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Supplementary Material 1

Many efforts have been made across the globe by organisations within the field of ageing research and policymakers to improve participant recruitment and retention in dementia clinical trials. Despite these efforts, challenges remain with recruiting and retaining people with dementia (PwD) to clinical research studies, as evidenced by the findings from a recent systematic review conducted by the research team. Further investigation is needed to explore the factors that affect recruitment and retention of PwD in clinical trials and the strategies employed by research teams to mitigate these issues. The aim of this study is to investigate the recruitment and retention of people with dementia in clinical trials focused on evaluating the pharmacological management of the cognitive symptoms of dementia. This scoping review will follow the most recent JBI methodological guidance for the conduct of scoping reviews and will be reported using the PRISMA-ScR checklist. In this study, relevant trial registration records (which may include randomised clinical trials in progress and not yet published), and relevant published studies (which may or may not have a corresponding trial registration record) will be included. Studies will be included if they utilised a randomised controlled trial design that focused on older PwD, of any sub-type or stage, and evaluated pharmacological treatments for the management of cognitive symptoms of dementia. Studies will not be excluded if they sought to include participants with other co-morbidities alongside dementia or on the basis of contextual setting. A comprehensive search of five databases (Medline, Embase, PsychINFO, Scopus, and Web of Science) and one clinical trial register [International Clinical Trials Registry Platform (ICTRP)] will be conducted using search terms devised with a subject librarian from the Medical Library at Queen’s University Belfast. Title and abstract screening will be conducted independently by one researcher (BS). Two reviewers (BS and HB) will then screen the full texts of potentially eligible articles and trial registration records. Any disagreements about study eligibility will be resolved through discussion with a third reviewer (CH) until consensus is reached. Data extraction from included studies/trial registration records will be performed independently by one reviewer (BS); a 10% subset will be checked by a second reviewer (HB). A data extraction table, constructed using Microsoft Excel, will be used to detail the results of the scoping review. Studies may be grouped by participant characteristics such as dementia severity (mild, moderate, severe). Data on the recruitment and retention rates reported by included studies will be summarised using frequencies and percentages. All other extracted data, i.e. participant eligibility criteria, recruitment and retention strategies, and reasons for loss or withdrawal of participants, will be summarised and presented in tables.

Additional file 1: Supplementary Table 1. CONSORT checklist.

Additional file 5. Frequency of availability of a consulting room for use by the PBP. Description of data: Figure showing the frequency of availability of a consulting room for use by the PBP as reported by GPs.

Additional file 2. GP-PBP communication as reported by responding GPs. Description of data: Three figures (A, B, and C) depicting GP-PBP communication reported by GPs: Figure A shows frequency of face-to-face meetings between GPs and PBPs; Figure B shows the most common method(s) of communication between GPs and PBPs; and Figure C shows the most preferred method(s) of communication between GPs and PBPs.

Additional file 1: Table S1. Primers used for the detection of dfrA genes.

Additional file 3: Supplementary Table 3. Delivery of the intervention components.

Additional file 3: Table S3. Microorganisms isolated from clinical urine samples.

Additional file 3. Communication [11, 12, 30, 48].

Additional file 2. Incentives [6, 8, 17].

Additional file 1. General practitioner questionnaire. Description of data: Questionnaire that was distributed to general practitioners during this study.

Additional file 4: Figure S1. Gels showing detection of dfrA1 (a), dfrA5 (b), dfrA12 (c) and dfrA7&17 (d) genes.

Additional file 2: Supplementary Table 2. Completeness of outcome data.

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*.

Additional file 4: Supplementary Table 4. Potential mechanisms of action in the PolyPrime intervention.

Additional file 2: Table S2. Antimicrobial susceptibility of urinary E. coli and Klebsiella spp. isolates. Abbreviations: S: Susceptible; I: Intermediate; R: Resistant. Breakpoints: Amoxicillin (S ≤ 8; R > 8); Ceftazidime (S ≤ 1; I = 1.5 – 4; R > 4); Ciprofloxacin (S ≤ 0.5; I = 0.75 – 1; R > 1); Co-amoxiclav (S ≤ 32; R > 32); Nitrofurantoin (S ≤ 64; R > 64); Trimethoprim (S ≤ 2; I = 3 - 4; R > 4). NA: Not Applicable. Intermediate category not approved for amoxicillin, co-amoxiclav and nitrofurantoin by EUCAST. MIC: minimum inhibitory concentration; MIC50 and MIC90, MICs that inhibit 50% and 90% of the isolates, respectively.

Additional file 3. Summary of data collection.

Additional file 6. Recommendations and issues for the PBP role with supporting comments reported by GPs. Description of data: Table summarising the recommendations and issues that have been reported by GPs in the free text comments with examples of GP quotes.

Additional file 4. MyComrade Logic Model.

Additional file 4. PBP-Patient communication as reported by responding GPs. Description of data: Three figures (A, B, and C) depicting PBP-Patient communication reported by GPs: Figure A shows frequency of face-to-face meetings between PBPs and patients; Figure B shows the most common method(s) of communication between PBPs and patients; and Figure C shows the most preferred method(s) of communication between PBPs and patients.

Additional file 3. Most common reasons for GP-PBP communication as reported by responding GPs. Description of data: Table summarising the most common reasons for GP-PBP communication (with selected examples) reported by GPs.

Additional file 2. CHIPPS Process evlauation: Topic guide.

Additional file 1. Patient feedback questionnaire. Questionnaire to be administered to patients from intervention arm practices following delivery of the intervention.

Additional file 4. Demographics of triads and participants in the CHIPPS study.

Additional file 1: Supplementary data for development of a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes; Table S1: Inventory of outcomes by categories before the three-round Delphi exercise; Table S2: Search strategies to identify studies reporting outcome measurement instruments for antimicrobial stewardship; Table S3: Summary of the percentage of Delphi panel members rating each outcome during the outcome Delphi consensus survey; Table S4: Distribution of importance based on the scale used for outcomes after the online consensus exercise; Table S5: Summary of 55 included studies; Table S6: Methodological quality of studies aimed at developing OMIs relevant to antimicrobial prescribing in care homes; Table S7: Summary of quality assessment of ‘objective’ outcome measurement instruments; Table S8: Summary of quality assessment of ‘subjective’ outcome measurement instruments; Table S9: Quality assessment of feasibility aspects of outcome measurement instruments for the Core Outcome Set; Table S10: Distribution of agreement levels for each OMI after the OMI Delphi consensus survey.

Additional file 1. CHIPPS Intervention Service Specification

Additional file 3. CHIPPS study coding summary.

Additional file 1. SPIRIT 2013 Checklist.

Additional file 2. SPIRIT figure.

Additional file 1: Table S1. Assumptions used in the application of STOPP criteria to LiLACS NZ data. Table S2. Assumptions used in the application of START to LiLACS NZ data. Table S3. Potentially inappropriate medicines (PIMs) identified by STOPP, for all individuals enrolled in LiLACS NZ at 12-months and 24-months. Table S4. Potential prescribing omissions (PPOs) identified by START, for all individuals enrolled in LiLACS NZ at 12-months and 24-months. Table S5. The prevalence of Potentially inappropriate medicines (PIMs) within each physiological system, identified by STOPP, for all individuals enrolled in LiLACS NZ at 12-months and 24-months. Table S6. The prevalence of Potential prescribing omissions (PPOs) within each physiological system, identified by START, for all individuals enrolled in LiLACS NZ at 12-months and 24-months.

Additional file 4. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Additional file 3. Community pharmacist interview topic guide. TDF-based topic guide used during community pharmacist that was used to explore theoretical domains as barriers and facilitators to medicines management for PwD in primary care.

Additional file 1. Service specification.

Additional file 2. Family members’ focus group guide; questions based on knowledge of antimicrobial resistance, usual practice, views on the algorithm. (DOCX 30 kb)

Additional file 6. Draft intervention outlines. Description of draft interventions to improve medicines management for PwD in primary care. (DOCX 24 kb)

Additional file 2. Study recruitment documentation.

Additional file 1.

Additional file 5. BCT mapping. Mapping of behaviour change techniques (BCTs) to key domains for inclusion in an intervention to improve medicines management for PwD in primary care

Additional file 3. Capacity assessment for residents.

Additional file 2. GP interview topic guide. TDF-based topic guide used during GP interviews that was used to explore theoretical domains as barriers and facilitators to medicines management for PwD in primary care.

Additional file 1. Care home staff focus group guide; questions based on knowledge of antimicrobial resistance, usual practice, views on the algorithm, and how data might be collected in the study.

Additional file 3. GP interview guide; questions based on usual practice, views on the algorithm.

Search History/Alerts Medline (Ebscohost) [9]. Search history for Medline. (DOCX 54 kb)

Service specification. (DOCX 21 kb)

Assessment of outcome measures based on data from Cochrane review [7] and experience of feasibility study. (DOCX 16 kb)

Recruitment strategies for GP and PIPs. (DOCX 14 kb)

Patient feedback questionnaire. (DOCX 50Â kb)

BCT definitions, BCT mapping and reasons for exclusions of BCTs in Stage 2. (DOCX 50Â kb)

Documents circulated to patient panel prior to attending. (PDF 1208 kb)

Summary of HCP expert panel findings. (PDF 119Â kb)