Skip to main content
Top
Published in: BMC Medical Research Methodology 1/2009

Open Access 01-12-2009 | Research article

Recruitment barriers in a randomized controlled trial from the physicians' perspective – A postal survey

Authors: Anne Spaar, Martin Frey, Alexander Turk, Werner Karrer, Milo A Puhan

Published in: BMC Medical Research Methodology | Issue 1/2009

Login to get access

Abstract

Background

The feasibility of randomized trials often depends on successful patient recruitment. Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most. Also, most surveys have focused on the patients' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention. Therefore, our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment.

Methods

We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease. We developed and pilot-tested a self-administered questionnaire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 (full agreement with statement = very substantial recruitment barrier) to 7 (no agreement with statement = no recruitment barrier).

Results

38 of 55 recruiting physicians returned questionnaires (69% response rate), of which 35 could be analyzed (64% useable response rate). Recruiting physicians reported that "time constraints" (median agreement of 3, interquartile range 2–5) had the most negative impact on recruitment followed by "difficulties including identified eligible patients" (median agreement of 5, IQR 3–6). Other barriers such as "trial design barriers", "lack of access to treatment", "individual barriers of recruiting physicians" or "insufficient training of recruiting physicians" were perceived to have little or no impact on patient recruitment.

Conclusion

Physicians perceived time constraints as the most relevant recruitment barrier in a randomized trial. To overcome recruitment barriers interventions, that are affordable for both industry- and investigator-driven trials, need to be developed and tested in randomized trials.

Trial registration

ISRCTN84612310
Appendix
Available only for authorised users
Literature
1.
go back to reference Ellis PM: Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol. 2000, 11 (8): 939-945. 10.1023/A:1008342222205.CrossRefPubMed Ellis PM: Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol. 2000, 11 (8): 939-945. 10.1023/A:1008342222205.CrossRefPubMed
2.
go back to reference Cox K, McGarry J: Why patients don't take part in cancer clinical trials: an overview of the literature. European journal of cancer care. 2003, 12 (2): 114-122. 10.1046/j.1365-2354.2003.00396.x.CrossRefPubMed Cox K, McGarry J: Why patients don't take part in cancer clinical trials: an overview of the literature. European journal of cancer care. 2003, 12 (2): 114-122. 10.1046/j.1365-2354.2003.00396.x.CrossRefPubMed
3.
go back to reference Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R: Barriers to participation in randomised controlled trials: a systematic review. Journal of clinical epidemiology. 1999, 52 (12): 1143-1156. 10.1016/S0895-4356(99)00141-9.CrossRefPubMed Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R: Barriers to participation in randomised controlled trials: a systematic review. Journal of clinical epidemiology. 1999, 52 (12): 1143-1156. 10.1016/S0895-4356(99)00141-9.CrossRefPubMed
4.
go back to reference Mapstone JED, Roberts IG: Strategies to improve recruitment to research studies. Cochrane Database of Systematic Reviews. 2004, MR000013-1 Mapstone JED, Roberts IG: Strategies to improve recruitment to research studies. Cochrane Database of Systematic Reviews. 2004, MR000013-1
5.
go back to reference Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL: Recruitment for controlled clinical trials: literature summary and annotated bibliography. Controlled clinical trials. 1997, 18 (4): 328-352. 10.1016/S0197-2456(96)00236-X.CrossRefPubMed Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL: Recruitment for controlled clinical trials: literature summary and annotated bibliography. Controlled clinical trials. 1997, 18 (4): 328-352. 10.1016/S0197-2456(96)00236-X.CrossRefPubMed
6.
go back to reference Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, Ellis P, Wright JR: Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. The Lancet Oncology. 2006, 7 (2): 141-148. 10.1016/S1470-2045(06)70576-9.CrossRefPubMed Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, Ellis P, Wright JR: Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. The Lancet Oncology. 2006, 7 (2): 141-148. 10.1016/S1470-2045(06)70576-9.CrossRefPubMed
7.
go back to reference Tournoux C, Katsahian S, Chevret S, Levy V: Factors influencing inclusion of patients with malignancies in clinical trials. Cancer. 2006, 106 (2): 258-270. 10.1002/cncr.21613.CrossRefPubMed Tournoux C, Katsahian S, Chevret S, Levy V: Factors influencing inclusion of patients with malignancies in clinical trials. Cancer. 2006, 106 (2): 258-270. 10.1002/cncr.21613.CrossRefPubMed
8.
go back to reference Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, Entwistle V, Garcia J, Roberts I, Grant A: Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health technology assessment (Winchester, England). 2007, 11 (48): iii-ix-105 Campbell MK, Snowdon C, Francis D, Elbourne D, McDonald AM, Knight R, Entwistle V, Garcia J, Roberts I, Grant A: Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study. Health technology assessment (Winchester, England). 2007, 11 (48): iii-ix-105
9.
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. Health technology assessment (Winchester, England). 1999, 3 (20): 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. Health technology assessment (Winchester, England). 1999, 3 (20): 1-143.
10.
go back to reference Langley C, Gray S, Selley S, Bowie C, Price C: Clinicians' attitudes to recruitment to randomised trials in cancer care: a qualitative study. Journal of health services research & policy. 2000, 5 (3): 164-169. Langley C, Gray S, Selley S, Bowie C, Price C: Clinicians' attitudes to recruitment to randomised trials in cancer care: a qualitative study. Journal of health services research & policy. 2000, 5 (3): 164-169.
11.
go back to reference Jones JM, Nyhof-Young J, Moric J, Friedman A, Wells W, Catton P: Identifying motivations and barriers to patient participation in clinical trials. J Cancer Educ. 2006, 21 (4): 237-242. 10.1080/08858190701347838.CrossRefPubMed Jones JM, Nyhof-Young J, Moric J, Friedman A, Wells W, Catton P: Identifying motivations and barriers to patient participation in clinical trials. J Cancer Educ. 2006, 21 (4): 237-242. 10.1080/08858190701347838.CrossRefPubMed
12.
go back to reference Grunfeld E, Zitzelsberger L, Coristine M, Aspelund F: Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates. Cancer. 2002, 95 (7): 1577-1583. 10.1002/cncr.10862.CrossRefPubMed Grunfeld E, Zitzelsberger L, Coristine M, Aspelund F: Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates. Cancer. 2002, 95 (7): 1577-1583. 10.1002/cncr.10862.CrossRefPubMed
13.
go back to reference Creel AH, Losina E, Mandl LA, Marx RJ, Mahomed NN, Martin SD, Martin TL, Millett PJ, Fossel AH, Katz JN: An assessment of willingness to participate in a randomized trial of arthroscopic knee surgery in patients with osteoarthritis. Contemporary clinical trials. 2005, 26 (2): 169-178. 10.1016/j.cct.2004.12.010.CrossRefPubMed Creel AH, Losina E, Mandl LA, Marx RJ, Mahomed NN, Martin SD, Martin TL, Millett PJ, Fossel AH, Katz JN: An assessment of willingness to participate in a randomized trial of arthroscopic knee surgery in patients with osteoarthritis. Contemporary clinical trials. 2005, 26 (2): 169-178. 10.1016/j.cct.2004.12.010.CrossRefPubMed
14.
go back to reference Gaul C, Schmidt T, Helm J, Hoyer H, Haerting J: [Motivation and barriers to participation in clinical trials]. Med Klin (Munich). 2006, 101 (11): 873-879. 10.1007/s00063-006-1116-7.CrossRef Gaul C, Schmidt T, Helm J, Hoyer H, Haerting J: [Motivation and barriers to participation in clinical trials]. Med Klin (Munich). 2006, 101 (11): 873-879. 10.1007/s00063-006-1116-7.CrossRef
15.
go back to reference Abraham NS, Young JM, Solomon MJ: A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery. 2006, 139 (4): 469-483. 10.1016/j.surg.2005.08.014.CrossRefPubMed Abraham NS, Young JM, Solomon MJ: A systematic review of reasons for nonentry of eligible patients into surgical randomized controlled trials. Surgery. 2006, 139 (4): 469-483. 10.1016/j.surg.2005.08.014.CrossRefPubMed
16.
go back to reference Fayter D, McDaid C, Eastwood A: A systematic review highlights threats to validity in studies of barriers to cancer trial participation. Journal of clinical epidemiology. 2007, 60 (10): 990-1001. 10.1016/j.jclinepi.2006.12.013.CrossRefPubMed Fayter D, McDaid C, Eastwood A: A systematic review highlights threats to validity in studies of barriers to cancer trial participation. Journal of clinical epidemiology. 2007, 60 (10): 990-1001. 10.1016/j.jclinepi.2006.12.013.CrossRefPubMed
17.
go back to reference Mc Daid C, Hodges Z, Fayter D, Stirk L, Eastwood A: Increasing participation of cancer patients in randomised controlled trials: a systematic review. Trials. 2006, 7: 16-10.1186/1745-6215-7-16.CrossRefPubMedPubMedCentral Mc Daid C, Hodges Z, Fayter D, Stirk L, Eastwood A: Increasing participation of cancer patients in randomised controlled trials: a systematic review. Trials. 2006, 7: 16-10.1186/1745-6215-7-16.CrossRefPubMedPubMedCentral
18.
go back to reference Watson JM, Torgerson DJ: Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC medical research methodology. 2006, 6: 34-10.1186/1471-2288-6-34.CrossRefPubMedPubMedCentral Watson JM, Torgerson DJ: Increasing recruitment to randomised trials: a review of randomised controlled trials. BMC medical research methodology. 2006, 6: 34-10.1186/1471-2288-6-34.CrossRefPubMedPubMedCentral
19.
go back to reference Puhan MA: Respiratory rehabilitation after acute exacerbations of chronic obstructive pulmonary disease. International Journal of Respiratory Care. 2007, 2: 90-93. Puhan MA: Respiratory rehabilitation after acute exacerbations of chronic obstructive pulmonary disease. International Journal of Respiratory Care. 2007, 2: 90-93.
20.
go back to reference Lacasse Y, Martin S, Lasserson TJ, Goldstein RS: Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Europa medicophysica. 2007, 43 (4): 475-485.PubMed Lacasse Y, Martin S, Lasserson TJ, Goldstein RS: Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Europa medicophysica. 2007, 43 (4): 475-485.PubMed
21.
go back to reference Puhan MA, Scharplatz M, Troosters T, Steurer J: Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality – a systematic review. Respiratory research. 2005, 6: 54-10.1186/1465-9921-6-54.CrossRefPubMedPubMedCentral Puhan MA, Scharplatz M, Troosters T, Steurer J: Respiratory rehabilitation after acute exacerbation of COPD may reduce risk for readmission and mortality – a systematic review. Respiratory research. 2005, 6: 54-10.1186/1465-9921-6-54.CrossRefPubMedPubMedCentral
22.
go back to reference Fallowfield L, Ratcliffe D, Souhami R: Clinicians' attitudes to clinical trials of cancer therapy. Eur J Cancer. 1997, 33 (13): 2221-2229. 10.1016/S0959-8049(97)00253-0.CrossRefPubMed Fallowfield L, Ratcliffe D, Souhami R: Clinicians' attitudes to clinical trials of cancer therapy. Eur J Cancer. 1997, 33 (13): 2221-2229. 10.1016/S0959-8049(97)00253-0.CrossRefPubMed
23.
go back to reference Rendell JM, Merritt RD, Geddes JR: Incentives and disincentives to participation by clinicians in randomised controlled trials. Cochrane database of systematic reviews (Online). 2007, MR000021-2 Rendell JM, Merritt RD, Geddes JR: Incentives and disincentives to participation by clinicians in randomised controlled trials. Cochrane database of systematic reviews (Online). 2007, MR000021-2
Metadata
Title
Recruitment barriers in a randomized controlled trial from the physicians' perspective – A postal survey
Authors
Anne Spaar
Martin Frey
Alexander Turk
Werner Karrer
Milo A Puhan
Publication date
01-12-2009
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2009
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-9-14

Other articles of this Issue 1/2009

BMC Medical Research Methodology 1/2009 Go to the issue