Training as an Intervention to Decrease Medical Record Abstraction Errors Multicenter Studies.

Studies often rely on medical record abstraction as a major source of data. However, data quality from medical record abstraction has long been questioned. Electronic Health Records (EHRs) potentially add variability to the abstraction process due to the complexity of navigating and locating study data within these systems. We report training for and initial quality assessment of medical record abstraction for a clinical study conducted by the IDeA States Pediatric Clinical Trials Network (ISPCTN) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) using medical record abstraction as the primary data source. As part of overall quality assurance, study-specific training for medical record abstractors was developed and deployed during study start-up. The training consisted of a didactic session with an example case abstraction and an independent abstraction of two standardized cases. Sixty-nine site abstractors from thirty sites were trained. The training was designed to achieve an error rate for each abstractor of no greater than 4.93% with a mean of 2.53%, at study initiation. Twenty-three percent of the trainees exceeded the acceptance limit on one or both of the training test cases, supporting the need for such training. We describe lessons learned in the design and operationalization of the study-specific, medical record abstraction training program.

Site-level variance for adverse tracheal intubation-associated events across 15 North American PICUs: a report from the national emergency airway registry for children*.

OBJECTIVE: Tracheal intubation in PICUs is associated with adverse tracheal intubation-associated events. Patient, provider, and practice factors have been associated with tracheal intubation-associated events; however, site-level variance and the association of site-level characteristics on tracheal intubation-associated event outcomes are unknown. We hypothesize that site-level variance exists in the prevalence of tracheal intubation-associated events and that site characteristics may affect outcomes. DESIGN: Prospective observational cohort study. SETTING: Fifteen PICUs in North America. SUBJECTS: Critically ill pediatric patients requiring tracheal intubation. INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: Tracheal intubation quality improvement data were collected in 15 PICUs from July 2010 to December 2011 using a National Emergency Airway Registry for Children with robust site-specific compliance. Tracheal intubation-associated events and severe tracheal intubation-associated events were explicitly defined a priori. We analyzed the association of site-level variance with tracheal intubation-associated events using univariate analysis and adjusted for previously identified patient- and provider-level risk factors. Analysis of 1,720 consecutive intubations revealed an overall prevalence of 20% tracheal intubation-associated events and 6.5% severe tracheal intubation-associated events, with considerable site variability ranging from 0% to 44% tracheal intubation-associated events and from 0% to 20% severe tracheal intubation-associated events. Larger PICU size (> 26 beds) was associated with fewer tracheal intubation-associated events (18% vs 23%, p = 0.006), but the presence of a fellowship program was not (20% vs 18%, p = 0.58). After adjusting for patient and provider characteristics, both PICU size and fellowship presence were not associated with tracheal intubation-associated events (p = 0.44 and p = 0.18, respectively). Presence of mixed ICU with cardiac surgery was independently associated with a higher prevalence of tracheal intubation-associated events (25% vs 15%; p < 0.001; adjusted odds ratio, 1.81; 95% CI, 1.29-2.53; p = 0.01). Substantial site-level variance was observed in medication use, which was not explained by patient characteristic differences. CONCLUSIONS: Substantial site-level variance exists in tracheal intubation practice, tracheal intubation-associated events, and severe tracheal intubation-associated events. Neither PICU size nor fellowship training program explained site-level variance. Interventions to reduce tracheal intubation-associated event prevalence and severity will likely need to be contextualized to variability in individual ICUs patients, providers, and practice.