The methodology of this study has been questioned, although it was randomised and controlled [ 6- 8].
The strengths of the trial on which this economic evaluation was based are that it was randomised and controlled, pragmatic in design, and provided a vehicle for collecting a comprehensive set of data on resource use and clinical effectiveness.
The procedure may be accessed from any web-connected computer; it clears the user for data access (user id/password); it requires the user to specify the screening number of the subject about to be randomised; it verifies inclusion/exclusion criteria and acquires stratification information; it finally assigns the subject to a treatment, and delivers the corresponding unique randomisation number.
Assuming that 10% of patients would be nonevaluable and approximately 20% would not be randomised, it was calculated that 105 patients should be enrolled.
A trial of menorrhagia management compared conventional randomisation with a patient preference design, where those with a preference for a specific treatment receive it, while the remainder are randomised.
In trial A, with a planned 200 patients to be randomised, it was expected that a 50% increase in median survival (from 90 days in the placebo arm to 135 days in the gastrazole arm) could be detected with at least 80% power (two-sided alpha=5%).
Although South Asian males were referred none were randomised, although it is not clear whether this reflects attitudes to the intervention, or to the research.
The education session was piloted on fifty patients and following the feedback from the pilot session, changes were made before delivering it to the patients who are randomised.
PEEP in CMH2O Lung Compliance in ml/CMH2O Number of quadrants with infiltration seen on chest X-ray Patients can be registered for the trial when the Murray Score exceeds 2.5, and are eligible to enter and be randomised when it exceeds 3.0.
Students were randomised using simple randomisation.
