Background/objectives: Pragmatic trials are increasingly used to study the implementation of weight loss interventions in real-world settings. This study compared researcher-measured body weights versus electronic medical record (EMR)-derived body weights from a pragmatic trial conducted in an underserved patient population.
Subjects/methods: The PROPEL trial randomly allocated 18 clinics to usual care (UC) or to an intensive lifestyle intervention (ILI) designed to promote weight loss. Weight was measured by trained technicians at baseline and at 6, 12, 18, and 24 months. A total of 11 clinics (6 UC/5 ILI) with 577 enrolled patients also provided EMR data (n = 561), which included available body weights over the period of the trial.
Results: The total number of assessments were 2638 and 2048 for the researcher-measured and EMR-derived body weight values, respectively. The correlation between researcher-measured and EMR-derived body weights was 0.988 (n = 1 939; p < 0.0001). The mean difference between the EMR and researcher weights (EMR-researcher) was 0.63 (2.65 SD) kg, and a Bland-Altman graph showed good agreement between the two data collection methods; the upper and lower boundaries of the 95% limits of agreement are -4.65 kg and +5.91 kg, and 71 (3.7%) of the values were outside the limits of agreement. However, at 6 months, percent weight loss in the ILI compared to the UC group was 7.3% using researcher-measured data versus 5.5% using EMR-derived data. At 24 months, the weight loss maintenance was 4.6% using the technician-measured data versus 3.5% using EMR-derived data.
Conclusion: At the group level, body weight data derived from researcher assessments and an EMR showed good agreement; however, the weight loss difference between ILI and UC was blunted when using EMR data. This suggests that weight loss studies that rely on EMR data may require larger sample sizes to detect significant effects.
Clinical trial registration: ClinicalTrials.gov number NCT02561221.
© 2022. The Author(s), under exclusive licence to Springer Nature Limited.