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Psychometric validation of the SF-36® Health Survey in ulcerative colitis: results from a systematic literature review

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Abstract

Purpose

To conduct a systematic literature review of the reliability, construct validity, and responsiveness of the SF-36® Health Survey (SF-36) in patients with ulcerative colitis (UC).

Methods

We performed a systematic search of electronic medical databases to identify published peer-reviewed studies which reported scores from the eight scales and/or two summary measures of the SF-36 collected from adult patients with UC. Study findings relevant to reliability, construct validity, and responsiveness were reviewed.

Results

Data were extracted and summarized from 43 articles meeting inclusion criteria. Convergent validity was supported by findings that 83% (197/236) of correlations between SF-36 scales and measures of disease symptoms, disease activity, and functioning exceeded the prespecified threshold (r ≥ |0.40|). Known-groups validity was supported by findings of clinically meaningful differences in SF-36 scores between subgroups of patients when classified by disease activity (i.e., active versus inactive), symptom status, and comorbidity status. Responsiveness was supported by findings of clinically meaningful changes in SF-36 scores following treatment in non-comparative trials, and by meaningfully larger improvements in SF-36 scores in treatment arms relative to controls in randomized controlled trials. The sole study of SF-36 reliability found evidence supporting internal consistency (Cronbach’s α ≥ 0.70) for all SF-36 scales and test–retest reliability (intraclass correlation coefficient ≥0.70) for six of eight scales.

Conclusions

Evidence from this systematic literature review indicates that the SF-36 is reliable, valid, and responsive when used with UC patients, supporting the inclusion of the SF-36 as an endpoint in clinical trials for this patient population.

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Acknowledgements

This research was funded by Pfizer Incorporated. The authors would like to thank Carla Hernandez for her support of the literature search.

Funding

This study was funded by Pfizer Inc.

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Authors and Affiliations

  1. Optum, 1301 Atwood Avenue, Suite 311N, Johnston, RI, 02919, USA

    Aaron Yarlas, Martha Bayliss & Stephen Maher

  2. Pfizer Inc, Groton, CT, USA

    Joseph C. Cappelleri, Andrew G. Bushmakin & Paul Healey

  3. New York University School of Medicine, New York, NY, USA

    Lea Ann Chen

  4. Pfizer Ltd, Walton Oaks, Augusta, UK

    Alireza Manuchehri

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  1. Aaron Yarlas
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  2. Martha Bayliss
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Correspondence to Aaron Yarlas.

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Conflict of interest

A Yarlas, M Bayliss, and S Maher are employees of Optum, who were contracted by Pfizer Inc. in connection with the conduct of the systematic literature review, interpretation of data, and drafting of this manuscript. Optum may receive revenue from the distribution and licensing of the SF-36 for commercial use. LA Chen is an employee of New York University School of Medicine, which is contracted by Pfizer Inc. to perform consultative services. JC Cappelleri, AG Bushmakin, and A Manuchehri are employees and stockholders of Pfizer Inc. P Healey was an employee and stockholder of Pfizer Inc. at the time this study was conducted and the first draft of this manuscript was developed.

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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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Yarlas, A., Bayliss, M., Cappelleri, J.C. et al. Psychometric validation of the SF-36® Health Survey in ulcerative colitis: results from a systematic literature review. Qual Life Res 27, 273–290 (2018). https://doi.org/10.1007/s11136-017-1690-6

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