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

Rebecca Mercieca-Bebber, Douglas Williams, Margaret Ann Tait, Claudia Rutherford, Lucy Busija, Natasha Roberts, Michelle Wilson, Chindhu Shunmuga Sundaram, Jessica Roydhouse, the International Society for Quality of Life Research (ISOQOL) Australia and New Zealand Special Interest Group

Research output: Contribution to journalArticleResearchpeer-review

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)955-962
Number of pages8
JournalQuality of Life Research
Volume28
Issue number4
DOIs
Publication statusPublished - Apr 2019

Keywords

  • Clinical trial endpoint
  • Clinical trial registration
  • Outcome measures
  • Proxy-reported outcomes
  • Quality of life

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