Barriers to participation in randomised controlled trials: A systematic review

S Ross, A Grant, C Counsell, W Gillespie, I Russell, R Prescott

Research output: Contribution to journalLiterature review

602 Citations (Scopus)

Abstract

Method: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Results: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. Conclusions: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers. (C) 1999 Elsevier Science Inc.

Original languageEnglish
Pages (from-to)1143-1156
Number of pages14
JournalJournal of Clinical Epidemiology
Volume52
Issue number12
Publication statusPublished - 1999

Keywords

  • systematic review
  • randomised controlled trials
  • patient participation
  • clinician participation
  • barriers to participation
  • cancer clinical-trials
  • informed consent process
  • breast-cancer
  • physician participation
  • recruitment
  • patient
  • selection
  • information
  • enrollment
  • children

Cite this

Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., & Prescott, R. (1999). Barriers to participation in randomised controlled trials: A systematic review. Journal of Clinical Epidemiology, 52(12), 1143-1156.

Barriers to participation in randomised controlled trials : A systematic review. / Ross, S ; Grant, A ; Counsell, C ; Gillespie, W ; Russell, I ; Prescott, R .

In: Journal of Clinical Epidemiology, Vol. 52, No. 12, 1999, p. 1143-1156.

Research output: Contribution to journalLiterature review

Ross, S, Grant, A, Counsell, C, Gillespie, W, Russell, I & Prescott, R 1999, 'Barriers to participation in randomised controlled trials: A systematic review', Journal of Clinical Epidemiology, vol. 52, no. 12, pp. 1143-1156.
Ross, S ; Grant, A ; Counsell, C ; Gillespie, W ; Russell, I ; Prescott, R . / Barriers to participation in randomised controlled trials : A systematic review. In: Journal of Clinical Epidemiology. 1999 ; Vol. 52, No. 12. pp. 1143-1156.
@article{8b1c512c3d904c4595f5832176551e99,
title = "Barriers to participation in randomised controlled trials: A systematic review",
abstract = "Method: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Results: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. Conclusions: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers. (C) 1999 Elsevier Science Inc.",
keywords = "systematic review, randomised controlled trials, patient participation, clinician participation, barriers to participation, cancer clinical-trials, informed consent process, breast-cancer, physician participation, recruitment, patient, selection, information, enrollment, children",
author = "S Ross and A Grant and C Counsell and W Gillespie and I Russell and R Prescott",
year = "1999",
language = "English",
volume = "52",
pages = "1143--1156",
journal = "Journal of Clinical Epidemiology",
issn = "0895-4356",
publisher = "Elsevier USA",
number = "12",

}

TY - JOUR

T1 - Barriers to participation in randomised controlled trials

T2 - A systematic review

AU - Ross, S

AU - Grant, A

AU - Counsell, C

AU - Gillespie, W

AU - Russell, I

AU - Prescott, R

PY - 1999

Y1 - 1999

N2 - Method: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Results: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. Conclusions: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers. (C) 1999 Elsevier Science Inc.

AB - Method: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Results: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. Conclusions: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers. (C) 1999 Elsevier Science Inc.

KW - systematic review

KW - randomised controlled trials

KW - patient participation

KW - clinician participation

KW - barriers to participation

KW - cancer clinical-trials

KW - informed consent process

KW - breast-cancer

KW - physician participation

KW - recruitment

KW - patient

KW - selection

KW - information

KW - enrollment

KW - children

M3 - Literature review

VL - 52

SP - 1143

EP - 1156

JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

SN - 0895-4356

IS - 12

ER -