Trials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).
Qual Life Res
; 28(4): 955-962, 2019 Apr.
Article
em En
| MEDLINE
| ID: mdl-30554370
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Qualidade de Vida
/
Medidas de Resultados Relatados pelo Paciente
Tipo de estudo:
Prognostic_studies
/
Qualitative_research
/
Systematic_reviews
Limite:
Female
/
Humans
/
Male
País/Região como assunto:
Oceania
Idioma:
En
Revista:
Qual Life Res
Assunto da revista:
REABILITACAO
/
TERAPEUTICA
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Austrália