Data sources for outcomes included randomized trials, monitoring and evaluation systems, organizational and government offices, demographic surveillance systems and patient treatment registers.
A total of 699 participants were randomized and monitored every 2 months in the first year and quarterly thereafter.
Futility monitoring of randomized clinical trials is becoming widely used.
For instance, reviewers could usefully point out that there was only small-scale observational evidence for a particular adverse outcome, while a different adverse effect was more comprehensively evaluated by specific monitoring in randomized studies.
After standardized education, 501 patients were randomized to intensive structured monitoring (ISM) with 4-point glycemic profiles (fasting, preprandial, 2-h postprandial, and postabsorptive measurements) performed 3 days/week; 523 patients were randomized to active control (AC) with 4-point glycemic profiles performed at baseline and at 6 and 12 months.
Aronson et al. [ 36] randomized men undergoing active monitoring to a low-fat diet, which included 35 mg of soy protein per day for 1 month, versus a Western diet but observed no differences in mean change in PSA or mean change in IGF-I between experimental and control groups.
The 864 randomized subjects will be monitored for a minimum of 4 years and a maximum of 5 years.
Randomized and quasi-randomized controlled trials compared trauma algorithms with ultrasonography, alone or in combination with other established diagnostic tests (i.e., computed tomography [CT], diagnostic peritoneal lavage [DPL], clinical monitoring), to algorithms without the use of ultrasound.
All randomized patients were clinically monitored for TEE including deep vein thrombosis (DVT) and pulmonary embolism (PE).
While registries generally allow a large number of patients to be followed prospectively in a "real-world" setting, they are not as rigorously monitored as randomized controlled studies.
