inguinal hernia-JAMA article:some you can just watch

An article in the Jan 18,2005 issue of JAMA reports on a randomized trial of watchful waiting versus surgical repair of "minimally symptomatic" inguinal hernias and conclude for some watchful waiting is appropriate.The accompanying editorial by Dr. David R. Flynn is interesting as it discusses in some detail some basic issues in the analysis of trials. Should one look at intention-to-treat (ITT) or make the comparison on the basis of the treatment actually received? This becomes an issue as it did in this instance when there is considerable cross over in a trial. Nearly 25% of those assigned to the watch and see group opted to have surgical repair by two years and about 1/3 had done so by the end of the trial (4 years).Further 17% of those assigned to surgery decided not have the procedure. At first thought one wonders what sense it makes to look at results in which nearly 4/10 patients did not actually receive the treatments assigned to them.The argument is that the alternative is worse because here selection bias may enter into the picture since randomization no longer controls who receives which management option.The important point made by the editorial is that what was compared here was not so much treatments per se but management advice, i.e. what you tell the patient and in this regard the two approaches were about the same.As always in RCTs before they are construed too broadly, one has to look at the exclusion criteria for the patients in the trials.Only men were in the trial and only those who were at most minimally symptomatic.