Quality of reporting of randomized controlled trials in polycystic ovary syndrome

Partsinevelou, Anna; Zintzaras, Elias

doi:10.1186/1745-6215-10-106

Cited by 19 publications

(11 citation statements)

References 42 publications

(57 reference statements)

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“…This is in stark contrast to the overall landscape in the literature in which RCTs in general are being published at an approximate rate of 200 per week, according to an estimate in the year 2000; neurosurgery clearly lags behind. 26 In terms of the quality of reporting, however, similar analyses to ours have identified significant deficiencies in other specialties such as oncology, 15,24 gynecology, 21 orthopedic surgery, 5,23 and plastic surgery.…”

Section: Discussionmentioning

confidence: 66%

Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered?

Mansouri

Cooper

Shin

et al. 2016

JNS

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(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014) was conducted. The medical subject heading (MeSH) terms used in the search included: "neurosurgery" OR "neurosurgical procedure," "brain neoplasms," "infarction" and "decompression," "carotid stenosis," "cerebral hemorrhage," and "spinal fusion." These studies were limited to RCTs, in humans, and in the English language. The Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scales were used to assess the quality of RCT design and reporting. The standardized median times cited (median citations divided by years since publication) were used to assess impact. A pragmatic-explanatory continuum indicator summary-based scale was used to assess the design of the studies as primarily pragmatic or explanatory. results Sixty-one articles were identified, and the following subspecialties were the most common: vascular (23, 37%), followed by functional neurosurgery and neurooncology (both 13, 21%). The following nations were the primary leaders in RCTs: US (25 studies, 41%), Germany (8 studies, 13%), and the United Kingdom (7 studies, 11%). Median sample size was 100 (interquartile range [IQR] 41.5-279). The majority of the studies (40, 66%) had pragmatic objectives. The median number of times cited overall was 69 . The combined median CONSORT score was 36 (IQR 27.5-39). Blinding was most deficiently reported. Other areas with a relatively low quality of reporting were sample size calculation (34.2% of surgical, 38.5% of drug, and 20% of device studies), allocation concealment (28.9% of surgical, 23.1% of drug, and 50% of device studies), and protocol implementation (18.4% of surgical, 23% of drug, and 20% of device studies). The quality of reporting did not correlate with the study impact. All studies had a median Jadad score ≤ 3. Thirty-three pragmatic studies (83%) and 5 explanatory studies (25%) met the design objectives. All pragmatic studies based on drug and device trials met their objectives, while 74% of pragmatic surgical trials met their objectives. coNclusioNs The prevalence of neurosurgical RCTs is low. The quality of RCT design and reporting in neurosurgery is also low. Many study designs are not compatible with stated objectives. Pragmatic studies were more likely to meet design objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting.

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Section: Discussionmentioning

confidence: 66%

Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered?

Mansouri

Cooper

Shin

et al. 2016

JNS

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“…The subgroup of high-impact journals showed even a larger proportion. A review on randomised trials in special medical fields found smaller proportions [19,20]. Surprisingly, Hopewell et al .…”

Section: Discussionmentioning

confidence: 99%

“…Hence, the basis of our investigation is the entire picture of published reports and considerably exceeds a more or less representative random sample [11,14] or an analysis of trials regarding only a specific therapeutic area [13,19-22]. …”

Section: Discussionmentioning

confidence: 99%

Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension

Schiller

Burchardi²,

Niestroj

et al. 2012

Trials

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BackgroundNon-inferiority and equivalence trials require tailored methodology and therefore adequate conduct and reporting is an ambitious task. The aim of our review was to assess whether the criteria recommended by the CONSORT extension were followed.MethodsWe searched the Medline database and the Cochrane Central Register for reports of randomised non-inferiority and equivalence trials published in English language. We excluded reports on bioequivalence studies, reports targeting on other than the main results of a trial, and articles of which the full-text version was not available. In total, we identified 209 reports (167 non-inferiority, 42 equivalence trials) and assessed the reporting and methodological quality using abstracted items of the CONSORT extension.ResultsHalf of the articles did not report on the method of randomisation and only a third of the trials were reported to use blinding. The non-inferiority or equivalence margin was defined in most reports (94%), but was justified only for a quarter of the trials. Sample size calculation was reported for a proportion of 90%, but the margin was taken into account in only 78% of the trials reported. Both intention-to-treat and per-protocol analysis were presented in less than half of the reports. When reporting the results, a confidence interval was given for 85% trials. A proportion of 21% of the reports presented a conclusion that was wrong or incomprehensible. Overall, we found a substantial lack of quality in reporting and conduct. The need to improve also applied to aspects generally recommended for randomised trials. The quality was partly better in high-impact journals as compared to others.ConclusionsThere are still important deficiencies in the reporting on the methodological approach as well as on results and interpretation even in high-impact journals. It seems to take more than guidelines to improve conduct and reporting of non-inferiority and equivalence trials.

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“…Since the creation of the CONSORT in 1996, studies showed that the quality of RCT reporting has improved , as it was introduced within journal guidelines. An improvement in RCT reporting has also been shown in manuscripts published after the introduction of this checklist in the medical literature . Therefore, we extracted the proportion of RCTs with low risk of bias (good internal validity) for each domain according to the Cochrane risk of bias tool for RCTs included in our review published before 1996 (the pre‐CONSORT period) and after 1996 (post‐CONSORT statement).…”

Section: Methodsmentioning

confidence: 99%

Methodological quality of antimalarial randomized controlled trials during pregnancy and its impact on the risk of low birth weight

Muanda

Bérard

2016

Brit J Clinical Pharma

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Aim To describe biases in antimalarial randomized controlled trials (RCTs) during pregnancy and their influence on antimalarial drug efficacy to reduce the risk of low birth weight (LBW). Methods RCT characteristics and results were retrieved from a previous systematic review on the efficacy of antimalarials. The Cochrane risk of bias assessment was used to investigate source of biases in each RCT. The quality of RCT reporting published after the introduction of the CONSORT statement in medical literature in 1996 were compared to those published before 1996. A meta‐regression analysis was performed to examine the impact of bias on the efficacy of antimalarials to reduce LBW after controlling for the time period prior to 1996. Results Twenty out of 25 RCTs (80%) had a high risk of bias. The proportion of RCTs having a low risk of bias was higher in manuscripts published after the introduction of CONSORT compared to those published before 1996 for sequence generation (P = 0.04) and allocation concealment (P = 0.04). Heterogeneity between RCTs was associated with an overestimation of the efficacy of antimalarial drugs in reducing LBW in RCTs with inadequate methods for randomization, allocation concealment or not being free of other bias. Conclusion Antimalarial RCTs during pregnancy are poorly reported but may be improved by using the CONSORT statement. After taking into account the time period before 1996, we found that biases had an impact on the efficacy of antimalarials to reduce the risk of LBW.

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Quality of reporting of randomized controlled trials in polycystic ovary syndrome

Cited by 19 publications

References 42 publications

Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered?

Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered?

Quality of reporting of clinical non-inferiority and equivalence randomised trials - update and extension

Methodological quality of antimalarial randomized controlled trials during pregnancy and its impact on the risk of low birth weight

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