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 13,352 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Data fabrication and scientific misconduct have been recently uncovered in the anesthesia literature, partly via the work of John Carlisle. In a recent article in Anaesthesia, Carlisle analyzed 5087 randomized clinical trials from anesthesia and general medicine journals from 2000 to 2015. He concluded that in about 6% of studies, data comparing randomized groups on baseline variables, before the given intervention, were either too similar or dissimilar compared to that expected by usual sampling variability under the null hypothesis. Carlisle used the Stouffer-Fisher method of combining P values in Table 1 (the conventional table reporting baseline patient characteristics) for each study, then calculated trial P values and assessed whether they followed a uniform distribution across studies. Extreme P values targeted studies as likely to contain data fabrication or errors. In this Statistical Grand Rounds article, we explain Carlisle's methods, highlight perceived limitations of the proposed approach, and offer recommendations. Our main findings are (1) independence was assumed between variables in a study, which is often false and would lead to "false positive" findings; (2) an "unusual" result from a trial cannot easily be concluded to represent fraud; (3) utilized cutoff values for determining extreme P values were arbitrary; (4) trials were analyzed as if simple randomization was used, introducing bias; (5) not all P values can be accurately generated from summary statistics in a Table 1, sometimes giving incorrect conclusions; (6) small numbers of P values to assess outlier status within studies is not reliable; (7) utilized method to assess deviations from expected distributions may stack the deck; (8) P values across trials assumed to be independent; (9) P value variability not accounted for; and (10) more detailed methods needed to understand exactly what was done. It is not yet known to what extent these concerns affect the accuracy of Carlisle's results. We recommend that Carlisle's methods be improved before widespread use (applying them to every manuscript submitted for publication). Furthermore, lack of data integrity and fraud should ideally be assessed using multiple simultaneous statistical methods to yield more confident results. More sophisticated methods are needed for nonrandomized trials, randomized trial data reported beyond Table 1, and combating growing fraudster sophistication. We encourage all authors to more carefully scrutinize their own reporting. Finally, we believe that reporting of suspected data fraud and integrity issues should be done more discretely and directly by the involved journal to protect honest authors from the stigma of being associated with potential fraud.
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PMID:An Appraisal of the Carlisle-Stouffer-Fisher Method for Assessing Study Data Integrity and Fraud. 2878 43

The 1893 operations to remove a maxillofacial tumor from President Grover Cleveland aboard a private yacht remained a secret until long after his unrelated death from heart disease. Many historical studies have suggested that Cleveland kept his health and surgical care confidential because of the fragility of the economy during the Panic of 1893. Although that observation is true, it does not fully address the underlying reason for why the public would react poorly to news about an operation on the president. The death of Ulysses S. Grant eight years prior unearthed the denial, stigma, and fear of cancer felt by many Americans. Despite revolutionary 19th century advances in anesthesia, pathology, and surgery, the social history of "cancerphobia" ran deep.
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PMID:The Clandestine Operations Performed on President Grover Cleveland and the Rationale for Surgical Secrecy. 3026 81

Pediatric anesthesiologists practice within a culture, a system, and a society. In this article, we provide an overview of the influence these have on the well-being or the unwellness of pediatric anesthesiologists. The scope of these issues is broad and far-reaching; thus, our goal has been to highlight those areas which would be likely to have the largest impact on well-being if addressed fully by society, institutions, and leaders in our field. We discuss the burnout-promoting aspects of medical education and training. We survey occupational factors, such as the high-stake pediatric anesthesia environment, occupational health hazards, time pressure, and the reduction in physician autonomy. We then describe societal barriers, such as the marginalization of certain populations, the US system of malpractice litigation, the stigma surrounding psychiatric care, and some of the issues related to physician reimbursement in the United States. We conclude that in order to move forward, improving physician wellness must be a focus of society, of the medical system as a whole, and of individual departments and leaders in pediatric anesthesia.
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PMID:It's the Culture!-How systemic and societal constructs impact well-being. 3310 60


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