I have been invited to comment on a manuscript reporting the result from a
randomised trial of a treatment of sepsis after GI perforation. I have doubts
about the randomisation. The authors describe that randomisation was made "using
the last two digits of the patients inpatient number and random number table".
In my opinion the randomisation resulted in an unlikely even distribution over a
number of variables, see table. I have therefore expressed doubts about the
study being truly randomised.
I would like to receive comments from others. How likely is it that a
randomisation of patients would result in such an even distribution over
factors?
Factor Treatment 1 Treatment 2
Male 17 16
Female 1 2
Site of perforation
Gastric 1 2
Duodenal 6 5
Enteric 11 11
Duration of symptoms
<1 day 15 14
>= 1 day 3 4
Hematocrit
Normal 18 14
Deranged 0 4
Serum Potassium
Normal 13 16
Decreased 5 2
Serum protein
Normal 15 13
Low 3 5
Roland Andersson
//\\//\\//\\//\\//\\//\\//\\//\\//\\//\\//\\
Roland Andersson, MD PhD
Department of Surgery
County Hospital Ryhov
S-551 85 Jönköping
SWEDEN
e-mail: [log in to unmask]
phone: +46-36-321344
fax: +46-36-321321
____________________________________________
//\\//\\//\\//\\//\\//\\//\\//\\//\\//\\//\\
|