Developing core outcome sets (COS) and core outcome measures sets (COMS) in cosmetic gynaecological interventions

Cosmetic gynaecology is an emerging area of gynaecology, often closely linked to the lower genital tract, and the practice of pelvic floor medicine and surgery / urogynaecology.

Cosmetic sequelae of pelvic floor disorders, such as childbirth perineal and vaginal trauma and associated healing complications, perineal, vulval and labial defects, pelvic organ prolapse, post-surgical interventions may affect women’s self-image, emotional and psychosexual wellbeing, relationships and quality of life.

Different approaches include surgical, non-surgical, regenerative and energy based techniques. Increases in labiaplasty and other labial and vulval procedures in recent years in different parts of the world, both for reconstructive as well as cosmetic indications may be partly due to an increasing popularity, lifestyle and media interest. In turn, increasing numbers of women seek cosmetic gynaecological procedures, but when the outcomes of these interventions are suboptimal or even catastrophic, lifelong implications on women’s anatomy, pelvic floor function, psychosexual function and overall quality of life may require additional and long term health resources and support.
On the other hand, associations between body dysmorphic disorders and requests for cosmetic procedures are well documented and patient treatment pathways require robust scientific justification.

Research evidence is limited and the small number of studies are mainly retrospective and observational with small numbers of patients and short term follow up. Validated measurement instruments are of paramount importance in this type of research as well as clinical practice, in order to support our understanding of the role and appropriateness of cosmetic gynaecological interventions.

The efficacy and safety of cosmetic genital procedures, scientific justification and validation should be confirmed by rigorous evaluation. Meta-analyses based on high quality trials are highly warranted. The development of core outcome sets (COS) and outcome measures sets (COMS) will form the basis for better quality research to inform clinical practice and support patient centered care.

An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health, including academic community members, researchers, healthcare professionals, policy makers and women with experience of cosmetic gynaecological interventions will lead the development of these COS and COMS.


Produce, disseminate, and implement core outcome and outcome measures sets for cosmetic gynaecological interventions.

Protocol development in progress

Chorus has developed an extensive agenda and work streams on core outcome sets in a series of pelvic floor disorders including stress urinary incontinence, overactive bladder, pelvic organ prolapse, childbirth trauma and pelvic pain. Based on our established methodology and previously published protocols on developing core outcome sets, we aim to form an international steering group of healthcare professionals, researchers, and women with experience on cosmetic gynaecological interventions, in order to steer the development of these core outcome and outcome measures sets.

Potential core outcomes will be identified through extensive literature reviews, focus groups and further research and entered into an international, multi-perspective online Delphi survey followed by consensus meetings. All key stakeholders will be invited to participate.

Once core outcomes have been agreed, the quality of potential outcome measures will be assessed. High quality outcome measures will be associated with core outcomes.


Principal investigator:
Professor Stergios K. Doumouchtsis MSc, MPH, PhD, FRCOG
Consultant Obstetrician Gynaecologist and Urogynaecologist
Epsom & St Helier University Hospitals NHS Trust
Honorary Senior Lecturer, St George's University of London
Visiting Professor, University of Athens
Associate Clinical Professor, American University of the Caribbean

(On behalf of CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health,

Further Study Information

Current Stage: Ongoing
Date: July 2020 - July 2022
Funding source(s): NIHR or other source funding will be sought.

Health Area

Disease Category: Gynaecology

Disease Name: Cosmetic procedures

Target Population

Age Range: 0 - 100

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Device manufacturers
- Epidemiologists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Service providers
- Service users
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)


- Delphi process
- Interview
- Other
- Systematic review

Delphi process
- Interviews
- Literature reviews
- Systematic reviews
- Other

Stage 1 Identifying Potential Outcomes

Systematic Reviews: Literature searches will identify studies evaluating interventions. Systematic reviews will facilitate the development of inventories of outcomes and outcome measures.

Outcome Inventories: Comprehensive inventories of outcomes identified by the literature reviews and qualitative patient interviews will be developed prior to entering into the Delphi process.

Stage 2 Determining Core Outcomes

Delphi methodology: All stakeholders will be invited to participate in a process which assesses the extent of agreement (consensus measurement) and then resolves disagreement (consensus development). Repeated reflection and scoring increases the likelihood of whole and stakeholder group convergence towards consensus “core” outcomes.

Stage 3 Determining How Core Outcomes Should be Measured

Stage 3 (A): Quality Assessment: Once core outcomes have been agreed, it is important to determine how they should be measured. An assessment framework (truth, discrimination, feasibility) will assess the quality of potential outcome measures. High quality outcome measures will be incorporated into the core outcome set.

Stage 3 (B): Stakeholder Consultation: A draft document summarising the background information, methodology, and results will be circulated and presented at international congresses. Stakeholder feedback will be collated, reviewed, and incorporated into the finalised core outcome sets prior to distribution.

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