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Sharing clinical trial results with participants may be beneficial

Offering patients the results of clinical trials that they have participated in could have a positive effect, suggests a study published in his week's issue of THE LANCET.

Clinical research trials designed to improve healthcare depend on the voluntary participation of patients. However, patients are not routinely given information about the aggregate results of trials in which they have participated, unless it affects their future care. The limited information available on this issue suggests that many patients would be interested in learning such results.

Ann Partridge (Dana-Faber Cancer Institute, MA, USA) and colleagues offered results to 135 participants in a cancer trial of breast excision alone for women with ductal carcinoma in situ. The study was stopped early because of a high rate of local recurrence. 85 (90%) of the 94 participants who responded chose to receive results; these women were more educated than those who chose not to. 68 (80%) patients received results by mail, 27 (32%) in person, two (2%) by telephone and two (2%) by other methods. Of the 68 patients who received results by mail, 63 (93%) were comfortable with this method. Respondents were asked if they were more anxious about the possibility of breast cancer in the future after being offered results, seven (7%) were much more concerned, ten (11%) somewhat more concerned, 29 (31%) a little more concerned, 44 (47%) were neither less or more concerned.

Despite the increased anxiety experienced by some participants, 90 (96%) of the 94 respondents were glad to have been offered the results, and 83 (88%) would want to be informed of overall results if they were to participate in other studies. 81 (95%) of the 85 respondents who learned results did not regret their decision, 13 (15%) felt the information had had an important effect on their lives. 88 (94%) believed they had been treated with dignity and respect; and 66 (70%) would recommend participation in a clinical tri
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Contact: Joe Santangelo
j.santangelo@elsevier.com
1-212-633-3810
Lancet
10-Mar-2005


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