Patient-Reported Outcome Measures of Utilizing Person-Generated Health Data in the Case of Simulated Stroke Rehabilitation: Development Method

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Person-generated health data (PGHD) are health data that people generate, record and analyse for themselves. Although health benefits of PGHD use have been reported, there is no systematic way for patients to measure and report health effects they experience from using their PGHD. Patient-reported outcome measures (PROMs) allow patients to systematically self-report their outcomes of a health care service. They generate first-hand evidence of the impact of health care services, and are able to reflect the real world diversity of actual patients and management approaches. Therefore, this paper argues that a PROM of utilising PGHD, or PROM-PGHD, is necessary to help build evidence-based practice in clinical work with PGHD. Objective: This paper describes a method for developing PROMs for people who are using PGHD in conjunction with their clinical care – ‘PROM-PGHD’, and illustrated through a case study. Methods: The five-step Qualitative Item Review (QIR) method was augmented to guide the development of a PROM-PGHD. However, using QIR as a guide to develop a PROM-PGHD requires additional socio-technical understanding of the PGHD and the health technologies from which they are produced. Therefore the QIR method is augmented for developing a PROM-PGHD, resulting in the PROM-PGHD Development Method. Results: A worked example was used to illustrate how the PROM-PGHD Development Method may be used systematically to develop PROMs applicable across a range of PGHD technology types used in relation with health conditions. Conclusions: This paper is the first to describe, and illustrate a method for developing a PROM-PGHD; which may be applied to many different cases of health conditions and technology categories. It has broad relevance for evidence-based practice in clinical work with PGHD.