Performance metric distribution characteristics of medical school exam items

Exams are used to measure student progress and subject mastery. Exam item performance can be assessed by Item Difficulty, Discrimination Index (DI), and Point Biserial (PB). A previous investigation descriptively characterized these metrics for 61 exams at the Oklahoma State University College of Osteopathic Medicine, however, the distribution characteristics remain unknown. The primary objective of this study was to determine the normality of the item Difficulty, DI, and PB for these 61 exams. Using the software suite R (version 4.0.2) and RStudio (Version 1.3.959) we performed graphical and numerical analysis of normality using both Q-Q plots (ggqqplot), and the Shapiro-Wilk Normality Test (ggpubr) as adjusted using the Benjamini-Hochberg procedure. For item Difficulty, 93.4% of exams had statistically significant deviations from normality. For DI, 63.9% of exams had statistically significant deviations form normality. For PB, 11.5% of exams had statistically significant deviations from normality. Our results suggest that item performance indicators vary drastically in their distribution characteristics within our sample. Our findings support the use of inferential statistics relying the assumption normality for PB but not item Difficulty or DI. These results may be useful for curriculum directors and test-writers.Osteopathic Medicin

Examining trends in the public’s awareness of exocrine pancreatic insufficiency in the United States using infodemiology metrics

Background: Exocrine Pancreatic Insufficiency (EPI) is a disorder caused by multiple etiologies leading to decreased pancreatic function. EPI presents with nonspecific symptoms and is largely unknown by the public, making EPI a difficult diagnosis. Awareness campaigns for EPI have been supported by AbbVie, a pharmaceutical company that manufactures the only available treatment for EPI (Creon), but it is unknown whether the campaigns have led to increased EPI awareness.Aims: We sought to assess changes in EPI awareness over time evidenced by internet searches in the United States. Findings from this study may reveal how awareness campaigns, such as radio ads, have influenced the public awareness of EPI.Methods: Google Trends is a popular and validated infodemiology tool. Using Google Trends allows for real-time data analysis that reflects public awareness over time, which is reported as relative search volume (RSV). RSV represents a relative percent change in Google searches for selected terms over a given time period. We observed trends for the term “Exocrine Pancreatic Insufficiency” over the date range January 1, 2011 to October 1, 2021 to capture search trends before and after AbbVie’s advertisement campaigns. We used an ARIMA model to forecast expected search volumes based on search data before Abbvie’s campaign for Creon.Results: We found many statistically significant increases in RSV since the launch of AbbVie’s campaign, with peak RSV occurring in August and September of 2021, together representing a 122.5% increase compared to expected values (P<.001). Similar peaks were observed in March 2019 and January 2020, though every year since the launch had multiple statistically significant increases in RSV for “Exocrine Pancreatic Insufficiency.”Conclusion: Results from our study suggest that the US public interest in EPI has increased steadily over the last 5 years compared to the 5 years prior, possibly reflecting the success of Abbvie advertisement campaigns. AbbVie has steadily increased advertisement spending since 2016, with reported net revenue for Creon following a similar trend. The success of AbbVie’s radio, TV, and internet advertisements may have served to educate patients on EPI, prompting them to search Google for more information or to find a physician who could evaluate them for EPI. Increasing awareness may support quicker and more accurate diagnosis of EPI

Associations of intimate partner violence and maternal comorbidities: a cross-sectional analysis

Background: Intimate-partner violence (IPV) is the act of inflicting physical, sexual, and/or emotional assault with coercive control and is a traumatic experience, the repercussions from which can be exacerbated in pregnant women. While screening for IPV during pregnancy is recommended regardless of risk, identifying clinical factors commonly associated with IPV during pregnancy may improve screening rates. Thus, our primary objective was to examine associations between IPV and maternal comorbidities.Methods: We conducted a cross-sectional analysis of the Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 8 spanning 2016 through 2019. Bivariate and multivariable logistic regression was used to calculate adjusted odds ratios (AORs) to determine associations between IPV and diabetes, hypertension, depression, asthma, PCOS, anxiety, and thyroid disease. Confidence intervals were reported at 95%.Results: Over 40% of women experiencing IPV reported a history of depression or anxiety. The odds of experiencing IPV were higher among women with depression (AOR: 3.27; CI: 2.88 - 3.71), hypertension (AOR: 1.49; CI: 1.26 - 1.77), asthma (AOR: 1.22; CI: 1.03 - 1.46), or anxiety (OR: 3.85; CI: 3.43 - 4.33), but were lower in women with thyroid disorders (AOR: 0.49; CI: 0.28-0.84).Conclusion: Our study identified an increased likelihood of IPV among pregnant women with certain comorbidities. Knowing clinically relevant associations of IPV in pregnant women may increase screening sensitivity among clinicians and in turn, increase the likelihood of receiving supportive care among individuals experiencing IPV

COVID 19 and its effects on pediatric orthopaedic clinical trials

Background: Clinical trials for the treatment of pediatric orthopaedics are critical to enhance the quality of life of these children. In response to the COVID-19 pandemic, the FDA updated guidance on conducting clinical trials to prioritize patient safety; however the degree to which the pandemic disrupted pediatric orthopaedic-related clinical trials is unknown. Thus, our objective is to quantify the number of these trials disrupted due to the COVID-19 pandemic.Methods: We searched ClinicalTrials.gov for ongoing and discontinued trials between 01/01/2020 - 10/31/2021. Trials were screened for relevance to the study and the number of participants, trial location, funding source, and reason for discontinuation. Associations between reasons for termination, funding source, trial location, and the number of participants enrolled were evaluated using MannWhitney U tests or ANOVA, where appropriate.Results: Our search returned 544 trials, of which 128 were included with a total of 15,194 participants. Of the included Pediatric trials of orthopaedic conditions, 9 were discontinued with a total of 497 participants. Of the 9 discontinued trials, 1 of 3 stated COVID-19 as a reason. Mann-Whitney U tests and ANOVA showed no statistically significant difference in enrollment between trials discontinued due to COVID-19 compared to other discontinued trials, nor among funding or location.Conclusion: Our study shows 33% of discontinued pediatric orthopaedic-related clinical trials cited COVID-19 as a reason for discontinuation; however, only 12% of all children enrolled in discontinued trials. Findings from this study highlight the importance of developing strategies for safely continuing clinical research amid global emergencies that will almost certainly arise in the future

Clinical trial discontinuation and non-publication for the pharmacologic treatment of Post-Traumatic Stress Disorder among military veterans

Background: Failures by researchers and clinicians to understand, confront, and overcome barriers in veteran-health research may result in the waste of finite resources. Research waste includes clinical trial discontinuation and non-publication which have been shown to be substantial among several fields of medicine. It is the ethical responsibility of researchers, as scientists, to contribute their findings to the existing literature as supported by the International Committee of Medical Journal Editors and the National Institute for Health Research and the Declaration of Helsinki regarding human subjects. Given the rates of discontinuation and non-publication of clinical trials among other fields of medicine and the lack of evidence demonstrating publication rates of clinical trials (CTs) among veterans, our primary objective was to determine rates of discontinuation and non-publication among post traumatic stress disorder (PTSD) focused CTs with pharmaceutical interventions specific to the veteran population.Methods: We performed a systematic search of registered trials using ClinicalTrials.gov for pharmaceutical interventions for the treatment of PTSD. Studies were screened in a duplicate masked fashion and extracted study characteristics including sample size, study design, trial status, phase, and funding source. We then searched the trials designation ID and title to identify publications associated with the study. If no study was found, and the study was not prematurely terminated, the study’s primary contact was emailed to identify potential publications. Studies were classified as completed or discontinued based on the status category provided from ClinicalTrials.gov. Descriptive statistics of trials will be reported and associations of trial termination and non-publication will be assessed using logistic regression.Results: Our search returned 351 studies, 54 of which met inclusion criteria. Among these 54 studies 11 were discontinued and 15 were not published. The median enrollment among all trials was 37 (IQR). Among the terminated studies, 0 participants were enrolled. Among the non-published trials, 12 were enrolled. Reasons for study termination included low enrollment, withdrawn funding, and deployment of the principal investigator overseas. We found a statistically significant association between sample size and discontinuation, but not among any other examined study characteristic.Conclusion: We found that a combined 29% of trials of medications for PTSD among veterans were either discontinued or not-published. Engaging in clinical trials research without publication of results wastes the finite resources available to investigators. This may also lead to limitations and bias within the existing medical literature. Further, it is not only the ethical responsibility of researchers to publish results, but a legal requirement under Section 801 of the FDA Amendments Act (FDAAA) of 2007 to report study results which has been reaffirmed and strengthened in 2017 and the first preliminary litigation was announced. In light of the dedication of our service men and women to serving the United States, sometimes at great personal cost, it is the ethical responsibility of researchers to advance clinical knowledge via CT publication as it relates to improving treatments for veterans diagnosed with PTSD is greater than ever before

Influence of the COVID-19 Pandemic on Clinical Trial Discontinuation in Anesthesiology: Cross-sectional Analysis

BackgroundThe COVID-19 pandemic drastically altered perioperative medical practice owing to safety concerns, postponing elective or nonemergent procedures, supply chain shortages, and reallocating perioperative staff to care for patients with COVID-19. However, the impact of the pandemic on the conduct on anesthesiology clinical research is unknown. ObjectiveThe primary objective was to quantify the magnitude of the COVID-19 pandemic’s impact on anesthesiology clinical research. MethodsWe performed a systematic search using ClinicalTrials.gov to identify clinical trials related to the practice of anesthesiology. We screened trials with status updates from January 1, 2020, through October 1, 2021, to capture trials potentially affected by the COVID-19 pandemic by the time of our search. Investigators screened for relevant studies and extracted trial characteristics along with the reason for discontinuation reported on the clinical trial registry. ResultsA total of 823 clinical trials met inclusion criteria, and 146 clinical trials were discontinued within the designated date range. In total, 24 (16.4%) of the 146 clinical trials were halted explicitly owing to the COVID-19 pandemic. A significant association existed between trial enrollment numbers and the likelihood of discontinuation due to the COVID-19 pandemic, as larger trials were more likely to be disrupted (z=–2.914, P=.004). ConclusionsThe COVID-19 pandemic is reportedly associated with the discontinuation of anesthesiology-related clinical trials. With the uncertain course of the COVID-19 pandemic, developing anesthesia trial protocols to help minimize social interaction and prevent premature trial disruption are imperative

Assessing patient burden and benefit: A decade of cabozantinib clinical trials

Drug development is complex and costly. Clinical trial participants take on risks, making it essential to maximize trial efficiency and maintain participant safety. Identifying periods of excessive burden during drug development can inform trial design, ensure patient benefit and prevent harm. This study aims to examine all published clinical trials for cabozantinib to assess patient benefit and burden over time. We conducted a retrospective cross-sectional review of interventional clinical trials of cabozantinib for solid cancer treatment. We searched PubMed/MEDLINE, Embase, Cochrane (CENTRAL) and ClinicalTrials.gov. We extracted adverse event rates, median progression-free survival (PFS), median overall survival and objective response rate (ORR) for each included trial. We calculated frequencies of trial characteristics, cumulative grade 3-5 adverse event rates and cumulative ORRs. Out of 1735 studies, 54 publications were included that involved 6372 participants and 21 cancers. Of the 54 studies in our sample, 31 (57.41%) were single-arm trials and 23 (42.60%) had negative results. Trials among and within various indications had conflicting results over time. Cumulative risk to participants increased over time, and clinical benefit decreased. The findings suggest that the risk profile of cabozantinib increased from 2011 to 2016 and has remained elevated but stable while benefit has decreased over time. The use of non-randomized and single-arm trials is concerning, and more methodologically rigorous trials are needed. The results of trials for different indications are inconsistent, and empirical administration may reduce the drug's efficacy