Receiving a summary of the results of a trial: qualitative study of participants' views

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