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

Gallacher, K. I. , Taylor-Rowan, M. , Eton, D. T., McLeod, H. , Kidd, L. , Wood, K., Sardar, A., Quinn, T. J. and Mair, F. S. (2023) Protocol for the development and validation of a patient reported measure (PRM) of treatment burden in stroke. Health Open Research, 5, 17. (doi: 10.12688/healthopenres.13334.1)

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Sardar, Dr Aleema and Kidd, Dr Lisa and Gallacher, Dr Katie and Wood, Miss Karen and Quinn, Professor Terry and Taylor-Rowan, Dr Martin and Mair, Professor Frances and McLeod, Professor Hamish
• Authors: Gallacher, K. I., Taylor-Rowan, M., Eton, D. T., McLeod, H., Kidd, L., Wood, K., Sardar, A., Quinn, T. J., and Mair, F. S.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > General Practice and Primary Care; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Mental Health and Wellbeing; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Nursing and Health Care
• Journal Name: Health Open Research
• Publisher: F1000Research
• ISSN: 2753-6416
• ISSN (Online): 2753-6416
• Copyright Holders: Copyright © 2023 Gallacher KI et al.
• First Published: First published in Health Open Research 5:17
• Publisher Policy: Reproduced under a Creative Commons licence

Project Code	Award No	Project Name	Principal Investigator	Funder's Name	Funder Ref	Lead Dept
313978		Development of a patient reported measure of treatment burden in stroke.	Katie Gallacher	Office of the Chief Scientific Adviser (CSO)	HIPS/21/13	SHW - General Practice & Primary Care
174158		Stroke Association Clinical Lectureship	Katie Gallacher	Stroke Association (STROKEAS)	TSA LECT 2017/01	SHW - General Practice & Primary Care