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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.

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. 

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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. 

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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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