Assessing differential attrition in clinical trials: Self-monitoring of oral anticoagulation and type II diabetes

Background: Analyzing drop out rates and when they occur may give important information about the patient characteristics and trial characteristics that affect the overall uptake of an intervention.

Methods: We searched Medline and the Cochrane library from the beginning of the databases to May 2006 for published systematic reviews that compared the effects of self-monitoring (self-testing) or self-management (self-testing and self-dosage) of oral anticoagulation or self-monitored blood glucose in type 2 diabetics who were not using insulin. We assessed all study withdrawals pre-randomization and post randomization and sought information on the reasons for discontinuation of all participants.

To measure the differential between groups in attrition we used the relative attrition ( RA), which is equivalent to relative risk but uses attrition as the outcome (i.e. attrition in intervention group/ attrition in control group). We determined the percentage drop outs for control and intervention groups and used DerSimonian and Laird random effects models to estimate a pooled relative attrition. L'abbe type plots created in R ( version 2.0.2) were used to represent the difference in the relative attrition among the trials with 95% confidence areas and weights derived from the random effects model.

Results: With self-monitoring of blood glucose in type 2 diabetes, attrition ranged from 2.3% to 50.0% in the intervention groups and 0% to 40.4% in the control groups. There was no significant difference between the intervention and control, with an overall RA of 1.18 [ 95% CI, 0.70 - 2.01]. With self-monitoring of oral anticoagulation attrition ranged from 0% to 43.2% in the intervention groups and 0% to 21.4% in the control group. The RA was significantly greater in the intervention group, combined RA, 6.05 [ 95% CI, 2.53 - 14.49].

Conclusion: This paper demonstrates the use of relative attrition as a new tool in systematic review methodology which has the potential to identify patient, intervention and trial characteristics which influences attrition in trials.