Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis

BMJ Open

Volumn 3, Issue 2, 2013, Pages

  Treweek, Shaun ^a   Lockhart, Pauline ^a   Pitkethly, Marie ^a   Cook, Jonathan A ^b   Kjeldstrøm, Monica ^c   Johansen, Marit ^d   Taskila, Taina K ^e   Sullivan, Frank M ^a   Wilson, Sue ^e   Jackson, Catherine ^f   Jones, Ritu ^g   Mitchell, Elizabeth D ^a  

^a UNIVERSITY OF DUNDEE   (United Kingdom)

^b UNIVERSITY OF ABERDEEN   (United Kingdom)

^c Norwegian Knowledge Centre for the Health Services ^*

^d NORWEGIAN KNOWLEDGE CENTRE FOR THE HEALTH SERVICES   (Norway)

^e UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^f UNIVERSITY OF ST ANDREWS   (United Kingdom)

^g Social Dimensions of Health Institute   (Malawi)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; COCHRANE LIBRARY; EMBASE; HUMAN; LIFESTYLE MODIFICATION; MEDICAL LITERATURE; MEDLINE; METHODOLOGY; OUTCOME ASSESSMENT; PRIMARY MEDICAL CARE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SECONDARY HEALTH CARE; SYSTEMATIC REVIEW; TELECONSULTATION;

EID: 84875022120     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-002360     Document Type: Review

References (67)

1. Odgaard-Jensen J, Vist GE, Timmer A, et al. Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2011;4:MR000012.
2. McDonald AM, 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.
3. Altman DG. Statistics and ethics in medical research III. How large a sample? BMJ 1980;281:1336-8. (Pubitemid 10029868)
4. Charlson ME, Horwitz RI. Applying results of randomised trials to clinical practice: impact of losses before randomisation. BMJ 1984;289:1281-4. (Pubitemid 15217616)
5. Haidich AB, Ioannidis JPA. Patterns of patient enrollment in randomized controlled trials. J Clin Epidemiol 2001;54:877-83. (Pubitemid 32755779)
6. Foy R, Parry J, Duggan A, et al. How evidence based are recruitment strategies to randomized controlled trials in primary care? Experience from seven studies. Fam Pract 2003;20:83-92. (Pubitemid 36163791)
7. Watson JM, Torgerson DJ. Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC Med Res Methodol 2006;6:34.
8. Mapstone J, Elbourne D, Roberts I. Strategies to improve recruitment to research studies. Cochrane Database Syst Rev 2007;2:MR000013.
9. Caldwell PHY, Hamilton S, Tan A, et al. Strategies for increasing recruitment to randomised controlled trials: systematic review. PLoS Med 2010;7:e1000368.
10. Treweek S, Mitchell E, Pitkethly M, et al. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev 2010;4:MR000013.
11. Edwards PJ, Roberts I, Clarke MJ, et al. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev 2009;3:MR000008.
12. Rendell JM, Merritt RK, Geddes J. Incentives and disincentives to participation by clinicians in randomised controlled trials. Cochrane Database Syst Rev 2007;2:MR000021.
13. Brueton VC, Rait G, Tierney J, et al. Strategies to reduce attrition in randomised trials (protocol). Cochrane Database Syst Rev 2011;2: MR000032.
14. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273:408-12.
15. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. Version 5.0.1. Cochrane Collaboration, 2008. http:// www.cochrane-handbook.org (accessed 7 Jan 2013).
16. Avenell A, Grant AM, McGee M, et al. The effects of an open design on trial participant recruitment, compliance and retention - a randomized controlled trial comparison with a blinded, placebo-controlled design. Clin Trials 2004;1:490-8.
17. Bentley JP, Thacker PG. The influence of risk and monetary payment on the research participation decision making process. J Med Ethics 2004;30:293-8. (Pubitemid 38868081)
18. Cooper KG, Grant AM, Garratt AM. The impact of using a partially randomised patient preference design when evaluating alternative managements for heavy menstrual bleeding. Br J Obstet Gynaecol 1997;104:1367-73. (Pubitemid 27517633)
19. Coyne CA, Xu R, Raich P, et al. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 2003;21:836-42. (Pubitemid 46606443)
20. DiGuiseppi C, Goss C, Xu S, et al. Telephone screening for hazardous drinking among injured patients seen in acute care clinics: feasibility study. Alcohol Alcohol 2006;41:438-45. (Pubitemid 43997274)
21. Du W, Mood D, Gadgeel S, et al. An educational video to increase clinical trials enrollment among lung cancer patients. J Thorac Oncol 2008;3:23-9.
22. Du W, Mood M, Gadgeel S, et al. An educational video to increase clinical trials enrollment among breast cancer patients. Breast Cancer Res Treat 2009;117:339-47.
23. Ellis PM, Butow PN, Tattersall MHN. Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet. Ann Oncol 2002;13:1414-23.
24. Ford ME, Havstad SL, Davis SD. A randomized trial of recruitment methods for older African American men in the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial. Clin Trials 2004;1:343-51.
25. Fowell A, Johnstone R, Finlay IG, et al. Design of trials with dying patients: a feasibility study of cluster randomisation versus randomised consent. Palliat Med 2006;20:799-804. (Pubitemid 46040131)
26. Free C, Hoile E, Robertson S, et al. Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support. Clin Trials 2010;7:265-73.
27. Freer Y, McIntosh N, Teunisse S, et al. More Information, less understanding: a randomized study on consent issues in neonatal research. Pediatrics 2009;123:1301-5.
28. Fureman I, Meyers K, McLellan AT, et al. Evaluation of a video-supplement to informed consent: injection drug users and preventive HIV vaccine efficacy trials. AIDS Educ Prev 1997;9:330-41. (Pubitemid 27434394)
29. Graham A, Goss C, Xu S, et al. Effect of using different modes to administer the AUDIT-C on identification of hazardous drinking and acquiescence to trial participation among injured patients. Alcohol Alcohol 2007;42:423-9. (Pubitemid 47604047)
30. Halpern SD, Karlawish JHT, Casarett D, et al. Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials. Arch Intern Med 2004;164:801-3. (Pubitemid 38478704)
31. Harris TJ, Carey IM, Victor CR, et al. Optimising recruitment into a study of physical activity in older people: a randomised controlled trial of different approaches. Age Ageing 2008;37:659-65.
32. Hemminki E, Hovi SL, Veerus P, et al. Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy. J Clin Epidemiol 2004;57:1237-43. (Pubitemid 40023143)
33. Hutchison C, Cowan C, McMahon T, et al. A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. Br J Cancer 2007;97:705-11. (Pubitemid 47396289)
34. Ives NJ, Troop M, Waters A, et al. Does an HIV clinical trial information booklet improve patient knowledge and understanding of HIV clinical trials? HIV Med 2001;2:241-9. (Pubitemid 33114767)
35. Jeste DV, Palmer BW, Golshan S, et al. Multimedia consent for research in people with schizophrenia and normal subjects: a randomized controlled trial. Schizophr Bull 2009;35:719-29.
36. Karunaratne AS, Korenman SG, Thomas SL, et al. Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants. Med J Aust 2010;192:388-92.
37. Kendrick D, Watson M, Dewey M, et al. Does sending a home safety questionnaire increase recruitment to an injury prevention trial? A randomised controlled trial. J Epidemiol Community Health 2001;55:845-6. (Pubitemid 32980468)
38. Kerr CEP, Robinson EJ, Lilford RJ, et al. The impact of describing clinical trial treatments as new or standard. Patient Educ Couns 2004;53:107-13. (Pubitemid 38519993)
39. Kimmick GG, Peterson BL, Kornblith AB, et al. Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001. J Clin Oncol 2005;23:2201-7. (Pubitemid 46218711)
40. Larkey LK, Staten LK, Ritenbaugh C, et al. Recruitment of Hispanic women to the Women's Health Initiative: the case of Embajadoras in Arizona. Control Clin Trials 2002;23:289-98. (Pubitemid 34621209)
41. Liénard J-L, Quinaux E, Fabre-Guillevin E, et al. Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clin Trials 2006;3:486-92.
42. Litchfield J, Freeman J, Schou H, et al. Is the future for clinical trials internet-based? A cluster randomized clinical trial. Clin Trials 2005;2:72-9. (Pubitemid 40332930)
43. Llewellyn-Thomas HA, McGreal MJ, Thiel EC. Cancer patients' decision making and trial-entry preferences: the effects of "framing" information about short-term toxicity and long-term survival. Med Decis Making 1995;15:4-12.
44. Llewellyn-Thomas HA, Thiel EC, Sem FWC, et al. Presenting clinical trial information: a comparison of methods. Patient Educ Couns 1995;25:97-107.
45. Mandelblatt J, Kaufman E, Sheppard VB, et al. Breast cancer prevention in community clinics: will low-income Latina patients participate in clinical trials? Prev Med 2005;40:611-18. (Pubitemid 40591821)
46. Miller NL, Markowitz JC, Kocsis JH, et al. Cost effectiveness of screening for clinical trials by research assistants versus senior investigators. J Psychiatr Res 1999;33:81-5. (Pubitemid 29134735)
47. Monaghan H, Richens A, Colman S, et al. A randomised trial of the effects of an additional communication strategy on recruitment into a large-scale, multi-centre trial. Contemp Clin Trials 2007;28:1-5. (Pubitemid 44780206)
48. Myles PS, Fletcher HE, Cairo S, et al. Randomized trial of informed consent and recruitment for clinical trials in the immediate preoperative period. Anesthesiology 1999;91:969-78. (Pubitemid 29466531)
49. Nystuen P, Hagen KB. Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. J Clin Epidemiol 2004;57:773-6. (Pubitemid 39370159)
50. Perrone F, De Placido S, Giusti C, et al. The request for consent in clinical research: a randomised study in healthy subjects. Epidemiol Prev 1995;19:282-90.
51. Pighills A, Torgerson DJ, Sheldon T. Publicity does not increase recruitment to falls prevention trials: the results of two quasi-randomized trials. J Clin Epidemiol 2009;62:1332-5.
52. Simel DL, Feussner Jr. A randomized controlled trial comparing quantitative informed consent formats. J Clin Epidemiol 1991;44:771-7.
53. Simes RJ, Tattersall MHN, Coates AS, et al. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer. BMJ 1986;293:1065-8. (Pubitemid 17201411)
54. Treschan TA, Scheck T, Kober A, et al. The influence of protocol pain and risk on patients' willingness to consent for clinical studies: a randomized trial. Anesth Analg 2003;96:498-506. (Pubitemid 36125772)
55. Trevena L, Irwig L, Barratt A. Impact of privacy legislation on the number and characteristics of people who are recruited for research: a randomised controlled trial. J Med Ethics 2006;32:473-7. (Pubitemid 44210083)
56. Wadland WC, Hughes JR, Secker-Walker RH, et al. Recruitment in a primary care trial on smoking cessation. Fam Med 1990;22:201-4. (Pubitemid 20242097)
57. Weinfurt KP, Hall MA, Dinan MA, et al. Effects of disclosing financial interests on attitudes toward clinical research. J Gen Intern Med 2008;23:860-6.
58. Weinfurt KP, Hall MA, Friedman JY, et al. Effects of disclosing financial interests on participation in medical research: a randomized vignette trial. Am Heart J 2008;156:689-97.
59. Welton AJ, Vickers MR, Cooper JA, et al. Is recruitment more difficult with a placebo arm in randomised controlled trials? A quasirandomised, interview based study. BMJ 1999;318:1114-17. (Pubitemid 29192152)
60. Weston J, Hannah M, Downes J. Evaluating the benefits of a patient information video during the informed consent process. Patient Educ Couns 1997;30:239-45. (Pubitemid 27104520)
61. Hewison J, Haines A. Overcoming barriers to recruitment in health research. BMJ 2006;333:300-2.
62. Engels EA, Schmid CH, Terrin N, et al. Heterogeneity and statistical significance in meta-analyses: an empirical study of 125 meta-analyses. Stat Med 2000;19:1707-28. (Pubitemid 30436058)
63. Treweek S, Barnett K, Maclennan G, et al. E-mail invitations to general practitioners were as effective as postal invitations and were more efficient. J Clin Epidemiol 2012;657:793-7.
64. Graffy J, Bower P, Ward E, et al. 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 2010;10:38.
65. McKinstry B, Hammersley V, Daly F, et al. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: a case study. BMC Med Res Methodol 2007;7:15.
66. van der Wouden JC, Blankenstein AH, Huibers MJH, et al. Survey among 78 studies showed that Lasagna's law holds in Dutch primary care research. J Clin Epidemiol 2007;60:819-24. (Pubitemid 46990809)
67. Prescott RJ, Counsell CE, Gillespie WJ, et al. Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999;3:1-143.