5 Apply: talk with the patient Return to the patient -- integrate that evidence with clinical expertise, patient preferences and apply it to practice 6 Self-evaluation Evaluate your performance with this patient
Key
Study procedures
Eligible patients were treated with single-blind placebo for 1 to 2 weeks before randomization; those who successfully completed this run-in phase
@ Concealed allocation can be done by using a remote call center for enrolling patients or the use of opaque
Massie article
Study procedures
Massie article: Study procedures: The randomization schedule was implemented with the use of an interactive voice-response system. This methodology would conceal the randomized allocation scheme.
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Massie article
Table 1
All investigators and committee members who were involved in the conduct
of the study (except for members of the data and safety monitoring board) were unaware of study-group assignments.
recalculated.
@ If these results still support the original conclusion of the study then the loss may be acceptable.
Massie Article: The mean follow-up time was 49.5 months, and the trial included 16,798 patient-years of follow-up.
At the end of the study, vital-status data were not available for 29 patients
(1%) in the irbesartan group and 44 patients (2%) in the placebo group.
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6. Were patients analyzed in the groups to which they were first allocated?
@ Anything that happens after randomization can affect the chances that a patient in a study has an event. @ Patients who forget or refuse their treatment should not be eliminated from the study results or allowed to change groups. @ Excluding noncompliant patients from a study group may leave only those that may be more likely to have a positive outcome, thus compromising the unbiased comparison that we got from the process of randomization.
@ Therefore all patients must be analyzed within their assigned group. Randomization must be preserved. This is
Massie article: Statistical analysis: Data from all patients who underwent randomization were analyzed according to the
intention-to-treat principle.
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In addition, Table 2 shows results for primary outcomes that includes all patients in the trial.
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