Intended for healthcare professionals


Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey

BMJ 2001; 322 doi: (Published 03 March 2001) Cite this as: BMJ 2001;322:519
  1. Bec Hanley, directora,
  2. Ann Truesdale (ann.truesdale{at}, study coordinatorb,
  3. Andy King, computer programmerb,
  4. Diana Elbourne, reader in health care evaluationb,
  5. Iain Chalmers, directorc
  1. a Consumers in NHS Research Support Unit, Help for Health Trust, Winchester SO22 5DH
  2. b Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London WC1E 7HT
  3. c UK Cochrane Centre, NHS Research and Development Programme, Oxford OX2 7LG
  1. Correspondence to: A Truesdale
  • Accepted 19 December 2000


Objective: To assess the extent to which consumers are involved in the work of clinical trial coordinating centres in the United Kingdom and the nature of consumers' involvement in randomised trials coordinated by these centres.

Design: National surveys using structured questionnaires with some open ended sections.

Setting: 103 clinical trial coordinating centres in the United Kingdom identified through a database assembled in 1997 by the NHS clinical trials adviser.

Participants: Named contacts at 62 coordinating centres and investigators in 60 trials that were identified as involving consumers.

Main outcome measures: Number of coordinating centres and number of trials in which consumers were involved and the nature of consumers' involvement.

Results: Of the 62 eligible centres, 23 reported that consumers had already been involved in their work, and most respondents were positive about this involvement. 17 centres planned to involve consumers. 15 centres had no plans to involve consumers, but only four of these considered such involvement irrelevant. Responses from investigators about the 48 individual trials were mostly positive, with respondents commenting that input from consumers had helped refine research questions, improve the quality of patient information, and make the trial more relevant to the needs of patients.

Conclusions: Consumer involvement in the design and conduct of controlled trials seems to be growing and seems to be welcomed by most researchers. Such involvement seems likely to improve the relevance to consumers of the questions addressed and the results obtained in controlled trials


  • Funding This study was commissioned by Consumers in NHS Research and funded by the Department of Health through the NHS Research and Development Programme.

  • Competing interests BH runs the Consumers in NHS Research Support Unit which is funded by the Department of Health.

  • Embedded Image Additional information about the trials and the centres is available on the BMJ's website

  • Accepted 19 December 2000
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