A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research

Abstract

Background: More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. Methods: An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. Discussion: Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development.

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study

“…Our methodology for the development of the COS and COMS in cosmetic gynecological interventions will be based on the standards set out by the COS-STAD (Core Outcome Set-Standards for Development) recommendations [ 33 - 35 ]. The COS-STAD recommendations suggest that the development of a protocol at the start of the COS development process is advisable, as it increases transparency of the process.…”

“…The question regarding ethics has been considered and addressed in a number of previous COS development projects. It has been suggested that these projects are considered a service evaluation not directly influencing patient care or safety [ 26 , 34 , 35 , 37 , 44 ]. Consent will be sought from all participants involved before their participation in either stakeholder interviews or the Delphi survey.…”

Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets

“…High-quality studies were considered those that reached score ≥ 4 based on these criteria. All assessments were undertaken independently by two assessors in line with our previous studies and similar research [7][8][9][10][11][12]. In cases of disagreement, a third assessor reviewed the scores and provided additional scores.…”

“…Our previous systematic review developed the inventory of reported outcomes and outcomes measures as a first step in the process of developing relevant COS based on established standards and following well-defined study protocols and high-quality methods [6]. Our systematic reviews on outcome reporting in trials evaluating surgical treatments in different prolapse procedures, incontinence and childbirth trauma [5,[7][8][9][10][11][12] included assessments of associations between outcome reporting quality, methodological quality and publication characteristics.…”

Systematic review and appraisal of clinical practice guidelines on pelvic organ prolapse using the AGREE II tool

“…One of the main aims of CHORUS is the development and dissemination of Core Outcome Sets in pelvic floor disorders. 4,5,[10][11][12][13][14][15][16][17][18][19][20][21][22][23] The development and quality of clinical guidelines is usually related to the quality of published evidence, which in turn is associated with the selection and reporting of outcomes and outcome measures. The process of development of core outcome sets is advisable to include guideline developers.…”