Addition of pyloroplasty may improve glycemic control and refractory early satiety in gastroparesis at rates similar to gastric neurostimulation alone: a retrospective analysis.

OBJECTIVES: Gastroparesis that is refractory to standard dietary and medical management may benefit from surgical treatment with gastric electrical neurostimulation, which has shown promise in reducing symptoms of the disease. Pyloroplasty may serve an adjunctive role to a gastric stimulator, but the precise benefit remains unclear. The present study compares reported rates of symptom improvement following gastric neurostimulator implantation with and without pyloroplasty. MATERIALS AND METHODS: A single center retrospective analysis of consecutive patients who received operative management for symptom refractory gastroparesis from 1 January 2020 to 31 December 2021 was performed. Subjects were assigned to cohorts based on treatment with gastric electrical stimulation alone (GES-only) or combined with pyloroplasty (GES + PP). A survey-based assessment was administered post-operatively that evaluated cardinal symptoms of gastroparesis (nausea, vomiting, early satiety) before and after treatment. RESULTS: In total, 42 patients (15 GES-only, 27 GES + PP) were included in the study. Both groups reported a high degree of improvement in global symptom control following surgery (93% vs 81%) with no differences between treatment cohorts (p = 0.09). Early satiety demonstrated better improvement in patients who received gastric stimulation alone (p = 0.012). Subgroup analysis of diabetic gastroparesis patients showed a 2.2% decrease in hemoglobin A1c levels in the GES + PP group (p-0.034). CONCLUSIONS: Symptom reduction in refractory gastroparesis appears to improve after placement of a gastric neurostimulator with or without the addition of a pyloroplasty procedure.

Aggressive Angiomyxoma of the Pelvis: 35-Year Experience.

BACKGROUND: Aggressive angiomyxoma is a very rare mesenchymal tumor most commonly found in the pelvic and perineal regions. Although many are estrogen and progesterone hormone receptor positive, the pathogenesis is unknown. Due to its rarity, there is a paucity of literature relating to this pathology. This article presents a case series on the management of aggressive angiomyxoma of the pelvis. OBJECTIVE: To present a 35-year experience managing aggressive angiomyxoma of the pelvis. DESIGN: This was a retrospective single-system analysis. SETTINGS: This study was conducted at a quaternary referral academic health care system. PATIENTS: All patients treated for aggressive angiomyxoma of the pelvis. INTERVENTIONS: All patients underwent surgical or medical management of their disease. MAIN OUTCOME MEASURES: The primary outcomes were disease recurrence and mortality. Secondary outcomes included risk factors for recurrence. RESULTS: A total of 32 patients (94% women) were identified with a median follow-up of 65 months. Thirty patients (94%) underwent operative resection and 2 patients were treated solely with medical management. Fifteen achieved an R0 resection (negative microscopic margins) at the index operation, of which 4 (27%) experienced tumor recurrence. There were no mortalities. No risk factors for disease recurrence were identified. LIMITATIONS: Limitations to our study include its nonrandomized retrospective nature, single health care system experience, and small patient sample size. CONCLUSIONS: Aggressive angiomyxoma is a rare, slow-growing tumor with locally invasive features and a high potential for recurrence even after resection with negative margins. Imaging modalities such as CT or MRI should be obtained to aid in diagnosis and surgical planning. Workup should be paired with preoperative biopsy and testing for hormone receptor status, which can increase diagnostic accuracy and guide medical treatment. Close posttreatment surveillance is imperative to detect recurrence. See Video Abstract . ANGIOMIXOMA AGRESIVO DE PELVIS EXPERIENCIA DE AOS: ANTECEDENTES:El angiomixoma agresivo es un tumor mesenquimal muy raro que se encuentra más comúnmente en las regiones pélvica y perineal. Aunque muchos son positivos para los receptores hormonales como el estrógeno y la progesterona, la patogénesis es aún desconocida. Debido a su rareza, existe escasa literatura relacionada con esta patología. Este artículo presenta una serie de casos sobre el tratamiento del angiomixoma agresivo de pelvis.OBJETIVO:Presentar una experiencia de 35 años en el manejo del angiomixoma agresivo de pelvis.DISEÑO:Este fue un análisis retrospectivo de sistema único.AJUSTES:Este estudio se llevó a cabo en un sistema de salud académico de referencia de nivel cuaternario.PACIENTES:Todos los pacientes tratados por angiomixoma agresivo de pelvis.INTERVENCIONES:Todos los pacientes se sometieron a tratamiento quirúrgico y/o médico de su enfermedad.PRINCIPALES MEDIDAS DE RESULTADO:Los resultados primarios fueron la recurrencia de la enfermedad y la mortalidad. Los resultados secundarios incluyeron factores de riesgo de recurrencia.RESULTADOS:Se identificaron un total de 32 pacientes (94% mujeres) con una mediana de seguimiento de 65 meses. Treinta (94%) fueron sometidos a resección quirúrgica y dos fueron tratados únicamente con tratamiento médico. Quince lograron una resección R0 (márgenes microscópicos negativos) en la operación inicial, de los cuales cuatro (27%) experimentaron recurrencia tumoral. No hubo mortalidades. No se identificaron factores de riesgo para la recurrencia de la enfermedad.LIMITACIONES:Las limitaciones de nuestro estudio incluyen su naturaleza retrospectiva no aleatoria, la experiencia de un solo sistema de atención médica y el tamaño pequeño de la muestra de pacientes.CONCLUSIONES:El angiomixoma agresivo es un tumor raro, de crecimiento lento, con características localmente invasivas y un alto potencial de recurrencia incluso después de una resección con márgenes negativos. Se deben obtener modalidades de imágenes como CT y/o MRI para la ayuda diagnóstica y la planificación quirúrgica. El estudio debe combinarse con una biopsia preoperatoria y pruebas del estado de los receptores hormonales, que pueden aumentar la precisión del diagnóstico y guiar el tratamiento médico. Es imperativa una estrecha vigilancia posterior al tratamiento para detectar recurrencia. (Traducción-Dr Osvaldo Gauto ).

Outcomes of Primary Tumor Excision do not Differ from Non-Resection Methods in Pediatric Mesenchymal Hamartoma of the Liver: A Rapid Systematic Review.

BACKGROUND: To conduct a rapid systematic review comparing the outcomes of primary tumor resection versus non-resection on patients with hepatic mesenchymal hamartoma. METHODS: We searched the Ovid MEDLINE, EMBASE, Scopus, PubMed, Web of Science, and Google Scholar databases from January 1, 2000 to March 31, 2022. Studies that described cases of hepatic mesenchymal hamartoma, including management and outcomes, were included. RESULTS: 62 articles met inclusion criteria with 95 cases in total. Patients were assigned to the primary tumor resection (n = 85) or non-resection (n = 10) cohort based on the described management. Similar rates of morbidity (17% vs 20%) and mortality (6 vs 10%) were identified between cohorts. There were no differences in sex, liver lobe involvement, or tumor size among study groups. CONCLUSIONS: Complete tumor resection should remain the gold standard for hepatic mesenchymal hamartomas when an adequate liver remnant exists. Reports of non-resected tumors demonstrating spontaneous regression or stability with watchful waiting have poor long term follow-up and have inadequate evidence of a true mesenchymal hamartoma diagnosis. LEVEL OF EVIDENCE: Level I.

Remdesivir-associated bradycardia in COVID-19: a rapid review protocol.

INTRODUCTION: Remdesivir is an antiviral medication that is used in the treatment of severe COVID-19. Research has highlighted the potential cardiac side effects of remdesivir, including the occurrence of remdesivir-associated bradycardia (RAB), but these findings have not been consistent. In addition, very little is known about the clinical implications and outcomes of RAB. The aim of this rapid systematic review is to determine the event rate of developing bradycardia while receiving remdesivir treatment compared with not receiving remdesivir in patients diagnosed with COVID-19. METHODS AND ANALYSIS: This study follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol guidelines and will include original papers related to COVID-19, remdesivir and bradycardia. Only English language papers published from 1 December 2019 to 31 December 2022 will be included. The following databases will be searched using keywords and controlled vocabulary: Ovid MEDLINE, Ovid EMBASE, Scopus, Cochrane, PubMed and Web of Science. Two reviewers will independently perform screening and data abstraction. Data will be synthesised qualitatively as well as quantitatively. A random-effects model will be used to calculate the pooled estimates. ETHICS AND DISSEMINATION: This review will systematically analyse the clinical studies available to help better characterise RAB. The results will support a retrospective study investigating RAB that is currently being conducted at the University Medical Center of Southern Nevada in Las Vegas, Nevada. PROSPERO REGISTRATION NUMBER: This protocol has been submitted to and approved by PROSPERO (Protocol ID: CRD42022331614).

The Data Error Criteria (DEC) for retrospective studies: development and preliminary application.

Retrospective chart review (RCR) studies rely on the collection and analysis of documented clinical data, a process that can be prone to errors. The aim of this study was to develop a defined set of criteria to evaluate RCR datasets for potential data errors. The Data Error Criteria (DEC) were developed by identifying data coding and data entry errors via literature review and then classifying them based on error types. Three components comprise the DEC: general errors, numerical-specific errors, and categorical variable-specific errors. Two reviewers independently applied these criteria via a manual review process to an existing de-identified database. A total of 10,168 errors were identified out of a total of 28,656 data points. The total number of errors included redundancies as certain errors may be included in multiple categories. These included 2515 general errors, 39 numerical-specific errors, and 7614 categorical variable-specific errors. Input-related categorical variable-specific errors occurred most frequently, followed by errors secondary to blank cells. Inter-rater agreement was near perfect for all categories. Identifying errors outlined in the DEC can be crucial for the data analysis stage as they can lead to inaccurate calculations and delay study timelines. The DEC offers a framework to evaluate datasets while reducing time and efforts needed to create high-quality RCR-related databases.

Clinical Characteristics and Implications of Bradycardia in COVID-19 Patients Treated with Remdesivir: A Single-Center Retrospective Cohort Study.

BACKGROUND AND OBJECTIVES: Remdesivir is an antiviral drug used to treat coronavirus disease 2019 (COVID-19) with a relatively obscure cardiac effect profile. Previous studies have reported bradycardia associated with remdesivir, but few have examined its clinical characteristics. The objective of this study was to investigate remdesivir associated bradycardia and its associated clinical characteristics and outcomes. METHODS: This is a single-institution retrospective study that investigated bradycardia in 600 patients who received remdesivir for treatment of COVID-19. A total of 375 patients were included in the study after screening for other known causes of bradycardia (atrioventricular [AV] nodal blockers). All patients were analyzed for episodes of bradycardia from when remdesivir was initiated up to 5 days after completion, a time frame based on the drug's putative elimination half-life. Univariate and multivariate statistical tests were conducted to analyze the data. RESULTS: The mean age of the sample was 56.63 ± 13.23 years. Of patients who met inclusion criteria, 49% were found to have bradycardia within 5 days of remdesivir administration. Compared to the cohort without a documented bradycardic episode, patients with bradycardia were significantly more likely to experience inpatient mortality (22% vs 12%, p = 0.01). The patients with bradycardia were found to have marginally higher serum D-dimer levels (5.2 vs 3.4 µg/mL, p = 0.05) and were more likely to undergo endotracheal intubation (28% vs 14%, p = 0.008). Male sex, hyperlipidemia, and bradycardia within 5 days of completing remdesivir were significant predictors of inpatient mortality. No significant differences in length of stay were found. CONCLUSIONS: Bradycardia that occurs during or shortly after remdesivir treatment in COVID-19 patients may be associated with an increased rate of in-hospital mortality. However, COVID-19 and its cardiac complications cannot be excluded as potential contributors of bradycardia in the present study. Future studies are needed to further delineate the cardiac characteristics of COVID-19 and remdesivir.

Unusual Case of Mirizzi Syndrome Presenting as Painless Jaundice.

BACKGROUND Isolated painless jaundice is an uncommon presenting sign for Mirizzi syndrome, which is typically characterized by symptoms of acute or chronic cholecystitis. We report a rare case of Mirizzi syndrome with an acute onset of painless obstructive jaundice. CASE REPORT A 60-year-old man with an unremarkable prior medical history presented with 1 week of jaundice, dark urine, and acholic stools. His laboratory studies revealed a pattern of cholestasis with marked direct hyperbilirubinemia. Ultrasound and magnetic resonance imaging studies demonstrated intrahepatic ductal dilation and cholelithiasis, including a stone within the cystic duct. Endoscopic retrograde cholangiopancreatography with SpyGlass cholangioscopy confirmed the diagnosis of Mirizzi syndrome. CONCLUSIONS An atypical presentation of Mirizzi syndrome should be suspected in the setting of biliary obstruction without pain. The differential diagnosis is broad and includes choledocholithiasis, ascending cholangitis, and hepatobiliary malignancy. Evaluation should include laboratory studies and biliary tract imaging. Noninvasive biliary tract imaging can help exclude malignancy and confirm ductal dilation but is not sensitive for Mirizzi syndrome. Endoscopic retrograde cholangiopancreatography can serve both diagnostic as well as therapeutic purposes via stone extraction and stent placement. SpyGlass cholangioscopy can also augment management in the form of Electrohydraulic lithotripsy. Although therapeutic biliary endoscopy can be very effective, cholecystectomy remains the definitive treatment for Mirizzi syndrome.

A single-center retrospective study on the incidence and clinical significance of the electrocardiographic "Triangular QRS-ST-T Waveform" pattern*.

BACKGROUND: The triangular QRS-ST-T waveform is a rare presentation of ST-segment elevation acute myocardial infarction associated with a poor in-hospital prognosis. OBJECTIVE: To evaluate the incidence and clinical implications of the QRS-ST-T waveform pattern. METHODS: Clinical data from non-pregnant adult patients who presented as STEMI activations at a single institution between 2017 and 2021 were reviewed. Patients who met electrocardiographic criteria for triangular QRS-ST-T waveform - a giant wave from the fusion of the QRS complex, the ST-segment, and the T-wave - were included in the study. RESULTS: There were 417 STEMI activations, eight (1.9%) of which fulfilled the criteria for the triangular QRS-ST-T waveform pattern on electrocardiography. Coronary angiography was performed in five of these patients, four of whom demonstrated a significant lesion to the left anterior descending artery. Three patients did not undergo angiography secondary to hemodynamic instability. Seven of the patients in our study experienced cardiogenic shock requiring vasopressor, inotropic, and/or mechanical support. Only two patients survived to discharge; one was successfully bridged to coronary artery bypass grafting via intra-aortic balloon pump, while the other underwent a staged percutaneous coronary intervention. CONCLUSIONS: The triangular QRS-ST-T waveform pattern is a rare ECG finding that may indicate hyper-acute STEMI and is an ominous sign of impending hemodynamic instability. Patients who survived received prompt aggressive therapeutic management.

Using macros in microsoft excel to facilitate cleaning of research data.

Background: Retrospective chart review studies may be delayed by inability to export clean clinical data from an electronic medical record (EMR) or data repository. Macros are pre-programmed procedures that can be used in Microsoft Excel to help streamline the process of cleaning clinical datasets. Objectives: To demonstrate how macros may be useful for researchers at community hospitals and smaller academic health centers that lack informatics support. Methods: Using an intrinsic function of our institution's EMR, vital signs and lab results from 20 individual hospitalizations were exported to a spreadsheet. Two macros were developed to sort through these datasets and output them into a specified format. The speed of macro-assisted data cleaning was compared to manual transcription. Results: Time spent on data cleaning was significantly reduced when using macro-assisted sorting compared to the manual approach for both vital signs (46.5 seconds versus 12.3 minutes per record, a 94% reduction; P < 0.001) and labs (13.7 seconds versus 2.6 minutes per record, a 91% reduction; P < 0.001). Conclusions:Macros offer a flexible and efficient tool for cleaning large sets of clinical data, particularly when an institution lacks informatics support or EMR functionality to export clinical data in an analysis-ready format.

The Impact of Educational Resources and Perceived Preparedness on Medical Education Performance.

INTRODUCTION: Undergraduate medical education has evolved necessarily with the increasing utilization of technology and the availability of ancillary resources developed for medical students. However, medical educational resources are expensive and there have been few studies validating these resources for their ability to significantly modify student exam performance. METHODS: A post-exam survey was devised to evaluate medical students for resource usage, student-perceived preparedness, and exam performance. RESULTS: Students who felt more prepared for exams performed better than students who felt less prepared (p = .017). Students who watched didactic lectures online and those who utilized peer-to-peer tutoring outperformed students who did not use these resources (p = .035, p = .008). Analyses of the data show that none of the purchased resources utilized significantly improved student exam performance. The majority of students used between six and eight resources for exam preparation. There may be a slightly negative association with the quantity of resources used and exam scores (p = .18). DISCUSSION: Contrary to traditional confidence studies that correlate overconfidence with underperformance, medical students who reported feeling more prepared for exams performed better than students who felt less prepared. CONCLUSION: Medical students may have a more complete grasp of their knowledge base and deficits, which may enable a more accurate match between exam expectations and academic performance. This post-exam survey method can be customized and applied to evaluate resource utility as it pertains to specific undergraduate medical education curricula at individual institutions.

Who funds Alzheimer's disease drug development?

INTRODUCTION: Despite the increase in Alzheimer's disease (AD) cases in the United States, no new treatments have been approved in the United States since 2003. The costs associated with drug development programs are high and serve as a significant deterrent to AD therapeutic investigations. In this study, we analyze the sponsorship data for AD clinical trials conducted since 2016 to assess the fiscal support for AD clinical trials. METHODS: We analyzed the funding sources of all AD trials over the past 5 years as reported on ClinicalTrials.gov. RESULTS: There were 136 trials being conducted for treatments in the US AD therapeutic pipeline on the index date of this study. Among non-prevention trials, disease-modifying therapies (DMT) in Phase 3 were almost entirely sponsored by the biopharmaceutical industry; Phase 2 DMT trials were split between the biopharmaceutical industry and funding from the National Institutes of Health (NIH) to academic medical centers (AMCs). The majority of prevention trials received sponsorship from public-private partnerships (PPP). Trials of symptomatic agents are equally likely to have biopharmaceutical or NIH/AMC sponsorship. Most trials with repurposed agents had NIH/AMC funding (89%). Since 2016, there has been consistent growth in the number of trials sponsored both in part and fully by NIH/AMC sources and in PPP, and there has been a reduction in biopharmaceutical company-sponsored trials. DISCUSSION: The number of trials supported by the biopharmaceutical industry has decreased over the past 5 years; trials supported from federal sources and PPP have increased. Repurposed compounds are mostly in Phase 2 trials and provide critical mechanistic information.

Repurposed agents in the Alzheimer's disease drug development pipeline.

BACKGROUND: Treatments are needed to address the growing prevalence of Alzheimer's disease (AD). Clinical trials have failed to produce any AD drugs for Food and Drug Administration (FDA) approval since 2003, and the pharmaceutical development process is both time-consuming and costly. Drug repurposing provides an opportunity to accelerate this process by investigating the AD-related effects of agents approved for other indications. These drugs have known safety profiles, pharmacokinetic characterization, formulations, doses, and manufacturing processes. METHODS: We assessed repurposed AD therapies represented in Phase I, Phase II, and Phase III of the current AD pipeline as registered on ClinicalTrials.gov as of February 27, 2020. RESULTS: We identified 53 clinical trials involving 58 FDA-approved agents. Seventy-eight percent of the agents in trials had putative disease-modifying mechanisms of action. Of the repurposed drugs in the pipeline 20% are hematologic-oncologic agents, 18% are drugs derived from cardiovascular indications, 14% are agents with psychiatric uses, 12% are drug used to treat diabetes, 10% are neurologic agents, and the remaining 26% of drugs fall under other conditions. Intellectual property strategies utilized in these programs included using the same drug but altering doses, routes of administration, or formulations. Most repurposing trials were supported by Academic Medical Centers and were not funded through the biopharmaceutical industry. We compared our results to a European trial registry and found results similar to those derived from ClinicalTrials.gov. CONCLUSIONS: Drug repurposing is a common approach to AD drug development and represents 39% of trials in the current AD pipeline. Therapies from many disease areas provide agents potentially useful in AD. Most of the repurposed agents are generic and a variety of intellectual property strategies have been adopted to enhance their economic value.