Dermatologic Research Potential of the Observational Health Data Sciences and Informatics (OHDSI) Network.

BACKGROUND: The Observational Health Data Sciences and Informatics (OHDSI) network enables access to billions of deidentified, standardized health records and built-in analytics software for observational health research, with numerous potential applications to dermatology. While the use of the OHDSI has increased steadily over the past several years, review of the literature reveals few studies utilizing OHDSI in dermatology. To our knowledge, the University of Colorado School of Medicine is unique in its use of OHDSI for dermatology big data research. SUMMARY: A PubMed search was conducted in August 2020, followed by a literature review, with 24 of the 72 screened articles selected for inclusion. In this review, we discuss the ways OHDSI has been used to compile and analyze data, improve prediction and estimation capabilities, and inform treatment guidelines across specialties. We also discuss the potential for OHDSI in dermatology - specifically, ways that it could reveal adherence to available guidelines, establish standardized protocols, and ensure health equity. Key Messages: OHDSI has demonstrated broad utility in medicine. Adoption of OHDSI by the field of dermatology would facilitate big data research, allow for examination of current prescribing and treatment patterns without clear best practice guidelines, improve the dermatologic knowledge base and, by extension, improve patient outcomes.

Assessment of Allergic and Anaphylactic Reactions to mRNA COVID-19 Vaccines With Confirmatory Testing in a US Regional Health System.

Importance: As of May 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths. Anaphylactic reactions associated with the Food and Drug Administration (FDA)-authorized mRNA COVID-19 vaccines have been reported. Objective: To characterize the immunologic mechanisms underlying allergic reactions to these vaccines. Design, Setting, and Participants: This case series included 22 patients with suspected allergic reactions to mRNA COVID-19 vaccines between December 18, 2020, and January 27, 2021, at a large regional health care network. Participants were individuals who received at least 1 of the following International Statistical Classification of Diseases and Related Health Problems, Tenth Revision anaphylaxis codes: T78.2XXA, T80.52XA, T78.2XXD, or E949.9, with documentation of COVID-19 vaccination. Suspected allergy cases were identified and invited for follow-up allergy testing. Exposures: FDA-authorized mRNA COVID-19 vaccines. Main Outcomes and Measures: Allergic reactions were graded using standard definitions, including Brighton criteria. Skin prick testing was conducted to polyethylene glycol (PEG) and polysorbate 80 (P80). Histamine (1 mg/mL) and filtered saline (negative control) were used for internal validation. Basophil activation testing after stimulation for 30 minutes at 37 °C was also conducted. Concentrations of immunoglobulin (Ig) G and IgE antibodies to PEG were obtained to determine possible mechanisms. Results: Of 22 patients (20 [91%] women; mean [SD] age, 40.9 [10.3] years; 15 [68%] with clinical allergy history), 17 (77%) met Brighton anaphylaxis criteria. All reactions fully resolved. Of patients who underwent skin prick tests, 0 of 11 tested positive to PEG, 0 of 11 tested positive to P80, and 1 of 10 (10%) tested positive to the same brand of mRNA vaccine used to vaccinate that individual. Among these same participants, 10 of 11 (91%) had positive basophil activation test results to PEG and 11 of 11 (100%) had positive basophil activation test results to their administered mRNA vaccine. No PEG IgE was detected; instead, PEG IgG was found in tested individuals who had an allergy to the vaccine. Conclusions and Relevance: Based on this case series, women and those with a history of allergic reactions appear at have an elevated risk of mRNA vaccine allergy. Immunological testing suggests non-IgE-mediated immune responses to PEG may be responsible in most individuals.

Baseline phenotype and 30-day outcomes of people tested for COVID-19: an international network cohort including >3.32 million people tested with real-time PCR and >219,000 tested positive for SARS-CoV-2 in South Korea, Spain and the United States.

Early identification of symptoms and comorbidities most predictive of COVID-19 is critical to identify infection, guide policies to effectively contain the pandemic, and improve health systems' response. Here, we characterised socio-demographics and comorbidity in 3,316,107persons tested and 219,072 persons tested positive for SARS-CoV-2 since January 2020, and their key health outcomes in the month following the first positive test. Routine care data from primary care electronic health records (EHR) from Spain, hospital EHR from the United States (US), and claims data from South Korea and the US were used. The majority of study participants were women aged 18-65 years old. Positive/tested ratio varied greatly geographically (2.2:100 to 31.2:100) and over time (from 50:100 in February-April to 6.8:100 in May-June). Fever, cough and dyspnoea were the most common symptoms at presentation. Between 4%-38% required admission and 1-10.5% died within a month from their first positive test. Observed disparity in testing practices led to variable baseline characteristics and outcomes, both nationally (US) and internationally. Our findings highlight the importance of large scale characterization of COVID-19 international cohorts to inform planning and resource allocation including testing as countries face a second wave.

Applying a Commercialization-Readiness Framework to Optimize Value for Achieving Sustainability of an Electronic Health Data Research Network and Its Data Capabilities: The SAFTINet Experience.

CONTEXT: Sustaining electronic health data networks and maximizing return on federal investment in their development is essential for achieving national data insight goals for transforming health care. However, crossing the business model chasm from grant funding to self-sustaining viability is challenging. CASE DESCRIPTION: This paper presents lessons learned in seeking the sustainability of the Scalable Architecture for Federated Translational Inquiries Network (SAFTINet), and electronic health data network involving over 50 primary care practices in three states. SAFTINet was developed with funding from the Agency for Healthcare Research and Quality to create a multi-state network for comparative effectiveness research (CER) involving safety-net patients. METHODS: Three analyses were performed: (1) a product gap analysis of alternative data sources; (2) a Strengths-Weaknesses-Opportunities-Threat (SWOT) analysis of SAFTINet in the context of competing alternatives; and (3) a customer discovery process involving approximately 150 SAFTINet stakeholders to identify SAFTINet's sustaining value proposition for health services researchers, clinical data partners, and policy makers. FINDINGS: The results of this business model analysis informed SAFTINet's sustainability strategy. The fundamental high-level product needs were similar between the three primary customer segments: credible data, efficient and easy to use, and relevance to their daily work or 'jobs to be done'. However, how these benefits needed to be minimally demonstrated varied by customer such that different supporting evidence was required. MAJOR THEMES: The SAFTINet experience illustrates that commercialization-readiness and business model methods can be used to identify multi-sided value propositions for sustaining electronic health data networks and their data capabilities as drivers of health care transformation.

A Harmonized Data Quality Assessment Terminology and Framework for the Secondary Use of Electronic Health Record Data.

OBJECTIVE: Harmonized data quality (DQ) assessment terms, methods, and reporting practices can establish a common understanding of the strengths and limitations of electronic health record (EHR) data for operational analytics, quality improvement, and research. Existing published DQ terms were harmonized to a comprehensive unified terminology with definitions and examples and organized into a conceptual framework to support a common approach to defining whether EHR data is 'fit' for specific uses. MATERIALS AND METHODS: DQ publications, informatics and analytics experts, managers of established DQ programs, and operational manuals from several mature EHR-based research networks were reviewed to identify potential DQ terms and categories. Two face-to-face stakeholder meetings were used to vet an initial set of DQ terms and definitions that were grouped into an overall conceptual framework. Feedback received from data producers and users was used to construct a draft set of harmonized DQ terms and categories. Multiple rounds of iterative refinement resulted in a set of terms and organizing framework consisting of DQ categories, subcategories, terms, definitions, and examples. The harmonized terminology and logical framework's inclusiveness was evaluated against ten published DQ terminologies. RESULTS: Existing DQ terms were harmonized and organized into a framework by defining three DQ categories: (1) Conformance (2) Completeness and (3) Plausibility and two DQ assessment contexts: (1) Verification and (2) Validation. Conformance and Plausibility categories were further divided into subcategories. Each category and subcategory was defined with respect to whether the data may be verified with organizational data, or validated against an accepted gold standard, depending on proposed context and uses. The coverage of the harmonized DQ terminology was validated by successfully aligning to multiple published DQ terminologies. DISCUSSION: Existing DQ concepts, community input, and expert review informed the development of a distinct set of terms, organized into categories and subcategories. The resulting DQ terms successfully encompassed a wide range of disparate DQ terminologies. Operational definitions were developed to provide guidance for implementing DQ assessment procedures. The resulting structure is an inclusive DQ framework for standardizing DQ assessment and reporting. While our analysis focused on the DQ issues often found in EHR data, the new terminology may be applicable to a wide range of electronic health data such as administrative, research, and patient-reported data. CONCLUSION: A consistent, common DQ terminology, organized into a logical framework, is an initial step in enabling data owners and users, patients, and policy makers to evaluate and communicate data quality findings in a well-defined manner with a shared vocabulary. Future work will leverage the framework and terminology to develop reusable data quality assessment and reporting methods.

Kaiser Permanente's performance improvement system, Part 4: Creating a learning organization.

BACKGROUND: In 2006, recognizing variations in performance in quality, safety, service, and efficiency, Kaiser Permanente leaders initiated the development of a performance improvement (PI) system. Kaiser Permanente has implemented a strategy for creating the systemic capacity for continuous improvement that characterizes a learning organization. Six "building blocks" were identified to enable Kaiser Permanente to make the transition to becoming a learning organization: real-time sharing of meaningful performance data; formal training in problem-solving methodology; workforce engagement and informal knowledge sharing; leadership structures, beliefs, and behaviors; internal and external benchmarking; and technical knowledge sharing. Putting each building block into place required multiple complex strategies combining top-down and bottom-up approaches. SUCCESSES AND CHALLENGES: Although the strategies have largely been successful, challenges remain. The demand for real-time meaningful performance data can conflict with prioritized changes to health information systems. It is an ongoing challenge to teach PI, change management, innovation, and project management to all managers and staff without consuming too much training time. Challenges with workforce engagement include low initial use of tools intended to disseminate information through virtual social networking. Uptake of knowledge-sharing technologies is still primarily by innovators and early adopters. Leaders adopt new behaviors at varying speeds and have a range of abilities to foster an environment that is psychologically safe and stimulates inquiry. CONCLUSIONS: A learning organization has the capability to improve, and it develops structures and processes that facilitate the acquisition and sharing of knowledge.

Kaiser Permanente's performance improvement system, Part 1: From benchmarking to executing on strategic priorities.

BACKGROUND: By 2004, senior leaders at Kaiser Permanente, the largest not-for-profit health plan in the United States, recognizing variations across service areas in quality, safety, service, and efficiency, began developing a performance improvement (PI) system to realizing best-in-class quality performance across all 35 medical centers. MEASURING SYSTEMWIDE PERFORMANCE: In 2005, a Web-based data dashboard, "Big Q," which tracks the performance of each medical center and service area against external benchmarks and internal goals, was created. PLANNING FOR PI AND BENCHMARKING PERFORMANCE: In 2006, Kaiser Permanente national and regional continued planning the PI system, and in 2007, quality, medical group, operations, and information technology leaders benchmarked five high-performing organizations to identify capabilities required to achieve consistent best-in-class organizational performance. THE PI SYSTEM: The PI system addresses the six capabilities: leadership priority setting, a systems approach to improvement, measurement capability, a learning organization, improvement capacity, and a culture of improvement. PI "deep experts" (mentors) consult with national, regional, and local leaders, and more than 500 improvement advisors are trained to manage portfolios of 90-120 day improvement initiatives at medical centers. IMPACT: Between the second quarter of 2008 and the first quarter of 2009, performance across all Kaiser Permanente medical centers improved on the Big Q metrics. CONCLUSIONS: The lessons learned in implementing and sustaining PI as it becomes fully integrated into all levels of Kaiser Permanente can be generalized to other health care systems, hospitals, and other health care organizations.

Systematic review of health information exchange in primary care practices.

BACKGROUND: Unprecedented federal interest and funding are focused on secure, standardized, electronic transfer of health information among health care organizations, termed health information exchange (HIE). The stated goals are improvements in health care quality, efficiency, and cost. Ambulatory primary care practices are essential to this process; however, the factors that motivate them to participate in HIE are not well studied, particularly among small practices. METHODS: We conducted a systematic review of the literature about HIE participation from January 1990 through mid-September 2008 to identify peer-reviewed and non-peer-reviewed publications in bibliographic databases and websites. Reviewers abstracted each publication for predetermined key issues, including stakeholder participation in HIE, and the benefits, barriers, and overall value to primary care practices. We identified themes within each key issue, then grouped themes and identified supporting examples for analysis. RESULTS: One hundred and sixteen peer-reviewed, non-peer-reviewed, and web publications were retrieved, and 61 met inclusion criteria. Of 39 peer-reviewed publications, one-half reported original research. Among themes of cost savings, workflow efficiency, and quality, the only benefits to be reliably documented were those regarding efficiency, including improved access to test results and other data from outside the practice and decreased staff time for handling referrals and claims processing. Barriers included cost, privacy and liability concerns, organizational characteristics, and technical barriers. A positive return on investment has not been documented. CONCLUSIONS: The potential for HIE to reduce costs and improve the quality of health care in ambulatory primary care practices is well recognized but needs further empiric substantiation.

Kaiser Permanente's performance improvement system, part 2: developing a value framework.

BACKGROUND: In 2008, Kaiser Permanente began phased implementation of a nationwide performance improvement (PI) system. The aim was to improve performance by providing consistent, highly meaningful performance measurement, increase PI skills in staff at all levels, develop organizational capabilities, and provide support for making improvements in medical centers and across regions. Evaluating the PI System: The intermediate results of the PI system were assessed in the 22 medical centers in four of the eight Kaiser Permanente regions. Implementation for 3 of these medical centers occurred in January 2008 through November 2008, with implementation for the remaining 19 medical centers occurring from September 2008 through September 2009. FINDINGS: The 22 medical centers that were evaluated achieved a 61% improvement in selected capabilities, and improvement advisors (IAs) successfully completed 84% of initial PI projects. For each dollar invested, estimates suggested an average return on investment of $2.36. LESSONS LEARNED: Critical factors include adequate dedicated time for PI activities by staff with necessary expertise, expert support to operations, alignment of projects with regional and national strategic priorities, and close working relationships between PI staff and operational management. Involving finance leaders in improvement planning, prioritization, and oversight is important. These elements can be adapted to smaller systems and single hospitals. CONCLUSIONS: The initial evaluation of the Kaiser Permanente PI system indicated that (1) IAs successfully led projects in conjunction with frontline teams, (2) organizational capabilities increased, and (3) the investment in PI infrastructure and staff was sound. Expansion throughout the entire Kaiser Permanente system is under way.

Statewide assessment of local wellness policies in Pennsylvania public school districts.

With the passage of the Child Nutrition and Women, Infants, and Children Reauthorization Act of 2004, schools that sponsor school meals programs are required to establish local wellness policies to address childhood obesity. Little is known about how school districts will respond to this mandate, the nature of local wellness policies, and their compliance with this mandate. The objectives of this cross-sectional descriptive study, conducted in early 2007, were to assess local wellness policies established by Pennsylvania public school districts, compare these policies to local wellness policy mandate requirements, and provide information about local wellness policy development and implementation. Local wellness policies were collected from all Pennsylvania public school districts that sponsor school meals programs (N=499). School district representatives also completed and submitted a local wellness policy checklist, providing information about local wellness policy development and implementation. Policy goal data were abstracted and entered into a Microsoft Access database along with local wellness policy data. Frequencies were calculated. All required public school districts (N=499) submitted local wellness policies. Most school district local wellness policies (85.6%-100%) met each mandate requirement (eg, included goals for nutrition education, physical activity, etc.). The most common policy goals were general and may be difficult to measure, suggesting school staff may need assistance developing action plans and measuring policy implementation. Most respondents identified the superintendent (n=377; 75.6%) and school foodservice director (n=301; 60.3%) as responsible for ensuring local wellness policy implementation. Questions remain about feasibility of these district-level personnel to ensure policy implementation at the school level. The ability of local wellness policies to impact childhood obesity will depend on efforts at both the school and district levels to implement and enforce local wellness policies.

Inaccessible novel questionnaires in published medical research: hidden methods, hidden costs.

Although critical analysis of survey research is limited when reviewers and readers cannot view a study's questionnaire, access to novel questionnaires used in published research has not been systematically examined. The authors identified publications reporting the results of novel questionnaires in three medical journals (JAMA, The New England Journal of Medicine, and The Lancet) in January 2000-May 2003 and searched portable document format (PDF) versions of the studies for the complete questionnaire or a Uniform Resource Locator (URL) providing access to the questionnaire. When the questionnaire was not provided in the publication or a published URL, the authors requested it from the corresponding author in writing up to three times over a 6-week period. Of 93 publications with novel questionnaires, four printed the questionnaire in the article and three provided online access. Corresponding authors failed to provide questionnaires for 37 of 81 (46%) studies. Novel questionnaires used in published research are frequently not available to readers or researchers. Policies that improve access to novel questionnaires will allow better assessment of study results, reduce duplicated efforts, and improve authorship attribution for questionnaire design.

Impact of a simple intervention to increase primary care provider recognition of patient referral concerns.

OBJECTIVE: To determine whether a brief previsit questionnaire about referral concerns can improve primary care provider (PCP) recognition of patient concerns and satisfaction with care. DESIGN: Sequential prospective study in the internal medicine clinic of an academic medical center providing primary care to patients enrolled in a gatekeeper-model managed care plan. PARTICIPANTS AND METHODS: Twelve faculty internists serving as PCPs for 1495 consecutive patient visits. Patients were given a previsit questionnaire asking about referral need and rationale and a postvisit questionnaire asking about discussion of referral concern and visit satisfaction. Providers were given a postvisit questionnaire asking whether a referral was discussed and made and about visit satisfaction. In the control phase, patient previsit questionnaires remained confidential, whereas in the intervention phase PCPs were shown the previsit questionnaires at the time of encounter. RESULTS: The intervention significantly increased PCP referral recognition from 61% to 81% (P < .001) and was associated with increased visit satisfaction (P = .05). Satisfaction of PCPs with the referral discussion, overall rate of referral, and visit duration were not affected by the intervention. CONCLUSIONS: Using a brief previsit questionnaire about patient referral concerns increases PCP recognition of such concerns. The intervention does not adversely affect PCP satisfaction with the referral discussion or the overall referral rate and may enhance patient visit satisfaction.