Community-Based COVID-19 Vaccine Clinics in Medically Underserved Neighborhoods to Improve Access and Equity, Philadelphia, 2021-2022.

Vaccination remains key to reducing the risk of COVID-19-related severe illness and death. Because of historic medical exclusion and barriers to access, Black communities have had lower rates of COVID-19 vaccination than White communities. We describe the efforts of an academic medical institution to implement community-based COVID-19 vaccine clinics in medically underserved neighborhoods in Philadelphia, Pennsylvania. Over a 13-month period (April 2021-April 2022), the initiative delivered 9038 vaccine doses to community members, a majority of whom (57%) identified as Black. (Am J Public Health. 2022;112(12):1721-1725. https://doi.org/10.2105/AJPH.2022.307030).

Understanding Contributors to Racial/Ethnic Disparities in Emergency Department Throughput Times: a Sequential Mixed Methods Analysis.

BACKGROUND: Ensuring equitable care remains a critical issue for healthcare systems. Nationwide evidence highlights the persistence of healthcare disparities and the need for research-informed approaches for reducing them at the local level. OBJECTIVE: To characterize key contributors in racial/ethnic disparities in emergency department (ED) throughput times. DESIGN: We conducted a sequential mixed methods analysis to understand variations in ED care throughput times for patients eventually admitted to an emergency department at a single academic medical center from November 2017 to May 2018 (n=3152). We detailed patient progression from ED arrival to decision to admit and compared racial/ethnic differences in time intervals from electronic medical record time-stamp data. We then estimated the relationships between race/ethnicity and ED throughput times, adjusting for several patient-level variables and ED-level covariates. These quantitative analyses informed our qualitative study design, which included observations and semi-structured interviews with patients and physicians. KEY RESULTS: Non-Hispanic Black as compared to non-Hispanic White patients waited significantly longer during the time interval from arrival to the physician's decision to admit, even after adjustment for several ED-level and patient demographic, clinical, and socioeconomic variables (Beta (average minutes) (SE): 16.35 (5.8); p value=.005). Qualitative findings suggest that the manner in which providers communicate, advocate, and prioritize patients may contribute to such disparities. When the race/ethnicity of provider and patient differed, providers were more likely to interrupt patients, ignore their requests, and make less eye contact. Conversely, if the race/ethnicity of provider and patient were similar, providers exhibited a greater level of advocacy, such as tracking down patient labs or consultants. Physicians with no significant ED throughput disparities articulated objective criteria such as triage scores for prioritizing patients. CONCLUSIONS: Our findings suggest the importance of (1) understanding how our communication style and care may differ by race/ethnicity; and (2) taking advantage of structured processes designed to equalize care.

Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial.

Importance: Many health systems are considering increasing price transparency at the time of order entry. However, evidence of its impact on clinician ordering behavior is inconsistent and limited to single-site evaluations of shorter duration. Objective: To test the effect of displaying Medicare allowable fees for inpatient laboratory tests on clinician ordering behavior over 1 year. Design, Setting, and Participants: The Pragmatic Randomized Introduction of Cost data through the electronic health record (PRICE) trial was a randomized clinical trial comparing a 1-year intervention to a 1-year preintervention period, and adjusting for time trends and patient characteristics. The trial took place at 3 hospitals in Philadelphia between April 2014 and April 2016 and included 98 529 patients comprising 142 921 hospital admissions. Interventions: Inpatient laboratory test groups were randomly assigned to display Medicare allowable fees (30 in intervention) or not (30 in control) in the electronic health record. Main Outcomes and Measures: Primary outcome was the number of tests ordered per patient-day. Secondary outcomes were tests performed per patient-day and Medicare associated fees. Results: The sample included 142 921 hospital admissions representing patients who were 51.9% white (74 165), 38.9% black (55 526), and 56.9% female (81 291) with a mean (SD) age of 54.7 (19.0) years. Preintervention trends of order rates among the intervention and control groups were similar. In adjusted analyses of the intervention group compared with the control group over time, there were no significant changes in overall test ordering behavior (0.05 tests ordered per patient-day; 95% CI, -0.002 to 0.09; P = .06) or associated fees ($0.24 per patient-day; 95% CI, -$0.42 to $0.91; P = .47). Exploratory subset analyses found small but significant differences in tests ordered per patient-day based on patient intensive care unit (ICU) stay (patients with ICU stay: -0.16; 95% CI, -0.31 to -0.01; P = .04; patients without ICU stay: 0.13; 95% CI, 0.08-0.17; P < .001) and the magnitude of associated fees (top quartile of tests based on fee value: -0.01; 95% CI, -0.02 to -0.01; P = .04; bottom quartile: 0.03; 95% CI, 0.002-0.06; P = .04). Adjusted analyses of tests that were performed found a small but significant overall increase in the intervention group relative to the control group over time (0.08 tests performed per patient day, 95% CI, 0.03-0.12; P < .001). Conclusions and Relevance: Displaying Medicare allowable fees for inpatient laboratory tests did not lead to a significant change in overall clinician ordering behavior or associated fees. Trial Registration: clinicaltrials.gov Identifier: NCT02355496.

Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study.

BACKGROUND: New tools are required for the diagnosis of pre-symptomatic leprosy towards further reduction of disease burden and its associated reactions. To address this need, two new skin test antigens were developed to assess safety and efficacy in human trials. METHODS: A Phase I safety trial was first conducted in a non-endemic region for leprosy (U.S.A.). Healthy non-exposed subjects (n = 10) received three titrated doses (2.5 µg, 1.0 µg and 0.1 µg) of MLSA-LAM (n = 5) or MLCwA (n = 5) and control antigens [Rees MLSA (1.0 µg) and saline]. A randomized double blind Phase II safety and efficacy trial followed in an endemic region for leprosy (Nepal), but involved only the 1.0 µg (high dose) and 0.1 µg (low dose) of each antigen; Tuberculin PPD served as a control antigen. This Phase II safety and efficacy trial consisted of three Stages: Stage A and B studies were an expansion of Phase I involving 10 and 90 subjects respectively, and Stage C was then conducted in two parts (high dose and low dose), each enrolling 80 participants: 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients, 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients, 20 household contacts of leprosy patients (HC), and 20 tuberculosis (TB) patients. The primary outcome measure for the skin test was delayed type hypersensitivity induration. FINDINGS: In the small Phase I safety trial, reactions were primarily against the 2.5 µg dose of both antigens and Rees control antigen, which were then excluded from subsequent studies. In the Phase II, Stage A/B ramped-up safety study, 26% of subjects (13 of 50) showed induration against the high dose of each antigen, and 4% (2 of 50) reacted to the low dose of MLSA-LAM. Phase II, Stage C safety and initial efficacy trial showed that both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients, but high specificity at 100% and 95% compared to TB patients. The high dose of both antigens showed lower specificity (70% and 60%) and sensitivity (10% and 15%). BL/LL leprosy patients were anergic to the leprosy antigens. INTERPRETATION: MLSA-LAM and MLCwA at both high (1.0 µg) and low (0.1 µg) doses were found to be safe for use in humans without known exposure to leprosy and in target populations. At a sensitivity rate of 20-25% these antigens are not suitable as a skin test for the detection of the early stages of leprosy infection; however, the degree of specificity is impressive given the presence of cross-reactive antigens in these complex native M. leprae preparations. TRIAL REGISTRATION: ClinicalTrials.gov NCT01920750 (Phase I), NCT00128193 (Phase II).

Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs.

OBJECTIVE: To estimate the proportion of healthcare-associated infections (HAIs) in US hospitals that are "reasonably preventable," along with their related mortality and costs. METHODS: To estimate preventability of catheter-associated bloodstream infections (CABSIs), catheter-associated urinary tract infections (CAUTIs), surgical site infections (SSIs), and ventilator-associated pneumonia (VAP), we used a federally sponsored systematic review of interventions to reduce HAIs. Ranges of preventability included the lowest and highest risk reductions reported by US studies of "moderate" to "good" quality published in the last 10 years. We used the most recently published national data to determine the annual incidence of HAIs and associated mortality. To estimate incremental cost of HAIs, we performed a systematic review, which included costs from studies in general US patient populations. To calculate ranges for the annual number of preventable infections and deaths and annual costs, we multiplied our infection, mortality, and cost figures with our ranges of preventability for each HAI. RESULTS: As many as 65%-70% of cases of CABSI and CAUTI and 55% of cases of VAP and SSI may be preventable with current evidence-based strategies. CAUTI may be the most preventable HAI. CABSI has the highest number of preventable deaths, followed by VAP. CABSI also has the highest cost impact; costs due to preventable cases of VAP, CAUTI, and SSI are likely less. CONCLUSIONS: Our findings suggest that 100% prevention of HAIs may not be attainable with current evidence-based prevention strategies; however, comprehensive implementation of such strategies could prevent hundreds of thousands of HAIs and save tens of thousands of lives and billions of dollars.

Integrating local data into hospital-based healthcare technology assessment: two case studies.

OBJECTIVES: Health technology assessment (HTA) programs influence practice on a broad scale through reimbursement decisions or national guidelines. Hospital-based HTA programs inform clinical decisions at the local level. Typically, they do this by adapting general HTA to their local setting, or by creating new HTA. However, unlike payer-based HTA organizations, hospital-based HTA organizations can also integrate local data into their reports. METHODS: We describe two examples of local data integrated into hospital-based HTA. In the first, qualitative data were used to select a new cardiac catheterization lab. In the second, quantitative data was used to inform a decision on whether to continue telemedicine services to critical care units. Local evidence sources included equipment service records, and interviews with physicians, technicians, and administrative staff in the first example, and the hospital's administrative and claims databases in the second example. RESULTS: In each case, there was little evidence from the peer-reviewed literature that could be applied to the decision. In the first example, staffing patterns and local preferences had considerable bearing on technology choices. In the second example, local outcomes data from administrative records were decisive. CONCLUSIONS: Hospital-based HTA using local data can fill gaps in the published evidence, and also improve the generalizability of evidence to the local setting. To take advantage of local evidence, health systems should encourage the development of hospital-based HTA centers, seek out local preference data, and maintain databases of patient outcomes and utilization of services.

Rapid variable-number tandem-repeat genotyping for Mycobacterium leprae clinical specimens.

Mycobacterium leprae is the noncultivable pathogen of leprosy. Since the genome sequence of an isolate of M. leprae has become available, multiple-locus variable-number tandem-repeat (VNTR) analysis (MLVA) has been explored as a tool for strain typing and identification of chains of transmission of leprosy. In order to discover VNTRs and develop methods transferable to clinical samples, MLVA was applied to a global collection of M. leprae isolates derived from leprosy patients and propagated in armadillo hosts. PCR amplification, agarose gel electrophoresis, and sequencing methods were applied to DNA extracts from these infected armadillo tissues (n = 21). We identified polymorphisms in 15 out of 25 short-tandem-repeat (STR) loci previously selected by in silico analyses of the M. leprae genome. We then developed multiplex PCR for amplification of these 15 loci in four separate PCRs suitable for fluorescent fragment length analysis and demonstrated STR profiles highly concordant with those from the sequencing methods. Subsequently, we extended this method to DNA extracts from human clinical specimens, such as skin biopsy specimens (n = 30). With these techniques, mapping of multiple loci and differentiation of genotypes have been possible using total DNA extracts from limited amounts of clinical samples at a reduced cost and with less time. These practical methods are therefore available and applicable to answer focused epidemiological questions and to allow monitoring of the transmission of M. leprae in different countries where leprosy is endemic.

Institutional leadership and faculty response: fostering professionalism at the University of Pennsylvania School of Medicine.

Fostering professionalism requires institutional leadership and faculty buy-in. At the University of Pennsylvania School of Medicine, policies and educational programs were developed to enhance professionalism in three areas: conduct of clinical trials, relations with pharmaceutical manufacturers, and the clinical and teaching environment. Responsible conduct of clinical trials has been addressed with mandatory online education and certification for clinical investigators, but some still fail to recognize conflicts of interest. Activity of pharmaceutical representatives has been strictly regulated, meals and gifts from pharmaceutical companies prohibited, and the role of the pharmaceutical industry in the formulary process and in continuing medical education curtailed. Some faculty members have resented such restrictions, particularly in regard to their opportunity to give paid lectures. Professionalism in the clinical and teaching environment has been addressed with interdisciplinary rounding, experiential learning for medical students and residents in small groups, increased recognition of role models of professionalism, and active management of disruptive physicians. Leadership has been exerted through policy development, open communications, and moral suasion and example. Faculty members have expressed both their support and their reservations. Development of communication strategies continues, including town hall meetings, small groups and critical incident narratives, and individual feedback. The understanding and endorsement of faculty, staff, and trainees are an essential element of the professionalism effort.