Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities

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• 作者：Peter Bower (13)
  Valerie Brueton (14)
  Carrol Gamble (15)
  Shaun Treweek (16)
  Catrin Tudur Smith (17)
  Bridget Young (18)
  Paula Williamson (17)
  
  13. National Institute for Health Research School for Primary Care Research ; North West Hub for Trials Methodology Research ; University of Manchester ; Oxford Road ; Manchester ; M13 9PL ; UK
  14. MRC Clinical Trials Unit at University College London ; 125 Kingsway ; London ; WC2B 6NH ; UK
  15. North West Hub for Trials Methodology Research ; University of Liverpool ; 1st floor Duncan Building ; Daulby Street ; Liverpool ; L69 3GA ; UK
  16. Health Services Research Unit ; University of Aberdeen ; Foresterhill ; Aberdeen ; AB25 2ZD ; UK
  17. North West Hub for Trials Methodology Research and Department of Biostatistics ; University of Liverpool ; 1st floor Duncan Building ; Daulby Street ; Liverpool ; L69 3GA ; UK
  18. North West Hub for Trials Methodology Research and Department of Psychological Sciences ; University of Liverpool ; 1st floor Duncan Building ; Daulby Street ; Liverpool ; L69 3GA ; UK
  
• 关键词：Trials ; Recruitment ; Retention
• 刊名：Trials
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：15
• 期：1
• 全文大小：344 KB
• 参考文献：Best Research for Best Health - A New National Health Research Strategy. Department of Health, London
  1. McDonald, A, Knight, R, Campbell, M, Entwistle, V, Grant, A, Cook, J, Elbourne, D, Francis, D, Garcia, J, Roberts, I, McDonald, A, Knight, R, Campbell, M, Entwistle, V, Grant, A, Cook, J, Elbourne, D, Francis, D, Garcia, J, Roberts, I, Snowdon, C (2006) What influences recruitment to randomized controlled trials? A review of trials funded by two UK funding agencies. Trials 7: pp. 9 CrossRef
  2. Bower, P, Wilson, S, Mathers, N (2007) How often do UK primary care trials face recruitment delays?. Fam Pract 24: pp. 601-603 CrossRef
  3. Darbyshire, J (2008) The UK Clinical Research Network - building a world-class infrastructure for clinical research. Rheumatology 47: pp. 745 CrossRef
  4. Sully, B, Julious, S, Nicholl, J (2013) A reinvestigation of recruitment to randomized, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials 14: pp. 166 CrossRef
  5. Tudur Smith, C, Hickey, H, Clarke, M, Blazeby, J, Williamson, PR (2014) The Trials Methodological Research Agenda: Results from a priority setting exercise. Trials 15: pp. 32 CrossRef
  6. Bower, P, Wallace, P, Ward, E, Graffy, J, Miller, J, Delaney, B, Kinmonth, A (2009) Improving recruitment to health research in primary care. Fam Pract 26: pp. 391-397 CrossRef
  7. Bell-Syer, S, Klaber-Moffett, J (2000) Recruiting patients to randomized trials in primary care: principles and case study. Fam Pract 17: pp. 187-191 CrossRef
  8. Mason, V, Shaw, A, Wiles, N, Mulligan, J, Peters, T, Sharp, D, Lewis, G (2007) GPs鈥?experience of primary care mental health research: a qualitative study of the barriers to recruitment. Fam Pract 24: pp. 518-525 CrossRef
  9. Raftery, J, Bryant, J, Powell, J, Kerr, C, Hawker, S (2008) Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. Health Technol Assess 12: pp. 1-128 CrossRef
  10. McCann, S, Campbell, M, Entwistle, V (2013) Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation. J Health Serv Res Policy 18: pp. 233-241 CrossRef
  11. Llewellyn-Thomas, H, McGreal, M, Thiel, E (2010) Cancer patients decision making and trial-entry preferences: the effects of framing information about short-term toxicity and long-term survival. Med Decis Making 15: pp. 4-12 CrossRef
  12. Leathem, C, Cupples, M, Byrne, M, O鈥橫alley, M, Houlihan, A, Murphy, A, Smith, S (2009) Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomized controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care. BMC Med Res Methodol 19: pp. 40 CrossRef
  13. Junghans, C, Feder, G, Hemingway, H, Timmis, A, Jones, M (2005) Recruiting patients to medical research: double blind randomized trial of 鈥渙pt-in鈥?versus 鈥渙pt-out鈥?strategies. BMJ 331: pp. 940 CrossRef
  14. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstr酶m M, Johansen M, Taskila TK, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P: Strategies to improve recruitment to randomized controlled trials. / Cochrane Database Syst Rev 2010,. MR000013
  15. Treweek, S, Lockhart, P, PitKethly, M, Cook, J, Kjeldstr酶m, M, Johansen, M, Taskila, T, Sullivan, F, Wilson, S, Jackson, C, Jones, R, Mitchell, ED (2013) Methods to improve recruitment to randomized controlled trials: Cochrane systematic review and meta-analysis. BMJ Open 3: pp. e002360 CrossRef
  16. Brueton V, Tierney J, Stenning S, Harding S, Meredith S, Nazareth I, Rait G: Strategies to improve retention in randomized trials. / Cochrane Database Syst Rev 2013, MR000032
  17. Caldwell, P, Hamilton, S, Tan, A, Craig, J (2010) Strategies for increasing recruitment to randomized controlled trials: systematic review. PLoS Med 7: pp. e1000368 CrossRef
  18. Watson, J, Torgerson, D (2006) Increasing recruitment to randomized trials: a review of randomized controlled trials. BMC Med Res Methodol 6: pp. 34 CrossRef
  19. Fletcher, B, Gheorghe, A, Moore, D, Wilson, S, Damery, S (2012) Improving the recruitment activity of clinicians in randomized controlled trials: a systematic review. BMJ Open 2: pp. e000496 CrossRef
  20. Rendell J, Merritt R, Geddes J: Incentives and disincentives to participation by clinicians in randomized controlled trials. / Cochrane Database Syst Rev 2007,. MR000021
  21. Edwards P, Roberts I, Clarke M, DiGuiseppi C, Wentz R, Kwan I, Cooper R, Felix L, Pratap S: Methods to increase response to postal and electronic questionnaires. / Cochrane Database Syst Rev 2009,. MR000008
  22. Nakash, R, Hutton, J, J酶rstad-Stein, E, Gates, S, Lamb, S (2006) Maximising response to postal questionnaires 鈥?a systematic review of randomized trials in health research. BMC Med Res Methodol 6: pp. 5 CrossRef
  23. Ennis, L, Wykes, T (2013) Impact of patient involvement in mental health research: longitudinal study. Br J Psychiatry 203: pp. 381-386 CrossRef
  24. King, M, Sibbald, B, Ward, E, Bower, P, Lloyd, M, Gabbay, M, Byford, S (2000) Randomised controlled trial of non-directive counselling, cognitive-behaviour therapy and usual general practitioner care in the management of depression as well as mixed anxiety and depression in primary care. Health Technol Assess 4: pp. 1-83
  25. Shilling, V, Williamson, P, Hickey, H, Sowden, E, Smyth, R, Young, B (2011) Processes in recruitment to randomized controlled trials of medicines for children (RECRUIT): a qualitative study. Health Technol Assess 15: pp. 1-116 CrossRef
  26. Gillies, K, Entwistle, V (2012) Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision. J Med Ethics 38: pp. 751-756 CrossRef
  27. Mills, N, Donovan, J, Wade, J, Hamdy, F, Neal, D, Lane, J (2011) Exploring treatment preferences facilitated recruitment to randomized controlled trials. J Clin Epidemiol 64: pp. 1127-1136 CrossRef
  28. Donovan, J, Mills, N, Smith, M, Brindle, L, Jacoby, A, Peters, T, Frankel, S, Neal, D, Hamdy, F (2002) Improving design and conduct of randomized trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ 325: pp. 766-770 CrossRef
  29. Moynihan, C, Lewis, R, Hall, E, Jones, E, Birtle, A, Huddart, R (2012) The Patient Deficit Model Overturned: a qualitative study of patients鈥?perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011). Trials 13: pp. 228 CrossRef
  30. Paramasivan, S, Huddart, R, Hall, E, Lewis, R, Birtle, A, Donovan, J (2011) Key issues in recruitment to randomized controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials 12: pp. 78 CrossRef
  31. Donovan, J, Lane, A, Peters, T, Brindle, L, Saltera, E, Gillatt, D, Powell, P, Bollinae, P, Neal, D, Hamdy, F (2009) Development of a complex intervention improved randomization and informed consent in a randomized controlled trial. J Clin Epidemiol 62: pp. 29-36 CrossRef
  32. Shneerson, C, Windle, R, Cox, K (2013) Innovating information-delivery for potential clinical trials participants. What do patients want from multi-media resources?. Pat Educ Couns 90: pp. 111-117 CrossRef
  33. Gillies K, Skea Z, Politi M, Brehaut J: Decision support interventions for people making decisions about participation in clinical trials (Protocol). / Cochrane Database Syst Rev 2012,. CD009736
  34. Antonious, E, Draper, H, Reed, K, Burls, A, Southwood, T, Zeegers, M (2011) An empirical study on the preferred size of the participant information sheet in research. J Med Ethics 37: pp. 557-562 CrossRef
  35. Graffy, J, Bower, P, Ward, E, Wallace, P, Delaney, B, Kinmonth, A, Collier, D, Miller, J (2010) Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials. BMC Med Res Methodol 10: pp. 38 CrossRef
  36. Graffy, J, Grant, J, Boase, S, Ward, E, Wallace, P, Miller, J, Kinmonth, A (2009) UK research staff perspectives on improving recruitment and retention to primary care research; nominal group exercise. Fam Pract 26: pp. 48-55 CrossRef
  37. Tulsky, J, Arnold, R, Alexander, S, Olson, M, Jeffreys, A, Rodriguez, K, Skinner, C, Farrell, D, Abernethy, A, Pollak, K (2011) Enhancing communication between oncologists and patients with a computer-based training program. Ann Intern Med 155: pp. 593-601 CrossRef
  38. Richards, D, Hughes-Morley, A, Hayes, R, Araya, R, Barkham, M, Bland, J, Bower, P, Cape, J, Chew-Graham, C, Gask, L, Gilbody, S, Green, C, Kessler, D, Lewis, G, Lovell, K, Manning, C, Pilling, S (2009) Collaborative Depression Trial (CADET): multi-centre randomized controlled trial of collaborative care for depression - study protocol. BMC Health Serv Res 9: pp. 188 CrossRef
  39. Michie, S (2008) Designing and implementing behaviour change interventions to improve population health. J Health Serv Res Policy 13: pp. 64-69 CrossRef
  40. Ziebland, S, Featherstone, K, Snowdon, C, Barker, K, Frost, H, Fairbank, J (2007) Does it matter if clinicians recruiting for a trial don鈥檛 understand what the trial is really about? Qualitative study of surgeons鈥?experiences of participation in a pragmatic multi-centre RCT. Trials 8: pp. 4 CrossRef
  41. Rick, J, Bower, P, Collier, D, Eldridge, S, Graffy, J, Kennedy, A, Knapp, P, Hughes-Morley, A, Salisbury, C, Small, N, Torgerson, D, Treweek, S, Wallace, P (2013) Systematic techniques for assisting recruitment to trials (START): developing the science of recruitment. Trials 14: pp. O61 CrossRef
  42. Smith, V, Clarke, M, Devane, D, Begley, C, Shorter, G, Maguire, L (2014) SWAT 1: what effects do site visits by the principal investigator have on recruitment in a multicentre randomized trial?. J Evid Base Med 6: pp. 136-137 CrossRef
  43. Treweek, S (2013) Trial forge: a systematic approach to making trials more efficient. Trials 14: pp. O121 CrossRef
  
• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Despite significant investment in infrastructure many trials continue to face challenges in recruitment and retention. We argue that insufficient focus has been placed on the development and testing of recruitment and retention interventions. Methods In this current paper, we summarize existing reviews about interventions to improve recruitment and retention. We report survey data from Clinical Trials Units in the United Kingdom to indicate the range of interventions used by these units to encourage recruitment and retention. We present the views of participants in a recent workshop and a priority list of recruitment interventions for evaluation (determined by voting among workshop participants). We also discuss wider issues concerning the testing of recruitment interventions. Results Methods used to encourage recruitment and retention were categorized as: patient contact, patient convenience, support for recruiters, monitoring and systems, incentives, design, resources, and human factors. Interventions felt to merit investigation by respondents fell into three categories: training site staff, communication with patients, and incentives. Conclusions Significant resources continue to be invested into clinical trials and other high quality studies, but recruitment remains a significant challenge. Adoption of innovative methods to develop, test, and implement recruitment interventions are required.