A novel application of SMART on FHIR architecture for interoperable and scalable integration of patient-reported outcome data with electronic health records

ObjectiveDespite a proliferation of applications (apps) to conveniently collect patient-reported outcomes (PROs) from patients, PRO data are yet to be seamlessly integrated with electronic health records (EHRs) in a way that improves interoperability and scalability. We applied the newly created PRO standards from the Office of the National Coordinator for Health Information Technology to facilitate the collection and integration of standardized PRO data. A novel multitiered architecture was created to enable seamless integration of PRO data via Substitutable Medical Apps and Reusable Technologies on Fast Healthcare Interoperability Resources apps and scaled to different EHR platforms in multiple ambulatory settings.Materials and MethodsWe used a standards-based approach to deploy 2 apps that source and surface PRO data in real-time for provider use within the EHR and which rely on PRO assessments from an external center to streamline app and EHR integration.ResultsThe apps were developed to enable patients to answer validated assessments (eg, a Patient-Reported Outcomes Measurement Information System including using a Computer Adaptive Test format). Both apps were developed to populate the EHR in real time using the Health Level Seven FHIR standard allowing providers to view patients’ data during the clinical encounter. The process of implementing this architecture with 2 different apps across 18 ambulatory care sites and 3 different EHR platforms is described.ConclusionOur approach and solution proved feasible, secure, and time- and resource-efficient. We offer actionable guidance for this technology to be scaled and adapted to promote adoption in diverse ambulatory care settings and across different EHRs.     

Harmonizing units and values of quantitative data elements in a very large nationally pooled electronic health record (EHR) dataset

ObjectiveThe goals of this study were to harmonize data from electronic health records (EHRs) into common units, and impute units that were missing.Materials and MethodsThe National COVID Cohort Collaborative (N3C) table of laboratory measurement data—over 3.1 billion patient records and over 19 000 unique measurement concepts in the Observational Medical Outcomes Partnership (OMOP) common-data-model format from 55 data partners. We grouped ontologically similar OMOP concepts together for 52 variables relevant to COVID-19 research, and developed a unit-harmonization pipeline comprised of (1) selecting a canonical unit for each measurement variable, (2) arriving at a formula for conversion, (3) obtaining clinical review of each formula, (4) applying the formula to convert data values in each unit into the target canonical unit, and (5) removing any harmonized value that fell outside of accepted value ranges for the variable. For data with missing units for all the results within a lab test for a data partner, we compared values with pooled values of all data partners, using the Kolmogorov-Smirnov test.ResultsOf the concepts without missing values, we harmonized 88.1% of the values, and imputed units for 78.2% of records where units were absent (41% of contributors’ records lacked units).DiscussionThe harmonization and inference methods developed herein can serve as a resource for initiatives aiming to extract insight from heterogeneous EHR collections. Unique properties of centralized data are harnessed to enable unit inference.ConclusionThe pipeline we developed for the pooled N3C data enables use of measurements that would otherwise be unavailable for analysis.     

Blueprint for aligned data exchange for research and public health

Making EHR Data More Available for Research and Public Health (MedMorph) is a Centers for Disease Control and Prevention-led initiative developing and demonstrating a reference architecture (RA) and implementation, including Health Level Seven International Fast Healthcare Interoperability Resources (HL7 FHIR) implementation guides (IGs), describing how to leverage FHIR for aligned research and public health access to clinical data for automated data exchange. MedMorph engaged a technical expert panel of more than 100 members to model representative use cases, develop IGs (architectural and content), align with existing efforts in the FHIR community, and demonstrate the RA in research and public health uses. The RA IG documents common workflows needed to automatically send research data to Research Patient Data Repositories for multiple use cases. Sharing a common RA and canonical data model will improve data sharing for research and public health needs and generate evidence. MedMorph delivers a robust, reusable method to utilize data from electronic health records addressing multiple research and public health needs.     

Brief communication: Patient-powered research networks: building capacity for conducting patient-centered clinical outcomes research

The Patient-Centered Outcomes Research Institute (PCORI) recently launched PCORnet to establish a single inter-operable multicenter data research network that will support observational research and randomized clinical trials. This paper provides an overview of the patient-powered research networks (PPRNs), networks of patient organizations focused on a particular health condition that are interested in sharing health information and engaging in research. PPRNs will build on their foundation of trust within the patient communities and draw on their expertise, working with participants to identify true patient-centered outcomes and direct a patient-centered research agenda. The PPRNs will overcome common challenges including enrolling a diverse and representative patient population; engaging patients in governance; designing the data infrastructure; sharing data securely while protecting privacy; prioritizing research questions; scaling small networks into a larger network; and identifying pathways to sustainability. PCORnet will be the first distributed research network to bring PCOR to national scale.     

An architecture for research computing in health to support clinical and translational investigators with electronic patient data

ObjectiveObtaining electronic patient data, especially from electronic health record (EHR) systems, for clinical and translational research is difficult. Multiple research informatics systems exist but navigating the numerous applications can be challenging for scientists. This article describes Architecture for Research Computing in Health (ARCH), our institution’s approach for matching investigators with tools and services for obtaining electronic patient data.Materials and MethodsSupporting the spectrum of studies from populations to individuals, ARCH delivers a breadth of scientific functions—including but not limited to cohort discovery, electronic data capture, and multi-institutional data sharing—that manifest in specific systems—such as i2b2, REDCap, and PCORnet. Through a consultative process, ARCH staff align investigators with tools with respect to study design, data sources, and cost. Although most ARCH services are available free of charge, advanced engagements require fee for service.ResultsSince 2016 at Weill Cornell Medicine, ARCH has supported over 1200 unique investigators through more than 4177 consultations. Notably, ARCH infrastructure enabled critical coronavirus disease 2019 response activities for research and patient care.DiscussionARCH has provided a technical, regulatory, financial, and educational framework to support the biomedical research enterprise with electronic patient data. Collaboration among informaticians, biostatisticians, and clinicians has been critical to rapid generation and analysis of EHR data.ConclusionA suite of tools and services, ARCH helps match investigators with informatics systems to reduce time to science. ARCH has facilitated research at Weill Cornell Medicine and may provide a model for informatics and research leaders to support scientists elsewhere.     

Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials

ObjectiveThis research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data.Materials and MethodsOn June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020–June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and in-hospital death.ResultsThere were 3251 patients diagnosed with COVID-19 from the CUIMC EHR included in the analysis. The median follow-up period was 10 days (interquartile range 4–28 days). The composite events occurred in 18.1% (n = 587) of the COVID-19 cohort during the follow-up. In a hypothetical trial with common eligibility criteria, 33.6% (690/2051) were eligible among patients with evaluable data and 22.2% (153/690) had the composite event.DiscussionBy adjusting the thresholds of common eligibility criteria based on the characteristics of COVID-19 patients, we could observe more composite events from fewer patients.ConclusionsThis research demonstrated the potential of using the EHR data of COVID-19 patients to inform the selection of eligibility criteria and their thresholds, supporting data-driven optimization of participant selection towards improved statistical power of COVID-19 trials.     

Integrating real-world data from Brazil and Pakistan into the OMOP common data model and standardized health analytics framework to characterize COVID-19 in the Global South

ObjectivesThe aim of this work is to demonstrate the use of a standardized health informatics framework to generate reliable and reproducible real-world evidence from Latin America and South Asia towards characterizing coronavirus disease 2019 (COVID-19) in the Global South.Materials and MethodsPatient-level COVID-19 records collected in a patient self-reported notification system, hospital in-patient and out-patient records, and community diagnostic labs were harmonized to the Observational Medical Outcomes Partnership common data model and analyzed using a federated network analytics framework. Clinical characteristics of individuals tested for, diagnosed with or tested positive for, hospitalized with, admitted to intensive care unit with, or dying with COVID-19 were estimated.ResultsTwo COVID-19 databases covering 8.3 million people from Pakistan and 2.6 million people from Bahia, Brazil were analyzed. 109 504 (Pakistan) and 921 (Brazil) medical concepts were harmonized to Observational Medical Outcomes Partnership common data model. In total, 341 505 (4.1%) people in the Pakistan dataset and 1 312 832 (49.2%) people in the Brazilian dataset were tested for COVID-19 between January 1, 2020 and April 20, 2022, with a median [IQR] age of 36 [25, 76] and 38 (27, 50); 40.3% and 56.5% were female in Pakistan and Brazil, respectively. 1.2% percent individuals in the Pakistan dataset had Afghan ethnicity. In Brazil, 52.3% had mixed ethnicity. In agreement with international findings, COVID-19 outcomes were more severe in men, elderly, and those with underlying health conditions.ConclusionsCOVID-19 data from 2 large countries in the Global South were harmonized and analyzed using a standardized health informatics framework developed by an international community of health informaticians. This proof-of-concept study demonstrates a potential open science framework for global knowledge mobilization and clinical translation for timely response to healthcare needs in pandemics and beyond.     

Potential limitations in COVID-19 machine learning due to data source variability: A case study in the nCov2019 dataset

ObjectiveThe lack of representative coronavirus disease 2019 (COVID-19) data is a bottleneck for reliable and generalizable machine learning. Data sharing is insufficient without data quality, in which source variability plays an important role. We showcase and discuss potential biases from data source variability for COVID-19 machine learning.Materials and MethodsWe used the publicly available nCov2019 dataset, including patient-level data from several countries. We aimed to the discovery and classification of severity subgroups using symptoms and comorbidities.ResultsCases from the 2 countries with the highest prevalence were divided into separate subgroups with distinct severity manifestations. This variability can reduce the representativeness of training data with respect the model target populations and increase model complexity at risk of overfitting.ConclusionsData source variability is a potential contributor to bias in distributed research networks. We call for systematic assessment and reporting of data source variability and data quality in COVID-19 data sharing, as key information for reliable and generalizable machine learning.     

Clinical data sharing improves quality measurement and patient safety

ObjectiveAccurate and robust quality measurement is critical to the future of value-based care. Having incomplete information when calculating quality measures can cause inaccuracies in reported patient outcomes. This research examines how quality calculations vary when using data from an individual electronic health record (EHR) and longitudinal data from a health information exchange (HIE) operating as a multisource registry for quality measurement. Materials and MethodsData were sampled from 53 healthcare organizations in 2018. Organizations represented both ambulatory care practices and health systems participating in the state of Kansas HIE. Fourteen ambulatory quality measures for 5300 patients were calculated using the data from an individual EHR source and contrasted to calculations when HIE data were added to locally recorded data.ResultsA total of 79% of patients received care at more than 1 facility during the 2018 calendar year. A total of 12 994 applicable quality measure calculations were compared using data from the originating organization vs longitudinal data from the HIE. A total of 15% of all quality measure calculations changed (P < .001) when including HIE data sources, affecting 19% of patients. Changes in quality measure calculations were observed across measures and organizations.DiscussionThese results demonstrate that quality measures calculated using single-site EHR data may be limited by incomplete information. Effective data sharing significantly changes quality calculations, which affect healthcare payments, patient safety, and care quality.ConclusionsFederal, state, and commercial programs that use quality measurement as part of reimbursement could promote more accurate and representative quality measurement through methods that increase clinical data sharing.     

Assessing the practice of data quality evaluation in a national clinical data research network through a systematic scoping review in the era of real-world data

ObjectiveTo synthesize data quality (DQ) dimensions and assessment methods of real-world data, especially electronic health records, through a systematic scoping review and to assess the practice of DQ assessment in the national Patient-centered Clinical Research Network (PCORnet).Materials and MethodsWe started with 3 widely cited DQ literature—2 reviews from Chan et al (2010) and Weiskopf et al (2013a) and 1 DQ framework from Kahn et al (2016)—and expanded our review systematically to cover relevant articles published up to February 2020. We extracted DQ dimensions and assessment methods from these studies, mapped their relationships, and organized a synthesized summarization of existing DQ dimensions and assessment methods. We reviewed the data checks employed by the PCORnet and mapped them to the synthesized DQ dimensions and methods.ResultsWe analyzed a total of 3 reviews, 20 DQ frameworks, and 226 DQ studies and extracted 14 DQ dimensions and 10 assessment methods. We found that completeness, concordance, and correctness/accuracy were commonly assessed. Element presence, validity check, and conformance were commonly used DQ assessment methods and were the main focuses of the PCORnet data checks.DiscussionDefinitions of DQ dimensions and methods were not consistent in the literature, and the DQ assessment practice was not evenly distributed (eg, usability and ease-of-use were rarely discussed). Challenges in DQ assessments, given the complex and heterogeneous nature of real-world data, exist.ConclusionThe practice of DQ assessment is still limited in scope. Future work is warranted to generate understandable, executable, and reusable DQ measures.     

Brief communication: Launching PCORnet,a national patient-centered clinical research network

The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI''s board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here.     

Validation of a common data model for active safety surveillance research

OBJECTIVE: Systematic analysis of observational medical databases for active safety surveillance is hindered by the variation in data models and coding systems. Data analysts often find robust clinical data models difficult to understand and ill suited to support their analytic approaches. Further, some models do not facilitate the computations required for systematic analysis across many interventions and outcomes for large datasets. Translating the data from these idiosyncratic data models to a common data model (CDM) could facilitate both the analysts' understanding and the suitability for large-scale systematic analysis. In addition to facilitating analysis, a suitable CDM has to faithfully represent the source observational database. Before beginning to use the Observational Medical Outcomes Partnership (OMOP) CDM and a related dictionary of standardized terminologies for a study of large-scale systematic active safety surveillance, the authors validated the model's suitability for this use by example. VALIDATION BY EXAMPLE: To validate the OMOP CDM, the model was instantiated into a relational database, data from 10 different observational healthcare databases were loaded into separate instances, a comprehensive array of analytic methods that operate on the data model was created, and these methods were executed against the databases to measure performance. CONCLUSION: There was acceptable representation of the data from 10 observational databases in the OMOP CDM using the standardized terminologies selected, and a range of analytic methods was developed and executed with sufficient performance to be useful for active safety surveillance.     

Building capacity of community health centers to overcome data challenges with the development of an agile COVID-19 public health registry: a multistate quality improvement effort

ObjectiveDuring the coronavirus disease 2019 (COVID-19) pandemic, federally qualified health centers rapidly mobilized to provide SARS-CoV-2 testing, COVID-19 care, and vaccination to populations at increased risk for COVID-19 morbidity and mortality. We describe the development of a reusable public health data analytics system for reuse of clinical data to evaluate the health burden, disparities, and impact of COVID-19 on populations served by health centers.Materials and MethodsThe Multistate Data Strategy engaged project partners to assess public health readiness and COVID-19 data challenges. An infrastructure for data capture and sharing procedures between health centers and public health agencies was developed to support existing capabilities and data capacities to respond to the pandemic.ResultsBetween August 2020 and March 2021, project partners evaluated their data capture and sharing capabilities and reported challenges and preliminary data. Major interoperability challenges included poorly aligned federal, state, and local reporting requirements, lack of unique patient identifiers, lack of access to pharmacy, claims and laboratory data, missing data, and proprietary data standards and extraction methods.DiscussionEfforts to access and align project partners’ existing health systems data infrastructure in the context of the pandemic highlighted complex interoperability challenges. These challenges remain significant barriers to real-time data analytics and efforts to improve health outcomes and mitigate inequities through data-driven responses.ConclusionThe reusable public health data analytics system created in the Multistate Data Strategy can be adapted and scaled for other health center networks to facilitate data aggregation and dashboards for public health, organizational planning, and quality improvement and can inform local, state, and national COVID-19 response efforts.     

基于FHIR术语组件构建统一术语服务

介绍快捷式医疗卫生互操作性资源(Fast Health Interoperable Resources,FHIR)标准应用现状以及FHIR标准中的术语组件知识,阐述基于FHIR术语组件构建统一术语服务的方法,对于医疗数据采集、大数据分析挖掘具有重要意义。     

Dynamically adjusting case reporting policy to maximize privacy and public health utility in the face of a pandemic

ObjectiveSupporting public health research and the public’s situational awareness during a pandemic requires continuous dissemination of infectious disease surveillance data. Legislation, such as the Health Insurance Portability and Accountability Act of 1996 and recent state-level regulations, permits sharing deidentified person-level data; however, current deidentification approaches are limited. Namely, they are inefficient, relying on retrospective disclosure risk assessments, and do not flex with changes in infection rates or population demographics over time. In this paper, we introduce a framework to dynamically adapt deidentification for near-real time sharing of person-level surveillance data.Materials and MethodsThe framework leverages a simulation mechanism, capable of application at any geographic level, to forecast the reidentification risk of sharing the data under a wide range of generalization policies. The estimates inform weekly, prospective policy selection to maintain the proportion of records corresponding to a group size less than 11 (PK11) at or below 0.1. Fixing the policy at the start of each week facilitates timely dataset updates and supports sharing granular date information. We use August 2020 through October 2021 case data from Johns Hopkins University and the Centers for Disease Control and Prevention to demonstrate the framework’s effectiveness in maintaining the PK11 threshold of 0.01.ResultsWhen sharing COVID-19 county-level case data across all US counties, the framework’s approach meets the threshold for 96.2% of daily data releases, while a policy based on current deidentification techniques meets the threshold for 32.3%.ConclusionPeriodically adapting the data publication policies preserves privacy while enhancing public health utility through timely updates and sharing epidemiologically critical features.