Reducing Transmission of Influenza by Face Masks

描述（由申请方提供）：将在随机干预中评价单独佩戴口罩或与手部卫生分层佩戴口罩在减少流感发生率方面的有效性。这项研究将在密歇根大学住在大学宿舍的学生中进行。将按照饲养单元进行随机化。第一年，将招募750名学生单独使用口罩，750名学生使用口罩和手部卫生，750名学生作为观察对照组。参与者总数将达到2，250人。两个小宿舍，6个较大的宿舍，和一个复杂的10个组成部分的单位已被确定为适合研究。住在每个宿舍的学生将被问到他们是否愿意参加这项研究。提供知情同意的患者将被要求每周完成一次调查，以确定疾病发生情况。当流感疾病被记录在大学环境中发生时，将实施干预措施。在此期间，将扩大调查范围，以包括有关干预措施使用情况的问题，视具体住房单元情况而定。此外，在此期间，那些患有符合病例定义的疾病的人将被要求提供病毒鉴定样本。该集合将不限于那些同意使用干预措施的人。所有居住在参与住房单元的人在知情同意后都有资格参加。有了这个样本量，就有可能检测到干预组和对照组之间减少了40%。在大流行期间，这种减少可能会对公共卫生产生重大影响。在第二年，研究可以根据第一年的发现进行扩展或修改。

DESCRIPTION (provided by applicant): The effectiveness in reducing influenza occurrence with use of face masks worn alone, or layered with hand hygiene will be evaluated in a randomized intervention. The study will be carried out among University of Michigan students living in University housing. Randomization will be by housing unit. In the first year, 750 students will be recruited to use face masks alone, 750 will use face masks and hand hygiene, and 750 will serve as an observed comparison group. Total number of participants will 2,250. Two small dormitories, 6 larger ones, and one complex with 10 component units have been identified as suitable for the study. Students living in each of the residence halls will be asked if they wish to participate in the study. Those giving informed consent will be asked to complete a survey each week to ascertain illness occurrence. When influenza illness is documented to be occurring in the University setting, the interventions will be implemented. During that period, the survey will be expanded to include questions on intervention use, as appropriate to the particular housing unit. Also during this period, those with illnesses meeting a case definition will be asked to provide specimens for the virus identification. This collection will not be limited to those agreeing to the use of the interventions. All living in the participating housing units will be eligible, after they give informed consent. With this sample size, it will be possible to detect a 40% reduction between those in an intervention group and the control group. Such a reduction could have a major public health impact during a pandemic. In the second year, the study can be expanded or modified based on findings in the first.