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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04820582
Recruitment Status : Completed
First Posted : March 29, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
Poissy-Saint Germain Hospital
Versailles Saint-Quentin-en-Yvelines University
PointGyn
Information provided by (Responsible Party):
One Clinic

Study Description
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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.

Condition or disease Intervention/treatment
Endometriosis Other: Delphi Questionnaire

Study Design
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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Other
Time Perspective: Prospective
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).
Actual Study Start Date : May 10, 2021
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04820582


Locations
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France
Hopital Intercomunal Poissy Saint Germain en Laye
Poissy, France
Sponsors and Collaborators
One Clinic
Poissy-Saint Germain Hospital
Versailles Saint-Quentin-en-Yvelines University
PointGyn
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: One Clinic
ClinicalTrials.gov Identifier: NCT04820582    
Other Study ID Numbers: Endo001
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by One Clinic:
Endometriosis
Delphi Study
Patient Reported Outcome Measures (PROMs)
Clinician Reported Outcome Measures (CROMs)
Additional relevant MeSH terms:
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Endometriosis