Developing Core Outcome sets in Female Idiopathic Chronic Pelvic Pain
Research type
Research Study
Full title
Developing, Disseminating and Implementing Core Outcome Set for Therapeutic Interventions in Chronic Pelvic Pain: Delphi Survey and Consensus Meeting
IRAS ID
277330
Contact name
Stergios Doumouchtsis
Contact email
Sponsor organisation
Epsom and St Helier's University Hospital NHS Trust
Clinicaltrials.gov Identifier
981, Core Outcome Measures in Effectiveness Trials Initiatives (COMET)
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is part of a wider initiative to produce a core outcome set in chronic pelvic pain. We have performed preliminary research, a systematic review that is currently under review for publication, that has indicated a wide variation in trials reporting on therapeutic interventions for chronic pelvic pain. At present there is no clear criteria that trials are required to report resulting in selection and outcome reporting bias. However, the development and implementation of core outcome sets will standardise outcomes reported by trials and minimise such discrepancies. Furthermore, the quality of future trials will improve allowing combination of data to allow for evidence based recommendation that can benefit patient care and management. Additionally, outcomes will reflect the interests and priorities of all stakeholders such as health professionals, researchers and participants.
We plan to formulate a core outcome set by performing a Delphi survey followed by a consensus meeting. This method has been successfully used by other groups developing core outcome sets. There are no clear guidelines regarding the calculation of sample size for the development of core outcome sets. However, based on previous studies, we aim to recruit a total of 60 participants including 20 per stakeholder group (patients, health professional and researchers). We have also sought to include a patient representative in the design/methodology of this study. The Delphi survey will include two online questionnaires that will be expected to take approximately 30-60 minutes . Only those completing both surveys will be invited to attend a consensus meeting in which the final core outcome set will be finalised.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0036
Date of REC Opinion
16 Mar 2020
REC opinion
Further Information Favourable Opinion