Patient-reported outcome measures for post-mastectomy breast reconstruction: A systematic review of development and measurement properties

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Abstract

Background: Breast reconstruction (BR) is performed to improve outcomes for patients undergoing mastectomy. A recently developed core outcome set for BR includes six patient-reported outcomes that should be measured and reported in all future studies. It is vital that any instrument used to measure these outcomes as part of a core measurement set has been robustly developed and validated so data are reliable and accurate. The aim of this systematic review was to evaluate the development and measurement properties of existing BR patient-reported outcome measures (PROMs) to inform instrument selection for future studies.

Methods: A PRISMA-compliant systematic review of development and validation studies of BR PROMs was conducted to assess their measurement properties. PROMs with adequate content validity were assessed using 3 steps: 1) The methodological quality of each identified study was assessed using the COSMIN Risk of Bias checklist, 2) criteria were applied for assessing good measurement properties and 3) evidence was summarized and the quality of evidence assessed using a modified GRADE approach.

Results: 14 articles reported the development and measurement properties of six PROMs. Of these, only three (BREAST-Q, BRECON-31 and EORTC QLQ-BRECON-23) were considered to have adequate content validity and proceeded to full evaluation. This showed that all three PROMs had been robustly developed and validated and demonstrated adequate quality.

Conclusion: The BREAST-Q, BRECON-31 and EORTC QLQ-BRECON-23 have been well-developed and demonstrate adequate measurement properties. Work with key stakeholders is now needed to generate consensus regarding which PROM should be recommended for inclusion in a core measurement set.
Original languageEnglish
Pages (from-to)386-404
Number of pages19
JournalAnnals of Surgical Oncology
Volume28
Issue number1
Early online date29 Jun 2020
DOIs
Publication statusPublished - 1 Jan 2021

Bibliographical note

Funding Information:
This work is funded by a National Institute for Health Research Clinician Scientist Award (CS-2016-16-019) to S.P. K.A. and R.M. are funded/supported by the NIHR Biomedical Research Centre (BRC) at University Hospitals Bristol NHS Foundation Trust and the University of Bristol and infrastructure support from the Royal College of Surgeons of England Bristol Surgical Trials Centre. J.M.B. is an NIHR Senior Investigator. The views and opinions expressed are those of the authors and do not necessarily reflect those of the National Institute for Health Research, the National Health Service, or the Department of Health and Social Care.

Publisher Copyright:
© 2020, The Author(s).

Keywords

  • Systematic review
  • Measurement properties
  • Patient reported outcome measure
  • Reconstructive breast surgery
  • Core measurement set
  • Core outcome set
  • COSMIN

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