Sharing clinical trial results with adolescent idiopathic scoliosis patients

Results from clinical trials are generally not shared with participants unless they are thought to affect their future medical care. Few institutional review boards require that participants receive results of the research. Research in this area has largely focused on life-threatening medical conditions, and little is known about sharing clinical trial results in other populations. The purpose of this study was to determine the experience of patients with adolescent idiopathic scoliosis who had participated in a clinical trial and the best method for sharing clinical trial results.

The participants were adolescents with idiopathic scoliosis from a randomized clinical trial comparing 2 spinal implants. Patients, and their parents, were surveyed by mail before (May 2005) and after (January 2008) receiving the results of the study. The first survey focused on clinical trial experience, satisfaction with surgery, and eliciting the preferred method for receiving clinical trial results. The second survey examined patient and parent reactions to the trial results letter.

Of 126 families who were mailed the pretrial results survey, 68% (86/126) of patients and 59% (74/126) of parents responded. Ninety-eight percent (84/86) of respondent patients and 96% (71/74) of respondent parents wanted to receive the results of the trial. Eighty-seven percent (75/86) of respondent patients and 86% (63/74) of respondent parents said the trial was a positive experience. Thirty-seven percent (32/86) of patients and 31% (23/74) of parents responded to the posttrial results survey, 25% (32/126) and 18% (23/126) of total trial participants, respectively. Sixty-three percent (20/32) of respondent patients and 70% (16/23) of respondent parents also felt that receiving the trial results by letter, with a telephone number for any questions, was the best way to receive the information. Seventy-two percent (23/32) of respondent patients and 70% (16/23) of respondent parents said they would participate in a future clinical trial.

Participating patients and parents want to know the results of research studies. Researchers should plan to inform patients by informing them of this option during the informed consent process.