Cognitive debriefing of the Scleroderma Health Assessment Questionnaire in diffuse cutaneous systemic sclerosis

Area of Science:

• Rheumatology
• Patient-Reported Outcomes
• Systemic Sclerosis Research

Background:

• Systemic sclerosis (scleroderma) significantly impacts patients' quality of life and functional abilities.
• Patient-reported outcome measures (PROMs) are crucial for understanding patient experiences in scleroderma.
• Existing PROMs like the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Scleroderma Health Assessment Questionnaire (S-HAQ) require validation for patient comprehension and content validity.

Purpose of the Study:

• To conduct cognitive debriefing of the Scleroderma Health Assessment Questionnaire (S-HAQ) in patients with diffuse cutaneous systemic sclerosis (dcSSc).
• To assess patient understanding of the HAQ-DI and S-HAQ items and measures.
• To evaluate and ensure the face, item, and content validity of the S-HAQ for systemic sclerosis patients.

Main Methods:

• Cognitive debriefing interviews were performed with 20 patients diagnosed with diffuse cutaneous systemic sclerosis (dcSSc).
• The S-HAQ, comprising the HAQ-DI and four specific scleroderma items, was used for the debriefing process.
• Analysis focused on patient comprehension of concepts, clarity of items, and relevance of symptoms assessed.

Main Results:

• Patients with dcSSc understood the concepts within the HAQ-DI, and its items were clear.
• A majority of participants (60-100%) reported using aids or assistance for daily activities.
• The S-HAQ's systemic sclerosis-specific items were relevant but needed revisions in wording and response scales (e.g., switching from visual analog to numerical rating scales).

Conclusions:

• The HAQ-DI demonstrated content validity, and the S-HAQ's specific items showed item validity.
• Minor modifications to the S-HAQ's instructions, item wording, and rating scales were implemented based on patient feedback.
• Cognitive debriefing confirmed the validity and improved the clarity of the S-HAQ for use in systemic sclerosis research and clinical practice.