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

Mercieca-Bebber, Rebecca; Williams, Douglas; Tait, Margaret-Ann; Rutherford, Claudia; Busija, Lucy; Roberts, Natasha; Wilson, Michelle; Sundaram, Chindhu Shunmuga; Roydhouse, Jessica

doi:10.1007/s11136-018-2080-4

Cited by 3 publications

(1 citation statement)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The frequency with which ProxROs are used in studies in adult health populations reflects health conditions. For example, a recent review showed that while only 3% of trials registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) from 2005-March 2017 included proxy-reported endpoints, that increased to 11, 10 and 8% of registered mental health, stroke and neurological trials, respectively [14]. Proxy-reported data play an important role in palliative care research [15] and proxies have been utilized in numerous health outcome and care experience surveys [16][17][18][19].…”

Section: Introductionmentioning

confidence: 99%

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

et al. 2021

Self Cite

View full text Add to dashboard Cite

Aims Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. Methods We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. ResultsThe database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. Discussion Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. Systematic review registration PROSPERO No. CRD42018103179 Keywords Proxy measures • Proxy-reported outcomes • Outcome measures • Quality of life • Systematic review * Jessica K. Roydhouse

show abstract

Section: Introductionmentioning

confidence: 99%

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

et al. 2021

Self Cite

View full text Add to dashboard Cite

show abstract

Depression clinical trials worldwide: a systematic analysis of the ICTRP and comparison with ClinicalTrials.gov

Namiot,

Smirnovová,

Sokolov

et al. 2024

Transl Psychiatry

View full text Add to dashboard Cite

Major depressive disorder (MDD), commonly known as depression, affects over 300 million people worldwide as of 2018 and presents a wide range of clinical symptoms. The international clinical trials registry platform (ICTRP) introduced by WHO includes aggregated data from ClinicalTrials.gov and 17 other national registers, making it the largest clinical trial platform. Here we analysed data in ICTRP with the aim of providing comprehensive insights into clinical trials on depression. Applying a novel hidden duplicate identification method, 10,606 depression trials were identified in ICTRP, with ANZCTR being the largest non- ClinicalTrials.gov database at 1031 trials, followed by IRCT with 576 trials, ISRCTN with 501 trials, CHiCTR with 489 trials, and EUCTR with 351 trials. The top four most studied drugs, ketamine, sertraline, duloxetine, and fluoxetine, were consistent in both groups, but ClinicalTrials.gov had more trials for each drug compared to the non-ClinicalTrials.gov group. Out of 9229 interventional trials, 663 unique agents were identified, including approved drugs (74.5%), investigational drugs (23.2%), withdrawn drugs (1.8%), nutraceuticals (0.3%), and illicit substances (0.2%). Both ClinicalTrials.gov and non-ClinicalTrials.gov databases revealed that the largest categories were antidepressive agents (1172 in ClinicalTrials.gov and 659 in non-ClinicalTrials.gov) and nutrients, amino acids, and chemical elements (250 in ClinicalTrials.gov and 659 in non-ClinicalTrials.gov), indicating a focus on alternative treatments involving dietary supplements and nutrients. Additionally, 26 investigational antidepressive agents targeting 16 different drug targets were identified, with buprenorphine (opioid agonist), saredutant (NK2 antagonist), and seltorexant (OX2 antagonist) being the most frequently studied. This analysis addresses 40 approved drugs for depression treatment including new drug classes like GABA modulators and NMDA antagonists that are offering new prospects for treating MDD, including drug-resistant depression and postpartum depression subtypes.

show abstract

Randomized comparative study of child and caregiver responses to three software functions added to the Japanese version of the electronic Pediatric Quality of Life Inventory (ePedsQL) questionnaire

Sato

Sakka

Soejima

et al. 2020

J Patient Rep Outcomes

View full text Add to dashboard Cite

Background: Patient-reported outcomes (PROs) refer to any report of the status of a patient's health condition, health behavior, or experience with healthcare directly from the patient, without interpretation of the patient's response by a clinician or any other external party. While many PROs, such as the Pediatric Quality of Life Inventory (PedsQL), were originally administered in paper-and-pencil format, these are now available as electronic versions (ePROs). Although ePROs might well have used the same structure as their paper versions, we developed an alternate ePedsQL incorporating three software functions: 1) a non-forcing non-response alert, 2) a conditional question branch of the School Functioning Scale that only displays for (pre) school children, and 3) a vertical itemby-item display for small-screen devices. This report evaluated the effect of these functions on item non-response rate, survey completion time, and user experience. Methods: All surveys were conducted via the online/computer mode. We compared the dynamic format containing the three functions with the basic format in a randomized comparative study in 2803 children and 6289 caregivers in Japan. Results: We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = − 4.411, p < 0.001 by generalized linear mixed model analysis). The conditional question branch had mixed effects on survey completion time depending on the respondents' age. Surprisingly, respondents rated the vertical question display for handheld devices less legible than the matrix format. Further, multigroup structural equation modelling revealed that the same configuration for both formats showed an acceptable fit (CFI 0.933, RMSEA 0.060, SRMR 0.038) but the errors of observed variables were larger for the dynamic format than the basic format.

show abstract

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

Cited by 3 publications

References 10 publications

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

Depression clinical trials worldwide: a systematic analysis of the ICTRP and comparison with ClinicalTrials.gov

Randomized comparative study of child and caregiver responses to three software functions added to the Japanese version of the electronic Pediatric Quality of Life Inventory (ePedsQL) questionnaire

Contact Info

Product

Resources

About