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.
RCT Entities:
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.
Authors: Nancy H Fultz; Kathryn Burgio; Ananias C Diokno; Kraig S Kinchen; Robert Obenchain; Richard C Bump Journal: Am J Obstet Gynecol Date: 2003-11 Impact factor: 8.661
Authors: Michael E Albo; Holly E Richter; Linda Brubaker; Peggy Norton; Stephen R Kraus; Philippe E Zimmern; Toby C Chai; Halina Zyczynski; Ananias C Diokno; Sharon Tennstedt; Charles Nager; L Keith Lloyd; MaryPat FitzGerald; Gary E Lemack; Harry W Johnson; Wendy Leng; Veronica Mallett; Anne M Stoddard; Shawn Menefee; R Edward Varner; Kimberly Kenton; Pam Moalli; Larry Sirls; Kimberly J Dandreo; John W Kusek; Leroy M Nyberg; William Steers Journal: N Engl J Med Date: 2007-05-21 Impact factor: 91.245