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Published in: BMC Medical Research Methodology 1/2006

Open Access 01-12-2006 | Research article

Increasing recruitment to randomised trials: a review of randomised controlled trials

Authors: Judith M Watson, David J Torgerson

Published in: BMC Medical Research Methodology | Issue 1/2006

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Abstract

Background

Poor recruitment to randomised controlled trials (RCTs) is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective.

Methods

We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies) were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors.

Results

We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive.

Conclusion

Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.
Appendix
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Literature
1.
go back to reference Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, Colthart IR, Ross S, Shepherd SM, Russell D: Factors that limit the quality, number and progress of randomised controlled trials. [Review]. Health Technology Assessment. Rockville, Md. 1999, 3: 1-143. Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, Colthart IR, Ross S, Shepherd SM, Russell D: Factors that limit the quality, number and progress of randomised controlled trials. [Review]. Health Technology Assessment. Rockville, Md. 1999, 3: 1-143.
2.
go back to reference Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL: Recruitment for Controlled Trials: Literature Summary and Annotated Bibliography. Controlled Clinical Trials. 1997, 18: 328-57. 10.1016/S0197-2456(96)00236-X.CrossRefPubMed Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL: Recruitment for Controlled Trials: Literature Summary and Annotated Bibliography. Controlled Clinical Trials. 1997, 18: 328-57. 10.1016/S0197-2456(96)00236-X.CrossRefPubMed
3.
go back to reference Puffer S, Torgerson D: Recruitment difficulties in Randomised Controlled Trials. Controlled Clinical Trials. 2003, 24 (3S): S214-15. Puffer S, Torgerson D: Recruitment difficulties in Randomised Controlled Trials. Controlled Clinical Trials. 2003, 24 (3S): S214-15.
4.
go back to reference Mapstone J, Elbourne D, Roberts I: Strategies to improve recruitment to research studies. The Cochrane Database of Methodology Reviews. 2002, 3 Mapstone J, Elbourne D, Roberts I: Strategies to improve recruitment to research studies. The Cochrane Database of Methodology Reviews. 2002, 3
5.
go back to reference Avenell A, Grant AM, McGee , McPherson G, Campbell MK, McGee MA: The effects of an open design on trial participant recruitment, compliance and retention – a randomized controlled trial comparison with a blinded, placebo-controlled design. Clinical Trials. 2004, 1: 1-9. 10.1191/1740774504cn053oa.CrossRef Avenell A, Grant AM, McGee , McPherson G, Campbell MK, McGee MA: The effects of an open design on trial participant recruitment, compliance and retention – a randomized controlled trial comparison with a blinded, placebo-controlled design. Clinical Trials. 2004, 1: 1-9. 10.1191/1740774504cn053oa.CrossRef
6.
go back to reference Hemminki E, Hovi S-L, Veerus P, Sevón T, Tuimala R, Rahu M, Hakama M: Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy. Journal of Clinical Epidemiology. 2004, 57: 1237-1243. 10.1016/j.jclinepi.2004.04.009.CrossRefPubMed Hemminki E, Hovi S-L, Veerus P, Sevón T, Tuimala R, Rahu M, Hakama M: Blinding decreased recruitment in a prevention trial of postmenopausal hormone therapy. Journal of Clinical Epidemiology. 2004, 57: 1237-1243. 10.1016/j.jclinepi.2004.04.009.CrossRefPubMed
7.
go back to reference Cooper KG, Grant AM, Garratt AM: The impact of using a partially randomised patient preference design when evaluating alternative managements for heavy menstrual bleeding. British Journal of Obstetrics and Gynaecology. 1997, 104 (12): 1367-1373.CrossRefPubMed Cooper KG, Grant AM, Garratt AM: The impact of using a partially randomised patient preference design when evaluating alternative managements for heavy menstrual bleeding. British Journal of Obstetrics and Gynaecology. 1997, 104 (12): 1367-1373.CrossRefPubMed
8.
go back to reference Donovan JL, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, Lane JA, Neal DE, Hamdy FC, for the ProtecT Study Group: Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). Journal of Clinical Epidemiology. 2003, 56: 605-609. 10.1016/S0895-4356(03)00083-0.CrossRefPubMed Donovan JL, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, Lane JA, Neal DE, Hamdy FC, for the ProtecT Study Group: Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study). Journal of Clinical Epidemiology. 2003, 56: 605-609. 10.1016/S0895-4356(03)00083-0.CrossRefPubMed
9.
go back to reference Quinaux E, Lienard J-L, Slimani Z, Jouhaud A, Piedbois P, Buyse M: Impact of monitoring visits on patient recruitment and data quality: case study of a phase IV trial in oncology. Controlled Clinical Trials. 2003, 24 (3S): 99S-(conference abstract) Quinaux E, Lienard J-L, Slimani Z, Jouhaud A, Piedbois P, Buyse M: Impact of monitoring visits on patient recruitment and data quality: case study of a phase IV trial in oncology. Controlled Clinical Trials. 2003, 24 (3S): 99S-(conference abstract)
10.
go back to reference Larkey LK, Staten LK, Ritenbaugh C, Hall RA, Buller DB, Bassford T, Altimari BR: Recruitment of Hispanic women to the Women's Health Initiative: the case of Embajadoras in Arizona. Controlled Clinical Trials. 2002, 23: 289-298. 10.1016/S0197-2456(02)00190-3.CrossRefPubMed Larkey LK, Staten LK, Ritenbaugh C, Hall RA, Buller DB, Bassford T, Altimari BR: Recruitment of Hispanic women to the Women's Health Initiative: the case of Embajadoras in Arizona. Controlled Clinical Trials. 2002, 23: 289-298. 10.1016/S0197-2456(02)00190-3.CrossRefPubMed
11.
go back to reference 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. Clinical Trials. 2004, 1: 343-351. 10.1191/1740774504cn029oa.CrossRefPubMed 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. Clinical Trials. 2004, 1: 343-351. 10.1191/1740774504cn029oa.CrossRefPubMed
12.
go back to reference Kiernan M, Phillips K, Fair JM, King AC: Using direct mail to recruit Hispanic adults into a dietary intervention: an experimental study. Annals of Behavioural Medicine. 2000, 11 (1): 89-93.CrossRef Kiernan M, Phillips K, Fair JM, King AC: Using direct mail to recruit Hispanic adults into a dietary intervention: an experimental study. Annals of Behavioural Medicine. 2000, 11 (1): 89-93.CrossRef
13.
go back to reference Valanis B, Blank J, Glass A: Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial. Controlled Clinical Trials. 1998, 19: 25-38. 10.1016/S0197-2456(97)00027-5.CrossRefPubMed Valanis B, Blank J, Glass A: Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial. Controlled Clinical Trials. 1998, 19: 25-38. 10.1016/S0197-2456(97)00027-5.CrossRefPubMed
14.
go back to reference Kendrick D, Watson M, Dewey M, Woods AJ: Does sending a home safety questionnaire increase recruitment to an injury prevention trial? A randomised controlled trial. Journal of Epidemiological Community Health. 2001, 55: 845-846. 10.1136/jech.55.11.845.CrossRef Kendrick D, Watson M, Dewey M, Woods AJ: Does sending a home safety questionnaire increase recruitment to an injury prevention trial? A randomised controlled trial. Journal of Epidemiological Community Health. 2001, 55: 845-846. 10.1136/jech.55.11.845.CrossRef
15.
go back to reference Nystuen P, Hagen KB: Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. Journal of Clinical Epidemiology. 2004, 57: 773-776. 10.1016/j.jclinepi.2003.12.015.CrossRefPubMed Nystuen P, Hagen KB: Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. Journal of Clinical Epidemiology. 2004, 57: 773-776. 10.1016/j.jclinepi.2003.12.015.CrossRefPubMed
16.
go back to reference Aaronson NK, Visser-Pol E, Leenhouts GHMW, Muller MJ, van der Schot ACM, van Dam FSAM, Keus RB, Koning CCE, ten Bokkel Huinink WW, van Dongen JA, Dubbelman R: Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Journal of Clinical Oncology. 1996, 13: 984-996. Aaronson NK, Visser-Pol E, Leenhouts GHMW, Muller MJ, van der Schot ACM, van Dam FSAM, Keus RB, Koning CCE, ten Bokkel Huinink WW, van Dongen JA, Dubbelman R: Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials. Journal of Clinical Oncology. 1996, 13: 984-996.
17.
go back to reference Litchfield J, Freeman J, Schou H, Elsley M, Fuller R, Chubb B: Is the future for clinical trials internet-based? A cluster randomised clinical trial. Clinical Trials. 2005, 2: 72-79. 10.1191/1740774505cn069oa.CrossRefPubMed Litchfield J, Freeman J, Schou H, Elsley M, Fuller R, Chubb B: Is the future for clinical trials internet-based? A cluster randomised clinical trial. Clinical Trials. 2005, 2: 72-79. 10.1191/1740774505cn069oa.CrossRefPubMed
18.
go back to reference Martinson BC, Lazovich D, Lando HA, Perry CL, McGovern PG, Boyle RG: Effectiveness of monetary incentives for recruiting adolescents to an intervention trial to reduce smoking. Preventive Medicine. 2000, 31: 706-713. 10.1006/pmed.2000.0762.CrossRefPubMed Martinson BC, Lazovich D, Lando HA, Perry CL, McGovern PG, Boyle RG: Effectiveness of monetary incentives for recruiting adolescents to an intervention trial to reduce smoking. Preventive Medicine. 2000, 31: 706-713. 10.1006/pmed.2000.0762.CrossRefPubMed
19.
go back to reference Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I: Increasing response rates to postal questionnaires: systematic review. British Journal of Medicine. 2002, 324: 1183-1191.CrossRef Edwards P, Roberts I, Clarke M, DiGuiseppi C, Pratap S, Wentz R, Kwan I: Increasing response rates to postal questionnaires: systematic review. British Journal of Medicine. 2002, 324: 1183-1191.CrossRef
21.
go back to reference Torgerson DJ, Klaber-Moffat J, Russell IT: Patient preferences in randomised trials: threat or opportunity?. Journal of Health Services Research Policy. 1996, 1: 194-197.PubMed Torgerson DJ, Klaber-Moffat J, Russell IT: Patient preferences in randomised trials: threat or opportunity?. Journal of Health Services Research Policy. 1996, 1: 194-197.PubMed
22.
go back to reference Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F, for the ProtecT Study Group: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. British Medical Journal. 2002, 325: 766-770.CrossRefPubMedPubMedCentral Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, Frankel S, Neal D, Hamdy F, for the ProtecT Study Group: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. British Medical Journal. 2002, 325: 766-770.CrossRefPubMedPubMedCentral
23.
go back to reference Farrin AJ, Russell IT, Torgerson DJ, Underwood M, for the UKBEAM team: Differential recruitment in a cluster randomized trial in primary care: the experience of the UK back pain, Exercise, Active management and Manipulation (UK BEAM) feasibility study. Clinical Trials. 2005, 2 (2): 119-124. 10.1191/1740774505cn073oa.CrossRefPubMed Farrin AJ, Russell IT, Torgerson DJ, Underwood M, for the UKBEAM team: Differential recruitment in a cluster randomized trial in primary care: the experience of the UK back pain, Exercise, Active management and Manipulation (UK BEAM) feasibility study. Clinical Trials. 2005, 2 (2): 119-124. 10.1191/1740774505cn073oa.CrossRefPubMed
24.
go back to reference Bryant J, Powell J: Payment to healthcare professionals for patient recruitment to trials: a systematic review. British Medical Journal. 2005, 331: 1377-1378.CrossRefPubMedPubMedCentral Bryant J, Powell J: Payment to healthcare professionals for patient recruitment to trials: a systematic review. British Medical Journal. 2005, 331: 1377-1378.CrossRefPubMedPubMedCentral
Metadata
Title
Increasing recruitment to randomised trials: a review of randomised controlled trials
Authors
Judith M Watson
David J Torgerson
Publication date
01-12-2006
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2006
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-6-34

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