Comparing Hospital Length of Stay Between Persons With LEP and English-Speaking Patients in a Large Rural Academic Medical Center.

BACKGROUND: Patients with limited English proficiency that are hospitalized without regular access to professional medical interpreters have a longer length of stay (LOS). 1 The authors studied the difference in LOS between English-speaking patients and patients with limited English proficiency in New Hampshire's only academic trauma medical center. The authors also examined race, ethnicity, and distance of residence from hospital. METHODS: Retrospective data were queried from EPIC, the electronic medical record system used by the authors. Queried data focused on inpatient hospitalizations between January 1, 2019, and December 31, 2021. Patient primary language was grouped into English, Spanish, and other non-English language. RESULTS: Spanish-speaking patients live on average 39.6 miles farther from a hospital than English-speaking patients and have a 0.34 lower case mix index. After English, Spanish is the second-most frequently spoken language. Regression analyses found language to be a significant factor in LOS, LOS variance, and case mix index. DISCUSSION: A 2.34-day longer LOS for Spanish-speaking patients demonstrates an important health care disparity warranting further attention.

Quantifying Fatigue Using Electrophysiological Techniques and Non-invasive Brain Stimulation in People With Multiple Sclerosis- A Review and Discussion.

Objective: The purpose of this literature review article is to provide a synthesis of recent research focused on the use of 3 techniques to evaluate MS-related fatigue: electroencephalography [EEG], transcranial direct-current stimulation (tDSC), and transcranial- magnetic stimulation (TMS). Method: We performed a literature search in the Cumulative Index to Nursing and Allied Health Literature (CINAHL, EBSCOhost), MEDLINE (OVID), APA PsycInfo (OVID), Scopus (Elsevier), and Web of Science (Clarivate) databases, limited to 2015 and after. Results: Our review revealed that fatigue in MS patients can be quantified and predicted using electrophysiological techniques. Such techniques, which yield objective data, are historically assessed in relation to subjective data, or perceived fatigue. We identified studies using EEG, TMS, and/or tDCS to study fatigue in people with MS. In total, 220 records were identified with 19 studies meeting inclusion criteria. Quality appraisal revealed that the level of evidence was generally graded "good". Conclusions: Despite the heterogenous nature of reviewed the studies and selected the varied self-report fatigue measures, our literature synthesis suggests promise for the use of EEG, TMS, and/or tDCS approaches in more accurately assessing fatigue in people with MS. Further research is needed in this arena.

Implementation of a Standardized Shared Decision-making Bundle to Improve Communication Practices in the Neurocritical Care Unit.

Background and Objective: Shared decision-making (SDM) aligns patient preferences with health care team treatment goals. This quality improvement initiative implemented a standardized SDM bundle within a neurocritical care unit (NCCU), where unique demands make existing, provider-driven SDM practices challenging. Methods: An interprofessional team defined key issues, identified barriers, and created change ideas to drive implementation of an SDM bundle using the Institute for Healthcare Improvement Model for Improvement framework incorporating Plan-Do-Study-Act cycles. The SDM bundle included (1) a health care team huddle pre-SDM and post-SDM conversation; (2) a social worker-driven SDM conversation with the patient family, including core standardized communication elements to ensure consistency and quality; and (3) an SDM documentation tool within the electronic medical record to ensure the SDM conversation was accessible to all health care team members. The primary outcome measure was percentage of SDM conversations documented. Results: Documentation of SDM conversations improved by 56%, from 27% to 83% pre/postintervention. Average time to documentation decreased by 4 days, from day 9 preintervention to day 5 postintervention. There was no significant change in NCCU length of stay, nor did palliative care consultation rates increase. Postintervention, SDM team huddle compliance was 94.3%. Discussion: A team-driven, standardized SDM bundle that integrates with health care team workflows enabled SDM conversations to occur earlier and resulted in improved documentation of SDM conversations. Team-driven SDM bundles have the potential to improve communication and promote early alignment with patient family goals, preferences, and values.

Harnessing the Collective Expertise of Patients, Care Partners, Clinical Teams, and Researchers Through a Coproduction Learning Health System: A Case Study of the Dartmouth Health Promise Partnership.

The coproduction learning health system (CLHS) model extends the definition of a learning health system to explicitly bring together patients and care partners, health care teams, administrators, and scientists to share the work of optimizing health outcomes, improving care value, and generating new knowledge. The CLHS model highlights a partnership for coproduction that is supported by data that can be used to support individual patient care, quality improvement, and research. We provide a case study that describes the application of this model to transform care within an oncology program at an academic medical center.

Bidirectional Correlations Between Health Confidence and Inflammatory Bowel Disease Activity: A Nationwide Longitudinal Cohort Study.

Health confidence­an individual's belief in their ability and agency to affect disease outcomes­has bidirectional temporal correlations with inflammatory bowel disease activity. Low health confidence is associated with higher risks for future disease activity, and inflammatory bowel disease flares erode confidence.

Achievement of age-friendly health systems committed to care excellence designation in a convenient care health care system.

OBJECTIVE: To describe the implementation of the age-friendly health systems (AFHS) 4Ms Framework, an evidence-based framework to assess and act on "What Matters, Medication, Mentation and Mobility to deliver Age-Friendly health care for patients 65 and older", to achieve the Institute for Health care Improvement (IHI) Committed to Care Excellence recognition in a convenient care health system and test two novel implementation strategies. SETTING: The study was conducted in over 1100 convenient care clinics in 35 states and DC. MinuteClinics are located in community-based retail pharmacies in rural, suburban, and urban areas and staffed with approximately 3300 nurse practitioners and physician associates. DESIGN: In Year 1, the project used a quality improvement design, and in Year 2, a quasi-experimental implementation research design to pilot two strategies at the provider level (Virtual Clinic and Plan-Do-Study-Act (PDSA)). Statistical process control charts were used to assess changes in 4Ms documentation over time. Mixed-effects Poisson regression was used to assess the effectiveness of the pilot studies. DATA COLLECTION: The electronic health record (EHR) was enhanced to capture documentation of the AFHS 4Ms assessments and actions. A learning platform was created to teach and evaluate provider 4Ms competency, and the two data sources were merged into a registry. A formative evaluation was conducted using Tableau and reporting dashboards. FINDINGS: After 18 months and the implementation of 20 strategies to improve the uptake of the 4Ms, MinuteClinic achieved the IHI Committed to Care Excellence recognition. A significant increase over time in the reliable delivery of all 4Ms and each M component individually was found. For the research, there were significant improvements in the mean number of Ms delivered per visit (M-Score) in the Virtual Clinic (Incident Rate Ratio [IRR]: 2.47, p = 0.001) and PDSA (IRR: 3.08, p = 0.002) strategy intervention groups when compared to controls. CONCLUSIONS: Application of quality improvement and implementation methodologies contributed to the success of implementing age-friendly 4Ms evidence-based practice.

Transitional Care Management Quality Improvement Methods That Reduced Readmissions in a Rural, Primary Care System.

BACKGROUND: Transitional Care Management (TCM) is a reimbursable service designed to minimize hospital readmissions. We describe a multifaceted approach to increase TCM services among 107 primary care providers in a rural catchment area of 4250 square miles. OBJECTIVE: The primary objective was to increase use of TCM phone calls, office visits, and billing codes; the secondary objective was to decrease hospital readmissions. METHODS: We utilized a learning health system model, an improvement support team (IST), and a learning collaborative that included webinars and in-person support. The process emphasized user-centered system redesign, coaching, electronic health record (EHR) improvements, and real-time feedback. Analyses included statistical process control charts, box plots, analysis of variance, and t-tests. RESULTS: The IST engaged stakeholders to design and test TCM workflows and EHR prototypes. This resulted in rapid, iterative improvements and system-wide spread of new processes. In the month following implementation, TCM calls and visits quadrupled and increased during 18 subsequent months. Pragmatically, most discharged patients (95% in a subsample) did not receive both the TCM call and visit, serving as a comparison group. The Readmission rate for patients receiving complete TCM services was 5.0% (n = 101) versus 11.9% for comparators (n = 2103, P = .03). Billing codes increased initially, then returned to baseline. CONCLUSIONS: Our approach led to rapid, sustained scaling of TCM calls and visits in a rural primary care group. Patients who received TCM calls and visits had significantly fewer readmissions. Training of new staff, including PCPs, is required for sustainability. Future research is warranted to increase adoption and evaluate additional outcomes including mortality rates, patient satisfaction, and health care economics.

Contact patterns and costs of multiple sclerosis in the Swedish healthcare system-A population-based quantitative study.

BACKGROUND: The burden of disease for persons with multiple sclerosis (MS) and society is changing due to new treatments. Knowledge about the total need for care is necessary in relation to changing needs and new service models. OBJECTIVE: The aim of this study was to describe the contact patterns for MS patients, calculate costs in health care, and create meaningful subgroups to analyze contact patterns. METHODS: All patients diagnosed with MS at Ryhov Hospital were included. All contacts in the region from January 1, 2018, until September 30, 2019, were retrieved from the hospital administrative system. Data about age, sex, contacts, and diagnosis were registered. The cost was calculated using case costing, and costs for prescriptions were calculated from medical files. RESULTS: During the 21-month period, patients (n = 305) had 9628 contacts and 7471 physical visits, with a total cost of $7,766,109. Seventeen percent of the patients accounted for 48% of the visits. The median annual cost was $7386 in the group with 10 or fewer visits, compared to $22,491 in patients with more than 50 visits. CONCLUSION: There are considerable differences in the utilization of care and cost between patients with MS in an unselected population, meaning that the care needs to be better customized to each patient's demands.

Utilization Patterns and Outcomes of People With Diabetes and COVID-19: Evidence From United States Medicare Beneficiaries in 2020.

Objective: Determine differences in utilization patterns, disease severity, and outcomes between patients with and without diabetes mellitus diagnosed with COVID-19 in 2020. Research Design and Methods: We used an observational cohort comprised of Medicare fee-for-service beneficiaries with a medical claim indicating a COVID-19 diagnosis. We performed inverse probability weighting between beneficiaries with and without diabetes to account for differences in socio-demographic characteristics and comorbidities. Results: In the unweighted comparison of beneficiaries, all characteristics were significantly different (P<0.001). Beneficiaries with diabetes were younger, more likely to be black, had more comorbidities, higher rates of Medicare-Medicaid dual-eligibility, and were less likely to be female. In the weighted sample, hospitalization rates for COVID-19 among beneficiaries with diabetes was higher (20.5% vs 17.1%; p < 0.001). Outcomes of hospitalizations were similarly worse among beneficiaries with diabetes: admissions to ICU during hospitalizations (7.78% vs. 6.11%; p < 0.001); in-hospital mortality (3.85% vs 2.93%; p < 0.001); and ICU mortality (2.41% vs 1.77%). Beneficiaries with diabetes had more ambulatory care visits (8.9 vs. 7.8, p < 0.001) and higher overall mortality (17.3% vs. 14.9%, p < 0.001) following COVID-19 diagnosis. Conclusion: Beneficiaries with diabetes and COVID-19 had higher rates of hospitalization, ICU use and overall mortality. While the mechanism of how diabetes impacts the severity of COVID-19 may not be fully understood, there are important clinical implications for persons with diabetes. A diagnosis of COVID-19 leads to greater financial and clinical burden than for their counterparts, persons without diabetes, including perhaps most significantly, higher death rates.

Development of Balanced Whole System Value Measures for Inflammatory Bowel Disease Care in the IBD Qorus Collaborative Using a Modified Delphi Process.

BACKGROUND: The IBD Qorus Collaborative aims to reduce variation and increase the value of care for the adult inflammatory bowel disease (IBD) community. To evaluate the success of the collaborative, we aimed to develop a balanced set of outcome measures that reflect a multistakeholder view of value in IBD care. To achieve this, we used the Clinical Value Compass framework and engaged a mixed-stakeholder group to conduct a modified Delphi process. The end result was a 10-measure set to assess the value of IBD care. METHOD: The modified Delphi process included 3 iterative rounds of blinded voting and interactive webinar-style discussion. We recruited 18 participants for the Delphi panel, including clinicians, researchers, patients, Crohn's & Colitis Foundation staff, and payers. Participants first identified constructs to measure, then identified the tools to measure those constructs. A literature review and environmental scan of current measures in 4 domains were performed, and relevant measures were proposed for discussion and voting in each domain. Throughout the process, participants were invited to contribute additional measures. CONCLUSION: The modified Delphi process led to selection of 10 value measures across 4 domains: (1) patient experience; (2) functional status; (3) clinical status; and (4) health care costs and utilization. We have successfully completed a 3-stage modified Delphi process to develop a balanced set of value measures for adult IBD care. The value measure set expands upon prior efforts that have established quality measures for IBD care by adding cost and experience of care elements. This work positions IBD Qorus to better assess, study, improve, and demonstrate value at individual, system, and population levels and will inform and empower related research, improvement, and implementation efforts.

System-Level Variation in Multiple Sclerosis Care Outcomes: Initial Findings from the Multiple Sclerosis Continuous Quality Improvement Research Collaborative.

Multiple sclerosis (MS) is a "3C" (complex, chronic, costly) condition that is a common and disabling neurological illness affecting approximately 1 million adults in the United States. MS has been studied at the basic science, individual, and population levels, but not at the system level to assess small-area variation effects on MS population health outcomes. System-level effects have been observed in other 3C conditions including cystic fibrosis, rheumatoid arthritis, and inflammatory bowel disease. The authors report here on system-level variation findings from the baseline period during the first year of the Multiple Sclerosis Continuous Quality Improvement (MS-CQI) study. Stepwise binary logistic regression analyses were conducted to investigate system-level (small-area variation) effects on MS relapses (exacerbations), disease-modifying therapy (DMT) utilization, and brain MRI utilization, controlling for demographics (age and sex) and other potential confounders. Significant differences were observed in people with MS (PwMS) between centers for a number of demographic and disease characteristics, including sex, age, and MS subtype. Controlling for these factors, significant system-level effects were observed on outcomes, including DMT utilization, MRI utilization, and relapses. Significant relationships also were observed between outcomes and urgent care utilization, including emergency department visits and hospitalizations. This initial study provides evidence establishing the presence of system-level variation effects on MS outcomes in a multicenter population study - where PwMS get their care can influence their outcomes. Results support continued systems-level research and improvement initiatives to optimize MS population health outcomes in this challenging and costly complex chronic condition.

Reducing New Ileostomy Readmissions in a Rural Health Care Setting: A Quality Improvement Initiative.

BACKGROUND: Readmission after ileostomy creation continues to be a major cause of morbidity with rates ranging from 15% to 30% due to dehydration and obstruction. Rural environments pose an added risk of readmission due to larger travel distances and lack of consistent home health services. OBJECTIVE: This study aimed to reduce ileostomy-related readmission rates in a rural academic medical center. DESIGN: This is a rapid cycle quality improvement study. SETTING: This single-center study was conducted in a rural academic medical center. PATIENTS: Colorectal surgery patients receiving a new ileostomy were included in this study. INTERVENTIONS: Improvement initiatives were identified through Plan-Do-Study-Act cycles (enhanced team continuity, standardized rehydration, nursing/staff education). MAIN OUTCOME MEASURES: Thirty-day readmission, average length of stay, and average time to readmission served as main outcome measures. RESULTS: Roughly equal rates of ileostomy were created in each time point, consistent with a tertiary care colorectal practice. The preimplementation readmission rate was 29%. Over the course of the entire quality improvement initiative, re-admission rates decreased by more than 50% (29% to 14%). PDSA cycle 1, which involved integrating a service-specific physician assistant to the team, allowed for greater continuity of care and had the most dramatic effect, decreasing rates by 27.5% (29% to 21%). Standardization of oral rehydration therapy and the implementation of a patient-directed intake/output sheet during PDSA cycle 2 resulted in further improvement in readmission rates (21% to 15%). Finally, implementation of nurse and physician assistant (PA)-driven patient education on fiber supplementation resulted in an additional yet nominal decrease in readmissions (15% to 14%). Latency to readmission also significantly increased throughout the study period. LIMITATIONS: This study was limited by its small sample size in a single-center study. CONCLUSION: Implementation of initiatives targeting enhanced team continuity, the standardization of rehydration therapies, and improved patient education decreased readmission rates in patients with new ileostomies. Rural centers, where outpatient resources are not as readily available or accessible, stand to benefit the most from these types of targeted interventions to decrease readmission rates. See Video Abstract at http://links.lww.com/DCR/B771. REDUCCIN EN LAS READMISIONES POR ILEOSTOMAS NE MEDIOS DE ATENCIN MDICA RURAL INICIATIVA DE MEJORA EN LA CALIDAD: ANTECEDENTES:La readmisión después de la creación de una ileostomía sigue siendo una de las principales causas de morbilidad con tasas que oscilan entre el 15% y el 30% debido a la deshidratación y la oclusión. Un entorno rurale presenta un riesgo adicional de readmisión debido a las mayores distancias de viaje y la falta de servicios de salud domiciliarios adecuados.OBJETIVO:Reducir las tasas de reingreso por ileostomía en un centro médico académico rural.DISEÑO:Estudio de mejoría de la calidad de ciclo rápido.AJUSTE:Estudio unicéntrico en una unidad de servicio médico académico rural.PACIENTES:Pacientes de cirugía colorrectal a quienes se les confeccionó una ileostomía.INTERVENCIONES:Iniciativas de mejoría identificadas a través de los ciclos Planificar-Hacer-Estudiar-Actuar (Continuidad del equipo mejorada, rehidratación estandarizada, educación de enfermería / personal).PRINCIPALES MEDIDAS DE RESULTADO:30 días de readmisión, duración media de la estadía hospitalaria, tiempo medio de reingreso.RESULTADOS:Se crearon tasas aproximadamente iguales de ileostomías un momento dado de tiempo, subsecuentes en la práctica colorrectal de atención terciaria. La tasa de readmisión previa a la implementación del estudio fue del 29%. En el transcurso de toda la iniciativa de mejoría en la calidad, las tasas de readmisión disminuyeron en más del 50% (29% a 14%). El ciclo 1 de PDSA, que implicó la integración en el equipo de un asistente médico específico, lo que permitió una mayor continuidad en la atención y tuvo el mayor efecto disminuyendo las tasas en un 27,5% (29% a 21%). La estandarización de una terapia de rehidratación oral y la implementación de una hoja de ingresos / perdidas dirigida al paciente durante el ciclo 2 de PDSA resultó en una mejoría adicional en las tasas de readmisión (21% a 15%). Finalmente, la implementación de la educación del paciente impulsada por enfermeras y AF sobre el consumo suplementario de dietas con fibra dio como resultado una disminución adicional, aunque nominal, de las readmisiones (15% a 14%). La latencia hasta la readmisión también aumentó significativamente durante el período de estudio.LIMITACIONES:Estudio de un solo centro con un muestreo de pequeño tamaño.CONCLUSIONES:La implementación de iniciativas dirigidas a mejorar la continuidad en el equipo, la estandarización de las terapias de rehidratación y la mejoría en la información de los pacientes disminuyeron las tasas de readmisión en todos aquellas personas con nuevas ileostomías. Los centros rurales, donde los recursos para pacientes ambulatorios no están tan fácilmente disponibles o accesibles, son los que más beneficiaron de este tipo de intervenciones específicas para reducir las tasas de readmisión. Consulte Video Resumen en http://links.lww.com/DCR/B771. (Traducción-Dr. Xavier Delgadillo).

Health Confidence Is Associated With Disease Outcomes and Health Care Utilization in Inflammatory Bowel Disease: A Nationwide Cross-sectional Study.

BACKGROUND: We aimed to examine the associations between health confidence (one's belief on the degree of control on their health and disease), inflammatory bowel disease (IBD) outcomes, and health care utilization among adults with IBD. METHODS: In total, 17,205 surveys were analyzed from a cross-sectional sample of IBD patients at 23 gastroenterology (GI) practices participating in the Crohn's and Colitis Foundations' IBD Qorus Learning Health System. We used bivariate analyses and multivariable logistic regression to examine associations between health confidence and disease activity, opioid use, glucocorticoid use, well-being, and health care utilization. We used receiver operating curve analysis to determine a clinically relevant cutoff for health confidence (0-10 Likert scale). RESULTS: Health confidence was highly correlated with patients' well-being, symptomatic disease activity, opioid use, and glucocorticoid use (all P < .0001). Health confidence scores <8 had 69% sensitivity for emergency department (ED) visits and 66% for hospitalizations. In patients with inactive disease, patients with low health confidence (<8) were 10 times more likely to call/message the GI office >4 times/month (adjusted odds ratio [aOR], 10.3; 95% CI, 6.1-17.3; P < .0001), 3-4 times more likely to have an IBD-related ED visit (aOR, 4.0; 95% CI, 2.9, 5.4. P < .0001), or hospitalization (aOR, 3.0, 95% CI, 2.1, 4.1, P < .0001) compared with patients with high health confidence (≥8). CONCLUSIONS: In a large, national sample of adults with IBD, there were strong associations between patients' health confidence and multiple disease outcome measures. Health confidence scores <8 on a 0-10 Likert scale may be clinically useful to screen for patients who are at risk for ED visits and hospitalizations.

International, national and local trends in the spread of COVID-19: a geographic view of COVID-19 spread and the role to be played by coproduction.

BACKGROUND: COVID-19, a respiratory disease caused by the SARS-CoV-2 virus, emerged in 2019 and led to a worldwide pandemic in 2020. The COVID-19 pandemic has been a massive natural experiment in the formation of mitigation strategies to prevent cases and to provide effective healthcare for those afflicted. Regional differences in the impact of the pandemic on morbidity and mortality have been driven by political and regional differences in the coproduction of public health and social policy. We explored the United States (US) experience of COVID-19 for trends and correlations with other nations and also at the national, regional, state and local levels. OBJECTIVE: To identify geographic and temporal trends in the spread of COVID-19 in the United States. METHODS: Population data on COVID-19 cases and mortality were acquired on a daily basis from multiple publicly available databases, including the New York Times and Johns Hopkins University. At each geographic level (national, state and county), geographic entities' reported cases were evaluated for correlations using linear least-squares methods to identify patterns of correlation in the cases independent of scale. We evaluated for two specific characteristics: (i) the nature of the curvature of the line linking across percentile scores, ranging from concave to convex and (ii) the area under this curve, indicating how effectively a selected region (nation, state and county) is linked to its entire containing unit (world, country and state). We used this approach to identify three distinct COVID behavior phenotypes, each of which consisted of a number of states in the USA. RESULTS: We found that COVID activity in the USA follows a unique trend compared to other countries and that within the USA during the first year of the pandemic, three initial COVID phenotypes emerged: (i) the metropolitan outbreak (early outbreak phenotype); (ii) the regional outbreak (summer peak phenotype) and (iii) trans-regional outbreak (fall/winter peak phenotype), which, taken in sum, represent the overall USA national trend. Each phenotype has specific behavioral characteristics and is composed of a cluster of different states experiencing different conditions. CONCLUSION: Our findings suggest a new opportunity for public health strategy in the pandemic, namely to apply targeted public health approaches to address the specific needs of each phenotype. In the future, we should create databases that capture key health and hardship data elements at the smallest geographic level possible and use these to track trends, predict the future and apply targeted coproduction approaches to more effectively and efficiently safeguard population health, economic vitality and social well-being.

Initial development of a self-assessment approach for coproduction value creation by an international community of practice.

BACKGROUND: Coproduction offers a new way of conceptualizing healthcare as a service that is co-created by people (health professionals and people seeking health services) rather than a product that is generated by providers or health systems and delivered to patients. This offers new possibilities for those introducing and testing changes, and it enables additional ways of creating value. Fjeldstad and colleagues describe the architecture of several kinds of value creating systems: (i) Chain; (ii) Shop; (iii) Network and (iv) Access. An international Value Creating Business Model Community of practice (VCBM CoP) was formed by the International Coproduction of Health Network and explored these types of systems and developed a self-assessment guide for health systems to use to assess value. METHODS: An international community of practice comprising leaders, clinicians, patients and finance specialists representing 12 health systems from four countries (USA, UK, Israel and Sweden) met monthly for 1 year and used a semi-structured process to iteratively refine and adapt Fjeldstad's model for use in healthcare and develop a draft self-assessment guide. The process concluded with initial focus group user experience sessions with six health systems. RESULTS: The community of practice successfully completed a 1-year journey of discovery, development and learning, resulting in two products: (1) a full-version self-assessment guide (detailed) and (2) an abbreviated 'short-form' of the guide. Initial focus-group results suggest that there is initial perceived feasibility, acceptability and utility of the guides and that further development and research is reasonable to pursue. Results suggest significant variation and context specificity in the use of the guide, simple and complex knowledge transfer applications in use, and the need for the development of simple and technology supported versions for use in the future. CONCLUSION: The VCBM CoP has successfully completed a 1-year collaborative learning cycle, resulting in the development of a self-assessment guide that is now ready for additional investigation using formal research methods. The CO-VALUE study has been designed to build on the work of the CoP and includes qualitative and quantitative assessment phases and a concept mapping study.

A 'COVID Compass' for navigating the pandemic.

INTRODUCTION: The greatest challenge confronting political, public health, business, education and social welfare leaders in the COVID pandemic era is to restore the economy, businesses and schools without further risking public health. The 'COVID Compass' project aims to provide helpful information to guide local decisions by tracking state and local policies over time and their impact on a balanced set of outcomes-health metrics, economic trends and social hardship indicators. METHODS: We selected a parsimonious set of 'local level' health, economic and hardship outcomes and linked them to 'local level' actions aimed to decrease COVID-19 health effects and to mitigate hardship for people, businesses and the economy. Data trends will be released frequently (e.g. weekly and monthly) to show changes in health economic and social hardship 'outcomes' (based on quantitative data), alongside policy, health care, public health and individual/social 'actions' (based on both qualitative and quantitative data). RESULTS: Work on initial analytic and visualization prototypes of the COVID Compass is currently in progress at national, state and local levels. CONCLUSION: Building a national, regional and local integrated database platform that captures upstream policies, actions and behaviors and links them to downstream health, economic and social hardship outcomes will offer a more comprehensive view of the data necessary for decision-makers and citizens to more effectively and intelligently monitor and mitigate harms caused by the pandemic.

International, national and local trends in the spread of COVID-19: a geographic view of COVID-19 spread and the role to be played by coproduction.

BACKGROUND: COVID-19, a respiratory disease caused by the SARS-CoV-2 virus, emerged in 2019 and led to a worldwide pandemic in 2020. The COVID-19 pandemic has been a massive natural experiment in the formation of mitigation strategies to prevent cases and to provide effective healthcare for those afflicted. Regional differences in the impact of the pandemic on morbidity and mortality have been driven by political and regional differences in the coproduction of public health and social policy. We explored the United States (US) experience of COVID-19 for trends and correlations with other nations and also at the national, regional, state and local levels. OBJECTIVE: To identify geographic and temporal trends in the spread of COVID-19 in the United States. METHODS: Population data on COVID-19 cases and mortality were acquired on a daily basis from multiple publicly available databases, including the New York Times and Johns Hopkins University. At each geographic level (national, state and county), geographic entities' reported cases were evaluated for correlations using linear least-squares methods to identify patterns of correlation in the cases independent of scale. We evaluated for two specific characteristics: (i) the nature of the curvature of the line linking across percentile scores, ranging from concave to convex and (ii) the area under this curve, indicating how effectively a selected region (nation, state and county) is linked to its entire containing unit (world, country and state). We used this approach to identify three distinct COVID behavior phenotypes, each of which consisted of a number of states in the USA. RESULTS: We found that COVID activity in the USA follows a unique trend compared to other countries and that within the USA during the first year of the pandemic, three initial COVID phenotypes emerged: (i) the metropolitan outbreak (early outbreak phenotype); (ii) the regional outbreak (summer peak phenotype) and (iii) trans-regional outbreak (fall/winter peak phenotype), which, taken in sum, represent the overall USA national trend. Each phenotype has specific behavioral characteristics and is composed of a cluster of different states experiencing different conditions. CONCLUSION: Our findings suggest a new opportunity for public health strategy in the pandemic, namely to apply targeted public health approaches to address the specific needs of each phenotype. In the future, we should create databases that capture key health and hardship data elements at the smallest geographic level possible and use these to track trends, predict the future and apply targeted coproduction approaches to more effectively and efficiently safeguard population health, economic vitality and social well-being.

Quality of Care Program Reduces Unplanned Health Care Utilization in Patients With Inflammatory Bowel Disease.

INTRODUCTION: There is significant variation in processes and outcomes of care for patients with inflammatory bowel disease (IBD), suggesting opportunities to improve quality of care. We aimed to determine whether a structured quality of care program can improve IBD outcomes, including the need for unplanned health care utilization. METHODS: We used a structured approach to improve adult IBD care in 27 community-based gastroenterology practices and academic medical centers. Patient-reported outcomes (PRO) and health care utilization were collected at clinical visits. Outcomes were monitored monthly using statistical process control charts; improvement was defined by special cause (nonrandom) variation over time. Multivariable logistic regression was applied to patient-level data. Nineteen process changes were offered to improve unplanned health care utilization. Ten outcomes were assessed, including disease activity, remission status, urgent care need, recent emergency department use, hospitalizations, computed tomography scans, health confidence, corticosteroid or opioid use, and clinic phone calls. RESULTS: We collected data prospectively from 20,382 discrete IBD visits. During the 15-month project period, improvement was noted across multiple measures, including need for urgent care, hospitalization, steroid use, and opioid utilization. Adjusted multivariable modeling showed significant improvements over time across multiple outcomes including urgent care need, health confidence, emergency department utilization, hospitalization, corticosteroid use, and opioid use. Attendance at monthly coached webinars was associated with improvement. DISCUSSION: Outcomes of IBD care were improved using a structured quality improvement program that facilitates small process changes, sharing of best practices, and ongoing feedback. Spread of these interventions may facilitate broad improvement in IBD care when applied to a large population.

Safety and Immune Effects of Blocking CD40 Ligand in Multiple Sclerosis.

BACKGROUND AND OBJECTIVES: Costimulation by CD40 and its ligand CD40L (CD154) is important for the functional differentiation of T cells. Preclinical studies have recognized the importance of this costimulatory interaction in the pathogenesis of experimental models of multiple sclerosis (MS). To determine safety, pharmacokinetics, and immune effect of a humanized monoclonal antibody (mAb) against CD40 ligand (toralizumab/IDEC-131) in patients with relapsing-remitting MS (RRMS). METHODS: This single-institution open-label dose-escalation study (phase I) enrolled 12 patients with RRMS to receive 4 doses of 1, 5, 10, or 15 mg/kg of humanized αCD40L (toralizumab) IV infusion every other week. Patients were followed up to 18 weeks, annually, and finally at 5 years. In addition to safety and pharmacokinetics, other secondary and exploratory measurements are immune effects, clinical, MRI, laboratory, and neuropsychological evaluations. RESULTS: Fifteen adverse events, all of mild to moderate severity, were considered to be of possible or of unknown relationship to treatment. No serious adverse events, including thromboembolic events, occurred during the 18-week defined study period. Annual and long-term follow-up at 5 years revealed no delayed toxicity. Pharmacokinetics were nonlinear between the 5 and 10 mg/kg dose groups. The serum half-life of toralizumab was consistent between the dose groups with a mean of 15.3 days (SD = 1.9). Flow cytometry revealed no depletion of lymphocyte subsets. An increase in the CD25+/CD3+ and CD25+/CD4+ ratio and a shift toward an anti-inflammatory cytokine response were seen after treatment. DISCUSSION: Our study suggests that blocking CD40L is safe and well tolerated in patients with RRMS while increasing CD25 + T cells and anti-inflammatory cytokine profile. These findings support further studies to assess the efficacy of blocking CD40L as a potential treatment of RRMS. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence on the safety, pharmacokinetics, and immune effects of an mAb to CD40L in patients with RRMS.