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Abstract：
No previous studies have validated current clinical practice guidelines for the management of non-blanching rashes in children who have received meningococcal B and C vaccinations. The aim of this study was to evaluate the performance of existing clinical practice guidelines in the diagnosis of invasive meningococcal disease in children presenting with a fever and non-blanching rash in the UK.
The Petechiae in Children (PiC) study was a prospective, multicentre cohort study involving children (aged <18 years) presenting to 37 paediatric emergency departments in the UK with a fever (≥38°C) and a new-onset non-blanching rash or features suggestive of meningococcal infection. Children with pre-existing haematological conditions (ie, haematological malignancy, idiopathic thrombocytopenic purpura, or coagulopathy) or an existing diagnosis of Henoch-Schonlein purpura were excluded. Invasive meningococcal disease was confirmed by positive culture or a quantitative PCR test for Neisseria meningitidis from either blood or cerebrospinal fluid samples. The primary outcome was the performance of six tailored clinical practice guidelines from participating centres (London, Nottingham, Newcastle-Birmingham-Liverpool, Glasgow, Chester, and Bristol) and two clinical practice guidelines from the National Institutes for Health and Care Excellence (NICE; CG102 and NG51) in identifying children with invasive meningococcal disease, assessed by the sensitivity and specificity of each clinical practice guideline. This study is registered with ClinicalTrials.gov, NCT03378258.
Between Nov 9, 2017, and June 30, 2019, 1513 patients were screened, of whom 1329 were eligible and were included in the analysis. The median age of patients was 24 months (IQR 12-48). 1137 (86%) of 1329 patients had a blood test and 596 (45%) received parenteral antibiotics. 19 (1%) patients had confirmed meningococcal disease. All eight clinical practice guidelines had a sensitivity of 1·00 (95% CI 0·82-1·00) for identifying meningococcal disease. The specificities of NICE guidelines CG102 (0·01 [95% CI 0·01-0·02]) and NG51 (0·00 [0·00-0·00]) for identifying meningococcal disease were significantly lower than that of tailored clinical practice guidelines (p<0·0001). The best performing clinical practice guidelines for identifying meningococcal disease were the London (specificity 0·36 [0·34-0·39]) and Nottingham (0·34 [0·32-0·37]) clinical practice guidelines.
Invasive meningococcal disease is a rare cause of non-blanching rashes in children presenting to the emergency department in the UK. Current NICE guidelines perform poorly when compared with tailored clinical practice guidelines. These findings suggest that UK national guidance could be improved by shifting towards a tailored approach.
Public Health Agency.
The Petechiae in Children (PiC) study was a prospective, multicentre cohort study involving children (aged <18 years) presenting to 37 paediatric emergency departments in the UK with a fever (≥38°C) and a new-onset non-blanching rash or features suggestive of meningococcal infection. Children with pre-existing haematological conditions (ie, haematological malignancy, idiopathic thrombocytopenic purpura, or coagulopathy) or an existing diagnosis of Henoch-Schonlein purpura were excluded. Invasive meningococcal disease was confirmed by positive culture or a quantitative PCR test for Neisseria meningitidis from either blood or cerebrospinal fluid samples. The primary outcome was the performance of six tailored clinical practice guidelines from participating centres (London, Nottingham, Newcastle-Birmingham-Liverpool, Glasgow, Chester, and Bristol) and two clinical practice guidelines from the National Institutes for Health and Care Excellence (NICE; CG102 and NG51) in identifying children with invasive meningococcal disease, assessed by the sensitivity and specificity of each clinical practice guideline. This study is registered with ClinicalTrials.gov, NCT03378258.
Between Nov 9, 2017, and June 30, 2019, 1513 patients were screened, of whom 1329 were eligible and were included in the analysis. The median age of patients was 24 months (IQR 12-48). 1137 (86%) of 1329 patients had a blood test and 596 (45%) received parenteral antibiotics. 19 (1%) patients had confirmed meningococcal disease. All eight clinical practice guidelines had a sensitivity of 1·00 (95% CI 0·82-1·00) for identifying meningococcal disease. The specificities of NICE guidelines CG102 (0·01 [95% CI 0·01-0·02]) and NG51 (0·00 [0·00-0·00]) for identifying meningococcal disease were significantly lower than that of tailored clinical practice guidelines (p<0·0001). The best performing clinical practice guidelines for identifying meningococcal disease were the London (specificity 0·36 [0·34-0·39]) and Nottingham (0·34 [0·32-0·37]) clinical practice guidelines.
Invasive meningococcal disease is a rare cause of non-blanching rashes in children presenting to the emergency department in the UK. Current NICE guidelines perform poorly when compared with tailored clinical practice guidelines. These findings suggest that UK national guidance could be improved by shifting towards a tailored approach.
Public Health Agency.
摘要：
以前没有研究验证当前的临床实践指南，以管理接受脑膜炎球菌B和C疫苗接种的儿童的非漂白性皮疹。这项研究的目的是评估现有临床实践指南在诊断英国发烧和非皮疹儿童的侵袭性脑膜炎球菌疾病中的表现。
儿童瘀斑(PiC)研究是一项前瞻性研究，多中心队列研究涉及到英国37个儿科急诊科就诊的儿童（年龄<18岁），发烧（≥38°C）和新发的非热斑皮疹或提示脑膜炎球菌感染的特征。先前存在血液学疾病的儿童（即，血液恶性肿瘤，特发性血小板减少性紫癜,或凝血病）或排除现有的过敏性紫癜诊断。通过血液或脑脊液样本中脑膜炎奈瑟菌的阳性培养或定量PCR测试证实了侵袭性脑膜炎球菌疾病。主要结果是来自参与中心的六个量身定制的临床实践指南的表现（伦敦，诺丁汉,纽卡斯尔-伯明翰-利物浦,格拉斯哥，切斯特,和布里斯托尔）和美国国立卫生与护理研究院（NICE；CG102和NG51）的两项临床实践指南，用于识别患有侵袭性脑膜炎球菌病的儿童，通过每个临床实践指南的敏感性和特异性进行评估。这项研究在ClinicalTrials.gov注册，NCT03378258。
在2017年11月9日至2019年6月30日之间，对1513名患者进行了筛查，其中1329人符合资格，并被纳入分析。患者的中位年龄为24个月(IQR12-48)。1329名患者中有1137名（86％）接受了血液检查，596名（45％）接受了肠胃外抗生素治疗。19例（1%）患者确诊为脑膜炎球菌病。所有8个临床实践指南对确定脑膜炎球菌疾病的敏感性均为1·00（95％CI0·82-1·00）。NICE指南CG102(0·01[95%CI0·01-0·02])和NG51(0·00[0·00-0·00])鉴别脑膜炎球菌疾病的特异性显著低于定制临床实践指南(p<0·0001)。识别脑膜炎球菌疾病的最佳临床实践指南是伦敦（特异性0·36[0·34-0·39]）和诺丁汉（0·34[0·32-0·37]）临床实践指南。
在英国急诊就诊的儿童中，侵袭性脑膜炎球菌病是一种罕见的非白斑性皮疹的病因。与量身定制的临床实践指南相比，当前的NICE指南表现不佳。这些发现表明，可以通过转向量身定制的方法来改善英国的国家指南。
公共卫生机构。
儿童瘀斑(PiC)研究是一项前瞻性研究，多中心队列研究涉及到英国37个儿科急诊科就诊的儿童（年龄<18岁），发烧（≥38°C）和新发的非热斑皮疹或提示脑膜炎球菌感染的特征。先前存在血液学疾病的儿童（即，血液恶性肿瘤，特发性血小板减少性紫癜,或凝血病）或排除现有的过敏性紫癜诊断。通过血液或脑脊液样本中脑膜炎奈瑟菌的阳性培养或定量PCR测试证实了侵袭性脑膜炎球菌疾病。主要结果是来自参与中心的六个量身定制的临床实践指南的表现（伦敦，诺丁汉,纽卡斯尔-伯明翰-利物浦,格拉斯哥，切斯特,和布里斯托尔）和美国国立卫生与护理研究院（NICE；CG102和NG51）的两项临床实践指南，用于识别患有侵袭性脑膜炎球菌病的儿童，通过每个临床实践指南的敏感性和特异性进行评估。这项研究在ClinicalTrials.gov注册，NCT03378258。
在2017年11月9日至2019年6月30日之间，对1513名患者进行了筛查，其中1329人符合资格，并被纳入分析。患者的中位年龄为24个月(IQR12-48)。1329名患者中有1137名（86％）接受了血液检查，596名（45％）接受了肠胃外抗生素治疗。19例（1%）患者确诊为脑膜炎球菌病。所有8个临床实践指南对确定脑膜炎球菌疾病的敏感性均为1·00（95％CI0·82-1·00）。NICE指南CG102(0·01[95%CI0·01-0·02])和NG51(0·00[0·00-0·00])鉴别脑膜炎球菌疾病的特异性显著低于定制临床实践指南(p<0·0001)。识别脑膜炎球菌疾病的最佳临床实践指南是伦敦（特异性0·36[0·34-0·39]）和诺丁汉（0·34[0·32-0·37]）临床实践指南。
在英国急诊就诊的儿童中，侵袭性脑膜炎球菌病是一种罕见的非白斑性皮疹的病因。与量身定制的临床实践指南相比，当前的NICE指南表现不佳。这些发现表明，可以通过转向量身定制的方法来改善英国的国家指南。
公共卫生机构。
