Questioning Patients About Adverse Medical Events: A Randomized Controlled Trial
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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.
Condition or disease
Benign Prostatic Hyperplasia
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).
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Ages Eligible for Study:
50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male, age > 49, American Urological Association Symptom Index > 8