Trends in Firearm Injury Prevention Research Funding, Clinical Trials, and Publications in the US, 1985-2022.

This cross-sectional study examines federal funding, registered clinical trials, and publications to quantify trends in firearm injury prevention research in the US from 1985 to 2022.

Core Descriptor Sets for Rectal Prolapse Outcomes Research Using a Modified Delphi Consensus.

BACKGROUND: There is wide variation in prolapse care. OBJECTIVE: To determine core descriptor sets for rectal prolapse to enhance outcomes research. DESIGN: Descriptors for patients undergoing rectal prolapse surgery were generated through a systematic review and expert opinion. Stakeholders were recruited internationally via listserv and social media. Experts were encouraged to consider the minimum descriptors that could be considered during clinical care, and descriptors were grouped into core descriptor sets. Consensus was defined as greater than 70% agreement. SETTING: A 3-round Delphi process using a 9-point Likert scale based on expert results was distributed via survey. The final interactive meeting used a polling platform. PARTICIPANTS: The Pelvic Floor Disorders Consortium interdisciplinary group convened to advance the clinical care of pelvic floor disorders. MAIN OUTCOME MEASURES: To achieve expert consensus for core descriptor sets for rectal prolapse using a modified Delphi method. RESULTS: A total of 206 providers participated, with survey response rates of 82% and 88%, respectively. Responders were from North America (56%), Europe (29%), and Latin America, Asia, Australia, New Zealand, and Africa (15%). Ninety-one percent of participants identified as colorectal surgeons and 80% reported >5 years of experience (35% reported >15 years). Fifty-seven attendees participated in the final meeting and voted on core descriptor sets. Ninety-three percent of participants agreed that descriptors such as age, BMI, frailty, nutrition, and the American Society of Anesthesiology score correlated to physiologic status. One hundred percent of participants agreed to include baseline bowel function. One hundred percent of participants reported willingness to complete a synoptic operative report. Follow-up intervals 1, 3, and 5 years after surgery (76%) with a collection of recurrence and functional outcomes at those time periods reached an agreement. LIMITATIONS: Individual bias, self-identification of experts, and paucity of knowledge related to rectal prolapse. CONCLUSIONS: This represents the first steps toward international consensus to unify language and data collection processes for rectal prolapse. See Video Abstract . CONJUNTOS DE DESCRIPTORES BSICOS PARA LA INVESTIGACIN DE RESULTADOS DE PROLAPSO RECTAL MEDIANTE UN CONSENSO DELPHI MODIFICADO: ANTECEDENTES:Existe una amplia variación en la atención del prolapso.OBJETIVO:Determinar conjuntos de descriptores básicos para el prolapso rectal para mejorar los resultados de la investigación.DISEÑO:Los descriptores para pacientes sometidos a cirugía de prolapso rectal se generaron a través de una revisión sistemática y la opinión de expertos. Las partes interesadas fueron reclutadas internacionalmente a través de listas de servicio y redes sociales. Se animó a los expertos a considerar los descriptores mínimos que podrían considerarse durante la atención clínica, y los descriptores se agruparon en conjuntos de descriptores básicos. El consenso se definió como > 70% de acuerdo.AJUSTE:Se distribuyó mediante encuesta un proceso Delphi de tres rondas que utiliza una escala Likert de 9 puntos basada en resultados de expertos. La reunión interactiva final utilizó una plataforma de votación.PARTICIPANTES:El grupo interdisciplinario del Consorcio de Trastornos del Suelo Pélvico se reunió para avanzar en la atención clínica de los trastornos del suelo pélvico.MEDIDAS PRINCIPALES DE RESULTADOS:Lograr el consenso de expertos para los conjuntos de descriptores básicos para el prolapso rectal utilizando un método Delphi modificado.RESULTADOS:Participaron 206 proveedores con tasas de respuesta a la encuesta del 82% y 88% respectivamente. Los encuestados procedían de América del Norte (56%), Europa (29%) y América Latina, Asia, Australia, Nueva Zelanda y África (15%). El noventa y uno por ciento se identificó como cirujanos colorrectales y el 80% reportó más de 5 años de experiencia (35% > 15 años). Cincuenta y siete asistentes participaron en la reunión final y votaron sobre conjuntos de descriptores básicos. El noventa y tres por ciento estuvo de acuerdo en que descriptores como edad, índice de masa corporal, fragilidad, nutrición y puntuación de la Sociedad Estadounidense de Anestesiología se correlacionaban con el estado fisiológico. El cien por ciento estuvo de acuerdo en incluir la función intestinal inicial. El 100% refirió disposición para realizar un informe operativo sinóptico. Los intervalos de seguimiento 1,3,5 años después de la cirugía (76%) con un conjunto de recurrencias y los resultados funcionales en esos períodos de tiempo coincidieron.LIMITACIONES:Sesgo individual, autoidentificación de los expertos y escasez de conocimientos relacionados con el prolapso rectal.CONCLUSIONES:Esto representa los primeros pasos hacia un consenso internacional para unificar el lenguaje y los procesos de recolección de datos para el prolapso rectal. (Traducción-Yesenia Rojas-Khalil ).

College Undergraduates in the Operating Room: an Educational Model for Early Surgical Education.

Undergraduate pre-medical education in the USA has not traditionally offered opportunities for hands-on surgical education to college-level students. The absence of exposure has been studied, but an educational model to remedy this has not been shared. This course was designed to share a replicable model for college surgical education. Supplementary Information: The online version contains supplementary material available at 10.1007/s40670-022-01577-y.

Ethical challenges of prospective clinical trials during the COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has created an unprecedented opportunity to reimagine clinical research. While much has been written about the challenges associated with generating real-world evidence during the COVID-19 pandemic, comparatively little attention has been paid to the ethical challenges facing patients, clinicians, researchers, and regulatory bodies. AREAS COVERED: In this manuscript, we examine these challenges through the lens of informed consent and explore how the consenting process changes as our understanding of the disease is altered. EXPERT OPINION: We also suggest ways to limit these ethical hurdles through the use of embedded pragmatic clinical trials, which generate real-world data without the limitations associated with observational trials or the resources and lack of generalizability that are obstacles to conducting conventional randomized clinical trials. We argue that clinical research must become more nimble, and must include embedded researchers to ensure that relevant questions and ethical issues are properly addressed.

Treatments Administered to the First 9152 Reported Cases of COVID-19: A Systematic Review.

The emergence of SARS-CoV-2/2019 novel coronavirus (COVID-19) has created a global pandemic with no approved treatments or vaccines. Many treatments have already been administered to COVID-19 patients but have not been systematically evaluated. We performed a systematic literature review to identify all treatments reported to be administered to COVID-19 patients and to assess time to clinically meaningful response for treatments with sufficient data. We searched PubMed, BioRxiv, MedRxiv, and ChinaXiv for articles reporting treatments for COVID-19 patients published between 1 December 2019 and 27 March 2020. Data were analyzed descriptively. Of the 2706 articles identified, 155 studies met the inclusion criteria, comprising 9152 patients. The cohort was 45.4% female and 98.3% hospitalized, and mean (SD) age was 44.4 years (SD 21.0). The most frequently administered drug classes were antivirals, antibiotics, and corticosteroids, and of the 115 reported drugs, the most frequently administered was combination lopinavir/ritonavir, which was associated with a time to clinically meaningful response (complete symptom resolution or hospital discharge) of 11.7 (1.09) days. There were insufficient data to compare across treatments. Many treatments have been administered to the first 9152 reported cases of COVID-19. These data serve as the basis for an open-source registry of all reported treatments given to COVID-19 patients at www.CDCN.org/CORONA . Further work is needed to prioritize drugs for investigation in well-controlled clinical trials and treatment protocols.