Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol.
Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol.
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DOI：
10.1186/s12879-018-3444-7
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发表时间：
2018-11-06
影响因子：
3.7
通讯作者：
SHIRI workgroup
中科院分区：
文献类型：
--
作者：
Hirsch A;Katz MA;Laufer Peretz A;Greenberg D;Wendlandt R;Shemer Avni Y;Newes-Adeyi G;Gofer I;Leventer-Roberts M;Davidovitch N;Rosenthal A;Gur-Arie R;Hertz T;Glatman-Freedman A;Monto AS;Azziz-Baumgartner E;Ferdinands JM;Martin ET;Malosh RE;Neyra Quijandría JM;Levine M;Campbell W;Balicer R;Thompson MG;SHIRI workgroup
以色列流感和其他呼吸道病毒医护人员研究（SHIRI）前瞻性跟踪了以色列两家医院的医护人员（HCP）队列。SHIRI将描述HCP中流感病毒感染的频率，确定疫苗接受的预测因素，检查重复流感疫苗接种如何改变免疫原性，并评价流感疫苗在预防流感疾病和漏诊方面的有效性。队列入组于2016年10月开始;研究的第二年和第二波队列入组于2017年6月开始。本研究将运行至少3年，并将随访约2000名HCP（既是Clalit Health Services [CHS]的员工也是成员），并与患者进行常规直接接触。采用分层抽样策略招募合格HCP。在知情同意后，参与者完成了一个简短的招募调查，其中包括有关流感疫苗的职业责任和知识，态度和实践的问题。在入组时和流感季节结束时采集血液样本;选择接种疫苗的HCP在接种疫苗后一个月提供额外的血液。在流感季节，参与者每周收到两次短信服务（SMS）信息，询问他们是否有急性呼吸道疾病或发热性疾病（ARFI）症状。患病的参与者会收到后续短信，以确认疾病症状和持续时间，并被要求自行采集鼻拭子。有关社会经济特征、当前和过去的医疗状况、医疗服务利用和疫苗接种史的信息从CHS数据库中提取。有关因病缺勤的信息通过自我报告和员工记录获得。采用经验证的多重定量实时逆转录聚合酶链反应检测试剂盒，对自采集鼻拭子的呼吸道标本进行甲型和B型流感病毒、呼吸道合胞病毒、人偏肺病毒和冠状病毒检测。血凝抑制试验将用于检测血清中是否存在中和流感抗体。SHIRI将扩大我们对HCP中呼吸道病毒感染负担的了解，以及当前和重复的年度流感疫苗接种在预防与患者直接接触的HCP中流感疾病、医疗利用和错过工作日方面的有效性。NCT 03331991。于2017年11月6日注册。本文的在线版本（10.1186/s12879-018-3444-7）包含补充材料，可供授权用户使用。
The Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI) prospectively follows a cohort of healthcare personnel (HCP) in two hospitals in Israel. SHIRI will describe the frequency of influenza virus infections among HCP, identify predictors of vaccine acceptance, examine how repeated influenza vaccination may modify immunogenicity, and evaluate influenza vaccine effectiveness in preventing influenza illness and missed work. Cohort enrollment began in October, 2016; a second year of the study and a second wave of cohort enrollment began in June 2017. The study will run for at least 3 years and will follow approximately 2000 HCP (who are both employees and members of Clalit Health Services [CHS]) with routine direct patient contact. Eligible HCP are recruited using a stratified sampling strategy. After informed consent, participants complete a brief enrollment survey with questions about occupational responsibilities and knowledge, attitudes, and practices about influenza vaccines. Blood samples are collected at enrollment and at the end of influenza season; HCP who choose to be vaccinated contribute additional blood one month after vaccination. During the influenza season, participants receive twice-weekly short message service (SMS) messages asking them if they have acute respiratory illness or febrile illness (ARFI) symptoms. Ill participants receive follow-up SMS messages to confirm illness symptoms and duration and are asked to self-collect a nasal swab. Information on socio-economic characteristics, current and past medical conditions, medical care utilization and vaccination history is extracted from the CHS database. Information about missed work due to illness is obtained by self-report and from employee records. Respiratory specimens from self-collected nasal swabs are tested for influenza A and B viruses, respiratory syncytial virus, human metapneumovirus, and coronaviruses using validated multiplex quantitative real-time reverse transcription polymerase chain reaction assays. The hemagglutination inhibition assay will be used to detect the presence of neutralizing influenza antibodies in serum. SHIRI will expand our knowledge of the burden of respiratory viral infections among HCP and the effectiveness of current and repeated annual influenza vaccination in preventing influenza illness, medical utilization, and missed workdays among HCP who are in direct contact with patients. NCT03331991. Registered on November 6, 2017. The online version of this article (10.1186/s12879-018-3444-7) contains supplementary material, which is available to authorized users.
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