Margaret A.WinkerMDIndividualAuthorPhil B.FontanarosaMD, Senior EditorsIndividualAuthor
In Reply.—Contrary to the assertions by Dr Wheeler and associates, the issue of intent to treat is not relevant. As indicated in "Treatment Protocol," our design was not typical; we had a provision for crossing over patients who did not respond initially to the other treatment. Assignment to the placebo arm carried with it the possibility of being switched to active drug after 10 days if there was no improvement; assignment to methylprednisolone implied that, if the drug was harmful or had no benefit, switching to the placebo arm would be done after 10 days. There were no protocol violations because of physicians' deciding to move their patients to the other arm. As stated in our article, all data were analyzed according to the randomization scheme. Therefore, calculations suggested by Wheeler et al make no sense.
Tolley EA, Meduri GU, Headley AS, Golden E, Carson SJ, Umberger RA. Methylprednisolone for Unresolving ARDS—Reply. JAMA. 1998;280(24):2074. doi:10-1001/pubs.JAMA-ISSN-0098-7484-280-24-jbk1223