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]
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:||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 Group:||Evaluation of health and support services|
|Objective Field:||Evaluation of health outcomes|
|UTAS Author:||Roydhouse, J (Dr Jessica Roydhouse)|
|Deposited By:||Menzies Institute for Medical Research|
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