The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years

Gates, Allison; Hartling, Lisa; Vandermeer, Ben; Caldwell, Patrina; Contopoulos‐Ioannidis, Despina G.; Curtis, Sarah; Fernandes, Ricardo M; Klassen, Terry P.; Williams, Katrina; Dyson, Michele P

doi:10.1016/j.jpeds.2017.09.014

Cited by 24 publications

(26 citation statements)

References 39 publications

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“…In November 2013, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) for trials published in 2012 19 20. CENTRAL is a comprehensive database of reports of randomised and quasirandomised trials, taken mainly from MEDLINE and Embase 21.…”

Section: Methodsmentioning

confidence: 99%

“…CENTRAL is a comprehensive database of reports of randomised and quasirandomised trials, taken mainly from MEDLINE and Embase 21. As this project was part of an ongoing surveillance initiative,19 the 2012 publication date was chosen because it was 5 years following an earlier evaluation of a random sample of 300 paediatric trials undertaken in 2007 9. The date also coincided with the publication of the StaR Child Health Standards, allowing for the establishment of baseline data for the reporting of priority items outlined within each.…”

Section: Methodsmentioning

confidence: 99%

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Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

Gates

Caldwell

Curtis

et al. 2019

bmjpo

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ObjectivesFor 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints.MethodsFor this cross-sectional evaluation, we randomly selected 300 paediatric trials published in 2012 from the Cochrane Central Register of Controlled Trials. We collected data on the reporting of a DMC; interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. We reported the findings descriptively and stratified by trial characteristics.ResultsEighty-five (28%) of the trials investigated drugs, and 18% (n=55/300) reported a DMC. The reporting of a DMC was more common among multicentre than single centre trials (n=41/132, 31% vs n=14/139, 10%, p<0.001) and industry-sponsored trials compared with those sponsored by other sources (n=16/50, 32% vs n=39/250, 16%, p=0.009). Trials that reported a DMC enrolled more participants than those that did not (median [range]): 224 (10–60480) vs 91 (10–9528) (p<0.001). Only 25% of these trials reported interim analyses, and 42% reported stopping rules. Less than half (n=143/300, 48%) of trials reported on adverse events, and 72% (n=215/300) reported on harm-related endpoints. Trials that reported a DMC compared with those that did not were more likely to report adverse events (n=43/55, 78% vs 100/245, 41%, p<0.001) and harm-related endpoints (n=52/55, 95% vs. 163/245, 67%, p<0.001). Only 32% of drug trials reported a DMC; 18% and 19% did not report on adverse events or harm-related endpoints, respectively.ConclusionsThe reporting of a DMC was infrequent, even among drug trials. Few trials reported stopping rules or interim analyses. Reporting of adverse events and harm-related endpoints was suboptimal.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

Gates

Caldwell

Curtis

et al. 2019

bmjpo

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“…We will leverage a pre-existing sample of child health RCTs published in 2007 (n = 300) [11] extraction, we will substitute it with the next relevant record. We will include the first 300 eligible citations from the randomly ordered list to make the sample size consistent with the previous publications [11,12].…”

Section: Search Strategy and Study Selectionmentioning

confidence: 99%

“…used by our team in previous study of reporting quality of pediatric RCTs to answer our review question: What is the magnitude and direction of change in P-value and Bayesian analysis reported in RCTs in child health research published over 10 years, if any? Details of the search strategy and study selection methods for the sample are available in our previous publications[11,12]. We will replicate thesemethods to identify a comparable sample of child health RCTs published in 2017.…”

mentioning

confidence: 99%

P-value and Bayesian Analysis in Randomized-controlled Trials in Child health Research Published Over Ten Years, 2007 to 2017: A Review Protocol

Aregbesola¹,

Gates²,

Coyle³

et al. 2020

Preprint

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Background: There is an unresolved debate about the reliability of the interpretation of P-value. Some investigators have suggested that an alternative Bayesian method is preferred in conducting health research. As randomized-controlled trials (RCTs) are important in generating research evidence, we decided to investigate the extent, if any, the inferential statistical framework in published RCTs in child health research have changed over 10 years. We aim to examine the change in P-value and Bayesian analysis in RCTs in child health research papers published from 2007 to 2017. Methods: We will search the Cochrane Central Register of Controlled Trials (Wiley) to identify relevant citations. We will leverage a pre-existing sample of child health RCTs published in 2007 (n=300) used in our previous study of reporting quality of pediatric RCTs. Using the same strategy and study selection methods, we will identify a comparable random sample of child health RCTs published in 2017 (n=300). Eligible studies will include RCTs in health research among individuals aged 21 years and below. One reviewer will select studies for inclusion and extract the data and another reviewer will verify these. Disagreements will be resolved by a discussion between reviewers or by involving another reviewer. We will perform a descriptive analysis of 2007 and 2017 samples and analyze the results using both the frequentist and Bayesian methods. Discussion: We will present specific characteristics of the clinical trials from 2007 and 2017 in tabular and graphical forms. We will report the difference in the proportion of P-value and Bayesian analysis between 2007 and 2017 to assess the 10-year change. Clustering around P-values of significance, if observed, will be reported. This review has the potential to help inform the need for a change in the methodological approach from the null hypothesis significance test to Bayesian methods.Systematic review registration: Open Science Framework https://osf.io/aj2df

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“…We read with interest the study from Workman et al 1 They presented the representative hospital expenditures of adolescent idiopathic scoliosis (AIS) surgery, based on a national database. Analyzing 16 992 cases, they noted that the primary contribution for hospital cost was derived from spinal implants.…”

Section: Critical Issues Underlying Expenditures For Adolescent Idiopmentioning

confidence: 99%

Deficiencies in the conduct and reporting of pediatric clinical trials

Moore

Popko

Tao

2018

The Journal of Pediatrics

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Deficiencies in the conduct and reporting of pediatric clinical trials We read with interest the report by Gates et al evaluating deficiencies in the conduct and reporting of randomized, controlled trials in pediatrics. 1 This work appropriately calls attention to limitations in pediatric research related to study design and selective reporting that negatively impact the quality of available evidence. Whether one uses the medical literature to gather information for direct patient care, guideline development, or health policy decision making, it is critical that the evidence be both sound and robust. Our editors routinely perform detailed literature searches to develop care guidelines in strict accordance with the principles of evidence-based medicine. We performed a survey of completed phase III randomized controlled trials for pediatric oncology using ClinicalTrials.gov; of 10 intervention trials that were correctly indexed as phase III randomized controlled trials with completion dates between 2004 and 2016, we were unable to locate peer-reviewed publication of the results of 8 of 10 of the trials using PubMed. This mirrored our past experience searching for peer-reviewed evidence of the pediatric oncology literature. We applaud the sentiments of Marušić and Pranić in their commentary on Gates; an "emphasis on critical appraisal and understanding of evidence" is likely to lead both to better patient care and better research. 2 Improving the quality of healthcare while bending its cost curve depends on having access to high-quality evidence. Our patients and trial participants deserve no less.

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The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years

Cited by 24 publications

References 39 publications

Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis

P-value and Bayesian Analysis in Randomized-controlled Trials in Child health Research Published Over Ten Years, 2007 to 2017: A Review Protocol

Deficiencies in the conduct and reporting of pediatric clinical trials

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