Real World Data Versus Probability Surveys for Estimating Health Conditions at the State Level.

Government statistical offices worldwide are under pressure to produce statistics rapidly and for more detailed geographies, to compete with unofficial estimates available from web-based big data sources or from private companies. Commonly suggested sources of improved health information are electronic health records (EHRs) and medical claims data. These data sources are collectively known as real world data (RWD) because they are generated from routine health care processes, and they are available for millions of patients.

SmartChart Suite: a Fast Healthcare Interoperability Resources-based framework for longitudinal syphilis surveillance using structured and unstructured data.

Objective: The resurgence of syphilis in the United States presents a significant public health challenge. Much of the information needed for syphilis surveillance resides in electronic health records (EHRs). In this manuscript, we describe a surveillance platform for automating the extraction of EHR data, known as SmartChart Suite, and the results from a pilot.

A Modified Public Health Automated Case Event Reporting Platform for Enhancing Electronic Laboratory Reports With Clinical Data: Design and Implementation Study.

Background: Public health reporting is the cornerstone of public health practices that inform prevention and control strategies. There is a need to leverage advances made in the past to implement an architecture that facilitates the timely and complete public health reporting of relevant case-related information that has previously not easily been available to the public health community. Electronic laboratory reporting (ELR) is a reliable method for reporting cases to public health authorities but contains very limited data.

Comparative First-Line Effectiveness and Safety of ACE (Angiotensin-Converting Enzyme) Inhibitors and Angiotensin Receptor Blockers: A Multinational Cohort Study.

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Normalizing Clinical Document Titles to LOINC Document Ontology: an Initial Study.

The normalization of clinical documents is essential for health information management with the enormous amount of clinical documentation generated each year. The LOINC Document Ontology (DO) is a universal clinical document standard in a hierarchical structure. The objective of this study is to investigate the feasibility and generalizability of LOINC DO by mapping from clinical note titles across five institutions to five DO axes.

Public health reporting and outbreak response: synergies with evolving clinical standards for interoperability.

Public health needs up-to-date information for surveillance and response. As healthcare application programming interfaces become widely available, a novel data gathering mechanism could provide public health with critical information in a timely fashion to respond to a fast-moving epidemic. In this article, we extrapolate from our experiences using a Fast Healthcare Interoperability Resource-based architecture for infectious disease surveillance for sexually transmitted diseases to its application to gather case information for an outbreak.

Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis.

Alendronate and raloxifene are among the most popular anti-osteoporosis medications. However, there is a lack of head-to-head comparative effectiveness studies comparing the two treatments. We conducted a retrospective large-scale multicenter study encompassing over 300 million patients across nine databases encoded in the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).

Extending an open-source tool to measure data quality: case report on Observational Health Data Science and Informatics (OHDSI).

Introduction: As the health system seeks to leverage large-scale data to inform population outcomes, the informatics community is developing tools for analysing these data. To support data quality assessment within such a tool, we extended the open-source software Observational Health Data Sciences and Informatics (OHDSI) to incorporate new functions useful for population health.

Methods: We developed and tested methods to measure the completeness, timeliness and entropy of information.

Comprehensive comparative effectiveness and safety of first-line antihypertensive drug classes: a systematic, multinational, large-scale analysis.

Background: Uncertainty remains about the optimal monotherapy for hypertension, with current guidelines recommending any primary agent among the first-line drug classes thiazide or thiazide-like diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, dihydropyridine calcium channel blockers, and non-dihydropyridine calcium channel blockers, in the absence of comorbid indications. Randomised trials have not further refined this choice.

Methods: We developed a comprehensive framework for real-world evidence that enables comparative effectiveness and safety evaluation across many drugs and outcomes from observational data encompassing millions of patients, while minimising inherent bias.

Integration of FHIR to Facilitate Electronic Case Reporting: Results from a Pilot Study.

Current approaches to gathering sexually transmitted infection (STI) case information for surveillance efforts are inefficient and lead to underreporting of disease burden. Electronic health information systems offer an opportunity to improve how STI case information can be gathered and reported to public health authorities. To test the feasibility of a standards-based application designed to automate STI case information collection and reporting, we conducted a pilot study where electronic laboratory messages triggered a FHIR-based application to query a patient's electronic health record for details needed for an electronic case report (eCR).

Predictive modeling of hypoglycemia for clinical decision support in evaluating outpatients with diabetes mellitus.

Hypoglycemia occurs in 20-60% of patients with diabetes mellitus. Identifying at-risk patients can facilitate interventions to lower risk. We sought to develop a hypoglycemia prediction model.

Risk of angioedema associated with levetiracetam compared with phenytoin: Findings of the observational health data sciences and informatics research network.

Recent adverse event reports have raised the question of increased angioedema risk associated with exposure to levetiracetam. To help address this question, the Observational Health Data Sciences and Informatics research network conducted a retrospective observational new-user cohort study of seizure patients exposed to levetiracetam (n = 276,665) across 10 databases. With phenytoin users (n = 74,682) as a comparator group, propensity score-matching was conducted and hazard ratios computed for angioedema events by per-protocol and intent-to-treat analyses.

Multisite Evaluation of a Data Quality Tool for Patient-Level Clinical Data Sets.

Introduction: Data quality and fitness for analysis are crucial if outputs of analyses of electronic health record data or administrative claims data should be trusted by the public and the research community.

Methods: We describe a data quality analysis tool (called Achilles Heel) developed by the Observational Health Data Sciences and Informatics Collaborative (OHDSI) and compare outputs from this tool as it was applied to 24 large healthcare datasets across seven different organizations.

Results: We highlight 12 data quality rules that identified issues in at least 10 of the 24 datasets and provide a full set of 71 rules identified in at least one dataset.

A comparison between physicians and computer algorithms for form CMS-2728 data reporting.

Introduction: CMS-2728 form (Medical Evidence Report) assesses 23 comorbidities chosen to reflect poor outcomes and increased mortality risk. Previous studies questioned the validity of physician reporting on forms CMS-2728. We hypothesize that reporting of comorbidities by computer algorithms identifies more comorbidities than physician completion, and, therefore, is more reflective of underlying disease burden.

Characterizing treatment pathways at scale using the OHDSI network.

Observational research promises to complement experimental research by providing large, diverse populations that would be infeasible for an experiment. Observational research can test its own clinical hypotheses, and observational studies also can contribute to the design of experiments and inform the generalizability of experimental research. Understanding the diversity of populations and the variance in care is one component.

Benchmarks for ethically credible partnerships between industry and academic health centers: beyond disclosure of financial conflicts of interest.

Relationships between industry and university-based researchers have been commonplace for decades and have received notable attention concerning the conflicts of interest these relationships may harbor. While new efforts are being made to update conflict of interest policies and make industry relationships with academia more transparent, the development of broader institutional partnerships between industry and academic health centers challenges the efficacy of current policy to effectively manage these innovative partnerships. In this paper, we argue that existing strategies to reduce conflicts of interest are not sufficient to address the emerging models of industry-academic partnerships because they focus too narrowly on financial matters and are not comprehensive enough to mitigate all ethical risk.

Observational Health Data Sciences and Informatics (OHDSI): Opportunities for Observational Researchers.

The vision of creating accessible, reliable clinical evidence by accessing the clincial experience of hundreds of millions of patients across the globe is a reality. Observational Health Data Sciences and Informatics (OHDSI) has built on learnings from the Observational Medical Outcomes Partnership to turn methods research and insights into a suite of applications and exploration tools that move the field closer to the ultimate goal of generating evidence about all aspects of healthcare to serve the needs of patients, clinicians and all other decision-makers around the world.

Supporting Clinical Cognition: A Human-Centered Approach to a Novel ICU Information Visualization Dashboard.

Advances in intensive care unit bedside displays/interfaces and electronic medical record (EMR) technology have not adequately addressed the topic of visual clarity of patient data/information to further reduce cognitive load during clinical decision-making. We responded to these challenges with a human-centered approach to designing and testing a decision-support tool: MIVA 2.0 (Medical Information Visualization Assistant, v.

An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making.

FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the 'signal-to-noise ratio' and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications.

Bridging islands of information to establish an integrated knowledge base of drugs and health outcomes of interest.

The entire drug safety enterprise has a need to search, retrieve, evaluate, and synthesize scientific evidence more efficiently. This discovery and synthesis process would be greatly accelerated through access to a common framework that brings all relevant information sources together within a standardized structure. This presents an opportunity to establish an open-source community effort to develop a global knowledge base, one that brings together and standardizes all available information for all drugs and all health outcomes of interest (HOIs) from all electronic sources pertinent to drug safety.