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

Charlotte F Davies; Rhiannon C Macefield; Kerry N L Avery; Jane M Blazeby; Shelley Potter

doi:10.1245/s10434-020-08736-8

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

Charlotte F Davies^*, Rhiannon C Macefield, Kerry N L Avery, Jane M Blazeby, Shelley Potter

^*Corresponding author for this work

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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 language	English
Pages (from-to)	386-404
Number of pages	19
Journal	Annals of Surgical Oncology
Volume	28
Issue number	1
Early online date	29 Jun 2020
DOIs	https://doi.org/10.1245/s10434-020-08736-8
Publication status	Published - 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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10.1245/s10434-020-08736-8

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

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. ",

keywords = "Systematic review, Measurement properties, Patient reported outcome measure, Reconstructive breast surgery, Core measurement set, Core outcome set, COSMIN",

author = "Davies, {Charlotte F} and Macefield, {Rhiannon C} and Avery, {Kerry N L} and Blazeby, {Jane M} and Shelley Potter",

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: {\textcopyright} 2020, The Author(s).",

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AU - Macefield, Rhiannon C

AU - Avery, Kerry N L

AU - Blazeby, Jane M

AU - Potter, Shelley

N1 - 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).

PY - 2021/1/1

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N2 - 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.

AB - 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.

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KW - Core outcome set

KW - COSMIN

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JO - Annals of Surgical Oncology

JF - Annals of Surgical Oncology

IS - 1

ER -

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

Abstract

Bibliographical note

Keywords

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International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction: A study protocol

The BRAVER Study - Methods to develop less and better research in reconstructive breast surgery

Cite this

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

Abstract

Bibliographical note

Keywords

Access to Document

Handle.net

Other files and links

Embargoed Document

Fingerprint

Research output

International development and implementation of a core measurement set for research and audit studies in implant-based breast reconstruction: A study protocol

Projects

The BRAVER Study - Methods to develop less and better research in reconstructive breast surgery

Cite this