He also writes for Psych Central’s Ask the Therapist column and the Proof Positive blog. View all posts by Daniel J. (2014). When bacteria were cultured, we tested them for sensitivity to antibiotics.Sample sizeAssuming a death rate of 15 per 100 person years in the previously untreated participants (based on a death rate of 18/100 person years in a trial in a similar population of patients in Lusaka15), a total of 1408 person years of observation would be needed to show a 35% reduction in death rate in patients receiving co trimoxazole, at the 5% level of significance with 80% power; a 40% reduction would require 1045 person years.Analysis of dataWe entered all data in duplicate locally and verified them by using Epi Info software version 6.04d. Master databases were backed up at regular intervals and copies transmitted by electronic mail to the MRC Clinical Trials Unit in London on a monthly basis.We set up trial management committees in London and Lusaka to review the progress of the trial on a regular basis and an independent data monitoring committee to monitor the progress of the trial and patient safety every six to eight months. We did no formal interim analyses.We used the Kaplan Meier method, the log rank test, and a Cox proportional hazard regression model to make comparisons of the groups for the primary end point by time to event analyses and tested heterogeneity of survival rates in subgroups by interaction tests within Cox models.
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