Centre for Academic Primary Care, School of Social and Community Based Medicine, NIHR School of Primary Care Research, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, UK.
BMC Health Serv Res. 2013 Aug 17;13:322. doi: 10.1186/1472-6963-13-322.
Children with respiratory tract infections are the single most frequent patient group to make use of primary care health care resources. The use of antibiotics remains highly prevalent in young children, but can lead to antimicrobial resistance as well as reinforcing the idea that parents should re-consult for similar symptoms. One of the main drivers of indiscriminate antimicrobial use is the lack of evidence for, and therefore uncertainty regarding, which children are at risk of poor outcome. This paper describes the protocol for the TARGET cohort study, which aims to derive and validate a clinical prediction rule to identify children presenting to primary care with respiratory tract infections who are at risk of hospitalisation.
METHODS/DESIGN: The TARGET cohort study is a large, multicentre prospective observational study aiming to recruit 8,300 children aged ≥3 months and <16 years presenting to primary care with a cough and respiratory tract infection symptoms from 4 study centres (Bristol, London, Oxford and Southampton). Following informed consent, symptoms, signs and demographics will be measured. In around a quarter of children from the Bristol centre, a single sweep, dual bacterial-viral throat swab will be taken and parents asked to complete a symptom diary until the child is completely well or for 28 days, whichever is sooner. A review of medical notes including clinical history, re-consultation and hospitalisations will be undertaken. Multivariable logistic regression will be used to identify the independent clinical predictors of hospitalisation as well as the prognostic significance of upper respiratory tract microbes. The clinical prediction rule will be internally validated using various methods including bootstrapping.
The clinical prediction rule for hospitalisation has the potential to help identify a small group of children for hospitalisation and a much larger group where hospitalisation is very unlikely and antibiotic prescribing would be less warranted. This study will also be the largest natural history study to date of children presenting to primary care with acute cough and respiratory tract infections, and will provide important information on symptom duration, re-consultations and the microbiology of the upper respiratory tract.
患有呼吸道感染的儿童是使用初级保健医疗资源的最常见的单一患者群体。在幼儿中，抗生素的使用仍然非常普遍，但会导致抗菌素耐药性，并强化家长应因类似症状再次咨询的观念。抗生素的无差别使用的一个主要驱动因素是缺乏证据，因此对哪些儿童有不良后果的风险存在不确定性。本文描述了 TARGET 队列研究的方案，该研究旨在制定和验证一种临床预测规则，以识别因呼吸道感染而到初级保健就诊的儿童中具有住院风险的儿童。
方法/设计：TARGET 队列研究是一项大型、多中心的前瞻性观察研究，旨在从 4 个研究中心（布里斯托尔、伦敦、牛津和南安普敦）招募 8300 名年龄≥3 个月且<16 岁的因咳嗽和呼吸道感染症状到初级保健就诊的儿童。在获得知情同意后，将测量症状、体征和人口统计学特征。在来自布里斯托尔中心的四分之一左右的儿童中，将进行一次单侧、双细菌-病毒咽喉拭子采集，并要求家长填写症状日记，直到孩子完全康复或 28 天（以先到者为准）。将对病历进行回顾，包括临床病史、再次就诊和住院情况。将使用多变量逻辑回归来确定住院的独立临床预测因素以及上呼吸道微生物的预后意义。将使用各种方法（包括自举法）对内部分类规则进行内部验证。
该住院临床预测规则有可能帮助识别一小部分需要住院的儿童，以及很大一部分不太可能住院且抗生素处方不太合理的儿童。这项研究也将是迄今为止最大的在初级保健就诊的急性咳嗽和呼吸道感染儿童的自然史研究，将提供有关症状持续时间、再次就诊和上呼吸道微生物学的重要信息。
