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OpenTrials
Completed

NCT Number: NCT04820582

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Intercomunal Poissy Saint Germain en Laye

Poissy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

One Clinic

Other

Collaborators

  • PointGyn
  • Poissy-Saint Germain Hospital
  • Versailles Saint-Quentin-en-Yvelines University

Registry information

Official study 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).

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.