The WHOQOL-BREF: a modern psychometric evaluation of its internal construct validity in people with multiple sclerosis

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Abstract

Purpose

Symptoms of Multiple Sclerosis (MS) differentially impact upon quality of life (QoL) and a comprehensive measure is required for use in observational and interventional studies. This study examines the abbreviated World Health Organisation Quality of Life tool (WHOQOL-BREF) which was designed to be used as a broad measure of QoL across different cultures and diseases.

Methods

Data were collected from 3186 subjects as part of the TONiC study in MS and was examined with a systematic, iterative approach using Rasch analysis to investigate the internal construct validity of the WHOQOL-BREF.

Results

Mean age was 49.8 years (SD 11.8), disease duration was 11.2 years (SD 9.6) and 73.2% were female. Subjects represented all stages of MS with EDSS scores of 0–4, 4.5–6.5, 7–7.5 and ≥ 8 seen in 49.8%, 38.5%, 6.8% and 4.9% of patients, respectively. Using a super-item approach, it was possible to demonstrate fit to the assumptions of the Rasch model for 3 of the 4 domains of the WHOQOL-BREF (physical, psychological and environment) as well as a broad 24-item total score. In addition, item subsets derived from the stem of each question were shown to function as novel scales measuring impact and life satisfaction. We have provided transformation tables from ordinal raw scores to interval scales where data are complete.

Conclusions

The validation of multiple conceptual frameworks validates the WHOQOL-BREF as a powerful and flexible end-point for use in clinical trials and in testing conceptual models of factors influencing QoL in MS.

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Most cited references 31

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Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes.

I B Wilson, P D Cleary (1995)

Our model proposes a taxonomy or classification scheme for different measures of health outcome. We divide these outcomes into five levels: biological and physiological factors, symptoms, functioning, general health perceptions, and overall quality of life. In addition to classifying these outcome measures, we propose specific causal relationships between them that link traditional clinical variables to measures of HRQL. As one moves from left to right in the model, one moves outward from the cell to the individual to the interaction of the individual as a member of society. The concepts at each level are increasingly integrated and increasingly difficult to define and measure. AT each level, there are an increasing number of inputs that cannot be controlled by clinicians or the health care system as it is traditionally defined.

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Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.

Jeffrey A Cohen, Alasdair J Coles, Douglas L Arnold … (2012)

The anti-CD52 monoclonal antibody alemtuzumab reduced disease activity in a phase 2 trial of previously untreated patients with relapsing-remitting multiple sclerosis. We aimed to assess efficacy and safety of first-line alemtuzumab compared with interferon beta 1a in a phase 3 trial. In our 2 year, rater-masked, randomised controlled phase 3 trial, we enrolled adults aged 18-50 years with previously untreated relapsing-remitting multiple sclerosis. Eligible participants were randomly allocated in a 2:1 ratio by an interactive voice response system, stratified by site, to receive intravenous alemtuzumab 12 mg per day or subcutaneous interferon beta 1a 44 μg. Interferon beta 1a was given three-times per week and alemtuzumab was given once per day for 5 days at baseline and once per day for 3 days at 12 months. Coprimary endpoints were relapse rate and time to 6 month sustained accumulation of disability in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT00530348. 187 (96%) of 195 patients randomly allocated interferon beta 1a and 376 (97%) of 386 patients randomly allocated alemtuzumab were included in the primary analyses. 75 (40%) patients in the interferon beta 1a group relapsed (122 events) compared with 82 (22%) patients in the alemtuzumab group (119 events; rate ratio 0·45 [95% CI 0·32-0·63]; p<0.0001), corresponding to a 54·9% improvement with alemtuzumab. Based on Kaplan-Meier estimates, 59% of patients in the interferon beta 1a group were relapse-free at 2 years compared with 78% of patients in the alemtuzumab group (p<0·0001). 20 (11%) of patients in the interferon beta 1a group had sustained accumulation of disability compared with 30 (8%) in the alemtuzumab group (hazard ratio 0·70 [95% CI 0·40-1·23]; p=0·22). 338 (90%) of patients in the alemtuzumab group had infusion-associated reactions; 12 (3%) of which were regarded as serious. Infections, predominantly of mild or moderate severity, occurred in 253 (67%) patients treated with alemtuzumab versus 85 (45%) patients treated with interferon beta 1a. 62 (16%) patients treated with alemtuzumab had herpes infections (predominantly cutaneous) compared with three (2%) patients treated with interferon beta 1a. By 24 months, 68 (18%) patients in the alemtuzumab group had thyroid-associated adverse events compared with 12 (6%) in the interferon beta 1a group, and three (1%) had immune thrombocytopenia compared with none in the interferon beta 1a group. Two patients in the alemtuzumab group developed thyroid papillary carcinoma. Alemtuzumab's consistent safety profile and benefit in terms of reductions of relapse support its use for patients with previously untreated relapsing-remitting multiple sclerosis; however, benefit in terms of disability endpoints noted in previous trials was not observed here. Genzyme (Sanofi) and Bayer Schering Pharma. Copyright © 2012 Elsevier Ltd. All rights reserved.

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The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper?

Alan Tennant, Philip G Conaghan (2007)

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Author and article information

Contributors

I. M. Pomeroy:

ORCID: http://orcid.org/0000-0001-6439-9776

ian.pomeroy@thewaltoncentre.nhs.uk

Journal

Journal ID (nlm-ta): Qual Life Res

Journal ID (iso-abbrev): Qual Life Res

Title: Quality of Life Research

Publisher: Springer International Publishing (Cham )

ISSN (Print): 0962-9343

ISSN (Electronic): 1573-2649

Publication date (Electronic): 19 March 2020

Publication date PMC-release: 19 March 2020

Publication date (Print): 2020

Volume: 29

Issue: 7

Pages: 1961-1972

Affiliations

[1 ]GRID grid.416928.0, ISNI 0000 0004 0496 3293, Department of Neurology, , Walton Centre NHS Foundation Trust, ; Liverpool, UK

[2 ]GRID grid.9909.9, ISNI 0000 0004 1936 8403, Leeds Institute of Rheumatic and Musculoskeletal Medicine, , University of Leeds, ; Leeds, UK

[3 ]GRID grid.10025.36, ISNI 0000 0004 1936 8470, University of Liverpool, ; Liverpool, UK

Author information

I. M. Pomeroy http://orcid.org/0000-0001-6439-9776

A. Tennant http://orcid.org/0000-0002-0728-2130

R. J. Mills http://orcid.org/0000-0001-6341-6220

C. A. Young http://orcid.org/0000-0003-1745-7720

Article

Publisher ID: 2463

DOI: 10.1007/s11136-020-02463-z

PMC ID: 7295715

PubMed ID: 32193839

SO-VID: 02089abf-a100-419e-a8dd-928517c3c147

License:

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/.

History

Date accepted : 26 February 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100000381, Multiple Sclerosis Society;

Award ID: 62

Award Recipient : C. A. Young

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ScienceOpen disciplines: Public health

Keywords: multiple sclerosis,rasch analysis,clinical outcomes,quality of life

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ScienceOpen disciplines: Public health

Keywords: multiple sclerosis, rasch analysis, clinical outcomes, quality of life

The WHOQOL-BREF: a modern psychometric evaluation of its internal construct validity in people with multiple sclerosis

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Karger: Neurology and Neuroscience

Most cited references 31

Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes.

Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial.

The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper?

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