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Journal ArticleDOI

Acceptability of oral solid medicines in older adults with and without dysphagia: A nested pilot validation questionnaire based observational study

30 Oct 2016-International Journal of Pharmaceutics (Int J Pharm)-Vol. 512, Iss: 2, pp 374-381

TL;DR: Assessment of acceptability of oral solid medicines in older ambulatory patients with and without dysphagia found that higher acceptability scores were seen in the dysphagic population than in the non-dysphagic population for all of the dosage forms that were easier to swallow than tablets and capsules.

AbstractOlder patients (aged 65years and over) are the major consumers of medicines and many barriers affect their ability in taking medicines orally, especially swallowing difficulties. Moreover, the characteristics of differing medicine formulations might have an impact on their acceptability in older patients. The aims of this study were to validate a Medicines Acceptability Questionnaire (MAQ) and to assess acceptability of oral solid medicines in older ambulatory patients with and without dysphagia. One hundred and fifty six older patients attending community pharmacies were recruited and attended face to face interviews. Two questionnaires were administered during the interviews, the validated Sydney Swallow Questionnaire (SSQ) assessing oral and pharyngeal swallowing function and the newly developed MAQ evaluating patient acceptability of oral solid medicines. Seventeen (11%) participants displayed symptoms compatible with swallowing difficulties identified by the SSQ. Participants with swallowing difficulties were considered themselves more likely to have problems in swallowing tablets and capsules of large sizes (11mm and 13mm tablets and size #00 capsules) compared to participants without dysphagia. Dispersible/effervescent tablets and orally disintegrating tablets were considered to be the most acceptable in this cohort, followed by mini-tablets. Chewable tablets and granules were the least favoured. Consistently higher acceptability scores were seen in the dysphagic population than in the non-dysphagic population for all of the dosage forms that were easier to swallow than tablets and capsules. The development of these formulations will assist in medication taking in older patients with dysphagia and potentially their adherence to drug treatments.

Topics: Dysphagia (52%), Population (51%)

Summary (2 min read)

1. Introduction

  • Previous knowledge on these effects has been demonstrated in healthy young subjects; however, this remains unclear in older people especially those with existing swallowing difficulties.
  • The type of formulation might be another factor affecting the ability and willingness of older patients to take their medicines.
  • A number of solid oral dosage forms that are "easier to swallow" than tablets and capsules have been made available in recent years including orally disintegrating tablets (ODTs), dispersible tablets, mini-tablets and multi-particulates .
  • For older patients who cannot swallow tablets, the availability of these formulations could be beneficial.

2.2 Administration of the Sydney Swallow Questionnaire (SSQ)

  • The SSQ is a validated questinnarie and composed of 17 questions assessing oral and pharyngeal swallowing function with responses entered onto a 101 mm visual analog scale except for question 12 (R. C. Dwivedi et al., 2010; K. L. Wallace et al., 2000) .
  • The SSQ was administered to the participants during an interview which took place in the private consultation room in the pharmacy.
  • The participant placed a mark on the horizontal line of the visual analog scale.
  • The first millimeter of the line was disregarded and a score of 0-100 was calculated by measuring the distance from the center of the mark to the first millimeter of the line for each question.
  • The maximum possible total score for the SSQ was 1700, with higher score indicating greater severity of swallowing dysfunction.

2.3 Pilot of the Medicines Acceptability Questionnaire (MAQ)

  • The content/face validity of the MAQ was assessed by two experts in the field acting as respondents.
  • Cronbach's alpha test was conducted to evaluate the level of reliability and internal consistency using the Statistical Package of the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY, USA).
  • Cronbach's alpha scores of 0.7 or above were deemed as acceptable according to Nunnally and Bernstein (J. Nunnally and L. Bernstein, 1994) .
  • The MAQ was administered to the participants during the interview together with the SSQ.
  • The interviews were conducted by two of the authors (AG and JB).

2.4 Data analysis

  • Data analysis was performed using the Statistical Package of the Social Sciences (SPSS) version 22.0 (IBM Corp., Armonk, NY, USA).
  • The results are reported as mean ± standard deviation (SD).
  • Spearman's nonparametric correlation was used to identify the presence of significant correlations between total SSQ score and age of participants or number of solid oral medicines taken daily.
  • The Mann-Whitney U test was conducted to assess links between gender of participants and total SSQ score, and comparing the means of participants' selfperceived health status between the dysphagia and non-dysphagia group.
  • Chi-Square test was conducted to evaluate the relationship between dysphagic status of the participant and difficulty in swallowing tablets and capsules.

3.1 Validation of the Medicines Acceptability Questionnaire (MAQ)

  • 3 Ability to swallow tablets and capsules in patients with and without dysphagia by the MAQ A total of 12 (7.8%) participants experienced ongoing difficulties in swallowing tablets and capsules according to the results from the MAQ.
  • Figure 1 shows percentage of participants who has chosen the size and shape of tablets that were perceived as starting to cause difficulty in swallowing.
  • The majority of participants with dysphagia found that tablets of sizes 11 mm and 13 mm might started to cause difficulties in swallowing; the percentages of participants selecting 11 mm or 13 mm were 52.9%, 52.9%, 58.8% and 64.7% for flat round, arched round, oblong and oval tablets respectively.
  • Similar results were observed regarding difficulties in swallowing capsules of different sizes in participants with and without dysphagia .
  • In participants with dysphagia, over a third (35%) selected size #00 as that which started to cause problems in swallowing; however, around 30% of these participants also considered size #2 to be difficult to swallow.

3.4 Acceptability of alternative solid oral dosage forms

  • A low proportion of participants had had experience of using the alternative solid oral dosage forms, except for dispersible/effervescent tablets which were referenced mainly to soluble paracetamol and dispersible aspirin tablets as examples (Table 3 ).
  • The acceptability scores of different oral solid dosage forms are shown in Figure 3 .
  • Participants described the good/bad points they considered for each formulation as listed in Table 4 .

4. Discussion

  • A range of medicine formulations have been made available for patients who find it difficult to swallow tablets and capsules.
  • The acceptability of these formulations in targeted patient groups is often unclear.
  • Studies have reported that increasing age is associated with increased severity and prevalence of dysphagia in elderly populations (G. Holland et al., 2011; K. Kawashima et al., 2004) .
  • Szcaesniak et al. studied SSQ score in a non-dysphagic population and found that there was no significant correlation between age and SSQ score (M. M. Szczesniak et al., 2014) .

5. Conclusions

  • A significant proportion of older patients attending community pharmacies have symptoms compatible with dysphagia.
  • These patients are more likely to have difficulties in swallowing tablets and capsules compared to those with no dysphagia.
  • Healthcare professionals should identify patients with high risk of having problems swallowing their medicines and assist in selecting most appropriate medicine dosage forms.
  • The development and availability of alternative oral formulations other than conventional tablets and capsules will likely to assist in medication administration and management in patient with dysphagia and might lead to better adherence.

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Citation for published version:
Fang Liu, Ambreen Ghaffur, Jackreet Bains, and Shaheen
Hamdy, Acceptability of oral solid medicines in older adults
with and without dysphagia: a nested pilot validation
questionnaire based observational study, International Journal
of Pharmaceutics, Vol 512 (2): 374-381, March 2016.
DOI:
https://doi.org/10.1016/j.ijpharm.2016.03.007
Document Version:
This is the Accepted Manuscript version.
The version in the University of Hertfordshire Research Archive
may differ from the final published version. Users should
always cite the published version of record.
Copyright and Reuse:
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https://creativecommons.org/licenses/by-nc-nd/3.0/
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If you believe this document infringes copyright, please contact the
Research & Scholarly Communications Team at rsc@herts.ac.uk

1
1
Acceptability of oral solid medicines in older adults with and without
1
dysphagia: a nested pilot validation questionnaire based observational
2
study
3
4
5
6
Fang Liu
1*
, Ambreen Ghaffur¹, Jackreet Bains¹, Shaheen Hamdy
2
7
8
1 Department of Pharmacy, pharmacology and postgraduate medicine, School of Life and
9
Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, UK
10
2 Centre for GI Sciences, Institute of Inflammation and Repair, Faculty of Medical and Human
11
Sciences, University of Manchester, Manchester, M6 8HD, UK
12
13
*Contact author: Fang Liu
14
email: f.liu3@herts.ac.uk,
15
Tele: +44-1707284273
16
Fax: +44-1707288503
17
18

2
2
19
Abstract
20
21
Older patients (aged 65 years and over) are the major consumers of medicines and many
22
barriers affect their ability in taking medicines orally, especially swallowing difficulties.
23
Moreover, the characteristics of differing medicine formulations might have an impact on
24
their acceptability in older patients. The aims of this study were to validate a Medicines
25
Acceptability Questionnaire (MAQ) and to assess acceptability of oral solid medicines in older
26
ambulatory patients with and without dysphagia. One hundred and fifty six older patients
27
attending community pharmacies were recruited and attended face to face interviews. Two
28
questionnaires were administered during the interviews, the validated Sydney Swallow
29
Questionnaire (SSQ) assessing oral and pharyngeal swallowing function and the newly
30
developed Medicines Acceptability Questionnaire (MAQ) evaluating patient acceptability of
31
oral solid medicines. Seventeen (11%) participants displayed symptoms compatible with
32
swallowing difficulties identified by the SSQ. Participants with swallowing difficulties were
33
considered themselves more likely to have problems in swallowing tablets and capsules of
34
large sizes (11 mm and 13 mm tablets and size #00 capsules) compared to participants
35
without dysphagia. Dispersible/effervescent tablets and orally disintegrating tablets were
36
considered to be the most acceptable in this cohort, followed by mini-tablets. Chewable
37
tablets and granules were the least favoured. Consistently higher acceptability scores were
38
seen in the dysphagic population than in the non-dysphagic population for all of the dosage
39
forms that were easier to swallow than tablets and capsules. The development of these
40
formulations will assist in medication taking in older patients with dysphagia and potentially
41
their adherence to drug treatments.
42
Keywords: geriatric, elderly, swallow, medication, acceptance, preference
43

3
3
44
45
46
1. Introduction
47
Patient acceptability to a pharmaceutical dosage form is critical to ensure adherence and
48
therapeutic outcomes, especially in children and older people (F. Liu et al., 2014).
49
Acceptability has previously been defined as “an overall ability of the patient and caregiver
50
(defined as ‘user’) to use a medicinal product as intended (or authorised)” (P. Kozarewicz,
51
2014). The European Medicines Agency has required the assessment of patient acceptability
52
to be an integrated part of paediatric medicinal product development (E. M. A. (EMA), 2013;
53
P. Kozarewicz, 2014). However, acceptability of medicines in older adults has been largely
54
overlooked. Older patients (aged 65 years and over) account for 50% of the medicine
55
prescriptions in the UK (Z. Rajaei-Dehkordi and G. McPherson, 1997). The oral route remains
56
the most preferred mode for medicine administration; however, there are barriers for older
57
patients to take medications orally (F. Liu et al., 2014). Swallowing difficulties (dysphagia) are
58
common in older people which affect their ability to take oral medicines, especially tablets
59
and capsules (C. M. Steele et al., 1997; I. Strachan and M. Greener, 2005). Consequently,
60
medicines are often modified such as crushing tablets or capsules opened to assist
61
administration to older patients (J. Kelly and D. Wright, 2009; D. Wright, 2002). This leads to
62
unlicensed used of medicines and can potentially cause ineffective use or toxicity of the
63
medicine (S. Stegemann et al., 2012).
64
65
Characteristics of a pharmaceutical dosage form, such as the size, shape, and surface texture
66
of a tablet, have an impact on how easily a solid oral medicine can be swallowed and pass
67
through the pharynx and oesophagus (K. S. Channer and J. P. Virjee, 1985; K. T. Evans and G.
68

4
4
M. Roberts, 1981; H. Hey et al., 1982; A. B. Overgaard et al., 2001). Previous knowledge on
69
these effects has been demonstrated in healthy young subjects; however, this remains
70
unclear in older people especially those with existing swallowing difficulties. The type of
71
formulation might be another factor affecting the ability and willingness of older patients to
72
take their medicines. A number of solid oral dosage forms that are “easier to swallow” than
73
tablets and capsules have been made available in recent years including orally disintegrating
74
tablets (ODTs), dispersible tablets, mini-tablets and multi-particulates (granules). As most of
75
these formulations are designed and developed for paediatric use, acceptability of some of
76
these dosage forms in children has been reported (I. T. Cohen et al., 2005; J. Motte et al.,
77
2005; D. Nasrin et al., 2005). For older patients who cannot swallow tablets, the availability
78
of these formulations could be beneficial. The use of dispersible/effervescent tablets and
79
ODTs has been demonstrated in older patients (A. J. Bayer et al., 1988; J. C. Nelson et al.,
80
2006). Especially, ODTs have been proven to be easier to swallow than conventional tablets
81
for patients with dysphagia (G. Carnaby-Mann and M. Crary, 2005). However, evidence in the
82
acceptability of these solid dosage forms in older patients is still sparse. This research is a pilot
83
study where a Medicines Acceptability Questionnaire (MAQ) was initially developed and
84
validated before assessing the acceptability of a range of solid oral medicine dosage forms in
85
older ambulatory patients attending community pharmacies and investigating the association
86
between patient acceptability and the presence of swallowing difficulties.
87
88
2. Materials and Methods
89
90
2.1 Study population and setting
91

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TL;DR: The study supports the use of five or more medications in the current definition of polypharmacy to estimate the medication-related adverse effects for frailty, disability, mortality, and falls.
Abstract: Objective This study aimed to determine an optimal discriminating number of concomitant medications associated with geriatric syndromes, functional outcomes, and mortality in community-dwelling older men. Study Design and Setting Older men aged ≥70 years ( n =1,705), enrolled in the Concord Health and Aging in Men Project were studied. Receiver operating characteristic curve analysis using the Youden Index and the area under the curve was performed to determine discriminating number of medications in relation to each outcome. Results The highest value of the Youden Index for frailty was obtained for a cutoff point of 6.5 medications compared with a cutoff of 5.5 for disability and 3.5 for cognitive impairment. For mortality and incident falls, the highest value of Youden Index was obtained for a cutoff of 4.5 medications. For every one increase in number of medications, the adjusted odds ratios were 1.13 (95% confidence interval [CI]=1.06–1.21) for frailty, 1.08 (95% CI=1.00–1.15) for disability, 1.09 (95% CI=1.04–1.15) for mortality, and 1.07 (95% CI=1.03–1.12) for incident falls. There was no association between increasing number of medications and cognitive impairment. Conclusion The study supports the use of five or more medications in the current definition of polypharmacy to estimate the medication-related adverse effects for frailty, disability, mortality, and falls.

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TL;DR: The results clearly demonstrate that the prevalence of a wide range of eating-related problems far exceeds accepted estimates of dysphagia alone and support a multidisciplinary approach to mealtime interventions for the institutionalized elderly.
Abstract: A mealtime screening tool was administered to 349 residents of a home for the aged to determine the prevalence of mealtime difficulties including, but not limited to, dysphagia. Mealtime difficulties, as assessed during a single meal observation of each resident, were documented in 87% of these individuals. Though 68% exhibited signs of dysphagia, 46% had poor oral intake, 35% had positioning problems, and 40% exhibited challenging behaviors. An increased prevalence of mealtime difficulties was related to both the presence and degree of cognitive impairment. Oral intake was best among residents with severe cognitive impairment, many of whom received partial to total feeding assistance. In contrast, poor oral intake was associated with mild-moderate cognitive impairment, pointing to a need for more aggressive intervention with this group. The results clearly demonstrate that the prevalence of a wide range of eating-related problems far exceeds accepted estimates of dysphagia alone and support a multidisciplinary approach to mealtime interventions for the institutionalized elderly. Additionally, the magnitude of problems identified has implications for both resource and staff-training requirements in long-term care facilities.

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  • ...Swallowing difficulties (dysphagia) are 58 common in older people which affect their ability to take oral medicines, especially tablets 59 and capsules (C. M. Steele et al., 1997; I. Strachan and M. Greener, 2005)....

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Abstract: The objective of this cross-sectional study was to determine the prevalence of dysphagia among elderly persons living at home in a community using a questionnaire for dysphagia screening. As the reliability of the questionnaire had not yet been confirmed in an epidemiological study, it was also verified. The relationship between dysphagia and the level of daily living competence was also clarified. The subjects consisted of 1313 elderly persons 65 years and older (575 males and 738 females) living at home in a community. The questionnaire included questions concerning the individual's past history of stroke, and questions for dysphagia screening, competence scoring, and perceived ill health. The reliability of the questionnaire was confirmed after calculating the Cronbach's alpha coefficient to be 0.83. The results of a factor analysis showed that the cumulative contribution rate was 61.8%. The prevalence rate of dysphagia was 13.8%. After matching for age and sex, there were significant differences in the competence scores, history of stroke, and perceived ill health status observed between the group with dysphagia and the group without dysphagia.

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  • ...Studies have reported that increasing age is associated with increased severity and prevalence of dysphagia in elderly populations (G. Holland et al., 2011; K. Kawashima et al., 2004)....

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  • ...This also broadly agrees with or is slightly lower than other published data on prevalence of dysphagia in older primary care patients (B. R. Bloem et al., 1990; P. H. Chen et al., 2009; K. Kawashima et al., 2004)....

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TL;DR: Applied to patients with neuromyogenic dysphagia, the 17-question inventory shows strong test-retest reliability over 2 weeks as well as face, content, and construct validity.
Abstract: Background & Aims: The aim of this study was to develop and evaluate the validity and reliability of a self-report inventory to measure symptomatic severity of oral-pharyngeal dysphagia. Methods: Test-retest reliability and face, content, and construct validity of a prototype visual analogue scale inventory were assessed in 45 patients who had stable, neuromyogenic dysphagia. Results: Normalized scores varied over time by −0.5% ± 17.6% (95% confidence interval, −9.2% to 8.2%). Factor analysis identified a single factor (dysphagia), to which 18 of 19 questions contributed significantly, that accounted for 56% of total variance ( P r = 0.7; P P Conclusions: Applied to patients with neuromyogenic dysphagia, the 17-question inventory shows strong test-retest reliability over 2 weeks as well as face, content, and construct validity. Discriminant validity (responsiveness) has been demonstrated in a population with a correctable, structural cricopharyngeal disorder. Responsiveness of the instrument to treatment in neuromyogenic dysphagia remains to be quantified. GASTROENTEROLOGY 2000;118:678-687

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"Acceptability of oral solid medicin..." refers methods in this paper

  • ...…Sydney Swallow Questionnaire (SSQ) 107 The SSQ is a validated questinnarie and composed of 17 questions assessing oral and 108 pharyngeal swallowing function with responses entered onto a 101 mm visual analog scale 109 except for question 12 (R. C. Dwivedi et al., 2010; K. L. Wallace et al., 2000)....

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Journal ArticleDOI
TL;DR: This older general practice population in Germany is among the top pharmaceutical user group of European study samples and GPs should be aware that low subjective health and medication disagreement are independent predictors of polypharmacy.
Abstract: Background Older people consume an increasing amount of medication. Polypharmacy is associated with an elevated risk of adverse health outcomes resulting in hospitalizations and sometimes death. Objectives To describe the prevalence of prescribed and over-the-counter (OTC) medications among older general practice patients living in the community. To determine predictors of polypharmacy (five or more prescribed drugs) from a variety of patient- and doctor-related factors. Methods Sixty-seven randomly selected practices in two areas of Germany and 466 of their older patients (70+ years) were recruited for a geriatric assessment study. A cross-sectional analysis of health problems, GPs' awareness and their interventions was conducted. In this post hoc analysis, we assessed the medication use as reported by older patients and compared it with doctors' perceived medication regimens for their respective patients. The detailed assessment of patients' health and well-being enabled us to explore a variety of predictors of polypharmacy using logistic regression analysis with forward selection. Results Study participants consumed an average of 3.7 prescribed medicines and an additional 1.4 OTC drugs. In all, 26.7% of patients used five and more chronically prescribed drugs. A set of five determinants predicted polypharmacy best: breathlessness, hypertension, dependency on instrumental activities of daily living, low subjective health and medication disagreement between doctors and patients. Conclusion This older general practice population in Germany is among the top pharmaceutical user group of European study samples. Apart from disease-specific determinants, GPs should be aware that low subjective health and medication disagreement are independent predictors of polypharmacy.

187 citations