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Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial.

ABSTRACT: BACKGROUND:Point-of-care blood C-reactive protein (CRP) testing has diagnostic value in helping clinicians rule out the possibility of serious infection. We investigated whether it should be offered to all acutely ill children in primary care or restricted to those identified as at risk on clinical assessment. METHODS:Cluster randomised controlled trial involving acutely ill children presenting to 133 general practitioners (GPs) at 78 GP practices in Belgium. Practices were randomised to undertake point-of-care CRP testing in all children (1730 episodes) or restricted to children identified as at clinical risk (1417 episodes). Clinical risk was assessed by a validated clinical decision rule (presence of one of breathlessness, temperature???40 °C, diarrhoea and age 12-30 months, or clinician concern). The main trial outcome was hospital admission with serious infection within 5 days. No specific guidance was given to GPs on interpreting CRP levels but diagnostic performance is reported at 5, 20, 80 and 200 mg/L. RESULTS:Restricting CRP testing to those identified as at clinical risk substantially reduced the number of children tested by 79.9 % (95 % CI, 77.8-82.0 %). There was no significant difference between arms in the number of children with serious infection who were referred to hospital immediately (0.16 % vs. 0.14 %, P?=?0.88). Only one child with a CRP?

SUBMITTER: Verbakel JY

PROVIDER: S-EPMC5052874 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial.

Verbakel Jan Y JY Lemiengre Marieke B MB De Burghgraeve Tine T De Sutter An A Aertgeerts Bert B Shinkins Bethany B Perera Rafael R Mant David D Van den Bruel Ann A Buntinx Frank F

BMC medicine 20161006 1

<h4>Background</h4>Point-of-care blood C-reactive protein (CRP) testing has diagnostic value in helping clinicians rule out the possibility of serious infection. We investigated whether it should be offered to all acutely ill children in primary care or restricted to those identified as at risk on clinical assessment.<h4>Methods</h4>Cluster randomised controlled trial involving acutely ill children presenting to 133 general practitioners (GPs) at 78 GP practices in Belgium. Practices were random ...[more]

PMID: 27716201

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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:Despite huge public campaigns, there is still overconsumption of antibiotics in children with self-limiting diseases. Possible explanations may be the physicians' and parents' uncertainty about the gravity of the disease and inadequate communication between physicians and parents leading to lack of reassurance for the parents. In this paper we describe the design and methods of a trial aiming to rationalize antibiotic prescribing by decreasing this uncertainty and parental anxiety.Acutely ill children without suspected serious disease consulting their family physician will be consecutively included in a four-armed cluster randomized factorial controlled trial. The intervention will consist a Point-of-Care C-reactive protein test and/or a brief intervention with safety net advice. The control group will receive usual care. We intend to include 2560 patients in 88 family practices. Patients will be followed up until cure. The primary outcome measure is the immediate antibiotic prescribing rate. Secondary outcomes are: comparison between groups of speed of clinical recovery, parental concern, parental perception of the quality of the communication, parental satisfaction, use of medication, use of diagnostic tests and medical services during the illness episode, and cost-effectiveness of the interventions. Besides this, we will observationally analyse data of the children included in the large ERNIE2-trial, but excluded in the cluster randomized trial, namely children suspected of serious disease presenting in primary care and children who initially present at the out-patient paediatric clinic or emergency department. We will search for predictors of antibiotic prescribing, speed of clinical recovery, parental concern, parental perception of communication, parental satisfaction, use of medication, diagnostic tests and medical services.This is a unique multifaceted intervention, in that it targets both physicians and parents by aiming specifically at their uncertainty and concerns during the consultation. Both interventions are easy to implement without special training. When proven effective, they could offer a feasible way to decrease inappropriate antibiotic prescribing for children in family practice and thus avoid emergence of bacterial resistance, side effects and unnecessary healthcare costs. Moreover, the observational part of the study will increase our insight in the course, management and parent's concern of acute illness in children.ClinicalTrials.gov Identifier: NCT02024282.

Project description:IntroductionIn children with asthma, daily symptoms and exacerbations have a significant impact on the quality of life of both children and parents. More effective use of asthma medication and, consequently, better asthma control is advocated, since both overtreatment and undertreatment are reported in primary care. Trials in adults suggest that asthma control is better when patients receive a regular medical review. Therefore, protocolled care by the general practitioner may also lead to better asthma control in children. However, such protocolled care by the general practitioner may be time consuming and less feasible. Therefore, this study aims to determine whether protocolled practice nurse-led asthma care for children in primary care provides more effective asthma control than usual care.Methods and analysisThe study will be a cluster-randomised open-label trial with an 18-month follow-up. Practice nurses will be the units of randomisation and children with asthma the units of analysis. It is planned to include 180 children aged 6-12 years. Primary outcome will be average asthma control during the 18-month follow-up measured by the Childhood Asthma Control Test (C-ACT). Secondary outcomes include C-ACT scores at t=3, t=6, t=12 and t=18 months; the frequency and severity of exacerbations; cost-effectiveness; quality of life; satisfaction with delivered care; forced expiratory volume in 1 s and forced expiratory flow at 75% and the association of high symptoms scores at baseline and baseline characteristics. Besides, we will conduct identical measurements in a non-randomised sample of children.Ethics and disseminationThis will be the first trial to evaluate the effectiveness of protocolled practice nurse-led care for children with asthma in primary care. The results may lead to improvements in asthma care for children and can be directly implemented in revisions of asthma guidelines.The study protocol was approved by the Medical Research Ethics Committee of the Erasmus Medical Centre in Rotterdam.Trial registrationNTR6847.

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).

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Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial.

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Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial.

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