Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting.

PURPOSE: Physicians in the United States report fewer than 1% of adverse drug events (ADEs) to the Food and Drug Administration (FDA), but frequently document ADEs within electronic health records (EHRs). We developed and implemented a generalizable, scalable EHR-based system to automatically send electronic ADE reports to the FDA in real-time. METHODS: Proof-of-concept study involving 26 clinicians given access to EHR-based ADE reporting functionality from December 2008 to May 2009. MEASUREMENTS: Number and content of ADE reports; severity of adverse reactions (clinician and computer algorithm defined); clinician survey. RESULTS: During the study period, 26 clinicians submitted 217 reports to the FDA. The clinicians defined 23% of the ADEs as serious and a computer algorithm defined 4% of the ADEs as serious. The most common drug classes were cardiovascular drugs (40%), central nervous system drugs (19%), analgesics (13%), and endocrine drugs (7%). The reports contained information, pre-filled from the EHR, about comorbid conditions (207 reports [95%] listed 1899 comorbid conditions), concurrent medications (193 reports [89%] listed 1687 concurrent medications), weight (209 reports [96%]), and laboratory data (215 reports [99%]). It took clinicians a mean of 53 seconds to complete and send the form. In the clinician survey, 21 of 23 respondents (91%) said they had submitted zero ADE reports to the FDA in the prior 12 months. CONCLUSIONS: EHR-based, triggered ADE reporting is efficient and acceptable to clinicians, provides detailed clinical information, and has the potential to greatly increase the number and quality of spontaneous reports submitted to the FDA.

The impact of medical informatics on patient satisfaction: a USA-based literature review.

PURPOSE: Patient satisfaction is increasingly recognized as an important component of quality. The expansion of health information technologies (HIT) might have an impact on patient satisfaction - either positively or negatively. We conducted a literature review to explore the impact of these technologies on patient satisfaction. METHODS: The database of PubMed was searched from inception through May 2010, using the MeSH terms "Medical Informatics" and "Patient Satisfaction". We included all original interventional studies regardless of their study design that were published in English and were evaluating HIT impact on patient satisfaction. Studies were categorized by technology type according to the American Medical Informatics Association framework and by study design. The major outcome of interest was the HIT impact on patient satisfaction. RESULTS: Of 1293 citations reviewed, 56 studies met our inclusion criteria. Design of these studies included mostly randomized controlled trials (RCTs) (n=20, 36%), cross-sectional surveys (n=17, 30%), and a pre and post studies (n=14, 25%). Overall, 54% (n=30) of the studies demonstrated a positive effect of HIT on patient satisfaction, 34% (n=19) failed to show any effect, 11% (n=6) had inconclusive results, and 2% (n=1) revealed a negative effect. Of the 20 RCTs, 40% (n=8) showed a positive effect of HIT on patient satisfaction, 50% (n=10) failed to show any effect, and 10% (2) had inconclusive results. CONCLUSIONS: Analysis suggested that while there is some evidence that HIT improves patient satisfaction, studies in this literature review, and in particularly RCTs, were not consistent in their findings. Although HIT may be a promising tool to improve patient satisfaction, more well-designed research studies are needed in order to get a better understanding of this domain and accordingly find new opportunities to improve quality of care.