How to Include Patient-Reported Outcome Measures in Clinical Trials
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THERAPEUTICS AND MEDICAL MANAGEMENT (S JAN DE BEUR AND B CLARKE, SECTION EDITORS)
How to Include Patient-Reported Outcome Measures in Clinical Trials Richard G. McGee 1,2
# Springer Science+Business Media, LLC, part of Springer Nature 2020
Abstract Purpose of Review Patient-reported outcome measures are increasingly important measures of patient experience, which can increase research robustness, maximise economic value and improve patient outcomes. This review outlines the benefits, challenges and practicalities of incorporating patient-reported outcome measures in clinical trials. Recent Findings Patient-reported outcome measures are often the best way of measuring patient symptoms and quality of life. Patient-reported outcome measures can help reduce observer bias, engage patients in the research process, and inform health service resource planning. A range of tools exist to help facilitate clinicians and researchers in selecting and utilising patient reported outcome measures. Key issues to consider when selecting an appropriate tool include the development, format and psychometric properties of the patient-reported outcome measures. Summary The use of patient-reported outcome measures allow us to better understand the patient experience and their values. A range of tools exist to help facilitate the use of patient-reported outcome measures. This article outlines how we can incorporate patient-reported outcome measures in clinical trials. Keywords Patient-reported outcome measures . Clinical trials . Outcome assessment . Health care . Clinical trial endpoint . Patient-centered care
Introduction Few factors are as important to the design, interpretation and impact of a trial as the choice of outcomes. Most clinicians now recognise the benefits of incorporating the views of patients alongside clinician selected measures of biomedical efficacy. Patient selected and reported outcomes can complement traditional clinician measures of health outcomes and potentially improve patient engagement by reflecting realworld concerns and assist with shared decision-making. In this review, I discuss the rationale, practicalities and pitfalls of including patient-related outcome measures in clinical trials of effectiveness. I outline key definitions of the This article is part of the Topical Collection on Therapeutics and Medical Management * Richard G. McGee [email protected] 1
The Central Coast Clinical School, Faculty of Health and Medicine, The University of Newcastle, Callaghan, NSW 2308, Australia
2
Department of Paediatrics, Gosford Hospital, Holden St, Gosford, NSW 2250, Australia
terminology used in this area in Table 1. An example of “patient-reported outcomes (PROs)” is fatigue, which is measured with “patient-reported outcome measures (PROMs)” such as “The Brief Fatigue Inventory”, which is a measure of the severity and impact of cancer-related fatigue and may be incorporated into a clinical trial [1].
Why Are Patient-Reported Outcomes Relevant? Including PROs in research studies brings a wide r
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