Band 122, Heft 9

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.

Context The most common skeletal disease, osteoporosis, causes bone fragility due to decreased bone mass and bone microarchitecture destruction. The health belief model is often applied to asymptomatic, prevention-related diseases such as osteoporosis. Steps to mitigate the insidious nature of osteoporosis, including education, motivation, and monitoring of bone mineral density, must begin at an earlier age. Objectives This study evaluates the knowledge and health beliefs surrounding osteoporosis in a population of males and females 35–50 years old to determine sex-based differences in osteoporosis knowledge and beliefs and to assess the correlation between perceptions and health motivation. Methods Participants (81 males, 92 females) completed two questionnaires: the Osteoporosis Knowledge Test and the Osteoporosis Health Belief Scale. Descriptive statistics were performed along with Pearson product-moment correlation analysis to determine the relationships between the variables. Sex-based differences were calculated utilizing independent t -tests. Results We discovered a statistically significant negative correlation between the barriers to exercise and health motivation (−0.434, p < 0.001) and a statistically significant positive correlation between the benefits of exercise and health motivation (0.385, p < 0.001). However, there was not a statistically significant correlation between health motivation with the following: the benefits of calcium, susceptibility, and the seriousness of osteoporosis. Between males and females, there was a statistically significant difference in exercise and calcium knowledge, susceptibility, and the benefits of both exercise and calcium (p < 0.05). Conclusions Males and females 35–50 years old perceive themselves to have a low susceptibility to osteoporosis. They do not consider osteoporosis a serious disease and have little motivation to mitigate its inception or progression. Their perceptions show that barriers to exercise impact health motivation more than the perceived benefits of exercise.

The Coalition for Physician Accountability’s Undergraduate Medical Education-Graduate Medical Education (UME-GME) Review Committee (UGRC): Recommendations for Comprehensive Improvement of the UME-GME Transition final report includes a total of 34 recommendations and outlines opportunities to transform the current processes of learner transition from a US-based MD- or DO-granting medical school or international medical education pathway into residency training in the United States. This review provides a reflection on the recommendations from the authors, all members of the UGRC, describing the pros and cons and the opportunities and limitations, in the hopes that they might inspire readers to dig deeper into the report and contribute to meaningful improvements to the current transition. The UGRC Recommendations highlight the many opportunities for improvement in the UME-to-GME transition. They are built on the connection to the system of education and formation of physicians to a more just healthcare system, with attention to diversity, equity, and inclusion to improve health disparities and to the quality of care that patients receive. However, there are justifiable concerns about changes that are not fully understood or that could potentially lead to unintentional consequences. This analysis, reached through author consensus, considers the pros and cons in the potential application of the UGRC Recommendations to improve the UME-to-GME transition. Further debate and discussion are warranted, without undue delay, all with the intention to continue to improve the education of tomorrow’s physicians and the care for the patients who we have the privilege to serve.

Neonatal subcutaneous emphysema is a very rare complication of endotracheal intubation or surgery; however, only a few cases of spontaneous subcutaneous emphysema were reported in a neonate. The patient presented in respiratory distress with a low S a O 2 ; however, no clinical signs of subcutaneous emphysema were seen. An initial chest radiograph was negative for subcutaneous emphysema. Nasal continuous positive airway pressure (CPAP) was started to manage the respiratory distress, and subcutaneous emphysema spontaneously developed. Discontinuation of nasal CPAP with close monitoring eventually resolved the subcutaneous emphysema. Recognition of rare complications due to nasal CPAP may provide physicians with more insight to intervene and provide patients with proper care.

Context Opioids are commonly utilized for the treatment of chronic pain. However, research regarding the long-term (≥12 months) outcomes of opioid therapy remains sparse. Objectives This study aims to evaluate the effects of long-term opioid therapy on measures of back-specific disability and health-related quality of life in patients with chronic low back pain. Methods In this retrospective cohort study, patients with chronic low back pain who reported consistent opioid use or abstinence for at least 12 months while enrolled in the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation Pain Research Registry were classified as long-term opioid users or nonusers, respectively. For comparison, intermediate-term and short-term opioid users and nonusers were also identified. Multiple linear regression analysis was performed to compare back-specific disability (Roland-Morris Disability Questionnaire [RMDQ]) and health-related quality of life (29-item Patient-Reported Outcomes Measurement Information System [PROMIS]) between opioid users and nonusers while controlling for pain intensity, depression, age, body mass index (BMI), and eight common comorbid conditions (herniated disc, sciatica, osteoporosis, osteoarthritis, heart disease, hypertension, diabetes, and asthma). Statistically significant findings were assessed for clinical relevance. Results There were 96 long-term opioid users and 204 long-term opioid nonusers. After controlling for potential confounders, long-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.85, p<0.001), physical function (adjusted mean difference=−2.90, p=0.001), fatigue (adjusted mean difference=4.32, p=0.001), participation in social roles (adjusted mean difference=−4.10, p<0.001), and pain interference (adjusted mean difference=3.88, p<0.001) outcomes. Intermediate-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.41, p<0.001), physical function (adjusted mean difference=−2.26, p=0.003), fatigue (adjusted mean difference=3.70, p=0.002), and sleep disturbance outcomes (adjusted mean difference=3.03, p=0.004), whereas short-term opioid use was a predictor of worse back-specific disability (adjusted mean difference=2.42, p<0.001) and physical function outcomes (adjusted mean difference=−1.90, p<0.001). Conclusions The findings of this study are largely consistent with existing literature regarding the outcomes of long-term opioid therapy. Taken in conjunction with the well-established risks of opioid medications, these findings draw into question the utility of long-term opioid therapy for chronic low back pain.

Coronavirus disease (COVID-19), an infection caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has severely ravaged the world since the end of 2019. Although most cases range from mild to severe with primarily respiratory symptoms, there have been some unusual clinical presentations, one of which is described in this case report. A 30 year-old woman with no significant medical history presented to the emergency department (ED) in October 2020 with sudden onset of severe left upper and lower abdominal pain. Her initial triaged blood pressure was 70 mmHg systolic, associated with mild tachycardia. Her beta human chorionic gonadotropin (beta-hCG) was negative, and her initial hemoglobin was 9.3 g/dL. A bedside ultrasound (US) was immediately performed, which showed moderate free fluid in the pelvis as well as in the right and left upper quadrants of the abdomen. She was stabilized with a fluid bolus and later underwent a CT scan of the abdomen and pelvis, which showed an apparent grade III splenic laceration without active extravasation. The patient underwent a successful embolization procedure by interventional radiology (IR) and was discharged from the hospital 2 days later. The initial medical workup included a positive polymerase chain reaction (PCR) COVID-19 test but included no other findings that could serve as a cause for her spleen to spontaneously rupture. The purpose of this case report is to illustrate and make other clinicians aware of unusual potential complications and clinical presentations of COVID-19. The condition of spontaneous splenic rupture (SSR) is an uncommon but an emergent differential diagnosis in an otherwise healthy person with potential drastic outcomes. A careful approach in the management and care of these patients is warranted. This is one of a handful of case reports on SSR secondary to COVID-19 to the best of our knowledge.