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Currently submitted to: JMIR Research Protocols

Date Submitted: Feb 17, 2021
Date Accepted: Sep 28, 2021

The final, peer-reviewed published version of this preprint can be found here:

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study

Doumouchtsis SD, Nama V, Falconi G, Rada MP, Manonai J, Iancu G, Haddad JM, Betschart C

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study

JMIR Res Protoc 2021;10(11):e28032

DOI: 10.2196/28032

PMID: 34779787

PMCID: 8663614

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynaecological Interventions: a protocol

  • Stergios D Doumouchtsis; 
  • Vivek Nama; 
  • Gabriele Falconi; 
  • Maria Patricia Rada; 
  • Jittima Manonai; 
  • George Iancu; 
  • Jorge Milhem Haddad; 
  • Cornelia Betschart

ABSTRACT

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 outcomes important to all stakeholders, primarily women requesting or with experience of cosmetic gynecological interventions.

Objective:

N/A

Methods:

An international steering group, within the CHORUS Collaboration, including healthcare professionals, researchers and women with experience in cosmetic gynecological interventions will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. COS and COMS will be entered into an international, multi-perspective online Delphi survey. The Delphi survey results will be evaluated 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:

Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to the enhancement of the value of research and improving overall patient care. Clinical Trial: Core Outcome Measures in Effectiveness Trials [COMET] initiative, registration number 1592


 Citation

Please cite as:

Doumouchtsis SD, Nama V, Falconi G, Rada MP, Manonai J, Iancu G, Haddad JM, Betschart C

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study

JMIR Res Protoc 2021;10(11):e28032

DOI: 10.2196/28032

PMID: 34779787

PMCID: 8663614

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