Guide

Comments

I. Will the results help me in caring for my patients?
1. Can the results be applied to my patient care? Yes
2. Were all clinically important outcomes considered? Sure looks like it!
3. Are the likely benefits worth the potential harms and costs? The treatment used in this study is relatively cheap (thiazides cost about $20 per year. The rate of adverse events (Table 7) was comparable between the two groups. They don’t report how many patients required potassium supplements.
II. Are the Results Valid?
1. Was the assignment of patients to treatments randomized? After a run-in period, all subjects were randomized to receive either placebo or active treatment.
2. Were all patients who entered the trial properly accounted for and attributed at its conclusion?

a) Was follow-up complete?

Subjects were followed monthly until target BP reached, then quarterly. Table 2 summarizes the attrition over time. At the end of the third year of the study, over 95% of the participants were still in the study.
b) Were patients analyzed in the groups to which they were randomized Yes (page 3258)
3. Were patients, health workers, and study personnel "blind" to treatment? Yes (page 3256)
4. Were the groups similar at the start of the trial? Table 1 shows the only statistically significant differences were in the pulse rate (70.3 vs. 71.3) and limitations in activities of daily living (95.4% independent vs 93.8% independent). You could make the argument that these differences, while statistically significant are clinically insignificant.
5. Aside from the experimental intervention, were the groups treated equally? Yes
III. What are the Results?
1. How large was the treatment effect?

2. How precise was the treatment effect?

Table 6 summarizes the treatment effects

The authors report confidence intervals for most events, stroke prevention and acute myocardial infarction were the only outcomes that did not overlap.