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      Developing the Breast Utility Instrument, a preference-based instrument to measure health-related quality of life in women with breast cancer: Confirmatory factor analysis of the EORTC QLQ-C30 and BR45 to establish dimensions

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          Abstract

          Objectives

          Breast cancer (BrC) and its treatments impair health-related quality of life (HRQoL). Utility is a measure of HRQoL that includes preferences for health outcomes, used in treatment decision-making. Generic preference-based instruments lack BrC-specific concerns, indicating the need for a BrC-specific preference-based instrument. Our objective was to determine dimensions of the European Organisation for Research and Treatment of Cancer (EORTC) general cancer (QLQ-C30) and breast module (BR45) instruments, the first step in our development of the novel Breast Utility Instrument (BUI).

          Methods

          Patients (n = 408) attending outpatient BrC clinics at an urban cancer centre, and representing a spectrum of BrC health states, completed the QLQ-C30 and BR45. We performed confirmatory factor analysis of the combined QLQ-C30 and BR45 using mean-and variance-adjusted unweighted least squares estimation. The hypothesized factor model was based on clinical relevance, item distributions, missing data, item-importance, and internal reliability of dimensions. Models were evaluated based on global and item fit, local areas of strain, and likelihood ratio tests of nested models.

          Results

          Our final model had 10 dimensions: physical and role functioning, emotional functioning, social functioning, body image, pain, fatigue, systemic therapy side effects, sexual functioning and enjoyment, arm and breast symptoms, and endocrine therapy symptoms. Good overall model fit was achieved: χ 2/df: 1.45, Tucker-Lewis index: 0.946, comparative fit index: 0.951, standardized root-mean-square residual: 0.069, root-mean-square error of approximation: 0.033 (0.030–0.037). All items had salient factor loadings ( λ>0.4, p<0.001).

          Conclusions

          We identified important BrC HRQoL dimensions to develop the BUI, a BrC-specific preference-based instrument.

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          Most cited references55

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          lavaan: AnRPackage for Structural Equation Modeling

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            The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

            In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
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              Fit indices in covariance structure modeling: Sensitivity to underparameterized model misspecification.

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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: SoftwareRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: MethodologyRole: SoftwareRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: ResourcesRole: ValidationRole: Writing – review & editing
                Role: Data curationRole: MethodologyRole: Project administrationRole: Writing – review & editing
                Role: Data curationRole: Project administrationRole: Resources
                Role: Formal analysisRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                4 February 2022
                2022
                : 17
                : 2
                : e0262635
                Affiliations
                [1 ] Toronto Health Economics and Technology Assessment (THETA) Collaborative, University Health Network, Toronto, Ontario, Canada
                [2 ] Graduate Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada
                [3 ] Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
                [4 ] Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada
                [5 ] Division of Biostatistics, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
                [6 ] Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
                [7 ] Department of Pharmacology and Toxicology, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada
                University of Bologna, ITALY
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                ‡ AMD and MDK are joint senior authors on this work.

                Author information
                https://orcid.org/0000-0002-9806-9393
                Article
                PONE-D-21-27345
                10.1371/journal.pone.0262635
                8815914
                35120148
                b84723f3-bacc-46a9-b6f1-e55c41a56e46
                © 2022 Tsui et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 24 August 2021
                : 31 December 2021
                Page count
                Figures: 2, Tables: 6, Pages: 23
                Funding
                Funded by: THETA Fund for Excellence
                Award ID: # 5790 6839 0706
                Award Recipient :
                Funded by: Dr. Kathleen Pritchard
                Award Recipient :
                The authors received financial support for patient honoraria from the THETA Fund for Excellence (# 5790 6839 0706), and for the Biomatrix data warehouse from Dr. Kathleen Pritchard’s direct donation.
                Categories
                Research Article
                Medicine and Health Sciences
                Oncology
                Cancer Treatment
                Endocrine Therapy
                Medicine and Health Sciences
                Oncology
                Cancers and Neoplasms
                Breast Tumors
                Breast Cancer
                Medicine and Health Sciences
                Oncology
                Cancer Treatment
                Biology and Life Sciences
                Psychology
                Emotions
                Social Sciences
                Psychology
                Emotions
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Pain
                Medicine and Health Sciences
                Oncology
                Cancer Treatment
                Surgical Oncology
                Medicine and Health Sciences
                Clinical Medicine
                Clinical Oncology
                Surgical Oncology
                Medicine and Health Sciences
                Oncology
                Clinical Oncology
                Surgical Oncology
                Physical Sciences
                Physics
                Classical Mechanics
                Damage Mechanics
                Material Fatigue
                Physical Sciences
                Materials Science
                Materials Physics
                Material Fatigue
                Physical Sciences
                Physics
                Materials Physics
                Material Fatigue
                Medicine and Health Sciences
                Clinical Medicine
                Signs and Symptoms
                Nausea
                Custom metadata
                Data cannot be shared publicly because data access is restricted by patient consent to use their study data. Anonymized data are available and can be obtained with approval of the Chair of the Sunnybrook Research Institute Research Ethics Board (current contact information available at: https://sunnybrook.ca/research/content/?page=sri-crs-reo-home, or telephone: 1-416-480-6100, ext. 88144) and the Chair of the University Health Network Research Ethics Board (current contact information available at: https://www.uhnresearch.ca/content/contacts1, or email: reb@ 123456uhnresearch.ca , telephone: 1- 416-581-7849), and approved institutional data sharing agreements. In Canada, research data are the property of the institution, not the investigators. Request for the data may be sent to the corresponding author ( teresa.tsui@ 123456utoronto.ca ).

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