Translation and Validation of the French mPCOSQ (mPCOSQ-F).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mPCOSQ-F and SF-36.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome Health-related Quality of Life. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.
Overview
This study is a prospective, observational, bicentric study, evaluating the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome. The first stage of the study consisted in translating the questionnaire from English to French. Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
Detailed description
The aim of this study is to assess the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.
Women aged 18 to 45 years with a diagnosis of polycystic ovary syndrome will be included.
The first stage of the study consisted in translating the questionnaire from English to French.
Patients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.
The pre-test phase purpose is to appraise the face validity and feasibility of the questionnaire through phone interviews with the thirty first respondents.
In the final phase, we aimed to evaluate the validity and reliability of the mPCOSQ, and to compare it to the SF-36.
Interventions
- Other mPCOSQ-F and SF-36
Questionnaires
Primary outcome measures
- Content validity of mPCOSQ as determined by the experts group [Time frame: At 2 years]
- Feasibility of mPCOSQ [Time frame: At 2 years]
- Acceptability of mPCOSQ [Time frame: At 2 years]
- Structure validity of mPCOSQ [Time frame: At 2 years]
- Reproductibility of mPCOSQ [Time frame: At 2 years]
- Reliabilty of mPCOSQ [Time frame: At 2 years]
- Total mPCSOQ score [Time frame: At 15 days]
- SF-36 scores [Time frame: At 1 day]
- Scores in the " weight " domain based on BMI [Time frame: At 1 day]
- Scores in the " fertility " domain based on the need for reproductive medicine or parenthood [Time frame: At 1 day]
Eligibility criteria
Inclusion criteria
- Women aged 18 to 45
- Fluent in french
- Having a diagnosis of PCOS according to the international recommendations published in 2023
- Willing to participate in the study
- Affiliated to the french social security system
Exclusion criteria
- Diagnosis of adrenal hyperplasia, androgen-producing tumor, Cushing's syndrome, or thyroid disorder
- Pregnancy or breast-feeding
- Under legal protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Damien JOLLY — Reims
Identifiers
NCT: NCT07016035 · PS25052