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Paul J Gomes,1 Mark B Abelson,1,2 Linda Stein,1 Erik Viirre,3 J Ernest Villafranca,3 Elliott C Lasser3 1Allergy Department, Ora, Inc., Andover, MA, USA; 2Department of Ophthalmology, Harvard Medical School, Cambridge, MA, USA; 33E Therapeutics Corporation, La Jolla, CA, USA Purpose: Allergic rhinitis (AR) affects ~20% of the population worldwide. The objectives of this study were to evaluate the safety and efficacy of iodixanol nasal solution (Nasapaque) for AR treatment, using the Allergen BioCube® (ABC®), an environmental exposure unit. Iodixanol is a commonly used contrast media agent that shows efficacy on the signs and symptoms of AR. Patients and methods: Seventy-three adult subjects with AR were randomized to iodixanol or placebo treatment in a double-masked efficacy and safety study conducted outside of ragweed pollen season. In-office treatment was administered after BioCube® ragweed pollen exposure, and again 8 days later prior to ragweed exposure. Nasal and ocular efficacy and safety assessments were conducted before and after treatment. Results: Iodixanol treatment resulted in statistically significantly lower total nasal symptom scores as compared to placebo at several time points post-treatment and ABC exposure. Individual nasal and ocular symptoms, notably nasal itching and ocular itching, showed evidence of lower scores in the iodixanol group. Peak nasal inspiratory flow (PNIF) improved (9%–16%) with iodixanol from baseline as compared to PNIF in the placebo group which ranged from 3% worsening to improvement of 2%. Few (9) adverse events occurred. Conclusion: Iodixanol nasal solution demonstrated efficacy for relief of several nasal and ocular allergic rhinoconjunctivitis signs and symptoms, and was safe and well tolerated in this early Phase II exploratory trial. Further studies with iodixanol are warranted. Allergy challenge models such as the ABC provide valuable assessments of allergen exposures and drug efficacies. Study Identification Number: NCT02377895 Keywords: allergic rhinitis, contrast media agent, allergy, environmental exposure unit

Background: Social needs and social determinants of health (SDOH) significantly outrank medical care when considering the impact on a person's length and quality of life, resulting in poor health outcomes and worsening life expectancy. Integrating social needs and SDOH data along with clinical risk information within operational clinical decision support (CDS) systems built into electronic health records (EHRs) is an effective approach to addressing health-related social needs. To achieve this goal, applied research is needed to develop EHR-integrated CDS tools and closed-loop referral systems and implement and test them in the digital and clinical workflows at health care systems and collaborating community-based organizations (CBOs)., Objective: This study aims to describe the protocol for a mixed methods study including a randomized controlled trial and a qualitative phase assessing the feasibility, acceptability, and effectiveness of an EHR-integrated digital platform to identify patients with social needs and provide navigation services and closed-loop referrals to CBOs to address their social needs., Methods: The randomized controlled trial will enroll and randomize adult patients living in socioeconomically challenged neighborhoods in Baltimore City receiving care at a single academic health care institution in the 3-month intervention (using the digital platform) or the 3-month control (standard-of-care assessment and addressing of social needs) arms (n=295 per arm). To evaluate the feasibility and acceptability of the digital platform and its impact on the clinical and digital workflow and patient care, we will conduct focus groups with the care teams in the health care system (eg, clinical providers, social workers, and care managers) and collaborating CBOs. The outcomes will be the acceptability, feasibility, and effectiveness of the CDS tool and closed-loop referral system., Results: This clinical trial opened to enrollment in June 2023 and will be completed in March 2025. Initial results are expected to be published in spring 2025. We will report feasibility outcome measures as weekly use rates of the digital platform. The acceptability outcome measure will be the provider's and patient's responses to the truthfulness of a statement indicating a willingness to use the platform in the future. Effectiveness will be measured by tracking a 3-month change in identified social needs and provided navigation services as well as clinical outcomes such as hospitalization and emergency department visits., Conclusions: The results of this investigation are expected to contribute to our understanding of the use of digital interventions and the implementation of such interventions in digital and clinical workflows to enhance the health care system and CBO ability related to social needs assessment and intervention. These results may inform the construction of a future multi-institutional trial designed to test the effectiveness of this intervention across different health care systems and care settings., Trial Registration: ClinicalTrials.gov NCT05574699; https://clinicaltrials.gov/study/NCT05574699., International Registered Report Identifier (irrid): DERR1-10.2196/57316., (©Elham Hatef, Thomas Richards, Kristin Topel, Sofia Hail, Christopher Kitchen, Katherine Shaw, Talan Zhang, Elyse C Lasser, Jonathan P Weiner. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.07.2024.)

Introduction: Patients receiving buprenorphine after a non-fatal overdose have lower risk of future nonfatal or fatal overdose, but less is known about the relationship between buprenorphine retention and the risk of adverse outcomes in the post-overdose year., Objective: To examine the relationship between the total number of months with an active buprenorphine prescription (retention) and the odds of an adverse outcome within the 12 months following an index non-fatal overdose., Materials and Methods: We studied a cohort of people with an index non-fatal opioid overdose in Maryland between July 2016 and December 2020 and at least one filled buprenorphine prescription in the 12-month post-overdose observation period. We used individually linked Maryland prescription drug and hospital admissions data. Multivariable logistic regression models were used to examine buprenorphine retention and associated odds of experiencing a second non-fatal overdose, all-cause emergency department visits, and all-cause hospitalizations., Results: Of 5439 people, 25% (n=1360) experienced a second non-fatal overdose, 78% had an (n=4225) emergency department visit, and 37% (n=2032) were hospitalized. With each additional month of buprenorphine, the odds of experiencing another non-fatal overdose decreased by 4.7%, all-cause emergency department visits by 5.3%, and all-cause hospitalization decreased by 3.9% (p<.0001, respectively). Buprenorphine retention for at least nine months was a critical threshold for reducing overdose risk versus shorter buprenorphine retention., Conclusions: Buprenorphine retention following an index non-fatal overdose event significantly decreases the risk of future overdose, emergency department use, and hospitalization even among people already on buprenorphine., Competing Interests: Declaration of Competing Interest No conflict declared., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Patients with unmet social needs and social determinants of health (SDOH) challenges continue to face a disproportionate risk of increased prevalence of disease, health care use, higher health care costs, and worse outcomes. Some existing predictive models have used the available data on social needs and SDOH challenges to predict health-related social needs or the need for various social service referrals. Despite these one-off efforts, the work to date suggests that many technical and organizational challenges must be surmounted before SDOH-integrated solutions can be implemented on an ongoing, wide-scale basis within most US-based health care organizations., Objective: We aimed to retrieve available information in the electronic health record (EHR) relevant to the identification of persons with social needs and to develop a social risk score for use within clinical practice to better identify patients at risk of having future social needs., Methods: We conducted a retrospective study using EHR data (2016-2021) and data from the US Census American Community Survey. We developed a prospective model using current year-1 risk factors to predict future year-2 outcomes within four 2-year cohorts. Predictors of interest included demographics, previous health care use, comorbidity, previously identified social needs, and neighborhood characteristics as reflected by the area deprivation index. The outcome variable was a binary indicator reflecting the likelihood of the presence of a patient with social needs. We applied a generalized estimating equation approach, adjusting for patient-level risk factors, the possible effect of geographically clustered data, and the effect of multiple visits for each patient., Results: The study population of 1,852,228 patients included middle-aged (mean age range 53.76-55.95 years), White (range 324,279/510,770, 63.49% to 290,688/488,666, 64.79%), and female (range 314,741/510,770, 61.62% to 278,488/448,666, 62.07%) patients from neighborhoods with high socioeconomic status (mean area deprivation index percentile range 28.76-30.31). Between 8.28% (37,137/448,666) and 11.55% (52,037/450,426) of patients across the study cohorts had at least 1 social need documented in their EHR, with safety issues and economic challenges (ie, financial resource strain, employment, and food insecurity) being the most common documented social needs (87,152/1,852,228, 4.71% and 58,242/1,852,228, 3.14% of overall patients, respectively). The model had an area under the curve of 0.702 (95% CI 0.699-0.705) in predicting prospective social needs in the overall study population. Previous social needs (odds ratio 3.285, 95% CI 3.237-3.335) and emergency department visits (odds ratio 1.659, 95% CI 1.634-1.684) were the strongest predictors of future social needs., Conclusions: Our model provides an opportunity to make use of available EHR data to help identify patients with high social needs. Our proposed social risk score could help identify the subset of patients who would most benefit from further social needs screening and data collection to avoid potentially more burdensome primary data collection on all patients in a target population of interest., (©Elham Hatef, Hsien-Yen Chang, Thomas M Richards, Christopher Kitchen, Janya Budaraju, Iman Foroughmand, Elyse C Lasser, Jonathan P Weiner. Originally published in JMIR Formative Research (https://formative.jmir.org), 12.03.2024.)

Objective: Given their association with varying health risks, lifestyle-related behaviors are essential to consider in population-level disease prevention. Health insurance claims are a key source of information for population health analytics, but the availability of lifestyle information within claims data is unknown. Our goal was to assess the availability and prevalence of data items that describe lifestyle behaviors across several domains within a large U.S. claims database., Methods: We conducted a retrospective, descriptive analysis to determine the availability of the following claims-derived lifestyle domains: nutrition, eating habits, physical activity, weight status, emotional wellness, sleep, tobacco use, and substance use. To define these domains, we applied a serial review process with three physicians to identify relevant diagnosis and procedure codes within claims for each domain. We used enrollment files and medical claims from a large national U.S. health plan to identify lifestyle relevant codes filed between 2016 and 2020. We calculated the annual prevalence of each claims-derived lifestyle domain and the proportion of patients by count within each domain., Results: Approximately half of all members within the sample had claims information that identified at least one lifestyle domain (2016 = 41.9%; 2017 = 46.1%; 2018 = 49.6%; 2019 = 52.5%; 2020 = 50.6% of patients). Most commonly identified domains were weight status (19.9-30.7% across years), nutrition (13.3-17.8%), and tobacco use (7.9-9.8%)., Conclusion: Our study demonstrates the feasibility of using claims data to identify key lifestyle behaviors. Additional research is needed to confirm the accuracy and validity of our approach and determine its use in population-level disease prevention., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

There is increased acceptance that social and behavioral determinants of health (SBDH) impact health outcomes, but electronic health records (EHRs) are not always set up to capture the full range of SBDH variables in a systematic manner. The purpose of this study was to explore rates and trends of social history (SH) data collection-1 element of SBDH-in a structured portion of an EHR within a large academic integrated delivery system. EHR data for individuals with at least 1 visit in 2017 were included in this study. Completeness rates were calculated for how often SBDH variable was assessed and documented. Logistic regressions identified factors associated with assessment rates for each variable. A total of 44,166 study patients had at least 1 SH variable present. Tobacco use and alcohol use were the most frequently captured SH variables. Black individuals were more likely to have their alcohol use assessed (odds ratio [OR] 1.21) compared with White individuals, whereas White individuals were more likely to have their "smokeless tobacco use" assessed (OR 0.92). There were also differences between insurance types. Drug use was more likely to be assessed in the Medicaid population for individuals who were single (OR 0.95) compared with the commercial population (OR 1.05). SH variable assessment is inconsistent, which makes use of EHR data difficult to gain better understanding of the impact of SBDH on health outcomes. Standards and guidelines on how and why to collect SBDH information within the EHR are needed.

Although most health care occurs in the ambulatory setting, limited research examines how providers and patients think about and enact ambulatory patient safety. This multimethod qualitative study seeks to identify perceived challenges and strategies to improve ambulatory safety from the perspectives of clinicians, staff, and patients. Data included interviews (N = 101), focus groups (N = 65), and observations of safety processes (N = 79) collected from 10 patient-centered medical homes. Key safety issues included the lack of interoperability among health information systems, clinician-patient communication failures, and challenges with medication reconciliation. Commonly cited safety strategies leveraged health information systems or involved dedicated resources (eg, providing access to social workers). Patients also identified strategies not mentioned by clinicians, emphasizing the need for their involvement in developing safety solutions. This work provides insight into safety issues of greatest concern to clinicians, staff, and patients and strategies to improve safety in the ambulatory setting., (Copyright © 2022 the American College of Medical Quality.)

Importance: Since the start of the COVID-19 pandemic, few studies have assessed the association of telehealth with outcomes of care, including patterns of health care use after the initial encounter., Objective: To assess the association of telehealth and in-person visits with outcomes of care during the COVID-19 pandemic., Design, Setting, and Participants: This cohort study assessed continuously enrolled members in private health plans of the Blue Cross and Blue Shield Association from July 1, 2019, to December 31, 2020., Main Outcomes and Measures: Main outcomes were ambulatory encounters per enrollee stratified by characteristics derived from enrollment files, practitioner claims, and community characteristics linked to the enrollee's zip code. Outcomes of care were assessed 14 days after the initial encounters and included follow-up encounters of any kind, emergency department encounters, and hospitalizations after initial telehealth or in-person encounters., Results: In this cohort study of 40 739 915 individuals (mean [SD] age, 35.37 [18.77] years; 20 480 768 [50.3%] female), ambulatory encounters decreased by 1.0% and the number of in-person encounters per enrollee decreased by 17.0% from 2019 to 2020; however, as a proportion of all ambulatory encounters, telehealth encounters increased substantially from 0.6% (n = 236 220) to 14.1% (n = 5 743 718). For members with an initial telehealth encounter for a new acute condition, the adjusted odds ratio was 1.44 (95% CI, 1.42-1.46) for all follow-ups combined and 1.11 (95% CI, 1.06-1.16) for an emergency department encounter. For members with an initial telehealth encounter for a new chronic condition, the adjusted odds ratios were 0.94 (95% CI, 0.92-0.95) for all follow-ups combined and 0.94 (95% CI, 0.90-0.99) for in-patient admissions., Conclusions and Relevance: In this cohort study of 40.7 million commercially insured adults, telehealth accounted for a large share of ambulatory encounters at the peak of the pandemic and remained prevalent after infection rates subsided. Telehealth encounters for chronic conditions had similar rates of follow-up to in-person encounters for these conditions, whereas telehealth encounters for acute conditions seemed to be more likely than in-person encounters to require follow-up. These findings suggest a direction for future work and are relevant to policy makers, payers, and practitioners as they manage the use of telehealth during the COVID-19 pandemic and afterward.

Patients' perspectives on patient safety have rarely been incorporated into quality initiatives in primary care. Our objective was to understand the patient perspective on patient safety in patient-centered medical homes (PCMHs). We conducted 12 patient focus groups/interviews in nine sites with 65 patients at a geographically diverse sample of National Committee on Quality Assurance Level 3 recognized PCMHs across three states. Using a patient safety framework, we coded and analyzed interviews for overarching themes and subthemes across patient safety domains. Overarching themes focused on (1) both clear and timely communication with and between clinicians and (2) trust in the care team, including being heard, respected, and treated as a whole person. Other themes important to specific patient safety domains included sharing of and access to information, patient education and patient-centered medication reconciliation process, clear documentation for the diagnostic process, patient-centered comprehensive visits, and timeliness of care. Communication and trust are key to patient perceptions of safe primary care. Focusing on these themes across safety domains may help to make primary care both more patient-centered and safer, and should be considered in future ambulatory safety initiatives.

Purpose: Social and behavioral determinants of health (SBDH) are important factors that affect the health of individuals but are not routinely captured in a structured and systematic manner in electronic health records (EHRs). The purpose of this study is to generate recommendations for systematic implementation of SBDH data collection in EHRs through (1) reviewing SBDH conceptual and theoretical frameworks and (2) eliciting stakeholder perspectives on barriers to and facilitators of using SBDH information in the EHR and priorities for data collection., Method: The authors reviewed SBDH frameworks to identify key social and behavioral variables and conducted focus groups and interviews with 17 clinicians and researchers at Johns Hopkins Health System between March and May 2018. Transcripts were coded and common themes were extracted to understand the barriers to and facilitators of accessing SBDH information., Results: The authors found that although the frameworks agreed that SBDH affect health outcomes, the lack of model consensus complicates the development of specific recommendations for the prioritization of SBDH data collection. Study participants recognized the importance of SBDH information and individual health and agreed that patient-reported information should be captured, but clinicians and researchers cited different priorities for which variables are most important. For the few SBDH variables that are captured, participants reported that data were often incomplete, unclear, or inconsistent, affecting both researcher and clinician responses to SBDH barriers to health., Conclusions: Health systems need to identify and prioritize the systematic implementation of collection of a high-impact but limited list of SBDH variables in the EHR. These variables should affect care and be amenable to change and collection should be integrated into clinical workflows. Improved data collection of SBDH variables can lead to a better understanding of how SBDH affect health outcomes and ways to better address underlying health disparities that need urgent action., (Copyright © 2021 by the Association of American Medical Colleges.)

Introduction: Patient safety in primary care is an emerging priority, and experts have highlighted medications, diagnoses, transitions, referrals, and testing as key safety domains. This study aimed to (1) describe how frontline clinicians, administrators, and staff conceptualize patient safety in primary care; and (2) compare and contrast these conceptual meanings from the patient's perspective., Methods: We conducted interviews with 101 frontline clinicians, administrators and staff, and focus groups with 65 adult patients at 10 patient-centered medical homes. We used thematic analysis to approach coding., Results: Findings indicate that frontline personnel conceptualized patient safety more in terms of work functions, which reflect the grouping of tasks or responsibilities to guide how care is being delivered. Frontline personnel and patients conceptualized patient safety in largely consistent ways., Discussion: Function-based conceptualizations of patient safety in primary care may better reflect frontline personnel and patients' experiences than domain-based conceptualizations, which are favored by experts., Competing Interests: Conflict of interest: Tyler Oberlander and Sarah H. Scholle are employed by the National Committee for Quality Assurance, which recognizes patient-centered medical homes. All other authors declare no conflict of interest., (© Copyright 2020 by the American Board of Family Medicine.)

Background: Social determinants of health (SDOH) have an inextricable impact on health. If remained unaddressed, poor SDOH can contribute to increased health care utilization and costs. We aimed to determine if geographically derived neighborhood level SDOH had an impact on hospitalization rates of patients receiving care at the Veterans Health Administration's (VHA) primary care clinics., Methods: In a 1-year observational cohort of veterans enrolled in VHA's primary care medical home program during 2015, we abstracted data on individual veterans (age, sex, race, Gagne comorbidity score) from the VHA Corporate Data Warehouse and linked those data to data on neighborhood socioeconomic status (NSES) and housing characteristics from the US Census Bureau on census tract level. We used generalized estimating equation modeling and spatial-based analysis to assess the potential impact of patient-level demographic and clinical factors, NSES, and local housing stock (ie, housing instability, home vacancy rate, percentage of houses with no plumbing, and percentage of houses with no heating) on hospitalization. We defined hospitalization as an overnight stay in a VHA hospital only and reported the risk of hospitalization for veterans enrolled in the VHA's primary care medical home clinics, both across the nation and within 1 specific case study region of the country: King County, WA., Results: Nationally, 6.63% of our veteran population was hospitalized within the VHA system. After accounting for patient-level characteristics, veterans residing in census tracts with a higher NSES index had decreased odds of hospitalization. After controlling all other factors, veterans residing in census tracts with higher percentage of houses without heating had 9% (Odds Ratio, 1.09%; 95% CI, 1.04 to 1.14) increase in the likelihood of hospitalization in our regional Washington State analysis, though not our national level analyses., Conclusions: Our results present the impact of neighborhood characteristics such as NSES and lack of proper heating system on the likelihood of hospitalization. The application of placed-based data at the geographic level is a powerful tool for identification of patients at high risk of health care utilization., Competing Interests: Conflict of interest: Any recommendations put forth in this paper are the views of the authors and do not necessarily represent the views of the U.S. Department of Veterans Affairs. Veterans Affairs (VA) had no disclosure of potential conflicts of interest., (© Copyright 2019 by the American Board of Family Medicine.)

The premise of this project was that social and behavioral determinants of health (SBDH) affect the use of healthcare services and outcomes for patients in an integrated healthcare system such as the Veterans Health Administration (VHA), and thus individual patient level socio-behavioral factors in addition to the neighborhood characteristics and geographically linked factors could add information beyond medical factors mostly considered in clinical decision making, patient care, and population health. To help VHA better address SBDH risk factors for the veterans it cares for within its primary care clinics, we proposed a conceptual and analytic framework, a set of evidence-based measures, and their data source. The framework and recommended SBDH metrics can provide a road map for other primary care-centric healthcare organizations wishing to use health analytic tools to better understand how SBDH affect health outcomes., Competing Interests: Conflict of interest: Any recommendations put forth in this paper are the views of the authors and do not necessarily represent the views of the US Department of Veterans Affairs. Veterans Affairs (VA) had no disclosure of potential conflicts of interest., (© 2019 the Author(s), licensee AIMS Press.)

Introduction: This study aims to assess the effect of individual and geographic-level social determinants of health on risk of hospitalization in the Veterans Health Administration primary care clinics known as the Patient Aligned Care Team., Methods: For a population of Veterans enrolled in the primary care clinics, the study team extracted patient-level characteristics and healthcare utilization records from 2015 Veterans Health Administration electronic health record data. They also collected census data on social determinants of health factors for all U.S. census tracts. They used generalized estimating equation modeling and a spatial-based GIS analysis to assess the role of key social determinants of health on hospitalization. Data analysis was completed in 2018., Results: A total of 6.63% of the Veterans Health Administration population was hospitalized during 2015. Most of the hospitalized patients were male (93.40%) and white (68.80%); the mean age was 64.5 years. In the generalized estimating equation model, white Veterans had a 15% decreased odds of hospitalization compared with non-white Veterans. After controlling for patient-level characteristics, Veterans residing in census tracts with the higher neighborhood SES index experienced decreased odds of hospitalization. A spatial-based analysis presented variations in the hospitalization rate across the Veterans Health Administration primary care clinics and identified the clinic sites with an elevated risk of hospitalization (hotspots) compared with other clinics across the country., Conclusions: By linking patient and population-level data at a geographic level, social determinants of health assessments can help with designing population health interventions and identifying features leading to potentially unnecessary hospitalization in selected geographic areas that appear to be outliers., (Copyright © 2019 American Journal of Preventive Medicine. All rights reserved.)

Purpose: Allergic rhinitis (AR) affects ~20% of the population worldwide. The objectives of this study were to evaluate the safety and efficacy of iodixanol nasal solution (Nasapaque) for AR treatment, using the Allergen BioCube ® (ABC ® ), an environmental exposure unit. Iodixanol is a commonly used contrast media agent that shows efficacy on the signs and symptoms of AR., Patients and Methods: Seventy-three adult subjects with AR were randomized to iodixanol or placebo treatment in a double-masked efficacy and safety study conducted outside of ragweed pollen season. In-office treatment was administered after BioCube ® ragweed pollen exposure, and again 8 days later prior to ragweed exposure. Nasal and ocular efficacy and safety assessments were conducted before and after treatment., Results: Iodixanol treatment resulted in statistically significantly lower total nasal symptom scores as compared to placebo at several time points post-treatment and ABC exposure. Individual nasal and ocular symptoms, notably nasal itching and ocular itching, showed evidence of lower scores in the iodixanol group. Peak nasal inspiratory flow (PNIF) improved (9%-16%) with iodixanol from baseline as compared to PNIF in the placebo group which ranged from 3% worsening to improvement of 2%. Few (9) adverse events occurred., Conclusion: Iodixanol nasal solution demonstrated efficacy for relief of several nasal and ocular allergic rhinoconjunctivitis signs and symptoms, and was safe and well tolerated in this early Phase II exploratory trial. Further studies with iodixanol are warranted. Allergy challenge models such as the ABC provide valuable assessments of allergen exposures and drug efficacies., Study Identification Number: NCT02377895.

Population health is one of the pillars of the Triple Aim to improve US health care. The authors developed a framework for population health measurement and a proposed set of measures for further exploration to guide the population health efforts in Maryland. The authors searched peer-reviewed, expert-authored literature and current public health measures. Using a semi-structured analysis, a framework was proposed, which consisted of a conceptual model of several domains and identified population health measures addressing them. Stakeholders were convened to review the framework and identified the most feasible population health measures considering the underlying health information technology (IT) infrastructure in Maryland. The framework was organized based on health system factors, determinants of health, and population-based and clinical outcomes. Measurement specifications were developed that addressed different aspects of selected measures and assessed various national and local data sources for selected measures. Data sources were identified based on their key characteristics, challenges, opportunities, and potential applicability to the proposed measures, as well as the issue of interoperability of data sources among different organizations. The proposed framework and measures can act as a platform to quantify the determinants of health and the state overall population health goals. Key considerations for developing a population health measures framework include health IT infrastructure, data denominators, feasibility, health system environment, and policy factors. Measurement development and progression using the framework will largely depend on the users' focus areas and availability of data. The authors believe that the proposed framework and road map can serve as a model for communities elsewhere.

Background: Using electronic health records (EHRs), in addition to claims, to systematically identify patients with factors associated with adverse outcomes (geriatric risk) among older adults can prove beneficial for population health management and clinical service delivery., Objective: To define and compare geriatric risk factors derivable from claims, structured EHRs, and unstructured EHRs, and estimate the relationship between geriatric risk factors and health care utilization., Research Design: We performed a retrospective cohort study of patients enrolled in a Medicare Advantage plan from 2011 to 2013 using both administrative claims and EHRs. We defined 10 individual geriatric risk factors and a summary geriatric risk index based on diagnosed conditions and pattern matching techniques applied to EHR free text. The prevalence of geriatric risk factors was estimated using claims, structured EHRs, and structured and unstructured EHRs combined. The association of geriatric risk index with any occurrence of hospitalizations, emergency department visits, and nursing home visits were estimated using logistic regression adjusted for demographic and comorbidity covariates., Results: The prevalence of geriatric risk factors increased after adding unstructured EHR data to structured EHRs, compared with those derived from structured EHRs alone and claims alone. On the basis of claims, structured EHRs, and structured and unstructured EHRs combined, 12.9%, 15.0%, and 24.6% of the patients had 1 geriatric risk factor, respectively; 3.9%, 4.2%, and 15.8% had ≥2 geriatric risk factors, respectively. Statistically significant association between geriatric risk index and health care utilization was found independent of demographic and comorbidity covariates. For example, based on claims, estimated odds ratios for having 1 and ≥2 geriatric risk factors in year 1 were 1.49 (P<0.001) and 2.62 (P<0.001) in predicting any occurrence of hospitalizations in year 1, and 1.32 (P<0.001) and 1.34 (P=0.003) in predicting any occurrence of hospitalizations in year 2., Conclusions: The results demonstrate the feasibility and potential of using EHRs and claims for collecting new types of geriatric risk information that could augment the more commonly collected disease information to identify and move upstream the management of high-risk cases among older patients.

Maryland Department of Health (MDH) has been preparing for alignment of its population health initiatives with Maryland's unique All-Payer hospital global budget program. In order to operationalize population health initiatives, it is required to identify a starter set of measures addressing community level health interventions and to collect interoperable data for those measures. The broad adoption of electronic health records (EHRs) with ongoing data collection on almost all patients in the state, combined with hospital participation in health information exchange (HIE) initiatives, provides an unprecedented opportunity for near real-time assessment of the health of the communities. MDH's EHR-based monitoring complements, and perhaps replaces, ad-hoc assessments based on limited surveys, billing, and other administrative data. This article explores the potential expansion of health IT capacity as a method to improve population health across Maryland. First, we propose a progression plan for four selected community-wide population health measures: body mass index, blood pressure, smoking status, and falls-related injuries. We then present an assessment of the current and near real-time availability of digital data in Maryland including the geographic granularity on which each measure can be assessed statewide. Finally, we provide general recommendations to improve interoperable data collection for selected measures over time via the Maryland HIE. This paper is intended to serve as a high level guiding framework for communities across the US that are undergoing healthcare transformation toward integrated models of care using universal interoperable EHRs., Competing Interests: Competing Interests: No Competing Interests.

Unlabelled: Reducing overuse of tests such as dual-energy X-ray absorptiometry (DXA) scans in younger women is an important quality issue. We evaluated trends in DXA ordering before and after Choosing Wisely recommendations were released. We found no significant difference in ordering trends suggesting that other initiatives are needed to change behavior., Introduction: Reducing overuse of tests such as dual-energy X-ray absorptiometry (DXA) scans in younger women is an important quality issue, but trends in care are difficult to change. We evaluated (1) trends in DXA ordering before and after the Choosing Wisely recommendation release and (2) patterns of key characteristics that indicate a potentially appropriate DXA scan order., Methods: We performed a retrospective longitudinal analysis of electronic health record data at a multi-specialty, ambulatory care network of 34 practices across Maryland and Washington, DC. Since the Choosing Wisely DXA recommendation was released April 2012, the study periods were April-December 2011 (pre-initiative) and April-December 2012 (post-initiative). Women between 50 and 64 years with primary care encounters, and primary care providers who saw ten or more women in the study population in both pre and post periods were included., Results: For 42,320 eligible patients, the mean provider ordering rate was 2.6 % pre-initiative and 2.0 % post-initiative; there was no significant difference in trend over time. Over 70 % of the population had no characteristics associated with potentially appropriate DXA ordering. Low body mass index, current smoker status, and osteopenia were the most common characteristics indicating potentially appropriate DXA orders. Patients with any of these three characteristics had DXA ordering rates between 3-20 %., Conclusions: The trend in provider ordering rates of DXA scans did not decrease after the release of the DXA Choosing Wisely recommendation. Targeted initiatives addressing providers with high ordering rates will be needed to change behavior.

A long history of searching for the etiology of X-ray contrast material (CM) reactions has led to the understanding that the CM do not produce anti-CM antigens. Since CM reactions are anaphylactoid in nature, however, a source for mast cell activation was sought. This resulted in the finding that concentrated CM could suppress mast cell activation by attachment to the Fc portion of IgE and IgG. This is presumed to be a steric hindrance effect. In a study of the effects of CM on BP and a study of the effects of CM in sensitized rats, it was concluded that less concentrated CM activated mast cells and that this mechanism was best explained by bridging of adjacent IgE molecules via attachment to their Fc segments. The mast cell release of heparin activating the contact system, as well as the release of histamine, is believed to be responsible for CM reactions and allergic diatheses.

X-ray contrast media are individually injected into human blood vessels in greater quantities than any other pharmacological substance. Adverse reactions to these substances have heretofore been considered anaphylactoid in nature. Others and we have demonstrated that the mechanisms involved are multifactorial and may involve activation of mast cells and basophils, activation of the complement system, activation of the contact system, and the conversion of L-arginine into nitric oxide. Appropriate pretreatment with corticosteriods will diminish the incidence of reactions. Most recently we have demonstrated that the contrast media function as 'pseudoantigens' (PsA). They can combine with antibodies, but cannot themselves produce antibodies. This property appears to be dependent on aggregation in high concentrations and varies with the individual media. It furthermore appears to be non-specific in relation to antibodies, and suggests that binding occurs to the Fc portion of immunoglobulins. We have now demonstrated that the least toxic of current media demonstrate the best antibody binding and in sufficient concentration can inhibit contrast induced mast cell activation and/or non-contrast antigen induced mast cell activation, apparently due to in vivo pseudoantigen excess. In lesser concentrations and/or lesser binding, the media can trigger mast cell activation.

Rationale and Objectives: The authors performed this study to determine whether adverse reactions similar to those that occur in patients receiving antipsychotic medication may occur after inadvertent intrathecal injections of some contrast material., Materials and Methods: Recombinant human dopamine-2 (D-2) receptors were incubated together with tritiated (hydrogen 3) spiperone, a D-2 receptor agonist commonly used in binding studies, and three types of contrast material (sodium/meglumine diatrizoate; meglumine iothalamate; and iohexol) in different concentrations to determine competitive binding potentials. Nonspecific binding was also assessed. Membranes were washed, filtered, and counted in a scintillation counter., Results: At several different concentrations, diatrizoate demonstrated a potential to displace the binding of spiperone to the D-2 receptors, whereas the other two contrast materials tested (iothalamate meglumine and iohexol) showed only weak binding potentials., Conclusion: Diatrizoate, which has been incriminated in most adverse reactions resulting from the inadvertent intrathecal injection of a contrast material, may produce symptoms similar to those of the neuroleptic malignant syndrome by blocking neurotransmission through dopamine receptors. Although antipsychotic drugs produce this parkinsonism-like effect only after prolonged use, it is probable that diatrizoate produces the effect immediately by virtue of the high concentrations that may accumulate at the base of the brain after myelography. Also worthy of note is the fact that the two other contrast materials that have produced a number of reported adverse reactions share a molecular similarity to diatrizoate that is not found with other contrast materials.

Background: X-ray contrast media (CM) toxicity resembles IgE-antigen-based anaphylaxis, and CM-related histamine release has been demonstrated in vitro and in vivo. While nobody has succeeded in producing antibodies against injections of neat CM, the ability of CM to compete with a series of antigens against their respective antibodies has recently been demonstrated. However, there is a paradox, since the CM with the strongest antibody binding are nevertheless the least likely to provoke antigen-antibody-related mast cell/basophil release., Methods: Two strains of rats were subjected to (a) passive cutaneous anaphylaxis (PCA) studies in the presence of various concentrations of CM, (b) blood pressure (BP) tracings following bolus administrations of various prototypical CM and (c) BP tracings in ovalbumin (OVA)-sensitized rats, challenged with OVA plus CM, vs. OVA plus CM-equivalent saline., Results: In the PCA studies, and the OVA challenge studies, the CM appear to act in an antigen excess mode, limiting the potential of the OVA to elicit anaphylactic changes, as demonstrated by permeability studies or by BP levels. The bolus CM studies demonstrate that the more potent CM 'antigens' actually produce an increase in BP and the less potent CM 'antigens', a drop in BP. These changes can be related to the CM acting in an 'antigen' excess mode vs. an 'antigen' equivalent mode., Conclusions: The CM have the potential to act in an 'antigen' excess or 'antigen'-equivalent mode. The potential to express an 'antigen'-excess mode in vivo, may be unique to CM because of the high concentrations injected., (Copyright 2000 S. Karger AG, Basel)

Purpose: To compare U.S. Food and Drug Administration (FDA) and manufacturer data about patient reactions to ionic and nonionic, low- and high-osmolar contrast media from 1990 through 1994., Materials and Methods: Reactions to all available high-osmolar and four low-osmolar contrast media (ioxaglate, iohexol, iopamidol, and ioversol) were compared. Ioxaglate is composed of charged particles, and data are reported separately. Reactions were also compared with data from 1980 to 1984, when only high-osmolar contrast media were available., Results: With high-osmolar contrast media compared with the three noncharged low-osmolar media, the incidence (per million examinations) was highest for all reported reactions (193.8 vs 44.4), severe reactions (37.4 vs 10.5), and deaths (3.9 vs 2.1). With high-osmolar media compared with ioxaglate, respectively, the incidence of total reactions was higher (193.8 vs 142.5), of severe reactions was almost the same (37.4 vs 33.6), and of death was lower (3.9 vs 6.4). The incidence of severe reactions to total reactions was higher with nonionic media (23.7%) and ioxaglate (23.6%) than with ionic media (19.3%). The incidence of death to severe reactions was 19.7% with nonionic media, 19.0% with ioxaglate, and 10.4% with high-osmolar media. The incidence of renal failure (as a percentage of total reports) was approximately 3.6 times higher with all low-osmolar contrast media (2.3%) than with high-osmolar media (0.6%), usually in patients with pathologic cardiac conditions., Conclusion: All of these factors merit consideration in the evaluation of the utility of a given contrast medium.

Cardiovascular disease (CVD) is more prevalent in elderly than in middle-aged patients. Symptoms such as intermittent wheezing with dyspnea may then be due to either CVD or asthma. The objective of this study was to determine the prevalence and correlates of asthma in the elderly and their associations with CVD and CVD risk factors. A community sample of 5201 elderly persons from the Cardiovascular Health Study was asked if they had a physician diagnosis of asthma, and multiple cardiovascular risk and disease variables were measured. Six percent of the participants (309) recalled a history of asthma, and half of these were never smokers. Thirty percent of those with asthma were currently taking a bronchodilator, 14% inhaled steroids, and 10% oral prednisone. Men and women with asthma who were cigarette smokers were more likely to report a concurrent diagnosis of congestive heart failure than smokers without asthma (p = .04). However, when we determined the independent CVD correlates of asthma in this cohort, controlling for smoking status, age, gender, and diagnoses of chronic bronchitis and emphysema, only higher levels of high-density lipoprotein cholesterol (HDL-C) and higher plasma fibrinogen levels were significantly associated with asthma. It was concluded that asthma is as prevalent in the elderly as in middle-aged persons and is associated with higher HDL-C and higher fibrinogen levels, but not with prevalent cardiovascular disease.

Rationale and Objectives: We assessed the role that nitric oxide (NO) plays in contrast media (CM) toxicity, using 100% lethal dose (LD100) studies in hyperimmune Brown Norway (BN) rats., Methods: Ninety-two BN rats and 41 Sprague-Dawley (SD) rats underwent CM LD100 tail vein injections with methylglucamine iothalamate or sodium iothalamate to the point of cessation of respiration. Methylglucamine hydrochloride also was injected. The injections were accompanied by L-arginine (L-Arg) or D-arginine (D-Arg) analogues or by an H1 blocker. L-Arg analogues inhibit NO formation, and D-Arg analogues do not., Results: An L-Arg analogue, but not a D-Arg analogue, increased the tolerance of BN rats (p < .005) for methylglucamine iothalamate but not for sodium iothalamate. The L-Arg analogue also protected BN rats against methylglucamine chloride injections (p < .002). H1 blockade protected BN rats against methylglucamine iothalamate (p < .0005) and methylglucamine chloride (p < .005) injections. None of these measures altered the CM tolerance of SD rats. In SD rats, injections of either methylglucamine iothalamate or sodium iothalamate along with a D-Arg analogue or normal saline were better tolerated than similar injections in BN rats (p < .01 and .002 for methylglucamine iothalamate and sodium iothalamate, respectively). In SD rats but not BN rats, sodium iothalamate was better tolerated than was methylglucamine iothalamate (p < .0005)., Conclusion: NO appears to play a significant role in BN rats LD100 CM toxicity and has been implicated by others in the blood pressure fall characterizing some forms of antigen-induced anaphylaxis [1, 2]. The results of the current study and the literature suggest that methylglucamine-modulated release of histamine from mast cells may underlie the NO production.

Objective: The purpose of this study was to determine whether patients receiving a two-dose corticosteroid regimen before IV injection of nonionic contrast medium gain protection against adverse reactions to contrast material., Subjects and Methods: A randomized, blinded study involving three institutions was initiated in 1988. Patients were divided into two groups. One group received a 32-mg oral dose of methylprednisolone administered 6-24 hr before and again 2 hr before injection of contrast material. The other group received placebo tablets administered in the same time periods. During a 3-year period, 1155 patients and control subjects successfully completed the protocol. Demographic characteristics, including histories of previous reactions and histories of asthma or allergy, did not differ in the two groups. All signs and symptoms that appeared after injection of contrast material were carefully recorded and graded according to an earlier scheme [1]. Patients, control subjects, and all attending personnel were blinded regarding the premedication., Results: Corticosteroid pretreatment conferred protection for overall reactions (1.7% vs 4.9%, p = .005) and grade I (mild) reactions (0.2% vs 1.9%, p = .004). Subjects receiving corticosteroids also had fewer grade II (moderate) (p = .63) and grade III (severe) (p = .11) reactions, but the total numbers involved were small, and the differences were not significant., Conclusion: A rigidly controlled study of the potential protective effects of a two-dose oral corticosteroid regimen preceding IV injection of nonionic contrast medium indicates that corticosteroid pretreatment confers significant protection, at least for overall reactions and grade I reactions.