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A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema

Melanie Thomas Orcid Logo, Marie Gabe-Walters, Ioan Humphreys Orcid Logo, Alan Watkins Orcid Logo

PLOS One, Volume: 20, Issue: 5, Start page: e0315314

Swansea University Authors: Ioan Humphreys Orcid Logo, Alan Watkins Orcid Logo

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DOI (Published version): 10.1371/journal.pone.0315314

Abstract

Background: A new lymphoedema-specific Patient Reported Outcome Measure (LYMPROM©) was developed to help patients easily report the impact of their lymphoedema and enable lymphoedema therapists to understand what matters most to patients. Aims: This paper describes the validation of LYMPROM© for adu...

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Published in: PLOS One
ISSN: 1932-6203
Published: Public Library of Science (PLoS) 2025
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Aims: This paper describes the validation of LYMPROM&#xA9; for adults with lymphoedema. Methods: A multi-phased iterative review was undertaken to investigate the reliability and validity of LYMPROM&#xA9;. Face and content validity were reviewed by surveying patient representatives and healthcare professionals, along with the validity of LYMPROM&#xA9; Cymraeg, a Welsh translation. Following COSMIN guidelines, validation study phases used anonymised routinely collected data to examine internal consistency, structural validity, construct validity (compared with the EQ5D-5L), measurement error, test-retest reliability and responsiveness. Results: LYMPROM&#xA9; demonstrated validity (content and construct) and reliability (test-retest, internal consistency). All items were regarded as relevant, comprehensive and clear, with item content validity index (CVI) between 0.83 to 1.00, and average overall assessment of 0.94. Robust development of LYMPROM&#xA9; Cymraeg ensured appropriate translation into Welsh. LYMPROM&#xA9; item scores, with means and medians generally in the lower half of the scale, were positively correlated, as were three (Physical health, Social health and Emotional health) domain scores (domain correlations: 0.595 to 0.812). LYMPROM&#xA9; total and domain scores showed moderate negative correlations (-0.577 to -0.435) with EQ5D-5L measures. LYMPROM&#xA9; total and domain scores showed good test-retest (within two weeks) properties, with little or no change in mean or median scores, and strong positive correlations between test and retest scores (Total: 0.919; Physical health domain: 0.922; Social health domain: 0.889; Emotional health domain: 0.820). LYMPROM&#xA9; showed good responsiveness, with strong, positive correlations between total and domain initial and repeat (between four weeks and seven months later) scores, with a slight reduction in scores (-3.8 to -2.0 units) and some indication of relationships between reduction and time interval (Total: p&#x2009;=&#x2009;0.025; Physical health domain: 0.034; Social health domain: 0.181; Emotional health domain: 0.009). Conclusion: Evidence shows that LYMPROM&#xA9; offers a reliable and valid tool for use in clinical practice. Scores on three domains allow a more granular assessment of the patient&#x2019;s view of their condition; these scores and the total LYMPROM&#xA9; score exhibit moderate correlations with more generic EQ5D-5L measures. 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spelling 2025-06-10T16:26:50.9899221 v2 68711 2025-01-20 A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema 399e932224d259fca801505dc92cebf7 0000-0001-7993-0179 Ioan Humphreys Ioan Humphreys true false 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false 2025-01-20 HSOC Background: A new lymphoedema-specific Patient Reported Outcome Measure (LYMPROM©) was developed to help patients easily report the impact of their lymphoedema and enable lymphoedema therapists to understand what matters most to patients. Aims: This paper describes the validation of LYMPROM© for adults with lymphoedema. Methods: A multi-phased iterative review was undertaken to investigate the reliability and validity of LYMPROM©. Face and content validity were reviewed by surveying patient representatives and healthcare professionals, along with the validity of LYMPROM© Cymraeg, a Welsh translation. Following COSMIN guidelines, validation study phases used anonymised routinely collected data to examine internal consistency, structural validity, construct validity (compared with the EQ5D-5L), measurement error, test-retest reliability and responsiveness. Results: LYMPROM© demonstrated validity (content and construct) and reliability (test-retest, internal consistency). All items were regarded as relevant, comprehensive and clear, with item content validity index (CVI) between 0.83 to 1.00, and average overall assessment of 0.94. Robust development of LYMPROM© Cymraeg ensured appropriate translation into Welsh. LYMPROM© item scores, with means and medians generally in the lower half of the scale, were positively correlated, as were three (Physical health, Social health and Emotional health) domain scores (domain correlations: 0.595 to 0.812). LYMPROM© total and domain scores showed moderate negative correlations (-0.577 to -0.435) with EQ5D-5L measures. LYMPROM© total and domain scores showed good test-retest (within two weeks) properties, with little or no change in mean or median scores, and strong positive correlations between test and retest scores (Total: 0.919; Physical health domain: 0.922; Social health domain: 0.889; Emotional health domain: 0.820). LYMPROM© showed good responsiveness, with strong, positive correlations between total and domain initial and repeat (between four weeks and seven months later) scores, with a slight reduction in scores (-3.8 to -2.0 units) and some indication of relationships between reduction and time interval (Total: p = 0.025; Physical health domain: 0.034; Social health domain: 0.181; Emotional health domain: 0.009). Conclusion: Evidence shows that LYMPROM© offers a reliable and valid tool for use in clinical practice. Scores on three domains allow a more granular assessment of the patient’s view of their condition; these scores and the total LYMPROM© score exhibit moderate correlations with more generic EQ5D-5L measures. Further research will explore relationships between patient-level characteristics and LYMPROM© responses, and extend initial work on its cross-cultural validity. Journal Article PLOS One 20 5 e0315314 Public Library of Science (PLoS) 1932-6203 23 5 2025 2025-05-23 10.1371/journal.pone.0315314 COLLEGE NANME Health and Social Care School COLLEGE CODE HSOC Swansea University SU Library paid the OA fee (TA Institutional Deal) 2025-06-10T16:26:50.9899221 2025-01-20T16:50:00.2508136 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Therapies Melanie Thomas 0000-0001-6631-9629 1 Marie Gabe-Walters 2 Ioan Humphreys 0000-0001-7993-0179 3 Alan Watkins 0000-0003-3804-1943 4 68711__34456__ea95128d5e2845a9bfbddb6b53af12ed.pdf 68711.VOR.pdf 2025-06-10T16:23:32.6420158 Output 1767660 application/pdf Version of Record true © 2025 Thomas et al. This is an open access article distributed under the terms of the Creative Commons Attribution License. true eng http://creativecommons.org/licenses/by/4.0/
title A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema
spellingShingle A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema
Ioan Humphreys
Alan Watkins
title_short A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema
title_full A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema
title_fullStr A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema
title_full_unstemmed A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema
title_sort A new validated Lymphoedema-specific Patient Reported Outcome Measure (LYMPROM) for adults with Lymphoedema
author_id_str_mv 399e932224d259fca801505dc92cebf7
81fc05c9333d9df41b041157437bcc2f
author_id_fullname_str_mv 399e932224d259fca801505dc92cebf7_***_Ioan Humphreys
81fc05c9333d9df41b041157437bcc2f_***_Alan Watkins
author Ioan Humphreys
Alan Watkins
author2 Melanie Thomas
Marie Gabe-Walters
Ioan Humphreys
Alan Watkins
format Journal article
container_title PLOS One
container_volume 20
container_issue 5
container_start_page e0315314
publishDate 2025
institution Swansea University
issn 1932-6203
doi_str_mv 10.1371/journal.pone.0315314
publisher Public Library of Science (PLoS)
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care - Therapies{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care - Therapies
document_store_str 1
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description Background: A new lymphoedema-specific Patient Reported Outcome Measure (LYMPROM©) was developed to help patients easily report the impact of their lymphoedema and enable lymphoedema therapists to understand what matters most to patients. Aims: This paper describes the validation of LYMPROM© for adults with lymphoedema. Methods: A multi-phased iterative review was undertaken to investigate the reliability and validity of LYMPROM©. Face and content validity were reviewed by surveying patient representatives and healthcare professionals, along with the validity of LYMPROM© Cymraeg, a Welsh translation. Following COSMIN guidelines, validation study phases used anonymised routinely collected data to examine internal consistency, structural validity, construct validity (compared with the EQ5D-5L), measurement error, test-retest reliability and responsiveness. Results: LYMPROM© demonstrated validity (content and construct) and reliability (test-retest, internal consistency). All items were regarded as relevant, comprehensive and clear, with item content validity index (CVI) between 0.83 to 1.00, and average overall assessment of 0.94. Robust development of LYMPROM© Cymraeg ensured appropriate translation into Welsh. LYMPROM© item scores, with means and medians generally in the lower half of the scale, were positively correlated, as were three (Physical health, Social health and Emotional health) domain scores (domain correlations: 0.595 to 0.812). LYMPROM© total and domain scores showed moderate negative correlations (-0.577 to -0.435) with EQ5D-5L measures. LYMPROM© total and domain scores showed good test-retest (within two weeks) properties, with little or no change in mean or median scores, and strong positive correlations between test and retest scores (Total: 0.919; Physical health domain: 0.922; Social health domain: 0.889; Emotional health domain: 0.820). LYMPROM© showed good responsiveness, with strong, positive correlations between total and domain initial and repeat (between four weeks and seven months later) scores, with a slight reduction in scores (-3.8 to -2.0 units) and some indication of relationships between reduction and time interval (Total: p = 0.025; Physical health domain: 0.034; Social health domain: 0.181; Emotional health domain: 0.009). Conclusion: Evidence shows that LYMPROM© offers a reliable and valid tool for use in clinical practice. Scores on three domains allow a more granular assessment of the patient’s view of their condition; these scores and the total LYMPROM© score exhibit moderate correlations with more generic EQ5D-5L measures. Further research will explore relationships between patient-level characteristics and LYMPROM© responses, and extend initial work on its cross-cultural validity.
published_date 2025-05-23T05:26:13Z
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