Abstract：
Monitoring the real-life effectiveness of respiratory syncytial virus (RSV) products is of major public health importance. This generic protocol for a test-negative design study aims to address currently envisioned approaches for RSV prevention (monoclonal antibodies and vaccines) to study effectiveness of these products among target groups: children, older adults, and pregnant women. The generic protocol approach was chosen to allow for flexibility in adapting the protocol to a specific setting. This protocol includes severe acute respiratory infection (SARI) and acute respiratory infection (ARI), both due to RSV, as end points. These end points can be applied to studies in hospitals, primarily targeting patients with more severe disease, but also to studies in general practitioner clinics targeting ARI.
摘要：
监测呼吸道合胞病毒（RSV）产品的实际有效性具有重要的公共卫生意义。这种测试阴性设计研究的通用方案旨在解决当前设想的RSV预防方法（单克隆抗体和疫苗），以研究这些产品在目标群体中的有效性：儿童，老年人和孕妇。选择通用协议方法以允许在使协议适应特定设置时的灵活性。该方案包括严重急性呼吸道感染（SARI）和急性呼吸道感染（ARI），都是因为RSV,作为端点。这些终点可以应用于医院的研究，主要针对疾病更严重的患者，而且还针对针对ARI的全科医生诊所的研究。
