Hi

I have been approacted by a specialist registrar wishing to conduct a study in which a 
treatment is to be given to patients to reduce the incidence of diarrhoea. He plans to 
use two wards in one hospital. All new patients attending one ward will be allocated 
to 
the test treatment and all new patients in the  other ward will form a control group. 
The 
outcome of interest is incidence of diarrhoea during one month of follow up. He then 
plans to allow for a "washout" period, of up to one month, after which the two wards 
crossover to the other treatment. His question was; how many patients do I need? (He 
didn't think about how he might analyse his results!)

My first reaction was that this is a cluster randomised trial with one cluster per arm 
(ignoring the "crossover" for the moment) and in the absence of any background 
information regarding likely incidence in the control group, I was not in a position 
to 
offer much advice. 

I do not feel that a crude linear contrast of incidence rates involving the two 
hospital 
wards over the two treatment periods is really appropriate. What do othes feel? Can 
anyone suggest a sensible way forward?


regards

Bernie
      -----------------------------------------  
      Bernie Higgins, email: [EMAIL PROTECTED]

      Department of Mathematics, University of Portsmouth
      Room 18, Floor 1, Buckingham Building 
      Lion Terrrace, Portsmouth PO1 3HE
        
      Tel  023 92  846361  Monday & Tueday
            023 92  286236  Wednesday - Friday
    


         

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