ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 0603

Barriers and Potential Solutions in the Recruitment and Retention of Older Patients in Clinical Trials – Lessons Learned from Six Large Multi-center Randomized Controlled Trials

Thomas Buttgereit1, Andriko Palmowski1, Noah Forsat1, Maarten Boers2, Miles Witham3, Nicolas Rodondi4, Elisavet Moutzouri4, Antonio Jesus Quesada Navidad5, Arnoud van’t Hof6, Bart van der Worp7, Laura Coll-Planas8, Marieke Voshaar9, Maarten de Wit10, Jose Pereira da Silva11, Sven Stegemann12, Johannes Bijlsma13, Marcus Koeller14, Simon Mooijaart15, Patricia Kearney16 and Frank Buttgereit1, 1Charité – Universitätsmedizin Berlin, Berlin, Germany, 2Amsterdam UMC, Vrije Universiteit, Amsterdam, Netherlands, 3AGE Research Group, NIHR Newcastle Biomedical Research Centre, Translational and Clinical Research Institute, Newcastle University and Newcastle upon Tyne Hospitals Trust, Newcastle, United Kingdom, 4Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland, 5CNIC – Spanish National Center for Cardiovascular Research, Madrid, 6Cardiology Department, Maastricht UMC, Maastricht, Netherlands, 7Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, Netherlands, 8Fundació Salut i Envelliment, Universitat Autònoma de Barcelona, Barcelona, Spain, 9Department Psychology, Health and Technology, University of Twente, Twente, Netherlands, 10EULAR Patient Research Partner, Zaltbommel, Netherlands, 11University of Coimbra | UC · Clínica Universitária de Reumatologia. Faculty of Medicine, Columbia, Portugal, 12TU Graz, Institute for Process and Particle Engineering, Graz, Australia, 13Department of Rheumatology and Clinical Immunology, University Medical Centre Utrecht, Utrecht, Netherlands, 14Faculty of Geriatric Medicine, Medical University of Vienna, Vienna, Austria, 15Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands; Institute for Evidence-based Medicine in Old Age | IEMO, Leiden, Netherlands, 16School of Epidemiology and Public Health, University College Cork, Cork, Ireland

Meeting: ACR Convergence 2021

Keywords: ,

Session Information

Date: Sunday, November 7, 2021

Title: Healthcare Disparities in Rheumatology Poster (0594–0622)

Session Type: Poster Session B

Session Time: 8:30AM-10:30AM

Background/Purpose: Older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients.

We aimed to identify key barriers and to discuss solutions to specific issues affecting recruitment and retention of older participants in clinical trials based on experience gained from six current European randomized controlled trials (RCTs) focusing on older People (Table 1).

Methods: A multidisciplinary group of experts including representatives of the six RCTs held two networking conferences and compiled lists of potential barriers and solutions. Every item was subsequently allocated points by each study team according to how important it was perceived to be for their RCTs.

Results: The six RCTs enrolled 7612 older patients (Table 1). Key barriers to recruitment were impaired health status, comorbidities and diverse health beliefs including priorities within different cultural Systems (Figure 1A). All trials had to increase the number of recruitment sites. Other measures felt to be effective included the provision of extra time, communication training for the study staff and a re-design of patient Information (Figure 1B). Key barriers for retention included the presence of severe comorbidities and the occurrence of adverse events. Long study duration, frequent study visits and difficulties accessing the study site were also mentioned (Figure 2A). Solutions felt to be effective included spending more time maintaining close contact with the participants, appropriate measures to show appreciation and reimbursement of travel Arrangements (Figure 2B).

Conclusion: Recruitment and retention of older patients in trials requires special recognition and a targeted approach. Our results provide scientifically-based practical recommendations for optimizing future studies in this population.

Six international multi-center randomized controlled trials (RCTs), designed for patients aged ≥ 65 years and supported by the European Commission Horizon 2020 research and innovation programme

A: Challenges in retention. Mean number of points awarded per item (standard error range: 1,92 – 4,84). The more points an item got, the more relevant it was perceived to be for the respective trial.
B: Solutions in retention. Mean number of points awarded per item (standard error range: 0,21 – 4,47). The more points an item got, the more relevant it was perceived to be for the respective trial.

A: Challenges in retention. Mean number of points awarded per item (standard error range: 1,92 – 4,84). The more points an item got, the more relevant it was perceived to be for the respective trial.
B: Solutions in retention. Mean number of points awarded per item (standard error range: 0,21 – 4,47). The more points an item got, the more relevant it was perceived to be for the respective trial.

Disclosures: T. Buttgereit, None; A. Palmowski, None; N. Forsat, None; M. Boers, BMS, 2, Pfizer, 2, GSK, 2, Novartis, 2; M. Witham, None; N. Rodondi, None; E. Moutzouri, None; A. Quesada Navidad, None; A. van’t Hof, None; B. van der Worp, None; L. Coll-Planas, None; M. Voshaar, None; M. de Wit, None; J. Pereira da Silva, Amgen, 6, Jaba Recordati, 6, Pfizer, 6; S. Stegemann, None; J. Bijlsma, None; M. Koeller, None; S. Mooijaart, None; P. Kearney, None; F. Buttgereit, Horizon Therapeutics, 2, 5, Mundipharma, 5, Roche, 1, 5, Pfizer, 1, 5, 6.

To cite this abstract in AMA style:

Buttgereit T, Palmowski A, Forsat N, Boers M, Witham M, Rodondi N, Moutzouri E, Quesada Navidad A, van’t Hof A, van der Worp B, Coll-Planas L, Voshaar M, de Wit M, Pereira da Silva J, Stegemann S, Bijlsma J, Koeller M, Mooijaart S, Kearney P, Buttgereit F. Barriers and Potential Solutions in the Recruitment and Retention of Older Patients in Clinical Trials – Lessons Learned from Six Large Multi-center Randomized Controlled Trials [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/barriers-and-potential-solutions-in-the-recruitment-and-retention-of-older-patients-in-clinical-trials-lessons-learned-from-six-large-multi-center-randomized-controlled-trials/. Accessed .

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/barriers-and-potential-solutions-in-the-recruitment-and-retention-of-older-patients-in-clinical-trials-lessons-learned-from-six-large-multi-center-randomized-controlled-trials/