Outcomes and outcome measures reported in clinical studies of therapeutic mammaplasty: a systematic review protocol.

[INTRODUCTION] Therapeutic mammaplasty (TM) is an oncological procedure which combines tumour resection with breast reduction and mastopexy techniques. Previous systematic reviews have demonstrated oncological safety of TM, 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. Standardisation of outcome reporting is required to enable study results to be compared and combined, for example, through core outcome set (COS) development. This systematic review aims to comprehensively describe the outcomes reported in clinical studies of TM, their respective outcome measures and the time points at which they were evaluated. The overall objective is to facilitate the development of a COS for TM.

[METHODS AND ANALYSIS] A systematic review of clinical studies evaluating outcomes following TM will be completed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The following electronic databases have been searched from inception to 5 August 2020: Ovid MEDLINE, Embase, CINAHL and Web of Science. Primary outcomes will include the number of reported outcomes of various types (clinical, aesthetic, functional, quality-of-life and cost-effectiveness), whether these are patient-reported or clinician-reported, how outcomes are defined and the outcome measurement tool(s) used. The time point(s) at which outcomes were measured will be a secondary outcome. No studies will be excluded on the basis of methodological quality in order to generate a comprehensive list of reported outcomes and outcome measures; hence, risk of bias assessment is not required. The data will be described narratively. This protocol has been reported in line with PRISMA-Protocols.

[ETHICS AND DISSEMINATION] This study does not involve human or animal participants, hence ethical approval is not required. The findings will be published in a peer-reviewed journal and presented at relevant conferences.

[PROSPERO REGISTRATION NUMBER] CRD42020200365.