Introduction: In recent years, the concept of "disease burden" has been given a central role in evaluating patient care, particularly in skin diseases. Measuring patient-reported outcomes (PRO) such as symptoms and disease burden may be useful.
Aim: To present a methodology that facilitates the development and validation of burden questionnaires for patients suffering from skin diseases.
Methodology: Based on past published burden questionnaires, a methodology for designing skin disease burden questionnaires was to be developed.
Results: Based on 16 burden questionnaires developed and published over the last 10 years, the authors propose a standardized methodology for the easy design and validation of disease burden questionnaires for patients with chronic skin diseases. The authors provide detailed guidance for the conception, development and validation of the questionnaires, including reliability, internal consistency, external validity, cognitive debriefing, testing-retesting, translation and cross-cultural adaptation, as well as for statistical analysis.
Conclusion: The proposed methodology enhances the design and validation of disease burden questionnaires in dermatology. Burden questionnaires may be used in clinical research as well as in daily clinical practice.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7417926 | PMC |
| http://dx.doi.org/10.2147/CCID.S260323 | DOI Listing |
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