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Gepubliceerd in: Quality of Life Research 4/2019

15-12-2018 | Brief Communication

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

Auteurs: 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

Gepubliceerd in: Quality of Life Research | Uitgave 4/2019

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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.
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Metagegevens
Titel
Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)
Auteurs
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
Publicatiedatum
15-12-2018
Uitgeverij
Springer International Publishing
Gepubliceerd in
Quality of Life Research / Uitgave 4/2019
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-018-2080-4