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Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial

Abstract

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.

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Fig. 1: EMR-derived and researcher-measured body weights.
Fig. 2: Bland–Altman plot for EMR-derived and researcher-measured body weights.
Fig. 3: Patient flow through the PROPEL trial.
Fig. 4: Mean percent weight change from baseline to 24 months.

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Data availability

The datasets analyzed and computer code utilized in the current study are available from the corresponding author on reasonable request.

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Acknowledgements

Supported by an award (OB-1402-10977) from PCORI, by a grant (U54 GM104940) from the National Institute of General Medical Sciences of the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center, and by a grant (“Nutrition and Metabolic Health through the Lifespan” [P30DK072476]) from the Nutrition and Obesity Research Center, sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. The statements in this article are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI) or its board of governors or methodology committee. The work related to this article occurred before Dr Price-Haywood’s appointment to the Patient-Centered Outcomes Research Institute Board of Governors. The PROPEL Research Group includes: Pennington Biomedical Research Center: Peter T. Katzmarzyk, PhD (principal investigator), Robert L. Newton Jr, PhD (outcomes assessment director), Corby K. Martin, PhD (intervention director), John W. Apolzan, PhD (intervention codirector), William Johnson, PhD (biostatistician), Kara D. Denstel, MPH (project manager), Emily F. Mire, MS (data manager), Robert K. Singletary Jr, MHS, Cheryl Lewis, MPH, Phillip Brantley, PhD, Ronald Horswell, PhD, Betty Kennedy, PhD, Dachuan Zhang, MAppStats, Stephanie Authement, RD, LDN, MS, Shiquita Brooks, RDN, LDN, Danielle S. Burrell, MEd, MCHES, Leslie Forest-Everage, MA, Angelle Graham Ullmer, RDN, LDN, MS, Laurie Murphy, RDN, LDN, Cristalyn Reynolds, MA, Kevin Sanders, MS, RDN, LDN, Stephen Bower, MS, Daishaun Gabriel, MHA, Hillary Gahagan, MPH, Tabitha K. Gray, MA, Jill Hancock, MPH, Marsha Herrera, Brittany Molinere, Georgia Morgan, MA, Brittany Neyland, Stephanie Rincones, Deanna Robertson, MA, Ekambi Shelton, MPH, Russell J. Tassin, MS, Kaili Williams; Louisiana State University Health Sciences Center at New Orleans: Benjamin F. Springgate, MD; Louisiana State University Health Sciences Center at Shreveport: Terry C. Davis, PhD, Connie L. Arnold, PhD; Ochsner Health System: Eboni Price-Haywood,MD, Carl J. Lavie, MD, Jewel Harden-Barrios, MEd; Tulane University Medical School: Vivian A. Fonseca, MD, Tina K. Thethi, MD (MEDICAL Monitor), Jonathan Gugel, MD; Xavier University: Kathleen B. Kennedy, PhD, Daniel F. Sarpong, PhD, Amina D. Massey. Study data were collected and managed with REDCap (Research Electronic Data Capture) electronic data capture tools hosted at Pennington Biomedical. REDCap is a secure, web-based application designed to support data capture for research studies, providing an intuitive interface for validated data entry, audit trails for tracking data manipulation and export procedures, automated export procedures for seamless data downloads to common statistical packages, and procedures for importing data from external sources.

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PK, CM, RN, JA, EPH, EM, KD, and WJ conducted the PROPEL trial; EM, RH and SC were involved in data collection and management; PK conceived this study, conducted the analyses, and wrote the first draft of the paper; all authors; all authors were involved in revising and writing the final paper and provided final approval of the submitted and published versions.

Corresponding author

Correspondence to Peter T. Katzmarzyk.

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Katzmarzyk, P.T., Mire, E.F., Martin, C.K. et al. Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial. Int J Obes 46, 1456–1462 (2022). https://doi.org/10.1038/s41366-022-01129-9

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