Keywords
Anticholinergic Deprescribing, Intellectual Disability
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Al Shuhaimi L, Henman MC, McCallion P et al. Prescriber’s view on anticholinergic deprescribing among older adults with intellectual disability: A qualitative study protocol [version 1; peer review: 1 approved]. HRB Open Res 2023, 6:39 (https://doi.org/10.12688/hrbopenres.13680.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Study Protocol
Prescriber’s view on anticholinergic deprescribing among older adults with intellectual disability: A qualitative study protocol
[version 1; peer review: 1 approved]
PUBLISHED 01 Aug 2023
OPEN PEER REVIEW
REVIEWER STATUS
This article is included in the Dementia Trials Ireland (DTI) and Dementia Research Network Ireland (DRNI) gateway.
Abstract
Corresponding author:
Lamya Al Shuhaimi
Competing interests:
No competing interests were disclosed.
Grant information:
Health Research Board Ireland [IDS-TILDA-2018-1]. The lead author (LAA) received funding from Provost PhD Awards Graduate Studies from the Trinity College Dublin.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2023 Al Shuhaimi L et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Al Shuhaimi L, Henman MC, McCallion P et al. Prescriber’s view on anticholinergic deprescribing among older adults with intellectual disability: A qualitative study protocol [version 1; peer review: 1 approved]. HRB Open Res 2023, 6:39 (https://doi.org/10.12688/hrbopenres.13680.1)
First published: 01 Aug 2023, 6:39 (https://doi.org/10.12688/hrbopenres.13680.1)
Latest published: 01 Aug 2023, 6:39 (https://doi.org/10.12688/hrbopenres.13680.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Background
Medications with anticholinergic activity are widely used in managing various disorders including cardiovascular disorders, urinary incontinence, gastrointestinal diseases, neurological and psychiatric disorders1,2. Additionally, there are medications which are not primarily anticholinergic but have some anticholinergic activity. Older people are at higher risk of anticholinergic adverse effects due to higher blood-Brain barrier permeability, lower elimination and metabolism rate and insufficiency in anticholinergic central transmission1,2. Additionally, both of multimorbidity and polypharmacy are increasing the probability and severity of the cumulative anticholinergic adverse-effects.
Studies have determined that older adults with intellectual disability are often exposed to higher cumulative anticholinergic burden compared to the general population3–5. The Intellectual Disability supplement to the Irish Longitudinal Study on Aging (IDS-TILDA) reported 29.1% had high anticholinergic Cognitive Burden Score (ACB) (ACB=5+) and 41.8% scored ACB 1-4 in people aged 40+ with intellectual disability4. Additionally, another study in IDS-TILDA, reported 54.2% of older adults with intellectual disability exposed to high anticholinergic burden (scored ≥1)5. Furthermore, high anticholinergic burden has been found to be greater with people with intellectual disabilities with increasing age4, living in community group houses and nursing home facilities3, and having neurological or psychiatric disorders3,4. Additionally, it has been reported to be associated with constipation and frequent laxative use3,4 and daytime drowsiness4.
According to our completed scoping review examining the long term impact of anticholinergic burden in older adults with intellectual disability, there are no longitudinal cohort studies which have been established to explore the long-term adverse effects of high anticholinergic burden among older adults with intellectual disabilities6. However, there are few longitudinal studies have been conducted on general elderly population. These studies have established that long-term exposure to high anticholinergic burden was associated with poorer cognitive2,7,8 and physical function7,9, increased risk of dementia10,11 and Alzheimer disease11. Although, anticholinergic-induced cognitive impairment is consider as reversible after discontinuation of anticholinergics, long-term exposure is associated with increased risk of dementia and Alzheimer disease11.
Although the studies have reported a high prevalence of anticholinergic burden and its associated adverse effects among people with intellectual disability, these medications are still being prescribed for this group of population (unpublished data). Therefore, this study aims to investigate prescriber’s views about the use of medication with anticholinergic activity and to use theory to examine the key factors associated with the prescribing of these medications and to propose recommendations to develop an intervention to optimize prescribing.
Aim and objectives: The study aims to explore prescribers’ views on anticholinergic deprescribing among older adults with intellectual disabilities.
Objectives:
3. To recruit 8 – 10 prescribers involved with older adults with intellectual disability
4. To explore prescriber’s knowledge on anticholinergic burden, adverse-effects, tools used to measure anticholinergic burden
5. To explore barriers and facilitators of anticholinergic deprescribing
Afterward, the following study will map the identified barriers and facilitators of deprescribing into COM-B and Behavioral Change Wheel to identify intervention needed to optimize prescribing of medication with anticholinergic activity for older adults with intellectual disabilities.
Methods
This will be a qualitative descriptive study which will be conducted based on The Theoretical Domaine Framework (TDF)12. TDF is a theoretical framework used to understand and assess influences on health care professional behaviour regarding implementation of an evidence-based recommendations. It has been proven that TDF was effective in assessing barriers and targeting resources to influence behaviour change for implementation of intervention, across various healthcare professionals13.
The study aim is to identify barriers and facilitators of “Deprescribing” behaviour to reduce high anticholinergic exposure among older adults with intellectual disability. The TDF will help to facilitate the complexity of prescribing and deprescribing for older adults with intellectual disability.
There are 7 stages/steps to conduct a TDF-Based implementation research and these are:
1. Select and Specify the target behaviours
2. Select the study design
3. Develop study materials
4. Decide the sampling strategy
5. Collect the data
6. Analyse the data
7. Report findings
Stage 1: Select and Specify the target behaviour/s
The main behaviour to be targeted by this study is the possibility of deprescribing to reduce Anticholinergic Burden in the case of high exposure among older adults with intellectual disability.
Additionally, the study will examine prescriber knowledge on anticholinergic burden and if they do consider/check the anticholinergic burden before prescribing new medicines or to rule out drug-induced adverse effect (when reporting a decline in cognitive or physical function).
Stage 2: Select the study design
The study will be designed as semi-structured interviews. The interviews will be conducted online via Microsoft teams, or in person, depending on the preference of the interviewee. The study is designed to examine prescriber view among deprescribing behaviour to reduce high anticholinergic exposure among older adults with intellectual disabilities. The study will recruit prescribers from different specialties who are involved in prescribing for older adults with intellectual disabilities. General Practitioner, specialists, consultants and nurse prescribers working from different healthcare setting might be included.
Stage 3: Develop study materials
An interview topic guide will be developed based on related domains in the Theoretical Domain Framework (TDF). There are two versions of TDF and this study will follow version 2 as it is the updated version. Therefore, the interview topic guide will be based on the related domains in V-2 TDF14. The topic guide will be focused on deprescribing behaviour to reduce high anticholinergic exposure and type of intervention needed in practice. Additionally, the topic guide will include the main finding of the longitudinal study and will explore the indications of anticholinergic prescribing and the awareness of associated adverse effects.
The topic guide will be piloted prior to conducting the interviews. It will be piloted with three members of IDS-TILDA and then it will be modified based on comments if required.
Stage 4: Decide the sampling strategy
The study will recruit around 8 – 10 prescribers or until it reaches its data saturation. Prescribers will be recruited from different specialties to include most of those involved in prescribing for this group of populations including psychiatrists, neurologists and general practitioners, TILDA team, etc.
A consultation process on a previous scoping review has been conducted previously and it helped to build-up a network with prescribers involved with older adults with intellectual disabilities. This network will be used to recruit prescribers for this study.
Stage 5: Collect the data
A time frame for conducting the interviews will be set-up upon obtaining ethical approval. The interviews will be conducted by one of the team members (LA) through Microsoft teams, or in person, depending on the preference of the interviewee. The interviewer will make sure to receive a returned and signed consents form prior to each interview. Each interview will take 25–45 minutes and all of the face-to-face and Microsoft teams interviews will be recorded. The recorded interview will be stored in LA’s folder with IDS-TILDA restricted Network Attached Storage. At the beginning of each interview, the interviewer will check the interviewee identity and eligibility to the inclusion criteria. Participants will be coded as P1, P2,P3,etc in the transcript and no personal data will be showing in the transcript.
Stage 6: Analyse the data
Data analysis will be conducted according to Framework Method15. The Framework Method provides a framework for management and analysis of qualitative data. It categories the data analysis process into the following stages:
1. Transcription
2. Familiarization with the interview
3. Coding
4. Developing a working analytical framework
5. Applying the analytical framework
6. Charting data into the framework matrix
7. Interpreting the data
Step 1: Transcription: the recorded interviews are going to be transcribed by using Microsoft Stream. The transcript will be checked by (LA) after each interview. In case of face-to-face interview, the recoded audio is going to be transcribed manually. The transcripts will have a large margins and line spacing for comments and coding notes.
Step 2: Familiarization with the interview: the transcripts and recorded interviews will be re-read and re-listened by LA and the interviewer notes will be check again to be familiarized with the interview. Any further thought or comments or analytical notes will be recorded by the margins.
Step 3: Coding: Then, a member of the team (LA) will read, re-read and code the transcribed interviews. A second member will code the first 3 transcripts and compare it with the original transcript. In case of any disagreement between the two members, a third member of the team (MH) is going to be involved.
Step 4: Developing a working analytical framework: The codes will be combined into subthemes. The main themes and the coding scheme is going to be developed based on the domains of the TDF V2. Each TDF domain is considered as a coding category and the coding scheme will be discussed and reviewed within the research team. Afterward, the working analytical framework will be developed after discussing and coding once the first three transcripts are complete.
Step 5: Applying the analytical framework: the analytical framework will be applied to all transcripts. Subsequently, there will be a number allocated for each code to make the coded transcripts ready for analysis.
Step 6: Charting data into the framework matrix: The data of coded transcript will be charted in an Excel table Form. Each scheme will be presented in separate sheet and there will a row for each participant using the participant non-identifiable PIN code. The data will be summarized while retaining its original meaning, to reduce the data size. Additionally, all of the interested quotations are going to be referenced so then it could be easily identified. N-Vivo will be used, a software used for statistical and qualitative data analysis.
Step 7: Interpreting the data: the research member (LA) will keep notes on any ideas, impression and early interpretation of data while processing the data. These notes will be discussed within the research team to explore any interesting ideas, themes, concepts, etc. Data interpretation will identify characteristics of data and any differences, association or causality between categories or any possible connections.
Stage 7: Report findings
Consolidated criteria for reporting qualitative research (COREQ-32)16 will be used to report important aspects of the research team , study design, analysis and study findings.
Additionally, the finding of this study is going to be anonymized and will be presented as part of LA PhD thesis and ready for publication. Participants involved are going to receive a report of the study findings and any published paper.
Patient and public involvement
People with intellectual disability, their families, carers or service providers have been involved in the development of IDS-TILDA study protocol. They have been called upon to input into build-on studies and to review the study tools including study protocol, consent forms, Pre-Interview Questionnaires (PIQ) and Computer-aided personal interview questionnaires (CAPI). In addition, they are involved in designing accessible dissemination, research reports and input into aspects of the study website.
The protocol of this qualitative study will be discussed with a member of the PPI newly formed panel within IDS-TILDA to get thoughts or comments on the aim, objectives and methodology of the study.
Ethical approval
An ethical approval is going to be obtained from the school of pharmacy and pharmaceutical science in Trinity College Dublin prior to conducting the study.
A written consent form is going to be obtained from participants prior to interview. Participants will receive a participant information leaflet which illustrate all of the needed details of the study.
Timeline
The application of the ethical approval submitted on December 2022 and it is in the reviewing process. The study is planned to be conducted by the end of April 2023 and might last for 9 to 12 months.
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how to cite this article
Al Shuhaimi L, Henman MC, McCallion P et al. Prescriber’s view on anticholinergic deprescribing among older adults with intellectual disability: A qualitative study protocol [version 1; peer review: 1 approved]. HRB Open Res 2023, 6:39 (https://doi.org/10.12688/hrbopenres.13680.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Current Reviewer Status:
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations
A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 01 Aug 2023
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How to cite this report:
Bishara D. Reviewer Report For: Prescriber’s view on anticholinergic deprescribing among older adults with intellectual disability: A qualitative study protocol [version 1; peer review: 1 approved]. HRB Open Res 2023, 6:39 (https://doi.org/10.21956/hrbopenres.14961.r39029)
The direct URL for this report is:
https://hrbopenresearch.org/articles/6-39/v1#referee-response-39029
https://hrbopenresearch.org/articles/6-39/v1#referee-response-39029
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 13 May 2024
Approved
VIEWS 21
I approve this protocol.
-I have the following comments:
This kind of study usually requires at least 10 interviews, so advise to aim for at least 10.
-In the background section, I would ... Continue reading
-I have the following comments:
This kind of study usually requires at least 10 interviews, so advise to aim for at least 10.
-In the background section, I would ... Continue reading
CITE
HOW TO CITE THIS REPORT
Bishara D. Reviewer Report For: Prescriber’s view on anticholinergic deprescribing among older adults with intellectual disability: A qualitative study protocol [version 1; peer review: 1 approved]. HRB Open Res 2023, 6:39 (https://doi.org/10.21956/hrbopenres.14961.r39029)
The direct URL for this report is:
https://hrbopenresearch.org/articles/6-39/v1#referee-response-39029
https://hrbopenresearch.org/articles/6-39/v1#referee-response-39029
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations -
A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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