Protocol for the development and validation of a patient reported measure (PRM) of treatment burden in stroke

Katie I Gallacher; Martin Taylor-Rowan; David T Eton; Hamish McLeod; Lisa Kidd; Karen Wood; Aleema Sardar; Terry J Quinn; Frances S Mair

doi:10.12688/healthopenres.13334.2

Protocol for the development and validation of a patient reported measure (PRM) of treatment burden in stroke

Health Open Res. 2023 Oct 12:5:17. doi: 10.12688/healthopenres.13334.2. eCollection 2023.

Authors

Katie I Gallacher¹, Martin Taylor-Rowan¹, David T Eton², Hamish McLeod³, Lisa Kidd⁴, Karen Wood¹, Aleema Sardar⁵, Terry J Quinn⁶, Frances S Mair¹

Affiliations

¹ General Practice and Primary Care, University of Glasgow, Glasgow, Scotland, G12 8TB, UK.
² Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, USA.
³ Mental Health and Wellbeing, Gartnavel Royal Hospital, Glasgow, Scotland, G12 0XH, UK.
⁴ Department of Nursing and Community Health, Glasgow Caledonian University, Glasgow, Scotland, G40BA, UK.
⁵ School of Medicine, University of Glasgow, Glasgow, Scotland, UK.
⁶ Institute of Cardiovascular and Metabolic sciences, University of Glasgow, Glasgow, Scotland, UK.

Abstract

Background: Treatment burden is the workload of healthcare for people with long-term conditions and the impact on wellbeing. A validated measure of treatment burden after stroke is needed. We aim to adapt a patient-reported measure (PRM) of treatment burden in multimorbidity, PETS (Patient Experience with Treatment and Self-Management version 2.0), to create a stroke-specific measure, PETS-stroke. We aim to examine content validity, construct validity, reliability and feasibility in a stroke survivor population.

Methods: 1) Adaptation of 60-item PETS to PETS-stroke using a taxonomy of treatment burden. 2) Content validity testing through cognitive interviews that will explore the importance, relevance and clarity of each item. 3) Evaluation of scale psychometric properties through analysis of data from stroke survivors recruited via postal survey (n=340). Factor structure will be tested with confirmatory factor analysis and Cronbach's alpha will be used to index internal consistency. Construct validity will be tested against: The Stroke Southampton Self-Management Questionnaire; The Satisfaction with Stroke Care Measure; and The Shortened Stroke Impact Scale. We will explore known-groups validity by exploring the association between treatment burden, socioeconomic deprivation and multimorbidity. Test-retest reliability will be examined via re-administration after 2 weeks. Acceptability and feasibility of use will be explored via missing data rates and telephone interviews with 30 participants.

Conclusions: We aim to create a validated PRM of treatment burden after stroke. PETS-stroke is designed for use as an outcome measure in clinical trials of stroke treatments and complex interventions to ascertain if treatments are workable for patients in the context of their everyday lives.

Keywords: PETS-stroke; Stroke; Treatment Burden; Validity.

Grants and funding

The project is funded by the Chief Scientist Office (CSO) Scotland (HIPS/21/13) and the Stroke Association (TSA LECT 2017_01).