Trial registration in pediatric surgery trials

Rokhsefat, Sana; Morra, Deanna E.; Offringa, Martin; Askie, Lisa; Kelly, Lauren

doi:10.1016/j.jpedsurg.2017.10.049

Cited by 4 publications

(5 citation statements)

References 17 publications

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“…Compliance in prospective registration of our included and unique randomised trials with valid registration and enrolment dates was 41.7%. Our results differ from those of other studies, which reported between 3.6% and 77% compliance in prospective trial registration 21822232425262728293031323334353637383940…”

Section: Discussioncontrasting

confidence: 99%

“…Our study showed higher overall compliance (71.2%) with reporting the trial registration number (TRN) in published trial papers compared with seven other studies reporting a compliance from 26% to 68% 2171819202122. These studies were limited in scope, with a substantially smaller size; between 54 and 317 included trials (see supplementary appendix O).…”

Section: Discussionmentioning

confidence: 55%

“…In several studies, compliance with inclusion of a TRN in trial publications was between 26.0% and 95.8% 217181920212223…”

Section: Introductionmentioning

confidence: 99%

“…Compliance with the prospective registration of RCTs was reported to be between 3.6% and 77.0% in a number of studies 21822232425262728293031323334353637383940. These studies were, however, limited in scope and included trials published in a specific group of journals, trials of a specific treatment or condition, or trials registered in a specific trial registry or a small group of trial registries.…”

Section: Introductionmentioning

confidence: 99%

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Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Al-Durra

Nolan

Seto

et al. 2020

BMJ

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Objectives To evaluate the compliance with prospective registration and inclusion of the trial registration number (TRN) in published randomised controlled trials (RCTs), and to analyse the rationale behind, and detect selective registration bias in, retrospective trial registration. Design Cross sectional analysis. Data sources PubMed, the 17 World Health Organization’s trial registries, University of Toronto library, International Committee of Medical Journal Editors (ICMJE) list of member journals, and the InCites Journal Citation Reports. Study selection criteria RCTs registered in any WHO trial registry and published in any PubMed indexed journal in 2018. Results This study included 10 500 manuscripts published in 2105 journals. Overall, 71.2% (7473/10500) reported the TRN and 41.7% (3013/7218) complied with prospective trial registration. The univariable and multivariable analyses reported significant relations (P<0.05) between reporting the TRN and the impact factor and ICMJE membership of the publishing journal. A significant relation (P<0.05) was also observed between prospective trial registration and the registry, region, condition, funding, trial size, interval between paper registration and submission dates, impact factor, and ICMJE membership of the publishing journal. A manuscript published in an ICMJE member journal was 5.8 times more likely to include the TRN (odds ratio 5.8, 95% confidence interval 4.0 to 8.2), and a published trial was 1.8 times more likely to be registered prospectively (1.8, 1.5 to 2.2) when published in an ICMJE member journal compared with other journals. This study detected a new form of bias, selective registration bias, with a higher proportion (85.2% (616/723)) of trials registered retrospectively within a year of submission for publication. Higher rates of retrospective registrations were observed within the first three to eight weeks after enrolment of study participants. Within the 286 RCTs registered retrospectively and published in an ICMJE member journal, only 2.8% (8/286) of the authors included a statement justifying the delayed registration. Reasons included lack of awareness, error of omission, and the registration process taking longer than anticipated. Conclusions This study found a high compliance in reporting of the TRN for trial papers published in ICMJE member journals, but prospective trial registration was low.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussionmentioning

confidence: 55%

“…In several studies, compliance with inclusion of a TRN in trial publications was between 26.0% and 95.8% 217181920212223…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Al-Durra

Nolan

Seto

et al. 2020

BMJ

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“…This might be in connection with the strict regulations surrounding drug trials. Differences in protocol quality ( 19 ) registration and publication tendencies were described already in previous publications ( 20 , 21 ), between trials with regulated and non-regulated interventions.…”

Section: Discussionmentioning

confidence: 60%

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Baasan

Freihat

Nagy

et al. 2022

Front. Cardiovasc. Med.

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BackgroundAll randomized-controlled trials (RCTs) are required to follow high methodological standards. In this study, we aimed to assess the methodological quality of published cardiovascular clinical research trials in a representative sample of RCTs published in 2017.MethodsCochrane Central Register of Controlled Trials was used to identify cardiovascular clinical research trials with adult participants published in 2017. Overall, 250 (10%) RCTs were randomly selected from a total of 2,419 studies. Data on general trial characteristics were extracted and the risk of bias (RoB) was determined.ResultsOverall, 86% of RCTs have reported at least one statistically significant result, with the primary outcome significant in 69%, treatment favored in 55%, and adverse events reported in 68%. Less than one-third (29%) of trials were overall low RoB, while the other two-thirds were rated unclear (40%) or with high RoB (31%). Sequence generation, allocation concealment, and selective reporting were the domains most often rated with high RoB. Drug trials were more likely to have low RoB than non-drug trials. Significant differences were found in RoB for the allocation concealment and blinding of participants and personnel between industry-funded and non-industry-funded trials, with industry-funded trials more often rated at low RoB.ConclusionAlmost two-thirds of RCTs in the field of cardiovascular disease (CVD) research, were at high or unclear RoB, indicating a need for more rigorous trial planning and conduct. Prospective trial registration is a factor predicting a lower risk of bias.

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Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study

Lohner

Gryaznov

Niederhäusern

et al. 2021

Journal of Clinical Epidemiology

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Trial registration in pediatric surgery trials

Cited by 4 publications

References 17 publications

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Prospective registration and reporting of trial number in randomised clinical trials: global cross sectional study of the adoption of ICMJE and Declaration of Helsinki recommendations

Methodological Quality and Risk of Bias Assessment of Cardiovascular Disease Research: Analysis of Randomized Controlled Trials Published in 2017

Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study

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