The promise of “personalized medicine” guided by an understanding of each individual’s genome has been fostered by increasingly powerful and economical methods to acquire clinically relevant features. We describe operational implementation of prospective genotyping linked to an advanced clinical decision support system to guide individualized healthcare in a large academic health center. This approach to personalized medicine includes patient and healthcare provider engagement, identifying relevant genetic variation for implementation, assay reliability, point-of-care decision support, and necessary institutional investments. In one year, approximately 3,000 patients, most scheduled for cardiac catheterization, were genotyped on a multiplexed platform including CYP2C19 variants that modulate response to the widely-used antiplatelet drug clopidogrel. These data are deposited into the Electronic Medical Record and point-of-care decision support is deployed when clopidogrel is prescribed for those with variant genotypes. The establishment of programs such as this is a first step toward implementing and evaluating strategies for personalized medicine.

This project tested the importance of enhanced information transfer of home monitoring results to health care providers. The study tested whether computer-assisted communication of medical information between the chronic care patient and the physician can result in health care benefit. The information tools were constructed/adapted as a test of this hypothesis for diabetes mellitus. Patients connected a glucometer to an intelligent modem weekly for six to nine months. Graphical and mathematical tools extracted and emphasized the information content of the home monitoring data arriving at the central site. Data smoothing, trend analysis, and calculation of quality control statistics were incorporated into a graphical time series oriented report that was used by the health care provider during an outpatient visit. The integrated home monitoring system was tested on 20 patients with diabetes in a double cross-over design over a 15-month period. A significant improvement in serum glucose control as measured by glycated hemoglobin was shown in the study group, but not in the control group.

The evolution of test performance analysis should include the long-term costs and benefits associated with testing. Evolutionary laboratory techniques to achieve this include introduction of a new methodological technique, a multivariate extension to a current analytical technique, receiver-operating characteristic (ROC) curve analysis (MultiROC analysis). This extension to ROC methodology allows the comparison of composite test rules in a format similar to that of ROC curves. Statistical properties, guidelines for use, and a detailed example are described. MultiROC is used in the outcomes analysis of the value of screening for prostate cancer. The effect of age and different test decision thresholds are examined in an extension of a previously published outcomes analysis. The results indicate that the variations in test performances caused by these components are important in assigning a final cost:benefit ratio of screening for prostate cancer.

Background: Current practices of reporting critical laboratory values make it challenging to measure and assess the timeliness of receipt by the treating physician as required by The Joint Commission’s 2008 National Patient Safety Goals. Methods: A multidisciplinary team of laboratorians, clinicians, and information technology experts developed an electronic ALERTS system that reports critical values via the laboratory and hospital information systems to alphanumeric pagers of clinicians and ensures failsafe notification, instant documentation, automatic tracking, escalation, and reporting of critical value alerts. A method for automated acknowledgment of message receipt was incorporated into the system design. Results: The ALERTS system has been applied to inpatients and eliminated approximately 9000 phone calls a year made by medical technologists. Although a small number of phone calls were still made as a result of pages not acknowledged by clinicians within 10 min, they were made by telephone operators, who either contacted the same physician who was initially paged by the automated system or identified and contacted alternate physicians or the patient’s nurse. Overall, documentation of physician acknowledgment of receipt in the electronic medical record increased to 95% of critical values over 9 months, while the median time decreased to <3 min. Conclusions: We improved laboratory efficiency and physician communication by developing an electronic system for reporting of critical values that is in compliance with The Joint Commission’s goals.

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