Who can participate in helping develop the fGAS-COS?

We are looking for members from both the professional community (surgeons, researchers, clinicians) and experts on TGNB lived experience (members of the community who have had or are interested in facial gender-affirming surgery). Each of the two groups will receive surveys evaluating the same topics tailored to the perspective of each group. You can click here to register for the group that best fits.

 

What is a Core Outcome Set (COS)?

A Core Outcome Set (COS) is a standardized collection of outcomes that should be measured and reported in all clinical trials for a specific condition or intervention. The purpose of a COS is to ensure that research consistently addresses outcomes that are important to all stakeholders, including patients, clinicians, and researchers, improving the comparability and quality of studies.

 

How does a COS differ from a Patient-Reported Outcome Measure (PROM)?

A Core Outcome Set refers to the specific outcomes that should be measured in all relevant studies. In contrast, a Patient-Reported Outcome Measure (PROM) is a tool or instrument used to collect data directly from patients about their health status, quality of life, or the outcomes of an intervention. While a COS might include PROMs as one component, it also covers other types of outcomes, like clinical or safety-related endpoints.

 

Why is a COS needed for Face Gender-Affirming Surgery (FGAS)?

FGAS is a vital intervention for many transgender individuals, but research on the outcomes of FGAS has been inconsistent, using a wide variety of outcome measures. This makes it difficult to compare results across studies. A COS ensures that future research on FGAS consistently measures outcomes that matter most to patients and clinicians, improving the quality and relevance of the evidence base.

 

Who develops a Core Outcome Set?

A COS is typically developed through a collaborative process that involves input from a wide range of stakeholders, including patients, healthcare providers, researchers, and sometimes policymakers. This ensures that the COS reflects the priorities and needs of everyone involved in the treatment and care related to the specific condition or procedure.

 

How are outcomes selected for inclusion in a COS?

Outcomes in a COS are selected through a systematic and inclusive process. This often includes a literature review, stakeholder surveys, and consensus-building methods like the Delphi technique, where experts and key stakeholders discuss and refine which outcomes are most important to measure.

 

How will a COS for FGAS benefit patients?

By establishing a standardized set of outcomes for FGAS, researchers and clinicians can ensure that studies focus on what is most meaningful to patients. This can improve the quality of care, promote better decision-making, and enhance shared decision-making between patients and clinicians by providing evidence-based information about surgery outcomes.

 

Are COSs mandatory in clinical trials?

While using a COS is not legally required, many funding bodies, journals, and regulatory agencies increasingly expect researchers to use COSs in clinical trials. Adopting a COS helps ensure that studies are more comparable, making it easier to combine data from different studies in systematic reviews and meta-analyses.

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