Lessons from a patient experience survey in a randomized surgical trial of treatment of stress urinary incontinence in women
Philippe E Zimmern, Kimberly J Dandreo, Larry Sirls, Alice Howell, Lynn Hall, Judy Gruss, Kathy Jesse, Tamara Dickinson, Caren Prather, Philippe E Zimmern, Kimberly J Dandreo, Larry Sirls, Alice Howell, Lynn Hall, Judy Gruss, Kathy Jesse, Tamara Dickinson, Caren Prather
Abstract
Introduction and hypothesis: To understand the patient burden of study procedures/measures at completion of a randomized controlled trial (RCT) requiring extensive testing and follow-up visits.
Methods: A survey sent after completing the 2-year visit of an RCT comparing Burch colposuspension and fascial retropubic sling to treat stress urinary incontinence assessed degree of bother for seven study procedures, eight study-related factors, and possible motivations to participate in the study.
Results: A total of 450 study participants (88%) returned the survey. Urodynamic testing was the most bothersome procedure, followed by 24-h pad test and Q-tip test. Self-administered questionnaires were the least bothersome. Main reasons to participate in the study were to help others, obtain better knowledge about the condition, and be guided by a committed team of investigators/study coordinators.
Conclusions: At the end of a large multicenter RCT, we learned from a confidential patient survey that the most burdensome activities involved invasive procedures, frequent visits, and multiple forms to fill out.
Source: PubMed