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Abstract

Aims: It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs)to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent oftrials registered with ClinicalTrials.gov (2007–2013) included PROs; however, a regional breakdown was not provided andno reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identifytrials registered with ANZCTR with PRO endpoints and describe their characteristics.Methods: ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints.Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and GridEnabled Measures, as well as generic PRO terms (e.g. “quality of life” (QOL)). Trial endpoints were individually codedusing an established framework to identify trials with PROs for the analysis.Results: Of 13,666 registered trials, 6168 (45.1%) included a PRO. The proportion of studies including PROs increasedbetween 2006 and 2016 (r=0.74, p=0.009). Among the 6168 trials, there were 17,961 individual PRO endpoints, including symptoms/functional outcomes/condition-specific QOL (65.6%), generic QOL (13.2%), patient-reported experiences(9.9%), patient-reported behaviours (7.9%). Mental health was the most common category (99.8% included PROs), followedby physical medicine/rehabilitation (65.6%), musculoskeletal (63.5%), public health (63.1%), and cancer (54.2%).Discussion: Our findings suggest growing use of PROs in the assessment of health and interventions in ANZ. Our reviewidentifies trial categories with limited patient-reported information and provides a basis for future work on the impact ofPRO findings in clinical care.

Item Type:	Article
Authors/Creators:	Mercieca-Bebber, R and Williams, D and Tait, M-A and Roydhouse, J and Busija, L and Sundaram, CS and Wilson, M and Langford, A and Rutherford, C and Roberts, N and King, M and Vodicka, E and Devine, B
Keywords:	patient-reported outcomes, quality of life, clinical trial registration, clinical trial endpoint, patient-reported outcome measures
Journal or Publication Title:	Quality of Life Research
Publisher:	Kluwer Academic Publ
ISSN:	0962-9343
DOI / ID Number:	10.1007/s11136-018-1921-5
Copyright Information:	© Springer International Publishing AG, part of Springer Nature 2018
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