eCite Digital Repository

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)


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, International Society for Quality of Life Research (ISOQOL), Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR), Quality of Life Research, 27, (10) pp. 2581-2591. ISSN 0962-9343 (2018) [Refereed Article]

Pending copyright assessment - Request a copy

DOI: doi:10.1007/s11136-018-1921-5


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 (20072013) 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.

Item Details

Item Type:Refereed Article
Keywords:patient-reported outcomes, quality of life, clinical trial registration, clinical trial endpoint, patient-reported outcome measures
Research Division:Biomedical and Clinical Sciences
Research Group:Other biomedical and clinical sciences
Research Field:Other biomedical and clinical sciences not elsewhere classified
Objective Division:Health
Objective Group:Evaluation of health and support services
Objective Field:Evaluation of health outcomes
UTAS Author:Roydhouse, J (Dr Jessica Roydhouse)
ID Code:142748
Year Published:2018
Web of Science® Times Cited:6
Deposited By:Menzies Institute for Medical Research
Deposited On:2021-02-10
Last Modified:2021-02-19

Repository Staff Only: item control page