Blood shortages and changes to massive transfusion protocols: Survey of hospital practices during the COVID-19 pandemic.

INTRODUCTION: The COVID-19 pandemic has resulted in severe ongoing blood shortages across the US, despite employment of numerous blood-conservation measures. Massive transfusion protocols (MTP) are one resource-intensive practice that utilize significant amounts of blood products. Alterations to the composition of MTP parameters to conserve scarce biologic resources have hitherto not been examined during the pandemic. METHODS: An anonymous 18-question survey was administered to 115 hospitals with valid email contact information. Survey questions addressed whether institutions have altered their MTPs due to the COVID-19 pandemic and blood shortages, and if so, what adjustments they have made. Additional details concerning potential differences in the number and cycles of MTPs and blood product wastage during the COVID-19 pandemic compared to the year prior were assessed. RESULTS: 50 responses were received (43 % response rate). 10 % (5/50) of institutions altered their MTPs utilizing a variety of approaches in attempt to conserve blood during the COVID-19 pandemic. Four additional institutions intend to alter them if it becomes necessary. Following onset of the COVID-19 pandemic, 24 % of institutions (12/50) reported an increase in monthly MTP activations, while 16 % (8/50) reported decreased activations compared to prior to the pandemic. 22 % (11/50) of institutions experienced increased blood wastage, whereas 16 % (8/50) reported decreased waste compared to pre-pandemic. DISCUSSION: The results of this survey highlight a variety of mechanisms by which institutions have attempted to conserve blood via altering MTPs. Whether an institution adjusted their MTP does not correlate with changes in blood product wastage compared to pre-pandemic.

Home-Based Telemental Health: A Proposed Privacy and Safety Protocol and Tool.

Objectives: To describe the development of a protocol and practical tool for the safe delivery of telemental health (TMH) services to the home. The COVID-19 pandemic forced providers to rapidly transition their outpatient practices to home-based TMH (HB-TMH) without existing protocols or tools to guide them. This experience underscored the need for a standardized privacy and safety tool as HB-TMH is expected to continue as a resource during future crises as well as to become a component of the routine mental health care landscape. Methods: The authors represent a subset of the Child and Adolescent Psychiatry Telemental Health Consortium. They met weekly through videoconferencing to review published safety standards of care, existing TMH guidelines for clinic-based and home-based services, and their own institutional protocols. They agreed on three domains foundational to the delivery of HB-TMH: environmental safety, clinical safety, and disposition planning. Through multiple iterations, they agreed upon a final Privacy and Safety Protocol for HB-TMH. The protocol was then operationalized into the Privacy and Safety Assessment Tool (PSA Tool) based on two keystone medical safety constructs: the World Health Organization (WHO) Surgical Safety Checklist/Time-Out and the Checklist Manifesto.Results: The PSA Tool comprised four modules: (1) Screening for Safety for HB-TMH; (2) Assessment for Safety During the HB-TMH Initial Visit; (3) End of the Initial Visit and Disposition Planning; and (4) the TMH Time-Out and Reassessment during subsequent visits. A sample workflow guides implementation. Conclusions: The Privacy and Safety Protocol and PSA Tool aim to prepare providers for the private and safe delivery of HB-TMH. Its modular format can be adapted to each site's resources. Going forward, the PSA Tool should help to facilitate the integration of HB-TMH into the routine mental health care landscape.

Editorial: Reporting Clinical Trials with Important Modifications Due to Extenuating Circumstances, Including the COVID-19 Pandemic: CONSERVE 2021.

During 2020 and 2021, the COVID-19 pandemic has resulted in interruptions and cancellations of clinical trials and has delayed drug development in all areas except SARS-CoV-2 vaccine development. A further concern is the need to rapidly share anonymized datasets and improve opportunities to conduct randomized clinical trials (RCTs) in low-resource developing countries, particularly for oncology trials and for other infectious diseases. The Consolidated Standards of Reporting Trials (CONSORT) 2010 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 currently guide the reporting of trial protocols and completed RCTs, respectively. Extenuating circumstances or unavoidable situations may occur that are beyond the control of study sponsors and investigators. On June 21, 2021, the CONSORT and SPIRIT Extension for RCTs Revised in Extenuating Circumstance (CONSERVE) was published. The scope of CONSERVE 2021 includes modifications that have substantive implications for the feasibility, ethical conduct, scientific content, and study analysis. This Editorial aims to provide the background to CONSERVE 2021 and show how these guidelines may reduce the number of clinical trials currently being paused or discontinued due to the COVID-19 pandemic, particularly in poorly resourced and developing countries.

Editorial: Updates from the World Health Organization (WHO) on Global Treatment Recommendations for Drug-Susceptible and Multidrug-Resistant Tuberculosis.

The World Health Organization (WHO) estimated that in 2019, 10.0 million people worldwide developed tuberculosis (TB), with 1.4 million deaths from TB in that year. Infection with Mycobacterium tuberculosis that is resistant to at least isoniazid and rifampin and an additional chemotherapeutic agent is known as multidrug-resistant TB (MDR TB). Until recently, the prevalence of drug resistance in patients with TB has been poorly understood due to a lack of infection surveillance and molecular testing. Countries with the highest prevalence of TB, including MDR TB, are also those most affected by the COVID-19 pandemic. The identification of MDR TB requires careful monitoring and resources for molecular testing. Previous treatment regimens have required intravenous treatments of long duration and high cost. The 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB have included oral treatment regimens and reduced treatment duration. This Editorial aims to present the rationale for the 2020 and 2021 recommendations from the WHO for the management of drug-susceptible TB and MDR TB.

Characterisation of in-hospital complications associated with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, multicentre cohort study.

BACKGROUND: COVID-19 is a multisystem disease and patients who survive might have in-hospital complications. These complications are likely to have important short-term and long-term consequences for patients, health-care utilisation, health-care system preparedness, and society amidst the ongoing COVID-19 pandemic. Our aim was to characterise the extent and effect of COVID-19 complications, particularly in those who survive, using the International Severe Acute Respiratory and Emerging Infections Consortium WHO Clinical Characterisation Protocol UK. METHODS: We did a prospective, multicentre cohort study in 302 UK health-care facilities. Adult patients aged 19 years or older, with confirmed or highly suspected SARS-CoV-2 infection leading to COVID-19 were included in the study. The primary outcome of this study was the incidence of in-hospital complications, defined as organ-specific diagnoses occurring alone or in addition to any hallmarks of COVID-19 illness. We used multilevel logistic regression and survival models to explore associations between these outcomes and in-hospital complications, age, and pre-existing comorbidities. FINDINGS: Between Jan 17 and Aug 4, 2020, 80 388 patients were included in the study. Of the patients admitted to hospital for management of COVID-19, 49·7% (36 367 of 73 197) had at least one complication. The mean age of our cohort was 71·1 years (SD 18·7), with 56·0% (41 025 of 73 197) being male and 81·0% (59 289 of 73 197) having at least one comorbidity. Males and those aged older than 60 years were most likely to have a complication (aged ≥60 years: 54·5% [16 579 of 30 416] in males and 48·2% [11 707 of 24 288] in females; aged <60 years: 48·8% [5179 of 10 609] in males and 36·6% [2814 of 7689] in females). Renal (24·3%, 17 752 of 73 197), complex respiratory (18·4%, 13 486 of 73 197), and systemic (16·3%, 11 895 of 73 197) complications were the most frequent. Cardiovascular (12·3%, 8973 of 73 197), neurological (4·3%, 3115 of 73 197), and gastrointestinal or liver (0·8%, 7901 of 73 197) complications were also reported. INTERPRETATION: Complications and worse functional outcomes in patients admitted to hospital with COVID-19 are high, even in young, previously healthy individuals. Acute complications are associated with reduced ability to self-care at discharge, with neurological complications being associated with the worst functional outcomes. COVID-19 complications are likely to cause a substantial strain on health and social care in the coming years. These data will help in the design and provision of services aimed at the post-hospitalisation care of patients with COVID-19. FUNDING: National Institute for Health Research and the UK Medical Research Council.

Safety and feasibility of resuming bariatric surgery under the cloud of COVID-19.

INTRODUCTION: Because of the COVID-19 pandemic, numerous bariatric surgical units globally have halted weight loss surgery. Obesity itself has been shown to be a predictor of poor outcome in people infected with the virus. The aim of this study was to report our experience as a high-volume bariatric institution resuming elective weight loss surgery safely amidst emergency admissions of COVID-19-positive patients. METHODS: A standard operating procedure based on national guidance and altered to accommodate local considerations was initiated across the hospital. Data were collected prospectively for 50 consecutive patients undergoing bariatric surgery following recommencement of elective surgery after the first national lockdown in the UK. RESULTS: Between 28 June and 5 August 2020, a total of 50 patients underwent bariatric surgery of whom 94% were female. Median age was 41 years and median body mass index was 43.8 (interquartile range 40.0-48.8)kg/m2. Half of the patients (n = 25/50) underwent laparoscopic sleeve gastrectomy and half underwent Roux-en-Y gastric bypass (RYGB). Of these 50 patients, 9 (18%) had revisional bariatric surgery. Overall median length of hospital stay was 1 day, with 96% of the study population being discharged within 24h of surgery. The overall rate of readmission was 6% and one patient (2%) returned to theatre with an obstruction proximal to jejuno-jejunal anastomosis. None of the patients exhibited symptoms or tested positive for COVID-19. CONCLUSION: With appropriately implemented measures and precautions, resumption of bariatric surgery during the COVID-19 pandemic appears feasible and safe with no increased risk to patients.

Utility Of An Emergency Department Clinical Protocol For Early Identification of Coronavirus Infection.

INTRODUCTION: We assessed the utility of an emergency department (ED) protocol using clinical parameters to rapidly distinguish likelihood of novel coronavirus 2019 (COVID-19) infection; the applicability aimed to stratify infectious-risk pre-polymerase chain reaction (PCR) test results and accurately guide early patient cohorting decisions. METHODS: We performed this prospective study over a two-month period during the initial surge of the 2020 COVID-19 pandemic in a busy urban ED of patients presenting with respiratory symptoms who were admitted for in-patient care. Per protocol, each patient received assessment consisting of five clinical parameters: presence of fever; hypoxia; cough; shortness of breath/dyspnea; and performance of a chest radiograph to assess for bilateral pulmonary infiltrates. All patients received nasopharyngeal COVID-19 PCR testing. RESULTS: Of 283 patients studied, 221 (78%) were PCR+ and 62 (22%) PCR-. Chest radiograph revealed bilateral pulmonary infiltrates in 85%, which was significantly more common in PCR+ (94%) vs PCR- (52%) patients (P < 0.0001). The rate of manifesting all five positive clinical parameters was significantly greater in PCR+ (63%) vs PCR- (6.5%) patients (P < 0.0001). For PCR+ outcome, the presence of all five positive clinical parameters had a specificity of 94%, positive predictive value of 98%, and positive likelihood ratio of 10. CONCLUSIONS: Using an ED protocol to rapidly assess five clinical parameters accurately distinguishes likelihood of COVID-19 infection prior to PCR test results, and can be used to augment early patient cohorting decisions.

Progesterone in Addition to Standard of Care vs Standard of Care Alone in the Treatment of Men Hospitalized With Moderate to Severe COVID-19: A Randomized, Controlled Pilot Trial.

BACKGROUND: Severity of illness in COVID-19 is consistently lower in women. A focus on sex as a biological factor may suggest a potential therapeutic intervention for this disease. We assessed whether adding progesterone to standard of care (SOC) would improve clinical outcomes of hospitalized men with moderate to severe COVID-19. RESEARCH QUESTION: Does short-term subcutaneous administration of progesterone safely improve clinical outcome in hypoxemic men hospitalized with COVID-19? STUDY DESIGN AND METHODS: We conducted a pilot, randomized, open-label, controlled trial of subcutaneous progesterone in men hospitalized with confirmed moderate to severe COVID-19. Patients were randomly assigned to receive SOC plus progesterone (100 mg subcutaneously twice daily for up to 5 days) or SOC alone. In addition to assessment of safety, the primary outcome was change in clinical status on day 7. Length of hospital stay and number of days on supplemental oxygen were key secondary outcomes. RESULTS: Forty-two patients were enrolled from April 2020 to August 2020; 22 were randomized to the control group and 20 to the progesterone group. Two patients from the progesterone group withdrew from the study before receiving progesterone. There was a 1.5-point overall improvement in median clinical status score on a seven-point ordinal scale from baseline to day 7 in patients in the progesterone group as compared with control subjects (95% CI, 0.0-2.0; P = .024). There were no serious adverse events attributable to progesterone. Patients treated with progesterone required three fewer days of supplemental oxygen (median, 4.5 vs 7.5 days) and were hospitalized for 2.5 fewer days (median, 7.0 vs 9.5 days) as compared with control subjects. INTERPRETATION: Progesterone at a dose of 100 mg, twice daily by subcutaneous injection in addition to SOC, may represent a safe and effective approach for treatment in hypoxemic men with moderate to severe COVID-19. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT04365127; URL: www.clinicaltrials.gov.

Moving forward in clinical research with master protocols.

With billions of dollars in research and development (R&D) funding continuing to be invested, the novel coronavirus disease 2019 (COVID-19) has become into a singular focus for the scientific community. However, the collective response from the scientific communities have seen poor return on investment, particularly for therapeutic research for COVID-19, revealing the existing weaknesses and inefficiencies of the clinical trial enterprise. In this article, we argue for the importance of structural changes to existing research programs for clinical trials in light of the lessons learned from COVID-19.

[Building the scientific commons. Conflictualities and pluralism in the light of clinical trials Covid-19]. / Faire du commun dans les sciences - Conflictualités et pluralisme à l'épreuve des essais cliniques COVID-19.

TITLE: Faire du commun dans les sciences - Conflictualités et pluralisme à l'épreuve des essais cliniques COVID-19. ABSTRACT: La crise de la COVID-19 s'est ouverte sur un déficit de moyens thérapeutiques permettant de lutter efficacement contre cette maladie pour les cas les plus graves et sur de nombreuses initiatives visant à mettre en évidence un traitement efficace. Si différentes options ont été explorées, parmi lesquelles la transfusion de plasma de patients guéris, la lutte contre les mécanismes immunitaires déclenchant une réponse trop forte (les orages cytokiniques) ou, à moyen terme, la vaccination, ce sont dans un premier temps surtout les médicaments antiviraux qui ont nourri les espoirs. Après l'identification d'un certain nombre de principes actifs montrant des effets in vitro, il s'agissait d'obtenir rapidement des réponses quant à leurs effets bénéfiques in vivo et aux risques induits. Aussi, s'est-on senti en droit d'attendre que la science nous apporte les connaissances nécessaires sur ces médicaments, qu'elle nous parle, une fois sollicitée, de manière claire et d'une seule voix ; et cela, dans une situation d'urgence où la synchronisation des rythmes de la recherche et du soin n'a rien d'une évidence.

An illumination of the ICN's core competencies in disaster nursing version 2.0: Advanced nursing response to COVID-19 outbreak in China.

AIM: This study aims to report on the actions and incident management of the advanced practice nurses of a disaster operation team who were deployed in response to the COVID-19 outbreak, and to explore how it illustrated the Core Competencies in Disaster Nursing Version 2.0 delineated by the International Council of Nurses in 2019. METHODS: This is a descriptive study. The participants (responders) communicated and reported their actions in the operation with headquarter on a popular social media platform in China (WeChat), established specifically for the three-rescue teams. RESULTS: The response approach of advanced nurses to COVID-19 encompassed six of the eight domains of the competencies outlined in ICN CCDN V2.0, namely on preparation and planning, communication, incident management systems, safety and security, assessment and intervention. CONCLUSIONS: The response teams of advanced practice nurses in this study clearly demonstrated their competencies in disaster rescue, which fulfilled most of the core competencies set forth by the ICN. IMPLICATIONS FOR NURSING MANAGEMENT: The findings of this study contributed to understand the roles played by advanced practice nurses and nurse managers in disaster management and how these relate to the competencies set forth by the ICN.

Rehabilitation programs for patients with COronaVIrus Disease 2019: consensus statements of Taiwan Academy of Cardiovascular and Pulmonary Rehabilitation.

The COronaVIrus Disease 2019 (COVID-19), which developed into a pandemic in 2020, has become a major healthcare challenge for governments and healthcare workers worldwide. Despite several medical treatment protocols having been established, a comprehensive rehabilitation program that can promote functional recovery is still frequently ignored. An online consensus meeting of an expert panel comprising members of the Taiwan Academy of Cardiovascular and Pulmonary Rehabilitation was held to provide recommendations for rehabilitation protocols in each of the five COVID-19 stages, namely (1) outpatients with mild disease and no risk factors, (2) outpatients with mild disease and epidemiological risk factors, (3) hospitalized patients with moderate to severe disease, (4) ventilator-supported patients with clear cognitive function, and (5) ventilator-supported patients with impaired cognitive function. Apart from medications and life support care, a proper rehabilitation protocol that facilitates recovery from COVID-19 needs to be established and emphasized in clinical practice.

Crisis standards of care in a pandemic: navigating the ethical, clinical, psychological and policy-making maelstrom.

The COVID-19 pandemic has caused clinicians at the frontlines to confront difficult decisions regarding resource allocation, treatment options and ultimately the life-saving measures that must be taken at the point of care. This article addresses the importance of enacting crisis standards of care (CSC) as a policy mechanism to facilitate the shift to population-based medicine. In times of emergencies and crises such as this pandemic, the enactment of CSC enables concrete decisions to be made by governments relating to supply chains, resource allocation and provision of care to maximize societal benefit. This shift from an individual to a population-based societal focus has profound consequences on how clinical decisions are made at the point of care. Failing to enact CSC may have psychological impacts for healthcare providers particularly related to moral distress, through an inability to fully enact individual beliefs (individually focused clinical decisions) which form their moral compass.

Description of a new biosafe procedure for cytological specimens from patients with COVID-19 processed by liquid-based preparations.

BACKGROUND: Coronavirus disease 2019 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and represents the causative agent of a potentially fatal disease. The spread of the infection and the severe clinical disease have led to the widespread adoption of social distancing measures. Special attention and efforts to protect or reduce transmission have been applied at all social levels, including health care operators. Hence, this reports focuses on the description of a new protocol for the safe management of cytological samples processed by liquid-based cytology (LBC) with an evaluation of the changes in terms of morphology and immunoreactivity. METHODS: From March 11 to April 25, 2020, 414 cytological cases suspicious for SARS-CoV-2 were processed with a new virus-inactivating method suggested by Hologic, Inc, for all LBC specimens. RESULTS: The samples showed an increased amount of fibrin in the background. A slight decrease in cellular size was also observed in comparison with the standard method of preparation. Nonetheless, the nuclear details of the neoplastic cells were well identified, and the immunoreactivity of the majority of those cells was maintained. The cell blocks did not show significant differences in morphology, immunoreactivity, or nucleic acid stability. CONCLUSIONS: Despite some minor changes in the morphology of the cells, the results of this study highlight that the adoption of the new protocol for the biosafety of LBC-processed samples in pathology laboratories is important for minimizing the risk for personnel, trainees, and cytopathologists without impairing the diagnostic efficacy of the technique.

Development of a Sterile Personal Protective Equipment Donning and Doffing Procedure to Protect Surgical Teams from SARS-CoV-2 Exposure during the COVID-19 Pandemic.

Background: The coronavirus disease 2019 (COVID-19) pandemic has become an increasingly challenging problem throughout the world. Because of the numerous potential modes of transmission, surgeons and all procedural staff represent a unique population that requires standardized procedures to protect themselves and their patients. Although several protocols have been implemented during other infectious disease outbreaks, such as Ebola virus, no standardized protocol has been published in regard to the COVID-19 pandemic. Methods: A multidisciplinary team of two surgeons, an anesthesiologist, and an infection preventionist was assembled to create a process with sterile attire adapted from the National Emerging Special Pathogen Training and Education Center (NETEC) donning and doffing process. After editing, a donning procedure and doffing procedure was created and made into checklists. The procedures were simulated in an empty operating room (OR) with simulation of all personnel roles. A "dofficer" role was established to ensure real-time adherence to the procedures. Results: The donning and doffing procedures were printed as one-page documents for easy posting in ORs and procedural areas. Pictures from the simulation were also obtained and made into flow chart-style diagrams that were also posted in the ORs. Conclusions: Coronavirus disease 2019 (COVID-19) is a quickly evolving pandemic that has spread all over the globe. With the rapid increase of infections and the increasing number of severely ill individuals, healthcare providers need easy-to-follow guidelines to keep themselves and patients as safe as possible. The processes for donning and doffing personal protective equipment (PPE) presented here provide an added measure of safety to surgeons and support staff to provide quality surgical care to positive and suspected COVID-19-positive patients.

Protocols for Personal Protective Equipment in a COVID-19 Medical Shelter.

The coronavirus disease 2019 (COVID-19) has greatly impacted health-care systems worldwide, leading to an unprecedented rise in demand for health-care resources. In anticipation of an acute strain on established medical facilities in Dallas, Texas, federal officials worked in conjunction with local medical personnel to convert a convention center into a Federal Medical Station capable of caring for patients affected by COVID-19. A 200,000 square foot event space was designated as a direct patient care area, with surrounding spaces repurposed to house ancillary services. Given the highly transmissible nature of the novel coronavirus, the donning and doffing of personal protective equipment (PPE) was of particular importance for personnel staffing the facility. Furthermore, nationwide shortages in the availability of PPE necessitated the reuse of certain protective materials. This article seeks to delineate the procedures implemented regarding PPE in the setting of a COVID-19 disaster response shelter, including workspace flow, donning and doffing procedures, PPE conservation, and exposure event protocols.