Prediction of disease severity in young children presenting with acute febrile illness in resource-limited settings: a protocol for a prospective observational study.
Prediction of disease severity in young children presenting with acute febrile illness in resource-limited settings: a protocol for a prospective observational study.
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在资源有限的环境下，对表现为急性发热性疾病的幼儿疾病严重程度的预测：一项前瞻性观察性研究的方案。
DOI：
10.1136/bmjopen-2020-045826
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发表时间：
2021-01-25
期刊：
影响因子：
2.9
通讯作者：
Lubell Y
中科院分区：
文献类型：
--
作者：
Chandna A;Aderie EM;Ahmad R;Arguni E;Ashley EA;Cope T;Dat VQ;Day NPJ;Dondorp AM;Illanes V;De Jesus J;Jimenez C;Kain K;Suy K;Koshiaris C;Lasry E;Mayxay M;Mondal D;Perera R;Pongvongsa T;Rattanavong S;Rekart M;Richard-Greenblatt M;Shomik M;Souvannasing P;Tallo V;Turner C;Turner P;Waithira N;Watson JA;Yosia M;Burza S;Lubell Y
在农村和交通困难的地区，及早准确地识别有发展为严重疾病风险的发热儿童可能有助于改善患者的治疗结果和更好的资源分配。本研究旨在开发一种预后临床预测工具，以帮助社区医疗保健提供者识别可能受益于转诊或入院医疗护理的发热儿童。这项前瞻性观察性研究将招募至少 4900 名 5 岁以下的住院和门诊儿科患者，这些患者在亚洲 6 个国家的 7 家医院出现急性发热性疾病。从每位参与者身上采集静脉血样本和鼻咽拭子，并在就诊时以及住院患者入院前 48 小时内每天记录详细的临床数据。在参考实验室进行多分析物测定，以测量一组宿主生物标志物，并对常见细菌和病毒病原体进行有针对性的病原学调查。临床结果在第 2 天和第 28 天确定。将描述和比较不同地点的急性发热性疾病的症状、临床结果和病因。遵循预测模型构建的最新指南，将得出一个预后临床预测模型，该模型结合了简单的临床特征和宿主生物标志物的测量，并在地理上进行外部验证。该模型的性能将根据具体的临床症状和发热病因进行评估。该研究已获得所有相关国际、国家和机构伦理委员会的批准。所有参与者的看护人均提供书面知情同意书。结果将与地方和国家利益相关者分享，并通过同行评审的开放获取期刊和科学会议进行传播。 NCT04285021。
In rural and difficult-to-access settings, early and accurate recognition of febrile children at risk of progressing to serious illness could contribute to improved patient outcomes and better resource allocation. This study aims to develop a prognostic clinical prediction tool to assist community healthcare providers identify febrile children who might benefit from referral or admission for facility-based medical care. This prospective observational study will recruit at least 4900 paediatric inpatients and outpatients under the age of 5 years presenting with an acute febrile illness to seven hospitals in six countries across Asia. A venous blood sample and nasopharyngeal swab is collected from each participant and detailed clinical data recorded at presentation, and each day for the first 48 hours of admission for inpatients. Multianalyte assays are performed at reference laboratories to measure a panel of host biomarkers, as well as targeted aetiological investigations for common bacterial and viral pathogens. Clinical outcome is ascertained on day 2 and day 28. Presenting syndromes, clinical outcomes and aetiology of acute febrile illness will be described and compared across sites. Following the latest guidance in prediction model building, a prognostic clinical prediction model, combining simple clinical features and measurements of host biomarkers, will be derived and geographically externally validated. The performance of the model will be evaluated in specific presenting clinical syndromes and fever aetiologies. The study has received approval from all relevant international, national and institutional ethics committees. Written informed consent is provided by the caretaker of all participants. Results will be shared with local and national stakeholders, and disseminated via peer-reviewed open-access journals and scientific meetings. NCT04285021.
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