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RESEARCH: Mary Dixon-Woods, Clare Jackson, Kate C Windridge, and Sara Kenyon Receiving a summary of the results of a trial: qualitative study of participants' views BMJ 2006; 332: 206-210 [Abstract] [Full text]

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Offering results to research participants

Eleanor M Dinnett, Moira MB Mungall, Claire Gordon, Elizabeth S Ronald and Allan Gaw   (10 February 2006)

Offering results to research participants 10 February 2006
Eleanor M Dinnett, Clinical Research Fellow Clinical Trials Unit, 4th Floor Walton Building,Glasgow Royal Infirmary, Glasgow. G4 0SF, Moira MB Mungall, Claire Gordon, Elizabeth S Ronald and Allan Gaw Send response to journal: Re: Offering results to research participants	The distinction between giving a general summary of trial results to a study participant and providing them with their own trial results, is not made clear in the recent paper by Dixon-Woods and colleagues (1) and in the accompanying editorial (2). We believe this is an important distinction. Investigators may provide patients with a summary of the trial results, but even if they do not they should be aware that study participants may access these results elsewhere. For example, in the case of large clinical trials they may be reported in the media. In such instances it would surely be better for study participants to receive clear, balanced and unsensationalised accounts of the trial results from their investigators. The provision of personalised trial results, and in particular treatment allocation (un-blinding), is quite a different matter and much debated (3,4). The provision of personalised results is the much more likely of the two to result in emotional consequences for the participants, because any adverse events or lack of perceived benefit may be ascribed to being in one or other of the treatment arms of a study. We have recent experience relevant to this discussion. In a large- scale study of cardiovascular disease prevention in older patients conducted over a five year period (5) we pledged at the outset to provide all study participants with a lay summary of the general study results on the same day that the results were to be published and this was done. With regard to un-blinding of participants this was considered as a completely separate and potentially more problematic exercise. (4). In designing our un-blinding strategy we acknowledged the right of patients to know their treatment allocations and personal results in the study, and their equal right not to know. At the end of the study in Scotland we sent all appropriate participants in the study (n=2067) a brief questionnaire asking if they wished to be un-blinded and if so whether this should be done by telephone or a face-to face visit with our study nurses. 1492 questionnaires were returned of which 850 requested face to face un-blinding, 541 requested a telephone un-blinding and the remainder asked for no un-blinding. Interestingly, many more subjects in our study (67%) requested details about their participation than that reported in the ORACLE Study (20%) (1) . This may be explained by differences in the demographics of our patient population, our longer follow-up period and important differences in the background disease being studied. Whatever the reason it perhaps suggests that we should be cautious in generalising these findings. We agree with Dixon-Woods and her colleagues that much more work should be done on this, but would counsel that any evaluations on the clinical trial methodology for providing participants with trial results should acknowledge the important distinction noted above. 1. Dixon-Woods M, Jackson C, Windridge KC, Kenyon S. Receiving a summary of the results of a trial: qualitative study of participants’ views. BMJ 2006, 332: 206-210. 2. MacNeil SD, Fernandez CV. Offering results to research participants (Editorial). BMJ 2006, 332: 188-189. 3. Shalowitz DA, Miller FG. Disclosing individual results of clinical research. JAMA 2005, 294: 737-740. 4. Dinnett EM, Mungall MMB, Kent JA, Ronald ES, Anderson E, Gaw A. Un-blinding of trial participants to their treatment allocation: lessons from the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER). Clinical Trials 2005, 2: 254-259. 5. Shepherd J, Blauw GJ, Murphy MB, Bollen ELEM, Buckley B.M Cobbe SM, et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002, 360: 1623-30. Competing interests: None declared