Analysis of Industry-Related Payments Among Physician Editors of Pathology Journals.

OBJECTIVES: Gender inequities in editorial board representation and physician compensation are well documented, but few studies have focused on how editors of journals are compensated. METHODS: In this cross-sectional study, we examined industry-related compensation (from 2014 to 2020) among physician editors of 35 pathology journals using publicly available data from the Centers for Medicare & Medicaid Services Open Payments Database. RESULTS: Of the physician editors included, 135 (69.9%) were men and 58 (30.1%) were women. Similar percentages of men and women physicians who were eligible received payments (112/135 [83.0%] men and 51/58 [87.9%] women; P = .38, χ2 test). Of the total transfer of value ($211,192,532), 112 men received $192,727,555 (91.3%), and 51 women received $18,464,978 (8.7%). Mean total payment per person was $1,720,782 for men and $362,058 for women (P = .05). The payment range for men was $18-$47,568,400 and the range of payments for women was $31-$2,375,637. CONCLUSIONS: The findings highlight significant gender inequities in industry-related payments to physician editors of pathology journals. The financial relationships of journal editors and industry deserve further study, particularly as they relate to advancing science and closing both workforce and patient care inequities.

A rapid, point-of-care red blood cell agglutination assay detecting antibodies against SARS-CoV-2.

The COVID-19 pandemic has caused significant morbidity and mortality. There is an urgent need for serological tests to detect antibodies against SARS-CoV-2, which could be used to assess past infection, evaluate responses to vaccines in development, and determine individuals who may be protected from future infection. Current serological tests developed for SARS-CoV-2 rely on traditional technologies such as enzyme-linked immunosorbent assays (ELISA) and lateral flow assays, which have not scaled to meet the demand of hundreds of millions of antibody tests so far. Herein, we present an alternative method of antibody testing that depends on one protein reagent being added to patient serum/plasma or whole blood with direct, visual readout. Two novel fusion proteins, RBD-2E8 and B6-CH1-RBD, were designed to bind red blood cells (RBCs) via a single-chain variable fragment (scFv), thereby displaying the receptor-binding domain (RBD) of SARS-CoV-2 spike protein on the surface of RBCs. Mixing mammalian-derived RBD-2E8 and B6-CH1-RBD with convalescent COVID-19 patient serum and RBCs led to visible hemagglutination, indicating the presence of antibodies against SARS-CoV-2 RBD. B6-CH1-RBD made in bacteria was not as effective in inducing agglutination, indicating better recognition of RBD epitopes from mammalian cells. Given that our hemagglutination test uses methods routinely used in hospital clinical labs across the world for blood typing, we anticipate the test can be rapidly deployed at minimal cost. We anticipate our hemagglutination assay may find extensive use in low-resource settings for detecting SARS-CoV-2 antibodies.

A Department-Sponsored, Hospital-Based Pathology Education Symposium Is a Cost-Effective Method to Provide Laboratory Staff With Highly Rated Continuing Education Experiences.

CONTEXT.­: Continuing education improves the quality of medical care and is a required part of most health care professions. Although a variety of educational modules are available online or at external conferences, completion of these activities can be expensive and time-consuming. In addition, externally produced modules may have limited applicability to a local practice. OBJECTIVE.­: To assess the ability of an economically efficient, locally produced, department-wide pathology educational seminar to efficiently meet education requirements for a large number of employees in a large health system. DESIGN.­: A multiday continuing education symposium was produced annually from 2013 through 2019 at no cost to participants. Metrics related to attendance, number of educational sessions available for registration, and participant satisfaction were tabulated, trended, and compared with similar metrics tabulated from an external continuing education conference that was offered from 2011 through 2012. RESULTS.­: The production of an internal, hospital-based educational symposium increased employee attendance (mean of 635 attendees per year versus 247 at the external program; P < .001) while reducing mean annual cost per attendee ($51 versus $140, P < .001). The number of sessions produced for the internal symposium was 39 per year on average, compared with 12 per year at the external program. Technical staff, residents, fellows, and faculty all contributed to internal educational programming, helping to build a team culture in the department. Overall employee satisfaction was 96.2%. CONCLUSIONS.­: An internal educational pathology symposium led to cost-efficient distribution of continuing education credits to a large number of technical staff, with a high degree of reported employee satisfaction.

Operational Recommendations for Scarce Resource Allocation in a Public Health Crisis.

The coronavirus disease 2019 pandemic may require rationing of various medical resources if demand exceeds supply. Theoretical frameworks for resource allocation have provided much needed ethical guidance, but hospitals still need to address objective practicalities and legal vetting to operationalize scarce resource allocation schemata. To develop operational scarce resource allocation processes for public health catastrophes, including the coronavirus disease 2019 pandemic, five health systems in Maryland formed a consortium-with diverse expertise and representation-representing more than half of all hospitals in the state. Our efforts built on a prior statewide community engagement process that determined the values and moral reference points of citizens and health-care professionals regarding the allocation of ventilators during a public health catastrophe. Through a partnership of health systems, we developed a scarce resource allocation framework informed by citizens' values and by general expert consensus. Allocation schema for mechanical ventilators, ICU resources, blood components, novel therapeutics, extracorporeal membrane oxygenation, and renal replacement therapies were developed. Creating operational algorithms for each resource posed unique challenges; each resource's varying nature and underlying data on benefit prevented any single algorithm from being universally applicable. The development of scarce resource allocation processes must be iterative, legally vetted, and tested. We offer our processes to assist other regions that may be faced with the challenge of rationing health-care resources during public health catastrophes.

Financial analysis of large-volume delayed sampling to reduce bacterial contamination of platelets.

BACKGROUND: Effective and financially viable mitigation approaches are needed to reduce bacterial contamination of platelets in the US. Expected costs of large-volume delayed sampling (LVDS), which would be performed by a blood center prior to shipment to a hospital, were compared to those of pathogen reduction (PR), point-of-release testing (PORt), and secondary bacterial culture (SBC). METHODS: Using a Markov-based decision-tree model, the financial and clinical impact of implementing all variants of LVDS, PR, PORt, and SBC described in FDA guidance were evaluated from a hospital perspective. Hospitals were assumed to acquire leukoreduced apheresis platelets, with LVDS adding $30 per unit. Monte Carlo simulations were run to estimate the direct medical costs for platelet acquisition, testing, transfusion, and possible complications associated with each approach. Input parameters, including test sensitivity and specificity, were drawn from existing literature and costs (2018US$) were based on a hospital perspective. A one-way sensitivity analysis varied the assumed additional cost of LVDS. RESULTS: Under an approach of LVDS (7-day), the total cost per transfused unit is $735.78, which falls between estimates for SBC (7-day) and PORt. Assuming 20,000 transfusions each year, LVDS would cost $14.72 million annually. Per-unit LVDS costs would need to be less than $22.32 to be cheaper per transfusion than all other strategies, less than $32.02 to be cheaper than SBC (7-day), and less than $196.19 to be cheaper than PR (5-day). CONCLUSIONS: LVDS is an effective and cost-competitive approach, assuming additional costs to blood centers and associated charges to hospitals are modest.

Reducing preoperative blood orders and costs for radical prostatectomy.

Aim: A maximum surgical blood order schedule (MSBOS) was implemented at our institution to optimize preoperative blood ordering and reduce unnecessary blood preparation for patients undergoing radical prostatectomy (RP), a common urologic procedure. Materials & methods: We conducted a retrospective review of patients who underwent RP from 2010 to 2016 and categorized patients by date of RP (pre- or post-MSBOS) and compared preoperative blood-ordering practices. Results: After MSBOS implementation, preoperative blood orders changed from predominantly type and cross-match 2 units (53%) to no sample (56%) for robot-assisted laparoscopic RP, and from mostly type and cross-match 2 units (62%) to type and screen (75%) for open RP with resultant cost savings. Conclusion: MSBOS implementation and compliance decreases unnecessary preoperative blood orders.

Reducing Unnecessary Phlebotomy Testing Using a Clinical Decision Support System.

INTRODUCTION: Reducing unnecessary tests reduces costs without compromising quality. We report here the effectiveness of a clinical decision support system (CDSS) on reducing unnecessary type and screen tests and describe, estimated costs, and unnecessary provider ordering. METHODS: We used a pretest posttest design to examine unnecessary type and screen tests 3 months before and after CDSS implementation in a large academic medical center. The clinical decision support system appears when the test order is initiated and indicates when the last test was ordered and expires. Cost savings was estimated using time-driven activity-based costing. Provider ordering before and after the CDSS was described. RESULTS: There were 26,206 preintervention and 25,053 postintervention specimens. Significantly fewer unnecessary type and screen tests were ordered after the intervention (12.3%, n = 3,073) than before (14.1%, n = 3,691; p < .001) representing a 12.8% overall reduction and producing an estimated yearly savings of $142,612. Physicians had the largest weighted percentage of unnecessary orders (31.5%) followed by physician assistants (28.5%) and advanced practice nurses (11.9%). CONCLUSIONS: The CDSS reduced unnecessary type and screen tests and annual costs. Additional interventions directed at providers are recommended. The clinical decision support system can be used to guide all providers to make judicious decisions at the time of care.

Pathogen Reduction: The State of the Science in 2019.

In the past 30 years, transfusion safety has increased substantially and blood transfusion is now a safer procedure than at any time in the past. Herein, we provide a comprehensive review of pathogen reduction, which is the new paradigm in transfusion safety. Specifically, we describe the various processes and technologies that are capable of diminishing or neutralizing infectious threats, including those that are not addressed or may not be detected by standard screening techniques. A special emphasis is placed on recent developments that are likely to impact patient care in 2019 and beyond.

On-label compared to off-label four-factor prothrombin complex concentrate use: a retrospective, observational study.

BACKGROUND: Four-factor prothrombin complex concentrate (4F-PCC) is US Food and Drug Administration approved for the urgent reversal of coagulation factor deficiency induced by a vitamin K antagonist complicated by acute major bleeding or in situations in which invasive procedures are urgently needed. Although recent evidence suggests the superiority of 4F-PCC over plasma for on-label indications, the off-label use of 4F-PCC has not been rigorously studied. STUDY DESIGN AND METHODS: Eighty-nine patients receiving 4F-PCC at a single institution from July 2016 to December 2017 were retrospectively analyzed. Two cohorts, "On-Label" and "Off-Label" uses of 4F-PCC, were evaluated, comparing patient characteristics, blood utilization, and clinical outcomes including in-hospital mortality. RESULTS: Patients receiving 4F-PCC for off-label reasons (n = 46) were younger and sicker compared to those receiving 4F-PCC for on-label reasons (n = 43). Notably, the mortality rate for off-label use was approximately twofold greater than the mortality rate for on-label use (26 of 46 [56.5%] vs. 12 of 43 [27.9%]; p = 0.006). Patients receiving 4F-PCC for off-label reasons received more units per patient of each blood component than their on-label counterparts. The average cost estimate per patient for 4F-PCC was similar (approx. $4300) in each cohort. CONCLUSION: 4F-PCC is an effective but expensive treatment option for those requiring urgent reversal of vitamin K antagonist-induced coagulopathy. However, providers should be conscious of the high costs and questionable efficacy when using 4F-PCC off-label.

Financial impact of alternative approaches to reduce bacterial contamination of platelet transfusions.

BACKGROUND: Bacterial contamination of platelets remains the leading infectious risk from blood transfusion. Pathogen reduction (PR), point-of-release testing (PORt), and secondary bacterial culture (SBC) have been proposed as alternative risk control strategies, but a comprehensive financial comparison has not been conducted. STUDY DESIGN AND METHODS: A Markov-based decision tree was constructed to model the financial and clinical impact of PR, PORt, and SBC, as well as a baseline strategy involving routine testing only. Hospitals were assumed to acquire leukoreduced apheresis platelets on Day 3 after collection, and, in the base case analysis, expiration would occur at the end of Day 5 (PR and SBC) or 7 (PORt). Monte Carlo simulations assessed the direct medical costs for platelet acquisition, testing, transfusion, and possible complications. Input parameters, including test sensitivity and specificity, were drawn from existing literature, and costs (2018 US dollars) were based on a hospital perspective. RESULTS: The total costs per unit acquired by the hospital under the baseline strategy, PR, PORt, and SBC were $651.45, $827.82, $686.33, and $668.50, respectively. All risk-reduction strategies decreased septic transfusion reactions and associated expenses, with the greatest reductions from PR. PR would add $191.09 in per-unit acquisition costs, whereas PORt and SBC would increase per-unit testing costs by $31.79 and $17.26, respectively. Financial outcomes were sensitive to platelet dating; allowing 7-day storage with SBC would lead to a cost savings of $12.41 per transfused unit. Results remained robust in probabilistic sensitivity analyses. CONCLUSIONS: All three strategies are viable approaches to reducing bacterially contaminated platelet transfusions, although SBC is likely to be the cheapest overall.

Medical and economic implications of strategies to prevent alloimmunization in sickle cell disease.

BACKGROUND: The pathogenesis of alloimmunization is not well understood, and initiatives that aim to reduce the incidence of alloimmunization are generally expensive and either ineffective or unproven. In this review, we summarize the current medical literature regarding alloimmunization in the sickle cell disease (SCD) population, with a special focus on the financial implications of different approaches to prevent alloimmunization. STUDY DESIGN AND METHODS: A review of EMBASE and MEDLINE data from January 2006 through January 2016 was conducted to identify articles relating to complications of SCD. The search was specifically designed to capture articles that evaluated the costs of various strategies to prevent alloimmunization and its sequelae. RESULTS: Currently, there is no proven, inexpensive way to prevent alloimmunization among individuals with SCD. Serologic matching programs are not uniformly successful in preventing alloimmunization, particularly to Rh antigens, because of the high frequency of variant Rh alleles in the SCD population. A genotypic matching program could offer some cost savings compared to a serologic matching program, but the efficacy of gene matching for the prevention of alloimmunization is largely unproven, and large-scale implementation could be expensive. CONCLUSIONS: Future reductions in the costs associated with genotype matching could make a large-scale program economically feasible. Novel techniques to identify patients at highest risk for alloimmunization could improve the cost effectiveness of antigen matching programs. A clinical trial comparing the efficacy of serologic matching to genotype matching would be informative.

Incidence of transfusion reactions: a multicenter study utilizing systematic active surveillance and expert adjudication.

BACKGROUND: Prevalence estimates of the serious hazards of transfusion vary widely. We hypothesized that the current reporting infrastructure in the United States fails to capture many transfusion reactions and undertook a multicenter study using active surveillance, data review, and adjudication to test this hypothesis. STUDY DESIGN AND METHODS: A retrospective record review was completed for a random sample of 17% of all inpatient transfusion episodes over 6 months at four academic tertiary care hospitals, with an episode defined as all blood products released to a patient in 6 hours. Data were recorded by trained clinical research nurses, and serious reactions were adjudicated by a panel of transfusion medicine experts. RESULTS: Of 4857 transfusion episodes investigated, 1.1% were associated with a serious reaction. Transfusion-associated circulatory overload was the most frequent serious reaction noted, being identified in 1% of transfusion episodes. Despite clinical notes describing a potential transfusion association in 59% of these cases, only 5.1% were reported to the transfusion service. Suspected transfusion-related acute lung injury/possible transfusion-related acute lung injury, anaphylactic, and hypotensive reactions were noted in 0.08, 0.02, and 0.02% of transfusion episodes, respectively. Minor reactions, including febrile nonhemolytic and allergic, were noted in 0.62 and 0.29% of transfusion episodes, respectively, with 30 and 50% reported to the transfusion service. CONCLUSION: Underreporting of cardiopulmonary transfusion reactions is striking among academic, tertiary care hospitals. Complete and accurate reporting is essential to identify, define, establish pathogenesis, and mitigate/treat transfusion reactions. A better understanding of the failure to report may improve the accuracy of passive reporting systems.

Variation in vital signs resulting from blood component administration in adults.

BACKGROUND: Although vital signs are routinely recorded before and after every transfusion, there are few published data on how these variables vary with component administration. Thus, there is very little evidence available to support guidelines that are intended to differentiate "benign" changes in vital signs from transfusion reactions. The aim of this study was to evaluate the variation in vitals observed after transfusion. STUDY DESIGN AND METHODS: Retrospective data were extracted from blood bank records for 3496 component infusions (red blood cells, n = 2359; platelets, n = 478; plasma, n = 659) over a 1-year period. The following were collected: recipient pre- and posttransfusion vital signs (temperature, pulse rate, and blood pressure) and whether a transfusion reaction was reported. RESULTS: Transfusion was associated with very mild median changes in temperature (approx. 0 °C), pulse rate (<5 beats/min), or blood pressure (<5 mmHg) across all components. The transfusion reaction rate reported by clinical teams was 0.5%, but reported temperature changes indicated a higher reaction rate of 2.1% based on institutional criteria. CONCLUSIONS: Blood transfusion is not associated with significant changes in recipient vital signs. Our data could be used to develop reference ranges for transfusion-related vital signs. More than 75% of transfusion reactions may not be reported to the blood bank.