A practical guide to applying the intention-to-treat principle to clinical trials in HIV infection.
It is recommended that randomized controlled trials be analyzed on an intention-to-treat (ITT) basis whereby patients are analyzed in the group to which they were originally assigned, irrespective of the treatment actually received. However, in trials of antiretroviral therapy, it is quite common for patients to withdraw from the trial, and information on virological or immunological endpoints may not be available. The way in which this missing information is dealt with in the analysis can have a large effect on the results of a trial and, therefore, the principle of ITT may be adhered to more closely in some studies than in others. This article describes some simple approaches commonly taken to impute missing data values and discusses the possible effects of these approaches on the results of a trial.
Sabin
C A
CA
Royal Free Centre for HIV Medicine, Department of Primary Care and Population Sciences, Royal Free and University College Medical School, London, United Kingdom.
Lepri
A C
AC
Phillips
A N
AN
D019380:Anti-HIV Agents / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000502:physiology; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D016896:Treatment Outcome; D019562:Viral Load
D019380:Anti-HIV Agents