Information on adverse events in randomised clinical trials assessing drug interventions published in four medical journals with high impact factors

2014 ◽  
Vol 26 (1) ◽  
pp. 9-22 ◽  
Author(s):  
Cátia Bauer Maggi ◽  
Isabel Heinzmann Griebeler ◽  
Tatiane da Silva Dal Pizzol
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
High Impact ◽  
Randomised Clinical Trials ◽  
Impact Factors ◽  
Medical Journals ◽  
Drug Interventions

scholarly journals A review of trauma and orthopaedic randomised clinical trials published in high-impact general medical journals

2021 ◽  
Author(s):  
Luke Farrow ◽  
William T. Gardner ◽  
Andrew D. Ablett ◽  
Vladislav Kutuzov ◽  
Alan Johnstone
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Trial Design ◽  
Sample Size Calculation ◽  
High Impact ◽  
Risk Of Bias ◽  
Randomised Clinical Trials ◽  
Medical Journals ◽  
General Medical Journals

Abstract Introduction The recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in “the big five” general medical journals. The quality of this research has, however, not yet been established. Methods We therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010–April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool. Results A total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias. Conclusions These findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted. Level of evidence Level 1.

scholarly journals SYSTEMATIC REVIEW PROTOCOL: The reporting standards of Randomised Clinical Trials in leading medical journals between 2019-2020

2020 ◽  
Author(s):  
Mairead McErlean ◽  
Jack Samways ◽  
Peter Godolphin ◽  
Yang Chen
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Specialty ◽  
Randomised Clinical Trials ◽  
Reporting Standards ◽  
Systematic Review Protocol ◽  
Quality Of Reporting ◽  
Medical Journals ◽  
Review Protocol

This is a systematic review protocol which outlines the basis and methodology for our intended review which at the time of writing is in the study screening phase. Our aim is to answer the fundamental questions:To systematically identify RCTs published in the four leading medical journals between January 1st 2019 to May 31st 2020.To assess the quality of reporting of such RCTs using the CONSORT 2010 statement.To identify any association with medical specialty or size or type of RCT and the rate of adherence to the CONSORT 2010 statement.

Assessing assumptions for statistical analyses in randomised clinical trials

2019 ◽  
Vol 24 (5) ◽  
pp. 185-189 ◽  
Author(s):  
Emil Eik Nielsen ◽  
Anders Kehlet Nørskov ◽  
Theis Lange ◽  
Lehana Thabane ◽  
Jørn Wetterslev ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Statistical Methods ◽  
Statistical Power ◽  
Current Practice ◽  
Statistical Analyses ◽  
Randomised Clinical Trials ◽  
Validity Of Results ◽  
Medical Journals ◽  
Statistical Assumptions

In order to ensure the validity of results of randomised clinical trials and under some circumstances to optimise statistical power, most statistical methods require validation of underlying statistical assumptions. The present paper describes how trialists in major medical journals report tests of underlying statistical assumptions when analysing results of randomised clinical trials. We also consider possible solutions how to improve current practice by adequate reporting of tests of underlying statistical assumptions. We conclude that there is a need to reach consensus on which underlying assumptions should be assessed, how these underlying assumptions should be assessed and what should be done if the underlying assumptions are violated.

scholarly journals Effects of adding ivabradine to usual care in patients with angina pectoris: a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis

Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001288
Author(s):  
Mathias Maagaard ◽  
Emil Eik Nielsen ◽  
Naqash Javaid Sethi ◽  
Liang Ning ◽  
Si-hong Yang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Angina Pectoris ◽  
Adverse Events ◽  
Sequential Analysis ◽  
Randomised Clinical Trials ◽  
Trial Sequential Analysis ◽  
Serious Adverse Events ◽  
All Cause Mortality ◽  
Artery Disease

ObjectiveTo determine the impact of ivabradine on outcomes important to patients with angina pectoris caused by coronary artery disease.MethodsWe conducted a systematic review. We included randomised clinical trials comparing ivabradine versus placebo or no intervention for patients with angina pectoris due to coronary artery disease published prior to June 2020. We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane methodology, Trial Sequential Analysis, Grading of Recommendations Assessment, Development, and Evaluation, and our eight-step procedure. Primary outcomes were all-cause mortality, serious adverse events and quality of life.ResultsWe included 47 randomised clinical trials enrolling 35 797 participants. All trials and outcomes were at high risk of bias. Ivabradine compared with control did not have effects when assessing all-cause mortality (risk ratio [RR] 1.04; 95% CI 0.96 to 1.13), quality of life (standardised mean differences −0.05; 95% CI −0.11 to 0.01), cardiovascular mortality (RR 1.07; 95% CI 0.97 to 1.18) and myocardial infarction (RR 1.03; 95% CI 0.91 to 1.16). Ivabradine seemed to increase the risk of serious adverse events after removal of outliers (RR 1.07; 95% CI 1.03 to 1.11) as well as the following adverse events classified as serious: bradycardia, prolonged QT interval, photopsia, atrial fibrillation and hypertension. Ivabradine also increased the risk of non-serious adverse events (RR 1.13; 95% CI 1.11 to 1.16). Ivabradine might have a statistically significant effect when assessing angina frequency (mean difference (MD) 2.06; 95% CI 0.82 to 3.30) and stability (MD 1.48; 95% CI 0.07 to 2.89), but the effect sizes seemed minimal and possibly without any relevance to patients, and we identified several methodological limitations, questioning the validity of these results.ConclusionOur findings do not support that ivabradine offers significant benefits on patient important outcomes, but rather seems to increase the risk of serious adverse events such as atrial fibrillation and non-serious adverse events. Based on current evidence, guidelines need reassessment and the use of ivabradine for angina pectoris should be reconsidered.PROSPERO registration numberCRD42018112082.

scholarly journals A systematic assessment of Cochrane reviews and systematic reviews published in high-impact medical journals related to cancer

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020869 ◽  
Author(s):  
Marius Goldkuhle ◽  
Vikram M Narayan ◽  
Aaron Weigl ◽  
Philipp Dahm ◽  
Nicole Skoetz
Keyword(s):  
Systematic Reviews ◽  
Methodological Quality ◽  
Grey Literature ◽  
High Impact ◽  
Impact Factors ◽  
High Impact Journal ◽  
Eligibility Criteria ◽  
Medical Journals ◽  
Cochrane Reviews ◽  
Meta Analyses

ObjectiveTo compare cancer-related systematic reviews (SRs) published in the Cochrane Database of SRs (CDSR) and high-impact journals, with respect to type, content, quality and citation rates.DesignMethodological SR with assessment and comparison of SRs and meta-analyses. Two authors independently assessed methodological quality using an Assessment of Multiple Systematic Reviews (AMSTAR)-based extraction form. Both authors independently screened search results, extracted content-relevant characteristics and retrieved citation numbers of the included reviews using the Clarivate Analytics Web of Science database.Data sourcesCancer-related SRs were retrieved from the CDSR, as well as from the 10 journals which publish oncological SRs and had the highest impact factors, using a comprehensive search in both the CDSR and MEDLINE.Eligibility criteria for selecting studiesWe included all cancer-related SRs and meta-analyses published from January 2011 to May 2016. Methodological SRs were excluded.ResultsWe included 346 applicable Cochrane reviews and 215 SRs from high-impact journals. Cochrane reviews consistently met more individual AMSTAR criteria, notably with regard to an a priori design (risk ratio (RR) 3.89; 95% CI 3.10 to 4.88), inclusion of the grey literature and trial registries (RR 3.52; 95% CI 2.84 to 4.37) in their searches, and the reporting of excluded studies (RR 8.80; 95% CI 6.06 to 12.78). Cochrane reviews were less likely to address questions of prognosis (RR 0.04; 95% CI 0.02 to 0.09), use individual patient data (RR 0.03; 95% CI 0.01 to 0.09) or be based on non-randomised controlled trials (RR 0.04; 95% CI 0.02 to 0.09). Citation rates of Cochrane reviews were notably lower than those for high-impact journals (Cochrane reviews: mean number of citations 6.52 (range 0–143); high-impact journal SRs: 74.45 (0–652)).ConclusionsWhen comparing cancer-related SRs published in the CDSR versus those published in high-impact medical journals, Cochrane reviews were consistently of higher methodological quality, but cited less frequently.

scholarly journals Publication Trends of Pediatric and Adult Randomized Controlled Trials in General Medical Journals, 2005–2018: A Citation Analysis

Children ◽  
2020 ◽  
Vol 7 (12) ◽  
pp. 293
Author(s):  
Michael L. Groff ◽  
Martin Offringa ◽  
Abby Emdin ◽  
Quenby Mahood ◽  
Patricia C. Parkin ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Pediatric Patients ◽  
Web Of Science ◽  
High Impact ◽  
Impact Factors ◽  
Controlled Trials ◽  
Publication Trends ◽  
Medical Journals ◽  
Randomized Controlled ◽  
General Medical Journals

Policy has been developed to promote the conduct of high-quality pediatric randomized controlled trials (RCTs). Whether these strategies have influenced publication trends in high-impact journals is unknown. We aim to evaluate characteristics, citation patterns, and publication trends of pediatric RCTs published in general medical journals (GMJs) compared with adult RCTs over a 13-year period. Studies were identified using Medline, and impact metrics were collected from Web of Science and Scopus. All RCTs published from 2005–2018 in 7 GMJs with the highest impact factors were identified for analysis. A random sample of matched pediatric and adult RCTs were assessed for publication characteristics, academic and non-academic citation. Citations were counted from publication until June 2019. Among 4146 RCTs, 2794 (67.3%) enrolled adults, 591 (14.2%) enrolled children, and 761 RCTs (18.3%) enrolled adult and pediatric patients. Adult RCTs published in GMJs grew by 5.1 publications per year (95% CI: 3.3–6.9), while the number of pediatric RCTs did not show significant change (−0.4 RCTs/year, 95% CI: −1.4–0.6). Adult RCTs were cited more than pediatric RCTs (median(IQR): 29.9 (68.5–462.8) citations/year vs. 13.2 (6.8–24.9) citations/year; p < 0.001); however, social media attention was similar (median(IQR) Altmetric Attention Score: 37 (13.75–133.8) vs. 26 (6.2–107.5); p = 0.25). Despite policies which may facilitate conduct of pediatric RCTs, the publishing gap in high-impact GMJs is widening.

Efficacy and safety of diosmectite in acute childhood diarrhoea: a meta-analysis

2015 ◽  
Vol 100 (7) ◽  
pp. 704-712 ◽  
Author(s):  
Rashmi Ranjan Das ◽  
Jhuma Sankar ◽  
Sushree Samiksha Naik
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Outcome Measures ◽  
Meta Analysis ◽  
Acute Diarrhoea ◽  
Randomised Clinical Trials ◽  
Secondary Outcome ◽  
Future Research ◽  
Open Label ◽  
Childhood Diarrhoea

ObjectiveWe evaluated the role of diosmectite as an add-on treatment to the ‘recommended treatment’ of acute diarrhoea in children.MethodsWe searched all published literature through the major databases: Medline via Ovid, PubMed, CENTRAL, Embase and Google Scholar till May 2014. Randomised clinical trials comparing diosmectite versus placebo were included (PROSPERO registration: CRD42014013783).Main outcome measuresThe primary outcome measures were duration of acute diarrhoea (h), and day-to-day cure rates (%). The secondary outcome measures were stool output (volume), stool output (frequency) and adverse events.ResultsOf 384 citations retrieved, a total of 13 randomised clinical trials (2164 children, 1–60 months old) were included in the meta-analysis. A dose of 3–6 grams per day of diosmectite was given for a duration from 3 days until recovery. Compared with placebo, diosmectite significantly decreased the duration of acute diarrhoea (mean difference, −23.39; 95% CI −28.77 to −18.01), and increased the cure rate (%) at day 5 (OR, 4.44; 95% CI 1.66 to 11.84), without any increases in the risk of adverse events. Diosmectite was effective in all types of acute childhood diarrhoea except dysentery. Because, most of the trials were open-label, and there was a high possibility of publication bias, the GRADE evidence generated was of ‘low quality’.ConclusionsDiosmectite may be a useful additive in the treatment of acute childhood diarrhoea. As the evidence generated was of ‘low quality’, future research is needed with higher quality designs before any firm recommendations can be made.Trial registration numberPROSPERO registration: CRD42014013783.

scholarly journals Magnitude of effects in clinical trials published in high-impact general medical journals

2011 ◽  
Vol 40 (5) ◽  
pp. 1280-1291 ◽  
Author(s):  
Konstantinos CM Siontis ◽  
Evangelos Evangelou ◽  
John PA Ioannidis
Keyword(s):  
Clinical Trials ◽  
High Impact ◽  
Medical Journals ◽  
General Medical Journals

scholarly journals Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals

2020 ◽  
Vol 17 (5) ◽  
pp. 552-559
Author(s):  
Nicolas A Bamat ◽  
Osayame A Ekhaguere ◽  
Lingqiao Zhang ◽  
Dustin D Flannery ◽  
Sara C Handley ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
High Impact ◽  
Adherence Rate ◽  
Trial Protocol ◽  
Medical Journals ◽  
Protocol Adherence ◽  
Noninferiority Trials ◽  
Superiority Trials

Background/aims: Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation. Methods: We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively. Results: Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4–96.7] and 89.8 [83.6–95.2], respectively; P = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3–46.3), P < 0.001. Conclusion: Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.

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