Core Outcome Set for Therapeutic Mammaplasty
Research type
Research Study
Full title
Core Outcome Set for Therapeutic Mammaplasty
IRAS ID
288371
Contact name
Daniel Leff
Contact email
Sponsor organisation
Head of Research Governance and Integrity, imperial college london
Clinicaltrials.gov Identifier
https://comet-initiative.org/Studies/Details/1655, Registration on COMET Database
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
A core outcome set (COS) is a minimum group of outcomes to be reported in all trials of a specific condition to reduce the heterogeneity of outcome reporting across trials. This enables study results to be compared and combined to inform best medical practice.
Therapeutic mammaplasty is an oncological procedure which combines cancer resection with breast reduction and reshaping. Previous systematic reviews have demonstrated good oncological safety of this procedure, but poor and inconsistent reporting of quality of life, aesthetic and functional outcomes, often with non-validated measurement tools. Moreover, there is a paucity of patient-reported outcome measures.
In conclusion, there is a need to (i) understand which outcomes are important to patients following therapeutic mammaplasty and (ii) generate a COS to standardise outcome reporting in clinical trials and clinical practice.
The rationale of this study is to develop a COS for therapeutic mammaplasty procedures. The COS will be developed by long listing all potential outcomes for inclusion via a systematic review and qualitative interviews and focus groups with patients to ensure all relevant outcomes are identified from the perspective of both patients and professionals. These outcomes will undergo a process of short listing using a multidisciplinary and multi-round Delphi survey in which participants (including patients and healthcare professionals) will be asked to rank the long listed outcomes in terms of importance. The final COS will be formed via consensus group discussions.
REC name
London - Bromley Research Ethics Committee
REC reference
20/LO/1251
Date of REC Opinion
25 Jan 2021
REC opinion
Further Information Favourable Opinion