Based on currently available information, cases have mainly but not exclusively been identified amongst men who have sex with men (MSM) seeking care in primary care and sexual health clinics. Reported cases thus far have no established travel links to an endemic area. Geographical distribution of confirmed and suspected cases of monkeypox in non-endemic between 13 to, as at 13:00. Cases of monkeypox in non-endemic countries reported to WHO between 13 to as at 13:00įigure 1. No associated deaths have been reported to date. WHO will be providing more technical recommendations in the coming days.Īs of 21 May, 13:00, 92 laboratory confirmed cases, and 28 suspected cases of monkeypox with investigations ongoing, have been reported to WHO from 12 Member States that are not endemic for monkeypox virus, across three WHO regions (Table 1, Figure 1). WHO is also working to provide guidance to protect frontline health care providers and other health workers who may be at risk such as cleaners. Current available evidence suggests that those who are most at risk are those who have had close physical contact with someone with monkeypox, while they are symptomatic. Immediate actions focus on informing those who may be most at risk for monkeypox infection with accurate information, in order to stop further spread. The situation is evolving and WHO expects there will be more cases of monkeypox identified as surveillance expands in non-endemic countries. The objective of this Disease Outbreak News is to raise awareness, inform readiness and response efforts, and provide technical guidance for immediate recommended actions. Epidemiological investigations are ongoing, however, reported cases thus far have no established travel links to endemic areas. A clinical trial example is given to illustrate the methods.Since, cases of monkeypox have been reported to WHO from 12 Member States that are not endemic for monkeypox virus, across three WHO regions. The Pocock boundary may be replaced by the ad hoc boundary for the secondary endpoint with a very little loss of secondary power if the practical concern is at issue. Numerical studies indicate that the O'Brien–Fleming boundary for the primary endpoint and the Pocock boundary for the secondary endpoint generally gives the best primary as well as secondary power performance. An ad hoc boundary is proposed for the secondary endpoint to address a practical concern that may be at issue in some applications. For the four combinations consisting of O'Brien–Fleming and Pocock boundaries for the primary and secondary endpoints, the critical constants required to control the FWER are computed for different values of ρ. We study this FWER analytically and numerically and find that it is maximized when the correlation coefficient ρ between the two endpoints equals 1. Given any particular α-level boundary for the primary endpoint, we study the problem of determining the boundary for the secondary endpoint to control the FWER. The type I error rate for the primary endpoint is controlled by choosing any α-level stopping boundary, e.g., the standard O'Brien–Fleming or the Pocock boundary.
The familywise error rate (FWER) of falsely concluding significance on either endpoint is to be controlled at a nominal level α. The trial uses a group sequential procedure with two stages. Summary We consider a clinical trial with a primary and a secondary endpoint where the secondary endpoint is tested only if the primary endpoint is significant.
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