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

Endometriosis Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04820582
• Other study ID #: Endo001
• Status: Completed
• Start date: May 10, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: January 2022
• Source: One Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 1, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
France	Hopital Intercomunal Poissy Saint Germain en Laye	Poissy

Sponsors (4)

Lead Sponsor	Collaborator
One Clinic	PointGyn, Poissy-Saint Germain Hospital, Versailles Saint-Quentin-en-Yvelines University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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