Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI): study protocol.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: NCT03331991 . Registered on November 6, 2017.

Knowledge, attitudes and practices related to the influenza virus and vaccine among older adults in Eastern China.

BACKGROUND: This study aims to assess the association between socio-demographic and health characteristics of older adults in Eastern China and knowledge, attitudes, and practices (KAP) about the influenza virus and vaccine. METHODS: A prospective cohort of 1506 older adults (aged ≥60 years) was enrolled from November to December 2015 in Jiangsu Province. We examined the association between demographics, health and functional status, and cognitive impairment at enrollment with awareness of influenza virus and vaccine and KAP items focused on five Health Belief Model domains. At a 12-month follow-up interview we assessed change in awareness and readiness to be vaccinated. RESULTS: One in five older adults was aware of the influenza virus (21%) or vaccine (20%); even fewer reported having at least "a little" knowledge of the virus and vaccine (7% and 4%, respectively); less than 1% reported ever receiving an influenza vaccine. Retirement, higher education and income, and normal cognitive status were consistently associated with both awareness and knowledge of influenza virus. The odds of having at least "a little" knowledge of the vaccine was 2.9-fold (95% CI = 1.6-5.3) higher among older adults with at least some secondary schooling. Among the 108 with knowledge of the virus, 55% said they "worry about getting the flu this season." Among the 73 with knowledge of the vaccine, 92% believed the vaccine was at least somewhat effective and less than half (43%) thought that influenza vaccination was safe. At a 12-month follow-up interview, 33% (442/1333) increased from no knowledge to at least "a little". CONCLUSIONS: If and when influenza vaccines become widely available to older adults in China, our results indicate that influenza vaccination campaigns with basic information on the virus and vaccine could be beneficial for all older adults, especially those with less education and/or more cognitive impairment.

Variability in IRBs regarding parental acceptance of passive consent.

OBJECTIVE: Passive, opt-out recruitment strategies have the potential to improve efficiency and enlarge the participant pool for clinical studies. We report on the feasibility of using a passive consent strategy for a multicenter pediatric study. METHODS: We assessed the response to passive and active control recruitment strategies used in a multicenter pediatric cohort study and describe the variability in acceptance among institutional review boards (IRBs) and parents of pediatric patients. RESULTS: Twenty-six pediatric centers submitted IRB applications; 24 centers participated. Sixteen IRBs approved the proposed passive recruitment strategy, and 6 IRBs required active consent strategies; 2 centers used a modified participation mode using control subjects from neighboring centers. In all, 4529 potential participants were identified across 22 centers. In the pre-enrollment phase, opt-out rates were significantly lower in the passive consent group compared with the active recruitment centers (1.6% vs. 11.8%; P < .001). During the enrollment phase, however, refusal rates in the passive consent group were significantly higher (38.1% vs. 12.2%; P = .004). The overall refusal rate across both groups was 33.3%. CONCLUSIONS: IRB variability in interpretation and application of regulations affects consistency of study procedure across sites and may reduce validity of study findings. Opt-out consent allowed us to create a large representative pool of control subjects. Parents were more likely to refuse to be approached for a study in the pre-enrollment phase when active consent was used, but were more likely to decline actual study enrollment when passive consent was used in the pre-enrollment period.