EG, Park SM, Lee KS. Use of acid-suppressive drugs and risk of pneumonia: a systematic review and meta-analysis. CMAJ 2011;183:310-319. 12. Takahashi T, Morimoto S, Okaishi K, Kanda T, Nakahashi T, Okuro M, et al. Reduction of pneumonia risk by an angiotensin I-converting enzyme inhibitor in elderly Japanese inpatients according to insertion/deletion polymorphism of the angiotensin I-converting enzyme gene. Am J Hypertens 2005;18:1353-1359. 13. Schols JM, Crebolder HF, van Weel C. Nursing home and nursing home physician: the Dutch experience. J Am Med Dir Assoc 2004;5:207-212. 14. Schols JM. Nursing home medicine in The Netherlands. Eur J Gen Pract 2005;11:141143. 15. Wallace KL, Middletonook IJ. Development and validation of a self-report symptom inventory to assess the severity of oral-pharyngeal dysphagia. Gastroenterology 2000;118: 678-687. 16. Suiter DM, Leder SB. Clinical utility of the 3-ounce water swallow test. Dysphagia 2008;23:244-250. 117

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17. Harrell FE Jr, Lee KL, Califf RM, Pryor DB, Rosati RA. Regression modelling strategies for improved prognostic prediction. Stat Med 1984;3:143-152. 18. Kalf JG, de Swart BJ, Bloem BR, Munneke M. Prevalence of oropharyngeal dysphagia in Parkinson’s disease: a meta-analysis. Parkinsonism Relat Disord 2012;18:311-315. 19. Mann G, Hankey GJ, Cameron D. Swallowing function after stroke: prognosis and prognostic factors at 6 months. Stroke 1999;30:744-748. 20. Paciaroni M, Mazzotta G, Corea F, Caso V, Venti M, Milia P, et al. Dysphagia following Stroke. Eur Neurol 2004;51:162-167. 21. Horner J, Alberts MJ, Dawson DV, Cook GM. Swallowing in Alzheimer’s disease. Alzheimer Dis Assoc Disord 1994;8:177-189. 22. Antonios N, Carnaby-Mann G, Crary M, Miller L, Hubbard H, Hood K, et al. Analysis of a physician tool for evaluating dysphagia on an inpatient stroke unit: the modified Mann Assessment of Swallowing Ability. J Stroke Cerebrovasc Dis 2010;19:49-57. 23. Bours GJ, Speyer R, Lemmens J, Limburg M, de Wit R. Bedside screening tests vs. videofluoroscopy or fibreoptic endoscopic evaluation of swallowing to detect dysphagia in patients with neurological disorders: systematic review. J Adv Nurs 2009;65:477-493. 24. Marik PE, Kaplan D. Aspiration pneumonia and dysphagia in the elderly. Chest 2003;124:328-336.

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The effect of daily applying a 0.05% chlorhexidine solution on the incidence of aspiration pneumonia in care home residents: design of a double-blind cluster randomized placebo-controlled trial Vanessa Hollaar, Claar van der Maarel-Wierink, Gert-Jan van der Putten, Ewald Bronkhorst, Jos Schols, Bert de Swart and Cees de Baat

Hollaar V, van der Maarel-Wierink CD, van der Putten GJ, Bronkhorst EM, Schols JMGA, de Swart B, de Baat C. The effect of daily applying a 0.05% chlorhexidine solution on the incidence of aspiration pneumonia in care home residents: design of a double-blind cluster randomized placebo-controlled trial. Submitted for publication.

Chapter 7

ABSTRACT Background: Pneumonia is an important cause of death in care home residents. Dysphagia and bad oral health are significant risk factors for developing aspiration pneumonia. Oral hygiene care reduces the number of oral bacteria and the risk of aspiration pneumonia, however, it is not yet clear which oral hygiene care intervention is most efficacious in reducing the risk of aspiration pneumonia. The aim of the study is to assess whether the application of a 0.05% chlorhexidine-containing solution in addition to usual daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia. Methods/design: The study is designed as a double-blind cluster randomized placebocontrolled trial, with care home wards as units of randomization. The randomization will be balanced for dysphagia severity and care dependency. During one year, 500 physically-disabled care home residents with dysphagia will be followed. The intervention consists of applying a 0.05% chlorhexidine-containing solution twice daily immediately after the usual oral hygiene care, whereas the control group receives a placebo. The application method of the 0.05% chlorhexidine-containing solution, rinsing the solution or cleaning the oral cavity with a gauze containing 0.05% chlorhexidine-containing solution, is depending on the severity of the dysphagia. Other research data which will be gathered are: age, gender, diseases diagnosed, dysphagia severity, care dependency, medications used actually, number of teeth and implants present, and presence of removable dentures. The study outcome is the incidence of pneumonia diagnosed by a physician, using a set of strictly described criteria. The effect of the intervention on the incidence of pneumonia will be determined using Cox regression analysis. Discussion: Using cluster randomization may result in random effect and cluster selection bias. Therefore, randomization will be balanced for dysphagia severity and care dependency. Furthermore, a frailty model will be included in the Cox regression analysis to take into account the clustering of data within care home wards. Trial registration: The trial has been registered in the Netherlands National Trial Register: TC = 3515

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BACKGROUND In care homes, pneumonia is the second most common infection, after urinary tract infection, and the leading cause of death from infection [1]. The incidence of pneumonia in care homes is tenfold the incidence of pneumonia in the community [2]. Also the risk of developing aspiration pneumonia in care home residents is higher than in community-dwelling older people [3]. Aspiration, with the risk of developing aspiration pneumonia, is defined as the inhalation of oropharyngeal or gastric contents into the larynx and lower respiratory tract [4]. Care home residents are often dependent on nurses for daily oral hygiene care. It has been found that care home residents in several countries have poorly cleaned teeth and removable dentures [5]. The accumulation of oral plaque emerges colonization of respiratory pathogens [6]. Not the type of oral bacteria, but the amount of bacteria inhaled is an important factor in developing aspiration pneumonia [7]. Although it has been suggested that oral hygiene care, such as tooth brushing after each meal, cleaning dentures once daily, and professional oral health care once weekly reduce the number of oral bacteria in care home residents sufficiently, it is not quite clear which oral health care intervention is most efficacious in reducing the risk of aspiration pneumonia [8-10]. Several randomized clinical trials have found evidence for a reduction of the risk of pneumonia in intensive care unit patients, often dependent on mechanical ventilation, through oropharyngeal cleansing with a 0.2% chlorhexidine gluconate solution. However, other studies found controversial evidence. A systematic literature review on this topic concluded that additional large-scale, multicentre randomized clinical trials are needed to fully understand the role of oral health care in preventing pneumonia in intensive care unit residents [11]. The pathogenesis of aspiration pneumonia onset is unknown. Four feasible mechanisms for oral bacteria causing respiratory infections have been described. Colonization of pulmonary pathogens in the oral biofilm and aspiration of these pathogens into the lungs, is the first mechanism. The second mechanism is that in saliva present periodontal-diseaseassociated enzymes may modify mucosal surfaces and facilitate the adherence of respiratory pathogens which can be aspirated into the lungs. The third mechanism involves periodontaldisease-associated enzymes destroying protective salivary pellicles. Fourth, cytokines from infected periodontal tissues may alter respiratory epithelium, which results in respiratory pathogen colonization and an increased risk of infection [6]. Recently, the literature published between January 2000 and April 2009 was systematically reviewed on the risk factors of aspiration pneumonia in frail older people [12]. The following risk factors could be identified: age, male gender, lung diseases, dysphagia, diabetes mellitus, severe dementia, angiotensine I-converting enzyme deletion/deletion genotype, bad oral health, malnutrition, Parkinson’s disease, the use of antipsychotic drugs, and the use of proton pump inhibitors. It was suggested that the presence of two or more of these risk factors could be an indicator that specific preventive oral health care is needed, attempting to reduce the risk of developing aspiration pneumonia [12]. A meta-analysis 123

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on dysphagia and aspiration pneumonia in frail older people confirmed dysphagia being a significant risk factor for aspiration pneumonia in frail older people (OR = 9.84; 95% CI = 4.15 23.33), specifically in patients with a cerebrovascular disease: OR = 12.93; 95% CI = 8.61-19.44 [13]. Data from another study demonstrated that completely dependent care home residents had a 42-fold and to a great extent dependent care home residents a 13-fold risk of selfreported (subjective) dysphagia when compared to independent care home residents [14]. The results of the aforementioned studies showed that care dependent residents have a high risk of dysphagia, that residents with dysphagia have a serious risk of developing aspiration pneumonia, and that the application of a chlorhexidine-containing solution in addition to usual daily oral hygiene care may reduce the risk of developing aspiration pneumonia. Therefore, the aim of the study is to assess whether the application of a 0.05% chlorhexidine-containing solution in addition to daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia. Study objectives The objectives of the study are: 1) Is there any statistically significant difference with regard to the incidence of pneumonia in physically-disabled care home residents with dysphagia, who in addition to usual daily oral hygiene care use a 0.05% chlorhexidine-containing solution or a placebo? 2) Is there any statistically significant correlation between on the one hand age, gender, diseases diagnosed, dysphagia severity, care dependency, medications used actually, number of teeth and implants present, and presence of removable dentures and on the other hand the incidence of pneumonia in physically-disabled care home residents with dysphagia who apply a 0.05% chlorhexidine-containing solution or a placebo in addition to usual daily oral hygiene care?

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METHODS/DESIGN Study design and setting The study design is a double-blind cluster randomized placebo-controlled trial, with care home wards as units of randomization (Figure 7.1). Care home wards will randomly be allocated to either the intervention group or the control group, while the groups will be balanced for dysphagia severity and care dependency. Care home residents fulfilling the inclusion criteria as well as participating physicians, speech therapists, oral health care providers, nurses, examiner and assistant examiners will be blinded to the assignment in order to prevent bias. The applied solutions will be labelled using encrypted codes which refer to the chlorhexidine-containing solution or the placebo. To prevent bias, the placebo will have the same wrapping, colour, odour, and taste as the chlorhexidine-containing solution. A key holder has a list with the meaning of the codes assigned to the care home wards until the intervention period of one year will be finished. In all participating care home wards, the application of the chlorhexidinecontaining solution or the placebo will be guided and monitored every two weeks by a group of visiting assistant examiners who are instructed by the examiner in using a strict guiding and monitoring protocol. Every assistant examiner will visit each time the same care home ward(s). In each care home ward, two coached study supervisors will monitor the usual daily oral hygiene care including the application of the chlorhexidine-containing solution or the placebo. The outcome variable is the incidence of pneumonia diagnosed by a physician, using a set of strictly described criteria. Since uniform criteria for diagnosing pneumonia in care home residents are lacking, a set of criteria will be assessed by a Delphi-panel of experts before the start of the study. The study is conducted according to the principles of the Declaration of Helsinki (version 7c, 2004) and in accordance with the Medical Research Involving Human Subjects ACT (WMO). The Medical Ethical Committee of the Radboud University Nijmegen Medical Centre has approved the study. Participants Based on a power calculation, 500 physically-disabled care home residents with dysphagia will be followed during one year. Care home wards, the units of randomization, will be allocated randomly to the intervention or control group. However, the groups will be balanced for dysphagia severity and care dependency (Figure 7.1). Factors taken into account in the sample size calculations are the distribution of the outcome variable in the population (σ) and the presumed effect of the intervention (μ1 – μ2), the requested power (1-β), the alpha (α) and the value of the intraclass correlation (design effect). The primary formula used to calculate the sample size is:

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Calculating the power, the incidence of pneumonia in care home residents is, in agreement with not internationally published incidence data for the year 2011, largely assessed as 25% [15], the presumed effect of the intervention is 0.6, the requested power is 0.8, and the alpha is 0,05. If the true relative risk of failure of residents of the intervention group relative to residents of the control group is 0.6, 250 residents are needed in the intervention group and 250 residents in the control group in order to be able to reject the hypothesis that the relative risk equals 1 with probability (power) 0.8. Written informed consent will be obtained from all participating residents or their legal representatives prior to their participation. Residents will be included when they meet the following criteria: aged 65 years or older, physically-disabled and dysphagia diagnosed. Dysphagia will be diagnosed by a speech therapist, using the Dysphagia Outcome Severity Scale [16]. This is a 7-point scale developed to systematically rate the functional severity of dysphagia. Residents with level 1 (severe), level 2 (moderate severe), level 3 (moderate), level 4 (mild-moderate), and level 5 (mild) will be included. Residents who at baseline are cognitively impaired (mainly suffering from dementia), in coma or vegetative state, terminally ill, dependent on mechanical ventilation, in day-care, in short-term care, or already using an oral hygiene care solution will be excluded. A physician has to withdraw a resident from the study when the resident’s conditions have altered according to one of the exclusion criteria. However, when pneumonia is the reason of the condition alteration, the pneumonia will be registered as a case with respect to the outcome variable. Withdrawn residents will not be replaced because with respect to determine the incidence of pneumonia significant bias would be introduced by replacement. Intervention The intervention consists of applying a 0.05% chlorhexidine-containing solution twice daily immediately after the usual oral hygiene care, whereas the control group receives a placebo. The placebo has the same wrapping, colour, odour, and taste, and contains the same ingredients as the chlorhexidine-containing solution, except the chlorhexidine. The application method of the 0.05% chlorhexidine-containing solution is depending on the severity of the dysphagia. Residents who tolerate thin liquids have to rinse with the 0.05% chlorhexidine-containing solution for 30 seconds twice daily immediately after the usual oral hygiene care. Residents with severe dysphagia who cannot tolerate thin liquids have to clean their teeth, gums, tongue, palate, and buccal mucosa with a gauze containing 0.05% chlorhexidine-containing solution twice daily immediately after the usual oral hygiene care. Data collection Research data will be gathered at baseline by the examiner (the first author of this article) and the assistant examiners (dental hygienists and bachelor dental hygiene students). The assistant examiners are educated by the examiner to perform a standardized oral examination and to gather data from the residents’ medical records. 126

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Every ward resident addressing the inclusion criteria and not addressing the exclusion criteria will be examined by a speech therapist of the care home to diagnose (the severity of) dysphagia. When dysphagia will have been diagnosed, the resident will be requested to sign an informed consent for participation in the study. Subsequently, the level of care dependency will be determined by a care provider using the Care Dependency Scale [17]. A short oral examination will be established by the examiner or an assistant examiner, determining the number of teeth and implants present and the presence of removable dentures. The following additional data are gathered from the patient’s medical record: age, gender, diseases diagnosed, and medications used actually. An overview of the data which will be collected is presented in Table 7.1. When during this study symptoms of pneumonia occur in the participating residents, they will be physically examined by a physician. If pneumonia will be diagnosed, the physician will inform the examiner to register the pneumonia as a case with respect to the outcome variable. Figure 7.1 presents a flow chart of the cluster randomized placebo-controlled trial. Statistical analysis The categorical and continuous variables will be subjected to an exploratory data analysis initially, employing a variety of mostly graphical methods and methods for testing the necessary assumptions. The effect of the intervention on the incidence of pneumonia will be determined using Cox regression analysis. The intervention will be the independent variable, the dependent variable is the occurrence of pneumonia. Additional to this main analysis, the influence of the other research variables on the incidence of pneumonia will be determined using an elaborate Cox regression analysis (age, gender, diseases diagnosed, dysphagia severity, care dependency, medications used actually, number of teeth and implants present, and presence of removable dentures). In this survival model a frailty model which aims to account for heterogeneity, caused by unmeasured covariates, will be included to take into account the clustering of data within care home wards. Recording the moment in the course of the study and the reason of withdrawals of participating residents facilitates the use of the data gathered from all participating residents for statistical analysis, even if they have been withdrawn prematurely.

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Table 7.1 Data Collected, Outcomes, Scales, and Collection Moment Data

Outcomes / scales

Collection moment

Baseline Dysphagia Outcome Level 7: Normal in all situations and Severity Scale Level 6: Within functional limits/modified independence Level 5: Mild dysphagia: Distant supervision, may need one diet consistency restricted Level 4: Mild-moderate dysphagia: Intermittent supervision/cueing, one or two consistencies restricted Level 3: Moderate dysphagia: Total assist, supervision, or strategies, two or more diet consistencies restricted Level 2: Moderately severe dysphagia: Maximum assistance or use of strategies with partial oral intake only Level 1: Severe dysphagia: No oral intake (NPO). Unable to tolerate any oral intake safely Care Dependency Scale

Baseline Completely care dependent, score < 25 To a great extent care dependent, score 25-44 Partially care dependent, score 45-59 To a limited extent care dependent, score 60-68 Almost independent, score > 68

Patient’s medical record

Gender, age Baseline Medical diagnoses and medications used actually

Oral examination

Number of teeth and implants, presence of removable dentures

Baseline

Pneumonia

A set of strictly described criteria

When symptoms occur during study

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Figure ClusterRandomized RandomizedPlacebo-Controlled Placebo-Controlled Trial. Figure7.1 7.1Flow Flowchart Chartof of the the Double-Blind Double-Blind Cluster Trial Participating care homes

Randomisation of comparable care home wards

Recruitment of physically-disabled residents with dysphagia (diagnosed by a speech therapist)

Intervention group wards 250 residents

Age, gender, diseases diagnosed, care dependency, dysphagia severity, medications used actually, number of teeth and implants, presence of removable dentures

Usual daily oral hygiene care + applying a 0.05% chlorhexidinecontaining solution

Incidence of pneumonia

Control group wards 250 residents

Age, gender, diseases diagnosed, care dependency, dysphagia severity, medications used actually, number of teeth and implants, presence of removable dentures

Usual daily oral hygiene care + applying a placebo

Incidence of pneumonia

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DISCUSSION For this study, randomization on ward level, reducing bias between residents, is most appropriate. In case of randomization on resident level, contamination may occur through exchange of some residents’ chlorhexidine-containing solutions and other residents’ placebos. Using cluster randomization may result in random effect and cluster selection bias. Therefore, the intervention and control group will be balanced for dysphagia severity and care dependency. Furthermore, a frailty model which aims to account for heterogeneity, caused by unmeasured covariates, will be included in the Cox regression analysis to take into account the clustering of data within care home wards. Chlorhexidine is a widely used oral rinse and often applied in critically-ill populations [18,19]. Adverse effects due to chlorhexidine are rare, but have been reported. Very rarely, applying a chlorhexidine-containing solution causes an allergic and/or hypersensitivity reaction. Other side effects are discoloration of teeth, removable dentures, mucosa or tongue, temporary taste disorder, swelling of salivary glands, and pain. However, these side effects may present when using a concentration of 0.2%, but very rarely when using a lower concentration, whereas the concentration used in this study is 0.05%. Oral ingestion of chlorhexidine is usually well tolerated because of the negligible systemic absorption [20]. Although it is not possible to comment on the effectiveness of the intervention in advance, the benefit for the residents in the intervention group may be a better oral hygiene status and oral health condition and, consequently, a reduction of the risk of developing pneumonia. The favourable results of studies using chlorhexidine to prevent pneumonia in patients dependent on mechanical ventilation are promising for a similar result in preventing aspiration pneumonia in physically-disabled care home residents with dysphagia [21]. The literature shows that adequate oral health care is needed structurally, in order to maintain and improve the quality of life of older people [22,23]. Preventing aspiration pneumonia by improving oral health care may be a significant contribution to the quality of life of care home residents.

AUTHORS’ CONTRIBUTIONS CvdM-W developed the first draft of this study. VH, CvdM-W, G-JvdP, EB, JS, BdS, and CdB contributed to further developing and designing the study protocol. All authors critically reviewed several drafts and approved the final manuscript. VH is the examiner and will coach the team of assistant examiners to collect the research data. G-JvdP will support VH in setting up the trial and will be of assistance with the logistic aspects of the trial. EB is responsible for the statistical analysis of the research data collected.

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COMPETING INTERESTS The authors declare that they have no competing interests.

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REFERENCES 1. Pace CC, McCullough GH.The association between oral microorganisms and aspiration pneumonia in the institutionalized elderly; review and recommendations. Dysphagia 2010; 25:307-322. 2. Marrie TJ. Pneumonia in the long-term-care facility. Infect Control Hosp Epidemiol 2002; 23:159-164. 3. Shariatzadeh MR, Huang JQ, Marrie TJ. Differences in the features of aspiration pneumonia according to site of acquisition: community or continuing care facility. J Am Geriatr Soc 2006; 54:296-302. 4. Marik PE. Aspiration pneumonitis and aspiration pneumonia. N Engl J Med 2001;344:665-671. 5. De Visschere LM, Grooten L, Theuniers G, Vanobbergen JN. Oral hygiene of elderly people in long-term care institutions - a cross-sectional study. Gerodontology 2006;23:195-204. 6. Scannapieco FA. Role of oral bacteria in respiratory infection. J Periodontol 1999;70:793-802. 7. Ingles TJ, Sherratt MJ, Sproat LJ, Gibson JS, Hawkey PM. Gastroduodenal dysfunction and bacterial colonization of the ventilated lung. Lancet 1993;341:911-913. 8. Yoneyama T, Yoshida M, Ohrui T, et al. Oral Care Working Group: Oral care reduces pneumonia in older patients in nursing home. J Am Geriatr Soc 2002;50:430-433. 9. Bassim CW, Gibson G, Ward T, Paphides BM, Denucci DJ. Modification of the risk of mortality from pneumonia with oral hygiene care. J Am Geriatr Soc 2008;56:16011607. 10. Ishikawa A, Yoneyama T, Hirota K, Miyake Y, Miyatake K. Professional oral health care reduces the number of oropharyngeal bacteria. J Dent Res 2008;87:594-598. 11. Scannapieco FA, Binkley CJ. Modest reduction in risk for ventilator-associated pneumonia in critically ill patients receiving mechanical ventilation following topical oral chlorhexidine. J Evid Based Dent Pract 2012;12:103-106. 12. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Risk factors for aspiration pneumonia in frail older people: a systematic literature review. J Am Med Dir Assoc 2011a;12:344-354. 13. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Meta-analysis of dysphagia and aspiration pneumonia in frail older people, a metaanalysis. J Dent Res 2011b;90:1398-1404. 14. van der Maarel-Wierink CD, Meijers JMM, De Visschere LMJ, de Baat C, Halfens RJG, Schols JMGA. Subjective dysphagia in older care home residents in the Netherlands. Submitted for publication. 15. Kerpiçlik F, Haenen A, Alblas J, Veldman-Ariesen MJ, van Benthem BHB. Surveillance Netwerk Infectieziekten Verpleeghuizen (SNIV). Referentiecijfers basis surveillance 2011. Bilthoven: Rijksinstituut voor Volksgezondheid en Milieu, 2012. 132

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16. O’Neill KH, Purdy M, Falk J, Gallo L. The Dysphagia Outcome and Severity Scale. Dysphagia 1999;14:139-145. 17. Dijkstra A, Tiesinga J, Plantinga L, Veltman G, Dassen TWN. Diagnostic accuracy of the care dependency scale. J Adv Nurs 2005;50:410-416. 18. O’Reilly M. Oral care of the critically ill: a review of the literature and guidelines for practice. Aust Crit Care 2003;16:101-110. 19. Berry AM, Davidson PM, Masters J, Rolls K. Systematic literature review of oral hygiene practices for intensive care patients receiving mechanical ventilation. Am J Crit Care 2007; 16:552-562. 20. El-Solh AA. Association between pneumonia and oral care in nursing home residents. Lung 2011;189:173–180. 21. Beraldo CC, Andrade D. Oral hygiene with chlorhexidine in preventing pneumonia associated with mechanical ventilation. J Bras Pneumol 2008;34:707-714. 22. Ghezzi EM, Ship JA. Systemic diseases and their treatments in the elderly: impact on oral health. J Public Health Dent 2000;60:289-296. 23. Kandelman D, Petersen PE, Ueda H. Oral health, general health, and quality of life in older people. Spec Care Dentist 2008;28:224-236.

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General discussion

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INTRODUCTION Aspiration pneumonia is causing high hospitalization rates, morbidity, and often death in frail older people [1]. The overall aim of this thesis was to explore the role of dysphagia and poor oral health, separately and in combination, on the development of aspiration pneumonia in frail older people. Five studies have been carried out, including two systematic literature reviews (Chapter 2 and 4), one meta-analysis (Chapter 3), one retrospective data-analysis of a crosssectional, multi-centre point prevalence measurement (Chapter 5) and one clinical crosssectional study (Chapter 6). Furthermore, a study design of a double-blind cluster randomized placebo-controlled trial was developed (Chapter 7). Critically reviewing the five studies, this chapter presents the main findings, considerations, and methodological issues of each study and presents recommendations for health care providers as well as recommendations for future research projects warranted with respect to each study. Finally, some overall conclusions and recommendations are described.

Study 1: Risk factors for aspiration pneumonia in frail older people: a systematic literature review Main findings and considerations The objective was to systematically review the literature published between January 2000 and April 2009 on the risk factors of aspiration pneumonia in frail older people and the contribution of bad oral health among the risk factors (Chapter 2). A comprehensive literature search was carried out. Twenty-one publications fulfilled the quality criteria, independently assessed by two authors. The included studies involved one case-cohort, twelve cohort, seven case-control and one cross-sectional study. Thirteen significant risk factors of aspiration pneumonia in frail older people could be identified. The results showed evidence level 2a (systematic review with homogeneity of cohort studies) for a positive relationship between aspiration pneumonia and the risk factors ‘age’, ‘male gender’, ‘lung diseases’, ‘dysphagia’, and ‘diabetes mellitus’. For the risk factors ‘severe dementia’, ‘angiotensin I-converting enzyme deletion/deletion genotype’, and ‘bad oral health’ evidence level 2b (individual cohort study) was found. The results showed evidence level 3a (systematic review with homogeneity of case-control studies) for a positive relationship between aspiration pneumonia and the risk factor ‘malnutrition’. For the risk factors ‘Parkinson’s disease’, ‘use of antipsychotic drugs’, and ‘use of proton pump inhibitors’ evidence level 3b (individual case-control study) was found. There was also evidence level 3b for the factor ‘use of angiotensin-converting enzyme inhibitors’ as a protective factor in the onset of aspiration pneumonia. Inconsistent evidence was found for the factors ‘cerebrovascular diseases’, ‘heart failure’, and ‘smoking’. Dysphagia might be a confounding factor in the relationship of aspiration pneumonia with the factors ‘severe dementia’, ‘Parkinson’s disease’, ‘cerebrovascular diseases’, 136

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‘malnutrition’, and ‘use of antipsychotic drugs’. The contribution of bad oral health among the risk factors seemed limited (evidence level 2b, individual cohort study). Methodological issues A limitation of the review results was the inconsistency of definitions used for the various risk factors. Dysphagia, for example, was defined as aspiration, absence of reflex cough after swallow, Logemann-aspiration, swallowing difficulty, and swallowing disorder. The dysphagiarelated factors ‘mechanically altered diet’, ‘suctioning use’, and ‘feeding tube’, although related to dysphagia, were not included because too much heterogeneity would have hindered an appropriate comparison of results. Another limitation when comparing different studies is the problem of adequately diagnosing aspiration pneumonia in frail older people. No validated diagnostic criteria seem to be available. In addition, the clinical symptoms of (aspiration) pneumonia are less clear in frail old than in young people. Moreover, in care home residents it is not always possible to make a chest radiograph to confirm the clinical diagnosis, which is recommended in most cases. These limitations might have contributed to the lack of conclusiveness after comparing the results of the various studies. Recommendation for health care providers The risk factors of aspiration pneumonia in frail older people, found in this study, might help health care providers to identify frail older people with a high risk of developing aspiration pneumonia. Awareness of the risk factors, noticing symptoms of aspiration attentively and arranging a consultation with a speech therapist for diagnosis and therapy in time, might decrease the prevalence of aspiration pneumonia. Recommendation for future research On the basis of this systematic literature review, it is not easy to assess the contribution of bad oral health among the risk factors of aspiration pneumonia in frail older people, because of the difficulty of comparing studies and study results. Future longitudinal research is warranted to assess whether improving oral health reduces aspiration pneumonia risk in frail older people.

Study 2: Meta-analysis of dysphagia and aspiration pneumonia in frail elders Main findings and considerations The results of the systematic literature review assessing risk factors for aspiration pneumonia, described in Chapter 2, underlined both the importance of a meta-analysis to assess a more precise estimate of the risk and the need to increase the understanding of the role of dysphagia in the development of aspiration pneumonia in frail older people. Therefore, the objective of the meta-analysis described in Chapter 3 was to assess the association of dysphagia with aspiration pneumonia in frail older people. The meta-analysis included 4 137

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cohort, 1 case-cohort, and 1 case-control study on dysphagia as a risk factor of aspiration pneumonia in frail older people. Using a random effect model, a positive correlation was found between dysphagia and aspiration pneumonia. An additional subgroup meta-analysis was performed with 4 cohort studies, all including patients with a cerebrovascular disease. Once again, a positive correlation was found between dysphagia and aspiration pneumonia. It was concluded that dysphagia is a serious risk factor of aspiration pneumonia in frail older people, particularly in those suffering from a cerebrovascular disease. Methodological issues Also in this study, the inconsistency in the descriptions of dysphagia as well as the previous mentioned inconsistency in diagnostic criteria of aspiration pneumonia in frail older people, were limitations hampering the assessment of clinical homogeneity. Furthermore, the literature search for risk factors of aspiration pneumonia in frail older people included publications published from January of the year 2000 onward. Excluding publications published before the year 2000 may have induced bias. Recommendation for health care providers The results confirm that frail older people with dysphagia are at greater risk of aspiration pneumonia when compared to frail older people without dysphagia. Furthermore, the subgroup meta-analysis showed that patients with cerebrovascular disease and dysphagia have an almost 13-fold higher risk of developing aspiration pneumonia when compared to patients with cerebrovascular disease, but without dysphagia. These findings might contribute to the awareness of health care providers for the care problem dysphagia. Noticing symptoms of aspiration in time and arranging a consultation with a speech therapist for diagnosing and therapy might decrease the prevalence of aspiration pneumonia. Recommendations for future research More research is warranted to find out whether dysphagia is also a significant risk factor of aspiration pneumonia in patients suffering from other diseases with dysphagia as complicating factor, such as dementia or Parkinson’s disease, and whether the risk of aspiration pneumonia in these patients may be decreased by supervised feeding, dietary modifications, swallowing therapy (compensatory strategies or exercises to strengthen swallowing muscles), or pharmacologic therapy [2]. In addition, assessing the effect of improving oral health care, the second modifiable factor after dysphagia, on the prevention of aspiration pneumonia would be of great interest.

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Study 3: Oral health care and aspiration pneumonia in frail older people: a systematic literature review Main findings and considerations The objective was to systematically review the literature on oral health care interventions in frail older people and the effect of these interventions on the incidence of aspiration pneumonia. Only five publications fulfilled the quality criteria, independently assessed by two authors. Two studies showed that improvement of oral health care diminished the risk of developing aspiration pneumonia and the risk of dying from aspiration pneumonia directly [3,4]. The three studies remaining showed that adequate oral health care decreased the amount of potential respiratory pathogens and suggested a reduction of the risk of aspiration pneumonia by improving the swallowing reflex and cough reflex sensitivity [5-7]. It was concluded that oral health care, consisting of tooth brushing after each meal, cleaning dentures once a day, and professional oral health care once a week, seems the best intervention to reduce the incidence of aspiration pneumonia. Methodological issues Assessing the risk of bias is important when conducting and reporting a systematic literature review [8]. The results of this systematic literature review showed that four of the five studies were carried out in one country, Japan, which may have resulted in some selection bias. The difference in methodological quality of the studies, might also have caused some bias. Furthermore, the outcome definitions are not the same across the different studies, hampering mutual comparison of the results. Consequently, performing a meta-analysis was not conceivable. Recommendation for health care providers To reduce the incidence of aspiration pneumonia, the results of this study recommend daily oral health care consisting of tooth brushing after each meal, cleaning dentures once a day, and professional oral health care once a week. Recommendation for future research More randomized controlled trials of high methodological quality, preferably carried out in various countries, are needed to assess the most efficacious oral health care intervention programme in reducing the incidence of aspiration pneumonia in frail older people.

Study 4: Subjective dysphagia in older care home residents in the Netherlands Main findings and considerations The objectives of this survey were to assess the prevalence of subjective dysphagia in care 139

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home residents in the Netherlands and to assess the associations of subjective dysphagia with feasible risk factors of dysphagia. Each year, many care homes in The Netherlands participate in the Dutch National Prevalence Survey of Care Problems (known as LPZ), with the purpose to create awareness of care problems and to improve the quality of care. Subjective dysphagia has been registered as a subdivision of the care problem ‘malnutrition’. In 2010, 119 (33%) out of the total number of 360 care homes in The Netherlands participated in the LPZ survey. Data of 8,119 care home residents aged 65 years or older were analyzed. Subjective dysphagia was present in 751 (9%) residents. A final prediction model for subjective dysphagia revealed several significant variables: scores ‘completely dependent’, ‘to a great extent dependent’, ‘partially dependent’ and ‘to a great extent independent’ of the Care Dependency Scale, ‘malnutrition’, ‘comorbidity’, and the disease clusters ‘nervous system disorder’ and ‘cerebrovascular disease/ hemiparesis’. It seemed justified to conclude that subjective dysphagia is a relevant care problem in older care home residents in the Netherlands. In order of importance (ranged from high to low) lower functional status, nervous system disorders including (the consequences of) cerebrovascular diseases, malnutrition, and comorbidity seemed significant predicting factors of subjective dysphagia in care home residents. Methodological issues One limitation of this study was the absence of a speech therapist in the research team for assessing dysphagia objectively in all care home residents. Furthermore, this survey was a secondary analysis of LPZ data and dysphagia was assessed as a subdivision of the care problem ‘malnutrition’. Thus, assessing feasible associations of dysphagia with diseases was not the primary objective of the LPZ survey, making it difficult to draw radical conclusions. A third limitation was that the LPZ survey arranged diseases in associated clusters. Consequently, the diseases of every resident could not be well specified, limiting the statistical analysis. Recommendation for health care providers The predicting factors of subjective dysphagia in care home residents, found in this study, might help health care providers to identify care home residents with a high risk of dysphagia and, consequently, developing aspiration pneumonia. Registering complaints of dysphagia or symptoms of aspiration in time and arranging a consultation with a speech therapist for diagnosing and therapy might decrease the prevalence of aspiration pneumonia. Recommendation for future research For properly diagnosing objective dysphagia, a video fluoroscopic swallowing investigation is the golden standard [9]. However, it is usually not possible or even contra-indicated to refer older care home residents for such major investigation. For future research, it was recommended to assess dysphagia by a speech therapist.

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Study 5: Dysphagia in care home residents, assessed by speech therapists, and its feasible risk factors Main findings and considerations The first objective of this study was to determine the prevalence of dysphagia in physicallydisabled and cognitively-impaired care home residents in the Netherlands, assessed by speech therapists. The second objective was to determine feasible associations of dysphagia with Parkinson’s disease (a nervous system disorder), cerebrovascular disease, dementia, and using antipsychotics, proton pump inhibitors, and angiotensin-converting enzyme inhibitors. Five experienced speech therapists assessed systematically 115 primarily physically-disabled and 88 primarily cognitively-impaired care home residents aged 60 years or older in the first week after admission to a care home. First, the speech therapists interviewed the residents. When a resident was not able to response, the questions were responded by the ward care provider. Second, a swallowing observation was performed. The speech therapists assessed in 43 (21.2%) residents the presence of dysphagia. The difference in prevalence of dysphagia between physically-disabled residents (26.1%) and cognitively-impaired residents (14.8%) was not statistically significant. The final prediction model for dysphagia, using multivariate logistic regression analysis, showed Parkinson’s disease as a significant factor. No significant associations of dysphagia with cerebrovascular disease, dementia, and using antipsychotics, proton pump inhibitors, and angiotensin-converting enzyme inhibitors were found. It seemed justified to conclude that dysphagia, assessed by speech therapists, is a relevant care problem in primarily physicallydisabled and also in primarily cognitively-impaired care home residents in the Netherlands. In this study, Parkinson’s disease was the only significant predicting factor for dysphagia. Methodological issues The golden standard in diagnosing dysphagia is a video fluoroscopic swallowing investigation [9]. However, it is not usual to refer older care home residents for such major investigation, because a hospital visit is more likely to be burdening than yielding beneficial effects. Nevertheless, the lack of a video fluoroscopic swallowing investigation has to be mentioned as a limitation of this study. A second limitation was that no inter- and intra-reliability tests of the speech therapists’ assessments have been performed. However, the speech therapists were experienced with the swallowing assessment, because the protocol was accurately implemented one year before the start of this study. Recommendation for health care providers This study showed that 20% of the care home residents suffered from objective dysphagia and, consequently, were at risk of developing aspiration pneumonia. The results of this study might contribute to the awareness of health care providers of the care problem ‘dysphagia’, particularly in Parkinson’s disease patients. Noticing symptoms of aspiration in time and arranging a consultation with a speech therapist for diagnosing and therapy might decrease the prevalence of aspiration pneumonia. 141

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Recommendation for future research More research on the incidence of objective dysphagia and the related aspiration risk in care home residents with validated screening tools is warranted to confirm the results of this study and to further assess the risk factors of dysphagia. Maybe, the recently validated Modified Mann Assessment of Swallowing Ability, a physician-administered screening tool for dysphagia, originally developed for screening of dysphagia in patients with acute cerebrovascular diseases, might be useful [10]. Pulse oximetry, using coughing, choking, and voice alteration as endpoints, might be a valuable addition to the water swallowing evaluation for the assessment of dysphagia by speech therapists [11].

Study 6: The effect of daily applying a 0.05% chlorhexidine solution on the incidence of aspiration pneumonia in care home residents: design of a doubleblind cluster randomized placebo-controlled trial Improving oral health care might decrease the risk of developing aspiration pneumonia by decreasing the concentration of potentially respiratory pathogens. A study design of a doubleblind cluster randomized placebo-controlled trial was developed to assess whether oral hygiene care with the addition of using a 0.05% chlorhexidine-containing solution to usual daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia. The method of using the 0.05% chlorhexidine-containing solution or placebo is depending on the severity of the dysphagia. Residents who tolerate thin liquids have to rinse with the 0.05% chlorhexidine-containing solution or placebo for 30 seconds twice daily immediately after the usual oral health care. In residents with severe dysphagia who cannot tolerate thin liquids, nurses have to clean their teeth, gums, tongue, palate, and buccal mucosa with a gauze containing 0.05% chlorhexidine-containing solution or placebo twice daily immediately after the usual oral health care. The favourable results of studies using chlorhexidine to prevent pneumonia in patients dependent on mechanical ventilation are promising for a similar result in preventing aspiration pneumonia in physically-disabled care home residents with dysphagia [12]. The literature shows that structurally adequate oral health care is needed to maintain and improve the quality of life of older people [13,14]. Preventing aspiration pneumonia by improving oral health care may be a significant contribution to the quality of life of care home residents.

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Overall conclusions and recommendations The overall aim of this thesis was to explore the role of dysphagia and poor oral health, separately or in combination, in the development of aspiration pneumonia in frail older people. Study 1, a systematic literature review assessing risk factors of aspiration pneumonia, showed that dysphagia and poor oral health are significant risk factors. The results of the study lead to two future research recommendations: a study assessing an exact estimate of the risk and the role of dysphagia in the development of aspiration pneumonia in frail older people and a study to assess whether improving oral health reduces aspiration pneumonia risk in frail older people. Study 2, a meta-analysis of dysphagia and aspiration pneumonia in frail older people, confirmed that dysphagia is a serious risk factor, particularly in those frail older people suffering from a cerebrovascular disease. More research is warranted to find out whether dysphagia is also a significant risk factor for aspiration pneumonia in patients suffering from other diseases with dysphagia as complicating factor, such as dementia or Parkinson’s disease, and whether the risk of aspiration pneumonia in these patients may decrease by supervised feeding, dietary modifications, swallowing therapy (compensatory strategies or exercises to strengthen swallowing musculature), or pharmacologic therapy [2]. Study 3, a systematic literature review on oral health care and aspiration pneumonia in frail older people, presented two studies showing that improvement of oral health care diminished the risk of developing aspiration pneumonia and the risk of dying from aspiration pneumonia directly. Performing additional randomized controlled trials is recommended to assess the most efficacious oral health care intervention programme in reducing the incidence of aspiration pneumonia in frail older people. Study 4, a retrospective data-analysis of the Dutch National Prevalence Survey of Care Problems into the prevalence of subjective dysphagia in care home residents, found subjective dysphagia as a relevant care problem. For future research, it was recommended to assess dysphagia objectively by a speech therapist. Study 5, a clinical cross-sectional study assessing objective dysphagia in care home residents, found an incidence of 21%. More research on the incidence of dysphagia and the related aspiration risk in care home residents, using validated screening tools, is warranted to confirm the results of this study and to further assess the risk factors of dysphagia.

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REFERENCES 1. Welte T, Torres A, Nathwani D. Clinical and economic burden of community-acquired pneumonia among adults in Europe. Thorax 2012;67:71-79. 2. Marik PE, Kaplan D. Aspiration pneumonia and dysphagia in the elderly. Chest 2003; 124:328-336. 3. Yoneyama T, Yoshida M, Ohrui T, et al. Oral Care Working Group. Oral care reduces pneumonia in older patients in nursing homes. J Am Geriatr Soc 2002;50:430-433. 4. Bassim CW, Gibson G, Ward T, Paphides BM, Denucci DJ. Modification of the risk of mortality from pneumonia with oral hygiene care. J Am Geriatr Soc 2008;56:16011607. 5. Ishikawa A, Yoneyama T, Hirota K, Miyake Y, Miyatake K. Professional oral health care reduces the number of oropharyngeal bacteria. J Dent Res 2008;87:594-598. 6. Yoshino A, Ebihara T, Ebihara S, Fuji H, Sasaki H. Daily oral care and risk factors for pneumonia among elderly nursing home patients. JAMA 2001;286:2235-2236. 7. Watando A, Ebihara S, Ebihara T, et al. Daily oral care and cough reflex sensitivity in elderly nursing home patients. Chest 2004;126:1066-1070. 8. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ 2009;339:b2700. 9. Logemann JA, Larsen K. Oropharyngeal dysphagia: pathophysiology and diagnosis for the anniversary issue of Diseases of the Esophagus. Dis Esophagus 2012;25:299-304. 10. Antonios N, Carnaby-Mann G, Crary M, et al. Analysis of a physician tool for evaluating dysphagia on an inpatient stroke unit: the modified Mann Assessment of Swallowing Ability. J Stroke Cerebrovasc Dis 2010;19:49-57. 11. Bours GJ, Speyer R, Lemmens J, Limburg M, de Wit R. Bedside screening tests vs. videofluoroscopy or fibreoptic endoscopic evaluation of swallowing to detect dysphagia in patients with neurological disorders: systematic review. J Adv Nurs 2009;65:477-493. 12. Beraldo CC, Andrade D. Oral hygiene with chlorhexidine in preventing pneumonia associated with mechanical ventilation. J Bras Pneumol 2008,34:707-714. 13. Ghezzi EM, Ship JA. Systemic diseases and their treatments in the elderly: impact on oral health. J Public Health Dent 2000;60:289-296. 14. Kandelman D, Petersen PE, Ueda H. Oral health, general health, and quality of life in older people. Spec Care Dentist 2008;28:224-236.

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CHAPTER 1: GENERAL INTRODUCTION (Aspiration) pneumonia is a significant and prevalent disease in frail older people with dysphagia and bad oral health as feasible risk factors. The literature shows prevalence estimations for dysphagia in care home residents of 50-75%. However, exact data on this topic are very scarce. Some evidence is available for the association between oral biofilm presence and onset of aspiration pneumonia in frail older people. The overall aim of this thesis was to explore the role of dysphagia and poor oral health, separately or in combination, on the development of aspiration pneumonia in frail older people. Related to this aim, the following main research questions were formulated: 1. Which are the risk factors for aspiration pneumonia in frail older people and what is the contribution of bad oral health among the risk factors? 2. What is the association of dysphagia with aspiration pneumonia in frail older people? 3. What kind of oral health care interventions in frail older people have been provided and what was the effect on the incidence of aspiration pneumonia? 4. What is the prevalence of subjective dysphagia in care home residents in the Netherlands? 5. Which are the associations of subjective dysphagia with feasible risk factors of dysphagia in care home residents? 6. What is the prevalence of objective dysphagia in physically-disabled and cognitivelyimpaired care home residents in the Netherlands? 7. Which are the associations of objective dysphagia with feasible risk factors of dysphagia in care home residents? 8. What is an adequate study design to assess whether a 0.05% chlorhexidine-containing solution in addition to usual daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia?

CHAPTER 2: RISK FACTORS FOR ASPIRATION PNEUMONIA IN FRAIL OLDER PEOPLE: A SYSTEMATIC LITERATURE REVIEW To address the research question ‘Which are the risk factors for aspiration pneumonia in frail older people and what is the contribution of bad oral health among the risk factors?’, a systematic literature review was conducted. The electronic retrieval systems and databases searched for relevant articles were: Pubmed (Medline), Web of Science, Cochrane Library, EMBASE and CINAHL. Only publications, published in English in the period January 2000 to April 2009, with regard to hospitalized, institutionalized, or frail home-dwelling people of 60 years and older were eligible. Two authors independently assessed the publications for their methodological quality. Unadjusted and adjusted odds ratios and their corresponding 95% confidence intervals for respective risk factors related to aspiration pneumonia were extracted from included 148

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publications. The results were evaluated according to the levels of evidence of the Oxford Centre for Evidence-based Medicine. A total of 21 publications fulfilled the quality criteria. Evidence level 2a (systematic review with homogeneity of cohort studies) was found for a positive relationship between aspiration pneumonia and age, male gender, lung diseases, dysphagia, and diabetes mellitus; 2b (individual cohort study) for severe dementia, angiotensin I-converting enzyme deletion/deletion genotype, and bad oral health; 3a (systematic review with homogeneity of case-control studies) for malnutrition; 3b (individual case-control study) for Parkinson’s disease and the use of antipsychotic drugs, proton pump inhibitors, and angiotensin-converting enzyme inhibitors. The contribution of bad oral health among the risk factors seems limited.

CHAPTER 3: META-ANALYSIS OF DYSPHAGIA AND ASPIRATION PNEUMONIA IN FRAIL ELDERS To address the research question ‘What is the association of dysphagia with aspiration pneumonia in frail older people?’ a meta-analysis of 4 cohort, 1 case-cohort, and 1 case-control study on dysphagia as a risk factor of aspiration pneumonia in frail older people, from the results of the systematic literature review assessing risk factors for aspiration pneumonia, was performed. Using a random effects model, we found a positive correlation between dysphagia and aspiration pneumonia: OR = 9.84; 95% CI = 4.15 - 23.33 (test for statistical homogeneity: p < 0.001). Then, a subgroup meta-analysis was performed with 4 cohort studies, all including patients with a cerebrovascular disease. Once again, a positive correlation was found between dysphagia and aspiration pneumonia: OR = 12.93; 95% CI = 8.61 - 19.44. The test for statistical homogeneity revealed no statistically significant result (p = 0.15). It was concluded that dysphagia is a serious risk factor for aspiration pneumonia in frail older people, particularly in those suffering from a cerebrovascular disease.

CHAPTER 4: ORAL HEALTH CARE AND ASPIRATION PNEUMONIA IN FRAIL OLDER PEOPLE: A SYSTEMATIC LITERATURE REVIEW To address the research question ‘What kind of oral health care interventions in frail older people have been provided and what was the effect on the incidence of aspiration pneumonia?’ a systematic literature review was conducted. The electronic retrieval systems and databases searched for relevant articles were: Pubmed, Web of Science, Cochrane Library, EMBASE and CINAHL. Only publications with regard to hospitalized or institutionalized older people, who were not dependent on mechanical ventilation were eligible. Two authors independently assessed the publications for their methodological quality. Five publications were included and reviewed. Two studies showed that improvement of oral health care diminished the risk of developing aspiration pneumonia and the risk of dying from aspiration pneumonia directly. The three studies remaining showed that adequate oral health care decreased the amount of 149

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potential respiratory pathogens and suggested a reduction in the risk of aspiration pneumonia by improving the swallowing reflex and cough reflex sensitivity. It was concluded that according to the results of the current systematic literature review oral health care, consisting of tooth brushing after each meal, cleaning dentures once a day, and professional oral health care once a week, seems the best intervention to reduce the incidence of aspiration pneumonia.

CHAPTER 5: SUBJECTIVE DYSPHAGIA IN OLDER CARE HOME RESIDENTS IN THE NETHERLANDS To address the research questions ‘What is the prevalence of subjective dysphagia in care home residents in the Netherlands?’ and ‘Which are the associations of subjective dysphagia with feasible risk factors of dysphagia in care home residents?’, a retrospective data analysis of a multi-centre, cross-sectional study was performed. Data of 8,119 care home residents aged 65 years or older were analyzed. Subjective dysphagia was assessed by a resident’s response to a dichotomous question with regard to experiencing swallowing problems. Several residents’ data were collected: gender, age, (number of) diseases, the presence of malnutrition, Care Dependency Scale scores, and Body Mass Index. Subjective dysphagia was present in 751 (9%) residents. A final prediction model for subjective dysphagia after multivariate backward stepwise regression analysis revealed several significant variables: CDS scores ‘completely dependent’ (OR 42.18; 95% CI 25.80-68.94), ‘to a great extent dependent’ (OR 12.71; 95% CI 7.84-20.63), ‘partially dependent’ (OR 5.30; 95% CI 3.19-8.80), and to a great extent independent (OR 2.24; 95% CI 1.27-4.00), ‘malnutrition’ (OR 1.55; 95% CI 1.28-1.86), ‘comorbidity’ (OR 1.07; 95% CI 1.01-1.14), and the disease clusters ‘nervous system disorder’ (OR = 1.59; 95% CI 1.23-2.05) and ‘cerebrovascular disease/hemiparesis’ (OR = 1.77; 95% CI 1.47-2.14). It seemed justified to conclude that subjective dysphagia is a relevant care problem in older care home residents in the Netherlands. In order of importance (ranged from high to low) lower functional status, nervous system disorders including (the consequences of) cerebrovascular diseases, malnutrition, and comorbidity seem significant predicting factors for subjective dysphagia in care home residents.

CHAPTER 6: DYSPHAGIA IN CARE HOME RESIDENTS, ASSESSED BY SPEECH THERAPISTS, AND ITS FEASIBLE RISK FACTORS To address the research questions: ‘What is the prevalence of objective dysphagia in physicallydisabled and cognitively-impaired care home residents in the Netherlands?’ and ‘Which are the associations of objective dysphagia with feasible risk factors of dysphagia in care home residents?’, five experienced speech therapists assessed systematically 115 primarily physicallydisabled and 88 primarily cognitively-impaired care home residents aged 60 years or older in the first week after admission to the care home. First, the speech therapists interviewed 150

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the residents. Second, a water swallowing observation was performed. Several residents’ data were also collected from the medical records, including age, gender, status of admission ‘primarily physically disabled’ or ‘primarily cognitively impaired’, registered diagnoses and actual medication use. The speech therapists assessed in 43 (21.2%) residents the presence of dysphagia. The difference in prevalence of dysphagia between physically-disabled residents (26.1%) and cognitively-impaired residents (14.8%) was not statistically significant. The final prediction model for dysphagia, using multivariate logistic regression analysis, showed Parkinson’s disease as a significant factor (OR = 5.11; CI 1.49 … 17.52). It seemed justified to conclude that dysphagia and, consequently, aspiration risk, assessed by speech therapists, is a relevant care problem in primarily physically-disabled and also in primarily cognitively-impaired care home residents in the Netherlands. Parkinson’s disease was the only significant predicting factor for dysphagia.

CHAPTER 7: The effect of daily applying a 0.05% chlorhexidine solution on the incidence of aspiration pneumonia in care home residents: design of a double-blind cluster randomized placebo-controlled trial This chapter describes a study design which will address the research question ‘What is an adequate study design to assess whether a 0.05% chlorhexidine-containing solution in addition to usual daily oral hygiene care reduces the incidence of pneumonia in physically-disabled care home residents with dysphagia?’. The study is designed as a double-blind cluster randomized placebo-controlled trial, with care home wards as units of randomization. The randomization will be balanced for dysphagia severity and care dependency. During one year, 500 physicallydisabled care home residents with dysphagia will be followed. The intervention consists of applying a 0.05% chlorhexidine-containing solution twice daily immediately after the usual oral hygiene care, whereas the control group receives a placebo. The application method of the 0.05% chlorhexidine-containing solution, rinsing the solution or cleaning the oral cavity with a gauze containing 0.05% chlorhexidine-containing solution, is depending on the severity of the dysphagia. Other research data which will be gathered are: age, gender, diseases diagnosed, dysphagia severity, care dependency, medications used actually, number of teeth and implants present, and presence of removable dentures. The study outcome is the incidence of pneumonia diagnosed by a physician, using a set of strictly described criteria. The effect of the intervention on the incidence of pneumonia will be determined using Cox regression analysis. Using cluster randomization may result in random effect and cluster selection bias. Therefore, randomization will be balanced for dysphagia severity and care dependency. Furthermore, a frailty model will be included in the Cox regression analysis to take into account the clustering of data within care home wards.

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CHAPTER 8: GENERAL DISCUSSION This chapter presents a general discussion with regard to the studies reported in the chapters 2-6, two systematic literature reviews, one meta-analysis, one retrospective data-analysis of a cross-sectional, multi-centre point prevalence measurement, and one clinical cross-sectional study. The systematic literature review assessing risk factors of aspiration pneumonia, showed that dysphagia and poor oral health are significant risk factors. A limitation of the results was the inconsistency of definitions used for the various risk factors and the problem of adequately diagnosing aspiration pneumonia in frail older people. These limitations might have contributed to the lack of conclusiveness after comparing the results of the various studies. Future research recommendations were: assessing an exact estimate of the risk and the role of dysphagia in the development of aspiration pneumonia in frail older people and assessing whether improving oral health reduces aspiration pneumonia risk in frail older people. The metaanalysis of dysphagia and aspiration pneumonia in frail older people, confirmed that dysphagia is a serious risk factor, particularly in those frail older people suffering from a cerebrovascular disease. Also in this study, the inconsistency in the descriptions of dysphagia as well as the problem of adequately diagnosing aspiration pneumonia in frail older people, were limitations hampering the assessment of clinical homogeneity. Furthermore, excluding publications published before the year 2000 may have induced bias. More research is warranted to find out whether dysphagia is also a significant risk factor for aspiration pneumonia in patients suffering from other diseases with dysphagia as complicating factor and whether the risk of aspiration pneumonia in these patients may decrease by any therapy. The systematic literature review on oral health care and aspiration pneumonia in frail older people showed that improvement of oral health care diminished the risk of developing aspiration pneumonia and the risk of dying from aspiration pneumonia directly. Four of the five studies were carried out in one country, Japan, which may have resulted in some selection bias. The difference in methodological quality of the studies, might also have caused some bias. Furthermore, the different outcome definitions across the studies, were hampering mutual comparison of the results. Performing additional randomized controlled trials is recommended to assess the most efficacious oral health care intervention programme in reducing the incidence of aspiration pneumonia in frail older people. The retrospective data-analysis of the Dutch National Prevalence Survey of Care Problems (LPZ) into the prevalence of subjective dysphagia in care home residents, found subjective dysphagia as a relevant care problem. One limitation of this study was the absence of a speech therapist for assessing dysphagia objectively. Furthermore, this survey was a secondary analysis of LPZ data and dysphagia was assessed as a subdivision of the care problem ‘malnutrition’. Thus, assessing feasible associations of dysphagia with diseases was not the primary objective of the LPZ survey, making it difficult to draw radical conclusions. A third limitation was that the LPZ survey arranged diseases in associated clusters, limiting the statistical analysis. For future research, it was recommended to assess dysphagia objectively by a speech therapist. The clinical cross-sectional study assessing objective dysphagia in care home 152

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residents, found an incidence of 20%. The lack of a video fluoroscopic swallowing investigation has to be mentioned as a limitation of this study. A second limitation was that no inter- and intra-reliability tests of the speech therapists’ assessments have been performed. More research on the incidence of dysphagia and the related aspiration risk in care home residents, using validated screening tools, is warranted to confirm the results of this study and to further assess the risk factors of dysphagia.

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Samenvatting

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HOOFDSTUK 1: ALGEMENE INLEIDING (Aspiratie)pneumonie is een ernstige en veelvoorkomende ziekte onder kwetsbare ouderen met dysfagie en slechte mondgezondheid als potentiële risicofactoren. De literatuur vermeldt schattingen van de prevalentie van dysfagie bij verpleeghuisbewoners van 50-75%. Exacte gegevens zijn echter nauwelijks voorhanden. Er bestaat wel enig wetenschappelijk bewijs voor een relatie tussen de aanwezigheid van orale biofilm en het ontwikkelen van aspiratiepneumonie bij kwetsbare ouderen. De algemene doelstelling van dit proefschrift was te onderzoeken welke rol dysfagie en slechte mondgezondheid, apart of in combinatie, spelen bij de ontwikkeling van aspiratiepneumonie onder kwetsbare ouderen. In dit verband zijn de volgende onderzoeksvragen geformuleerd: 1. Welke factoren zijn risicofactoren voor het ontstaan van een aspiratiepneumonie bij kwetsbare ouderen en welke bijdrage levert een slechte mondgezondheid hieraan? 2. Welke relatie bestaat er tussen dysfagie en aspiratiepneumonie bij kwetsbare ouderen? 3. Welke mondzorginterventies zijn reeds toegepast bij kwetsbare ouderen en welk effect hadden deze interventies op de incidentie van aspiratiepneumonie? 4. Wat is de prevalentie van subjectieve dysfagie onder verpleeghuisbewoners in Nederland? 5. Welke relaties bestaan er tussen subjectieve dysfagie en de potentiële risicofactoren voor dysfagie bij verpleeghuisbewoners? 6. Wat is in Nederland de prevalentie van objectieve dysfagie onder verpleeghuisbewoners met een lichamelijke en onder verpleeghuisbewoners met een cognitieve beperking? 7. Welke relaties bestaan er tussen objectieve dysfagie en de potentiële risicofactoren voor dysfagie bij verpleeghuisbewoners? 8. Welke onderzoeksopzet is geschikt om vast te stellen of het gebruik van een oplossing van 0,05% chloorhexidine als toevoeging op de dagelijkse mondverzorging de incidentie van pneumonie onder verpleeghuisbewoners met een lichamelijke beperking doet afnemen?

HOOFDSTUK 2: RISICOFACTOREN VOOR ASPIRATIEPNEUMONIE BIJ KWETSBARE OUDEREN: EEN SYSTEMATISCH LITERATUURONDERZOEK Om antwoord te geven op de onderzoeksvraag ‘Welke factoren zijn risicofactoren voor het ontstaan van een aspiratiepneumonie bij kwetsbare ouderen en welke bijdrage levert een slechte mondgezondheid hieraan?’, is een systematisch literatuuronderzoek verricht. Gezocht werd in de volgende gegevensbestanden: Pubmed (Medline), Web of Science, Cochrane Library, EMBASE en CINAHL. Alleen Engelstalige artikelen die zijn gepubliceerd in de periode 156

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van januari 2000 tot april 2009 en die betrekking hadden op ouderen van ten minste 60 jaar die waren opgenomen in een ziekenhuis of een verpleeghuis of kwetsbare ouderen die thuis woonden, kwamen in aanmerking. Twee onderzoekers beoordeelden, onafhankelijk van elkaar, de publicaties op basis van de kwaliteit van de toegepaste methodologie. Van de verschillende risicofactoren voor aspiratiepneumonie werden de gecorrigeerde en de niet-gecorrigeerde oddsratio’s en de daarbij behorende 95% betrouwbaarheidsintervallen geregistreerd. De resultaten werden beoordeeld op basis van de criteria voor het niveau van wetenschappelijk bewijs die worden gehanteerd door het Oxford Centre for Evidence-based Medicine. Eenentwintig publicaties voldeden aan de kwaliteitscriteria voor de methodologie. Bewijsniveau 2a (systematisch literatuuronderzoek van homogene cohortonderzoeken) werd gevonden voor de associatie tussen aspiratiepneumonie en leeftijd, mannelijk geslacht, longziekten, dysfagie en diabetes mellitus; bewijsniveau 2b (individueel cohortonderzoek) voor ernstige dementie, het Deletie/Deletie-genotype van het angiotensine I-converterend enzym en slechte mondgezondheid; bewijsniveau 3a (systematisch literatuuronderzoek van homogene patiënt-controleonderzoeken) voor ondervoeding; bewijsniveau 3b (individueel patiënt-controleonderzoek) voor de ziekte van Parkinson en voor het gebruik van antipsychotica, protonpompremmers en ACE (angiotensine I-converterend enzym)-remmers. De bijdrage van slechte mondgezondheid aan deze risicofactoren lijkt beperkt.

HOOFDSTUK 3: META-ANALYSE VAN DYSFAGIE EN ASPIRATIEPNEUMONIE BIJ KWETSBARE OUDEREN Om antwoord te geven op de onderzoeksvraag ‘Welke relatie bestaat er tussen dysfagie en aspiratiepneumonie bij kwetsbare ouderen?’, werd een meta-analyse uitgevoerd van 4 cohortonderzoeken, 1 patiënt-cohortonderzoek en 1 patiënt-controleonderzoek uit het systematische literatuuronderzoek naar de risicofactoren voor aspiratiepneumonie bij kwetsbare ouderen. Met behulp van een statistisch model werd een positieve correlatie gevonden tussen dysfagie en aspiratiepneumonie: OR = 9.84; 95% CI = 4.15 - 23.33 (toets voor statistische homogeniteit: p < 0.001). Vervolgens werd een meta-analyse uitgevoerd van de 4 cohortonderzoeken die alle over patiënten met een cerebrovasculair accident gingen. Opnieuw werd een positieve correlatie gevonden tussen dysfagie en aspiratiepneumonie: OR = 12.93; 95% CI = 8.61 - 19.44. De toets voor statistische homogeniteit wees geen statistisch significant resultaat uit (p = 0,15). Geconcludeerd werd dat dysfagie een belangrijke risicofactor is voor aspiratiepneumonie bij kwetsbare ouderen, vooral bij ouderen met een cerebrovasculair accident.

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HOOFDSTUK 4: MONDZORG EN ASPIRATIEPNEUMONIE BIJ KWETSBARE OUDEREN: EEN SYSTEMATISCH LITERATUURONDERZOEK Dit hoofdstuk richtte zich op de onderzoeksvraag ‘Welke mondzorginterventies zijn reeds toegepast bij kwetsbare ouderen en welk effect hadden deze interventies op de incidentie van aspiratiepneumonie?’. Een systematisch literatuuronderzoek werd verricht en daarbij werd in de volgende gegevensbestanden gezocht naar relevante publicaties: Pubmed, Web of Science, Cochrane Library, EMBASE and CINAHL. Enkel onderzoeken die betrekking hadden op ouderen die waren opgenomen in een ziekenhuis of een verpleeghuis en die niet afhankelijk waren van mechanische beademing, kwamen voor inclusie in aanmerking. Twee onderzoekers beoordeelden, onafhankelijk van elkaar, de publicaties op basis van de kwaliteit van de toegepaste methodologie. Vijf publicaties werden geïncludeerd en beschreven. Twee onderzoeken toonden aan dat verbetering van de mondzorg het risico op het ontwikkelen van aspiratiepneumonie en het risico op overlijden aan een aspiratiepneumonie deed afnemen. De andere drie onderzoeken toonden aan dat adequate mondzorg de concentratie potentiële pathogene respiratoire micro-organismen deed afnemen en suggereerden een afname van het risico op aspiratiepneumonie door verbetering van de slikreflex en de hoestreflex. Geconcludeerd werd dat volgens de resultaten van dit systematisch literatuuronderzoek mondverzorging bestaande uit tandenpoetsen na elke maaltijd, reinigen van gebitsprothesen één maal per dag en professionele mondreiniging één maal per week, de beste interventie lijkt om de incidentie van aspiratiepneumonie te reduceren.

HOOFDSTUK 5: SUBJECTIEVE DYSFAGIE BIJ OUDERE VERPLEEGHUISBEWONERS IN NEDERLAND In dit hoofdstuk werd een antwoord op de volgende onderzoeksvragen gezocht ‘Wat is de prevalentie van subjectieve dysfagie onder verpleeghuisbewoners in Nederland?’en ‘Welke relaties bestaan er tussen subjectieve dysfagie en de potentiële risicofactoren voor dysfagie bij verpleeghuisbewoners?’. De gegevens van een cross-sectioneel onderzoek onder 8.119 bewoners van meerdere verpleeghuizen in de leeftijd van 65 jaar of ouder werden retrospectief geanalyseerd. Subjectieve dysfagie was vastgesteld door de verpleeghuisbewoners de vraag te stellen of zij problemen hadden met slikken. Daarnaast werden de volgende gegevens verzameld: geslacht, leeftijd, (aantal) ziekten, de aanwezigheid van ondervoeding en hun scores op de Care Dependency Scale (CDS) en de Body Mass Index (BMI). Subjectieve dysfagie werd geconstateerd bij 751 (9%) verpleeghuisbewoners. Na een stapsgewijze multivariate logistische regressie-analyse werden diverse variabelen gevonden die een significante rol speelden: CDS-scores ‘volledig zorgafhankelijk’ (OR 42.18; 95% CI 25.80-68.94), ‘voor een groot deel zorgafhankelijk’ (OR 12.71; 95% CI 7.84-20.63), ‘gedeeltelijk zorgafhankelijk’ (OR 5.30; 95% CI 3.19-8.80), en ‘voor een groot deel onafhankelijk van zorg’ (OR 2.24; 95% CI 1.27158

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4.00), ‘ondervoeding’ (OR 1.55; 95% CI 1.28-1.86), ‘comorbiditeit’ (OR 1.07; 95% CI 1.01-1.14) en de ziekteclusters ‘aandoeningen van het zenuwstelsel’ (OR = 1.59; 95% CI 1.23-2.05) en ‘cerebrovasculaire ziekten/hemiparese’ (OR = 1.77; 95% CI 1.47-2.14). Het lijkt verantwoord te concluderen dat subjectieve dysfagie een relevant probleem is in de zorg voor oudere verpleeghuisbewoners in Nederland. In volgorde van belangrijkheid (geordend van sterk naar minder sterk) lijken de volgende factoren significante risicofactoren voor subjectieve dysfagie bij oudere verpleeghuisbewoners: zorgafhankelijkheid, aandoeningen van het zenuwstelsel inclusief (de gevolgen van) een cerebrovasculair accident, ondervoeding en comorbiditeit.

HOOFDSTUK 6: DOOR LOGOPEDISTEN GEDIAGNOSTICEERDE DYSFAGIE BIJ VERPLEEGHUISBEWONERS EN DE MOGELIJKE RISICOFACTOREN VAN DYSFAGIE Dit hoofdstuk richtte zich op de onderzoeksvragen ‘Wat is in Nederland de prevalentie van objectieve dysfagie onder verpleeghuisbewoners met een lichamelijke en onder verpleeghuisbewoners met een cognitieve beperking?’ en ‘Welke relaties bestaan er tussen objectieve dysfagie en de potentiële risicofactoren voor dysfagie bij verpleeghuisbewoners?’. Vijf ervaren logopedisten onderzochten systematisch 115 verpleeghuisbewoners met primair een lichamelijk beperking en 88 verpleeghuisbewoners met primair een cognitieve beperking van 60 jaar of ouder in de eerste week na opname. Eerst werden de verpleeghuisbewoners geïnterviewd door een logopedist. Vervolgens werd een watersliktest uitgevoerd. Daarnaast werden de volgende gegevens verzameld uit de patiëntendossiers: leeftijd, geslacht, status bij opname ‘primair lichamelijke beperking’ of ‘primair cognitieve beperking’, de geregistreerde diagnosen en huidige medicatie. De logopedisten constateerden bij 43 (21,2%) verpleeghuisbewoners dysfagie. Het verschil in de prevalentie van dysfagie tussen bewoners met een lichamelijke (26,1%) en cognitieve beperking (14,8%) was niet statistisch significant. Na een stapsgewijze multivariate logistische regressie-analyse bleek de ziekte van Parkinson een significante variabele (OR = 5,11; CI 1,49 … 17,52). Het leek verantwoord te concluderen dat dysfagie, gediagnosticeerd door logopedisten, een relevant probleem is in de zorg voor verpleeghuisbewoners met primair een lichamelijke beperking en voor verpleeghuisbewoners met primair een cognitieve beperking in Nederland. In dit onderzoek kwam alleen de ziekte van Parkinson als significante risicofactor voor dysfagie naar voren.

HOOFDSTUK 7: HET EFFECT VAN CHLOORHEXIDINE OP DE INCIDENTIE VAN ASPRITATIEPNEUMONIE BIJ VERPLEEGHUISBEWONERS: ONDERZOEKSOPZET VAN EEN DUBBELBLIND CLUSTERGERANDOMISEERD PLACEBO-GECONTROLEERD ONDERZOEK Dit hoofdstuk geeft antwoord op de onderzoeksvraag ‘Welke onderzoeksopzet is geschikt om vast te stellen of het gebruik van een oplossing van 0,05% chloorhexidine als toevoeging 159

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op de dagelijkse mondverzorging de incidentie van pneumonie onder verpleeghuisbewoners met een lichamelijke beperking doet afnemen?’. De onderzoeksopzet is een dubbel-blind clustergerandomiseerd placebo-gecontroleerd onderzoek met verpleeghuisafdelingen als eenheden van randomisatie. De randomisatie zal op bewonersniveau worden gebalanceerd op de ernst van dysfagie en zorgafhankelijkheid. Gedurende een jaar zullen 500 verpleeghuisbewoners met een lichamelijke beperking en dysfagie worden gevolgd. De interventie bestaat uit twee maal per dag het gebruik van een oplossing van 0,05% chloorhexidine als aanvulling op de gebruikelijke dagelijkse mondverzorging, terwijl de controlegroep een placebo krijgt. De wijze van gebruik van de oplossing van 0,05% chloorhexidine, namelijk spoelen met de oplossing of de mond reinigen met gazen gedrenkt in de oplossing, is afhankelijk van de ernst van de dysfagie. Andere onderzoeksgegevens die zullen worden verzameld, zijn: leeftijd, geslacht, medische diagnosen, ernst van dysfagie, zorgafhankelijkheid, actuele medicatie, aantal aanwezige gebitselementen en implantaten en de aanwezigheid van gebitsprothesen. De primaire uitkomstmaat van het onderzoek is de incidentie van pneumonie die volgens strikt omschreven criteria wordt gediagnosticeerd door een arts. Het effect van de interventie op de incidentie van pneumonie zal worden bepaald met de regressie–analyse volgens Cox. Clusterrandomisatie kan resulteren in een effect dat het gevolg is van de randomisatie en in selectiebias op basis van de clustering. Om die reden zal de randomisatie worden gebalanceerd voor de ernst van dysfagie en zorgafhankelijkheid. Tot slot zal een kwetsbaarheidmodel in de statistische analyse worden opgenomen om de clustering van onderzoeksgegevens binnen verpleeghuisafdelingen te compenseren.

HOOFDSTUK 8: ALGEMENE DISCUSSIE Dit hoofdstuk geeft een algemene discussie weer over de in de hoofdstukken 1-6 beschreven onderzoeken, twee systematische literatuuronderzoeken, één meta-analyse, één retrospectieve analyse van resultaten van een cross-sectioneel onderzoek in meerdere verpleeghuizen en één klinisch cross-sectioneel onderzoek. Het systematisch literatuuronderzoek naar risicofactoren voor een aspiratiepneumonie bij kwetsbare ouderen, toonde aan dat dysfagie en slechte mondgezondheid significante risicofactoren zijn. Een beperking van dit onderzoek was dat de diverse risicofactoren niet eenduidig waren gedefinieerd en dat het niet eenvoudig is aspiratiepneumonie bij kwetsbare ouderen zuiver te diagnosticeren. Hierdoor konden de resultaten van de verschillende onderzoeken slechts in beperkte mate met elkaar worden vergeleken, waardoor het trekken van harde conclusies niet mogelijk was. Aanbevelingen voor in de toekomst uit te voeren onderzoek waren: een nauwkeurige bepaling van het risico en de rol van dysfagie bij het ontstaan van aspiratiepneumonie bij kwetsbare ouderen en nagaan of verbetering van de mondgezondheid het risico op aspiratiepneumonie bij kwetsbare ouderen vermindert. De meta-analyse van dysfagie en aspiratiepneumonie bij kwetsbare ouderen bevestigde dat dysfagie een belangrijke risicofactor is, in het bijzonder bij patiënten 160

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die een cerebrovasculair accident hebben ondergaan. Ook in dit onderzoek waren zowel de niet eenduidige definiëring van dysfagie als het probleem van het zuiver diagnosticeren van aspiratiepneumonie bij kwetsbare ouderen beperkingen, waardoor de verschillende onderzoeken maar beperkt met elkaar konden worden vergeleken. Daarnaast kan het excluderen van publicaties van voor het jaar 2000 enige bias hebben veroorzaakt. Voor de toekomst werd aanbevolen te onderzoeken of dysfagie ook een belangrijke risicofactor is voor aspiratiepneumonie bij patiënten die aan andere ziekten lijden die dysfagie als complicerende factor hebben en of het risico op aspiratiepneumonie bij deze patiënten kan afnemen door therapeutische maatregelen. Het systematische literatuuronderzoek naar mondzorginterventies en het effect daarvan op de incidentie van aspiratiepneumonie bij kwetsbare ouderen toonde aan dat verbetering van de mondzorg het risico op het ontwikkelen van aspiratiepneumonie en het overlijden als gevolg van aspiratiepneumonie deed afnemen. Vier van de vijf onderzoeken waren uitgevoerd in één land, Japan, en dat kan enige selectiebias hebben veroorzaakt. Ook het verschil in kwaliteit van de toegepaste methodologie zou enige bias tot gevolg kunnen hebben gehad. Bovendien stonden de verschillende uitkomstvariabelen in de onderzoeken vergelijking van de resultaten in de weg. Aanbevolen werd meer gerandomiseerd gecontroleerde onderzoeken uit te voeren om de meest efficiënte mondzorginterventie te vinden voor het reduceren van het risico op aspiratiepneumonie bij kwetsbare ouderen. De retrospectieve analyse van de resultaten van het cross-sectionele onderzoek in meerdere verpleeghuizen (Landelijke Prevalentie Meting Zorgproblemen, LPZ) naar subjectieve dysfagie onder verpleeghuisbewoners, toonde aan dat subjectieve dysfagie een relevant probleem is in de zorg voor verpleeghuisbewoners. Een eerste beperking van dit onderzoek was dat dysfagie niet objectief was vastgesteld door logopedisten. Een tweede beperking was dat dit onderzoek een secundaire data-analyse is en dat dysfagie slechts is onderzocht als onderdeel van de module ‘ondervoeding’. Het onderzoeken van mogelijke relaties tussen dysfagie en ziekten was dus niet primair het doel van het onderzoek. Dit maakt het trekken van harde conclusies moeilijk. Een derde beperking was dat in het onderzoek de ziekten zijn geclusterd, hetgeen statistische analyse soms moeilijk maakt. Voor toekomstige onderzoeken werd aangeraden dysfagie objectief door logopedisten te laten vaststellen. Het klinische cross-sectionele onderzoek naar objectieve dysfagie liet een incidentie zien van 21%. Het ontbreken van videofluorscopisch slikonderzoek was een eerste beperking van het onderzoek. Een tweede beperking was dat geen metingen van de inter- en intra-beoordelaarsbetrouwbaarheid onder de logopedisten waren uitgevoerd. Aanbevolen werd bij verpleeghuisbewoners meer onderzoek te doen naar de incidentie van dysfagie en het risico op aspiratie als gevolg daarvan met behulp van gevalideerde screeningsinstrumenten om zo de resultaten van dit onderzoek te bevestigen en de risicofactoren voor dysfagie verder in kaart te brengen.

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Publications and award Dankwoord Curriculum vitae

PUBLICATIONS IN PEER REVIEWED JOURNALS 1. Bots-van’t Spijker PC, Wierink CD, de Baat C. Proactieve mondzorg voor onzelfredzame ouderen. Een toenemende verantwoordelijkheid. Ned Tijdschr Tandheelkd 2006;113:197-201. 2. Wierink CD, Bots-van ‘t Spijker PC, de Baat C. Beroepsdifferentiatie in de tandheelkunde. Speekselvloed en slikvermogen bij de ziekte van Parkinson. Ned Tijdschr Tandheelkd 2006;113:502-505. 3. Wierink CD, van Diermen DE, Aartman IH, Heymans HS. Dental enamel defects in children with coeliac disease. Int J Paediatr Dent 2007;17:163-168. 4. Wierink CD, de Baat C. Dementie en mondgezondheid. Ned Tijdschr Tandheelkd 2009;116:82-86. 5. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Risk factors for aspiration pneumonia in frail older people: a systematic literature review. J Am Med Dir Assoc 2011;12:344-354. 6. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Meta-analysis of dysphagia and aspiration pneumonia in frail elders. J Dent Res 2011;90:1398-1404. 7. van der Maarel-Wierink CD, Vanobbergen JNO, Bronkhorst EM, Schols JMGA, de Baat C. Oral health care and aspiration pneumonia in frail older people. A systematic literature review. Gerodontology 2012. Epub ahead of print.

OTHER PUBLICATIONS 1. Wierink CD, Bots-van ‘t Spijker PC, de Baat C. Depressie bij ouderen en de orale implicaties. In: de Baat C, Aps JKM, Brands WG, Carels CEL, Jacobs R, Koole R, van Welsenes D (red.). Het tandheelkundig jaar 2007. Houten: Bohn Stafleu van Loghum, 2007. 2. Wierink CD, van Diermen DE. Glazuurafwijkingen bij kinderen met coeliakie. In: de Baat C, Aps JKM, Brands WG, Carels CEL, Jacobs R, Koole R, van Welsenes D (red.). Het tandheelkundig jaar 2007. Houten: Bohn Stafleu van Loghum, 2007.

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AWARD Vereniging Medisch Tandheelkundige Interactie. Wetenschappelijke prijs, 2012.

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DANKWOORD In eerste plaats is dit proefschrift tot stand gekomen dankzij de uitstekende begeleiding van mijn drie promotoren. Het is uitzonderlijk om drie promotoren te hebben, de meeste promovendi hebben er slechts twee. Mijn drie promotoren hebben echter ieder hun eigen deskundigheid, waarmee zij mij tot deze prestatie hebben gebracht. Ik ben hen dan ook ieder afzonderlijk veel dank verschuldigd. Prof. dr. C. de Baat, mijn eerste promotor. Beste Cees, tijdens de differentiatieopleiding tot tandarts-geriatrie, liet u al weten dat u hoopte dat Nelleke en ik, na onze opleiding, verder met een promotieonderzoek aan de slag zouden gaan. Persoonlijk zag ik dat toen niet zo zitten. Mijn plan was om een geriatrische verwijspraktijk op te zetten. Maar toen ik dat eenmaal gedaan had, begon het toch weer te kriebelen om iets nieuws te gaan doen. Een casus in het verpleeghuis bracht mij bij het onderwerp mondzorg en aspiratiepneumonie. Ik stuurde u een e-mail en u reageerde direct enthousiast. Vanaf dat moment kon ik op ieder moment een beroep op u doen. U voorzag mijn werk altijd binnen enkele dagen van verbeteringen en gedegen commentaar, zodat ik weer verder kon. Ik heb veel van u geleerd, allereerst op wetenschappelijk gebied, maar ook op het gebied van het juiste gebruik van de Nederlandse en Engelse taal. Ik hoop van harte nog vele jaren met u samen te mogen werken, want volleerd ben ik nog lang niet! Prof dr. J.M.G.A. Schols, tweede promotor. Beste Jos, als hoogleraar verpleeghuisgeneeskunde met een schat aan ervaring op het gebied van onderzoek in verpleeghuizen, wist jij mijn onderzoeksvoorstellen altijd van nuttig commentaar en frisse ideeën te voorzien. Je bent een grote bron van inspiratie voor de vele promovendi die je begeleidt. Je hebt altijd de grote lijnen van mijn promotietraject in de gaten gehouden, het mocht geen 10-jaren plan worden. Je snelle reactie op mijn e-mails is verbazingwekkend! Ik heb je begeleiding en steun altijd zeer gewaardeerd! Prof dr. J.N.O. Vanobbergen, derde promotor. Beste Jackie, u was mijn grote leermeester op het gebied van de systematische reviews en de meta-analyses! Heel veel dank voor uw vele werk, geduld en steun. Uw kennis is een belangrijke basis geweest voor mijn wetenschappelijke vorming. Gert-Jan, mijn copromotor. Beste Gert-Jan, ik heb jou leren kennen als een geweldig energiek en enthousiast persoon. Je hebt een grote drang naar onderzoek doen. Jouw boodschap ‘Poor oral health; a potential new geriatric giant’ ondersteun ik van harte! Ik kijk uit naar onze toekomstige samenwerking! Ewald Bronkhorst wil ik bedanken voor zijn statistische ondersteuning, maar ook vooral voor zijn geduld, waarmee hij de vele vragen die ik per e-mail stelde, wilde beantwoorden. Ook Judith Meijers en Gildy Hertogs wil ik bedanken voor de prettige samenwerking. De bijeenkomsten van BENECOMO heb ik altijd als zeer leerzaam, prettig en motiverend ervaren. Ik wens de andere promovendi Kersti, Nelleke, Barbara, Dennis en Vanessa 166

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veel succes toe met hun promoties. Vanessa, jou volg ik natuurlijk in het bijzonder, omdat jij mijn onderzoekslijn hebt opgepakt en daadwerkelijk het klinisch onderzoek gaat uitvoeren, waar ik met mijn proefschrift naartoe heb gewerkt. Ik ben blij je copromotor te mogen zijn en we gaan er alles aan doen om het onderzoek ten uitvoer te brengen. Ad van Andel en Denise van Diermen wil ik graag ook noemen in dit dankwoord. Beste Ad, als docent aan ACTA, vertelde jij tijdens jouw colleges enthousiast over je werk in Amstelhof. Daarmee sta jij aan de basis van mijn interesse voor de gerodontologie. Na mijn afstuderen schreef ik een open sollicitatie aan jou en zo kon ik direct aan de slag als tandarts in verpleeghuis Vreugdehof. Beste Denise, jij hebt mij ingewijd in de complexe problematiek van de medisch gecompromitteerde patiënt. Onder jouw begeleiding heb ik een onderzoek gedaan bij kinderen met coeliakie. Dit onderzoek heeft geleid tot mijn eerste internationale publicatie. Af en toe praten we bij over onze vorderingen op wetenschappelijk gebied, maar ook over onze man en kinderen. De docent-leerling relatie is uitgegroeid tot een vriendschappelijk band, die ik zeer waardeer! Inmiddels ben ik al bijna 9 jaar werkzaam in verpleeghuis Vreugdehof. Mondzorg leeft in ons verpleeghuis, maar het kan en moet nog beter. Ik ben erg blij met de steun van Anja Schouten, onze locatiemanager, die goede dagelijkse mondverzorging ook hoog op de agenda heeft staan. Verder waardeer ik de samenwerking in het verpleeghuis met al mijn collega’s, zoals mijn vroegere assistente Margot en mijn nieuwe assistente Sacha, maar ook met alle andere disciplines, zoals de specialisten ouderengeneeskunde, ergotherapeuten, fysiotherapeuten, logopediste, diëtisten, maatschappelijk werk en medisch secretariaat. Het multidisciplinair werken is één van de facetten, die het werk in een verpleeghuis zo leuk maakt. Eind 2010 heb ik de Zonnehuisgroep Amstelland mogen ondersteunen bij het opzetten van de professionele mondzorg. Faisal Nabi, mondhygiënist, en Martijn Merssman, tandprotheticus, leveren zorg op locatie. Voor meer uitgebreide behandelingen bezoeken de bewoners mij in de praktijk. Vooral de inzet van het vrijwilligersbusje om de bewoners van het verpleeghuis naar de praktijk te vervoeren is een geweldige succesfactor. De bewoners kennen de chauffeur en hiermee worden ellenlange wachttijden voorkomen. Ik waardeer de inzet van de Zonnehuisgroep om dit project neer te zetten. Ik hoop dat andere groepen van verpleeghuizen hun voorbeeld zullen volgen. Mijn Aemstelgroep collega’s wil ik bedanken voor hun fijne samenwerking. Mike Beem wil ik in eerste plaats bedanken voor zijn bereidheid om mee te denken en mee te werken aan het opzetten van de geriatrische verwijspraktijk. De verwerking van AWBZ-nota’s en de declaratie van bijzondere tandheelkunde nota’s brengt vaak extra werk met zich mee. Mike, je zoekt altijd met mij mee naar oplossingen. Dank je voor jouw inzet! Aemstelgroep collega’s, ik werk fijn met jullie samen en hoop dat nog lang te mogen doen. Fijn dat ik tijdens mijn aanstaande verlof weer op jullie steun kan rekenen. Mijn paranimfen Ellen van Bruggen-van der Linden en Nelleke Bots-van ’t Spijker zijn bijzondere collega’s en vriendinnen voor mij. Ellen, met jouw geriatrische verwijspraktijk was en ben je een groot voorbeeld voor mij. Altijd weer spreek jij zoveel waardering uit voor mijn 167

werk, dat ik mij wel eens afvraag of ik dat wel voldoende doe voor jouw werk. Je bent een geweldig persoon en het is een eer dat jij mijn paranimf wilt zijn. Nelleke, mijn studiegenoot in de opleiding tot tandarts-geriatrie. Wat hebben wij veel uurtjes samen in de trein, maar vooral samen achter de computer doorgebracht. Ik heb onze samenwerking altijd fijn gevonden en hoop ook in de toekomst nog veel met jou te mogen samenwerken! In de trein vond ik het altijd leuk om over jouw gezin te horen, je was in dat opzicht een beetje een voorbeeld voor mij. Tijdens mijn promotie zal ik ter zijde worden gestaan door mijn paranimfen Nelleke en Ellen. Nu wordt het vakgebied van de gerodontologie wel eens weinig-sexy genoemd. Er waren nogal wat mannen op leeftijd werkzaam in het vakgebied. Bovendien lijkt het hipper om kindertandarts, implantoloog of endodontoloog te worden. Ik zie ons, drie energieke dames, als drie kopstukken van de gerodontologie. Het kan toch niet anders, dan dat dat bijdraagt aan het imago van de gerodontologie?! In veel proefschriften lees je excuses aan vrienden voor de weinige tijd, die promovendi voor hun vrienden hadden. Zelf heb ik dat niet zo ervaren. Juist mijn afspraken met Bonnie, Marloes, Jacqueline, Claire, Anita, Michiel en Marieke, Martin en Joyce, Irene en Wikke, hebben mij altijd energie opgeleverd. Jullie interesse, gastvrijheid en gezelligheid betekenen veel voor mij. Ik ben opgegroeid in de gelukkige omstandigheid twee opa’s en twee oma’s om mij heen te hebben. Nu op 33-jarige leeftijd heb ik nog steeds één opa en één oma. Mijn oma is helaas een zorgafhankelijke oudere. Haar mond wordt netjes verzorgd… Mijn opa is een kwetsbare, maar bijzonder inventieve zelfstandig wonende oudere. Waarom thuiszorg om een steunkous aan te trekken? Daar heeft opa een handigheidje op verzonnen. En maaltijden die thuis worden bezorgd, die smaken vast niet! Mijn opa heeft op zijn 80ste leren koken. Want een vers bordje bruine bonen en een zelf gedraaid gehaktballetje smaken toch het lekkerst! Helaas beperkt het zicht mijn opa in zijn dagelijkse dingen. Ik hoop van harte dat mijn opa tijdens mijn promotie in de zaal aanwezig kan zijn, zodat u kennis met hem kan maken. De ouders van Marc wil ik heel hartelijk bedanken voor al hun steun! Ik hoefde maar even te bellen met het verhaal dat ik een lezing moest geven, of naar Gent zou afreizen voor een BENECOMO bijeenkomst en natuurlijk wilden zij op Karsten passen! Ik ben blij met zulke lieve schoonouders. Charlotte en Kasper, pap en mam, wat zou ik zonder jullie moeten? Lieve Lot, je bent een geweldige zus. Je bent altijd geïnteresseerd en we kunnen altijd veel plezier maken! Lieve Mam, jij past iedere maandag op op onze kleine Karsten. Daarnaast ben je vakinhoudelijk betrokken, omdat je ook tandarts bent. Aan het begin van het promotietraject heb je mij wel eens gevraagd, waar ik aan begon. Of ik dat nu echt leuk vond? Zelf werd je gelukkiger van de praktijk. Mam, je hebt mij altijd 100% ruimte, steun en vertrouwen gegeven om mijn ambities na te streven. Je bent de liefste moeder die ik mij kan wensen! Lieve pap, jij begreep mijn ambitie direct. Achteraf heb ik wel eens over een onderonsje met Cees gehoord, waarin Cees jou vroeg of je mij niet kon enthousiasmeren voor het wetenschappelijk onderzoek. Je hebt 168

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toen iets gezegd in de trend van ‘motivatie voor een dergelijk project moet echt uit Claar zelf komen, maar als ze ergens aan begint, gaat ze er ook echt voor!’. En zo is het exact gegaan. De liefde om kennis over te dragen heb ik van jou, wat dat betreft heb ik een mooie match van jullie genen. Iets meer gevoel voor de Engelse taal was wel handig geweest, maar daarvoor kan ik altijd een beroep op jou doen. Pap, dank je wel voor alles, je bent geweldig! Tot slot, mijn lieve Marc, mijn grote steun en toeverlaat. Jij hebt mij leren relativeren. Voor spannende lezingen gaf jij mij het motto mee ‘Feel the fear, but do it anyway!’. Je bent er altijd voor mij als ik dat nodig heb. Ik ben zielsgelukkig met jou, de kleine Karsten en ons tweede kindje op komst!

Mijn opa’s en oma’s als vitale ouderen (oktober 1998).

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CURRICULUM VITAE Clara Debora Wierink is op 8 december 1979 geboren in Amsterdam. In 1998 behaalde zij haar gymnasium-diploma aan het Herbert Vissers College te Nieuw-Vennep. Datzelfde jaar startte zij met de studie tandheelkunde aan het Academisch Centrum Tandheelkunde Amsterdam. In 2003 behaalde zij haar tandartsdiploma. Tijdens haar postdoctorale studieperiode verrichtte zij onderzoek naar het voorkomen van specifieke glazuurafwijkingen bij kinderen met coeliakie (glutenallergie). Eén van haar klinische keuzevakken was ‘De behandeling van de medisch gecompromitteerde patiënt’. Tijdens haar studententijd was Claar actief, zowel op het water als op organisatorisch vlak binnen de studentenroeivereniging Skøll. Vlak na haar tandartsexamens is zij een jaar voorzitter van Skøll geweest. Na haar afstuderen nam zij waar in verschillende tandartspraktijken, waaronder die van haar moeder, en tevens startte zij met haar werkzaamheden in verpleeghuis Vreugdehof. In 2004 begon zij met de differentiatieopleiding tot tandarts-geriatrie aan het Universitair Medisch Centrum St Radboud te Nijmegen. Vanaf maart 2006 tot heden werkt Claar met plezier binnen de groepspraktijk de Aemstelgroep Tandartsen te Amstelveen. Binnen de praktijk is zij werkzaam als tandarts-algemeen practicus en als tandarts-geriatrie. Na de afronding van de differentiatieopleiding in 2007 is zij binnen de Aemstelgroep een geriatrische verwijspraktijk begonnen. Op verwijzing van tandartsen, huisartsen, specialisten ouderengeneeskunde en andere zorgverleners behandelt zij ouderen met specifieke problematiek. De Zonnehuisgroep Amstelland ondersteunde zij bij het opzetten van de professionele mondzorg. Op locatie wordt nu zorg verleend door een mondhygienist en een tandprotheticus. Voor uitgebreide behandeling bezoeken cliënten van de Zonnehuisgroep de praktijk. Sinds maart 2008 is zij als onderzoeker verbonden aan de vakgroep Orale Functieleer van het Universitair Medisch Centrum St Radboud in Nijmegen. Sindsdien maakt zij ook deel uit van de onderzoeksgroep BENECOMO. BENECOMO is een onderzoeksconsortium waarin hoogleraren en promovendi van de Radboud Universiteit Nijmegen, Universteit Maastricht, Universiteit Gent, Rijksuniversiteit Groningen en Universiteit Leuven participeren met als doel het verrichten van kwalitatief hoogwaardig onderzoek, gericht op het verbeteren van de mondgezondheid en daarmee samenhangend het welzijn van kwetsbare ouderen. Samen met Nelleke Bots-van ’t Spijker schreef zij een digitale nascholingscursus (e-wise) voor specialisten ouderengeneeskunde. Daarnaast geeft zij jaarlijks colleges voor huisartsen die de kaderopleiding Ouderengeneeskunde van het Nederlands Huisartsen Genootschap volgen en voor verpleegkundigen die de opleiding geriatrieverpleegkunde volgen aan de Amstel Academie. Ook geeft zij lezingen aan tandartsen, tandartsassistenten, mondhygiënisten, tandprothetici, huisartsen, specialisten ouderengeneeskunde en begeleidt zij studenten tandheelkunde en mondzorgkunde tijdens hun stage in Vreugdehof. Binnen de Nederlandse Maatschappij tot bevordering der Tandheelkunde is zij voorzitter van de Commissie Bijzondere Zorggroepen. Claar is getrouwd met Marc van der Maarel. Zij hebben een zoon Karsten en er is een tweede kindje op komst. Zij wonen in Ouderkerk aan de Amstel. 170

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