A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb

Aims: Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients,...

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Main Authors: Jennie Lister, Sophie James, Hemant K. Sharma, Catherine Hewitt, Helen Fulbright, Heather Leggett, Catriona McDaid
Format: Article
Language:English
Published: The British Editorial Society of Bone & Joint Surgery 2024-12-01
Series:Bone & Joint Open
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Online Access:https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.512.BJO-2024-0074.R1
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author Jennie Lister
Sophie James
Hemant K. Sharma
Catherine Hewitt
Helen Fulbright
Heather Leggett
Catriona McDaid
author_facet Jennie Lister
Sophie James
Hemant K. Sharma
Catherine Hewitt
Helen Fulbright
Heather Leggett
Catriona McDaid
author_sort Jennie Lister
collection DOAJ
description Aims: Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients. Methods: A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts. Results: The systematic searches found 13 studies, while hand searches found 50 PROM development studies, and copies of all 37 measures. Although several studies discussed content validity, none were found which formally assessed this measurement property in the adult LLR population. Development of many PROMs was rated as inadequate, no PROM had sufficient content validity in the study population, and none covered all areas of the PROLLIT framework. The LIMB-Q was the most promising and comprehensive measure assessed, although further validation in a wider sample of LLR patients was recommended. Conclusion: Current PROMs used in adults requiring, undergoing, or after undergoing LLR lack content validity and do not assess all important and relevant outcomes. There is an urgent need for improved outcome measurement in this population. This can be achieved through development of a new PROM, or through validation of existing measures in representative samples. Cite this article: Bone Jt Open 2024;5(12):1049–1066.
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spelling doaj-art-b54163eb013949e09468193547c08b3c2025-01-28T05:38:30ZengThe British Editorial Society of Bone & Joint SurgeryBone & Joint Open2633-14622024-12-015121049106610.1302/2633-1462.512.BJO-2024-0074.R1A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limbJennie Lister0Sophie James1Hemant K. Sharma2Catherine Hewitt3Helen Fulbright4https://orcid.org/0000-0002-1073-1099Heather Leggett5Catriona McDaid6York Trials Unit (YTU), Department of Health Sciences, University of York, York, UKYork Trials Unit (YTU), Department of Health Sciences, University of York, York, UKDepartment of Trauma & Orthopaedics, Hull Royal Infirmary, Hull, UKYork Trials Unit (YTU), Department of Health Sciences, University of York, York, UKCentre for Reviews and Dissemination (CRD), University of York, York, UKYork Trials Unit (YTU), Department of Health Sciences, University of York, York, UKYork Trials Unit (YTU), Department of Health Sciences, University of York, York, UKAims: Lower limb reconstruction (LLR) has a profound impact on patients, affecting multiple areas of their lives. Many patient-reported outcome measures (PROMs) are employed to assess these impacts; however, there are concerns that they do not adequately capture all outcomes important to patients, and may lack content validity in this context. This review explored whether PROMs used with adults requiring, undergoing, or after undergoing LLR exhibited content validity and adequately captured outcomes considered relevant and important to patients. Methods: A total of 37 PROMs were identified. Systematic searches were performed to retrieve content validity studies in the adult LLR population, and hand-searches used to find PROM development studies. Content validity assessments for each measure were performed following Consensus-based Standards for the selection of health measurement Instruments (COSMIN) guidelines. A mapping exercise compared all PROMs to a conceptual framework previously developed by the study team (‘the PROLLIT framework’) to explore whether each PROM covered important and relevant concepts. Results: The systematic searches found 13 studies, while hand searches found 50 PROM development studies, and copies of all 37 measures. Although several studies discussed content validity, none were found which formally assessed this measurement property in the adult LLR population. Development of many PROMs was rated as inadequate, no PROM had sufficient content validity in the study population, and none covered all areas of the PROLLIT framework. The LIMB-Q was the most promising and comprehensive measure assessed, although further validation in a wider sample of LLR patients was recommended. Conclusion: Current PROMs used in adults requiring, undergoing, or after undergoing LLR lack content validity and do not assess all important and relevant outcomes. There is an urgent need for improved outcome measurement in this population. This can be achieved through development of a new PROM, or through validation of existing measures in representative samples. Cite this article: Bone Jt Open 2024;5(12):1049–1066.https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.512.BJO-2024-0074.R1limb reconstructionlower limbsurgerypatient-reported outcome measurepromsystematic reviewpatient-reported outcome measures (proms)lower extremityreconstructive surgerylimb reconstructionshort form 36visual analogue scale; vaslower limb reconstructionknee society scoringlower limb traumaorthopaedic surgeons
spellingShingle Jennie Lister
Sophie James
Hemant K. Sharma
Catherine Hewitt
Helen Fulbright
Heather Leggett
Catriona McDaid
A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb
Bone & Joint Open
limb reconstruction
lower limb
surgery
patient-reported outcome measure
prom
systematic review
patient-reported outcome measures (proms)
lower extremity
reconstructive surgery
limb reconstruction
short form 36
visual analogue scale; vas
lower limb reconstruction
knee society scoring
lower limb trauma
orthopaedic surgeons
title A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb
title_full A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb
title_fullStr A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb
title_full_unstemmed A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb
title_short A systematic review and mapping exercise to assess the content validity of patient-reported outcome measures for adults having reconstructive surgery of the lower limb
title_sort systematic review and mapping exercise to assess the content validity of patient reported outcome measures for adults having reconstructive surgery of the lower limb
topic limb reconstruction
lower limb
surgery
patient-reported outcome measure
prom
systematic review
patient-reported outcome measures (proms)
lower extremity
reconstructive surgery
limb reconstruction
short form 36
visual analogue scale; vas
lower limb reconstruction
knee society scoring
lower limb trauma
orthopaedic surgeons
url https://online.boneandjoint.org.uk/doi/epdf/10.1302/2633-1462.512.BJO-2024-0074.R1
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