TY  - JOUR
AU  - Doumouchtsis, Stergios K
AU  - Nama, Vivek
AU  - Falconi, Gabriele
AU  - Rada, Maria Patricia
AU  - Manonai, Jittima
AU  - Iancu, George
AU  - Haddad, Jorge Milhem
AU  - Betschart, Cornelia
PY  - 2021
DA  - 2021/11/15
TI  - Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study
JO  - JMIR Res Protoc
SP  - e28032
VL  - 10
IS  - 11
KW  - core outcome sets
KW  - core outcome measures sets
KW  - cosmetic gynecological surgery
KW  - intervention
KW  - labiaplasty
KW  - vulva
KW  - gynecology
KW  - cosmetic surgery
KW  - surgery
KW  - framework
KW  - outcome
KW  - effective
KW  - implementation
AB  - Background: Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions. Objective: This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions. Methods: An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing “core” outcomes. Results: Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. Conclusions: This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care. Trial Registration: Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh International Registered Report Identifier (IRRID): PRR1-10.2196/28032 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2021/11/e28032
UR  - https://doi.org/10.2196/28032
UR  - http://www.ncbi.nlm.nih.gov/pubmed/34779787
DO  - 10.2196/28032
ID  - info:doi/10.2196/28032
ER  -