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Diagnosing serious infections in acutely ill children in ambulatory care (ERNIE 2 study protocol, part A): diagnostic accuracy of a clinical decision tree and added value of a point-of-care C-reactive protein test and oxygen saturation.

ABSTRACT: Acute illness is the most common presentation of children to ambulatory care. In contrast, serious infections are rare and often present at an early stage. To avoid complications or death, early recognition and adequate referral are essential. In a recent large study children were included prospectively to construct a symptom-based decision tree with a sensitivity and negative predictive value of nearly 100%. To reduce the number of false positives, point-of-care tests might be useful, providing an immediate result at bedside. The most probable candidate is C-reactive protein, as well as a pulse oximetry.This is a diagnostic accuracy study of signs, symptoms and point-of-care tests for serious infections. Acutely ill children presenting to a family physician or paediatrician will be included consecutively in Flanders, Belgium. Children testing positive on the decision tree will get a point-of-care C-reactive protein test. Children testing negative will randomly either receive a point-of-care C-reactive protein test or usual care. The outcome of interest is hospital admission more than 24 hours with a serious infection within 10 days. Aiming to include over 6500 children, we will report the diagnostic accuracy of the decision tree (+/- the point-of-care C-reactive protein test or pulse oximetry) in sensitivity, specificity, positive and negative likelihood ratios, and positive and negative predictive values. New diagnostic algorithms will be constructed through classification and regression tree and multiple logistic regression analysis.We aim to improve detection of serious infections, and present a practical tool for diagnostic triage of acutely ill children in primary care. We also aim to reduce the number of investigations and admissions in children with non-serious infections.ClinicalTrials.gov Identifier: NCT02024282.

SUBMITTER: Verbakel JY

PROVIDER: S-EPMC4287386 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Diagnosing serious infections in acutely ill children in ambulatory care (ERNIE 2 study protocol, part A): diagnostic accuracy of a clinical decision tree and added value of a point-of-care C-reactive protein test and oxygen saturation.

Verbakel Jan Y JY Lemiengre Marieke B MB De Burghgraeve Tine T De Sutter An A Bullens Dominique M A DM Aertgeerts Bert B Buntinx Frank F

BMC pediatrics 20141002

<h4>Background</h4>Acute illness is the most common presentation of children to ambulatory care. In contrast, serious infections are rare and often present at an early stage. To avoid complications or death, early recognition and adequate referral are essential. In a recent large study children were included prospectively to construct a symptom-based decision tree with a sensitivity and negative predictive value of nearly 100%. To reduce the number of false positives, point-of-care tests might b ...[more]

PMID: 25277457

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Project description:BackgroundDiagnosing serious infections in children is challenging, because of the low incidence of such infections and their non-specific presentation early in the course of illness. Prediction rules are promoted as a means to improve recognition of serious infections. A recent systematic review identified seven clinical prediction rules, of which only one had been prospectively validated, calling into question their appropriateness for clinical practice. We aimed to examine the diagnostic accuracy of these rules in multiple ambulatory care populations in Europe.MethodsFour clinical prediction rules and two national guidelines, based on signs and symptoms, were validated retrospectively in seven individual patient datasets from primary care and emergency departments, comprising 11,023 children from the UK, the Netherlands, and Belgium. The accuracy of each rule was tested, with pre-test and post-test probabilities displayed using dumbbell plots, with serious infection settings stratified as low prevalence (LP; <5%), intermediate prevalence (IP; 5 to 20%), and high prevalence (HP; >20%) . In LP and IP settings, sensitivity should be >90% for effective ruling out infection.ResultsIn LP settings, a five-stage decision tree and a pneumonia rule had sensitivities of >90% (at a negative likelihood ratio (NLR) of < 0.2) for ruling out serious infections, whereas the sensitivities of a meningitis rule and the Yale Observation Scale (YOS) varied widely, between 33 and 100%. In IP settings, the five-stage decision tree, the pneumonia rule, and YOS had sensitivities between 22 and 88%, with NLR ranging from 0.3 to 0.8. In an HP setting, the five-stage decision tree provided a sensitivity of 23%. In LP or IP settings, the sensitivities of the National Institute for Clinical Excellence guideline for feverish illness and the Dutch College of General Practitioners alarm symptoms ranged from 81 to 100%.ConclusionsNone of the clinical prediction rules examined in this study provided perfect diagnostic accuracy. In LP or IP settings, prediction rules and evidence-based guidelines had high sensitivity, providing promising rule-out value for serious infections in these datasets, although all had a percentage of residual uncertainty. Additional clinical assessment or testing such as point-of-care laboratory tests may be needed to increase clinical certainty. None of the prediction rules identified seemed to be valuable for HP settings such as emergency departments.

Project description:IntroductionChildren become ill quite often, mainly because of infections, most of which can be managed in the community. Many children are prescribed antibiotics which contributes to antimicrobial resistance and reinforces health-seeking behaviour. Point-of-care C reactive protein (POC CRP) testing, prescription guidance and safety-netting advice can help safely reduce antibiotic prescribing to acutely ill children in ambulatory care as well as save costs at a systems level.Methods and analysisThe ARON (Antibiotic prescribing Rate after Optimal Near-patient testing in acutely ill children in ambulatory care) trial is a pragmatic cluster randomized controlled superiority trial with a nested process evaluation and will assess the clinical and cost effectiveness of a diagnostic algorithm, which includes a standardised clinical assessment, a POC CRP test, and safety-netting advice, in acutely ill children aged 6 months to 12 years presenting to ambulatory care. The primary outcome is antibiotic prescribing at the index consultation; secondary outcomes include clinical recovery, reconsultation, referral/admission to hospital, additional testing, mortality and patient satisfaction. We aim to recruit a total sample size of 6111 patients. All outcomes will be analysed according to the intent-to-treat approach. We will use a mixed-effect logistic regression analysis to account for the clustering at practice level.Ethics and disseminationThe study will be conducted in compliance with the principles of the Declaration of Helsinki (current version), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. Ethics approval for this study was obtained on 10 November 2020 from the Ethics Committee Research of University Hospitals Leuven under reference S62005. We will ensure that the findings of the study will be disseminated to relevant stakeholders other than the scientific world including the public, healthcare providers and policy-makers. The process evaluation that is part of this trial may provide a basis for an implementation strategy. If our intervention proves to be clinically and cost-effective, it will be essential to educate physicians about introducing the diagnostic algorithm including POC CRP testing and safety-netting advice in their daily practice.Trial registration numberClinicalTrials.gov Identifier: NCT04470518. Protocol V.2.0 date 2 October 2020. (Pre-results).

Project description:BACKGROUND:Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. OBJECTIVE:Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. DESIGN:Randomized controlled trial. PARTICIPANTS:Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. INTERVENTION:Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. MAIN MEASURES:Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. KEY RESULTS:Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p?=?0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p?<?0.01) and less often received consultations (0% vs. 27%; p?=?0.04). Home patients were more physically active (median minutes, 209 vs. 78; p?<?0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p?<?0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p?=?0.08) and fewer readmissions (11% vs. 36%; p?=?0.32). Patient experience was similar in both groups. CONCLUSIONS:The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

Project description:IntroductionPoint-of-care ultrasound (POCUS) use is increasing in pediatric clinical settings. However, gastric POCUS is rarely used, despite its potential value in optimizing the diagnosis and management in several clinical scenarios (i.e., assessing gastric emptying and gastric volume/content, gastric foreign bodies, confirming nasogastric tube placement, and hypertrophic pyloric stenosis). This review aimed to assess how gastric POCUS may be used in acute and critically ill children.Materials and methodsAn international expert group was established, composed of pediatricians, pediatric intensivists, anesthesiologists, radiologists, nurses, and a methodologist. A scoping review was conducted with an aim to describe the use of gastric POCUS in pediatrics in acute and critical care settings. A literature search was conducted in three databases, to identify studies published between 1998 and 2022. Abstracts and relevant full texts were screened for eligibility, and data were extracted, according to the JBI methodology (Johanna Briggs Institute).ResultsA total of 70 studies were included. Most studies (n = 47; 67%) were conducted to assess gastric emptying and gastric volume/contents. The studies assessed gastric volume, the impact of different feed types (breast milk, fortifiers, and thickeners) and feed administration modes on gastric emptying, and gastric volume/content prior to sedation or anesthesia or during surgery. Other studies described the use of gastric POCUS in foreign body ingestion (n = 6), nasogastric tube placement (n = 5), hypertrophic pyloric stenosis (n = 8), and gastric insufflation during mechanical ventilatory support (n = 4). POCUS was performed by neonatologists, anesthesiologists, emergency department physicians, and surgeons. Their learning curve was rapid, and the accuracy was high when compared to that of the ultrasound performed by radiologists (RADUS) or other gold standards (e.g., endoscopy, radiography, and MRI). No study conducted in critically ill children was found apart from that in neonatal intensive care in preterms.DiscussionGastric POCUS appears useful and reliable in a variety of pediatric clinical settings. It may help optimize induction in emergency sedation/anesthesia, diagnose foreign bodies and hypertrophic pyloric stenosis, and assist in confirming nasogastric tube placement, avoiding delays in obtaining confirmatory examinations (RADUS, x-rays, etc.) and reducing radiation exposure. It may be useful in pediatric intensive care but requires further investigation.

Project description:BackgroundSubstitutive hospital-level care in a patient's home ("home hospital") has been shown to lower cost, utilization, and readmission compared to traditional hospital care. However, patients' perspectives to help explain how and why interventions like home hospital accomplish many of these results are lacking.ObjectiveElucidate and explain patient perceptions of home hospital versus traditional hospital care to better describe the different perceptions of care in both settings.DesignQualitative evaluation of a randomized controlled trial.Participants36 hospitalized patients (19 home; 17 control).InterventionTraditional hospital ("control") versus home hospital ("home"), including nurse and physician home visits, intravenous medications, remote monitoring, video communication, and point-of-care testing.ApproachWe conducted a thematic content analysis of semi-structured interviews. Team members developed a coding structure through a multiphase approach, utilizing a constant comparative method.Key resultsThemes clustered around 3 domains: clinician factors, factors promoting healing, and systems factors. Clinician factors were similar in both groups; both described beneficial interactions with clinical staff; however, home patients identified greater continuity of care. For factors promoting healing, home patients described a locus of control surrounding their sleep, activity, and environmental comfort that control patients lacked. For systems factors, home patients experienced more efficient processes and logistics, particularly around admission and technology use, while both noted difficulty with discharge planning.ConclusionsCompared to control patients, home patients had better experiences with their care team, had more experiences promoting healing such as better sleep and physical activity, and had better experiences with systems factors such as the admission processes. Potential explanations include continuity of care, the power and familiarity of the home, and streamlined logistics. Future improvements include enhanced care transitions and ensuring digital interfaces are usable.Trial registrationNCT03203759.

Dataset Information

Diagnosing serious infections in acutely ill children in ambulatory care (ERNIE 2 study protocol, part A): diagnostic accuracy of a clinical decision tree and added value of a point-of-care C-reactive protein test and oxygen saturation.

Publications

Diagnosing serious infections in acutely ill children in ambulatory care (ERNIE 2 study protocol, part A): diagnostic accuracy of a clinical decision tree and added value of a point-of-care C-reactive protein test and oxygen saturation.

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