Using electronic medical records analysis to investigate the effectiveness of lifestyle programs in real-world primary care is challenging: a case study in diabetes mellitus

Objective: The increasing prevalence of diabetes suggests a gap between real world and controlled trial effectiveness of lifestyle interventions, but real-world investigations are rare. Electronic medical registration facilitates research on real-world effectiveness, although such investigations may require specific methodology and statistics. We investigated the effects of real-world primary care for patients with type 2 diabetes mellitus (T2DM). Study Design and Setting: We used medical records of patients (n = 2,549) with T2DM from 10 primary health care centers. A mixed-effects regression model for repeated measurements was used to evaluate the changes in weight and Hemoglobin A1c (HbA1c) over time. Results: There was no statistically significant change in weight (+0.07 kg, P = 0.832) and HbA1c (+0.03%, P = 0.657) during the observation period of 972 days. Most patients maintained their physical activity level (70%), and 54 % had an insufficient activity level. The variability in the course of weight and HbA1c was because of differences between patients and not between health care providers. Conclusion: Despite effective lifestyle interventions in controlled trial settings, we found that real-world primary care is only able to stabilize weight and HbA1c in patients with T2DM over time. Medical registration can be used to monitor the actual effectiveness of interventions in primary care.