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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).

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04820582
Enrollment
56
Registered
2021-03-29
Start date
2021-05-10
Completion date
2021-11-01
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

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

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.

Interventions

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

Sponsors

Poissy-Saint Germain Hospital
CollaboratorOTHER
Versailles Saint-Quentin-en-Yvelines University
CollaboratorOTHER
PointGyn
CollaboratorUNKNOWN
One Clinic
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Agreement on a list of PROMs and CROMs that are relevant and feasible in endometriosis care by the expert panel6 monthsAgreement is defined as a consensus of 70% between expert panel members

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026