Recruitment and retention of participants in randomised controlled trials: A review of trials funded and published by the United Kingdom Health Technology Assessment Programme

BMJ Open

Volumn 7, Issue 3, 2017, Pages

  Walters, Stephen J ^a   Dos Anjos Henriques Cadby, Inês Bonacho ^a   Bortolami, Oscar ^a   Flight, Laura ^a   Hind, Daniel ^a   Jacques, Richard M ^a   Knox, Christopher ^a   Nadin, Ben ^a   Rothwell, Joanne ^a   Surtees, Michael ^a   Julious, Steven A ^a  

^a UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

Health Technology Assessment; Publicly funded; Randomised Controlled Trials; recruitment; Retention; review

Indexed keywords

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA EXTRACTION; FOLLOW UP; HUMAN; MEDICAL RESEARCH; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; UNITED KINGDOM; BIOMEDICAL TECHNOLOGY ASSESSMENT; COST BENEFIT ANALYSIS; ECONOMICS; MULTICENTER STUDY (TOPIC); PATIENT DROPOUT; PATIENT SELECTION; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS AND NUMERICAL DATA;

COST-BENEFIT ANALYSIS; HUMANS; MULTICENTER STUDIES AS TOPIC; PATIENT DROPOUTS; PATIENT SELECTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TECHNOLOGY ASSESSMENT, BIOMEDICAL; UNITED KINGDOM;

EID: 85015819779     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-015276     Document Type: Article

References (36)

1. Chakma J, Gordon H, Sun MD, et al. Asia's ascent - global trends in biomedical R&D expenditures. N Engl J Med 2014;370:3-6.
2. National Institute for Health Research Annual Report 2014/15 (online). http://www.nihr.ac.uk/news/nihr-annual-report-201415/3111 (accessed 28 Feb 2017).
3. McDonald AL, Knight RC, Campbell MK, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 2006;7:9.
4. Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials 2013;14:166.
5. Prescott RJ, Counsell CE, Gillespie WJ, et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess (Winchester, England). 1999;3:1-143.
6. Treweek S, Mitchell E, Pitkethly M, et al. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev 2010;(4):MR000013.
7. Rendell JM, Merritt RD, Geddes JR. Incentives and disincentives to participation by clinicians in randomised controlled trials. Cochrane Database Syst Rev 2007;(2):MR000021.http://dx.doi.org/10.1002/ 14651858.MR000021.pub3
8. Brueton VC, Tierney J, Stenning S, et al. Strategies to improve retention in randomised trials. Cochrane Database Syst Rev 2013; (12):MR000032.
9. King M, Nazareth I, Lampe F, et al. Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials. Health Technol Assess 2005;9:1-186.
10. Raftery J, Bryant J, Powell J, et al. Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. Health Technol Assess 2008;12:1-128.
11. Smith TC, Hickey H, Clarke M, et al. The trials methodological research agenda: results from a priority setting exercise. Trials 2014;15:32.
12. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637-9.
13. Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:570-1.
14. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001;134:657-62.
15. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.
16. Edwards SJL, Braunholtz DA, Lilford RJ, et al. Ethical issues in the design and conduct of cluster randomised controlled trials. BMJ 1999;318:1407-9.
17. Schulz KF, Altman DG, Moher D. Factors that limit the quality, number and progress of randomised controlled trials. BMC Med 2010;8:18.
18. Campbell MJ, Machin D, Walters SJ. Medical statistics: a text book for the health sciences, 4th edn. Chichester: Wiley, 2007.
19. Cuzick J. AWilcoxon-type test for trend. Stat Med 1985;4:87-90.
20. R Core Team. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2016. https://www.r-project.org/.
21. Roberts I, Shakur H, Coats T, et al. The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients. Health Technol Assess 2013;17:1-79.
22. Kitchener HC, Almonte M, Gilham C, et al. ARTISTIC: a randomised trial of human papillomavirus (HPV) testing in primary cervical screening. Health Technol Assess 2009;13:1-150, iii-iv.
23. Robson SC, Kelly T, Howel D, et al. Randomised preference trial of medical versus surgical termination of pregnancy less than 14 weeks' gestation (TOPS). Health Technol Assess 2009;13:1-124.
24. Townsend J, Wolke D, Hayes J, et al. Routine examination of the newborn: the EMREN study. Evaluation of an extension of the midwife role including a randomised controlled trial of appropriately trained midwives and paediatric senior house officers. Health Technol Assess 2004;8:iii-iv, ix-xi, 1-100.
25. Wiggins M, Oakley A, Roberts I, et al. The social support and family health study: a randomised controlled trial and economic evaluation of two alternative forms of postnatal support for mothers living in disadvantaged inner-city areas. Health Technol Assess 2004;8:iii, ix-x, 1-120.
26. Kalra L, Evans A, Perez I, et al. A randomised controlled comparison of alternative strategies in stroke care. Health Technol Assess 2005;9: iii-iv, 1-79.
27. Sharples L, Hughes V, Crean A, et al. Cost-effectiveness of functional cardiac testing in the diagnosis and management of coronary artery disease: a randomised controlled trial. The CECaT trial. Health Technol Assess 2007;11:iii-iv, ix-115.
28. Goodacre S, Bradburn M, Fitzgerald P, et al. The RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department. Health Technol Assess 2011;15:iii-xi, 1-102.
29. Pickard R, Lam T, Maclennan G, et al. Types of urethral catheter for reducing symptomatic urinary tract infections in hospitalised adults requiring short-term catheterisation: multicentre randomised controlled trial and economic evaluation of antimicrobial-and antiseptic-impregnated urethral catheters (the CATHETER trial). Health Technol Assess 2012;16:1-197.
30. Allen SJ, Wareham K, Wang D, et al. A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE). Health Technol Assess 2013;17:1-140.
31. Nicholson KG, Abrams KR, Batham S, et al. Randomised controlled trial and health economic evaluation of the impact of diagnostic testing for influenza, respiratory syncytial virus and Streptococcus pneumoniae infection on the management of acute admissions in the elderly and high-risk 18-to 64-year-olds. Health Technol Assess 2014;18:1-274, vii-viii.
32. Walters SJ. Quality of life outcomes in clinical trials and health care evaluation: a practical guide to analysis and interpretation. Chichester: Wiley, 2009.
33. Turner S, Wright D, Maeso R, et al. Publication rate for funded studies from a major UK health research funder: a cohort study. BMJ Open 2013;3:e002521.
34. White D, Hind D. Projection of participant recruitment to primary care research: a qualitative study. Trials 2015;16:473.
35. Stuardi T, Cox H, Torgerson DJ. Database recruitment: a solution to poor recruitment in randomized trials? Fam Pract 2011;28:329-33.
36. Cooper CL, Hind D, Duncan R, et al. A rapid review indicated higher recruitment rates in treatment trials than in prevention trials. J Clin Epidemiol 2015;68:3, 347-354.