Moving from to : A collaborative continuous quality improvement process for advancing Clinical and Translational Science.

Structured processes to improve the quality and impact of clinical and translational research are a required element of the Clinical and Translational Sciences Awards (CTSA) program and are central to awardees' strategic management efforts. Quality improvement is often assumed to be an ordinary consequence of evaluation programs, in which standardized metrics are tabulated and reported externally. Yet evaluation programs may not actually be very effective at driving quality improvement: required metrics may lack direct relevance; they lack incentive to improve on areas of relative strength; and the validity of inter-site comparability may be limited.

Case-Control Study of Cervicovaginal Beta-/Gamma-HPV Infection in Women with HIV and Its Relation with Incident Cervical Precancer.

We studied cervicovaginal β-/γ-human papillomavirus (HPV) and their relationship to cervical precancer in women with HIV (WWH); having previously reported strong positive associations of β-/γ-HPV with incident head and neck cancer in the general population. Cases (N=124) had cervical intraepithelial neoplasia (CIN)-3 or CIN-2. Controls (N=247) were individually matched 2:1 to cases.

Understanding Attitudes of Postpartum Cisgender Women Toward Integration of HIV Prevention Services into Routine Prenatal and Postpartum Sexual Health Discussions.

Oral pre-exposure prophylaxis (PrEP) is an effective, user-controlled method for HIV prevention. However, awareness, uptake, and adherence to PrEP remain low among cisgender women (CGW). The prenatal and postpartum periods present an opportunity for delivery of comprehensive sexual health services that include HIV prevention education and services.

COVID-19 Convalescent Plasma Therapy: Long-term Implications.

Background: The long-term effect of coronavirus disease 2019 (COVID-19) acute treatments on postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) is unknown. The CONTAIN-Extend study explores the long-term impact of COVID-19 convalescent plasma (CCP) therapy on postacute sequelae of SARS-CoV-2 infection (PASC) symptoms and general health 18 months following hospitalization.

Methods: The CONTAIN-Extend study examined 281 participants from the original CONTAIN COVID-19 trial (CONTAIN-RCT, NCT04364737) at 18 months post-hospitalization for acute COVID-19.

Clinical Presentations and Treatment Outcomes of Mycoplasma genitalium Infections at a Large New York City Health Care System.

Background: Mycoplasma genitalium (MG) is an emerging sexually transmitted infection. Treatment of MG is complicated by increasing resistance to primary treatment regimens, including macrolides and fluoroquinolones. Understanding the various clinical presentations and relative effectiveness of treatments for MG is crucial to optimizing care.

IgA coating of vaginal bacteria is reduced in the setting of bacterial vaginosis (BV) and preferentially targets BV-associated species.

Immunoglobulin (Ig) bacterial coating has been described in the gastrointestinal tract and linked to inflammatory bowel disease; however, little is known about Ig coating of vaginal bacteria and whether it plays a role in vaginal health including bacterial vaginosis (BV). We examined Ig coating in 18 women with symptomatic BV followed longitudinally before, 1 week, and 1 month after oral metronidazole treatment. Immunoglobulin A (IgA) and/or immunoglobulin G (IgG) coating of vaginal bacteria was assessed by flow cytometry, and Ig coated and uncoated bacteria were sorted and characterized using 16S rRNA sequencing.

Challenges in catalyzing and sustaining research in translational science.

Advancing the new field of translational science and developing innovative solutions to overcome translational roadblocks are key priorities of the Clinical and Translational Science Awards (CTSA) Program of the National Center for Advancing Translational Science (NCATS). However, interpreting this emerging concept of "translational science" (TS) as a field of inquiry distinct from "translational research" (TR) and developing real-world investigations in TS can be challenging. The goal of this paper is to share the obstacles the Einstein-Montefiore CTSA hub has faced in generating institutional interest and research in TS and to present potential strategies for addressing them.

Using K-Means Clustering to Identify Physician Clusters by Electronic Health Record Burden and Efficiency.

Electronic health records (EHRs) have transformed the way modern medicine is practiced, but they remain a major source of documentation burden among physicians. This study aims to use data from Signal, a tool provided by the Epic EHR, to analyze physician metadata in the Montefiore Health System via cluster analysis to assess EHR burden and efficiency. Data were obtained for a one-month period (July 2020) representing a return to normal operation post-telemedicine implementation.

Physician Electronic Health Record Usage as Affected by the COVID-19 Pandemic.

Objectives: To utilize metrics from physician action logs to analyze volume, physician efficiency and burden as impacted by telemedicine implementation during the COVID-19 (coronavirus disease 2019) pandemic, and physician characteristics such as gender, years since graduation, and specialty category.

Methods: We selected 11 metrics from Epic Signal, a functionality of the Epic electronic health record (EHR). Metrics measuring time spent in the EHR outside working hours were used as a correlate for burden.

Results of a phase 1, randomized, placebo-controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel.

HIV pre-exposure prophylaxis (PrEP) is dominated by clinical therapeutic antiretroviral (ARV) drugs. Griffithsin (GRFT) is a non-ARV lectin with potent anti-HIV activity. GRFT's preclinical safety, lack of systemic absorption after vaginal administration in animal studies, and lack of cross-resistance with existing ARV drugs prompted its development for topical HIV PrEP.

Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients: A Randomized Clinical Trial.

Importance: There is clinical equipoise for COVID-19 convalescent plasma (CCP) use in patients hospitalized with COVID-19.

Objective: To determine the safety and efficacy of CCP compared with placebo in hospitalized patients with COVID-19 receiving noninvasive supplemental oxygen.

Design, Setting, And Participants: CONTAIN COVID-19, a randomized, double-blind, placebo-controlled trial of CCP in hospitalized adults with COVID-19, was conducted at 21 US hospitals from April 17, 2020, to March 15, 2021.

Post-severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Treatment Hospitalizations as a Sentinel for Emergence of Viral Variants in New York City.

We partnered with the US Department of Health and Human Services to treat high-risk, nonadmitted coronavirus disease 2019 (COVID-19) patients with bamlanivimab in the Bronx, New York per Emergency Use Authorization criteria. Increasing posttreatment hospitalizations were observed monthly between December 2020 and March 2021 in parallel to the emergence of severe acute respiratory syndrome coronavirus 2 variants in New York City.

Natural mucosal barriers and COVID-19 in children.

BACKGROUNDCoronavirus disease 2019 (COVID-19) is more benign in children compared with adults for unknown reasons. This contrasts with other respiratory viruses where disease manifestations are often more severe in children. We hypothesize that a more robust early innate immune response to SARS coronavirus 2 (SARS-CoV-2) protects against severe disease.

Teamwork and Leadership Under Fire at the Epicenter of the COVID-19 Epidemic in the Bronx.

The first Covid-19 patient was admitted to Montefiore Medical Center (MMC) on March 10, 2020. Soon thereafter there was a rapid and exponential surge of Covid-19 admissions to MMC that could have resulted in catastrophic consequences if MMC had been overwhelmed, as happened in Europe. To adjust to this crisis our institution, under the inspiring leadership of Dr.

Natural Mucosal Barriers and COVID-19 in Children.

COVID-19 is more benign in children compared to adults for unknown reasons. This contrasts with viruses such as influenza where disease manifestations are often more severe in children1. We hypothesized that a more robust early innate immune response to SARS-CoV-2 may protect against severe disease and compared clinical outcomes, viral copies and cellular gene and protein expression in nasopharyngeal swabs from 12 children and 27 adults upon presentation to the Emergency Department.

Acceptability of a Tenofovir Disoproxil Fumarate Intravaginal Ring for HIV Pre-Exposure Prophylaxis Among Sexually Active Women.

Introduction: Vaginal ring delivery of antiretroviral drugs may provide protection against acquisition of HIV-1 when used as Pre-Exposure prophylaxis. As part of a randomized placebo-controlled safety trial of a tenofovir disoproxil fumarate (TDF) intravaginal ring (IVR), we assessed product acceptability through surveys of women after continuous ring use.

Methods: Sexually active, HIV-negative women were enrolled to investigate the safety and pharmacokinetics of 3 months of continuous TDF IVR use.

Immune responses to SARS-CoV-2 infection in hospitalized pediatric and adult patients.

Children and youth infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have milder disease than do adults, and even among those with the recently described multisystem inflammatory syndrome, mortality is rare. The reasons for the differences in clinical manifestations are unknown but suggest that age-dependent factors may modulate the antiviral immune response. We compared cytokine, humoral, and cellular immune responses in pediatric (children and youth, age <24 years) ( = 65) and adult ( = 60) patients with coronavirus disease 2019 (COVID-19) at a metropolitan hospital system in New York City.

Primary HPV and Molecular Cervical Cancer Screening in US Women Living With Human Immunodeficiency Virus.

Background: Primary human papillomavirus (HPV) screening (PHS) utilizes oncogenic human papillomavirus (oncHPV) testing as the initial cervical cancer screening method and typically, if positive, additional reflex-triage (eg, HPV16/18-genotyping, Pap testing). While US guidelines support PHS usage in the general population, PHS has been little studied in women living with HIV (WLWH).

Methods: We enrolled n = 865 WLWH (323 from the Women's Interagency HIV Study [WIHS] and 542 from WIHS-affiliated colposcopy clinics).

Effect of Systemic Glucocorticoids on Mortality or Mechanical Ventilation in Patients With COVID-19.

The efficacy of glucocorticoids in COVID-19 is unclear. This study was designed to determine whether systemic glucocorticoid treatment in COVID-19 patients is associated with reduced mortality or mechanical ventilation. This observational study included 1,806 hospitalized COVID-19 patients; 140 were treated with glucocorticoids within 48 hours of admission.

Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial.

Background: Faecal microbiota transplantation (FMT) has shown promise in alleviating the symptoms of irritable bowel syndrome (IBS); however, controlled data on this technique are scarce. The aim of this clinical trial was to assess the efficacy of FMT in alleviating diarrhoea-predominant IBS (IBS-D).

Methods: We did a double-blind, randomised, placebo-controlled crossover trial in patients aged 18-65 years with moderate-to-severe IBS-D defined by an IBS-Symptom Severity Score (IBS-SSS) of more than 175, recruited from three US centres.