Centre for Academic Primary Care, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK.
Bristol Trials Centre (Bristol Randomised Trial Collaboration), Bristol Medical School, University of Bristol, University of Bristol, Bristol, Avon, UK.
BMJ Open. 2021 Mar 29;11(3):e041769. doi: 10.1136/bmjopen-2020-041769.
Respiratory tract infections (RTIs) in children are common and present major resource implications for primary care. Unnecessary use of antibiotics is associated with the development and proliferation of antimicrobial resistance. In 2016, the National Institute for Health Research (NIHR)-funded 'TARGET' programme developed a prognostic algorithm to identify children with acute cough and RTI at very low risk of 30-day hospitalisation and unlikely to need antibiotics. The intervention includes: (1) explicit elicitation of parental concerns, (2) the results of the prognostic algorithm accompanied by prescribing guidance and (3) provision of a printout for carers including safety netting advice. The CHIldren's COugh feasibility study suggested differential recruitment of healthier patients in control practices. This phase III 'efficiently designed' trial uses routinely collected data at the practice level, thus avoiding individual patient consent. The aim is to assess whether embedding a multifaceted intervention into general practitioner (GP) practice Information Technology (IT) systems will result in reductions of antibiotic prescribing without impacting on hospital attendance for RTI.
The coprimary outcomes are (1) practice rate of dispensed amoxicillin and macrolide antibiotics, (2) hospital admission rate for RTI using routinely collected data by Clinical Commissioning Groups (CCGs). Data will be collected for children aged 0-9 years registered at 310 practices (155 intervention, 155 usual care) over a 12-month period. Recruitment and randomisation of practices (using the Egton Medical Information Systems web data management system) is conducted via each CCG stratified for children registered and baseline dispensing rates of each practice. Secondary outcomes will explore intervention effect modifiers. Qualitative interviews will explore intervention usage. The economic evaluation will be limited to a between-arm comparison in a cost-consequence analysis.
Research ethics approval was given by London-Camden and Kings Cross Research Ethics Committee (ref:18/LO/0345). This manuscript refers to protocol V.4.0. Results will be disseminated through peer-reviewed journals and international conferences.
ISRCTN11405239.
儿童呼吸道感染（RTI）很常见，给初级保健带来了巨大的资源负担。不必要地使用抗生素与抗菌药物耐药性的产生和传播有关。2016 年，英国国家卫生与保健研究所（NIHR）资助的“TARGET”项目开发了一种预测算法，以识别急性咳嗽和 RTI 患儿，这些患儿在 30 天内住院的风险极低，不太可能需要使用抗生素。该干预措施包括：（1）明确了解父母的担忧，（2）预测算法的结果，并附有处方指导，（3）为照顾者提供一份包括安全网建议的打印件。儿童咳嗽可行性研究表明，对照组中招募的患者健康状况更好。本项 III 期“高效设计”试验利用实践层面的常规数据收集，因此避免了对患者的个体知情同意。其目的是评估将多方面的干预措施嵌入全科医生（GP）实践信息技术（IT）系统是否会减少抗生素的使用，而不会影响因 RTI 而住院的人数。
主要结局指标是：（1）开具阿莫西林和大环内酯类抗生素的实践率；（2）通过临床委托组（CCG）常规收集的数据计算 RTI 的住院率。将在 310 个实践点（155 个干预组，155 个常规护理组）招募年龄在 0-9 岁的儿童，为期 12 个月。实践点的招募和随机分组（使用 Egton Medical Information Systems 网络数据管理系统）通过每个 CCG 进行分层，根据儿童登记情况和每个实践点的初始配药率分层。次要结局指标将探索干预措施的效应修饰剂。定性访谈将探索干预措施的使用情况。经济评价将仅限于成本-效果分析中的臂间比较。
伦敦-卡姆登和国王十字研究伦理委员会（编号：18/LO/0345）已批准该研究。本文引用了方案 V.4.0。结果将通过同行评议期刊和国际会议进行传播。
ISRCTN11405239。
