Table 1.
Approaches to identify influenza infection and illness or their correlates in community-based studies.
Table 2.
Parameter values and ranges of the input values in sensitivity analysis.
Figure 1.
Comparison of alternative study designs.
In the plot, the three rows indicate: (A) power, (B) total sample size per arm, and (C) estimated cumulative incidence of influenza in the control arm. Scenario I assumes the unbiased control non-influenza attack ARI and FARI rates are 0.4 and 0.1 respectively which exactly correspond to estimates made in advance of the study. Scenario II assumes the unbiased control non-influenza attack ARI and FARI rates are 0.4 and 0.1 but are underestimated at 0.2 and 0.06 when planning the study. Scenario III assumes the unbiased control non-influenza attack ARI and FARI rates are 0.4 and 0.1 and but are overestimated at 0.6 and 0.14 when planning the study. Control arm cumulative incidence proportion refers to the expected proportion of participants identified as having influenza infection among the control arm. “Combined” refers to paired serology analyzed by HAI plus RT-PCR upon ARI trigger. Black lines are used to denote design variants using RT-PCR confirmation. Grey lines are used to denote design variants using serologic confirmation or serologic plus RT-PCR confirmation.
Table 3.
Sample size per arm and total budget needed to achieve 80% power for differing methods of identification of influenza infections for both short (2 months) and long (6 months) influenza seasons.