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.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1007/s11136-018-2080-4 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Benefits of specialist palliative care by identifying active ingredients of service composition, structure, and delivery model: A systematic review with meta-analysis and meta-regression.
PLoS Med
August 2024
Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, United Kingdom.
Background: Specialist palliative care (SPC) services address the needs of people with advanced illness. Meta-analyses to date have been challenged by heterogeneity in SPC service models and outcome measures and have failed to produce an overall effect. The best service models are unknown.
View Article and Find Full Text PDFA phase I/II study of ribociclib following radiation therapy in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
J Neurooncol
September 2020
Division of Oncology, Department of Pediatrics College of Medicine, Brain Tumor Center, Cincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Avenue, MLC 7015, Cincinnati, OH, 45209, USA.
Purpose: Cyclin-dependent kinase-retinoblastoma (CDK-RB) pathway is dysregulated in some diffuse intrinsic pontine gliomas (DIPG). We evaluated safety, feasibility, and early efficacy of the CDK4/6-inhibitor ribociclib, administered following radiotherapy in newly-diagnosed DIPG patients.
Methods: Following radiotherapy, eligible patients received ribociclib in 28-day cycles (350 mg/m; 21 days on/7 days off).
Assessment of pediatric asthma exacerbation with the use of new PROMIS measures.
J Asthma
October 2021
Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI, USA.
Objective: Patient reported outcome measures, such as the Patient Reported Outcomes Measurement Information System (PROMIS) may be used to assess patient functioning for asthma and aid in understanding the impact of asthma exacerbation. These domains may be utilized as endpoints in clinical trials and to guide clinical care. The purpose of this study was to determine psychometric properties of the new PROMIS measures for children with asthma, at baseline and with exacerbation.
View Article and Find Full Text PDFTrials with proxy-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR).
Qual Life Res
April 2019
Department of Health Services, Policy & Practice, Brown University School of Public Health, Providence, USA.
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.
View Article and Find Full Text PDFIntramuscular botulinum toxin prior to comprehensive rehabilitation has no added value for improving motor impairments, gait kinematics and goal attainment in walking children with spastic cerebral palsy.
J Rehabil Med
August 2018
Rehabilitation Medicine, Erasmus MC, 3000 CA Rotterdam, The Netherlands.
Objective: Botulinum toxin (BoNT-A) is widely used in combined treatment for spastic cerebral palsy, but its added value preceding comprehensive rehabilitation for motor impairments, gait, and goal attainment has not been studied.
Design: A comparative multi-centre trial, in which two groups underwent comprehensive rehabilitation (i.e.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!