BACKGROUND: Quality systematic reviews with meta-analyses (SRMA's) are the standard for recommendations in clinical practice. One problem with the current literature is susceptibility to publication bias, which has been shown to inflate effect estimates of SRMA's. OBJECTIVE: To combat publication bias, Cochrane Collaboration requires searching at least 1 clinical trial registry (CTR) for unpublished data. Therefore, we investigated SRMA's published in the top 5 neurosurgery journals and whether they incorporated CTR searches. METHODS: All meta-analyses published the top 5 journals in Neurosurgery over the past 5 years were queried using the h-5 index of Google Scholar: Journal of Neurosurgery, Neurosurgery, World Neurosurgery, Journal of Neurosurgery: Spine, and Neurosurgical Focus. Search strings were generated to incorporate SRMA's over the past 5 years in these journals. We selected a random sample of 100 studies from the list of SRMA's that did not incorporate CTR searches and searched ClinicalTrials.gov for unpublished, completed CTR's with relevant outcomes. RESULTS: Of 761 papers, 22/761 searched CTR's, meaning only 2.8% of SRMA's in these journals included CTR data. Among 100 randomized papers in secondary analysis, 39% had relevant CTR data, and 16 of those 39 papers had multiple sets of data relevant to the study (41%). Meanwhile, papers published by Cochrane had 69 of 72 reviews (95.8%) that included CTR searches. CONCLUSION: This shows that the top neurosurgery journals seldom published SRMA's containing searches for unpublished CTR's while Cochrane almost always had searches. In addition, 41% of the randomized sample in our secondary analysis could have included CTR studies.
Dissection of the brain and central nervous system for medical education is an informative but often wholly destructive process, leaving students with little reference material from which to review neural structures and their anatomical relationships. Here, we explore the use of diffusible iodine contrast enhancement followed by high‐resolution microCT (diceCT) to combine destructive physical dissection with more permanent digital dissection. DiceCT methods render soft tissues radiodense to X‐rays, emulating the tissue discrimination of magnetic resonance imaging (MRI). Such imaging studies provide students the opportunity to identify and interpret pathological findings in ex‐vivo neural tissues. To identify best‐practices for incorporating diceCT imaging into the medical neuroanatomy lab, we stained formalin‐preserved human brains with three concentrations of iodine (3, 4, and 5% aqueous I2KI) for 3 weeks, replacing the iodine solutions after the first and second weeks. All brains were microCT scanned at 63‐micron resolution, and the resulting image stack was rendered in Avizo version 2019.2. The stained brains were then bisected, and one hemisphere was de‐stained for 4 weeks by alternating baths of 1% sodium thiosulfate with deionized water each on a week‐long cycle. All concentrations of iodine were effectively de‐stained using this protocol. Students then performed comparative physical dissections on never‐stained, stained only, and stained‐then‐de‐stained brains, and comparative digital dissections were performed on brains of each iodine concentration. In physical dissection, stained only brains had few advantages—although the dark iodine stain enhanced some fiber tracts, specimens were smaller, physically difficult to manipulate, and harbored subcortical nuclei (e.g. the basal ganglia) that were more difficult to identify. Dissection of never‐stained and de‐stained brains was found to be equivocal, with de‐stained brains regaining much of their original size. In digital dissection, the 5% aqueous I2KI solution provided the clearest discrimination between structures, and pathologies such as age‐related atrophy and hydrocephalus were apparent. In addition to leaving a more permanent imaging study record of nervous tissue specimens, digital dissection allows for 3D printing of brain regions. These benefits were positively received by students, and we recommend incorporation of rapid, inexpensive tissue staining and tomography to enhance participation and clinical skills in the anatomy lab. Support or Funding Information Federal Work Study, OSU Center for Health Sciences
Context The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the Food and Drug Administration (FDA) reviews safety and efficacy data for cardiovascular and renal drugs, ultimately making recommendations to the Commissioner of Food and Drugs for approval. The Open Public Hearing segment of these meetings allows for patients, advocates, healthcare professionals, clinical trialists, and members of the public to provide testimony, which often results in expressing their preference for, or against, drug approval. Prior to providing testimony, the public speakers are highly encouraged to disclose any financial conflicts of interest (FCOIs) with the sponsor or other groups. Given the potential influence of these speakers on drug approval recommendations, we investigated the industry associations disclosed by public speakers in the Open Public Hearing section of the CRDAC meetings. Previous studies, such as one done by Lurie et al. indicated that positive testimony is tied to a higher likelihood of drug approval, and because drug companies provide financial compensation for speakers to provide testimony in general, we wanted to determine the likelihood with which speakers who have an FCOI provided a positive testimony vs. those without any FCOI. Objectives The purpose is to evaluate whether public speakers with an FCOI are more likely to provide positive testimony regarding the drug in question during the CRDAC of the FDA between February 2009 and December 2019 through the use of publicly available transcripts. Methods Independent researchers investigated public transcripts and minutes of the CRDAC meetings with public speakers (n=20). We identified all speakers, along with characteristics such as an FCOI, and classified statements utilizing a pilot-tested Google form. The data collected were analyzed utilizing Stata. The speaker’s testimony was then compared with their FCOI. An ordered logistic regression was performed utilizing the speaker’s testimony regarding the drug as the dependent variable. Results Of the 88 speakers represented in our sample, 35 (35/88, 39.8%) disclosed an FCOI, most commonly regarding travel cost. Among speakers with an FCOI, 30 (30/35, 85.7%) spoke positively. Speakers with an FCOI were 4.96 times more likely to provide positive testimony (OR=4.96, 95% CI 1.67–14.78). Speakers with the disease were also more likely to provide positive testimony (OR=13.05, 95% CI 2.84–59.93). Conclusions Public speakers often play a role during meetings, and they may also have an FCOI, most commonly related to travel expenses. Our study shows that speakers with an FCOI are more likely to provide positive testimony. Stipulations, such as requiring disclosure of FCOI and randomizing the selection process of speakers, can help ensure the integrity of the drug approval process.
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