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

Citation

Mercieca Bebber, R and Williams, D and Tait, MA and Rutherford, C and Busija, L and Roberts, N and Wilson, M and Sundaram, CS and Roydhouse, J, Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR), Quality of Life Research, 28 pp. 955-962. ISSN 1573-2649 (2019) [Refereed Article]

Copyright Statement

© Springer Nature Switzerland AG 2018

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

Abstract

Aims A proxy is someone other than a patient who reports a patientís 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:clinical trial, proxy, outcomes
Research Division:Health Sciences
Research Group:Health services and systems
Research Field:Health services and systems not elsewhere classified
Objective Division:Health
Objective Group:Evaluation of health and support services
Objective Field:Evaluation of health outcomes
ID Code:137359
Year Published:2019
Deposited By:Menzies Institute for Medical Research
Deposited On:2020-02-11
Last Modified:2020-08-24
Downloads:0

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