The effect of providing usual care only for control subjects on the reliability of results obtained by controlled clinical trials assessing the benefits of diabetes self-management educational programs

Abstract

Diabetes self-management (DSM) is a crucial part in the management of diabetic patients. Most randomized controlled clinical trials reported significant benefits by diabetes self-management education (DSME) on DSM behaviors and metabolic control. Although the randomized clinical trials are the gold standard method in assessing the effectiveness of any intervention, including DSME interventions, the outcomes of these studies may reflect exaggerated effects; because in most of these studies, subjects in control group receive usual (standard) care with no any DSME. The lack of such education in the control group had many drawbacks: ( 1 ) make blindness impossible; at which non blinded studies may result in false-positive findings; ( 2 ) it may be unethical to recruit patients for participation in DSME studies as control subjects, most of these studies with long periods of follow up, without any direct benefit to them during the study period; the lack of direct benefit to control subjects in any clinical trial may results in high attrition (drop-out) rate. The high attrition rate in clinical trials especially in the control group can lower the statistical power of the study results; thus, the DSME program would appear to have positive effects even if the program had no real benefit. This problem of the DSME exaggerated effects can be solved partially through providing control subjects with education about some DSM behaviors or comparing the effect of DSME through different educational approaches (for example DSME by didactic vs interactive approach).