Impact of a randomized control group on perceived effectiveness of a Disease Management Programme for diabetes type 2
Clinical Trials Thursday, September 27th, 2012Oxford Journals: 10/11/11
Disease Management Programmes (DMPs) are proposed to enhance the quality of care, to improve health outcomes and to reduce costs. Yet, the evidence regarding the effectiveness of such structured approaches remains uncertain. Randomized controlled trials (RCTs) represent the gold standard of evaluation for complex interventions. However, most of the evidence derives from non-randomized or even uncontrolled trials. We therefore tried to assess the impact of a randomized control group on the interpretation of DMP effectiveness. Methods: We analyzed the data of a RCT on a DMP for diabetes type 2 by creating two scenarios. The first solely includes data of the intervention group (n = 649), representing an ‘uncontrolled pre-test–post-test analysis’. The second comprehends all data (n = 1489) of the ‘randomized controlled analysis’. HbA1c was used as the primary outcome measure for metabolic control in diabetes. Depending on either scenario, we calculated relative and absolute risk reduction regarding clinically relevant endpoints and estimated costs by extrapolating our results according to the UK Prospective Diabetes Study (UKPDS) findings. Read More