Thomas Buttgereit1,2, Andriko Palmowski2, Noah Forsat2, Maarten Boers3,4, Miles D Witham5, Nicolas Rodondi6,7, Elisavet Moutzouri6,7, Antonio Jesus Quesada Navidad8, Arnoud W J Van't Hof9, Bart van der Worp10, Laura Coll-Planas11, Marieke Voshaar12, Maarten de Wit13, José da Silva14, Sven Stegemann15, Johannes W Bijlsma16, Marcus Koeller17, Simon Mooijaart18, Patricia M Kearney19, Frank Buttgereit2. 1. Department of Dermatology, Venerology, and Allergology, Charité - University Medicine Berlin, Berlin, Germany. 2. Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany. 3. Department of Rheumatology, Amsterdam Rheumatology & Immunology Center, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, The Netherlands. 4. Department of Epidemiology & Data Science, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, The Netherlands. 5. AGE Research Group, NIHR Newcastle Biomedical Research Centre, Translational and Clinical Research Institute, Newcastle University and Newcastle upon Tyne Hospitals Trust, UK. 6. Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland. 7. Institute of Primary Health Care (BIHAM), University of Bern, Switzerland. 8. Clinical Trials Coordination Unit (UCEC), CNIC - Spanish National Center for Cardiovascular Research, Madrid, Spain. 9. Department of Cardiology, University Medical Center Maastricht, Maastricht, The Netherlands. 10. Department of Neurology and Neurosurgery, Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands. 11. Fundació Salut i Envelliment-Universitat Autònoma de Barcelona, Barcelona, Spain. 12. Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands. 13. Patient Research Partner, VU Medical Center, Amsterdam, The Netherlands. 14. Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal. 15. Institute of Process and Particle Engineering , Graz University of Technology, Graz, Austria. 16. Department of Rheumatology and Clinical Immunology, University Medical Centre Utrecht, Utrecht, The Netherlands. 17. Department Acute Geriatric Care, Faculty of Geriatric Medicine, Medical University of Vienna, Vienna, Austria. 18. Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, The Netherlands; Institute for Evidence-based Medicine in Old Age|IEMO, Leiden, The Netherlands. 19. School of Epidemiology and Public Health, University College Cork, Cork, Ireland.
Abstract
BACKGROUND: older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients. OBJECTIVE: 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 randomised controlled trials (RCTs) focusing on older people. 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 7,612 older patients. Key barriers to recruitment were impaired health status, comorbidities and diverse health beliefs including priorities within different cultural systems. 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. 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. 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. 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.
BACKGROUND: older people remain underrepresented in clinical trials, and evidence generated in younger populations cannot always be generalized to older patients. OBJECTIVE: 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 randomised controlled trials (RCTs) focusing on older people. 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 7,612 older patients. Key barriers to recruitment were impaired health status, comorbidities and diverse health beliefs including priorities within different cultural systems. 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. 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. 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. 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.