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

Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis: A Delphi Study Conducted by the Study Group VALue Based HEalth CaRe In Endometriosis (VALHERIE).

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Other: Delphi Questionnaire

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• France
  • Poissy, France
    • Hopital Intercomunal Poissy Saint Germain en Laye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: One Clinic
• Collaborators: Poissy-Saint Germain Hospital; Versailles Saint-Quentin-en-Yvelines University; PointGyn

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Endometriosis; Delphi Study; Patient Reported Outcome Measures (PROMs); Clinician Reported Outcome Measures (CROMs)
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: endo001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No