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ID
Source
Brief title
Health condition
Polycystic ovary syndrome (PCOS)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the development of a Dutch and Flemisch version of the PCOSQ and PCOSQOL measured with the PCOSQ and PCOSQOL at T0 (start)
Secondary outcome
The secondary outcomes of this study are the test-retest reliability and the domain structure of the PCOSQ and PCOSQOL for the Dutch and Flemish population by measuring the PCOSQ and PCOSQOL. This secondary outcome will be measured with the PCOSQ and PCOSQOL at T0 (start) and two weeks later (T1)
Background summary
We aim to evaluate the test-retest reliability and to determine the domain structure of the Dutch and Flemish PCOSQ and PCOSQOL in women who have been diagnosed after 2010 or will be diagnosed with PCOS at the Erasmus University Medical Center Rotterdam or at the Department of Reproductive Medicine of Gent University Hospital. The setting for initial assessment (occasion 1), will be self-administration in the home environment. To demonstrate stability over time, a test-retest design will be applied where all women complete the PCOSQ and PCOSQOL a second time (occasion 2); 14 days later in the home environment.
Study objective
The aim is to determine if the Dutch and Flemish PCOSQ and PCOSQL can be validated in a Dutch and Flemish population of women diagnosed with PCOS.
Study design
At the start (T0) and two weeks later (T1) the PCOSQ and the PCOSQOL will be administered
Intervention
None
Inclusion criteria
Female gender
- 18 years old and above
- Dutch or Flemish as a first language
- Diagnosed with PCOS according to the Rotterdam 2003 consensus criteria [2] and International evidence-based guideline for the assessment and management of polycystic ovary syndrome 2018 [1].
Exclusion criteria
- Women with inadequate knowledge of the Dutch or Flemish language.
- Pregnant at moment of occasion 1 or 2.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8561 |
| Other | Erasmus MC : MEC-2019-0628 |