Testing the feasibility of operationalizing a prospective, randomized trial with remote cardiac safety EKG monitoring during a pandemic.

BACKGROUND: The coronavirus SARS-CoV-2 is highly contagious. Hydroxychloroquine (HCQ) has in vitro activity against SARS-CoV-2. The FDA authorized emergency use of HCQ against COVID-19. HCQ may have dose-related cardiotoxicity. This clinical trial received ethical approval on May 15, 2020, operationalized in June to evaluate a low prophylaxis dose of HCQ (200mg BID) in household contacts of COVID-19-positive patients without physical contact between investigators and participants. It represents the first report of the FDA approved 6-lead EKGs with a smartphone KardiaMobile® 6L application. METHODS: To reach a sample size of 170, household members were contacted by telephone, emailed consent forms with electronic signature capability, and randomized 2:1 to HCQ or observation for 10 days with follow-up of 14 days. Home saliva PCR tests recorded COVID status on days 1 and 14. Symptoms and 6-lead EKGs were obtained daily. RESULTS: Fifty-one participants were randomized with 42 evaluable at day 14. Remote monitoring of 407 EKGs revealed no QTc prolongation or other ECG changes in either group. At time of consent, no participants were symptomatic or COVID+. On days 1 and 14, COVID tests were positive in 4 and 2 in the HCQ group and 4 and 0 in the observation group. No tests converted to positive. There were no deaths or hospitalizations. CONCLUSIONS: A clinical trial without personal contact, rapidly initiated and operationalized to exclude cardiac toxicity using daily remote 6-lead EKG monitoring, is feasible. Of 407 EKGs from 42 participants, there was no evidence of cardiac toxicity. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov : NCT04652648 registration date: December 3, 2020.

The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic.

BACKGROUND: The World Health Organization declared the outbreak of SARS-CoV-2 a pandemic on February 11, 2020. This organism causes COVID-19 disease and the rapid rise in cases and geographic spread strained healthcare systems. Clinical research trials were hindered by infection control measures discouraging physical contact and diversion of resources to meet emergent requirements. The need for effective treatment and prevention of COVID-19 prompted an untested investigational response. Trial groups adapted approaches using remote enrolment and consenting, newly developed diagnostic tests, delivery of study medications and devices to participants' homes, and remote monitoring to ensure investigator/enrollee safety while preserving ethical integrity, confidentiality, and data accuracy. METHODS: Clinical researchers at our community health system in the USA undertook an outpatient randomized open-label study of hydroxychloroquine (HCQ) prophylaxis versus observation of SARS-CoV-2 infection in household COVID-19 contacts. Designed in March 2020, challenges included COVID-19 infection in the research group, HCQ shortage, and lack of well-established home SARS-CoV-2 tests and remote ECG monitoring protocols in populations naive to these procedures. The study was written, funded, and received ethical committee approval in 4 months and was completed by September 2020 during a period of fluctuating infection rates and conflicting political opinions on HCQ use; results have been published. Singular methodology included the use of a new RNA PCR saliva SARS-CoV-2 home diagnostic test and a remote smartphone-based 6-lead ECG recording system. RESULTS: Of 483 households contacted regarding trial participation, 209 (43.3%) did not respond to telephone calls/e-mails and 90 (18.6%) declined; others were not eligible by inclusion or exclusion criteria. Ultimately, 54 individuals were enrolled and 42 completed the study. Numbers were too small to determine the efficacy of HCQ prophylaxis. No serious treatment-related adverse events were encountered. CONCLUSIONS: Flexibility in design, a multidisciplinary research team, prompt cooperation among research, funding, ethics review groups, and finding innovative study approaches enabled this work. Concerns were balancing study recruitment against unduly influencing individuals anxious for protection from the pandemic and exclusion of groups based on lack of Internet access and technology. An issue to address going forward is establishing research cooperation across community health systems before emergencies develop. TRIAL REGISTRATION: ClinicalTrials.gov NCT04652648 . Registered on December 3, 2020.

Bacterial and fungal growth in sputum cultures from 165 COVID-19 pneumonia patients requiring intubation: evidence for antimicrobial resistance development and analysis of risk factors.

BACKGROUND: Coronavirus SARS-CoV-2 causes COVID-19 illness which can progress to severe pneumonia. Empiric antibacterials are often employed though frequency of bacterial coinfection superinfection is debated and concerns raised about selection of bacterial antimicrobial resistance. We evaluated sputum bacterial and fungal growth from 165 intubated COVID-19 pneumonia patients. Objectives were to determine frequency of culture positivity, risk factors for and outcomes of positive cultures, and timing of antimicrobial resistance development. METHODS: Retrospective reviews were conducted of COVID-19 pneumonia patients requiring intubation admitted to a 1058-bed four community hospital system on the east coast United States, March 1 to May 1, 2020. Length of stay (LOS) was expressed as mean (standard deviation); 95% confidence interval (95% CI) was computed for overall mortality rate using the exact binomial method, and overall mortality was compared across each level of a potential risk factor using a Chi-Square Test of Independence. All tests were two-sided, and significance level was set to 0.05. RESULTS: Average patient age was 68.7 years and LOS 19.9 days. Eighty-three patients (50.3% of total) originated from home, 10 from group homes (6.1% of total), and 72 from nursing facilities (43.6% of total). Mortality was 62.4%, highest for nursing home residents (80.6%). Findings from 253 sputum cultures overall did not suggest acute bacterial or fungal infection in 73 (45%) of 165 individuals sampled within 24 h of intubation. Cultures ≥ 1 week following intubation did grow potential pathogens in 72 (64.9%) of 111 cases with 70.8% consistent with late pneumonia and 29.2% suggesting colonization. Twelve (10.8% of total) of these late post-intubation cultures revealed worsened antimicrobial resistance predominantly in Pseudomonas, Enterobacter, or Staphylococcus aureus. CONCLUSIONS: In severe COVID-19 pneumonia, a radiographic ground glass interstitial pattern and lack of purulent sputum prior to/around the time of intubation correlated with no culture growth or recovery of normal oral flora ± yeast. Discontinuation of empiric antibacterials should be considered in these patients aided by other clinical findings, history of prior antimicrobials, laboratory testing, and overall clinical course. Continuing longterm hospitalisation and antibiotics are associated with sputum cultures reflective of hospital-acquired microbes and increasing antimicrobial resistance. TRIAL REGISTRATION: Not applicable as this was a retrospective chart review study without interventional arm.

Increasing Babesiosis in Southeastern Pennsylvania, 2008-2017.

Tick-borne illnesses are increasing but are often underreported. Few cases of babesiosis have been reported from Pennsylvania. Our 4-hospital system in southeastern Pennsylvania saw a rise in cases from 7 or fewer yearly in 2008-2014 to 26 cases in 2015. There appear to be multiple potential causes of this increase in frequency.

Hepatitis C screening beyond CDC guidelines in an Egyptian immigrant community.

BACKGROUND & AIMS: Many Egyptian-born persons in the U.S. are at high risk of chronic hepatitis C virus (HCV) infection, yet are not aware of their infection and lack healthcare coverage or linkage to care. In this study, we target Egyptian-born persons living in the New York City area for screening and link to care. METHODS: A unique partnership, the Hepatitis Outreach Network (HONE), combines the expertise and resources of the Mount Sinai School of Medicine, the NYC Department of Health and Mental Hygiene and community-based organizations, to provide education, screening and link to care in communities with high prevalence of chronic viral hepatitis. RESULTS: Through four community-based screening events, 192 Egyptian-born persons were screened for HCV. Thirty (15.6%) persons were HCV positive. HCV antibody prevalence in those, whose national origin was Egypt, increased strongly with age and was associated with increasing number of years resident in Egypt and rural residents. Of the 30 Egyptian persons with HCV infection, 18 (60%) received a medical evaluation (2 with local providers and 16 at Mount Sinai). Of the HCV-infected persons evaluated, treatment was recommended in four and begun in three (75%). CONCLUSION: Egyptian-born persons living in the New York City area have a high burden of HCV disease. HONE has successfully established targeted HCV screening in Egyptian-born persons through use of several unique elements that effectively link them to care.

Chagas disease in Latin American immigrants with dilated cardiomyopathy in New York City.

Chagas disease-associated cardiomyopathy is clinically similar to other causes of cardiomyopathy and, therefore, the diagnosis can be easily overlooked. We found a 13% point prevalence of Chagas disease in a sample of New York City immigrants with dilated cardiomyopathy.

Hepatitis Outreach Network: a practical strategy for hepatitis screening with linkage to care in foreign-born communities.

BACKGROUND & AIMS: Many foreign-born persons in the US are at high risk of chronic hepatitis B (HBV) and C (HCV) infections, yet are not aware of their infection, and lack healthcare coverage or linkage to care. METHODS: A unique partnership, the Hepatitis Outreach Network, combines the expertise and resources of the Mount Sinai School of Medicine, the NYC Department of Health and Mental Hygiene, and community-based organizations, to provide education, screening and link to care in communities with high prevalence of chronic viral hepatitis. Comprehensive HBV and HCV screening identifies infected patients, who then receive further evaluation from either local or Mount Sinai physicians, combined with patient-navigators who organize follow-up visits. RESULTS: Of 1603 persons screened, 76 had HBV and 75 had HCV. Importantly, screening for HCV based on traditional risk factors would have missed 67% of those who tested positive. Of the 76 persons with HCV infection, 49 (64%) received a medical evaluation (26 with local providers and 23 at Mount Sinai). Of the 49 HCV-infected persons evaluated, treatment was recommended in 11 and begun in 8 (73%). Of the 76 persons with HBV infection, 43 (57%) received a medical evaluation (31 with local providers and 12 at Mount Sinai). Of the 43 HBV-infected persons evaluated, treatment was recommended and begun in 5 (100%). CONCLUSIONS: Hepatitis Outreach Network has successfully established novel proof of concept for identifying HBV and HCV infections in foreign-born persons through use of several unique elements that effectively link them to care.

Disseminated histoplasmosis presenting as AIDS cholangiopathy.

Histoplasma capsulatum is a common opportunistic pathogen that often causes disseminated infection among AIDS patients from endemic areas. Virtually any organ system can be affected, but biliary involvement has not been described. We report the first case of AIDS cholangiopathy associated with H. capsulatum.

Severe pandemic (H1N1) 2009 influenza with false negative direct fluorescent antibody assay: case series.

Between May and June of 2009 we observed 4 patients that presented with severe influenza-like symptoms and respiratory failure. All cases tested negative for influenza A and B by direct fluorescent antibody assay. Further investigation revealed all cases to be positive for pandemic (H1N1) 2009 influenza virus by real-time RT-PCR. This article includes a description of these cases and the characteristics associated with them.

The impact of medical interpretation method on time and errors.

BACKGROUND: Twenty-two million Americans have limited English proficiency. Interpreting for limited English proficient patients is intended to enhance communication and delivery of quality medical care. OBJECTIVE: Little is known about the impact of various interpreting methods on interpreting speed and errors. This investigation addresses this important gap. DESIGN: Four scripted clinical encounters were used to enable the comparison of equivalent clinical content. These scripts were run across four interpreting methods, including remote simultaneous, remote consecutive, proximate consecutive, and proximate ad hoc interpreting. The first 3 methods utilized professional, trained interpreters, whereas the ad hoc method utilized untrained staff. MEASUREMENTS: Audiotaped transcripts of the encounters were coded, using a prespecified algorithm to determine medical error and linguistic error, by coders blinded to the interpreting method. Encounters were also timed. RESULTS: Remote simultaneous medical interpreting (RSMI) encounters averaged 12.72 vs 18.24 minutes for the next fastest mode (proximate ad hoc) (p = 0.002). There were 12 times more medical errors of moderate or greater clinical significance among utterances in non-RSMI encounters compared to RSMI encounters (p = 0.0002). CONCLUSIONS: Whereas limited by the small number of interpreters involved, our study found that RSMI resulted in fewer medical errors and was faster than non-RSMI methods of interpreting.