Abstract
Purpose
The aim of this study was to examine the acceptability, validity, and reliability of the EuroQoL Five-Dimension Five-Level (EQ-5D-5L) and Short-Form Six-Dimension (SF-6D) health utility measures in patients with symptomatic benign thyroid nodules.
Methods
Data from a randomized controlled trial (ClinicalTrials.gov identifier: NCT02398721) of 294 patients with symptomatic benign thyroid nodules were utilized for this psychometric evaluation of health-related quality of life (HR-QOL) measurement. Three HR-QOL questionnaires—the generic 12-item Short Form Health Survey (SF-12v2), EQ-5D-5L, and SF-6D—were interviewer-administered at baseline and 2 weeks afterwards. Responses to SF-6D were transformed to SF-6D utility scores using a Hong Kong population scoring algorithm derived by standard gamble, whereas responses to EQ-5D-5L were mapped onto EQ-5D-3L response via interim mapping algorithms and then converted to EQ-5D-5L utility scores using a Chinese-specific value set. Construct validity was determined by evaluating Spearman correlation between SF-12v2 scores and utility scores. Two-week test–retest reliability was assessed using intra-class correlation coefficient.
Results
No significant (>15%) floor and ceiling effects were observed for SF-6D utility scores. The SF-6D utility scores had a moderate Spearman rank correlation with the SF-12v2 domain score providing evidence for adequate construct validity. The SF-6D utility scores showed good test–retest reliability (0.794; range 0.696–0.860). Better reliability was observed in SF-6D utility scores than in EQ-5D-5L utility scores.
Conclusions
While the EQ-5D-5L instrument was less reproducible, the SF-6D instrument appeared to be an applicable, valid, and reliable measure in assessing the HR-QOL of Chinese patients with symptomatic benign thyroid nodules. The impact of utility score selection on the effectiveness and cost effectiveness of clinical interventions targeted to these patients needs further exploration.
Clinical trial number and registry
NCT02398721, ClinicalTrials.gov.
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Author contribution
CKHW wrote the manuscript, researched data, and contributed to statistical analysis and interpretation of results. BHHL contributed to the study design, acquisition of data and reviewed/edited the manuscript. HMSY contributed to the acquisition of data and reviewed/edited the manuscript. CLKL reviewed/edited the manuscript.
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Financial support for this study was provided by the Health and Medical Research Fund (HMRF#12132941) of the Food and Health Bureau, HKSAR. The funding agreement ensured the authors independence in designing the study, interpreting the data, writing, and publishing the report.
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Carlos K.H. Wong, Brian H.H. Lang, Hill M.S. Yu, and Cindy L.K. Lam declare they have no conflicts of interest.
Ethical approval
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all individual participants included in the study.
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Wong, C.K.H., Lang, B.H.H., Yu, H.M.S. et al. EQ-5D-5L and SF-6D Utility Measures in Symptomatic benign Thyroid Nodules: Acceptability and Psychometric Evaluation. Patient 10, 447–454 (2017). https://doi.org/10.1007/s40271-017-0220-5
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DOI: https://doi.org/10.1007/s40271-017-0220-5