The development and validation of the Treatment of Autoimmune Bullous Disease Quality of Life questionnaire, a tool to measure the quality of life impacts of treatments used in patients with autoimmune blistering disease

Authors

Errata

This article is corrected by:

  1. Errata: Erratum Volume 170, Issue 2, 481–483, Article first published online: 18 February 2014

  • Funding sources This study was supported in part by D.F. Murrell, the Australasian Blistering Diseases Foundation and the University of New South Wales Independent Learning and Honours Programs, with grants provided to A.T., S.C., D.F.S., A.M.H., J.W.F., A.D., C.Q.W. and C.L. to work with D.F.M. Premier Specialists Research and Development, Sydney, provided support for nursing staff (L.M.R. and J. Cochrane) and administrative support.
  • Conflicts of interest None declared.

Summary

Background

Treatments for autoimmune blistering diseases have significant risk of medical complications and quality of life impacts during treatment, and it is difficult to differentiate these impacts from disease burden or the effects of treatment.

Objectives

To develop a quality of life instrument specific to the effects of treatments used in patients with autoimmune bullous disease (AIBD).

Methods

A comprehensive item generation process was used to build a 45-item pilot Autoimmune Bullous Disease Quality of Life (ABQOL) questionnaire, distributed to 70 patients with AIBD. Experts in bullous disease refined the pilot ABQOL, selecting only those questions pertaining to the treatment effects. This pilot Treatment of Autoimmune Bullous Disease Quality of Life (TABQOL) questionnaire was administered to 70 patients, before factor analysis was performed to yield the final questionnaire of 17 questions. Validity and reliability were evaluated across a range of indices.

Results

Face and content validity were established through a comprehensive patient interview process, expert review and summaries of treatments used. The questionnaire was found to have appropriate correlation with the Dermatology Life Quality Index (= 0·64) and the level of treatments used (< 0·01), and was found to be responsive to overall variations in treatment burden. The TABQOL was also found to be a reliable instrument as evaluated by internal consistency (Cronbach α = 0·892) and test–retest reliability (= 0·99).

Conclusions

We have shown that the TABQOL questionnaire is a valid and reliable instrument that may to be used to measure treatment burden in AIBD and serve as an end point in clinical trials.

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