Acceptability of oral solid medicines in older adults with and without dysphagia: A nested pilot validation questionnaire based observational study
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.
About: This article is published in International Journal of Pharmaceutics.The article was published on 2016-10-30 and is currently open access. It has received 71 citations till now. The article focuses on the topics: Dysphagia & Population.
Summary (2 min read)
Jump to: [1. Introduction] – [2.2 Administration of the Sydney Swallow Questionnaire (SSQ)] – [2.3 Pilot of the Medicines Acceptability Questionnaire (MAQ)] – [2.4 Data analysis] – [3.1 Validation of the Medicines Acceptability Questionnaire (MAQ)] – [3.4 Acceptability of alternative solid oral dosage forms] – [4. Discussion] and [5. Conclusions]
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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Figures (7)
Table 1. Products used to represent 9 mm tablets in different shapes 
Table 2. Products used to represent various oral formulations 
Fig 3. Acceptability scores of different oral solid dosage forms (ODT: orally disintegrating tablet). 
Table 4. Participants’ impression on the flexible solid oral dosage forms. 2 
Figure 1. Percentage of participants selecting the tablet size and shape that started to cause difficulty in swallowing. 
Fig 2. Percentage of participants selecting the capsule size that might start to cause difficulty in swallowing 
Table 3. Number of participants who had previously used the flexible solid oral formulations.
Citations
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TL;DR: To understand the barriers and facilitators of medication administration to aged care residents with swallowing difficulties, the aim is to understand the mechanisms behind resistance to medication administration and how these can be addressed.
Abstract: Objectives To understand the barriers and facilitators of medication administration to aged care residents with swallowing difficulties. Methods Health‐care workers in aged care facilities across Australia involved in medication administration to residents completed an online survey. Results Of 355 respondents, 90.9% reported ‘everyday’ encounters with residents with swallowing difficulties and 94.1% modified medications to facilitate administration. Time constraints (63.4%) and workload (69.0%) were common barriers. Only 39.0% believed swallowing abilities are considered at the prescribing stage. Pill size (95.8%), polypharmacy (75.2%) and lack of alternative formulations (74.9%) contributed to these challenges. Support from other health‐care professionals (91.5%) and training (85.9%) were the most favoured facilitators. Conclusion Health‐care workers are faced with various challenges when caring for residents with swallowing difficulties. Promoting multidisciplinary collaborations, provision of training and medication review services, and improving skill mix and staffing composition in aged care facilities are needed to address these challenges.
6 citations
TL;DR: Poly(meth)acrylate polymers commonly available under the trade name of Eudragit®, such as S100, RS PO, RL100 and E100, were used to get defined drug release profiles and guaranteed the stability of the reconstituted liquid syrup during 2 weeks of storage at room temperature.
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TL;DR: The version of the SWAMECO questionnaire in English contains 28 items and is ready for use in adults with polypharmacy and is complete content and face validity with healthcare professionals (HCPs) and patients from the target population that is, community-dwelling adult patients taking three or more medicines forThree or more months.
Abstract: Objectives To translate the SWAMECO from German into English; to complete content and face validity with healthcare professionals (HCPs) and with patients from the target population that is, community-dwelling adult patients taking three or more medicines for three or more months. Design The process followed guidance from Sousa et al and included translation and cross-cultural adaptation, and cognitive testing among selected HCPs and patients. As the SWAMECO questionnaire is a screening instrument, pilot testing was performed in the target population. Setting Three community pharmacies in and around Cork (Ireland) recruited patients for interviews and pilot testing. Participants Community-dwelling patients with ≥3 oral medications for ≥3 months, aged ≥18 years. Outcome measures Answers to the SWAMECO questionnaire; clarity of each question, each instruction and each response format. Results Issues related to cultural and conceptual differences were resolved by rewording some items. Ten HCPs and 11 patients completed the questionnaire and gave their feedback and opinions on criteria according to Fitzpatrick et al. Revisions included rewording; deleting of two questions; using of colour to signpost that is, where to skip questions that were not applicable to the participants; and replacement of the A-14 medication adherence scale with three validated items. Of the 66 patients enrolled for pilot testing, eight (12.1%) indicated swallowing difficulties. Difficulties with ingesting foods or liquids correlated with swallowing difficulties (p=0.001). All patients perceived discomfort (mean 6.9 on a Visual Analogue Scale from 0 to 10). Patients with swallowing difficulties were significantly more likely to report modifying their medicines (p=0.004) and having poorer medication adherence (p=0.028) than those who had no swallowing difficulties. Conclusions The version of the SWAMECO questionnaire in English contains 28 items and is ready for use in adults with polypharmacy.
4 citations
Dissertation•
01 Jan 2019
TL;DR: The present study focused on the evaluation of the psychometric properties of screening and evaluation tools for oro-pharyngeal dysphagia in adults with cancer outside the upper GI tract.
Abstract: s 1. Kenny C, Regan J, Walsh D. Cancer cachexia and dysphagia: A nutritional and therapeutic dilemma? Clinical Nutrition. 2018;37(S1):S77-78. 2. Kenny C, Regan J, Walsh D. Dysphagia in cancer patients: Common, dangerous, and under-diagnosed. Support Care Cancer. 2018;26(S2):S170. 3. Kenny C, Uí Dhuibhír P, O’Donoghue N, Barrett M, Parkes C, Daly S, Thirion P, Walsh D. (2017) Wireless intra-oral measurement of dynamic tongue pressures: A clinical utility pilot study. Dysphagia. (2017);32(1), 147. 4. Kenny C, Regan J, Walsh D. Psychometric properties of screening and evaluation tools for oro-pharyngeal dysphagia in adults with cancer outside the upper GI tract: A systematic review. Dysphagia. (2017);32(1), 133.
4 citations
Cites background from "Acceptability of oral solid medicin..."
...Orally disintegrating tablets are often favoured by those with dysphagia (494, 496)....
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...For those with dysphagia, pill size and shape influence ability to swallow medication, where larger sizes are usually more difficult (494, 495)....
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...Future studies should take care to examine this separately, as dysphagic individuals are known to have greater difficulties swallowing solid oral medications (494)....
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TL;DR: In this article, the authors developed various in vitro analytical tools to assess physical properties governing the swallowing process of tablets by mimicking static and dynamic stages of time-independent oral transitioning events.
Abstract: A lack of effective intervention in addressing patient non-adherence and the acceptability of solid oral dosage forms combined with the clinical consequences of swallowing problems in an ageing world population highlight the need for developing methods to study the swallowability of tablets. Due to the absence of suitable techniques, this study developed various in vitro analytical tools to assess physical properties governing the swallowing process of tablets by mimicking static and dynamic stages of time-independent oral transitioning events. Non-anatomical models with oral mucosa-mimicking surfaces were developed to assess the swallowability of tablets; an SLA 3D printed in vitro oral apparatus derived the coefficient of sliding friction and a friction sledge for a modified tensometer measured the shear adhesion profile. Film coat hydration and in vitro wettability was evaluated using a high-speed recording camera that provided quantitative measurements of micro-thickness changes, simulating static in vivo tablet-mucosa oral processing stages with artificial saliva. In order to ascertain the discriminatory power and validate the multianalytical framework, a range of commonly available tablet coating solutions and new compositions developed in our lab were comparatively evaluated according to a quantitative swallowability index that describes the mathematical relationship between the critical physical forces governing swallowability. This study showed that the absence of a film coat significantly impeded the ease of tablet gliding properties and formed chalky residues caused by immediate tablet surface erosion. Novel gelatin- and λ-carrageenan-based film coats exhibited an enhanced lubricity, lesser resistance to tangential motion, and reduced stickiness than polyvinyl alcohol (PVA)-PEG graft copolymer, hydroxypropyl methylcellulose (HPMC), and PVA-coated tablets; however, Opadry® EZ possessed the lowest friction-adhesion profile at 1.53 a.u., with the lowest work of adhesion profile at 1.28 J/mm2. For the first time, the in vitro analytical framework in this study provides a fast, cost-effective, and repeatable swallowability ranking method to screen the in vitro swallowability of solid oral medicines in an effort to aid formulators and the pharmaceutical industry to develop easy-to-swallow formulations.
4 citations
References
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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.
852 citations
"Acceptability of oral solid medicin..." refers background in this paper
...Almost half of participants took 5 or more solid oral medicines daily, which qualifies as polypharmacy by definition of some published studies (D. Gnjidic et al., 2012; U. JuniusWalker et al., 2007; D. Koper et al., 2013)....
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TL;DR: 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.
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.
256 citations
"Acceptability of oral solid medicin..." refers background or result in this paper
...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)....
[...]
...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)....
[...]
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.
253 citations
"Acceptability of oral solid medicin..." refers background in this paper
...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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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.
215 citations
"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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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.
203 citations