Li Xianzhi, Wang Qiuxia, Chen Zhenhua, Duan Xiaoxia, Han Yutong, Luan Rongsheng, Long Lu
Department of Epidemiology and Health Statistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu.
Department of Radiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan.
Medicine (Baltimore). 2020 Jul 17;99(29):e21258. doi: 10.1097/MD.0000000000021258.
Hand, foot, and mouth disease (HFMD) has been an important public health concern worldwide, especially in the Asia-Pacific region. Unfortunately, the effect of current measures on preventing and controlling HFMD may be limited. Isolation of infectious sources is reported as an important way to prevent and control this disease. The isolation period is determined on the basis of duration of viral shedding in patients with HFMD. However, the results of previous researches on duration of viral shedding remain controversial. Here, we present a protocol of a systematic review and single-arm meta-analysis for assessing the duration of viral shedding in patients with HFMD induced by Enterovirus 71 (EV71), Coxsackievirus A16 (CA16), or Coxsackievirus A6 (CA6).
A comprehensive literature search will be performed in PubMed, EMBASE, the Cochrane library, Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), and Wanfang Database, covering the period from inception to May 1, 2019. Point estimate of positive rate with corresponding 95% confidence intervals (CIs) of EV71, CA16, or CA6 in HFMD patients' fecal or throat samples will be carried out using STATA 14.0. Subgroup analyses will be performed for mild cases, severe cases, and close contacts. Sensitive analysis will also be performed to evaluate the influences of individual studies on the final effect by exclusion of a few articles of poor quality. We will assess the risk of bias for the final studies included in our meta-analysis using previously available tools and the modified risk of bias tool.
The results of this systematic review and meta-analysis will be published in a peer-reviewed journal.
To the best of our knowledge, this paper will be the first systematic review and meta-analysis for assessing the duration of viral shedding in patients with HFMD induced by EV71, CA16, or CA6. The conclusions drawn from this review will provide the scientific basis to formulate the isolation period of HFMD.
Ethical review is not required as this article is for a systematic review since there is no direct involvement of patients in the whole process. We will publish the results of this systematic review and meta-analysis of single-arm studies in a peer-reviewed journal.
Prospero CRD42020139999.
手足口病（HFMD）一直是全球重要的公共卫生问题，尤其是在亚太地区。不幸的是，当前防控手足口病措施的效果可能有限。报告称隔离传染源是防控该疾病的重要途径。隔离期是根据手足口病患者的病毒排毒持续时间确定的。然而，先前关于病毒排毒持续时间的研究结果仍存在争议。在此，我们提出一项系统评价和单臂荟萃分析方案，以评估由肠道病毒71型（EV71）、柯萨奇病毒A16型（CA16）或柯萨奇病毒A6型（CA6）引起的手足口病患者的病毒排毒持续时间。
将在PubMed、EMBASE、考克兰图书馆、中国知网（CNKI）、中国生物医学文献数据库（CBM）和万方数据库中进行全面的文献检索，涵盖从创刊到2019年5月1日的时间段。使用STATA 14.0对手足口病患者粪便或咽喉样本中EV71、CA16或CA6的阳性率点估计值及相应的95%置信区间（CIs）进行分析。将对轻症病例、重症病例和密切接触者进行亚组分析。还将进行敏感性分析，通过排除少数质量较差的文章来评估个别研究对最终结果的影响。我们将使用先前可用的工具和改良的偏倚风险工具评估纳入荟萃分析的最终研究的偏倚风险。
本系统评价和荟萃分析的结果将发表在同行评审期刊上。
据我们所知，本文将是第一项评估由EV71、CA16或CA6引起的手足口病患者病毒排毒持续时间的系统评价和荟萃分析。本综述得出的结论将为制定手足口病的隔离期提供科学依据。
由于本文是一项系统评价，整个过程中没有患者直接参与，因此无需伦理审查。我们将在同行评审期刊上发表这项单臂研究的系统评价和荟萃分析结果。
Prospero CRD42020139999。
