In this study, the rate of treatment success in the as-treated analysis
was 72% in the intervention group and 48% in the control group.
In the prespecified intent-to-treat analysis they were counted in the OMT group, whereas an as-treated analysis
might well have shown statistically significant reductions in death and MI in the PCI group.
. There were 4990 cases (58.4% females) of incident insulin users, mean age at inception 62.1 [+ or -] 9.3 years (62.8 [+ or -] 9.3 years for females versus 61.2 [+ or -] 9.2 years for males, p < 0.001), with a mean follow-up time from screening to insulin initiation (prestudy) follow-up time of 4.45 [+ or -] 1.91 years (4.51 [+ or -] 1.90 years for females versus 4.37 [+ or -] 1.93 years for males, p = 0.015).
Using multiple office visits to identify ambulatory cases in an as-treated analysis
would have required the introduction of immortal person time into the design, (30) hence those potential cases did not meet the study outcome definition.
However, this was significant using an as-treated analysis
Nevertheless, the as-treated analysis
of 654 patients in the combined randomized and observational cohorts showed that the surgery group had a mean 19.8-point improvement in Short Form-36 bodily pain scores at 6 weeks and a 26.9-point gain at 2 years over a baseline of 31.4, which are effect sizes roughly twice those seen with conservative therapy, Dr.
The researchers combined the outcome data from both cohorts in an as-treated analysis
. The results showed a clear advantage with surgery on measures of bodily pain, physical function, patient-reported improvement, and patient satisfaction with care.