scholarly journals Development of an electronic health records datamart to support clinical and population health research

Author(s):  
Jillian H. Hurst ◽  
Yaxing Liu ◽  
Pamela J. Maxson ◽  
Sallie R. Permar ◽  
L. Ebony Boulware ◽  
...  

Abstract Introduction: Electronic health record (EHR) data have emerged as an important resource for population health and clinical research. There have been significant efforts to leverage EHR data for research; however, given data security concerns and the complexity of the data, EHR data are frequently difficult to access and use for clinical studies. We describe the development of a Clinical Research Datamart (CRDM) that was developed to provide well-curated and easily accessible EHR data to Duke University investigators. Methods: The CRDM was designed to (1) contain most of the patient-level data elements needed for research studies; (2) be directly accessible by individuals conducting statistical analyses (including Biostatistics, Epidemiology, and Research Design (BERD) core members); (3) be queried via a code-based system to promote reproducibility and consistency across studies; and (4) utilize a secure protected analytic workspace in which sensitive EHR data can be stored and analyzed. The CRDM utilizes data transformed for the PCORnet data network, and was augmented with additional data tables containing site-specific data elements to provide additional contextual information. Results: We provide descriptions of ideal use cases and discuss dissemination and evaluation methods, including future work to expand the user base and track the use and impact of this data resource. Conclusions: The CRDM utilizes resources developed as part of the Clinical and Translational Science Awards (CTSAs) program and could be replicated by other institutions with CTSAs.

2020 ◽  
Vol 17 (4) ◽  
pp. 370-376
Author(s):  
Benjamin A Goldstein

Electronic health records data are becoming a key data resource in clinical research. Owing to issues of data efficiency, electronic health records data are being used for clinical trials. This includes both large-scale pragmatic trails and smaller—more focused—point-of-care trials. While electronic health records data open up a number of scientific opportunities, they also present a number of analytic challenges. This article discusses five particular challenges related to organizing electronic health records data for analytic purposes. These are as follows: (1) data are not organized for research purposes, (2) data are both densely and irregularly observed, (3) we don’t have all data elements we may want or need, (4) data are both cross-sectional and longitudinal, and (5) data may be informatively observed. While laying out these challenges, the article notes how many of these challenges can be addressed by careful and thoughtful study design as well as by integration of clinicians and informaticians into the analytic team.


Author(s):  
Timothy D. McFarlane ◽  
Brian E. Dixon ◽  
P. Joseph Gibson

ObjectiveTo assess the equivalence of hypertension prevalence estimates between longitudinal electronic health record (EHR) data from a community-based health information exchange (HIE) and the Behavioral Risk Factor Surveillance System (BRFSS).IntroductionHypertension (HTN) is a highly prevalent chronic condition and strongly associated with morbidity and mortality. HTN is amenable to prevention and control through public and population health programs and policies. Therefore, public and population health programs require accurate, stable estimates of disease prevalence, and estimating HTN prevalence at the community-level is acutely important for timely detection, intervention, and effective evaluation. Current surveillance methods for HTN rely upon community-based surveys, such as the BRFSS. While BRFSS is the standard at the state- and national-level, they are expensive to collect, released once per year, and their confidence intervals are too wide for precise estimates at the local level. More timely, frequently updated, and locally precise prevalence estimates could greatly improve the timeliness and precision of public health interventions. The current study evaluated EHR data from a large, mature HIE as an alternative to community-based surveys for timely, accurate, and precise HTN prevalence estimation.MethodsTwo years (2014-2015) of EHR data were obtained from the Indiana Network for Patient Care for two major health systems in Marion County, Indiana, representing approximately 75% of the total county population (n=530,244). These data were linked and evaluated for prevalent HTN. Six HTN phenotypes were defined using structured data variables including clinical diagnoses (ICD9/10 codes), blood pressure (BP) measurements (HTN = ≥140mmhg systolic or ≥90mmHg diastolic), and dispensed HTN medications (Table 1). Phenotypes were validated using a random sample of 600 records, comparing EHR phenotype HTN to HTN as determined through manual chart review by a Registered Nurse. Each phenotype was further evaluated against BRFSS estimates for Marion County, and stratified by sex, race, and age to compare EHR-generated HTN prevalence measures to those known and in current use for chronic disease surveillance. Comparisons were made using the two one-sided statistical test (TOST) of equivalence, wherein the null hypothesis is the BRFSS and EHR prevalence estimates are different by +/-5% and the alternative is estimates differ by less than +/-5%. Rejection of the null resulted in the conclusion of equivalence of the estimates for use in population/public health.ResultsIn general, the performance of the EHR phenotypes was characterized by high specificity (>87%) and low to moderate sensitivity (range 25.4%-95.3%). The false positive rate was lowest among the phenotype defining HTN by both clinical diagnosis and BP measurements (0.3%), and sensitivity was greatest for the phenotype combining all three structured data elements (95.2%). The prevalence of HTN in Marion County, Indiana (2014-2015) for the EHR sample (n=530,244) ranged between 13.7% and 36.2%, compared to 28.4% in the BRFSS sample (Table 1). Only one EHR phenotype (≥1 HTN BP measurement) demonstrated equivalence with BRFSS prevalence at the county level (difference 0.9%, 90% CI for difference -2.3%-4.0%). HTN prevalence by sex, race, age, sex and age, and sex and race (n=120 comparisons) failed to demonstrate equivalence between EHR and BRFSS measures in all but two comparisons, both among females aged 18-39 years. Differences between EHR and BRFSS HTN prevalence at the subgroup level varied but were particularly pronounced among older adults. As suspected, HTN prevalence precision was improved in the EHR sample with the largest subgroup 95% CI width of 0.7% for male African Americans compared to the BRFSS sample 95% CI width of 29.6%.ConclusionsThe applicability of the tested HTN phenotypes will vary based upon which EHR structured data elements are available to public health (i.e., ICD10, vitals, medications). We found that HTN surveillance using a community-based HIE was not a valid replacement for the BRFSS, although the HIE-based estimates could be readily generated and had much narrower confidence intervals.ReferencesMozaffarian D, et al. Heart Disease and Stroke Statistics — 2016 Update. Circulation. 2016; 133: e38-e360.Yoon S, Fryar C, Carroll M. HTN Prevalence and Control Among Adults: United States, 2011–2014. NCHS Data Brief No. 220. 2015; Hyattsville, MD: National Center for Health Statistics, Centers for Disease Control and Prevention, US Dept of Health and Human Services. 


2015 ◽  
Vol 2015 ◽  
pp. 1-10
Author(s):  
Julie M. James ◽  
Dipak Kalra ◽  
Jane Portlock

A “Medication Profile,” the information about the medicines a person is using and has used, is a core part of many electronic health record systems and summaries. However, there is little objective research into the data elements that the profile should contain to support the uses it must serve. With the increasing emphasis on secondary uses of electronic health information, as well as supporting the requirements to support direct to patient care, the Medication Profile should also support the requirements from clinical research. However, there is little, if any, description of these available. This paper describes an analysis of a set of study eligibility criteria that was undertaken to investigate which medication-related data elements would be required to support two clinical research use cases: the parameters to query a patient’s Medication Profile to assess their suitability for entry into a trial (patient recruitment) and the parameters to query a set of Medication Profiles in a data warehouse to assess whether the eligibility criteria as described would yield a reasonable cohort of patients as potential subjects (protocol feasibility). These medication-related data elements then become information requirements that a Medication Profile should ideally meet, in order to be able to support these two uses in the clinical research domain.


Author(s):  
Donald L. Bliwise ◽  
Michael K. Scullin

Possible associations between sleep and cognition are provocative across different domains and hold the promise of prevention or reversibility. A vast array of studies has been reported. Evidence is suggestive but hardly definitive. We provide an overview of this literature, adopting the framework of Hill’s perspective on epidemiological causation. With rare exception, formal meta-analyses have yet to appear. Apparent consistency of findings suggests relationships, but the diversity of findings involving specific components of cognitive function raises interpretative caution. Large effect sizes have been noted, but small-to-moderate effects predominate. Natural history data are similarly enticing, and studies of biological plausibility and gradient indicate likely neurobiological substrates. Perhaps the ultimate population-health criterion, demonstration of reversibility of impairment, remains elusive at best. This area offers an exciting topic for future work.


2021 ◽  
pp. 174077452110015
Author(s):  
E Ray Dorsey ◽  
Karl Kieburtz

The proposed triple aim of health care—enhanced patient experience, improved population health, and reduced per capita costs—can be applied to clinical research. A triple aim for clinical research would (1) improve the individual research participant’s experience; (2) promote the health of populations; and (3) reduce per capita costs of clinical research. Such an approach is possible by designing trials around the needs of participants rather than sites, embracing digital measures of health, and advancing decentralized studies. Recent studies, including those evaluating therapies for COVID-19, have demonstrated the value of such an approach. Accelerating the adoption of these methods can help fulfill this new triple aim of clinical research.


Author(s):  
David W. Loring ◽  
Russell M. Bauer ◽  
Lucia Cavanagh ◽  
Daniel L. Drane ◽  
Kristen D. Enriquez ◽  
...  

Abstract Objective. The National Neuropsychology Network (NNN) is a multicenter clinical research initiative funded by the National Institute of Mental Health (NIMH; R01 MH118514) to facilitate neuropsychology’s transition to contemporary psychometric assessment methods with resultant improvement in test validation and assessment efficiency. Method: The NNN includes four clinical research sites (Emory University; Medical College of Wisconsin; University of California, Los Angeles (UCLA); University of Florida) and Pearson Clinical Assessment. Pearson Q-interactive (Q-i) is used for data capture for Pearson published tests; web-based data capture tools programmed by UCLA, which serves as the Coordinating Center, are employed for remaining measures. Results: NNN is acquiring item-level data from 500–10,000 patients across 47 widely used Neuropsychology (NP) tests and sharing these data via the NIMH Data Archive. Modern psychometric methods (e.g., item response theory) will specify the constructs measured by different tests and determine their positive/negative predictive power regarding diagnostic outcomes and relationships to other clinical, historical, and demographic factors. The Structured History Protocol for NP (SHiP-NP) helps standardize acquisition of relevant history and self-report data. Conclusions: NNN is a proof-of-principle collaboration: by addressing logistical challenges, NNN aims to engage other clinics to create a national and ultimately an international network. The mature NNN will provide mechanisms for data aggregation enabling shared analysis and collaborative research. NNN promises ultimately to enable robust diagnostic inferences about neuropsychological test patterns and to promote the validation of novel adaptive assessment strategies that will be more efficient, more precise, and more sensitive to clinical contexts and individual/cultural differences.


2021 ◽  
Author(s):  
Jennifer Lahl ◽  
Kallie Fell ◽  
Kate Bassett ◽  
Frances Broghammer ◽  
Maggie Eastman ◽  
...  

Abstract Purpose: To evaluate the retrospective pregnancy experiences of American women by comparing spontaneous pregnancies with gestational surrogate pregnancies. Methods: Data were collected via structured interviews following an approved survey tool utilizing an online video platform. In total, 97 interviews were conducted. Results: Demographic data was collected on age, ethnicity, primary language, country of birth, education, and income level. Data revealed that a woman was more likely to have a pregnancy that was high-risk during a surrogate pregnancy than a non-surrogate pregnancy, independent of maternal age or gravidity (OR 7.22, p<0.001). A surrogate pregnancy had 4 times higher odds of resulting in a c-section (p<0.001) as well as delivering at an earlier gestational age (p<0.001). Further, women were more likely to experience adverse effects, including postpartum depression, following delivery of a surrogate child than their own biological child (p<0.001). Finally, the rate of new post-surrogacy chronic health issues for non-Caucasian women was significantly higher than for Caucasians (p<0.001). Women reported using the payment they received for their surrogacy for basic needs. Almost half of the women reported using the money to pay bills or get out of debt.Conclusions: These results are among the first of their kind. This study reveals that surrogate health disparities exist and that there may be long-term complications after a surrogate pregnancy. This raises important social, economic, and ethical issues related to surrogacy which must be further explored. Future work will build on this study and help elucidate the circumstances and consequences surrounding this complex issue.


2016 ◽  
Vol 25 (01) ◽  
pp. 219-223
Author(s):  
R. Choquet ◽  
C. Daniel ◽  

Summary Objectives: To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2015. Method: A bibliographic search using a combination of MeSH and free terms search over PubMed on Clinical Research Informatics (CRI) was performed followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was finally organized to conclude on the selection of best papers. Results: Among the 579 returned papers published in the past year in the various areas of Clinical Research Informatics (CRI) - i) methods supporting clinical research, ii) data sharing and interoperability, iii) re-use of healthcare data for research, iv) patient recruitment and engagement, v) data privacy, security and regulatory issues and vi) policy and perspectives - the full review process selected four best papers. The first selected paper evaluates the capability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) to support the representation of case report forms (in both the design stage and with patient level data) during a complete clinical study lifecycle. The second selected paper describes a prototype for secondary use of electronic health records data captured in non-standardized text. The third selected paper presents a privacy preserving electronic health record linkage tool and the last selected paper describes how big data use in US relies on access to health information governed by varying and often misunderstood legal requirements and ethical considerations. Conclusions: A major trend in the 2015 publications is the analysis of observational, “nonexperimental” information and the potential biases and confounding factors hidden in the data that will have to be carefully taken into account to validate new predictive models. In addiction, researchers have to understand complicated and sometimes contradictory legal requirements and to consider ethical obligations in order to balance privacy and promoting discovery.


2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
A. Anil Sinaci ◽  
Gokce B. Laleci Erturkmen ◽  
Suat Gonul ◽  
Mustafa Yuksel ◽  
Paolo Invernizzi ◽  
...  

Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing safety studies. In terms of the secondary use of EHRs, access and analysis of patient data across different domains are a critical factor; we address this data interoperability problem between EHR systems and clinical research systems in this paper. We demonstrate that this problem can be solved in an upper level with the use of common data elements in a standardized fashion so that clinical researchers can work with different EHR systems independently of the underlying information model. Postmarketing Safety Study Tool lets the clinical researchers extract data from different EHR systems by designing data collection set schemas through common data elements. The tool interacts with a semantic metadata registry through IHE data element exchange profile. Postmarketing Safety Study Tool and its supporting components have been implemented and deployed on the central data warehouse of the Lombardy region, Italy, which contains anonymized records of about 16 million patients with over 10-year longitudinal data on average. Clinical researchers in Roche validate the tool with real life use cases.


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