Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis

Completed

• Conditions: Endometriosis

• Registration Number: NCT04820582
• Lead Sponsor: One Clinic

Brief Summary

Endometriosis is a chronic disease that affects one out of 10 women. Endometriosis care is full of variation. Recommendations for optimal management vary between clinician and centers. One way of dealing with this unwanted variation is the shift towards a value -based endometriosis care. Value-based healthcare (VBHC) is a strategy focused on the optimization of the balance between outcomes that are important to patients and cost to achieve these outcomes. To do so, for a given condition it is important to define a standardized set of outcomes metrics allowing quality of care monitoring and comparison in order to optimize clinical practices and patient pathways. A common set of outcomes combining clinical outcomes (Clinical Reported Outcome Measures, CROMs) as well as quality of life and functional recovery indicators through Patient Reported Outcome Measures (PROMs). Different standardized data sets have already been developed to measure outcomes in other pathologies, however a standardized set of outcome measurements have not yet been determined for endometriosis. The objective of this study is to determine a standard set of outcome measurements for endometriosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Study Start: 2021-05-10
• Primary Completion: 2021-10-31
• Study Completion: 2021-11-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Profession: gynecologists, radiologist, psychologists, nurses and researchers having an expertise in the field of endometriosis
• Patient experts having an active role in an endometriosis patient association

Exclusion Criteria

• Retirement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement on a list of PROMs and CROMs that are relevant and feasible in endometriosis care by the expert panel	6 months	Agreement is defined as a consensus of 70% between expert panel members

Trial Locations

Locations (1)

Hopital Intercomunal Poissy Saint Germain en Laye; 🇫🇷 Poissy, France