A Protocol for the Development of Core Outcome Sets in Pelvic Organ Prolapse Research
Abstract Background The high prevalence of symptomatic pelvic organ prolapse (POP) and the women's lifetime risk of requiring surgery, as well as the significant impact of POP on women’s health related quality of life has resulted in a variety of studies on POP interventions. A wide variety of outcomes have been reported across randomized trials evaluating interventions for POP and various outcome measures have been used. Such variation leads to a limited value of research to provide reliable evidence-based data for clinical practice guidance. The development and use of a core outcome set (COS) would help to address these issues ensuring outcomes important to all stakeholders, primarily women with POP. We aim to produce, disseminate and implement a COS for POP. Methods A steering group within the CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health will guide the development of this COS. Systematic reviews of trials that reported outcomes and outcome measures on interventions for POP will form the basis for the creation of an outcome inventory. Core outcome selection process will be performed using an international, multi-perspective, online Delphi survey. The modified Delphi method encourages stakeholder group agreement towards consensus core outcomes through repeated reflection and rescoring of items. Discussion Dissemination and implementation of the resulting COS within an international context will be promoted. An embedded COS for POP within future studies will most likely be reflected by an increased value of research that provides guidance for clinical practice. The paradigm of the COS development could further inform research priorities in POP treatments, and support clinical guidelines development and better patient care. KEYWORDS: core outcome sets, outcome measures, pelvic organ prolapse, Delphi survey, randomized trials.