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The PCOS Phenotypes in Unselected Populations (P-PUP) study: participant clinical features and data harmonization on analysis of individual participant data

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机构: [1]Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, 3168, Australia. [2]School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia. [3]Departments of Obstetrics and Gynecology, and Medicine, University of Alabama at Birmingham, Birmingham, AL, 35294, USA. [4]Department of Reproductive Health Protection, Scientific Center for Family Health and Human Reproduction Problems, Irkutsk, 664003, Russian Federation. [5]Department of Reproductive Medicine, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, 106 Zhongshan 2 Road, Guangzhou, 510080, China. [6]Department of Medical and Surgical Science-DIMEC, Division of Endocrinology and Diabetes Prevention and Care, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Via Massarenti 9, Bologna, 40138, Italy. [7]Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, 24 Parvaneh, Yaman Street, Velenjak, Tehran, 19395-4763, Iran. [8]Division of Endocrinology and Metabolism, Department of Internal Medicine, Hacettepe University School of Medicine, Ankara, 06100, Turkey. [9]Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Healthcare System Gangnam Center, Seoul National University Hospital, Seoul, 06236, Republic of Korea. [10]Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, 610041, China. [11]Department of Obstetrics and Gynaecology, College of Medicine, University of Lagos, Idi-Araba, Lagos, Nigeria, P.M.B. 12003, Surulere, Lagos, Nigeria. [12]Department of Endocrinology and Diabetes, Monash Health, Clayton, Melbourne, VIC, 3168, Australia.
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关键词: Data harmonization Androgens Polycystic ovary syndrome PCOS Hirsutism Acne Female pattern hair loss Polycystic ovary Phenotype Individual participant data IPD

摘要:
Polycystic ovary syndrome (PCOS) is a multifaceted condition with diagnostic challenges and clinical heterogeneity across populations. Research priorities include enhanced accuracy in defining cut-offs for diagnostic features. Here, we aim to describe participant clinical features and data harmonization in the international PCOS Phenotype in Unselected Populations (P-PUP) study.We searched EMBASE and Medline (Ovid) from 1990 to October 2, 2020, in population-based, medically unbiased study cohorts. Included studies had ≥ 300 participants, directly assessed PCOS-related features, and provided Individual Participant Data (IPD). Risk of bias was assessed using the AXIS tool. Data integrity was ensured via cross-referencing, identifying outliers/implausible data, and variable harmonization. Reporting follows PRISMA-IPD guidelines, summarizing findings with frequencies and proportions.The study included 9979 reproductive-age women from 12 studies across eight countries (China, Iran, Italy, Nigeria, Russia, South Korea, Turkey, and the USA), representing 11 ethnicities. Ovulatory dysfunction was variably recorded, from mean menstrual cycle length, minimum or maximum cycle length, number of cycles per year, or urinary progesterone measurements. Clinical hyperandrogenism was assessed via modified Ferriman-Gallwey (mFG) scores, with a few also including acne and alopecia. Biochemical hyperandrogenism thresholds varied (95th, 97.5th, or 98th percentile of healthy controls). Polycystic ovary morphology was assessed via transvaginal, transabdominal, or transrectal approaches. Harmonization adhered to International PCOS Guidelines for ovulatory dysfunction, ethnicity-specific cut-offs for hirsutism (via k-means clustering), and 95th percentile thresholds for biochemical hyperandrogenism. PCOS prevalence ranged from 3.3 to 19.8% in the original studies and was 11.0% overall after harmonization.The P-PUP study offers an unprecedented, ethnically diverse, medically unbiased population-based cohort, an extraordinarily valuable tool to enhance knowledge and research in PCOS. However, variability in data collection methods and definitions of PCOS diagnostic features across studies limited the ability to fully integrate data for analysis. Despite these limitations, we optimized harmonization in this IPD, and the findings provided valuable insights into the challenges of data harmonization and established a foundation for future collaborative research. Future research should focus on standardizing data collection, establishing normative cut-offs based on true natural groupings, and linking diagnostic clusters to outcomes in diverse populations.CRD42021267847.© 2025. The Author(s).

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大类 | 1 区 医学
小类 | 1 区 医学:内科
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大类 | 1 区 医学
小类 | 1 区 医学:内科
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Q1 MEDICINE, GENERAL & INTERNAL
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, 3168, Australia.
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通讯机构: [1]Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, 3168, Australia. [12]Department of Endocrinology and Diabetes, Monash Health, Clayton, Melbourne, VIC, 3168, Australia.
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