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Rebecca Mercieca-Bebber,1 Madeleine T King,2,3 Melanie J Calvert,4,5 Martin R Stockler,1 Michael Friedlander1,6 1NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia; 2Central Clinical School, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia; 3School of Psychology, The University of Sydney, Sydney, NSW, Australia; 4Centre for Patient-Reported Outcomes Research and NIHR Birmingham Biomedical Research Centre, University of Birmingham, Edgbaston, Birmingham, UK; 5Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, UK; 6Prince of Wales Clinical School, University of New South Wales, Sydney, NSW, Australia Abstract: Patient-reported outcomes (PROs) can be included in clinical trials as primary or secondary endpoints and are increasingly recognized by regulators, clinicians, and patients as valuable tools to collect patient-centered data. PROs provide unique information on the impact of a medical condition and its treatment from the patient’s perspective; therefore, PROs can be included in clinical trials to ensure the impact of a trial intervention is comprehensively assessed. This review first discusses examples of how PRO endpoints have added value to clinical trial interpretation. Second, it describes the problems with current practices in designing, implementing, and reporting PRO studies, and how these problems may be addressed by complying with guidance for protocol development, selecting appropriate PRO measures to match clinically motivated PRO hypotheses, minimizing the rates of avoidable missing PRO data, analyzing and interpreting PRO data, and transparently reporting PRO findings. Keywords: patient-reported outcomes, quality of life, trial conduct, research practices, clinical trials as topic |
