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.

Addressing the Opioid Crisis One Surgical Patient at a Time: Outcomes of a Novel Perioperative Pain Program.

Opioid prescriptions in the surgical setting have been implicated as contributors to the opioid epidemic. The authors hypothesized that a multidisciplinary approach to perioperative pain management for patients on chronic opioid therapy could decrease postoperative opioid requirements while reducing postoperative pain scores and improving functional outcomes. Therefore, a Perioperative Pain Program (PPP) for chronic opioid users was implemented. This study presents outcomes from the first 9 months of the PPP. Sixty-one patients met the inclusion criteria. Opioid consumption in morphine milligram equivalent (MME) was calculated and physical and health status of patients was assessed with the Brief Pain Inventory, Short-Form McGill Pain Questionnaire, and Short Form-12. Preliminary results showed significant reduction in MME, improved pain scores, and improved function for surgical patients on chronic opioids. PPP effectively reduced opioid usage without negatively influencing patient-reported outcomes, such as physical pain score assessment and health-related quality of life.

Effect of red blood cell storage duration on major postoperative complications in cardiac surgery: A randomized trial.

BACKGROUND: Although observational studies suggest an association between transfusion of older red blood cell (RBC) units and increased postoperative risk, randomized trials have not supported this. The objective of this randomized trial was to test the effect of RBC storage age on outcomes after cardiac surgery. METHODS: From July 2007 to May 2016, 3835 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination, were randomized to transfusion of RBCs stored for ≤14 days (younger units) or for ≥20 days (older units) intraoperatively and throughout the postoperative hospitalization. According to protocol, 2448 patients were excluded because they did not receive RBC transfusions. Among the remaining 1387 modified intent-to-treat patients, 701 were randomized to receive younger RBC units (median age, 11 days) and the remaining 686 to receive older units (median age, 25 days). The primary endpoint was composite morbidity and mortality, analyzed using a generalized estimating equation (GEE) model. The trial was discontinued midway owing to enrollment constraints. RESULTS: A total of 5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group. The GEE average relative-effect odds ratio was 0.77 (95% confidence interval [CI], 0.50-1.19; P = .083) for the composite morbidity and mortality endpoint. In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n = 23]), as was occurrence of other adverse events except for atrial fibrillation, although all CIs crossed 1.0. CONCLUSIONS: This clinical trial, which was stopped at its midpoint owing to enrollment constraints, supports neither the efficacy nor the futility of transfusing either younger or older RBC units. The effects of transfusing RBCs after even more prolonged storage (35-42 days) remains untested.

Prognostic Value of Preoperative Red Cell Distribution Width: Fine-Tuning by Mean Corpuscular Volume.

BACKGROUND: Abnormal red cell distribution width (RDW), reflecting heterogeneity of red blood cell (RBC) size, is associated with cardiovascular disease outcomes. However, whether RBC size itself, expressed as mean corpuscular volume (MCV), provides additional prognostic value is unclear. We therefore investigated the relationship between outcomes after cardiac surgery and both RDW and MCV simultaneously. METHODS: From January 2010 to January 2014, 16,097 patients underwent cardiac surgery at Cleveland Clinic and had complete blood count findings available for analysis. Outcomes included RBC transfusion, postoperative complications, and intensive care unit (ICU) and postoperative hospital lengths of stay. Risk-adjusted associations of RDW and MCV with outcomes and their relative importance in predicting outcome were identified by random forest machine learning. RESULTS: High RDW was associated with more RBC transfusions. Except for postoperative atrial fibrillation, risks of complications and ICU and postoperative lengths of stay were at their minimum when RDW was normal, 13% to 14%. The relationship of MCV to complications was U-shaped: high (macrocytosis) and low (microcytosis) values were associated with higher risk. RDW was an important risk factor for most postoperative outcomes and lengths of stay; MCV was less so, but provided prognostic value in addition to RDW alone, particularly when there was macrocytosis. CONCLUSIONS: Abnormal RDW and MCV are associated with higher risk of transfusion and postoperative outcomes after cardiac surgery. RDW is one of the most important variables in predicting outcomes, but MCV provides additional prognostic value. Both should be taken into consideration when estimating the perioperative risk of patients undergoing cardiac surgery.

An Innovative Perioperative Pain Program for Chronic Opioid Users: An Academic Medical Center's Response to the Opioid Crisis.

Increased utilization of prescription opioids for pain management has led to a nationwide public health crisis with alarming rates of addiction and opioid-related deaths. In the surgical setting, opioid prescriptions have been implicated as a contributing factor to the opioid epidemic. The authors developed an innovative model to address aspects of pain management and opioid utilization during preoperative evaluation, acute surgical hospitalization, and postoperative follow-up for chronic opioid users. This program involves multidisciplinary teams that include acute and chronic pain specialists, psychiatrists, integrative medicine specialists, and physical medicine and rehabilitation services. It also features a novel infrastructure for triage and pain management education and treatment. Individualized patient plans are devised that can include preoperative opioid weaning, regional anesthesia that minimizes opioid use, and multimodal techniques for surgical pain treatment. Multidisciplinary programs such as this have the potential to both improve perioperative pain control and prevent escalation of opioid use among chronic opioid users.

A model for an institutional response to the opioid crisis.

The use of opioid analgesics for pain management has increased dramatically over the past decade, with corresponding increases in negative sequelae including overdose and death. Physicians, policymakers, and researchers are focused on finding ways to decrease opioid use and overdose. This crisis calls for a coordinated response that includes the entire healthcare sector. In this work, the authors lay out a blueprint for such a response at the level of the academic medical center. The proposed model is a comprehensive opioid overdose prevention, response, and education program to evaluate, monitor, and address prescription opioid-related adverse events and addiction among all patients within a healthcare system. The approach includes three inter-related elements: (1) creation of an organizational structure that is subdivided into subcommittees to facilitate cross-functional collaboration and implementation. These subcommittees will focus on Research and Design, Implementation, Advisory, and Compliance with the recommendation. (2) Development of an effective communication plan throughout the institution to enable the organization to function seamlessly and efficiently as a single unit, (3) development of a data tracking and reporting system that intended to have a 360° view of all aspects of opioid prescription and downstream patient outcomes. The most effective response system will require an organizational structure that facilitates the ad hoc constitution of cross-functional teams with members drawn from all levels of the organizational hierarchy (executive leadership to frontline staff). Such a structure provides the teams with immediate solutions as developed by the frontline staff and authority to remove institutional barriers that may delay or limit the successful implementation. The model described was developed in our institution by a cross-functional team that included members from the Johns Hopkins School of Medicine and Johns Hopkins University Carey Business School, Department of Operations Management. The multidisciplinary nature of collaboration allowed us to develop a model for an immediate institution-wide response to the opioid crisis, and one that other healthcare organizations could adopt with local modification as a template for execution. The model also meant to serve as a template for an institutional rapid-response that can be seamlessly implemented during any future drug-related crisis or epidemic.

Real Age: Red Blood Cell Aging During Storage.

BACKGROUND: During cold storage, some red blood cell (RBC) units age more rapidly than others. Yet, the Food and Drug Administration has set a uniform storage limit of 42 days. Objectives of this review are to present evidence for an RBC storage lesion and suggest that functional measures of stored RBC quality-which we call real age-may be more appropriate than calendar age. METHODS: During RBC storage, biochemical substances and byproducts accumulate and RBC shape alters. Factors that influence the rate of degradation include donor characteristics, bio-preservation conditions, and vesiculation. Better understanding of markers of RBC quality may lead to standardized, quantifiable, and operationally practical measures to improve donor selection, assess quality of an RBC unit, improve storage conditions, and test efficacy of the transfused product. RESULTS: The conundrum is that clinical trials of younger versus older RBC units have not aligned with in vitro aging data; that is, the units transfused were not old enough. In vitro changes are considerable beyond 28 to 35 days, and average storage age for older transfused units was 14 to 21 days. CONCLUSIONS: RBC product real age varies by donor characteristics, storage conditions, and biological changes during storage. Metrics to measure temporal changes in quality of the stored RBC product may be more appropriate than the 42-day expiration date. Randomized trials and observational studies are focused on average effect, but, in the evolving age of precision medicine, we must acknowledge that vulnerable populations and individuals may be harmed by aging blood.

Wrong-Patient Blood Transfusion Error: Leveraging Technology to Overcome Human Error in Intraoperative Blood Component Administration.

BACKGROUND: Confirmation of match between patient and blood product remains a manual process in most operating rooms (ORs), and documentation of dual-signature verification remains paper based in most medical institutions. A sentinel event at Johns Hopkins Hospital in which a seriously ill patient undergoing an emergent surgical procedure was transfused with a unit of incompatible red blood cells that had been intended for another patient in an adjacent OR led the hospital to conduct a quality improvement project to improve the safety of intraoperative blood component transfusions. METHODS: A multidisciplinary quality improvement project team led a four-phase implementation of bedside bar code transfusion verification (BBTV) for intraoperative blood product administration. Manual random sample audits of blood component transfusions were used to examine accuracy of documentation from July 2014 through June 2016. After the transition to the Epic anesthesia information management system (AIMS) in July 2016, automated Epic reports were generated to provide population-level audits. RESULTS: After initiation of BBTV and the addition of Epic AIMS, compliance with obtaining three metrics on documentation of patient identification (two electronic signatures, start and stop times of transfusion, and blood volume transfused) was improved during a one-year period to > 96%. Pre-Epic audits had shown a mean compliance of only 86%, mainly reflecting a lack of paper blood component requisitions. CONCLUSION: By implementing BBTV and using a novel intraoperative documentation process within the Epic AIMS, a safer process of blood transfusion in the ORs was initiated and documentation improved.

Engaging the Front Line: Tapping into Hospital-Wide Quality and Safety Initiatives.

Healthcare increasingly is moving from volume- to value-based care, with an emphasis on linking a larger percentage of payments to the quality of care provided. There is a renewed interest in designing a focused, strategic approach to quality and safety education and engagement of trainees in hospital-wide quality, safety, and patient experience initiatives. Hospitals, trainees, and patients benefit as a result of engaging frontline learners in these activities. Hospitals can leverage the intelligence from the front line to contribute to improved hospital safety, increased employee and patient engagement, and better identification of vulnerable areas of safety risks. Trainees benefit from increased engagement by acquiring fundamentals in quality and safety; are able to satisfy Clinical Learning Environment Review recommendations; have an opportunity to practice a number of skill sets (leadership, communication, collaboration); and complete quality and safety hands-on projects. Patients benefit from a more engaged work force, safer environment for their healthcare, and an improved overall experience. In this article, the current state of the Johns Hopkins Department of Anesthesiology and Critical Care Medicine's efforts to engage its front line in quality, safety, and patient experience initiatives that are in evolutionary phases of implementation is presented. Evolutionary concepts relate to the Johns Hopkins Health System and the aim of its training program to continuously improve and innovate.

Preoperative Anemia in Cardiac Operation: Does Hemoglobin Tell the Whole Story?

BACKGROUND: Preoperative anemia, defined by hemoglobin level, is associated with elevated risk after cardiac operation. Better understanding of anemia requires characterization beyond this. This investigation focuses on red cell size and its association with patient characteristics and outcomes after cardiac operation. METHODS: From January 2010 to January 2014, 10,589 patients underwent elective cardiac operations at Cleveland Clinic. Anemia was characterized as normocytic, microcytic, or macrocytic based on mean corpuscular volume (MCV). Models for hospital complications were developed using multivariable logistic regression. Other outcomes were postoperative transfusion and intensive care unit (ICU) and postoperative hospital lengths of stay. RESULTS: A total of 2,715 patients (26%) were anemic. Of these, 2,365 (87%) had normocytic, 219 (8.1%) microcytic, and 131 (4.8%) macrocytic anemia. Non-anemic patients (n = 2,041, 26%) received transfusions compared with 1,553 (66%) normocytic, 148 (68%) microcytic, and 97 (74%) macrocytic anemia patients. Patients with normocytic or macrocytic anemia had more renal failure (normocytic: odds ratio (OR) 1.9, macrocytic: OR 3.5), other complications (normocytic: OR 1.3, macrocytic: OR 2.2) and death (normocytic: OR 2.0, macrocytic: OR 6.2) than non-anemic patients; patients with microcytic anemia had fewer reoperations (OR 0.35) and less postoperative atrial fibrillation (OR 0.50). Anemic patients experienced longer ICU (27 versus 48 hours, p < 0.001) and postoperative hospital (6.1 versus 7.4 days, p < 0.001) length of stay than non-anemic patients. CONCLUSIONS: Cardiac surgical patients are often anemic. Demographic characteristics, comorbidities, and outcomes are dissimilar according to red cell size. Patients with microcytic anemia had the lowest hemoglobin levels, yet the best clinical outcomes among anemic patients. MCV from the standard complete blood count adds additional information beyond hemoglobin for targeted intervention.

A Randomized Clinical Trial of Red Blood Cell Transfusion Triggers in Cardiac Surgery.

BACKGROUND: Class I evidence supporting a threshold for transfusion in the cardiac surgical setting is scarce. We randomly allocated patients to a transfusion hematocrit trigger of 24% versus 28% to compare morbidity, mortality, and resource use. METHODS: From March 2007 to August 2014, two centers randomly assigned 722 adults undergoing coronary artery bypass graft surgery or valve procedures to a 24% hematocrit trigger (n = 363, low group) or 28% trigger (n = 354, high group). One unit of red blood cells was transfused if the hematocrit fell below the designated threshold. The primary endpoint was a composite of postoperative morbidities and mortality. Treatment effect was primarily assessed using an average relative effect generalized estimating equation model. RESULTS: At the second planned interim analysis, the a priori futility boundary was crossed, and the study was stopped. There was no detected treatment effect on the composite outcome (average relative effect odds ratio, low versus high, 0.86, 95% confidence interval: 0.29 to 2.54, p = 0.71). However, the low group received fewer red blood cell transfusions than the high group (54% versus 75%, p < 0.001), mostly administered in the operating room (low group, 112 [31%]; high group, 208 [59%]), followed by intensive care unit (low, 105 [31%]; high, 115 [34%]) and floor (low, 41 [12%]; high, 42 [13%]). The low group was exposed to lower hematocrits: median before transfusion, 22% (Q1 = 21%, Q3 = 23%) versus 24% (Q1 = 22%, Q3 = 25%). CONCLUSIONS: Negative exposures differed between treatment groups, with lower hematocrit in the 24% trigger group and more red blood cells used in the 28% group, but adverse outcomes did not differ. Because red blood cell use was less with a 24% trigger without adverse effects, our randomized trial results support aggressive blood conservation efforts in cardiac surgery.

Does a similar procedure result in similar survival for women and men undergoing isolated coronary artery bypass grafting?

OBJECTIVES: To (1) identify sex-related differences in risk factors and revascularization strategies for patients undergoing coronary artery bypass grafting (CABG), (2) assess whether these differences influenced early and late survival, and (3) determine whether clinical effectiveness of the same revascularization strategy was influenced by sex. METHODS: From January 1972 to January 2011, 57,943 adults-11,009 (19%) women-underwent primary isolated CABG. Separate models for long-term mortality were developed for men and women, followed by assessing sex-related differences in strength of risk factors (interaction terms). RESULTS: Incomplete revascularization was more common in men than women (26% vs 22%, P < .0001), but women received fewer bilateral internal thoracic artery (ITA) grafts (4.8% vs 12%; P < .0001) and fewer arterial grafts (68% vs 70%; P < .0001). Overall, women had lower survival than men after CABG (65% and 31% at 10 and 20 years, respectively, vs 74% and 41%; P ≤ .0001), even after risk adjustment. Incomplete revascularization was associated equally (P > .9) with lower survival in both sexes. Single ITA grafting was associated with equally (P = .3) better survival in women and men. Although bilateral ITA grafting was associated with better survival than single ITA grafting, it was less effective in women-11% lower late mortality (hazard ratio, 0.89 [0.77-1.022]) versus 27% lower in men (hazard ratio, 0.73 [0.69-0.77]; P = .01). CONCLUSIONS: Women on average have longer life expectancies than men but not after CABG. Every attempt should be made to use arterial grafting and complete revascularization, but for unexplained reasons, sex-related differences in effectiveness of bilateral arterial grafting were identified.

Magnitude of Anemia at Discharge Increases 30-Day Hospital Readmissions.

BACKGROUND: Anemia during hospitalization is associated with poor health outcomes. Does anemia at discharge place patients at risk for hospital readmission within 30 days of discharge? Our objectives were to examine the prevalence and magnitude of anemia at hospital discharge and determine whether anemia at discharge was associated with 30-day readmissions among a cohort of hospitalizations in a single health care system. METHODS: From January 1, 2009, to August 31, 2011, there were 152,757 eligible hospitalizations within a single health care system. The endpoint was any hospitalization within 30 days of discharge. The University HealthSystem Consortium's clinical database was used for demographics and comorbidities; hemoglobin values are from the hospitals' electronic medical records, and readmission status was obtained from the University HealthSystem Consortium administrative data systems. Mild anemia was defined as hemoglobin of greater than 11 to less than 12 g/dl in women and greater than 11 to less than 13 g/dl in men; moderate, greater than 9 to less than or equal to 11 g/dl; and severe, less than or equal to 9 g/dl. Logistic regression was used to assess the association of anemia and 30-day readmissions adjusted for demographics, comorbidity, and hospitalization type. RESULTS: Among 152,757 hospitalizations, 72% of patients were discharged with anemia: 31,903 (21%), mild; 52,971 (35%), moderate; and 25,522 (17%), severe. Discharge anemia was associated with severity-dependent increased odds for 30-day hospital readmission compared with those without anemia: for mild anemia, 1.74 (1.65-1.82); moderate anemia, 2.76 (2.64-2.89); and severe anemia, 3.47 (3.30-3.65), P < 0.001. CONCLUSIONS: Anemia at discharge is associated with a severity-dependent increased risk for 30-day readmission. A strategy focusing on anemia treatment care paths during index hospitalization offers an opportunity to influence subsequent readmissions.

From Bad to Worse: Anemia on Admission and Hospital-Acquired Anemia.

BACKGROUND: Anemia at hospitalization is often treated as an accompaniment to an underlying illness, without active investigation, despite its association with morbidity. Development of hospital-acquired anemia (HAA) has also been associated with increased risk for poor outcomes. Together, they may further heighten morbidity risk from bad to worse. OBJECTIVES: The aims of this study were to (1) examine mortality, length of stay, and total charges in patients with present-on-admission (POA) anemia and (2) determine whether these are exacerbated by development of HAA. DESIGN/SETTING/PATIENTS: In this cohort investigation, from January 1, 2009, to August 31, 2011, a total of 44,483 patients with POA anemia were admitted to a single health system compared with a reference group of 48,640 without POA anemia or HAA. MEASUREMENTS: Data sources included the University HealthSystem Consortium database and electronic medical records. Risk-adjustment methods included logistic and linear regression models for mortality, length of stay, and total charges. Present-on-admission anemia was defined by administrative coding. Hospital-acquired anemia was determined by changes in hemoglobin values from the electronic medical record. RESULTS: Approximately one-half of the patients experienced worsening of anemia with development of HAA. Risk for death and resource use increased with increasing severity of HAA. Those who developed severe HAA had 2-fold greater odds for death; that is, mild POA anemia with development of severe HAA resulted in greater mortality (odds ratio, 2.57; 95% confidence interval, 2.08-3.18; P < 0.001), increased length of stay (2.23; 2.16-2.31; P < 0.001), and higher charges (2.09; 2.03-2.15; P < 0.001). CONCLUSIONS: Present-on-admission anemia is associated with increased mortality and resource use. This risk is further increased from bad to worse when patients develop HAA. Efforts to address POA anemia and HAA deserve attention.

Process Improvement in Thoracic Donor Organ Procurement: Implementation of a Donor Assessment Checklist.

BACKGROUND: Donor organs are often procured by junior staff in stressful, unfamiliar environments where a single adverse event can be catastrophic. A formalized checklist focused on preprocedural processes related to thoracic donor organ procurement could improve detection and prevention of near miss events. METHODS: A checklist was developed centered on patient identifiers, organ compatibility and quality, and team readiness. It went through five cycles of feedback and revision using a panel of expert procurement surgeons. Educational in-service sessions were held on the use of the checklist as well as best organ assessment practices. Near miss events before the survey were tallied by retrospective review of 20 procurements, and near misses after checklist implementation were prospectively recorded. We implemented the checklist for 40 donor lung and heart procurements: 20 from Cleveland Clinic and 20 from the University of Minnesota. A final survey assessment was used to determine ease of use. RESULTS: Nine near miss events were reported in 20 procurements before use of the checklist. Thirty-one near miss events of 40 organ procurements were identified and potentially prevented by the checklist. Eighty-seven percent of fellows found the checklist to be unobtrusive to work flow, and 100% believed its use should be mandatory. Mortality was the same before and after implementation of the checklist despite increased patient volumes. CONCLUSIONS: Implementation of a simple checklist for use during thoracic organ procurement uncovered a substantial number of near miss events. A preprocedural checklist for all thoracic organ transplants in the United States and abroad is feasible and would likely reduce adverse events.