[Show abstract][Hide abstract] ABSTRACT: The prevention of near and actual cardiopulmonary arrest in hospitalized children is a patient safety imperative. Prevention is contingent upon the timely identification, referral and treatment of children who are deteriorating clinically. We designed and validated a documentation-based system of care to permit identification and referral as well as facilitate provision of timely treatment. We called it the Bedside Pediatric Early Warning System (BedsidePEWS). Here we describe the rationale for the design, intervention and outcomes of the study entitled Evaluating Processes and Outcomes of Children in Hospital (EPOCH).
EPOCH is a cluster-randomized trial of the BedsidePEWS. The unit of randomization is the participating hospital. Eligible hospitals have a Pediatric Intensive Care Unit (PICU), are anticipated to have organizational stability throughout the study, are not using a severity of illness score in hospital wards and are willing to be randomized. Patients are >37 weeks gestational age and <18 years and are hospitalized in inpatient ward areas during all or part of their hospital admission. Randomization is to either BedsidePEWS or control (no severity of illness score) in a 1:1 ratio within two strata (<200, ≥200 hospital beds). All-cause hospital mortality is the selected primary outcome. It is objective, independent of do-not-resuscitate status and can be reliably measured. The secondary outcomes include (1) clinical outcomes: clinical deterioration, severity of illness at and during ICU admission, and potentially preventable cardiac arrest; (2) processes of care outcomes: immediate calls for assistance, hospital and ICU readmission, and perceptions of healthcare professionals; and (3) resource utilization: ICU days and use of ICU therapies.
Following funding by the Canadian Institutes of Health Research and local ethical approvals, site enrollment started in 2010 and was closed in February 2014. Patient enrollment is anticipated to be complete in July 2015. The results of EPOCH will strengthen the scientific basis for local, regional, provincial and national decision-making and for the recommendations of national and international bodies. If negative, the costs of hospital-wide implementation can be avoided. If positive, EPOCH will have provided a scientific justification for the major system-level changes required for implementation.
NCT01260831 ClinicalTrials.gov date: 14 December 2010.
[Show abstract][Hide abstract] ABSTRACT: Patient safety is a powerful motivating force for change in modern medicine, and is often cited as a rationale for reducing resident duty hours. However, current data suggest that resident duty hours are not significantly linked to important patient outcomes. We performed a narrative review and identified four potential explanations for these findings. First, we question the relevance of resident fatigue in the creation of harmful errors. Second, we discuss factors, including workload, experience, and individual characteristics, that may be more important determinants of resident fatigue than are duty hours. Third, we describe potential adverse effects that may arise from - and, therefore, counterbalance any potential benefits of - duty hour reductions. Fourth, we explore factors that may mitigate any risks to patient safety associated with using the services of resident trainees.
[Show abstract][Hide abstract] ABSTRACT: Deficiencies in communication in health care are a common source of medical error. Preferred communication patterns are a component of resuscitation teaching. We audio-recorded resuscitations in a mixed pediatric medical and surgical ICU to describe communication METHODS: In the Intensive Care Unit, resuscitation events were prospectively audio-recorded by 2 trained observers (using handheld recorders). Recordings were transcribed and anonymised within 24hours. We grouped utterances regarding the same subject matter from beginning (irrespective of response) as a communication epoch. For each epoch we describe the initiator, audience and content of message. Teamwork behaviors were described using Anesthesia Nontechnical Skills framework (ANTS), a behavioural marker system for crisis-resource management.
[Show abstract][Hide abstract] ABSTRACT: In 2005 the International Committee of Medical Journal Editors issued a requirement that all randomized controlled trials (RCTs) be registered primarily to prevent selective reporting (publication bias). However, registries allow for alterations in study protocol. Changes occurring before (or after) study completion could invalidate the original study intent, leading to publication of misleading conclusions. In RCTs involving critically ill patients, these concerns may be particularly acute because mortality is high and conditions investigated are usually syndromes rather than specific diseases. This study was conducted to estimate the registration rate of RCTs in critical care; and, among registered RCTs, to determine timing of registration and whether sample size or primary outcome were altered.
We searched the MEDLINE database for RCTs that began after or continued through July 2005. We determined whether each trial had been registered and, for registered trials, compared registry data to data in the published manuscript.
Approximately two-thirds (66 %) of trials were registered. Of these, 66 % of registrations occurred after enrolment had commenced. Overall, 6 % (5/90) of trials appropriately registered a sample size which was unchanged from the interval between registration and publication, and only 12 % (11/90) reported primary outcomes that were both appropriately registered and unchanged.
Non-registration, or registration after trial initiation, are common in RCTs of critically ill patients. Among registered trials important protocol changes are often made between trial commencement and publication. This study identifies and quantifies the extent of this serious-but correctable-problem for RCTs in critically ill patients.
Intensive Care Medicine 04/2014; 40(5). DOI:10.1007/s00134-014-3250-7 · 7.21 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To determine dose and eligibility criteria for once-daily dosing (ODD) of gentamicin in critically ill pediatric patients.
Retrospective chart review of patients admitted to the Pediatric Intensive Care Unit or Cardiac Critical Care Unit at The Hospital for Sick Children (SickKids) who received traditionally dosed intravenous (IV) gentamicin (January 2008 to June 2010). Statistically significant patient characteristics associated with gentamicin pharmacokinetic (PK) parameters were determined by multiple linear regression. Binary partitioning was used to set critical values for these characteristics to derive dose for ODD of gentamicin. Feasibility of implementing ODD of gentamicin in critically ill children was assessed using individualized PK parameters to simulate area under the concentration-time curves and drug-free intervals while targeting a maximum concentration (Cmax) of 16-20 mg/L. Eligibility criteria were determined by patient characteristics that had a statistically significant impact on gentamicin PK.
Volume of distribution (Vd) and elimination rate constant (ke) were calculated for 140 patients. Weight and admission unit were significantly associated with weight-normalized Vd (Vd/kg), whereas age and serum creatinine (SCr) were significantly associated with ke. Weight <5 kg and SCr ≥20% over age-specific upper normal limit before gentamicin initiation were associated with prolonged gentamicin elimination. Gentamicin 6 mg/kg IV every 24 hours, the dose at which the highest percentage of patients achieved Cmax, area under the curve, and drug-free interval within target ranges simultaneously, was selected as the proposed ODD regimen.
A regimen of gentamicin 6 mg/kg IV every 24 hours for Pediatric Intensive Care Unit/Cardiac Critical Care Unit patients at SickKids weighing ≥5 kg with SCr <20% above age-specific upper normal limit before initiation of gentamicin is proposed.
Therapeutic drug monitoring 04/2014; DOI:10.1097/FTD.0000000000000016 · 1.93 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objectives: To evaluate the preferences and self-reported practices of pediatric acute care physicians with respect to sodium bicarbonate administration to infants and children in shock or cardiac arrest.
[Show abstract][Hide abstract] ABSTRACT: To describe sleep quantity, sleep patterns, fatigue, and sleepiness for parents of critically ill hospitalized children.
Prospective observational study.
Quaternary academic PICU.
One hundred eighteen parents of 91 children recruited during their child's PICU stay.
For 5 days and nights, parents wore an actigraph to determine objective sleep-wake times and reported sleep location, level of fatigue (Fatigue Visual Analogue Scale), and sleepiness (Stanford Sleepiness Scale). Mean amounts of nocturnal sleep were less than recommended for optimal health (398 min, fathers vs 422 min, mothers; p = 0.04). Parents woke frequently (7.8 wakes, fathers; 7.2 wakes, mothers) and spent over an hour awake at night (65 min, fathers; 60 min, mothers). On 130 nights (26%), parents slept less than 6 hours and 209 nights (44%) were evaluated as "worse" sleep than usual. Fifty-four parents (53%) experienced more than 30% difference in minutes of sleep between consecutive nights. Mean morning fatigue levels (41 mm, fathers vs 46 mm, mothers; p = 0.03) indicated clinically significant fatigue. Sleeping in a hotel, parent room, or residence was associated with 3.2 more wakes per night (95% CI, 0.61-5.78; p = 0.015) than sleeping in a hospital lounge or waiting room.
We performed a prospective observational study of 118 parents of critically ill children using objective measures of sleep and validated scales to assess fatigue and sleepiness. We found that more than a quarter of nights met criteria for acute sleep deprivation, there was considerable variability in the amount of nocturnal sleep that individual participants slept on different nights, and sleep was fragmented with a large portion of the night spent awake. Future research should focus on interventions that improve parents' ability to return to sleep upon awakening and maintain regular sleep-wake schedules.
Pediatric Critical Care Medicine 11/2013; 15(2). DOI:10.1097/01.pcc.0000436198.15337.15 · 2.33 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Indirect and direct health-related quality of life (HRQoL) measures are intended to assess the same underlying constructs. There is evidence that the two types of assessments can show important differences. We assessed the agreement between the utilities of direct and indirect HRQoL measurements in children following pediatric intensive care unit (PICU) admission. We collected Health Utilities Index 3 (HUI-3) and Visual Analog Scale (VAS) ratings of children who were urgently admitted to the PICU of a university-affiliated pediatric hospital at ICU admission (baseline) and one month post-ICU admission. The mean (SD) VAS converted standard gamble and HUI-3 utilities were 0.82 (±0.19) and 0.70 (±0.39), respectively, at baseline (n = 51), and 0.81 (±0.15) and 0.58 (±0.39) at one month (n = 36). The VAS utilities were significantly greater than the HUI-3 utilities (p = 0.009). At baseline, the intraclass coefficient (95% confidence interval) was 0.49 (0.25-0.68), representing moderate agreement, and at one month, was 0.18 (-0.87 to 0.45), representing negligible agreement. There were significant differences between indirect and direct measures, and inconsistent agreement between utilities derived from the two measures. These data illustrate the potential impact of HRQoL assessment techniques on economic analyses used to inform health policy decision-making for pediatric critical care.
Journal of Child Health Care 08/2013; 19(1). DOI:10.1177/1367493513496909 · 0.97 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To determine the rate of documented infections and prevalence of antimicrobial use among pediatric patients admitted to the PICU. To assess the appropriateness of antimicrobial prescribing according to clinical and microbiological findings, Infectious Disease Consult recommendations, and formulary guidelines.
Prospective point prevalence study.
Cardiac and medical-surgical critical care units (CCCU-PICU) in a tertiary care pediatric teaching hospital in Toronto, Canada.
All patients admitted to the CCCU-PICU during the week of October 27, 2008 (period A) and February 9, 2009 (period B) were followed until completion of their antimicrobial course(s). Data were collected on infection types and indications, frequency, and types of antimicrobials used. Appropriateness of antimicrobial prescribing was assessed according to predefined criteria by four blinded clinician assessors.
Forty-two of 60 patients (70%) received antimicrobials in period A and 42 of 53 patients (79%) received antimicrobials in period B. Of the patients on antimicrobials, 45% in period A and 52% in period B had a definitive diagnosis of infection. Pneumonia and sepsis were the most common infections in period A, whereas pneumonia and other respiratory tract infections were the most common in period B. Antimicrobials were commonly prescribed for documented infection (38%) during period A and empiric therapy (47%) during period B. Cefazolin, cefuroxime, vancomycin, and gentamicin were the commonly used antimicrobials during both periods. Inappropriate antimicrobial use ranged from 16.7% to 61.9%, depending on assessors and surveillance period. The most common reasons for inappropriate use were overly broad spectrum, wrong dosage, and unwarranted overlap of spectrum.
There was a high prevalence of antimicrobial use in CCCU-PICU patients. Because a significant proportion of antimicrobial use was deemed inappropriate, interventions are required to optimize antimicrobial use in critically ill children.
Pediatric Critical Care Medicine 07/2013; 14(6):e280-e288. DOI:10.1097/PCC.0b013e31828a846d · 2.33 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: PURPOSE: To evaluate whether variability in milrinone blood levels (MBL) occurs during administration to critically ill children after surgical repair of congenital heart disease, and the clinical relevance of this variability. METHODS: Prospective cohort study conducted in the pediatric intensive care unit of a tertiary care teaching and referral hospital. MBL were measured at three time periods after starting milrinone infusion (9-12, 18-24, 40-48 h) and at the end of the infusion. MBL were categorized as within (100-300 ng/ml) or outside the therapeutic range. Low cardiac output syndrome was defined by elevation of either lactate (>2 mmol/l) or arteriovenous oxygen difference (>30 %). Five other clinical outcomes were evaluated. Regression analyses evaluated the relationships between MBL and outcomes. RESULTS: Sixty-three patients were included with a total of 220 MBL. Quantification of MBL was by high-performance liquid chromatography. Overall, 114 (52 %) MBL were outside the therapeutic range: 78 (36 %) subtherapeutic, and 36 (16 %) supratherapeutic. Repeated-measures analysis found a significant association between supratherapeutic MBL and low cardiac output syndrome (p = 0.02), and supratherapeutic MBL were associated with arterial-central venous oxygen saturation difference >30 % at time 3 (p = 0.007). CONCLUSIONS: In this cohort, nontherapeutic MBL were common. Further investigation of milrinone dosing recommendations may improve the postoperative outcomes of children.
Intensive Care Medicine 02/2013; 39(5). DOI:10.1007/s00134-013-2858-3 · 7.21 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE:: To describe the adaptive behavior and functional outcomes, and health-related quality of life of children who were urgently admitted to the intensive care unit. DESIGN:: Prospective observational study. SETTING:: Critical Care Medicine program at a University-affiliated pediatric institution. PATIENTS:: Urgently admitted patients, aged 1 month to 18 yrs. INTERVENTIONS:: None. MEASUREMENTS AND MAIN RESULTS:: We evaluated children's adaptive behavior functioning with the Vineland Adaptive Behavior Scale-2, functional outcomes with the pediatric cerebral performance category and pediatric overall performance category, and health-related quality of life with the Pediatric Quality of Life Inventory 4 and Visual Analogue Scale. We enrolled 91 children and 65 (71%) completed the 1-month assessment. Patients had a mean (SD) Vineland Adaptive Behavior Scale-2 rating of 83.2 (±24.8), considered to be moderate-low adaptive behavior functioning. From baseline to 1 month, pediatric cerebral performance category ratings did not significantly change (p ;= .59) and pediatric overall performance category ratings significantly improved (p = .03). Visual Analogue Scale ratings significantly worsened from baseline to 1 wk (p < 0.0001) and significantly improved from 1 wk to 1 month (p = 0.002). At 1 month, patients had a mean (SD) Pediatric Quality of Life Inventory 4 rating of 52.8 (±27.9) of 100, a poor quality of life rating. Circulatory admissions, worse pediatric cerebral performance category score at baseline, worse transcutaneous oxygen saturation, and longer cardiac compression duration were independently associated with worse adaptive behavior functioning. Neurological admissions, worse pediatric cerebral performance category score at baseline, longer intensive care unit stay, and longer duration of extracorporeal membrane oxygenation were independently associated with worse functional outcome. Worse pediatric cerebral performance category score at baseline, longer intensive care unit stay, and longer duration of extracorporeal membrane oxygenation were independently associated with worse health-related quality of life. CONCLUSIONS:: Children surviving pediatric intensive care unit have significant adaptive behavior functioning and functional morbidity and reduced health-related quality of life. Although neurologic morbidity following intensive care unit was associated with baseline state, we found that resuscitation intensity and illness severity factors were independently associated with the development of acquired brain injury and reduced quality of life.
Pediatric Critical Care Medicine 11/2012; 14(1). DOI:10.1097/PCC.0b013e31825b64b3 · 2.33 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: PURPOSE: To describe satisfaction, involvement, presence, and preferences of parents following their child's admission to an intensive care unit (ICU). METHODS: A survey, administered 1 month after their child's ICU admission, described perceptions of parental satisfaction with their interaction with healthcare providers, their presence during resuscitation, involvement in treatment decision-making, and preferences if events were to be re-enacted. RESULTS: One hundred three parents of 91 patients were enrolled; 64 primary parents (70%) completed the survey at 1 month. The mean (SD) satisfaction rating was 87.6 (±14.8) and involvement rating was 70.2 (±34.4) on a scale from 0 (not satisfied/involved) to 100 (completely satisfied/involved). There were no differences in satisfaction (P = .46), involvement (P = .69) and change in preferences (P = .97) between parents who were present and not present. After adjusting for child's baseline illness, receipt of more ICU therapies was associated with worse parental satisfaction (P = .03). Twenty-four (38%) parents reported that if events were repeated, they would have changed their preferences. CONCLUSIONS: Overall, parental satisfaction ratings were high, lower in parents of children receiving more ICU therapies, and not associated with presence during resuscitation. These data contrast the American Heart Association's recommendation and suggestion of benefit from parental presence during periods of intensive therapies.
Journal of critical care 07/2012; 28(1). DOI:10.1016/j.jcrc.2012.05.011 · 2.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The RIFLE criteria were developed to improve consistency in the assessment of acute kidney injury. The high face validity, collaborative development method, and validation against mortality have supported the widespread adoption of the RIFLE to evaluate adult patients; however, its inconsistent application in adult studies is associated with significant effects on the estimated incidence of acute kidney injury. As the RIFLE criteria are now being used to determine acute kidney injury in children, we conducted a systematic review to describe its application and assess associations between the RIFLE and measures of mortality and morbidity in pediatric patients. In 12 studies we found wide variation in the application of the RIFLE, including the range of assessed RIFLE categories, omission of urine output criteria, varying definitions of baseline renal function, and methods for handling missing baseline measurements. Limited and conflicting associations between the RIFLE and mortality, length of stay, illness severity, and measures of kidney function were found. Thus, although the RIFLE was developed to improve the consistency of defining acute kidney injury, there are still major discrepancies in its use in pediatric patients that may undermine its potential utility as a standardized measure of acute kidney injury in children.
Kidney International 01/2012; 81(8):791-8. DOI:10.1038/ki.2011.466 · 8.52 Impact Factor