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

Mercieca-Bebber, R, Williams, D, Tait, M-A, Rutherford, C, Busija, L, Roberts, N, Wilson, M, Sundaram, CS and Roydhouse, J ORCID: 0000-0002-8025-5841 2019 , 'Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)' , Quality of Life Research, vol. 28 , 955–962 , doi: 10.1007/s11136-018-2080-4.

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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 Type: Article
Authors/Creators: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
Keywords: proxy-reported outcomes, quality of life, clinical trial registration, clinical trial endpoint, outcome measures
Journal or Publication Title: Quality of Life Research
Publisher: Kluwer Academic Publ
ISSN: 0962-9343
DOI / ID Number: 10.1007/s11136-018-2080-4
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© Springer Nature Switzerland AG 2018

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