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To identify potential participants for clinical trials, electronic health records (EHRs) are searched at potential sites. As an alternative, we investigated using medical devices used for real-time diagnostic decisions for trial enrollment.
To project cohorts for a trial in acute coronary syndromes (ACS), we used electrocardiograph-based algorithms that identify ACS or ST elevation myocardial infarction (STEMI) that prompt clinicians to offer patients trial enrollment. We searched six hospitals’ electrocardiograph systems for electrocardiograms (ECGs) meeting the planned trial’s enrollment criterion: ECGs with STEMI or > 75% probability of ACS by the acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI). We revised the ACI-TIPI regression to require only data directly from the electrocardiograph, the e-ACI-TIPI using the same data used for the original ACI-TIPI (development set n = 3,453; test set n = 2,315). We also tested both on data from emergency department electrocardiographs from across the US (n = 8,556). We then used ACI-TIPI and e-ACI-TIPI to identify potential cohorts for the ACS trial and compared performance to cohorts from EHR data at the hospitals.
Receiver-operating characteristic (ROC) curve areas on the test set were excellent, 0.89 for ACI-TIPI and 0.84 for the e-ACI-TIPI, as was calibration. On the national electrocardiographic database, ROC areas were 0.78 and 0.69, respectively, and with very good calibration. When tested for detection of patients with > 75% ACS probability, both electrocardiograph-based methods identified eligible patients well, and better than did EHRs.
Using data from medical devices such as electrocardiographs may provide accurate projections of available cohorts for clinical trials.
On April 15, 2013, two improvised explosive devices (IEDs) exploded at the Boston Marathon and 264 patients were treated at 26 hospitals in the aftermath. Despite the extent of injuries sustained by victims, there was no subsequent mortality for those treated in hospitals. Leadership decisions and actions in major trauma centers were a critical factor in this response.
The objective of this investigation was to describe and characterize organizational dynamics and leadership themes immediately after the bombings by utilizing a novel structured sequential qualitative approach consisting of a focus group followed by subsequent detailed interviews and combined expert analysis.
Across physician leaders representing 7 hospitals, several leadership and management themes emerged from our analysis: communications and volunteer surges, flexibility, the challenge of technology, and command versus collaboration.
Disasters provide a distinctive context in which to study the robustness and resilience of response systems. Therefore, in the aftermath of a large-scale crisis, every effort should be invested in forming a coalition and collecting critical lessons so they can be shared and incorporated into best practices and preparations. Novel communication strategies, flexible leadership structures, and improved information systems will be necessary to reduce morbidity and mortality during future events. (Disaster Med Public Health Preparedness. 2015;9:489–495)
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