Centre for Trials Research, Cardiff University, Cardiff, UK.
Division of Population Medicine, National Centre for Population Health and Wellbeing Research, Cardiff University, Cardiff, UK.
BMJ Open. 2019 Apr 20;9(4):e024210. doi: 10.1136/bmjopen-2018-024210.
Current guidelines advise the prompt diagnosis and treatment of urinary tract infection (UTI) in children to improve both short and longer term outcomes. However, the risk of long-term complications following childhood UTI is unclear.UTI is relatively common but difficult to diagnose in children as symptoms are non-specific. Diagnosis requires a urine sample, but sampling is difficult and infrequent, and it is not clear if sampling should be given greater priority in primary care. The LUCI study will assess the short, medium and longer term outcomes of childhood UTI associated with routine and systematic sampling practices.
Two data sets will be established. The first will consist of routinely collected data (hospital, general practice (GP), microbiology) from children born and resident in Wales, linked via the Secure Anonymised Information Linkage (SAIL) Databank (an 'e-cohort'). Urine sampling in this data set reflects normal practice 'routine sampling'. Outcomes (including renal scarring, hypertension, end-stage renal failure, hospital admissions, GP consultations, antibiotic prescriptions) for children with at least one UTI confirmed with microbiological culture (mcUTI) or no mcUTI before the age of 5 will be compared.The second will combine data from two prospective observational studies ('DUTY' and 'EURICA') employing systematic urine sampling for children presenting to primary care with acute, undifferentiated illness, linked to routine data via SAIL (Wales) and NHS Digital (England). Outcomes (as above, plus features of mcUTI) for children with an mcUTI in this data set, identified through systematic urine sampling, will be compared with those with an mcUTI identified through routine urine sampling (data set 1).
The study protocol has been approved by NHS Wales Research Ethics Committee and the Health Research Authority's Confidentiality Advisory Group. Methods of innovative study design and findings will be disseminated through peer-review journals and conferences. Results will be of interest to clinical and policy stakeholders in the UK.
目前的指南建议及时诊断和治疗儿童尿路感染（UTI），以改善短期和长期预后。然而，儿童 UTI 后长期并发症的风险尚不清楚。UTI 在儿童中相对常见，但难以诊断，因为症状不特异。诊断需要尿液样本，但采样困难且不频繁，目前尚不清楚在初级保健中是否应优先进行采样。LUCI 研究将评估与常规和系统采样实践相关的儿童 UTI 的短期、中期和长期结局。
将建立两个数据集。第一个数据集将由威尔士出生和居住的儿童的常规收集数据（医院、全科医生（GP）、微生物学）组成，通过安全匿名信息链接（SAIL）数据库（电子队列）链接。该数据集的尿液采样反映了常规实践“常规采样”。将比较至少有一次经微生物学培养证实的 UTI（mcUTI）或 5 岁前无 mcUTI 的儿童的结局（包括肾脏瘢痕形成、高血压、终末期肾衰竭、住院、全科医生就诊、抗生素处方）。第二个数据集将结合两项前瞻性观察性研究（“DUTY”和“EURICA”）的数据，这些研究对因急性、未分化疾病就诊于初级保健的儿童进行系统尿液采样，并通过 SAIL（威尔士）和 NHS Digital（英格兰）与常规数据链接。将比较通过系统尿液采样在该数据集中识别的 mcUTI 儿童与通过常规尿液采样（数据集 1）识别的 mcUTI 儿童的结局（如上所述，外加 mcUTI 的特征）。
该研究方案已获得 NHS 威尔士研究伦理委员会和卫生研究管理局保密咨询小组的批准。创新性研究设计和发现方法将通过同行评审期刊和会议进行传播。结果将引起英国临床和政策利益相关者的兴趣。
