Venous-origin chronic pelvic pain (VO-CPP) is a distinct clinical presentation within the spectrum of pelvic venous disorders and is associated with substantial symptom burden and impaired quality of life. A systematic review by Daniels et al. published in the Journal of Vascular and Interventional Radiology highlighted significant heterogeneity in outcome domains and measurement instruments used in clinical studies of pelvic venous disorders. Building on these findings, a subsequent scoping review identified and catalogued all outcome measures reported in the literature and confirmed the extent of outcome heterogeneity specific to VO-CPP. This variability limits comparison across studies, impedes evidence synthesis, and contributes to uncertainty regarding treatment effectiveness, underscoring the need for a standardized Core Outcome Set (COS).
This study is a consensus-based methodological project conducted in accordance with guidance from the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. The study consists of two phases: (1) an international, multi-stakeholder Delphi process to prioritize candidate outcomes and (2) a steering committee consensus phase to finalize outcome domains and reporting recommendations. The study does not involve therapeutic intervention, randomization, or alteration of clinical care.
There is a relevant COS in development that has been registered with COMET. This COS is being developed by the CHORUS team (https://i-chorus.org/core-outcome-sets/chronic-pelvic-pain) and is developing a COS for chronic pelvic pain women in general. Our project steering committee has arranged multiple virtual meetings with the CHORUS leadership (state their names) and have discussed potential avenues for collaboration, to avoid duplication of COS work. It was decided that our COS would represent a disease specific set for venous-origin chronic pelvic pain, within the wider framework defined by CHORUS. The leadership of CHORUS plans to participate in an advisory role within our study. Following completion of our steering committee phase of the VO-CPP COS development, the two teams will meet to consider harmonizing outcome measurement instrument selection, where appropriate.
PI - Neil Khilnani MD - Division of Interventional Radiology, Weill Cornell Medicine, New York Presbyterian Hospital, New York, New York
Konstantinos Kavallieros MD - Academic Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London
Adam M. Gwozdz MD PhD - Academic Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London
Bruce Fleck PhD - Cook Medical, Bloomington, Indiana, United States
Kathleen Gibson MD - Division of Vascular Surgery, University of Washington Medical Center, Seattle, Washington
Mark Meissner MD - Division of Vascular Surgery, University of Washington Medical Center, Seattle, Washington.
Aleksandra Jaworucka-Kaczorowska MD - Center of Phlebology and Aesthetic Medicine, Gorzów Wielkopolski, Poland
Disease Category: Gynaecology, Radiology
Disease Name: Chronic pelvic pain
Age Range: 18 - 120
Sex: Female
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Semi structured discussion
- Survey
- Systematic review
This study follows COMET guidance for COS development and consists of two phases. First, candidate outcomes were informed by the published systematic review, a comprehensive scoping review of reported outcomes, and patient focus group interviews to identify patient-prioritized concepts. These outcomes were prioritized through an international, multi-stakeholder Delphi process involving patients, clinicians, and researchers. Second, a multidisciplinary steering committee will finalize outcome domains and reporting recommendations. Outcome domain identification is informed by IMMPACT recommendations for chronic pain trials, while selection and appraisal of patient-reported outcome measures are guided by COSMIN standards and OMERACT principles.