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

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. 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. The adapted PETS-stroke had 34 items, spanning 13 domains; 10 items unchanged from PETS, 6 new and 18 amended. Interviews (<i>n</i> = 15) resulted in further changes to 19 items, including: instructions; wording; item location; answer options; and recall period. 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. 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. 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.

卒中幸存者往往承受着沉重的治疗负担，但目前由于缺乏经过验证的测量工具，我们对该负担的研究能力受到极大限制。
本研究旨在对包含60个条目、涵盖12个维度的患者治疗与自我管理体验量表（Patient Experience with Treatment and Self-Management，简称PETS，2.0英文原版）这一患者报告结局测量工具进行调适，以开发卒中专用版量表（PETS-stroke），并针对卒中幸存者开展内容效度检验。
步骤1：PETS量表调适以开发PETS-stroke：本研究借助卒中治疗负担的概念模型，对条目进行修订、删除与新增。
步骤2：内容效度检验：通过卒中互助团体与基层医疗渠道招募了苏格兰地区的15名卒中幸存者。开展3轮共15次认知访谈，对访谈过程进行录音并转录文本。采用框架分析法探讨PETS-stroke各条目的重要性、相关性与清晰度，研究严格遵循健康测量工具研究报告规范（COSMIN）。
调适后的PETS-stroke共包含34个条目，涵盖13个维度；其中10个条目直接沿用原PETS量表，6个为新增条目，18个为修订条目。
本次访谈（n=15）进一步对19个条目进行了调整，调整内容包括：指导语、表述措辞、条目编排、应答选项与回忆时限。
PETS-stroke的条目内容对于卒中幸存者而言具备相关性、意义性与可理解性。目前仍需开展内容效度与信度检验。该经验证的工具将有助于评估旨在减轻治疗负担的个性化干预措施效果。
卒中幸存者自述存在治疗负担，但目前尚无卒中专用的治疗负担测量工具。
本研究对一款适用于多病共存患者的现有治疗负担测量工具（PETS）进行调适，开发出卒中专用版量表（PETS-stroke）。
PETS-stroke的条目内容对于卒中患者而言具备相关性与意义性。
后续仍需开展结构效度、信度与可用性检验。
该量表将在未来的随机对照试验（Randomized Controlled Trial，简称RCT）中，用于测量治疗负担并识别出存在高治疗负担风险的卒中患者。
卒中幸存者自述存在治疗负担，但目前尚无卒中专用的治疗负担测量工具。本研究对一款适用于多病共存患者的现有治疗负担测量工具（PETS）进行调适，开发出卒中专用版量表（PETS-stroke）。PETS-stroke的条目内容对于卒中患者而言具备相关性与意义性。后续仍需开展结构效度、信度与可用性检验。该量表将在未来的RCT中，用于测量治疗负担并识别出存在高治疗负担风险的卒中患者。