Brief Communication: Better Ways To Question Patients about Adverse Medical Events

A Randomized, Controlled Trial

21 February 2006 | Volume 144 Issue 4 | Pages 257-261

Background: There is no standard method of identifying adverse events in clinical trials.

Objective: To determine whether 3 different methods of questioning patients about adverse events in a clinical trial affect the frequency of reported events.

Design: Randomized, single-blind, controlled trial.

Setting: A Veterans Administration medical center, San Francisco, California.

Participants: Men 50 years of age or older who had benign prostatic hyperplasia.

Measurement: Frequency of self-reported medical problems.

Intervention: The authors randomly assigned 214 men who were undergoing a 1-month, single-blind, placebo run-in period during an existing clinical trial to 3 groups to test different self-administered methods of assessing medical problems at the end of the run-in period. The first group was asked an open-ended question; the second group was asked an open-ended, defined question; and the third group was given a checklist of 53 common side effects.

Results: All 214 patients completed the study. Patients assigned to the checklist group reported a total of 238 adverse events; in comparison, patients who were asked an open-ended question or an open-ended, defined question reported 11 and 14 adverse events, respectively (P < 0.001). The percentage of patients reporting any adverse event was also much higher in the group assigned to the checklist (77%) than in the first group (14%) or second group (13%) (P < 0.001).

Limitations: The study included only relatively healthy, well-educated, middle-aged men and assessed only self-reported medical problems after the participants had taken placebo for 1 month. All personnel overseeing the study were aware of the group assignments.

Conclusions: Different methods of collecting patient data regarding adverse events lead to large differences in the reported rates of adverse events in clinical trials, potentially reducing the validity of comparisons between the side effect profiles of drugs and other interventions.

Editors' Notes Context Investigators use diverse methods to assess the adverse events experienced by study participants. Contribution During a 1-month placebo run-in period of a clinical trial, this single-blind substudy randomly assigned 214 men with benign prostatic hyperplasia to 3 groups to test different methods of asking about recent medical problems. Men who completed a checklist about 53 common side effects reported many more problems than participants in the 2 groups that were given different formats of open-ended questions. For example, 77% of the checklist group reported 1 or more medical problems, compared with 13% and 14% of the open-ended groups. Implications Varying the assessment method can cause large differences in reported rates of adverse events. —The Editors

 

Author and Article Information

From University of California and San Francisco Veterans Administration Medical Center, San Francisco, California.

Acknowledgments: The authors thank Drs. Suzanne Staccone and Evelyn Badua, Ms. Bertina Lee, and Ms. Arleen Sakamoto for their work and for establishing the patient rapport that made this study possible.

Grant Support: By the National Center for Complementary and Alternative Medicine (grant 1 K08 ATO1338-01) and by the National Institute of Diabetes and Digestive and Kidney Diseases (grant 1 RO1 DK56199-01).

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Stephen Bent, MD, San Francisco Veterans Administration Medical Center, 111-A1, 4150 Clement Street, San Francisco, CA 94121; e-mail, bent{at}itsa.ucsf.edu.

Current Author Addresses: Drs. Bent and Avins and Ms. Padula: San Francisco Veterans Administration Medical Center, 111-A1, 4150 Clement Street, San Francisco, CA 94121.

Author Contributions: Conception and design: S. Bent, A.L. Avins.

Analysis and interpretation of the data: S. Bent, A. Padula, A.L. Avins.

Drafting of the article: S. Bent.

Critical revision of the article for important intellectual content: S. Bent, A. Padula, A.L. Avins.

Final approval of the article: S. Bent, A.L. Avins.

Statistical expertise: S. Bent.

Administrative, technical, or logistic support: A. Padula.

Collection and assembly of data: A. Padula.