eCite Digital Repository

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


Mercieca-Bebber, R and Williams, D and Tait, M-A and Rutherford, C and Busija, L and Roberts, N and Wilson, M and Sundaram, CS and Roydhouse, J, International Society for Quality of Life Research (ISOQOL) Australia and New Zealand Special Interest Group, Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR), Quality of Life Research, 28 pp. 955-962. ISSN 0962-9343 (2019) [Refereed Article]

Pending copyright assessment - Request a copy

DOI: doi:10.1007/s11136-018-2080-4


Aims: A proxy is someone other than a patient who reports a patient's outcomes as if they are the patient. Due to known discordance with patient reports, proxies are often not recommended in clinical trials; however, proxies may be needed in certain research contexts. We aimed to identify and describe trials registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) with proxy-reported endpoints.

Methods: ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with proxy-reported endpoints. Primary and secondary endpoints for each trial retrieved by the search were individually coded (proxy-reported: yes/no), and trials with confirmed proxy-reported endpoints were included in the analysis.

Results: Of 13,666 registered trials, 469 (3.4%) included a proxy-reported endpoint (867 individual proxy-reported endpoints in total: 62% family member proxy, 22% health professional). Proxy endpoint inclusion did not significantly increase over time (r = 0.18, p = 0.59). Mental health (11.5%), stroke (10.3%) and neurological (8.3%) trials had the highest proportion of trials using proxies. Of the 469 trials, 123 (26.2%) studies involved paediatric patients.

Discussion: Proxy-reported endpoints are included in a small but notable number of studies, which may indicate other types of outcomes are used for patients unable to self-report, or that these patients are under-researched.

Item Details

Item Type:Refereed Article
Keywords:proxy-reported outcomes, quality of life, clinical trial registration, clinical trial endpoint, 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:142749
Year Published:2019
Deposited By:Menzies Institute for Medical Research
Deposited On:2021-02-10
Last Modified:2021-02-19

Repository Staff Only: item control page