PCOS Phenotype in Unselected Populations Study (P-PUP): Protocol for a Systematic Review and Defining PCOS Diagnostic Features with Pooled Individual Participant Data
Abstract
:1. Introduction
2. Experimental Design and Procedure
2.1. Selection of Studies and Participants
Specific Definitions for PCOS Diagnostic Features
2.2. Data Sharing and Safety
2.3. Data Analysis
3. Expected Results
4. Ethics and Dissemination
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Participants (P) | Intervention (I) | Comparison (C) | Outcomes (O) | Setting | |
---|---|---|---|---|---|
Inclusion | Women of any age, ethnicity, or weight | Direct assessment of any of the PCOS features and/or end points | Women without any PCOS features | Primary outcomes -Ovulatory dysfunction: (Menstrual cycle lengths) -Clinical hyperandrogenism (Hirsutism (mFG scores)) -Biochemical hyperandrogenism: (Total testosterone, free testosterone, FAI) -PCOM: Ovarian volume, Follicle number per ovary Secondary outcomes -A4, DHEAS, AMH, SHBG | Unselected population such as school and employee databases |
Exclusion | Pregnant populations or if women were on any hormonal treatment during assessment or (within 3 months pre-assessment), or cardiometabolic related comorbidity | Studies where these features are self-reported or used ICD Codes, or unverified registry data | n/a | Studies not reporting PCOS features and/or related endpoints | Selected or referred population such as a hospital |
Study type | Cross sectional/prevalence, or longitudinal studies with sample size ≥ 300 | ||||
Language | No limit | ||||
Year of publication | 1990 onwards |
Study Characteristics | Participants | Primary PCOS Features |
---|---|---|
First author, year, and country of publication | Age at assessment, ethnicity, education level, marital status | Menstrual cycle length (days) or number of menstrual periods per year |
Study design, sample size | Smoking status, physical activity, alcohol consumption | Modified Ferriman Gallwey (mFG) score, |
Selection criteria | Weight, height, or Body mass index (BMI), (kg/m2), waist circumference (cm), waist hip ratio, | Total testosterone (TT) *, Sex hormone-binding globulin (SHBG) *, Free androgen Index (FAI) *, Androstenedione (A4) *, Dehydroepiandrosterone sulphate (DHEAS) * with units and assay types used for each |
Study duration and timing of data collection | Hormonal treatment (OCPs/HRT) | Ovarian volume (OV), cm3, Follicle number per ovary (FNPO)-including transducer frequency used, Anti-müllerian hormone (AMH) * with units and assay or test types used |
- | - | Other features and outcomes as per the PCOS core outcomes set |
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Kiconco, S.; Mousa, A.; Azziz, R.; Enticott, J.; Suturina, L.V.; Zhao, X.; Gambineri, A.; Tehrani, F.R.; Yildiz, B.O.; Kim, J.-J.; et al. PCOS Phenotype in Unselected Populations Study (P-PUP): Protocol for a Systematic Review and Defining PCOS Diagnostic Features with Pooled Individual Participant Data. Diagnostics 2021, 11, 1953. https://doi.org/10.3390/diagnostics11111953
Kiconco S, Mousa A, Azziz R, Enticott J, Suturina LV, Zhao X, Gambineri A, Tehrani FR, Yildiz BO, Kim J-J, et al. PCOS Phenotype in Unselected Populations Study (P-PUP): Protocol for a Systematic Review and Defining PCOS Diagnostic Features with Pooled Individual Participant Data. Diagnostics. 2021; 11(11):1953. https://doi.org/10.3390/diagnostics11111953
Chicago/Turabian StyleKiconco, Sylvia, Aya Mousa, Ricardo Azziz, Joanne Enticott, Larisa V. Suturina, Xiaomiao Zhao, Alessandra Gambineri, Fahimeh Ramezani Tehrani, Bulent O. Yildiz, Jin-Ju Kim, and et al. 2021. "PCOS Phenotype in Unselected Populations Study (P-PUP): Protocol for a Systematic Review and Defining PCOS Diagnostic Features with Pooled Individual Participant Data" Diagnostics 11, no. 11: 1953. https://doi.org/10.3390/diagnostics11111953