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Evaluation of the internal and external responsiveness of Short Form-12 Health Survey version 2 (SF-12v2) in patients with type 2 diabetes mellitus

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Abstract

Purpose

The evidence on the responsiveness of the Short Form-12 Health Survey version 2 (SF-12v2) in patients with type 2 diabetes mellitus (T2DM) is limited. The aim of this study was to examine both the internal and external responsiveness of the SF-12 measures in Chinese patients with T2DM.

Methods

A prospective longitudinal observational study was conducted on 1443 T2DM patients managed in public primary care clinics between 2012 and 2013. These patients were surveyed at baseline and at 12 months using SF-12v2. The internal responsiveness was evaluated by linear mixed effect models. Meanwhile, the external responsiveness was tested by multiple linear regression models and receiver operating characteristic (ROC) curve analysis.

Results

The internal responsiveness of the SF-12v2 to detect negative change was satisfactory among T2DM patients in worsened group, but only the general health domain of SF-12v2 could detect positive change among T2DM patients with improved group. For external responsiveness, the SF-12v2 detected a significant difference-in-difference between patients with worsened and stable/improved group, but not between patients with stable and improved group. The areas under the ROC curve for all domains and summary scales of the SF-12v2 were not statistically different from 0.7.

Conclusion

This study showed that the responsiveness of SF-12v2 might not achieve the standard. Despite the wide use of the SF-12v2, we would like to urge that both clinicians and researchers should use it with caution in longitudinal study.

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Acknowledgements

The authors wish to acknowledge the contributions of the Risk Assessment Management Program for Diabetes Mellitus (RAMP-DM) program team at the Hospital Authority head office, and the Chiefs of Service and RAMP-DM program coordinators in each cluster, and the Statistics and Workforce Planning Department at the Hong Kong Hospital Authority.

Funding

This study was funded by the Health Services Research Fund, Food and Health Bureau, HKSAR Commissioned Research on Enhanced Primary Care Study (Ref. No. EPC-HKU-2). No funding organization had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation of the manuscript. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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Author notes

  1. Eric Y. F. Wan and Edmond P. H. Choi have contributed equally to this work.

Authors and Affiliations

  1. Department of Family Medicine and Primary Care, The University of Hong Kong, 3/F Ap Lei Chau Clinic, 161 Main Street, Ap Lei Chau, Hong Kong

    Eric Yuk Fai Wan, Esther Yee Tak Yu, Weng Yee Chin, Colman Siu Cheung Fung, Anca Ka Chun Chan & Cindy Lo Kuen Lam

  2. School of Nursing, The University of Hong Kong, 4/F William MW Mong Block, 21 Sassoon Road, Pokfulam, Hong Kong

    Edmond Pui Hang Choi

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  1. Eric Yuk Fai Wan
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Correspondence to Eric Yuk Fai Wan.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

Ethics approval of this study was granted by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West (UW 10-369), Hong Kong East (HKEC-2010-093), Kowloon East and Kowloon Central (KC/KE-10-0210/ER-3), Kowloon West (KW/EX/10-317 (34-04)), New Territories East (CRE-2010.543), and New Territories West clusters (NTWC/CREC/1091/12). 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.

Informed consent

Written informed consent was obtained from all individual participants included in the study.

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Wan, E.Y.F., Choi, E.P.H., Yu, E.Y.T. et al. Evaluation of the internal and external responsiveness of Short Form-12 Health Survey version 2 (SF-12v2) in patients with type 2 diabetes mellitus. Qual Life Res 27, 2459–2469 (2018). https://doi.org/10.1007/s11136-018-1908-2

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