Norbert David Yanez

Background: The field of clinical research informatics includes creation of clinical data repositories (CDRs) used to conduct quality improvement (QI) activities and comparative effectiveness research (CER). Ideally, CDR data are accurately and directly abstracted from disparate electronic health records (EHRs), across diverse health-systems.Objective: Investigators from Washington State’s Surgical Care Outcomes and Assessment Program (SCOAP) Comparative Effectiveness Research Translation Network (CERTAIN) are creating such a CDR. This manuscript describes the automation and validation methods used to create this digital infrastructure.Methods: SCOAP is a QI benchmarking initiative. Data are manually abstracted from EHRs and entered into a data management system. CERTAIN investigators are now deploying Caradigm’s Amalga™ tool to facilitate automated abstraction of data from multiple, disparate EHRs. Concordance is calculated to compare data automatically to manually abstracted. Performance measures are calculated between Amalga and each parent EHR. Validation takes place in repeated loops, with improvements made over time. When automated abstraction reaches the current benchmark for abstraction accuracy - 95% - itwill ‘go-live’ at each site.Progress to Date: A technical analysis was completed at 14 sites. Five sites are contributing; the remaining sites prioritized meeting Meaningful Use criteria. Participating sites are contributing 15-18 unique data feeds, totaling 13 surgical registry use cases. Common feeds are registration, laboratory, transcription/dictation, radiology, and medications. Approximately 50% of 1,320 designated data elements are being automatically abstracted – 25% from structured data; 25% from text mining.Conclusion: In semi-automating data abstraction and conducting a rigorous validation, CERTAIN investigators will semi-automate data collection to conduct QI and CER, while advancing the Learning Healthcare System.

Background: Previous studies have shown that children's nonnutritive sucking habits may lead to delayed development of their oral anatomy and functioning. However, these findings were inconsistent. We investigated associations between use of bottles, pacifiers, and other sucking behaviors with speech disorders in children attending three preschools in Punta Arenas (Patagonia), Chile. Methods: Information on infant feeding and sucking behaviors, age starting and stopping breast- and bottle-feeding, pacifier use, and other sucking behaviors, was collected from self-administered questionnaires completed by parents. Evaluation of speech problems was conducted at preschools with subsequent scoring by a licensed speech pathologist using age-normative standards. Results: A total of 128 three- to five-year olds were assessed, 46% girls and 54% boys. Children were breastfed for an average of 25.2 (SD 9.6) months and used a bottle 24.4 (SD 15.2) months. Fifty-three children (41.7%) had or currently used a pacifier for an average of 11.4 (SD 17.3) months; 23 children (18.3%) were reported to have sucked their fingers. Delayed use of a bottle until after 9 months appeared to be protective for subsequent speech disorders. There was less than a one-third lower relative odds of subsequent speech disorders for children with a delayed use of a bottle compared to children without a delayed use of a bottle (OR: 0.32, 95% CI: 0.10-0.98). A three-fold increase in relative odds of speech disorder was found for finger-sucking behavior (OR: 2.99, 95% CI: 1.10-8.00) and for use of a pacifier for 3 or more years (OR: 3.42, 95% CI: 1.08-10.81). Conclusion: The results suggest extended use of sucking outside of breastfeeding may have detrimental effects on speech development in young children.

Introduction: Intensive insulin therapy (IIT) with tight glycemic control may reduce mortality and morbidity in critically ill patients and has been widely adopted in practice throughout the world. However, there is only one randomized controlled trial showing unequivocal benefit to this approach and that study population was dominated by post-cardiac surgery patients. We aimed to determine the association between IIT and mortality in a mixed population of critically ill patients. Methods: We conducted a cohort study comparing three consecutive time periods before and after IIT protocol implementation in a Level 1 trauma center: period I (no protocol); period II, target glucose 80 to 130 mg/dL; and period III, target glucose 80 to 110 mg/dL. Subjects were 10,456 patients admitted to intensive care units (ICUs) between 1 March 2001 and 28 February 2005. The main study endpoints were ICU and hospital mortality, Sequential Organ Failure Assessment score, and occurrence of hypoglycemia. Multivariable regression analysis was used to evaluate mortality and organ dysfunction during periods II and III relative to period I. Results: Insulin administration increased over time (9% period I, 25% period II, and 42% period III). Nonetheless, patients in period III had a tendency toward higher adjusted hospital mortality (odds ratio [OR] 1.15, 95% confidence interval [CI] 0.98, 1.35) than patients in period I. Excess hospital mortality in period III was present primarily in patients with an ICU length of stay of 3 days or less (OR 1.47, 95% CI 1.11, 1.93 There was an approximately fourfold increase in the incidence of hypoglycemia from periods I to III. Conclusion: A policy of IIT in a group of ICUs from a single institution was not associated with a decrease in hospital mortality. These results, combined with the findings from several recent randomized trials, suggest that further study is needed prior to widespread implementation of IIT in critically ill patients.