Protocol for the Development of a Core Outcome Set for facial Gender-Affirming Surgery (fGAS-COS)

Brief Summary: Facial gender-affirming surgery (fGAS) is an essential component of gender-affirming care, which has been shown to improve the well-being and quality of life for transgender and gender non-binary (TGNB) individuals. While clinical and psychosocial outcomes are widely reported in the surgical literature, they have historically employed ad hoc and non-validated outcome measures with wide variability across studies. Achieving a high-level of evidence is further complicated by the highly specialized nature of fGAS resulting in a predominance of single-surgeon retrospective case-series. This heterogeneity in outcomes reporting has limited comparative analysis across studies and reduced the overall level of evidence within the field of fGAS. As the field matures and surgical practices expand, it is imperative that surgeons and researchers consolidate around a standardized minimum core outcome set (COS).

Specific Aim: This study will outline the protocol for the development a COS for fGAS which will establish a minimum set of outcomes that should be measured and reported consistently in clinical research and practice. This will enhance the comparability of outcomes across studies and facilitate evidence-based decision-making.

NOTE: Gender-affirming care is an umbrella term that encompasses the many medical, surgical, and mental health treatment modalities used in the care of transgender people. While treatment of gender dysphoria is a unifying goal across specialties, the various types of interventions are varied and require tailored core outcome sets. I.e., the GenderCOS is a project focused on developing a COS for genital gender-affirming surgery whereas the fGAS-COS will focus on developing a COS for facial gender-affirming surgery.


Sarah K. Fadich, PA-C (lead) [1]
Nghiem Nguyen, BA [1]
Meghan Miller, BA [1]
Kaavian Shariati, MEng, BS [1]
Miles Pfaff, MD, MHS [5]
Kavitha Ranganathan [3,2]
Thomas Satterwhite, MD [7,8]
Jens Berli, MD, MBA [6]
Manraj Kaur, PT, PhD [3,4]
Justine C. Lee, MD, PhD (PI) [1]

1. Division of Plastic & Reconstructive Surgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
2. Harvard Medical School, Boston, MA, USA.
3. Division of Plastic and Reconstructive Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.
4. Patient-Reported Outcomes, Value and Experience (PROVE) Center, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA.
5. Division of Plastic & Reconstructive Surgery, University of California, Irvine, Orange, CA, USA
6. Division of Plastic & Reconstructive Surgery, Oregon & Health Science University, Portland, OR, USA
7. Align Surgical Associates, San Francisco, CA, USA
8. Division of Plastic & Reconstructive Surgery, Stanford University Medical Center, Palo Alto, CA, USA

Further Study Information

Current Stage: Ongoing
Date: May 2024 - October 2024
Funding source(s): None

Health Area

Disease Category: Other

Disease Name: N/A

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Other
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice


- Consensus meeting
- Delphi process
- Focus group(s)
- Systematic review

This study represents a multi-institutional steering committee to develop a consensus driven standardized COS in fGAS. This project is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database and will follow guidelines set forth in the Core Outcomes Set-STandards for Development (COS-STAD) and Core Outcome Set-STandardized Protocol Items (COS-STAP). A systematic review of the literature yielded a list of previously used clinician reported outcome measures, patient reported outcome measures, variables, and taxonomy. Next the University of California Los Angeles Gender Health Program community advisory board will be convened to review and addend the preliminary list of outcomes relevant to the TGNB community. A work-group comprising key stakeholders, surgeons, researchers, and health policy experts will convene to consolidate, review, and redistribute after each of the two phases in the DELPHI process. Participation will be sought internationally among practicing fGAS surgeons by means of conferences, professional networks, and a fGAS-COS website. Finally, the workgroup will convene to analyze the results and finalize the fGAS COS.

Through a systematic review of the literature and a multi-institutional collaboration between prominent fGAS surgical sites, this study will yield a COS for fGAS, thus providing a standardized framework for future research and practice. Application of the fGAS-COS may be utilized to enhance comparability between outcomes studies.

This development, dissemination, and implementation of the fGAS-COS for fGAS will standardize outcome measurement and reporting, facilitate scientific advancement and guide evidence-based clinical decision-making.

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