Paul J. Sharek

Temporal Trends in Rates of Patient Harm Resulting from Medical Care

BACKGROUND In the 10 years since publication of the Institute of Medicines report To Err Is Human, extensive efforts have been undertaken to improve patient safety. The success of these efforts remains unclear. METHODS We conducted a retrospective study of a stratified random sample of 10 hospitals in North Carolina. A total of 100 admissions per quarter from January 2002 through December 2007 were reviewed in random order by teams of nurse reviewers both within the hospitals (internal reviewers) and outside the hospitals (external reviewers) with the use of the Institute for Healthcare Improvements Global Trigger Tool for Measuring Adverse Events. Suspected harms that were identified on initial review were evaluated by two independent physician reviewers. We evaluated changes in the rates of harm, using a random-effects Poisson regression model with adjustment for hospital-level clustering, demographic characteristics of patients, hospital service, and high-risk conditions. RESULTS Among 2341 admissions, internal reviewers identified 588 harms (25.1 harms per 100 admissions; 95% confidence interval [CI], 23.1 to 27.2) [corrected]. Multivariate analyses of harms identified by internal reviewers showed no significant changes in the overall rate of harms per 1000 patient-days (reduction factor, 0.99 per year; 95% CI, 0.94 to 1.04; P=0.61) or the rate of preventable harms. There was a reduction in preventable harms identified by external reviewers that did not reach statistical significance (reduction factor, 0.92; 95% CI, 0.85 to 1.00; P=0.06), with no significant change in the overall rate of harms (reduction factor, 0.98; 95% CI, 0.93 to 1.04; P=0.47). CONCLUSIONS In a study of 10 North Carolina hospitals, we found that harms remain common, with little evidence of widespread improvement. Further efforts are needed to translate effective safety interventions into routine practice and to monitor health care safety over time. (Funded by the Rx Foundation.).

Rates of medication errors among depressed and burnt out residents: prospective cohort study

Objective To determine the prevalence of depression and burnout among residents in paediatrics and to establish if a relation exists between these disorders and medication errors. Design Prospective cohort study. Setting Three urban freestanding children’s hospitals in the United States. Participants 123 residents in three paediatric residency programmes. Main outcome measures Prevalence of depression using the Harvard national depression screening day scale, burnout using the Maslach burnout inventory, and rate of medication errors per resident month. Results 24 (20%) of the participating residents met the criteria for depression and 92 (74%) met the criteria for burnout. Active surveillance yielded 45 errors made by participants. Depressed residents made 6.2 times as many medication errors per resident month as residents who were not depressed: 1.55 (95% confidence interval 0.57 to 4.22) compared with 0.25 (0.14 to 0.46, P<0.001). Burnt out residents and non-burnt out residents made similar rates of errors per resident month: 0.45 (0.20 to 0.98) compared with 0.53 (0.21 to 1.33, P=0.2). Conclusions Depression and burnout are major problems among residents in paediatrics. Depressed residents made significantly more medical errors than their non-depressed peers; however, burnout did not seem to correlate with an increased rate of medical errors.

Development, Testing, and Findings of a Pediatric- Focused Trigger Tool to Identify Medication-Related Harm in US Children's Hospitals

OBJECTIVES. The purposes of this study were to develop a pediatric-focused tool for adverse drug event detection and describe the incidence and characteristics of adverse drug events in childrens hospitals identified by this tool. METHODS. A pediatric-specific trigger tool for adverse drug event detection was developed and tested. Eighty patients from each site were randomly selected for retrospective chart review. All adverse drug events identified using the trigger tool were evaluated for severity, preventability, ability to mitigate, ability to identify the event earlier, and presence of associated occurrence report. Each trigger and the entire tool were evaluated for positive predictive value. RESULTS. Review of 960 randomly selected charts from 12 childrens hospitals revealed 2388 triggers (2.49 per patient) and 107 unique adverse drug events. Mean adverse drug event rates were 11.1 per 100 patients, 15.7 per 1000 patient-days, and 1.23 per 1000 medication doses. The positive predictive value of the trigger tool was 3.7%. Twenty-two percent of all adverse drug events were deemed preventable, 17.8% could have been identified earlier, and 16.8% could have been mitigated more effectively. Ninety-seven percent of the identified adverse drug events resulted in mild, temporary harm. Only 3.7% of adverse drug events were identified in existing hospital-based occurrence reports. The most common adverse drug events identified were pruritis and nausea, the most common medication classes causing adverse drug events were opioid analgesics and antibiotics, and the most common stages of the medication management process associated with preventable adverse drug events were monitoring and prescribing/ordering. CONCLUSIONS. Adverse drug event rates in hospitalized children are substantially higher than previously described. Most adverse drug events resulted in temporary harm, and 22% were classified as preventable. Only 3.7% were identified by using traditional voluntary reporting methods. Our pediatric-focused trigger tool is effective at identifying adverse drug events in inpatient pediatric populations.

Effects of the accreditation council for graduate medical education duty-hour limits on sleep, work hours, and safety.

OBJECTIVE. To mitigate the risks of fatigue-related medical errors, the Accreditation Council for Graduate Medical Education introduced work hour limits for resident physicians in 2003. Our goal was to determine whether work hours, sleep, and safety changed after implementation of the Accreditation Council for Graduate Medical Education standards. METHODS. We conducted a prospective cohort study in which residents from 3 large pediatric training programs provided daily reports of work hours and sleep. In addition, they completed reports of near-miss and actual motor vehicle crashes, occupational exposures, self-reported medical errors, and ratings of educational experience. They were screened for depression and burnout. Concurrently, at 2 of the centers, data on medication errors were collected prospectively by using an established active surveillance method. RESULTS. A total of 220 residents provided 6007 daily reports of their work hours and sleep, and 16 158 medication orders were reviewed. Although scheduling changes were made in each program to accommodate the standards, 24- to 30-hour shifts remained common, and the frequency of residents’ call remained largely unchanged. There was no change in residents’ measured total work hours or sleep hours. There was no change in the overall rate of medication errors, and there was a borderline increase in the rate of resident physician ordering errors, from 1.06 to 1.38 errors per 100 patient-days. Rates of motor vehicle crashes, occupational exposures, depression, and self-reported medical errors and overall ratings of work and educational experiences did not change. The mean length of extended-duration (on-call) shifts decreased 2.7% to 28.5 hours, and rates of resident burnout decreased significantly (from 75.4% to 57.0%). CONCLUSIONS. Total hours of work and sleep did not change after implementation of the duty hour standards. Although fewer residents were burned out, rates of medication errors, resident depression, and resident injuries and educational ratings did not improve.

The Effect of Inhaled Steroids on the Linear Growth of Children With Asthma: A Meta-analysis

Objective. To determine whether inhaled steroid therapy causes delayed linear growth in children with asthma. Data Sources. Medline (1966–1998), Embase (1980–1998), and Cinahl (1982–1998) databases and bibliographies of included studies were searched for randomized, controlled trials of inhaled steroid therapy in children with asthma that evaluated linear growth. Study Selection. Studies were included if they met the following criteria: subjects 0 to 18 years of age with the clinical diagnosis of asthma; subjects randomized to inhaled beclomethasone, budesonide, flunisolide, fluticasone, or triamcinolone versus a nonsteroidal inhaled control for a minimum of 3 months; single- or double-blind; and outcome convertible to linear growth velocity. English- and non–English-language trials were included. Data Extraction. Data were extracted using a priori guidelines. Methodologic quality was assessed independently by both authors. Outcome was extracted as linear growth velocity. Results. Included trials were subgrouped by inhaled steroid. The beclomethasone subgroup, with 4 studies and 450 subjects, showed a decrease in linear growth velocity of 1.51 cm/year (95% confidence interval: 1.15,1.87). The fluticasone subgroup, with 1 study and 183 subjects, showed a decrease in linear growth velocity of .43 cm/year (95% confidence interval: .01,.85). Sensitivity analysis in the beclomethasone subgroup, which evaluated study quality, mode of medication delivery, control medication, and statistical model, showed similar results. Conclusions. This meta-analysis suggests that moderate doses of beclomethasone and fluticasone in children with mild to moderate asthma cause a decrease in linear growth velocity of 1.51 cm/year and .43 cm/year, respectively. The effects of inhaled steroids when given for >54 weeks, or on final adult height, remain unknown.

Decrease in hospital-wide mortality rate after implementation of a commercially sold computerized physician order entry system.

BACKGROUND: Implementations of computerized physician order entry (CPOE) systems have previously been associated with either an increase or no change in hospital-wide mortality rates of inpatients. Despite widespread enthusiasm for CPOE as a tool to help transform quality and patient safety, no published studies to date have associated CPOE implementation with significant reductions in hospital-wide mortality rates. OBJECTIVE: The objective of this study was to determine the effect on the hospital-wide mortality rate after implementation of CPOE at an academic childrens hospital. PATIENTS AND METHODS: We performed a cohort study with historical controls at a 303-bed, freestanding, quaternary care academic childrens hospital. All nonobstetric inpatients admitted between January 1, 2001, and April 30, 2009, were included. A total of 80 063 patient discharges were evaluated before the intervention (before November 1, 2007), and 17 432 patient discharges were evaluated after the intervention (on or after November 1, 2007). On November 4, 2007, the hospital implemented locally modified functionality within a commercially sold electronic medical record to support CPOE and electronic nursing documentation. RESULTS: After CPOE implementation, the mean monthly adjusted mortality rate decreased by 20% (1.008–0.716 deaths per 100 discharges per month unadjusted [95% confidence interval: 0.8%–40%]; P = .03). With observed versus expected mortality-rate estimates, these data suggest that our CPOE implementation could have resulted in 36 fewer deaths over the 18-month postimplementation time frame. CONCLUSION: Implementation of a locally modified, commercially sold CPOE system was associated with a statistically significant reduction in the hospital-wide mortality rate at a quaternary care academic childrens hospital.

Prevalence of adverse events in pediatric intensive care units in the United States.

Objectives: Selection of relevant patient safety interventions for the pediatric intensive care (PICU) requires identification of the types and severity of adverse events (AEs) and adverse drug events (ADEs) that occur in this setting. The studys objectives were to: 1) determine the rates of AEs/ADEs, including types, severity, and preventability, in PICU patients; 2) identify population characteristics associated with increased risk of AEs/ADEs; 3) develop and test a PICU specific trigger tool to facilitate identification of AEs/ADEs. Design, Setting, Patients: Retrospective, cross-sectional, randomized review of 734 patient records who were discharged from 15 U.S. PICUs between September and December 2005. Intervention: A novel PICU-focused trigger tool for AE/ADE detection. Measurements and Results: Sixty-two percent of PICU patients had at least one AE. A total of 1488 AEs, including 256 ADEs, were identified. This translates to a rate of 28.6 AEs and 4.9 ADEs per 100 patient-days. The most common types of AEs were catheter complications, uncontrolled pain, and endotracheal tube malposition. Ten percent of AEs were classified as life-threatening or permanent; 45% were deemed preventable. Higher adjusted rates of AEs were found in surgical patients (p = .02), patients intubated at some point during their PICU stay (p = .002), and patients who died (p < .001). Surgical patients had higher preventable adjusted AE (p = .01) and ADE rates (p = .02). The adjusted cumulative risk of an AE per PICU day was 5.3% and 1.6% for an ADE alone. There was a 4% increase in adjusted ADEs rates for every year increase in age. Conclusions: AEs and ADEs occur frequently in the PICU setting. These data provide areas of focus for evidence-based prevention strategies to decrease the substantial risk to this vulnerable pediatric population.

NICU Practices and Outcomes Associated With 9 Years of Quality Improvement Collaboratives

OBJECTIVE: Quality improvement collaboratives (QICs) can improve short-term outcomes, but few have examined their long-term results. This study evaluated the changes in treatment practices and outcomes associated with participation in multiple sequential QICs. DESIGN AND METHODS: This retrospective, 9-year, pre-post study of very low birth weight infants, we assessed treatment and outcomes from the 8 NICUs of the Reduce Lung Injury (ReLI) group of a QIC sponsored by the Vermont Oxford Network (VON). We analyzed data from 1998 (pre-ReLI), 2001 (last ReLI year), and 2006 (5 years after ReLI) by using univariate and multiple regression. RESULTS: A total of 4065 very low birth weight infants were treated in ReLI NICUs in 1998, 2001, and 2006. From 1998 to 2006, the ReLI group decreased delivery room intubation (70% vs 52%; adjusted odds ratio [aOR]: 0.2 [95% confidence interval (CI): 0.2–0.3]; P < .001), conventional ventilation (75% vs 62%; aOR: 0.3 [95% CI: 0.2–0.4]; P < .001), and postnatal steroids for BPD (35% vs 10%; aOR: 0.09 [95% CI: 0.07–0.1]; P < .001). They increased the use of nasal continuous positive airway pressure (57% vs 78%; aOR: 3.3 [95% CI: 2.7–3.9]; P < .001). BPD-free survival remained unchanged (68% vs 66%; aOR: 0.9 [95% CI: 0.7–1.1]; P = .16), the BPD rate increased (25% vs 29%; aOR: 1.3 [95% CI: 1.1–1.6]; P = .017), survival to discharge increased (90% vs 93%; aOR: 1.5 [95% CI: 1.1–2.2]; P < .001), and nosocomial infections decreased (18% vs 15%; aOR: 0.8 [95% CI: 0.6–0.99]; P = .045). CONCLUSIONS: Participation in VON–sponsored QICs was associated with sustained implementation of potentially better respiratory practices, increased survival, and reduced nosocomial infections. The BPD-free survival rate did not change, and the BPD rate increased. Implemented changes endured for at least 5 years after the QIC.

Burnout in the NICU setting and its relation to safety culture

Background Burnout is widespread among healthcare providers and is associated with adverse safety behaviours, operational and clinical outcomes. Little is known with regard to the explanatory links between burnout and these adverse outcomes. Objectives (1) Test the psychometric properties of a brief four-item burnout scale, (2) Provide neonatal intensive care unit (NICU) burnout and resilience benchmarking data across different units and caregiver types, (3) Examine the relationships between caregiver burnout and patient safety culture. Research design Cross-sectional survey study. Subjects Nurses, nurse practitioners, respiratory care providers and physicians in 44 NICUs. Measures Caregiver assessments of burnout and safety culture. Results Of 3294 administered surveys, 2073 were returned for an overall response rate of 62.9%. The percentage of respondents in each NICU reporting burnout ranged from 7.5% to 54.4% (mean=25.9%, SD=10.8). The four-item burnout scale was reliable (α=0.85) and appropriate for aggregation (intra-class correlation coefficient-2=0.95). Burnout varied significantly between NICUs, p<0.0001, but was less prevalent in physicians (mean=15.1%, SD=19.6) compared with non-physicians (mean=26.9%, SD=11.4, p=0.0004). NICUs with more burnout had lower teamwork climate (r=−0.48, p=0.001), safety climate (r=−0.40, p=0.01), job satisfaction (r=−0.64, p<0.0001), perceptions of management (r=−0.50, p=0.0006) and working conditions (r=−0.45, p=0.002). Conclusions NICU caregiver burnout appears to have ‘climate-like’ features, is prevalent, and associated with lower perceptions of patient safety culture.

A quality improvement project to increase breast milk use in very low birth weight infants.

OBJECTIVE: To evaluate a multihospital collaborative designed to increase breast milk feeding in premature infants. METHODS: Eleven NICUs in the California Perinatal Quality of Care Collaborative participated in an Institute for Healthcare Improvement–style collaborative to increase NICU breast milk feeding rates. Multiple interventions were recommended with participating sites implementing a self-selected combination of these interventions. Breast milk feeding rates were compared between baseline (October 2008–September 2009), implementation (October 2009–September 2010), and sustainability periods (October 2010–March 2011). Secondary outcome measures included necrotizing enterocolitis (NEC) rates and lengths of stay. California Perinatal Quality of Care Collaborative hospitals not participating in the project served as a control population. RESULTS: The breast milk feeding rate in the intervention sites improved from baseline (54.6%) to intervention period (61.7%; P = .005) with sustained improvement over 6 months postintervention (64.0%; P = .003). NEC rates decreased from baseline (7.0%) to intervention period (4.3%; P = .022) to sustainability period (2.4%; P < .0001). Length of stay increased during the intervention but returned to baseline levels in the sustainability period. Control hospitals had higher rates of breast milk feeding at baseline (64.2% control vs 54.6% participants, P < .0001), but over the course of the implementation (65.7% vs 61.7%, P = .049) and sustainability periods (67.7% vs 64.0%, P = .199), participants improved to similar rates as the control group. CONCLUSIONS: Implementation of a breast milk/nutrition change package by an 11-site collaborative resulted in an increase in breast milk feeding and decrease in NEC that was sustained over an 18-month period.