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

NCT ID: NCT04820582

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 56 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2021-11-01

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Delphi Questionnaire

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poissy-Saint Germain Hospital

OTHER

Sponsor Role: collaborator

Versailles Saint-Quentin-en-Yvelines University

OTHER

Sponsor Role: collaborator

PointGyn

UNKNOWN

Sponsor Role: collaborator

One Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Intercomunal Poissy Saint Germain en Laye

Poissy, , France

Countries

France

Other Identifiers

Endo001

Identifier Type: -

Identifier Source: org_study_id