Innovative approaches to COVID-19 medical countermeasure development.

Background: The COVID-19 pandemic, while unfortunately notable for immense strain and death throughout the world, has also shown great promise in the development of medical countermeasures. As the global scientific community shifted almost entirely towards vaccines, diagnostics and therapeutics, new trial designs most significantly adaptive platform trials, began to be used with greater speed and broader reach. These designs allowed for deploying and investigating new therapeutics, repurposing currently existing therapeutics and flexibly removing or adding additional medications as data appeared in real-time.

Exclusion of pregnant people from emergency vaccine clinical trials: A systematic review of clinical trial protocols and reporting from 2009 to 2019.

Background: Existing ethics guidance and regulatory requirements emphasize the need for pregnancy-specific safety and efficacy data during the development of vaccines in health emergencies. Our objective was to conduct a systematic review of vaccine clinical trials during active epidemic periods.

Methods: We searched for Phase II and Phase III vaccine clinical trials initiated during the H1N1 influenza, Middle East Respiratory Syndrome Coronavirus (MERS-CoV), Zika, and Ebola virus disease (EVD) outbreaks from 2009 to 2019.

US Hospital Capacity Managers' Experiences and Concerns Regarding Preparedness for Seasonal Influenza and Influenza-like Illness.

Importance: The 2017-2018 influenza season in the US was marked by a high severity of illness, wide geographic spread, and prolonged duration compared with recent previous seasons, resulting in increased strain throughout acute care hospital systems.

Objective: To characterize self-reported experiences and views of hospital capacity managers regarding the 2017-2018 influenza season in the US.

Design, Setting, And Participants: In this qualitative study, semistructured telephone interviews were conducted between April 2018 and January 2019 with a random sample of capacity management administrators responsible for throughput and hospital capacity at short-term, acute care hospitals throughout the US.

Design for Implementation of a System-Level ICU Pandemic Surge Staffing Plan.

Background: The current coronavirus disease 2019 pandemic is causing significant strain on ICUs worldwide. Initial and subsequent regional surges are expected to persist for months and potentially beyond. As a result of this, as well as the fact that ICU provider staffing throughout the United States currently operate at or near capacity, the risk for severe and augmented disruption in delivery of care is very real.

Variation among state-level approaches to addressing alcohol abuse in opioid treatment programs.

In view of their role in licensing opioid treatment programs (OTPs), state opioid treatment authorities (SOTAs) are in a unique position to influence how OTPs address their patients' alcohol abuse. Using data from a telephone survey of SOTAs from the District of Columbia and states that have at least one OTP (n = 46), this study examines the extent to which SOTAs address alcohol abuse in their respective state policies and guidelines for OTPs. Findings indicate that 27 states have overall measures on how to address patients' problematic alcohol use, 23 states require or recommend alcohol education to be provided to all patients, and 17 states have stipulations that address specific actions to be taken if patients present at daily dosing under the influence of alcohol.