Faculty Bibliography

BACKGROUND AND AIMS:One manifestation of low-value medical practice is the medical reversal, a practice in widespread use that, once subjected to a randomized controlled trial (RCT), is found to be no better-or worse-than a prior established standard of care. We aimed to determine the prevalence of medical reversals in gastroenterology (GI) journals and characterize these reversals. METHODS:We searched the American Journal of Gastroenterology, Clinical Gastroenterology and Hepatology, Gastroenterology, Gut, Hepatology, and the Journal of Hepatology, reviewing studies published in 2015-2019. We identified RCTs that tested an established clinical practice and produced negative results, considered tentative reversals. Any systematic review or meta-analysis that included the article was categorized as confirming the reversal, refuting the reversal, or providing insufficient data. RESULTS:During the 5-year period, we identified 5,898 original articles, of which 212 tested an established practice and 52 were categorized as unrefuted medical reversals (25% of articles testing standard of care). Of the reversals, 21 (40%) tested procedures and devices, 15 (29%) tested medications, and 8 (15%) tested vitamins/supplements/diet. Twenty-three (44%) considered the alimentary tract, 12 (23%) considered the liver, pancreas, or biliary tract, and 17 (33%) considered endoscopy. Thirty-eight (73%) were funded exclusively by non-industry sources. CONCLUSION:This review reveals a total of 52 reversals across all subfields of GI and medical, procedural, screening, and diagnostic interventions, occurring in 25% of randomized trials testing an established practice. More research is needed to determine the optimal way to engage stakeholders and remove reversed practices from medical care.

Buprenorphine is an effective treatment for opioid dependence; however, it demonstrates individual variability in efficacy. Pharmacogenomics may explain this drug response variability and could allow for tailored therapy on an individual basis. The Food and Drug Administration and the Clinical Pharmacogenomics Implementation Consortium have guidelines on pharmacogenomic testing for some opioids (e.g., codeine); however, no guidelines exist for the partial opioid agonist buprenorphine. Pharmacogenomic testing targets for buprenorphine include pharmacodynamic genes like the mu-opioid receptor (MOP receptor) and catechol-O-methyltransferase (COMT), as well as the pharmacokinetic genes like the CYP enzymes. In this review we identified genotypes in patients with opioid addiction receiving buprenorphine that may result in altered therapeutic dosing and increased rate of relapse. The OPRM1 A118G single nucleotide polymorphism (SNP rs1799971) gene variant encoding the N40D MOP receptor has been associated with variable efficacy and response to treatment in both adult and neonatal patients receiving buprenorphine for treatment of opioid withdrawal. An SNP associated with rs678849 of OPRD1, coding for the delta opioid receptor, was associated with opioid relapse as indicated by opioid positive urine drug screens; there was also sex specific SNP identified at rs581111 and rs529520 in the European American population. COMT variability, particularly in rs4680, has been associated with length of stay and need for opioid treatment in patients with neonatal abstinence syndrome. Variations of the pharmacokinetic gene for CYP3A4 showed that the ultrarapid metabolizer phenotype required higher doses of buprenorphine. Genotyping of patients may allow us to appropriately tailor buprenorphine therapy to individual patients and lead to improved patient outcomes; however, further research on the pharmacogenomics of buprenorphine is needed.

BACKGROUND/AIM/OBJECTIVE:Palbociclib is an FDA-approved cyclin-dependent kinase inhibitor for the treatment of advanced breast cancer. Limited information is available regarding the toxicity of palbociclib and concurrent radiation therapy. CASE REPORT/METHODS:Herein, we report a case of esophageal toxicity in a patient treated with palbociclib and radiation therapy. A 63-year-old woman was treated with palbociclib followed by palliative radiation therapy. The patient presented three days after completing radiation therapy with severe odynophagia, and dysphagia and was found to have grade 2-3 esophageal ulcers. Palbociclib and radiation therapy was held on admission, and a resolution of her symptoms and improvement in her oral intake was noted at which time she was restarted on palbociclib with no further radiation treatment. CONCLUSION/CONCLUSIONS:Caution is advised when patients are undergoing concurrent palbociclib and even low-dose palliative radiation treatment. In these patients, providers should maintain a high index of suspicion for toxicities such as dermatitis or mucositis.

INTRODUCTION:As evidenced by student performance on various assessments, pharmacotherapy remains a comparative weakness in undergraduate medical education, with several institutions developing novel strategies for students to apply these principles in a practical setting. Medical curricula have recently prioritized group-learning modalities and evidence-based medicine education. However, these principles have yet to impact pharmacology education. We developed and implemented an evidence-based, group-learning exercise for first-year medical students focusing on pharmacology through the practical lens of pharmacotherapy and pharmacopolicy. METHODS:First-year medical students in different groups were assigned a particular medication and, during an in-class session, were encouraged to meet with other representatives assigned the same drug to interpret the provided package insert and any online information. Students then reconvened with their groups to engage in collaborative teaching about each assigned drug before completing a group quiz using online resources. Facilitators reviewed the group quiz and allowed time for student questions. RESULTS:For 180 participants, the average group-quiz score was 86%, ranging from 68% to 100%. Student-reported satisfaction with the activity in meeting its preset objectives averaged 3.7 on a 5-point scale, with 5 being most positive. DISCUSSION:Overall, this activity effectively integrates principles of pharmacotherapy and pharmacopolicy into a group-based, evidence-based exercise. Limitations of the activity include the number of possible example drugs and the amount of material covered in a given time frame. However, the activity lends itself to the role of an introductory session in a longer curriculum centered on clinical-applied pharmacology and evidence-based practice.

PURPOSE/OBJECTIVE:Medical error in the United States carries substantial economic and safety costs, which manifest in a large number of malpractice suits filed each year. The aim of this study was to characterize the various sociologic and medical factors that influence malpractice suits occurring from cases of facial trauma. MATERIALS AND METHODS/METHODS:test, and Fisher t test were performed using SPSS. RESULTS:Of the 69 defendants (76.8% men and 23.2% women; age range, 17 to 57 yr), which resulted from 53 claims, 12 (17.4%) involved plastic surgeons and 10 (14.5%) involved emergency physicians. Most complaints consisted of inadequate care that deviated from treatment standards (32 [46.4%]) and delayed diagnosis (24 [34.8%]). Of delayed diagnosis cases, 14 patients had radiographic imaging performed. Geographic location of the claim was statistically significant-the Midwest upheld 40% of complaints (P = .007) and the South dismissed 91.4% (P = .027). CONCLUSIONS:The impact of sociologic factors, including geographic region, informed consent, and cosmesis, and medical factors, such as delayed diagnosis and deviation from standard of care, in facial trauma litigation were found to be incongruent with previous studies describing the medicolegal influences in facial plastic procedures. This analysis provides greater insight to surgical practitioners across subspecialty disciplines regarding the potential legal implications of malpractice.

OBJECTIVE:Analyze the risk for perioperative complications associated with body mass index (BMI) class in patients undergoing head and neck free flap reconstruction. STUDY DESIGN AND SETTING:Retrospective cohort study. SUBJECTS AND METHODS:and binary logistic regression analyses. RESULTS:Underweight patients (n = 160) had significantly higher rates of numerous comorbidities, including disseminated cancer, preoperative chemotherapy, and anemia, while obese patients (n = 447) had higher rates of diabetes and hypertension. Rates of overall surgical complications, medical complications, and flap loss were insignificantly different between BMI groups. Following regression, obese BMI was protective for perioperative transfusion requirement (odds ratio [OR] = 0.63, P = .001), while underweight status conferred increased risk (OR = 2.43, P < .001). Recent weight loss was found to be an independent predictor of perioperative cardiac arrest (OR = 3.16, P = .006) while underweight BMI was not (OR = 1.21, P = .763). However, both weight loss and underweight status were associated with significantly increased risk for 30-day mortality (OR = 4.48, P = .032; OR = 4.02, P = .010, respectively). CONCLUSION:Obesity does not increase the risk for postoperative complications in head and neck free flap surgery and may be protective in some cases. When assessing a patient's fitness for surgery, underweight status or recent weight loss may suggest a reduced ability to tolerate extensive free flap reconstruction.