Objectives: The aim of this study was to characterize the benefits of converting Electronic Medical Records (EMRs) to a common data model (CDM) and to assess the potential of CDM-converted data to rapidly generate insights for benefit-risk assessments in post-market regulatory evaluation and decisions. Methods: EMRs from January 2013 to December 2016 were mapped onto the Observational Medical Outcomes Partnership-CDM (OMOP-CDM) schema. Vocabulary mappings were applied to convert source data values into OMOP-CDM-endorsed terminologies. Existing analytic codes used in a prior OMOP-CDM drug utilization study were modified to conduct an illustrative analysis of oral anticoagulants used for atrial fibrillation in Singapore and South Korea, resembling a typical benefit-risk assessment. A novel visualization is proposed to represent the comparative effectiveness, safety and utilization of the drugs. Results: Over 90% of records were mapped onto the OMOP-CDM. The CDM data structures and analytic code templates simplified the querying of data for the analysis. In total, 2,419 patients from Singapore and South Korea fulfilled the study criteria, the majority of whom were warfarin users. After 3 months of follow-up, differences in cumulative incidence of bleeding and thromboembolic events were observable via the proposed visualization, surfacing insights as to the agent of preference in a given clinical setting, which may meaningfully inform regulatory decision-making. Conclusions While the structure of the OMOP-CDM and its accessory tools facilitate real-world data analysis, extending them to fulfil regulatory analytic purposes in the post-market setting, such as benefit-risk assessments, may require layering on additional analytic tools and visualization techniques.

INTRODUCTIONThis study aimed to evaluate compliance with and performance of the Canadian Computed Tomography Head Rule (CCHR), and its applicability to the Singapore adult population with minor head injury.

METHODSWe conducted a retrospective study over six months of consecutive patients who presented to the adult emergency department (ED) with minor head injury. Data on predictor variables indicated in the CCHR was collected and compliance with the CCHR was assessed by comparing the recommendations for head computed tomography (CT) to its actual usage.

RESULTSIn total, 349 patients satisfied the inclusion criteria. Common mechanisms of injury were falls (59.3%), motor vehicle crashes (16.9%) and assault (12.0%). 249 (71.3%) patients underwent head CT, yielding 42 (12.0%) clinically significant findings. 1 (0.3%) patient required neurosurgical intervention. According to the CCHR, head CT was recommended for 209 (59.9%) patients. Compliance with the CCHR was 71.3%. Among the noncompliant group, head CT was overperformed for 20.1% and underperformed for 8.6% of patients. Multivariate logistic regression analysis revealed that absence of retrograde amnesia (odds ratio [OR] 4.1, 95% confidence interval [CI] 1.8-9.7) was associated with noncompliance to the CCHR. Factors associated with underperformance were absence of motor vehicle crashes as a mechanism of injury (OR 6.6, 95% CI 1.2-36.3) and absence of headache (OR 10.8, 95% CI 1.3-87.4).

CONCLUSIONCompliance with the CCHR for adult patients with minor head injury remains low in the ED. A qualitative review of physicians' practices and patients' preferences may be carried out to evaluate reasons for noncompliance.

Accidental Falls ; Accidents, Traffic ; Adult ; Aged ; Canada ; Craniocerebral Trauma ; diagnostic imaging ; Decision Making ; Decision Support Systems, Clinical ; Electronic Health Records ; Female ; Glasgow Coma Scale ; Guideline Adherence ; Head ; diagnostic imaging ; Humans ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Practice Patterns, Physicians' ; Retrospective Studies ; Tomography, X-Ray Computed ; Violence

Humans ; Aged ; Psychotic Disorders/therapy* ; Acute Disease