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

journal contribution
posted on 2023-05-20, 20:51 authored by Mercieca-Bebber, R, Williams, D, Tait, M-A, Rutherford, C, Busija, L, Roberts, N, Wilson, M, Sundaram, CS, Jessica RoydhouseJessica Roydhouse

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.

History

Publication title

Quality of Life Research

Volume

28

Pagination

955-962

ISSN

0962-9343

Department/School

Menzies Institute for Medical Research

Publisher

Kluwer Academic Publ

Place of publication

Van Godewijckstraat 30, Dordrecht, Netherlands, 3311 Gz

Rights statement

© Springer Nature Switzerland AG 2018

Repository Status

  • Restricted

Socio-economic Objectives

Evaluation of health outcomes

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