A severe pediatric life-threatening metabolic ketoacidosis.

This case report presents a 9-year-old child without underlying pathology, with a severe life-threatening non-diabetic metabolic ketoacidosis occurring less than 48 h after the onset of fasting and vomiting. The patient was admitted to the pediatric intensive care unit. He received volume expansion and maintenance fluid therapy which allowed a favorable evolution. Because of the unusual rapid onset of intense ketonemia and acidosis, a hereditary metabolic disease was investigated. The association between short fasting period and severe metabolic ketoacidosis has never been described in children outside of the neonatal period. This clinical case emphasizes urgent recognition, rigorous diagnostic and appropriate management in clinical practice.

Central role of the ramAR locus in the multidrug resistance in ESBL-Enterobacterales.

The aim of this study was to evaluate the proportion of resistance to a temocillin, tigecycline, ciprofloxacin, and chloramphenicol phenotype called t2c2 that resulted from mutations within the ramAR locus among extended-spectrum ß-lactamases-Enterobacterales (ESBL-E) isolated in three intensive care units for 3 years in a French university hospital. Two parallel approaches were performed on all 443 ESBL-E included: (i) the minimal inhibitory concentrations of temocillin, tigecycline, ciprofloxacin, and chloramphenicol were determined and (ii) the genomes obtained from the Illumina sequencing platform were analyzed to determine multilocus sequence types, resistomes, and diversity of several tetR-associated genes including ramAR operon. Among the 443 ESBL-E strains included, isolates of Escherichia coli (n = 194), Klebsiella pneumoniae (n = 122), and Enterobacter cloacae complex (Ecc) (n = 127) were found. Thirty-one ESBL-E strains (7%), 16 K. pneumoniae (13.1%), and 15 Ecc (11.8%) presented the t2c2 phenotype in addition to their ESBL profile, whereas no E. coli presented these resistances. The t2c2 phenotype was invariably reversible by the addition of Phe-Arg-ß-naphthylamide, indicating a role of resistance-nodulation-division pumps in these observations. Mutations associated with the t2c2 phenotype were restricted to RamR, the ramAR intergenic region (IR), and AcrR. Mutations in RamR consisted of C- or N-terminal deletions and amino acid substitutions inside its DNA-binding domain or within key sites of protein-substrate interactions. The ramAR IR showed nucleotide substitutions involved in the RamR DNA-binding domain. This diversity of sequences suggested that RamR and the ramAR IR represent major genetic events for bacterial antimicrobial resistance.IMPORTANCEMorbimortality caused by infectious diseases is very high among patients hospitalized in intensive care units (ICUs). A part of these outcomes can be explained by antibiotic resistance, which delays the appropriate therapy. The transferable antibiotic resistance gene is a well-known mechanism to explain the high rate of multidrug resistance (MDR) bacteria in ICUs. This study describes the prevalence of chromosomal mutations, which led to additional antibiotic resistance among MDR bacteria. More than 12% of Klebsiella pneumoniae and Enterobacter cloacae complex strains presented mutations within the ramAR locus associated with a dysregulation of an efflux pump called AcrAB-TolC and a porin: OmpF. These dysregulations led to an increase in antibiotic output notably tigecycline, ciprofloxacin, and chloramphenicol associated with a decrease of input for beta-lactam, especially temocillin. Mutations within transcriptional regulators such as ramAR locus played a major role in antibiotic resistance dissemination and need to be further explored.

How to follow the guidelines, when the appropriate fluid is missing?

Intravenous maintenance fluid therapy (IV-MFT) is probably the most prescribed drug in paediatric hospital care. Recently paediatric societies have produced evidence-based practice guidelines that recommend the use of balanced isotonic fluid when prescribing IV-MFT in both acute and critical paediatric care. Unfortunately, the applicability of these guidelines could be called into question when a ready-to-use glucose-containing balanced isotonic fluid is not available. The main objective of this study was to describe the availability of glucose-containing balanced isotonic fluids in European and Middle Eastern paediatric acute and critical care settings. This work is an ancillary study of the survey dedicated to IV-MFT practices in the paediatric acute and critical care settings in Europe and Middle East, a cross-sectional electronic 27-item survey, emailed in April-May 2021 to paediatric critical care physicians across 34 European and Middle East countries. The survey was developed by an expert multi-professional panel within the European Society of Peadiatric and Neonatal Intensive Care (ESPNIC). Balanced isotonic fluid with glucose 5% was available for only 32/153 (21%) responders. Balanced isotonic fluid with glucose 5% was consistently available in the UK (90%) but not available in France, Greece, The Netherlands and Turkey.    Conclusion: Ready-to-use isotonic balanced IV solutions containing glucose in sufficient amount exist but are inconsistently available throughout Europe. National and European Medication Safety Incentives should guarantee the availability of the most appropriate and safest IV-MFT solution for all children. What is Known: • Intravenous maintenance fluid therapy (IV-MFT) is probably the most prescribed drug in paediatric hospital care. • Balanced isotonic fluid is recommended when prescribing IV-MFT in both acute and critical paediatric care. What is New: • Balanced isotonic fluid with glucose 5% is available for less than 25% of the prescribers in Europe and the Middle East. Availability of balanced isotonic fluid with glucose 5% varies from one country to another but can also be inconsistent within the same country. • Clinicians who have access to a ready-to-use balanced isotonic fluid with glucose 5% are more likely to consider its use than clinicians who do not have access to such an IV solution.

Severe acute respiratory syndrome coronavirus-2-related and imputable deaths in children: results from the French pediatric national registry.

BACKGROUND: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is responsible for an important mortality rate worldwide. We aimed to evaluate the actual imputability of SARS-CoV-2 on the mortality rate associated with SARS-CoV-2-related illnesses in the pediatric intensive care unit (PICU). Secondary objectives were to identify risk factors for death. METHODS: This national multicenter comparative study comprised all patients under 18 years old with positive SARS-CoV-2 polymerase chain reactions (PCRs) [acute corona virus disease 2019 (COVID-19) or incidental SARS-CoV-2 infection] and/or pediatric inflammatory multisystem syndrome (PIMS) recorded in the French PICU registry (PICURe) between September 1, 2021, and August 31, 2022. Included patients were classified and compared according to their living status at the end of their PICU stay. Deceased patients were evaluated by four experts in the field of pediatric infectiology and/or pediatric intensive care. The imputability of SARS-CoV-2 as the cause of death was classified into four categories: certain, very probable, possible, or unlikely, and was defined by any of the first three categories. RESULTS: There were 948 patients included of which 43 died (4.5%). From this, 26 deaths (67%) could be attributed to SARS-CoV-2 infection, with an overall mortality rate of 2.8%. The imputability of death to SARS-CoV-2 was considered certain in only one case (0.1%). Deceased patients suffered more often from comorbidities, especially heart disease, neurological disorders, hematological disease, cancer, and obesity. None of the deceased patients were admitted for pediatric inflammatory multisystem syndrome (PIMS). Mortality risk factors were male gender, cardiac comorbidities, cancer, and acute respiratory distress syndrome. CONCLUSIONS: SARS-CoV-2 mortality in the French pediatric population was low. Even though the imputability of SARS-CoV-2 on mortality was considered in almost two-thirds of cases, this imputability was considered certain in only one case.

ROX (Respiratory rate-OXygenation) index to predict early response to high-flow nasal cannula therapy in infants with viral bronchiolitis.

INTRODUCTION: High-flow nasal cannula (HFNC) is commonly used as first step respiratory support in infants with moderate-to-severe acute viral bronchiolitis (AVB). This device, however, fails to effectively manage respiratory distress in about a third of patients, and data are limited on determinants of patient response. The respiratory rate-oxygenation (ROX) index is a relevant tool to predict the risk for HFNC failure in adult patients with lower respiratory tract infections. The primary objective of this study was to assess the relationship between ROX indexes collected before and 1 h after HFNC initiation, and HFNC failure occurring in the following 48 h in infants with AVB. METHOD: This is an ancillary study to the multicenter randomized controlled trial TRAMONTANE 2, that included 286 infants of less than 6 months with moderate-to-severe AVB. Collection of physiological variables at baseline (H0), and 1 h after HFNC (H1), included heart rate (HR), respiratory rate (RR), fraction of inspired oxygen (FiO2), respiratory distress score (modified Wood's Clinical Asthma Score [mWCAS]), and pain and discomfort scale (EDIN). ROX and ROX-HR were calculated as SpO 2 FiO 2 RR $\frac{\left(\frac{{\mathrm{SpO}}_{2}}{{\mathrm{FiO}}_{2}}\right)}{\mathrm{RR}}$ and 100 × ROX HR $100\times \frac{\mathrm{ROX}}{\mathrm{HR}}$ , respectively. Predefined HFNC failure criteria included increase in respiratory distress score or RR, increase in discomfort, and severe apnea episodes. The accuracies of ROX, ROX-HR indexes and clinical variable to predict HFNC failure were assessed using receiver operating curve analysis. We analyzed predictive factors of HFNC failure using multivariate logistic regressions. RESULT: HFNC failure occurred in 111 of 286 (39%) infants, and for 56 (50% of the failure) of them within the first 6 h. The area under the curve of ROX indexes at H0 and H1 were, respectively, 0.56 (95% confidence interval [CI] 0.48-0.63, p = 0.14), 0.56 (95% CI 0.49-0.64, p = 0.09). ROX-HR performances were better but remained poorly discriminant. HFNC failure was associated with higher mWCAS score at H1 (p < 0.01) and lower decrease in EDIN scale during the first hour of HFNC delivery (p = 0.02). In the multivariate analyses, age and mWCAS score were were found to be independent factors associated with HFNC failure at H0. At H1, weight and mWCAS were associated factors. CONCLUSION: In this study, neither ROX index, nor physiological variables usually collected in infants with AVB had early discriminatory capacity to predict HFNC failure.

Intravenous maintenance fluid therapy in acutely and critically ill children: state of the evidence.

Intravenous maintenance fluid therapy (IV-MFT) is one of the most prescribed, yet one of the least studied, interventions in paediatric acute and critical care settings. IV-MFT is not typically treated in the same way as drugs with specific indications, contraindications, compositions, and associated adverse effects. In the last decade, societies in both paediatric and adult medicine have issued evidence-based practice guidelines for the use of intravenous fluids in clinical practice. The main objective of this Viewpoint is to summarise and compare the rationales on which these international expert guidelines were based and how these recommendations affect IV-MFT practices in paediatric acute and critical care. Although these guidelines recommend the use of isotonic fluids as a standard in IV-MFT, some discrepancies and uncertainties remain regarding the systematic use of balanced fluids, glucose and electrolyte requirements, and appropriate fluid volume. IV-MFT should be considered in the same way as any other prescription drug and none of the components of IV-MFT prescription should be overlooked (ie, choice of drug, dosing rate, duration of treatment, and de-escalation). Furthermore, most evidence that was used to inform the guidelines comes from high-income countries. Although some principles of IV-MFT are universal, the direct relevance to and feasibility of implementing the guidelines in low-income and middle-income countries is uncertain.

Withholding life support for children with severe neurological impairment: Prevalence and predictive factors prior to admission in the PICU.

BACKGROUND: Our study aimed to evaluate the prevalence and predictive factors of withholding life support for children suffering from severe neurological impairment before admission to the pediatric intensive care unit (PICU). METHOD: Children under 18 years of age with severe neurological impairment, who were hospitalized between January 2006 and December 2016, were included in this retrospective study. They were allocated to a withholding group or a control group, depending on whether life support was withheld or not, before admission to the PICU. RESULTS: Overall, 119 patients were included. At admission to the PICU, the rate of withholding life support was 10 % (n = 12). Predictive factors were: (1) a previous stay in the PICU (n = 11; 92 %, p<0.01, odds ratio [OR]: 14 [2-635], p = 0.001); (2) the need for respiratory support (n = 5; 42 %, p = 0.01, OR: 6 [1-27], p = 0.01); (3) the need for feeding support (n = 10; 83 %, p = 0.01, OR: 10 [2-100], p = 0.001); and (4) a higher functional status score (FSS: 16 [12.5-19] vs. 10 [8-13], p<0.01). CONCLUSION: The withholding of life support for children suffering from severe neurological impairment appeared limited in our pediatric department. The main predictor was at least one admission to the PICU, which raised the question of the pediatrician's role in the decision to withhold life support.

Evaluation of the SIMULRESP: A simulation software of child and teenager cardiorespiratory physiology.

BACKGROUND: Mathematical models based on the physiology when programmed as a software can be used to teach cardiorespiratory physiology and to forecast the effect of various ventilatory support strategies. We developed a cardiorespiratory simulator for children called "SimulResp." The purpose of this study was to evaluate the quality of SimulResp. METHODS: SimulResp quality was evaluated on accuracy, robustness, repeatability, and reproducibility. Blood gas values (pH, PaCO2 , PaO2,  and SaO2 ) were simulated for several subjects with different characteristics and in different situations and compared to expected values available as reference. The correlation between reference and simulated data was evaluated by the coefficient of determination and Intraclass correlation coefficient. The agreement was evaluated with the Bland & Altman analysis. RESULTS: SimulResp produced healthy child physiological values within normal range (pH 7.40 ± 0.5; PaCO2 40 ± 5 mmHg; PaO2 90 ± 10 mmHg; SaO2 97 ± 3%) starting from a weight of 25-35 kg, regardless of ventilator support. SimulResp failed to simulate accurate values for subjects under 25 kg and/or affected with pulmonary disease and mechanically ventilated. Based on the repeatability was considered as excellent and the reproducibility as mild to good. SimulResp's prediction remains stable within time. CONCLUSIONS: The cardiorespiratory simulator SimulResp requires further development before future integration into a clinical decision support system.

Post traumatic cerebral sinovenous thrombosis in children: A retrospective and multicenter study.

CONTEXT: Cerebral sinovenous thrombosis (CSVT) is a rare but life-threatening condition in the pediatric population and there is no pediatric guidelines regarding anticoagulation for post traumatic CSVT. OBJECTIVE: This study aims to describe a cohort of children with post traumatic CSVT and the use of anticoagulant therapy in this population. METHODS: A multicenter retrospective study. Patients admitted with post traumatic CSVT in the six participating Pediatric Intensive Care Unit were included. RESULTS: Overall, 29 patients (median age 8.2 years [IQR 4.8-14.6], n = 22 (76%) males) were included in the study (Table 1). CSVT was observed within the first 24 h after admission for a half of the patients (n = 14, 50%). Anticoagulation was initiated in 18 patients (62%). No patient received thrombolytic therapy or endovascular treatment. The presence of epidural hematoma was associated with the absence of anticoagulation (n = 0 versus n = 10, p = 0.003). One patient (3%) died of extracranial injury (not related with adverse event of anticoagulation) and in survivors, median Pediatric Overall Performance Category Outcome (POPC) score at discharge from PICU was 2 [IQR 2-4] (i.e., mild disability). Regarding the outcomes of patients, we found no association according to the anticoagulation status (p = 1). Overall, 23 patients (79%) had a follow-up cerebral imaging with a median delay of 42 days [IQR 6-63] after admission. CSVT was still seen in 9 patients (31%). We found no difference regarding the persistence of CSVT between patients according to the anticoagulation status (p = 0.36). The median duration of anticoagulant treatment was 58 days [IQR 44-91] and one patient (3%) experienced adverse event related to anticoagulation. CONCLUSION: There were minimal adverse events in patients with post traumatic CSVT treated with therapeutic anticoagulation. However, the effect of anticoagulation on outcomes needs to be confirmed in further studies.

Prevalence of anemia at diagnosis of pediatric chronic myeloid leukemia and prognostic impact on the disease course.

The clinical presentation of chronic myeloid leukemia (CML) at diagnosis differs in children compared to adults. At younger age, anemia appears to be frequent at diagnosis, but its prevalence and its impact on prognosis are not well known. In the International Registry of Childhood CML, we selected children and adolescents in chronic phase at diagnosis of CML and treated upfront with imatinib. We examined their hemoglobin level at diagnosis according to the WHO grades to assess the prevalence of anemia and its impact on response to tyrosine kinase inhibitors (TKIs). Data on 430 patients were included. Anemia at diagnosis was observed in 350 patients (81%), with a mean hemoglobin level of 96.4 g/l (SD 23.6). Among them, 182 patients (52%) presented with moderate anemia and 110 (31%) with severe anemia while 58 (17%) had mild anemia. Compared with mild and no anemia, moderate and severe forms were significantly associated with younger age at diagnosis, asthenia, splenomegaly, and increased leukocyte and basophil counts. Delays in achieving major and deep molecular responses were significantly increased for patients with moderate and severe anemia, and also failure of imatinib treatment was more frequent in these two sub-cohorts. However, hemoglobin level was not significantly associated with survival. Anemia at diagnosis of pediatric CML was frequent and may be considered as a prognostic factor.

ESPNIC clinical practice guidelines: intravenous maintenance fluid therapy in acute and critically ill children- a systematic review and meta-analysis.

PURPOSE: Intravenous maintenance fluid therapy (IV-MFT) prescribing in acute and critically ill children is very variable among pediatric health care professionals. In order to provide up to date IV-MFT guidelines, the European Society of Pediatric and Neonatal Intensive Care (ESPNIC) undertook a systematic review to answer the following five main questions about IV-MFT: (i) the indications for use (ii) the role of isotonic fluid (iii) the role of balanced solutions (iv) IV fluid composition (calcium, magnesium, potassium, glucose and micronutrients) and v) and the optimal amount of fluid. METHODS: A multidisciplinary expert group within ESPNIC conducted this systematic review using the Scottish Intercollegiate Guidelines Network (SIGN) grading method. Five databases were searched for studies that answered these questions, in acute and critically children (from 37 weeks gestational age to 18 years), published until November 2020. The quality of evidence and risk of bias were assessed, and meta-analyses were undertaken when appropriate. A series of recommendations was derived and voted on by the expert group to achieve consensus through two voting rounds. RESULTS: 56 papers met the inclusion criteria, and 16 recommendations were produced. Outcome reporting was inconsistent among studies. Recommendations generated were based on a heterogeneous level of evidence, but consensus within the expert group was high. "Strong consensus" was reached for 11/16 (69%) and "consensus" for 5/16 (31%) of the recommendations. CONCLUSIONS: Key recommendations are to use isotonic balanced solutions providing glucose to restrict IV-MFT infusion volumes in most hospitalized children and to regularly monitor plasma electrolyte levels, serum glucose and fluid balance.

Proton Pump Inhibitor Use and Associated Infectious Complications in the PICU: Propensity Score Matching Analysis.

OBJECTIVES: We aimed to evaluate the association between proton pump inhibitor (PPI) exposure and nosocomial infection (NI) during PICU stay. DESIGN: Propensity score matched analysis of a single-center retrospective cohort from January 1, 2017, to December 31, 2018. SETTING: Tertiary medical and surgical PICU in France. PATIENTS: Patients younger than 18 years old, admitted to the PICU with a stay greater than 48 hours. INTERVENTION: Patients were retrospectively allocated into two groups and compared depending on whether they received a PPI or not. MEASUREMENTS AND MAIN RESULTS: Seven-hundred fifty-four patients were included of which 231 received a PPI (31%). PPIs were mostly used for stress ulcer prophylaxis (174/231; 75%), but upper gastrointestinal bleed risk factors were rarely present (18%). In the unadjusted analyses, the rate of NI was 8% in the PPI exposed group versus 2% in the nonexposed group. After propensity score matching ( n = 184 per group), we failed to identify an association between PPI exposure and greater odds of NI (adjusted odds ratio 2.9 [95% CI, 0.9-9.3]; p = 0.082). However, these data have not excluded the possibility that there is up to nine-fold greater odds of NI. CONCLUSIONS: This study highlights the prevalent use of PPIs in the PICU, and the potential association between PPIs and nine-fold greater odds of NI is not excluded.

Intravenous maintenance fluid therapy practice in the pediatric acute and critical care settings: a European and Middle Eastern survey.

The ideal fluid for intravenous maintenance fluid therapy (IV-MFT) in acutely and critically ill children is controversial, and evidence-based clinical practice guidelines are lacking and current prescribing practices remain unknown. We aimed to describe the current practices in prescribing IV-MFT in the context of acute and critically ill children with regard to the amount, tonicity, composition, use of balanced fluids, and prescribing strategies in various clinical contexts. A cross-sectional electronic 27-item survey was emailed in April-May 2021 to pediatric critical care physicians across European and Middle East countries. The survey instrument was developed by an expert multi-professional panel within the European Society of Pediatric and Neonatal Intensive Care (ESPNIC). A total of 154 respondents from 35 European and Middle East countries participated (response rate 64%). Respondents were physicians in charge of acute or critically ill children. All respondents indicated they routinely use a predefined formula to prescribe the amount of IV-MFT and considered fluid balance monitoring very important in the management of acute and critically ill children. The use of balanced solution was preferred if there were altered serum sodium and chloride levels or metabolic acidosis. Just under half (42%, 65/153) of respondents believed balanced solutions should always be used. Respondents considered the use of isotonic IV solutions as important for acute and critically ill children. In terms of the indication and the composition of IV-MFT prescribed, responses were heterogeneous among centers. Almost 70% (107/154) respondents believed there was a gap between current practice and what they considered ideal IV-MFT due to a lack of guidelines and inadequate training of healthcare professionals.   Conclusions: Our study showed considerable variability in clinical prescribing practice of IV-MFT in acute pediatric settings across Europe and the Middle East. There is an urgent need to develop evidence-based guidelines for IV-MFT prescription in acute and critically ill children. What is Known: • The administration of maintenance intravenous fluid therapy is a standard of care for a lot of hospitalized children • Maintenance intravenous fluid therapy prescriptions are often based on Holliday and Segar's historical guidelines even if this practice has been associated with several complications. What is New: • This study provided information on the prescribing practice regarding fluid restriction, fluid tonicity, and balance. • This study showed considerable variability in clinical prescribing practice of intravenous maintenance fluid therapy across Europe and the Middle East.

Impact of the French National Lockdown on Admissions to 14 Pediatric Intensive Care Units During the 2020 COVID-19 Pandemic-A Retrospective Multicenter Study.

Background: After the COVID-19 pandemic reached France in January 2020, a national lockdown including school closures was officially imposed from March 17, 2020, to May 10, 2020. Pediatric intensive care units (PICUs) admit critically ill infants, children and teenagers with severe acute conditions, in particular infectious and traumatic diseases. We hypothesized that PICU admissions would be considerably modified by the lockdown. Aims: The objectives of the study were to describe the type of admissions to French PICUs and to compare the occupation of PICU beds according to local epidemic conditions during the French national lockdown period, compared with the same period the previous year. Methods: We conducted a retrospective multicenter study in 14 French PICUs. All children aged from 7 days to 18 years admitted to one of the 14 participating PICUs over two 3-month period (March 1, 2020, to May 31, 2020 and March 1, 2019, to May 31, 2019) were included. Analysis was based on data extracted from the medicalized information systems program (a national database used in all French hospitals, into which all admissions and their diagnoses are coded for the purpose of calculating hospital funding). Each main diagnosis was reclassified in 13 categories, corresponding to normal PICU admissions. Results: We analyzed a total of 3,040 admissions, 1,323 during the 2020 study period and 1,717 during the same period in 2019. Total admissions decreased by 23% [incidence rate ratio (IRR) 0.77, 95% CI 0.71-0.83, p < 0.001], in particular for viral respiratory infections (-36%, IRR 0.64, 95% CI 0.44-0.94, p = 0.001). Admissions for almost all other diagnostic categories decreased, except intoxications and diabetes which increased, while admissions for cardiac and hemodynamic disorders were stable. Patient age and the sex ratio did not differ between the two periods. Median length of stay in the PICU was longer in 2020 [4 (IQR 2-9) vs. 3 (IQR 1-8) days, p = 0.002] in 2019. Mortality remained stable. Conclusions: In this large national study, we showed a decrease in the number of PICU admissions. The most severe patients were still admitted to intensive care and overall mortality remained stable.

Therapeutic drug monitoring of intravenous anti-tuberculous therapy: management of an 8-month-old child with tuberculous meningitis.

Tuberculous meningitis (TBM) is now uncommon in high-income countries. It is the most severe form of extrapulmonary tuberculosis with high rates of mortality and morbidity if diagnosis and treatment are delayed. An 8-month-old girl with TBM who was treated with high-dose intravenous anti-tuberculous drugs (ATD) is reported. Therapeutic drug monitoring (TDM) of isoniazid and rifampicin was undertaken by measuring serial drug concentrations in serum and cerebrospinal fluid (CSF). There was rapid eradication of Mycobacterium tuberculosis from the CSF with a good clinical outcome and no adverse effects. Using high-dose regimens of intravenous ATD to treat TBM is an important option in order to obtain sufficient CSF diffusion. When available, TDM and a multidisciplinary approach are essential for efficient therapeutic management.

Validation process of a high-resolution database in a paediatric intensive care unit-Describing the perpetual patient's validation.

RATIONALE: High data quality is essential to ensure the validity of clinical and research inferences based on it. However, these data quality assessments are often missing even though these data are used in daily practice and research. AIMS AND OBJECTIVES: Our objective was to evaluate the data quality of our high-resolution electronic database (HRDB) implemented in our paediatric intensive care unit (PICU). METHODS: We conducted a prospective validation study of a HRDB in a 32-bed paediatric medical, surgical, and cardiac PICU in a tertiary care freestanding maternal-child health centre in Canada. All patients admitted to the PICU with at least one vital sign monitored using a cardiorespiratory monitor connected to the central monitoring station. RESULTS: Between June 2017 and August 2018, data from 295 patient days were recorded from medical devices and 4645 data points were video recorded and compared to the corresponding data collected in the HRDB. Statistical analysis showed an excellent overall correlation (R2 = 1), accuracy (100%), agreement (bias = 0, limits of agreement = 0), completeness (2% missing data), and reliability (ICC = 1) between recorded and collected data within clinically significant pre-defined limits of agreement. Divergent points could all be explained. CONCLUSIONS: This prospective validation of a representative sample showed an excellent overall data quality.

Qualitative subjective assessment of a high-resolution database in a paediatric intensive care unit-Elaborating the perpetual patient's ID card.

OBJECTIVE: The main purpose of our study was to subjectively assess the quality of a paediatric intensive care unit (PICU) database according to the Directory of Clinical Databases (DoCDat) criteria. DESIGN AND SETTING: A survey was conducted between April 1 and June 15, 2018, among the Sainte Justine PICU research group. POPULATION: Every member of this group whose research activity required the use of the database and/or who was involved in the development/validation of the database. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: All 10 research team members (one Information Technology specialist, one junior medical student, and eight clinician researchers) who used the high-resolution database fulfilled the survey (100% response rate). The median quality level of the Sainte Justine PICU database across all the 10 criteria was 3 (2-4), rated on a 1 (worst) to 4 (best) numeric scale. When compared with previously assessed databases through the DoCDat criteria, we found that the Sainte Justine PICU database performance was similar. CONCLUSIONS: The PICU high-resolution database appeared of good quality when subjectively assessed by the DoCDat criteria. Further validation procedures are mandatory. We suggest that data quality assessment and validation procedures should be reported when creating a new database.