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Clinical Issues and Guidance

Promising Therapeutics

VA Study Shows Hydroxychloroquine Is of No Benefit to COVID-19 Patients

Yet another study has emerged that shows no benefit to the addition of hydroxychloroquine only (HCQ) or with added azithromycin (HC + AZ) to the standard of care (SOC) in a large retrospective comparison from the Department of Veterans Affairs (VA) hospitals. The outcomes for a total of 368 hospitalized male patients in the VA system who were treated for COVID-19 between March 9 and April 11 were examined. The outcomes assessed were death or need for ventilator support. The risk of death was highest in the HC-only group compared with SOC. Risk for need for ventilator support was no different in the groups (HC, HC + AZ, SOC). Although it was a retrospective study, the data were derived from electronic health records, not administrative or billing claims.

Bruton Tyrosine Kinase Inhibitor May Ameliorate Cytokine Storm

An interesting brief report in the American Society of Clinical Oncologists’ ASCO Post described the use of a Bruton tyrosine kinase (BTK) inhibitor to reverse critical pulmonary insufficiency in a patient with Waldenstrom’s macroglobulinemia. This report and commentary explain the potential role of such tyrosine kinase inhibitors and the mechanism by which they may ameliorate the cytokine storm present in many critically ill COVID-19 patients by inhibiting many of the pro-inflammatory cytokines released in this setting. The findings were first published as a letter to the editor of journal Blood.

New ACS COVID-19 Registry: Registration Now Open

The American College of Surgeons (ACS) COVID-19 Registry is now available to all hospitals interested in collecting important clinical patient data for a disease about which little is known. Hospitals are now joining.

We ask that you participate in this very important initiative.

The registry gathers data on surgical and nonsurgical COVID-19 positive patients. The ACS COVID-19 Registry is a quality improvement program and has been officially granted non-human subject research status, which does not require institutional review board oversight.

Participation in the registry is free of charge.

The ACS COVID-19 Registry was developed with the input of several expert clinicians who are treating COVID-19 patients. In addition to patient demographics, variables are designed to allow ease of data collection and are based on relevant severity predictors, admission information, hospitalization information, therapies used, and discharge information, as well as other factors. All patients ages 18 and older may be tracked from hospital admission through discharge by participating hospitals.

With the decades of experience in data collection and because of the immediate importance, this registry was created in an expedited time frame to respond to the ongoing pandemic crisis. The data collection platform uses REDCap—a known system that all hospitals can easily access. Each hospital will have 100 percent access to their collected data, and the ACS will provide each participating hospital benchmarked data reports at interval time periods. This information will help hospitals to better understand their efforts and results in context to other facilities.

Again, we ask that you participate in this very important initiative. We all need to learn more about COVID-19 patients, and this ACS COVID-19 Registry will unequivocally help to advance our collective knowledge. Learn more about the ACS COVID-19 Registry, and contact COVID19Registry@facs.org to join.

University of Chicago Surgeons Offer Advice on Obtaining Informed Consent during COVID-19

The department of surgery at the University of Chicago, IL, developed policy changes for obtaining informed consent from patients requiring surgery during the COVID-19 outbreak. These guidelines have been published in Annals of Surgery and call for the following: attending responsibility for obtaining consent, circulation of a conversation guide for use in discussions between attending surgeons and their patients, and standardized documentation regarding discussion of COVID-19.

The first element of the COVID-19 enhanced informed consent discussion concerns the lack of information on the true risks of otherwise “routine” procedures during the pandemic. Second, the authors advise surgeons to discuss the uncertain (but likely increased) risk of nosocomial infection with COVID-19. Third, the authors believe that it is important to inform patients that the COVID-19 pandemic has changed day-to-day hospital operations at many hospitals in ways that have the potential to significantly affect their perioperative care and experience. They also suggest that surgeons discuss the possible impact of pandemic-associated health care resource shortages on postoperative care.

NIH Issues Updated Guidelines on Treatment of COVID-19 Patients

The National Institutes of Health (NIH) has issued updated treatment guidelines to inform clinical decision making when providing care to patients with COVID-19. Because clinical information about the optimal management of COVID-19 is evolving quickly, the NIH guidelines, which are crafted by a panel of experts in respiratory, infectious, and emergency patient care, are updated frequently as published data and other authoritative information becomes available. The latest iteration can be summarized as follows:

  • The COVID-19 Treatment Guidelines Panel does not recommend the use of any agents for pre-exposure prophylaxis (PrEP) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outside of the setting of a clinical trial.
  • The panel does not recommend the use of any agents for postexposure prophylaxis (PEP) against SARS-CoV-2 infection outside of the setting of a clinical trial.
  • The panel recommends no additional laboratory testing and no specific treatment for persons with suspected or confirmed asymptomatic or presymptomatic SARS-CoV-2 infection.
  • At present, no drug has proven to be safe and effective for treating COVID-19. The data are insufficient to recommend either for or against the use of any antiviral or immunomodulatory therapy in patients with COVID-19 who have mild, moderate, severe, or critical illness.

Study Shows Benefits of Self-Proning in COVID-19 ED Patients

A pilot study carried out in a New York, NY, emergency department (ED) shows that awake early self‐proning improves oxygen saturation in COVID‐19-positive patients, according to a report published in Academic Emergency Medicine. The study included 50 patients suspected of having COVID-19 with hypoxia on arrival in the ED. A standard pulse oximeter was used to measure SpO2 (peripheral capillary oxygen saturation). SpO2 measurements were recorded at triage and after five minutes of proning. Supplemental oxygenation methods included non‐rebreather mask and nasal cannula. Investigators also characterized post‐proning failure rates of intubation within the first 24 hours of arrival to the ED.

Overall, the median SpO2 at triage was 80 percent (interquartile range [IQR] 69 to 85). After application of supplemental oxygen was given to patients on room air it was 84 percent (IQR 75 to 90). After five minutes of proning was added, SpO2 improved to 94 percent (IQR 90 to 95). Comparison of the pre- to postmedian by the Wilcoxon rank-sum test yielded P=0.001. A total of 13 patients (24 percent) failed to improve or maintain their oxygen saturations and required endotracheal intubation within 24 hours of arrival to the ED.

Further studies are needed to support causality and determine the effect of proning on disease severity and mortality.

JAMA Report on Mortality Rates for COVID-19 Patients on Ventilators: Incomplete Picture

A recent study by Richardson and colleagues in the Journal of the American Medical Association (JAMA) has made national headlines for its report of an 88 percent mortality rate for COVID-19 mechanically ventilated patients in a New York, NY, area health system. Although the mortality rate of COVID-19 patients with acute respiratory distress syndrome is undoubtedly high, it is important to note that in this study, due to the limited follow-up period, the clinical outcomes are unknown overall for 54 percent of the patients. Of the 1,151 mechanically ventilated patients in the study, at a median follow-up period of 4.5 days, 3 percent had been discharged home, 25 percent had died, and 72 percent were still hospitalized, intubated, and mechanically ventilated. The reported mortality rate of 88 percent was calculated based on deaths and discharges of 320 out of 1,151 mechanically ventilated patients. The outcomes for the remainder 831 patients who remained intubated at the end of study will change the reported mortality rate, likely downward, though possibly even upward. Preliminary data from other centers suggests a mortality rate lower than the 88 percent reported by the study authors. More research clearly is needed.

Surgical Specialty Societies Offer Recommendations for Ramp Up of Elective Operations

Most surgical specialty societies have not committed to a policy or time frame to resume elective surgery. The American Academy of Ophthalmology (AAO) and the American Academy of Orthopaedic Surgeons (AAOS) state on their websites that decisions to reopen normal practice should be made locally and regionally, not nationally, and should be based on available resources. The AAOS has developed clinical considerations, and the AAO is in the process of developing guidelines. Most of the societies refer their members to Centers for Medicare & Medicaid Services and American College of Surgeons guidelines.

More specific information is as follows:

Ophthalmologists Offer Recommendations on Eye Care during Pandemic

A study published in Current Eye Research indicates that, to minimize COVID-19 infection of both health care personnel and patients, ophthalmologists should use nonpharmaceutical interventions, follow hygienic recommendations, and wear personal protective equipment to contain viral spread. The authors also suggest conducting risk assessment for postponement of nonurgent cases and triage for ophthalmic outpatient clinic. The study was conducted in Bergamo, Italy, an epicenter of the COVID-19 outbreak in Europe.

Resuming Elective Surgery at UTMB Predicated on Patient and Staff Well-Being

J. Patrick Walker, MD, FACS, Professor, Minimally Invasive Surgery/Foregut Surgery Division, Department of Surgery; James C. Thompson, MD, Distinguished Chair in Surgery; Vice-Chair for Surgical Operations; and Surgical Director of Perioperative Services, University of Texas Medical Branch, Galveston, shares his health system’s experience during COVID-19. He also describes how the health system has sought to prepare to resume the provision of elective surgery. Read more here.