Cargando…

Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy

AIM: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluati...

Descripción completa

Detalles Bibliográficos
Autores principales: Bulamu, Norma B., Vissapragada, Ravi, Chen, Gang, Ratcliffe, Julie, Mudge, Louise A., Smithers, B. Mark, Isenring, Elizabeth A., Smith, Lorelle, Jamieson, Glyn G., Watson, David I.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487554/
https://www.ncbi.nlm.nih.gov/pubmed/34600554
http://dx.doi.org/10.1186/s12955-021-01867-w
_version_ 1784577980820881408
author Bulamu, Norma B.
Vissapragada, Ravi
Chen, Gang
Ratcliffe, Julie
Mudge, Louise A.
Smithers, B. Mark
Isenring, Elizabeth A.
Smith, Lorelle
Jamieson, Glyn G.
Watson, David I.
author_facet Bulamu, Norma B.
Vissapragada, Ravi
Chen, Gang
Ratcliffe, Julie
Mudge, Louise A.
Smithers, B. Mark
Isenring, Elizabeth A.
Smith, Lorelle
Jamieson, Glyn G.
Watson, David I.
author_sort Bulamu, Norma B.
collection PubMed
description AIM: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy. METHODS: Participants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman’s correlation and the level of agreement was explored using Bland–Altman plots. RESULTS: Data from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores. CONCLUSION: The QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L. Trial registration: The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12955-021-01867-w.
format Online
Article
Text
id pubmed-8487554
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-84875542021-10-04 Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy Bulamu, Norma B. Vissapragada, Ravi Chen, Gang Ratcliffe, Julie Mudge, Louise A. Smithers, B. Mark Isenring, Elizabeth A. Smith, Lorelle Jamieson, Glyn G. Watson, David I. Health Qual Life Outcomes Research AIM: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy. METHODS: Participants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman’s correlation and the level of agreement was explored using Bland–Altman plots. RESULTS: Data from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores. CONCLUSION: The QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L. Trial registration: The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12955-021-01867-w. BioMed Central 2021-10-02 /pmc/articles/PMC8487554/ /pubmed/34600554 http://dx.doi.org/10.1186/s12955-021-01867-w Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Bulamu, Norma B.
Vissapragada, Ravi
Chen, Gang
Ratcliffe, Julie
Mudge, Louise A.
Smithers, B. Mark
Isenring, Elizabeth A.
Smith, Lorelle
Jamieson, Glyn G.
Watson, David I.
Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy
title Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy
title_full Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy
title_fullStr Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy
title_full_unstemmed Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy
title_short Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy
title_sort responsiveness and convergent validity of qlu-c10d and eq-5d-3l in assessing short-term quality of life following esophagectomy
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487554/
https://www.ncbi.nlm.nih.gov/pubmed/34600554
http://dx.doi.org/10.1186/s12955-021-01867-w
work_keys_str_mv AT bulamunormab responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT vissapragadaravi responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT chengang responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT ratcliffejulie responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT mudgelouisea responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT smithersbmark responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT isenringelizabetha responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT smithlorelle responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT jamiesonglyng responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT watsondavidi responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy
AT responsivenessandconvergentvalidityofqluc10dandeq5d3linassessingshorttermqualityoflifefollowingesophagectomy