TY - JOUR
T1 - Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)
AU - Mercieca-Bebber, Rebecca
AU - Williams, Douglas
AU - Tait, Margaret Ann
AU - Rutherford, Claudia
AU - Busija, Lucy
AU - Roberts, Natasha
AU - Wilson, Michelle
AU - Shunmuga Sundaram, Chindhu
AU - Roydhouse, Jessica
AU - the International Society for Quality of Life Research (ISOQOL) Australia and New Zealand Special Interest Group
PY - 2019/4
Y1 - 2019/4
N2 - 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.
AB - 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.
KW - Clinical trial endpoint
KW - Clinical trial registration
KW - Outcome measures
KW - Proxy-reported outcomes
KW - Quality of life
UR - http://www.scopus.com/inward/record.url?scp=85058520904&partnerID=8YFLogxK
U2 - 10.1007/s11136-018-2080-4
DO - 10.1007/s11136-018-2080-4
M3 - Article
AN - SCOPUS:85058520904
SN - 0962-9343
VL - 28
SP - 955
EP - 962
JO - Quality of Life Research
JF - Quality of Life Research
IS - 4
ER -
