Harmonizing research outcomes for polycystic ovary syndrome (HARP), a marathon not a sprint: current challenges and future research need
Open accessAbstract
Investing in clinical research and evidence-based medicine has helped to improve the care for women with polycystic ovary syndrome (PCOS). However, several important questions remain unanswered on the optimal prevention and management strategies for PCOS. Addressing this uncertainty is often hindered by suboptimal research conduct leading to inefficient evidence synthesis and research wastage. PCOS research is often practised by varied specialized teams in silo leading to disharmonious and fragmented efforts neglecting the lifelong impact of PCOS on women's wellbeing. Poor engagement among key stakeholders and lay consumers continues to limit the impact and benefits of research to society. Selective reporting on surrogate outcomes with a 'significant' P-value is a common malpractice in PCOS outputs. Effective adoption of the harmonizing research outcomes for PCOS (HARP) core outcome set is needed to minimize heterogeneity in reporting and promote research excellence. Small single-centre studies offer limited value to assess the varied PCOS phenotypes. Efficient large scale data-sharing is needed to address complex research questions and glean the benefits of big data research. We propose a roadmap to address these challenges and remedy future research need by promoting patient and public involvement in PCOS research to guide research efforts and address real patients' needs; engaging all key stakeholder groups to promote a multi-disciplinary lifelong approach to new research; continuously refining research needs and priorities to revise the knowledge gap and allocate resources judiciously; standardizing outcomes definitions and measurement tools to harmonize reporting and promote excellence in research; and by investing in large data-sharing infrastructure to facilitate big data research and govern ethical data sharing.
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Core outcomes were based on a Delphi process involving 700 clinicians, academic opinion leaders, and consumers.
“Core outcomes were based on a Delphi process involving 700 clinicians, academic opinion leaders, and consumers (19).”
From Metformin and Combined Oral Contraceptive Pills in the Management of Polycystic Ovary Syndrome: A Systematic Review and Meta-analysis (2024) · cites this paper as [19]
The Current challenges section says patient representatives and lay consumers were engaged in the HARP core outcome set, and the P-hacking section describes it as an international effort. Our copy does not say the set was based on a Delphi process, give a figure of 700 participants, or identify academic opinion leaders among them. (LLM, conf=0.84)
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- Authors
- Al Wattar, B. H., Bueno, A., Martin, M. G., Ibáñez, N. C., Harasani, K., Garad, R., Franks, S., Balen, A., Bhide, P., Piltonen, T., Romualdi, D., Laven, J., Moss, N., Andrews, C., Hawkes, R., Mol, B. W., Teede, H., Thangaratinam, S., & Khan, K. S.
- Affiliations
- Warwick Medical School, University of Warwick, Coventry, UK
- Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain
- Universidad de Granada (ES)
- University of Medicine Tirana (AL)
- National Health and Medical Research Council (AU)
- Hammersmith Hospital (GB)
- Leeds Teaching Hospitals NHS Trust (GB)
- Queen Mary University of London (GB)
- Oulu University Hospital (FI)
- Agostino Gemelli University Polyclinic (IT)
- Erasmus MC (NL)
- Verity—The PCOS Self Help Group, Surry, UK
- University of Aberdeen (GB)
- University of Birmingham (GB)
- ORCID
- Venue
- Human Reproduction
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-12-17
- Volume
- 36
- Issue
- 3
- Pages
- 523-528
- ISSN
- 0268-1161 (ISSN-L)
- 1460-2350
- OpenAlex
- W3113777696
- Cited by
- 14
- References
- 33
- Citations by year
- 2025: 2 · 2024: 3 · 2023: 6 · 2022: 1 · 2021: 2
- FWCI
- 1.98
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Human Reproduction (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, cc-by)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, cc-by)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
- Spiral (Imperial College London) (submittedVersion)
- Funders
- Lecturership from the UK National Health Institute of Research
- University of Granada funded by the Beatriz Galindo (senior modality) program of the Spanish Ministry of Education
- NHMRC
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- polycystic ovary syndrome, core outcome set, harp, outcome harmonization, research priorities, patient and public involvement, stakeholder engagement, selective reporting, surrogate endpoints, data sharing, big data research, research waste, PCOS phenotypes
- MeSH terms
- Carrier Proteins, Female, Humans, Polycystic Ovary Syndrome, Cytokines, Evidence-Based Medicine
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