Department of Pediatrics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
Department of Health Research Methods, Evidence, and Impact, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.
BMJ Open. 2022 Nov 17;12(11):e062360. doi: 10.1136/bmjopen-2022-062360.
INTRODUCTION: Evidence-based recommendations for paediatric community-acquired pneumonia (CAP) diagnosis and management are needed. Uncomplicated CAP is often caused by respiratory viruses, especially in younger children; these episodes self-resolve without antibiotic treatment. Unfortunately, there are no clinical criteria that reliably discriminate between viral and bacterial disease, and so the majority of children diagnosed with CAP are given antibiotics-even though these will often not help and may cause harm. We have developed a novel care pathway that incorporates point-of-care biomarkers, radiographic patterns, microbiological testing and targeted follow-up. The primary study objective is to determine if the care pathway will be associated with less antimicrobial prescribing. METHODS AND ANALYSIS: A prospective, before-after, study. Previously well children aged≥6 months presenting to a paediatric emergency department (ED) that have at least one respiratory symptom/sign, receive chest radiography, and are diagnosed with CAP by the ED physician will be eligible. Those with medical comorbidities, recently diagnosed pulmonary infection, or ongoing fever after≥4 days of antimicrobial therapy will be excluded. In the control (before) phase, eligible participants will be managed as per the standard of care. In the intervention (after) phase, eligible participants will be managed as per the novel care pathway. The primary outcome will be the proportion of participants in each phase who receive antimicrobial treatment for CAP. The secondary outcomes include: clinical cure; re-presentation to the ED; hospitalisation; time to resolution of symptoms; drug adverse events; caregiver satisfaction; child absenteeism from daycare/school; and caregiver absenteeism from work. ETHICS AND DISSEMINATION: All study documentation has been approved by the Hamilton Integrated Research Ethics Board and informed consent will be obtained from all participants. Data from this study will be presented at major conferences and published in peer-reviewed publications to facilitate collaborations with networks of clinicians experienced in the dissemination of clinical guidelines. TRIAL REGISTRATION NUMBER: NCT05114161.
简介:需要有循证推荐来指导儿科社区获得性肺炎(CAP)的诊断和管理。不复杂的 CAP 通常由呼吸道病毒引起,尤其是在年幼的儿童中;这些发作无需抗生素治疗即可自行缓解。不幸的是,目前没有可靠的临床标准来区分病毒和细菌疾病,因此大多数被诊断为 CAP 的儿童都接受了抗生素治疗——尽管这些治疗通常没有帮助,而且可能会造成伤害。我们开发了一种新的护理途径,其中包括即时护理生物标志物、影像学模式、微生物学测试和针对性随访。主要研究目标是确定该护理途径是否与减少抗菌药物的使用有关。
方法和分析:一项前瞻性、前后对照研究。先前健康的≥6 个月大的儿童,他们在儿科急诊部门(ED)出现至少一种呼吸道症状/体征,接受胸部 X 光检查,并由 ED 医生诊断为 CAP,将符合入选标准。有合并症的儿童、最近诊断为肺部感染的儿童或在接受≥4 天抗菌治疗后仍持续发热的儿童将被排除在外。在对照(前)阶段,符合条件的参与者将按照标准护理进行管理。在干预(后)阶段,符合条件的参与者将按照新的护理途径进行管理。主要结局是每个阶段接受 CAP 抗菌治疗的参与者比例。次要结局包括:临床治愈;再次到 ED 就诊;住院;症状缓解时间;药物不良反应;护理人员满意度;儿童因疾病缺勤日托/学校;护理人员因疾病缺勤工作。
伦理和传播:所有研究文件均已获得汉密尔顿综合研究伦理委员会的批准,并将获得所有参与者的知情同意。本研究的数据将在主要会议上报告,并发表在同行评议的出版物中,以促进与经验丰富的临床指南传播网络的合作。
试验注册号码:NCT05114161。
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