title: Factors influencing women's decision to participate or not in a surgical randomised controlled trial for surgical treatment of female stress urinary incontinence.
abstract: The study aims to explore the potentially influential factors affecting women's decision to accept/decline participation in surgical randomised trial using a novel acceptance/refusal questionnaire (ARQ). All women who were eligible to participate in SIMS-RCT were asked to complete the relevant section (acceptance/refusal) of the ARQ. Women reported its degree of relevance for their decision on a six-point Likert scale (0 = highly irrelevant, 5 = highly relevant). 135 (98%) and 31 (70%) women completed the acceptance and refusal sections of the ARQ, respectively. The most influencing factor in women's acceptance was the anticipation of "potential personal benefit"; percentage of relevance (POR) was 91.9%, followed by interest in helping others by "supporting innovative medical research"; POR was 87.7%. Most influencing factor in refusal for participation was "do not have time for follow-up"; POR was 56.8%, followed by "do not like the concept of randomisation"; POR was 54.4%. In conclusion, this study identifies the most influential factors relevant to women decision-making whether or not to participate in RCTs assessing surgical interventions for female stress urinary incontinence (SUI). A number of factors leading to refusal of participation are potentially correctable leading to better recruitment rates in future RCTs.
authors.affiliation: Division of Applied Health Sciences, University of Aberdeen, 2nd Floor, Aberdeen Maternity Hospital, Foresterhill, Aberdeen AB25 2ZD, UK.
authors.forename: Alyaa
authors.initials: A
authors.lastname: Mostafa
authors.forename: James
authors.initials: J
authors.lastname: N'Dow
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdel-Fattah
mesh_terms: D000328:Adult; D000368:Aged; D003657:Decision Making; D005260:Female; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D016032:Randomized Controlled Trials as Topic; D014550:Urinary Incontinence, Stress / Q000473:pathology / Q000523:psychology* / Q000601:surgery*