Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?

Poolman, Rudolf W.; Struijs, Peter; Krips, Rover; Sierevelt, Inger N.; Lutz, Kristina; Bhandari, Mohit

doi:10.1186/1471-2288-6-44

Cited by 97 publications

(67 citation statements)

References 20 publications

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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: 67%

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: 67%

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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“…First, our data build on reported information, which is not necessarily complete or correct. This is a well-known problem when extracting data from publications [4,13]. Not only errors but also considerations concerning publication length and print space may result in limited data, especially related to statistical detail.…”

Section: Discussionmentioning

confidence: 99%

Management of Confounding in Controlled Orthopaedic Trials

Vavken

Culen

Dorotka

2008

Clinical Orthopaedics &Amp; Related Research

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Confounding occurs when the effect of an exposure on an outcome is distorted by a confounding factor and will lead to spurious effect estimates in clinical studies. Although confounding can be minimized at the design stage, residual confounding may remain. An argument therefore can be made for controlling for confounding during data analysis in all studies. We asked whether confounding is considered in controlled trials in orthopaedic research and hypothesized the likelihood of doing so is affected by participation of a scientifically trained individual and associated with the magnitude of the impact factor. We performed a cross-sectional study of all controlled trials published in 2006 in eight orthopaedic journals with a high impact factor. In 126 controlled studies, 20 (15.9%; 95% confidence interval, 9.5%-22.3%) studies discussed confounding without adjusting in the analysis. Thirty-eight (30.2%; 95% confidence interval, 22.2%-38.2%) controlled for confounding, although we suspect the true proportion might be somewhat higher. Participation of a methodologically trained researcher was associated with (odds ratio, 3.85) controlling for confounding, although there was no association between impact factor and controlling for confounding. The question remains to what extent the validity of published findings is affected by failure to control for confounding.

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“…Data derived from RCTs is considered to be the highest level of evidence, mainly because randomization is the best way to balance known-and the only way to balance unknown-prognostic factors within both treatment and control groups in a therapeutic study (Sackett et al 2000. Although rated as Level I, an RCT can still have methodological flaws (Poolman et al 2006). Surgical trials, for example, have several important issues that differentiate them from trials of drug therapies.…”

Section: Misconception 2: Ebm Is Not Possible Without Rctsmentioning

confidence: 99%