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Feasibility analysis of conducting observational studies with the electronic health record.

ABSTRACT: BACKGROUND:The secondary use of electronic health records (EHRs) promises to facilitate medical research. We reviewed general data requirements in observational studies and analyzed the feasibility of conducting observational studies with structured EHR data, in particular diagnosis and procedure codes. METHODS:After reviewing published observational studies from the University Hospital of Erlangen for general data requirements, we identified three different study populations for the feasibility analysis with eligibility criteria from three exemplary observational studies. For each study population, we evaluated the availability of relevant patient characteristics in our EHR, including outcome and exposure variables. To assess data quality, we computed distributions of relevant patient characteristics from the available structured EHR data and compared them to those of the original studies. We implemented computed phenotypes for patient characteristics where necessary. In random samples, we evaluated how well structured patient characteristics agreed with a gold standard from manually interpreted free texts. We categorized our findings using the four data quality dimensions "completeness", "correctness", "currency" and "granularity". RESULTS:Reviewing general data requirements, we found that some investigators supplement routine data with questionnaires, interviews and follow-up examinations. We included 847 subjects in the feasibility analysis (Study 1 n?=?411, Study 2 n?=?423, Study 3 n?=?13). All eligibility criteria from two studies were available in structured data, while one study required computed phenotypes in eligibility criteria. In one study, we found that all necessary patient characteristics were documented at least once in either structured or unstructured data. In another study, all exposure and outcome variables were available in structured data, while in the other one unstructured data had to be consulted. The comparison of patient characteristics distributions, as computed from structured data, with those from the original study yielded similar distributions as well as indications of underreporting. We observed violations in all four data quality dimensions. CONCLUSIONS:While we found relevant patient characteristics available in structured EHR data, data quality problems may entail that it remains a case-by-case decision whether diagnosis and procedure codes are sufficient to underpin observational studies. Free-text data or subsequently supplementary study data may be important to complement a comprehensive patient history.

SUBMITTER: von Lucadou M

PROVIDER: S-EPMC6819452 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Feasibility analysis of conducting observational studies with the electronic health record.

von Lucadou Marcel M Ganslandt Thomas T Prokosch Hans-Ulrich HU Toddenroth Dennis D

BMC medical informatics and decision making 20191028 1

<h4>Background</h4>The secondary use of electronic health records (EHRs) promises to facilitate medical research. We reviewed general data requirements in observational studies and analyzed the feasibility of conducting observational studies with structured EHR data, in particular diagnosis and procedure codes.<h4>Methods</h4>After reviewing published observational studies from the University Hospital of Erlangen for general data requirements, we identified three different study populations for ...[more]

PMID: 31660955

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Project description:ObjectiveTo identify observational studies which used data from more than one primary care electronic health record (EHR) database, and summarise key characteristics including: objective and rationale for using multiple data sources; methods used to manage, analyse and (where applicable) combine data; and approaches used to assess and report heterogeneity between data sources.DesignA systematic review of published studies.Data sourcesPubmed and Embase databases were searched using list of named primary care EHR databases; supplementary hand searches of reference list of studies were retained after initial screening.Study selectionObservational studies published between January 2000 and May 2018 were selected, which included at least two different primary care EHR databases.Results6054 studies were identified from database and hand searches, and 109 were included in the final review, the majority published between 2014 and 2018. Included studies used 38 different primary care EHR data sources. Forty-seven studies (44%) were descriptive or methodological. Of 62 analytical studies, 22 (36%) presented separate results from each database, with no attempt to combine them; 29 (48%) combined individual patient data in a one-stage meta-analysis and 21 (34%) combined estimates from each database using two-stage meta-analysis. Discussion and exploration of heterogeneity was inconsistent across studies.ConclusionsComparing patterns and trends in different populations, or in different primary care EHR databases from the same populations, is important and a common objective for multi-database studies. When combining results from several databases using meta-analysis, provision of separate results from each database is helpful for interpretation. We found that these were often missing, particularly for studies using one-stage approaches, which also often lacked details of any statistical adjustment for heterogeneity and/or clustering. For two-stage meta-analysis, a clear rationale should be provided for choice of fixed effect and/or random effects or other models.

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Project description:BackgroundElectronic health record (EHR) system users devise workarounds to cope with mismatches between workflows designed in the EHR and preferred workflows in practice. Although workarounds appear beneficial at first sight, they frequently jeopardize patient safety, the quality of care, and the efficiency of care.ObjectiveThis review aims to aid in identifying, analyzing, and resolving EHR workarounds; the Sociotechnical EHR Workaround Analysis (SEWA) framework was published in 2019. Although the framework was based on a large case study, the framework still required theoretical validation, refinement, and enrichment.MethodsA scoping literature review was performed on studies related to EHR workarounds published between 2010 and 2021 in the MEDLINE, Embase, CINAHL, Cochrane, or IEEE databases. A total of 737 studies were retrieved, of which 62 (8.4%) were included in the final analysis. Using an analytic framework, the included studies were investigated to uncover the rationales that EHR users have for workarounds, attributes characterizing workarounds, possible scopes, and types of perceived impacts of workarounds.ResultsThe SEWA framework was theoretically validated and extended based on the scoping review. Extensive support for the pre-existing rationales, attributes, possible scopes, and types of impact was found in the included studies. Moreover, 7 new rationales, 4 new attributes, and 3 new types of impact were incorporated. Similarly, the descriptions of multiple pre-existing rationales for workarounds were refined to describe each rationale more accurately.ConclusionsSEWA is now grounded in the existing body of peer-reviewed empirical evidence on EHR workarounds and, as such, provides a theoretically validated and more complete synthesis of EHR workaround rationales, attributes, possible scopes, and types of impact. The revised SEWA framework can aid researchers and practitioners in a wider range of health care settings to identify, analyze, and resolve workarounds. This will improve user-centered EHR design and redesign, ultimately leading to improved patient safety, quality of care, and efficiency of care.

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Feasibility analysis of conducting observational studies with the electronic health record.

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Feasibility analysis of conducting observational studies with the electronic health record.

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