Faculty Bibliography

Importance: Medical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection. Objective: To compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports. Design, Setting, and Participants: We conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%-90%; kappa, 0.50-0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient. Main Outcomes and Measures: Error and AE rates. Results: Overall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26-40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95% CI, 1.1-1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95% CI, 1.0-1.2; P = .006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95% CI, .5-1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95% CI, 0.8-2.2). Family-reported error rates were 5.0-fold (95% CI, 1.9-13.0) higher and AE rates 2.9-fold (95% CI, 1.2-6.7) higher than hospital incident report rates. Conclusions and Relevance: Families provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better design and assessment of interventions to improve safety.

OBJECTIVE: To determine which of the 21 general pediatrics milestone subcompetencies are most difficult to assess using traditional methodologies and which are best suited to simulation-based assessment. METHODS: We surveyed 2 samples: pediatric simulation experts and pediatric program directors. Respondents were asked about current use of simulation for assessment and to select 5 of the 21 pediatric subcompetencies most difficult to assess using traditional methods and the 5 best suited to simulation-based assessment. Spearman rank correlation was used to determine a correlation between how the 2 samples ranked the subcompetencies. RESULTS: Forty-eight percent (29 of 60) simulation experts and 20% (115 of 571) program directors completed the survey. Few respondents reported using simulation for summative assessment. There are clear differences across the pediatric subcompetencies in perceived difficulty of assessment and suitability to simulation-based assessment. The 3 most difficult to assess subcompetencies were "recognize ambiguity," "demonstrate emotional insight," and "identify one's own strengths and deficiencies." The subcompetencies most suitable to assessment using simulation were "interprofessional teamwork," "clinical decision making," and "effective communication." Program directors and simulation experts had high agreement for both questions: difficult to assess (rho = 0.76, P < .001) and suitable to simulation-based assessment (rho = 0.94, P < .001). CONCLUSIONS: Several general pediatrics milestone subcompetencies were identified by pediatric simulation experts and pediatric program directors as difficult to assess using current methodologies and as amenable to simulation-based assessment. The pediatric simulation community should target development of simulation-based assessment tools to these areas.

Entrustable professional activities (EPAs) provide a framework to standardize medical education outcomes and advance competency-based assessment. Direct observation of performance plays a central role in entrustment decisions; however, data obtained from these observations are often insufficient to draw valid high-stakes conclusions. One approach to enhancing the reliability and validity of these assessments is to create videos that establish performance standards to train faculty observers. Little is known about how to create videos that can serve as standards for assessment of EPAs.The authors report their experience developing videos that represent five levels of performance for an EPA for patient handoffs. The authors describe a process that begins with mapping the EPA to the critical competencies needed to make an entrustment decision. Each competency is then defined by five milestones (behavioral descriptors of performance at five advancing levels). Integration of the milestones at each level across competencies enabled the creation of clinical vignettes that were converted into video scripts and ultimately videos. Each video represented a performance standard from novice to expert. The process included multiple assessments by experts to guide iterative improvements, provide evidence of content validity, and ensure that the authors successfully translated behavioral descriptions and vignettes into videos that represented the intended performance level for a learner. The steps outlined are generalizable to other EPAs, serving as a guide for others to develop videos to train faculty. This process provides the level of content validity evidence necessary to support using videos as standards for high-stakes entrustment decisions.

Neither guidelines nor best practices for the treatment of external ventricular drain (EVD) and ventriculoperitoneal shunt infections exist. An antimicrobial regimen with a broad spectrum of activity and adequate cerebrospinal fluid (CSF) penetration is vital in the management of both EVD and ventriculoperitoneal infections. In this case report, we describe the pharmacokinetics of continuous-infusion meropenem for a 2-year-old girl with Serratia marcescens ventriculitis. A right frontal EVD was placed for the management of a posterior fossa mass with hydrocephalus and intraventricular hemorrhage. On hospital day 6, CSF specimens were cultured, which identified a pan-sensitive Serratia marcescens with an initial cefotaxime minimum inhibitory concentration of 1 mug/ml or less. The patient was treated with cefotaxime monotherapy from hospital days 6 to 17, during which her CSF cultures and Gram's stain remained positive. On hospital day 26, Serratia marcescens was noted to be resistant to cefotaxime (minimum inhibitory concentration > 16 mug/ml), and the antimicrobial regimen was ultimately changed to meropenem and amikacin. Meropenem was dosed at 40 mg/kg/dose intravenously every 6 hours, infused over 30 minutes, during which, simultaneous serum and CSF meropenem levels were measured. Meropenem serum and CSF levels were measured at 2 and 4 hours from the end of the infusion with the intent to perform a pharmacokinetic/pharmacodynamic analysis. The resulting serum meropenem levels were 12 mug/ml at 2 hours and "undetectable" at 4 hours, with CSF levels of 1 and 0.5 mug/ml at 2 and 4 hours, respectively. On hospital day 27, the meropenem regimen was changed to a continuous infusion of 200 mg/kg/day, with repeat serum and CSF meropenem levels measured on hospital day 33. The serum and CSF levels were noted to be 13 and 0.5 mug/ml, respectively. The serum level of 13 mug/ml corresponds to an estimated meropenem clearance from the serum of 10.2 ml/kg/minute. Repeat meropenem levels from the serum and CSF on hospital day 37 were 15 and 0.5 mug/ml, respectively. After instituting the continuous-infusion meropenem regimen, only three positive CSF Gram's stains were noted, with the CSF cultures remaining negative. The continuous-infusion dosing regimen allowed for 100% probability of target attainment in the serum and CSF and a successful clinical outcome.

BACKGROUND:Miscommunications are a leading cause of serious medical errors. Data from multicenter studies assessing programs designed to improve handoff of information about patient care are lacking. METHODS:We conducted a prospective intervention study of a resident handoff-improvement program in nine hospitals, measuring rates of medical errors, preventable adverse events, and miscommunications, as well as resident workflow. The intervention included a mnemonic to standardize oral and written handoffs, handoff and communication training, a faculty development and observation program, and a sustainability campaign. Error rates were measured through active surveillance. Handoffs were assessed by means of evaluation of printed handoff documents and audio recordings. Workflow was assessed through time-motion observations. The primary outcome had two components: medical errors and preventable adverse events. RESULTS:In 10,740 patient admissions, the medical-error rate decreased by 23% from the preintervention period to the postintervention period (24.5 vs. 18.8 per 100 admissions, P<0.001), and the rate of preventable adverse events decreased by 30% (4.7 vs. 3.3 events per 100 admissions, P<0.001). The rate of nonpreventable adverse events did not change significantly (3.0 and 2.8 events per 100 admissions, P=0.79). Site-level analyses showed significant error reductions at six of nine sites. Across sites, significant increases were observed in the inclusion of all prespecified key elements in written documents and oral communication during handoff (nine written and five oral elements; P<0.001 for all 14 comparisons). There were no significant changes from the preintervention period to the postintervention period in the duration of oral handoffs (2.4 and 2.5 minutes per patient, respectively; P=0.55) or in resident workflow, including patient-family contact and computer time. CONCLUSIONS:Implementation of the handoff program was associated with reductions in medical errors and in preventable adverse events and with improvements in communication, without a negative effect on workflow. (Funded by the Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, and others.).

Patient handoffs are a key source of communication failures and adverse events in hospitals. Despite Accreditation Council for Graduate Medical Education requirements for residency training programs to provide formal handoff skills training and to monitor handoffs, well-established curricula and validated skills assessment tools are lacking. Developing a handoff curriculum is challenging because of the need for standardized processes and faculty development, cultural resistance to change, and diverse institution- and unit-level factors. In this article, the authors apply a logic model to describe the process they used from June 2010 to February 2014 to develop, implement, and disseminate an innovative, comprehensive handoff curriculum in pediatric residency training programs as a fundamental component of the multicenter Initiative for Innovation in Pediatric Education-Pediatric Research in Inpatient Settings Accelerating Safe Sign-outs (I-PASS) Study. They describe resources, activities, and outputs, and report preliminary learner outcomes using data from resident and faculty evaluations of the I-PASS Handoff Curriculum: 96% of residents and 97% of faculty agreed or strongly agreed that the curriculum promoted acquisition of relevant skills for patient care activities. They also share lessons learned that could be of value to others seeking to adopt a structured handoff curriculum or to develop large-scale curricular innovations that involve redesigning firmly established processes. These lessons include the importance of approaching curricular implementation as a transformational change effort, assembling a diverse team of junior and senior faculty to provide opportunities for mentoring and professional development, and linking the educational intervention with the direct measurement of patient outcomes.

The Accreditation Council for Graduate Medical Education has partnered with member boards of the American Board of Medical Specialties to initiate the next steps in advancing competency-based assessment in residency programs. This initiative, known as the Milestone Project, is a paradigm shift from traditional assessment efforts and requires all pediatrics residency programs to report individual resident progression along a series of 4 to 5 developmental levels of performance, or milestones, for individual competencies every 6 months beginning in June 2014. The effort required to successfully make this shift is tremendous given the number of training programs, training institutions, and trainees. However, it holds great promise for achieving training outcomes that align with patient needs; developing a valid, reliable, and meaningful way to track residents' development; and providing trainees with a roadmap for learning. Recognizing the resources needed to implement this new system, the authors, all residency program leaders, provide their consensus view of the components necessary for implementing and sustaining this effort, including resource estimates for completing this work. The authors have identified 4 domains: (1) Program Review and Development of Stakeholders and Participants, (2) Assessment Methods and Validation, (3) Data and Assessment System Development, and (4) Summative Assessment and Feedback. This work can serve as a starting point and framework for collaboration with program, department, and institutional leaders to identify and garner necessary resources and plan for local and national efforts that will ensure successful transition to milestones-based assessment.