Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)
Mercieca Bebber, R and Williams, D and Tait, MA and Roydhouse, J and Busija, L and Sundaram, CS and Langford, A and Rutherford, C and Roberts, N and King, M and Vodicka, E and Devine, B, Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR), Quality of Life Research, 27 pp. 2581-2591. ISSN 1573-2649 (2018) [Refereed Article]
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 of
trials registered with ClinicalTrials.gov (2007–2013) included PROs; however, a regional breakdown was not provided and
no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify
trials 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 coded
using 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 increased
between 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), followed
by 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 review
identifies trial categories with limited patient-reported information and provides a basis for future work on the impact of
PRO findings in clinical care.