研究技术人员收集的体重减轻数据与电子病历的比较：PROPEL试验。
Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial.
作者信息
Katzmarzyk Peter T, Mire Emily F, Martin Corby K, Newton Robert L, Apolzan John W, Price-Haywood Eboni G, Denstel Kara D, Horswell Ronald, Chu San T, Johnson William D
机构信息
Pennington Biomedical Research Center, Baton Rouge, LA, USA.
Ochsner Xavier Institute for Health Equity and Research, New Orleans, LA, USA.
出版信息
Int J Obes (Lond). 2022 Aug;46(8):1456-1462. doi: 10.1038/s41366-022-01129-9. Epub 2022 May 6.
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.
背景/目的：实用试验越来越多地用于研究现实环境中减肥干预措施的实施情况。本研究比较了在服务不足的患者群体中进行的一项实用试验中研究人员测量的体重与电子病历（EMR）得出的体重。
受试者/方法：PROPEL试验将18家诊所随机分配至常规护理（UC）组或旨在促进减肥的强化生活方式干预（ILI）组。在基线以及6、12、18和24个月时，由训练有素的技术人员测量体重。共有11家诊所（6家UC/5家ILI）的577名入组患者也提供了EMR数据（n = 561），其中包括试验期间可用的体重数据。
结果
研究人员测量的体重值和EMR得出的体重值的评估总数分别为2638次和2048次。研究人员测量的体重与EMR得出的体重之间的相关性为0.988（n = 1939；p < 0.0001）。EMR体重与研究人员测量的体重之间的平均差值（EMR - 研究人员）为0.63（标准差2.65）kg，Bland - Altman图显示两种数据收集方法之间具有良好的一致性；95%一致性界限的上限和下限分别为 - 4.65 kg和 + 5.91 kg，71个（3.7%）值超出了一致性界限。然而，在6个月时，使用研究人员测量的数据，ILI组与UC组相比的体重减轻百分比为7.3%，而使用EMR得出的数据为5.5%。在24个月时，使用技术人员测量的数据体重减轻维持率为4.6%，而使用EMR得出的数据为3.5%。
结论
在组水平上，研究人员评估得出的体重数据与EMR显示出良好的一致性；然而，使用EMR数据时，ILI与UC之间的体重减轻差异不明显。这表明依赖EMR数据的减肥研究可能需要更大的样本量才能检测到显著效果。
临床试验注册
ClinicalTrials.gov编号NCT02561221。
Zotero 插件