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

NCT04820582 | Completed

• 1 other identifier: Endo001
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Delphi Study; Patient Reported Outcome Measures (PROMs); Clinician Reported Outcome Measures (CROMs)

Outcome Measures

Primary Outcomes (1)

• Agreement on a list of PROMs and CROMs that are relevant and feasible in endometriosis care by the expert panel

  Agreement is defined as a consensus of 70% between expert panel members

  6 months

Study Arms (1)

Delphi Panel

A group of international experts comprising patients experts, gynecologists, radiologist, psychologists, nurses and researchers, were identified based on their expertise in the field or due to your active role in an endometriosis patient association that have accepted to participate to this study.

Other: Delphi Questionnaire

Interventions

Delphi Questionnaire OTHER

Evaluation of a list of PROMs and CROMs specific for endometriosis (previously selected from a litterature review) on a Likert scale of 1 to 9 for their relevance and feasibility

Delphi Panel

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A group of international experts comprising patients experts, gynecologists, radiologist, psychologists, nurses and researchers, that have been identified based on their expertise in the field or due to their active role in an endometriosis patient association

You may qualify if:

• 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

You may not qualify if:

• Retirement

Sponsors & Collaborators

• One Clinic: lead
• Poissy-Saint Germain Hospital: collaborator
• Versailles Saint-Quentin-en-Yvelines University: collaborator
• PointGyn: collaborator

Study Sites (1)

Hopital Intercomunal Poissy Saint Germain en Laye

Poissy, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: May 10, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)