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

Abstract

Background: Systemic sclerosis (scleroderma) is associated with functional disability and poor quality of life. Patient-reported outcome measures provide valuable insights into patients' experiences, symptoms, and perceptions of their health. The Health Assessment Questionnaire-Disability Index (HAQ-DI) and the Scleroderma Health Assessment Questionnaire (S-HAQ) are widely used patient-reported outcome measures in scleroderma research and clinical care. However, there is lack of data to (a) ensure and document patients with systemic sclerosis understand the concepts contained in these measure and (b) demonstrate face, item, and content validity for these items and measures.

Methods: We conducted cognitive debriefing of the S-HAQ in patients with diffuse cutaneous systemc sclerosis (dcSSc). The S-HAQ includes the HAQ-DI, a 20-item questionnaire that assesses functional ability for performing day-to-day activities, four systemic sclerosis-specific items that assess scleroderma symptoms, and one item on overall scleroderma-related limitations.

Results: The total sample of patients with dcSSc (N = 20) had a mean age of 57.6 years and average disease duration of 3.4 years. For the HAQ-DI, the participants understood the concepts and the items were clear. In addition, majority (60%-100%) of participants reported using aids and devices to perform activities of daily living and/or utilizing assistance from another person. The systemic sclerosis-specific items of the S-HAQ were relevant to participants but required revisions to item wording and response options, including a change from the visual analog scales to numerical rating scales.

Conclusion: The HAQ-DI and S-HAQ systemic sclerosis-specific items demonstrated content and item validity, respectively. Several minor modifications were made to the S-HAQ instructions, item wording, and rating scales.