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Peer-reviewedCC BY-NC 4.0BMJ Open

Expert consensus for the classification of female genital malformations: protocol for a Delphi study

  • Beatriz Orozco1
  • Adriana Lopez-Pineda2
  • Grigoris Grimbizis3
  • Hazel Isabella Learner4
  • Ephia Yasmin5
  • Carmina Bermejo6
  • Maria Isabel Acién7
7 affiliations
  1. 1PhD Programme in Public Health, Miguel Hernandez University of Elche, Alicante, Valencian Community, Spain
  2. 2Medicina Clinica, Universidad Miguel Hernandez de Elche Facultad de Medicina, Alicante, Spain
  3. 3Aristotle University of Thessaloniki, Thessaloniki, Greece
  4. 4Women's Health, University College London Faculty of Medical Sciences, London, UK
  5. 5University College London Faculty of Medical Sciences, London, UK
  6. 6Complutense University of Madrid, Madrid, Community of Madrid, Spain
  7. 7Gynaecology Department, Miguel Hernandez University of Elche, Alicante, Valencian Community, Spain
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Abstract

Introduction: Female genital malformations are common but are not always correctly diagnosed. They have a great impact on women’s lives as they can cause pelvic pain and have been associated with poor reproductive outcomes. Current classification systems for female genital tract malformations lack consensus, leading to diagnostic and therapeutic discrepancies between clinicians and researchers worldwide. This study aims to identify the barriers and facilitators of current classification systems through expert consensus.

Methods and analysis: International, observational, modified Delphi consensus study using a mixed-methods design, conducted and reported following the CREDES (Conducting and Reporting of Delphi Studies) guidelines. The predominant component is quantitative, based on structured 5-point Likert-scale ratings and numerical consensus thresholds; free-text comments collected in round 1 provide complementary qualitative data that will inform refinement of questionnaire items between rounds. An international, geographically and professionally diverse multidisciplinary expert panel will be recruited, comprising a gynaecology block (specialising in reproduction, ultrasound, adolescent gynaecology and gynaecological surgery) and an ‘other specialties’ block (radiologists, urologists, paediatricians specialising in urology and paediatric surgeons). A minimum of 25 panellists per block is estimated. A scientific committee of international experts will review and validate the questionnaire prior to distribution and will conduct a final consensus validation phase after completion of the Delphi rounds. Experts will complete two rounds of anonymous online questionnaires. A 70% agreement threshold will define consensus.

Ethics and dissemination: This study has been approved by the Office of Responsible Research (COIR) at Miguel Hernández University (reference number: 240720141743) and complies with the Declaration of Helsinki. Results will be disseminated through peer-reviewed publications and presentations at national and international scientific meetings.

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Cite

BibTeXRIS
BibTeX
@article{orozco2026expert,
  title = {{Expert consensus for the classification of female genital malformations: protocol for a Delphi study}},
  author = {Beatriz Orozco and Adriana Lopez-Pineda and Grigoris Grimbizis and Hazel Isabella Learner and Ephia Yasmin and Carmina Bermejo and Maria Isabel Acién},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-123979},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123979},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Expert consensus for the classification of female genital malformations: protocol for a Delphi study
AU  - Beatriz Orozco
AU  - Adriana Lopez-Pineda
AU  - Grigoris Grimbizis
AU  - Hazel Isabella Learner
AU  - Ephia Yasmin
AU  - Carmina Bermejo
AU  - Maria Isabel Acién
PY  - 2026
DA  - 2026/10/27
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-123979
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123979
AB  - Introduction: Female genital malformations are common but are not always correctly diagnosed. They have a great impact on women’s lives as they can cause pelvic pain and have been associated with poor reproductive outcomes. Current classification systems for female genital tract malformations lack consensus, leading to diagnostic and therapeutic discrepancies between clinicians and researchers worldwide. This study aims to identify the barriers and facilitators of current classification systems through expert consensus.  Methods and analysis: International, observational, modified Delphi consensus study using a mixed-methods design, conducted and reported following the CREDES (Conducting and Reporting of Delphi Studies) guidelines. The predominant component is quantitative, based on structured 5-point Likert-scale ratings and numerical consensus thresholds; free-text comments collected in round 1 provide complementary qualitative data that will inform refinement of questionnaire items between rounds. An international, geographically and professionally diverse multidisciplinary expert panel will be recruited, comprising a gynaecology block (specialising in reproduction, ultrasound, adolescent gynaecology and gynaecological surgery) and an ‘other specialties’ block (radiologists, urologists, paediatricians specialising in urology and paediatric surgeons). A minimum of 25 panellists per block is estimated. A scientific committee of international experts will review and validate the questionnaire prior to distribution and will conduct a final consensus validation phase after completion of the Delphi rounds. Experts will complete two rounds of anonymous online questionnaires. A 70% agreement threshold will define consensus.  Ethics and dissemination: This study has been approved by the Office of Responsible Research (COIR) at Miguel Hernández University (reference number: 240720141743) and complies with the Declaration of Helsinki. Results will be disseminated through peer-reviewed publications and presentations at national and international scientific meetings.
SN  - 2044-6055
SN  - 2044-6055
ER  -