Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial
This trial studies whether 3 different methods of asking patients about adverse medical events in a clinical trial affects the rate of reported side effects.
Benign Prostatic Hyperplasia
|Study Design:||Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
|Official Title:||Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial|
|Study Start Date:||April 2002|
|Estimated Study Completion Date:||April 2003|
214 patients involved in a larger randomized controlled trial of the herb, saw palmetto, for benign prostatic hyperplaisa were randomly assigned to 3 different methods of adverse event ascertainment after a 1-month placebo run-in visit. Two methods of ascertainment were open ended questions, and 1 was a checklist. Patients were blinded to group assignment, but investigators were aware (single blind). All patients had taken placebo for one month, but had been told it was a study drug (single blind).
|United States, California|
|San Francisco VA Medical Center|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Stephen Bent, MD||University of California, San Francisco|