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Development and validation of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF)

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Abstract

Background: The Diabetic Foot Ulcer Scale (DFS) provides comprehensive measurement of the impact of diabetic foot ulcers on patients’ QOL through self-administration of 64 items comprising 15 subscales.

Objective: To develop and evaluate a short form of the DFS (DFS-SF) to reduce patient burden and the number of outcome measures, and to improve sensitivity to change in clinical condition.

Methods: The DFS-SF was created through the analysis of data from a doubleblind, placebo-controlled, randomised trial of the efficacy and safety of becaplermin (recombinant human platelet-derived growth factor BB) in the treatment of chronic, full-thickness, neuropathic, diabetic foot ulcers. Using these data, items demonstrating poor psychometric properties were eliminated. Exploratory factor analyses were then conducted to develop a new, more parsimonious scaling algorithm that optimised the internal consistency of the new subscales. Finally, data from two additional clinical trials were used to assess replicability of the DFS-SF subscale structure.

Results: The DFS-SF contains a total of 29 items comprising six subscales. The results of both confirmatory and exploratory factor analyses provided support for the scaling algorithm. The DFS-SF subscales showed good internal consistency, reliability and construct validity, and demonstrated sensitivity to ulcer healing.

Conclusions: The results of this investigation indicate that the DFS-SF has good psychometric properties and replicability.

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Acknowledgements

This study was funded by Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey, USA.

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Authors and Affiliations

  1. Statistics Research Division, RTI International, Research Triangle Park, 3040 Cornwallis Road, North Carolina, 27709-2194, USA

    Carla M. Bann

  2. RTI Health Solutions, RTI International, Research Triangle Park, North Carolina, USA

    Sheri E. Fehnel

  3. Johnson & Johnson Pharmaceutical Research & Development, Raritan, New Jersey, USA

    Dennis D. Gagnon

Authors
  1. Carla M. Bann
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  2. Sheri E. Fehnel
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  3. Dennis D. Gagnon
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Correspondence to Carla M. Bann.

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Bann, C.M., Fehnel, S.E. & Gagnon, D.D. Development and validation of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF). Pharmacoeconomic 21, 1277–1290 (2003). https://doi.org/10.2165/00019053-200321170-00004

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