A group among patients initially admitted to hospital, the opposite occurring among those treated as outpatients. Analyses which were pre-specified in the trial protocol have much greater reliability than those which may have been suggested by the data. Authors should indicate which analyses were pre-specified. If subgroup analyses were undertaken, authors should report which subgroups were examined and why. They noted that it was often difficult to determine whether subgroup analyses had been specified in the protocol.
Similar recommendations apply to analyses in which adjustment was made for baseline variables.
If done, both unadjusted and adjusted analyses should be reported. Authors should indicate whether or not adjusted analyses, including the choice of variables to adjust for, were planned.