Adaptation and content validation of a patient-reported measure of treatment burden for use in stroke survivors: the patient experience with treatment and self-management in stroke (PETS-stroke) measure

Purpose: Stroke survivors often live with significant treatment burden yet our ability to examine this is limited by a lack of validated measurement instruments. We aimed to adapt the 60-item, 12-domain Patient Experience with Treatment and Self-Management (PETS) (version 2.0, English) patient-reported measure to create a stroke-specific measure (PETS-stroke) and to conduct content validity testing with stroke survivors. Materials and Methods: Step 1–Adaptation of PETS to create PETS-stroke: a conceptual model of treatment burden in stroke was utilised to amend, remove or add items. Step 2 - Content validation: Fifteen stroke survivors in Scotland were recruited through stroke groups and primary care. Three rounds of five cognitive interviews were audio recorded and transcribed. Framework analysis was used to explore importance/relevance/clarity of PETS-stroke content. COSMIN reporting guidelines were followed. Results: The adapted PETS-stroke had 34 items, spanning 13 domains; 10 items unchanged from PETS, 6 new and 18 amended. Interviews (n = 15) resulted in further changes to 19 items, including: instructions; wording; item location; answer options; and recall period. Conclusions: PETS-stroke has content that is relevant, meaningful and comprehensible to stroke survivors. Content validity and reliability testing are now required. The validated tool will aid testing of tailored interventions to lessen treatment burden. IMPLICATIONS FOR REHABILITATION: Treatment burden is reported by stroke survivors but no stroke-specific measure of treatment burden exists. We adapted an existing measure of treatment burden for use in multimorbid patients (PETS) to create a stroke specific version (PETS-stroke). The items in PETS-stroke are relevant and meaningful to people with stroke. Further testing will examine construct validity, reliability, and useability. This measure will be useful in future RCTs to measure treatment burden and to identify stroke patients who are at high risk of treatment burden.