EndometriosisNCT04820582
Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis
An observational study of Endometriosis, run by One Clinic at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endometriosis
- What is being tested?
- Delphi Questionnaire
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2021to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Retirement
Trial locations and contacts
1 site in 1 country.
About this study
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).
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
- Being tested
- Delphi Questionnaire
- Keywords
- Endometriosis, Delphi Study, Patient Reported Outcome Measures (PROMs), Clinician Reported Outcome Measures (CROMs)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Delphi Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start10 May 2021
- Primary completion31 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- One Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Poissy-Saint Germain Hospital, Versailles Saint-Quentin-en-Yvelines University, PointGyn
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820582
- Sponsor's protocol ID
- Endo001
- Status last verified
- Jan 2022
- First submitted
- 25 Mar 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04820582
- Acronym / sponsor ID
- Endo001
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Delphi Study, Patient Reported Outcome Measures (PROMs), Clinician Reported Outcome Measures (CROMs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- One ClinicUniversity, hospital or other
- Collaborators
- Poissy-Saint Germain Hospital, Versailles Saint-Quentin-en-Yvelines University, PointGyn
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delphi Panel | – | Other: Delphi QuestionnaireA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Retirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi QuestionnaireEvaluation 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 | Other | Delphi Panel |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by One Clinic at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement on a list of PROMs and CROMs that are relevant and feasible in endometriosis care by the expert panel (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.