University of Oulu

Bassel H Al Wattar, Helena Teede, Rhonda Garad, Steve Franks, Adam Balen, Priya Bhide, Terhi Piltonen, Daniela Romualdi, Joop Laven, Mala Thondan, Aurora Bueno-Cavanillas, Ngawai Moss, Caroline Andrews, Rachel Hawkes, Ben W Mol, Khalid S Khan, Shakila Thangaratinam, Harmonising research outcomes for polycystic ovary syndrome: an international multi-stakeholder core outcome set, Human Reproduction, Volume 35, Issue 2, February 2020, Pages 404–412, https://doi.org/10.1093/humrep/dez272

Harmonising research outcomes for polycystic ovary syndrome : an international multi-stakeholder core outcome set

Saved in:
Author: Wattar, Bassel H. Al1,2; Teede, Helena3,4; Garad, Rhonda3,4;
Organizations: 1Barts Research Centre for Women’s Health (BARC), Women’s Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
2Warwick Medical School, University of Warwick, Coventry, UK
3National Health and Medical Research Council Centre for Research Excellence in PCOS, Monash Centre for Health Research and Implementation, Monash University, Melbourne, VIC, Australia
4Endocrine and Diabetes Units, Monash Health, Melbourne, VIC, Australia
5Imperial CollegeSchool of Medicine, Institute of Reproductive and Developmental Biology, Hammersmith Hospital, London, UK
6Leeds Fertility, Seacroft Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK
7Reproductive medicine, Homerton University Hospital NHS Foundation Trust, London, UK
8Department of Obstetrics and Gynecology, PEDEGO Research Unit, Medical Research Centre, Oulu University Hospital, University of Oulu, Oulu, Finland
9Department of Woman and Child Health and Public Health, Woman Health Area, Fondazione Policlinico Universitario A. Gemelli, Rome, Italy
10Department of Woman and Child Health, Azienda Ospedaliera Card. Panico, Tricase, Italy
11Div Reproductive Endocrinology and Infertility, Dept of Obstetrics and Gynecology, Erasmus University Medical Centre, Rotterdam, The Netherlands
12Harp Family Medical Centre, Melbourne, VIC, Australia
13Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain
14Consortium for Biomedical Research in Epidemiology and Public Health, (CIBER Epidemiología y Salud Pública-CIBERESP), Madrid, Spain
15Ibs Granada, Instituto de Investigación Biosanitaria de Granada, Granada, Spain
16Verity, The PCOS Self Help Group, Surry, UK
17Department of Obstetrics and Gynaecology, University of Monash, Melbourne, Australia
18Barts Research Centre for Women’s Health (BARC), Women’s Health Research Unit, Barts and the London School of Medicine andDentistry, Queen Mary University of London, London, UK
Format: article
Version: accepted version
Access: open
Online Access: PDF Full Text (PDF, 0.3 MB)
Persistent link: http://urn.fi/urn:nbn:fi-fe2020091669803
Language: English
Published: Oxford University Press, 2020
Publish Date: 2021-02-04
Description:

Abstract

STUDY QUESTION: What are the key core outcomes to be reported in studies on polycystic ovary syndrome (PCOS)?

SUMMARY ANSWER: We identified 3 generic and 30 specific core outcomes in 6 specialist domains: metabolic (8), reproductive (7), pregnancy (10), oncological (1), psychological (1) and long-term outcomes (1).

WHAT IS KNOWN ALREADY: Research reporting PCOS is heterogeneous with high variation in outcome selection, definition and quality.

STUDY DESIGN, SIZE, DURATION: Evidence synthesis and a modified Delphi method with e-surveys were used as well as a consultation meeting.

PARTICIPANTS/MATERIALS, SETTING, METHODS: Overall, 71 health professionals and 123 lay consumers (women with lived experience of PCOS and members of advocacy and peer support groups) from 17 high-, middle- and low-income countries were involved in this analysis.

MAIN RESULTS AND THE ROLE OF CHANCE: The final core outcome set included 3 generic outcomes (BMI, quality of life, treatment satisfaction) that are applicable to all studies on women with PCOS and 30 specific outcomes that were categorised into six specialist domains: 8 metabolic outcomes (waist circumference, type 2 diabetes, insulin resistance, impaired glucose tolerance, hypertension, coronary heart disease, lipid profile, venous thromboembolic disease); 7 reproductive outcomes [viable pregnancy (confirmed by ultrasound including singleton, twins and higher multiples), clinical and biochemical hyperandrogenism, menstrual regularity, reproductive hormonal profile, chronic anovulation, ovulation stimulation success including the number of stimulated follicles ≥ 12 mm, incidence and severity of ovarian hyperstimulation syndrome]; 10 pregnancy outcomes (live birth, miscarriage, stillbirth, neonatal mortality, gestational weight gain, gestational diabetes, preterm birth, hypertensive disease in pregnancy, baby birth weight, major congenital abnormalities); 3 psychological outcomes (depression, anxiety, eating disorders); 1 oncological (abnormal endometrial proliferation including atypical endometrial hyperplasia and endometrial cancer); and 1 outcome in the long-term domain (long-term offspring metabolic and developmental outcomes).

LIMITATIONS, REASONS FOR CAUTION: We involved lay consumers in all stages of study through e-surveys but not through focus groups, thereby limiting our understanding of their choices. We did not address the variations in the definitions and measurement tools for some of the core outcomes.

WIDER IMPLICATIONS OF THE FINDINGS: Implementing this core outcome set in future studies on women with PCOS will improve the quality of reporting and aid evidence synthesis.

STUDY FUNDING/COMPETING INTEREST(S): Evidence synthesis was funded through the Australian government, National Health and Medical Research Council (NHMRC) Centre for Research Excellence in PCOS, and H.T. is funded through an NHMRC fellowship. B.H.A. is funded through an NIHR lectureship. All authors have no competing interest to declare.

see all

Series: Human reproduction
ISSN: 0268-1161
ISSN-E: 1460-2350
ISSN-L: 0268-1161
Volume: 35
Pages: 404 - 412
DOI: 10.1093/humrep/dez272
OADOI: https://oadoi.org/10.1093/humrep/dez272
Type of Publication: A1 Journal article – refereed
Field of Science: 3123 Gynaecology and paediatrics
Subjects:
Funding: Australian government, National Health and Medical Research Council (NHMRC) Centre for Research Excellence in PCOS; NHMRC fellowship (to H.T.); National Institute for Health Research lectureship (to B.H.A.).
Copyright information: © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permission@oup.com. This is a pre-copyedited, author-produced version of an article accepted for publication in Human Reproduction following peer review. The version of record Bassel H Al Wattar, Helena Teede, Rhonda Garad, Steve Franks, Adam Balen, Priya Bhide, Terhi Piltonen, Daniela Romualdi, Joop Laven, Mala Thondan, Aurora Bueno-Cavanillas, Ngawai Moss, Caroline Andrews, Rachel Hawkes, Ben W Mol, Khalid S Khan, Shakila Thangaratinam, Harmonising research outcomes for polycystic ovary syndrome: an international multi-stakeholder core outcome set, Human Reproduction, Volume 35, Issue 2, February 2020, Pages 404–412 is available online athttps://doi.org/10.1093/humrep/dez272.