Study participants want to know the results

People who participate in clinical studies are interested in how the trials turn out, results of a small pilot study suggest.

Although many researchers think that study participants should be informed of trial results, this is often not the case.

“Potential negative emotional effect on participants, participants’ difficulty in understanding results, and concern about consumption of resources, including money and clinician time” are the biggest barriers to informing patients of study outcomes, lead author Dr. Ann H. Partridge told AMN Health.

Partridge, at the Dana-Farber Cancer Institute in Boston, and colleagues offered to tell patients who had participated in a study of surgery for early breast cancer about the outcomes. Out of 135 participants, 117 wanted to learn the results.

The authors then surveyed 94 of the subjects, and report their findings in the medical journal The Lancet.

Women who were better educated were more likely to want to know results. Seventy-one subjects found the lay summary explaining the study findings easy to understand.

The authors also found that seven women were “much more concerned” about the possibility that they would develop breast cancer in the future, while 10 said that they were “somewhat more concerned.”

Other survey findings indicated that 90 were glad to have been offered trial results, 81 of those who learned results did not regret their decision, and 66 would recommend participation in a study to others.

“The bottom line,” Partridge said, is that “while there was some increased anxiety among those who learned the results, overall, the patients were glad to have been offered the results even if they did not decide to receive them.”

She sees this process as a means to “increase communication, improve relationships between patients and doctors, and expand patients’ trust in the system.”

SOURCE: The Lancet, March 10, 2005.

Provided by ArmMed Media
Revision date: June 11, 2011
Last revised: by Janet A. Staessen, MD, PhD