Do Surgical Trials Meet the Scientific Standards for Clinical Trials?

Wenner, Danielle M.; Brody, Baruch A.; Jarman, Anna F.; Kolman, J. M.; Wray, Nelda P.; Ashton, Carol M.

doi:10.1016/j.jamcollsurg.2012.06.018

Cited by 30 publications

(31 citation statements)

References 26 publications

(22 reference statements)

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“…the ConsoRt diagram was not present in 52.8% of the articles, and funding was not reported in 52.8%. the results of our study are similar to those reported previously in the literature [8][9][10][11][12] ; Balasubramanian et al 9 showed that only 13.3% of the trials clearly explained allocation, 43.5% had no description of sample size, and 58.0% did not state the method of randomization. these deficiencies increase the risk of bias and might be associated with exaggerated treatment effects.…”

Section: Discussionsupporting

confidence: 92%

“…similar results were identified by other studies. Balasubramanian et al 9 reported that, among surgical trials where blinding was possible, only 30% of the articles clearly explained the blinding techniques; Wenner et al 8 showed that only 4 in 10 surgical articles reported blinding techniques; sinha et al 10 also described that blinding was rarely adequately reported. although blinding in surgical clinical trials is often difficult, there are techniques that can be used to decrease the risk of bias: determination of adverse effects and outcomes is performed by a blinded assessor, and analysis of the data is performed by a blinded reviewer.…”

Section: Discussionmentioning

confidence: 99%

“…8,21 this single item can improve surgical research by decreasing observer bias without increasing the risk to the patients. We identified some factors associated with the achieved score, year of publication, journal impact factor, multi-institutional studies, and declared funding.…”

Section: Discussionmentioning

confidence: 99%

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Are Our Publications Failing the Inspection?

Pinzon

Hayden²,

Ariel³

et al. 2014

Diseases of the Colon &Amp; Rectum

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A total of 20.8% of the articles published were case reports and 25.0% of the articles were prospective or clinical trials. Although randomized clinical trials and systematic reviews provide the highest level of evidence, publications with missing data limit replication of the study and affect the generalizability of results to other populations. To improve the quality of our publications, authors, reviewers, and journal editors should consider the endorsement of standardize checklists.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

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Are Our Publications Failing the Inspection?

Pinzon

Hayden²,

Ariel³

et al. 2014

Diseases of the Colon &Amp; Rectum

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“…Wenner et al [14] conducted a systematic review of publications from 1999 to 2008 evaluating invasive therapeutic procedures. They found numerous shortcomings such as the mentioning of funding sources (36% failure), complete statistical power calculations (45% failure), and factors required to assess the generalizability of trial results including the number and inclusion criteria of interventionists.…”

Section: The Current Clinical Research Landscape In Surgerymentioning

confidence: 99%

Clinical Research in Surgery: Threats and Opportunities

Ceelen¹

2014

Eur Surg Res

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Surgery is a discipline which profoundly affects human integrity. Therefore, there is an ethical and scientific imperative that surgical practice depends on the best possible trial-based evidence. Traditionally, the quality and quantity of clinical research have been lagging behind other disciplines in clinical medicine. However, recent collaborative initiatives, such as the IDEAL framework which tests surgical innovation, international registries, and quality assurance platforms, the development of modified randomized controlled trials and alternative trial designs as well as the impending reforms of the regulatory framework surrounding nonpharmaceutical interventions and devices offer significant and timely opportunities to enhance the relevance of clinical research in surgery. Here, we provide an overview of the current state of clinical research in surgery, identify possible obstacles, and discuss realistic and emerging solutions that have the potential to change the way surgical research is organized, funded, and translated to the patient's benefit.

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“…An opportunity to study it arose as part of a larger project we are conducting to analyze the methodologic and ethical strengths and weaknesses of influential comparative surgical trials whose results were reported between 2000 and 2008. 1 In a sample of 290 surgical trials, we observed 130 that did not report a priori power calculations or left out important components of the power calculation. However, in many cases, the authors of these trials claimed no significant differences between the treatment arms and made clinical recommendations to introduce the treatment.…”

mentioning

confidence: 99%

Are Surgical Trials with Negative Results Being Interpreted Correctly?

Brody

Ashton

Liu

et al. 2013

Journal of the American College of Surgeons

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Background Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. Study Design We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. Results Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. Conclusions Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.

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Do Surgical Trials Meet the Scientific Standards for Clinical Trials?

Cited by 30 publications

References 26 publications

Are Our Publications Failing the Inspection?

Are Our Publications Failing the Inspection?

Clinical Research in Surgery: Threats and Opportunities

Are Surgical Trials with Negative Results Being Interpreted Correctly?

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