Abstract

Qualitative interviews are used to assess understandability and content validity of patient-reported outcomes. However, the common approach of asking patients to paraphrase items may not be sufficient to completely reveal item content as understood by patients. We used qualitative interviews to elicit more detailed information about patients' understanding of treatment goal items for the Patient Benefit Index 2.0 (PBI 2.0). This questionnaire measures patient-relevant benefit from treatments for skin diseases by assessing goal importance prior to and goal attainment after treatment. We interviewed 16 patients with psoriasis, atopic dermatitis, leg ulcers, and vitiligo. Patients were asked to elaborate in detail on their understanding of 15 treatment goal items. Subsequently, they were asked to suggest changes in item wording and to name missing treatment goals. Interview transcripts were analyzed according to an adapted approach of content analysis. The task was easy for the patients to understand, and they shared detailed information on what each goal meant to them. Results of the content analysis induced a range of revisions of the PBI 2.0 items, including changes in wording (four items) and item order (two items). Four items were deleted because they were found to be redundant or irrelevant, and one item was added to the list of treatment goals. Asking patients to elaborate on their item understanding in qualitative interviews provided detailed insight into item content and understandability. This method has helped considerably to improve feasibility and content validity of the PBI 2.0.

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