TY  - JOUR
T1  - Lactobacilli vs antibiotics to prevent recurrent urinary tract infections: An inconclusive, not inferior, outcome—reply
AU  - Beerepoot M, ter Riet G, Geerlings SE
Y1  - 2012/11/26
N1  - 10.1001/2013.jamainternmed.111
JO  - Archives of Internal Medicine
SP  - 1690
EP  - 1694
VL  - 172
IS  - 21
N2  - 
As far as we are aware, there are no validated rules to determine noninferiority margins. Nor can there be, since almost every clinical situation has its own peculiarities. What constitutes a clinically acceptable difference is ultimately a matter of judgment and may vary across patients, physicians, investigators, regulators, or payers.1 It is striking but perhaps not surprising that in trial registrations of noninferiority trials, the noninferiority margins are very often absent.2 A rational approach to planning noninferiority trials would involve performing a cost-utility analysis to derive the noninferiority margins before embarking on the trial. Such analyses could incorporate the different opinions of the various stakeholders.

SN  - 0003-9926
M3  - doi: 10.1001/2013.jamainternmed.111
UR  - http://dx.doi.org/10.1001/2013.jamainternmed.111
ER  -