Gavin Kara L, Almeida Emily J, Voils Corrine I, Crane Melissa M, Shaw Ryan, Yancy William S, Pendergast Jane, Olsen Maren K
William S. Middleton Memorial Veterans Hospital Madison WI USA.
Department of Surgery University of Wisconsin Madison WI USA.
Obes Sci Pract. 2023 Jan 12;9(4):337-345. doi: 10.1002/osp4.656. eCollection 2023 Aug.
Obtaining body weights remotely could improve feasibility of pragmatic trials. This investigation examined whether weights collected via cellular scale or electronic health record (EHR) correspond to gold standard in-person study weights.
The agreement of paired weight measurements from cellular scales were compared to study scales from a weight loss intervention and EHR-collected weights were compared to study scales from a weight loss maintenance intervention. Differential weight change estimates between intervention and control groups using both pragmatic methods were compared to study collected weight. In the Log2Lose feasibility weight loss trial, in-person weights were collected bi-weekly and compared to weights collected via cellular scales throughout the study period. In the MAINTAIN weight loss maintenance trial, in-person weights were collected at baseline, 14, 26, 42 and 56 weeks. All available weights from the EHR during the study period were obtained.
On average, in Log2Lose cellular scale weights were 0.6 kg (95% CI: -2.9, 2.2) lower than in-person weights; in MAINTAIN, EHR weights were 2.8 kg (SE: -0.5, 6.0) higher than in-person weights. Estimated weight change using pragmatic methods and study scales in both studies were in the same direction and of similar magnitude.
Both methods can be used as cost-effective and real-world surrogates within a tolerable variability for the gold-standard.
NCT02691260; NCT01357551.
远程获取体重数据可提高实用性试验的可行性。本研究旨在探讨通过手机秤或电子健康记录(EHR)收集的体重数据是否与金标准的现场研究体重数据相符。
将手机秤测量的配对体重数据与减肥干预研究秤的数据进行比较,并将EHR收集的体重数据与减肥维持干预研究秤的数据进行比较。使用这两种实用方法估算的干预组和对照组之间的体重变化差异与研究收集的体重数据进行比较。在Log2Lose可行性减肥试验中,每两周收集一次现场体重数据,并在整个研究期间与通过手机秤收集的体重数据进行比较。在MAINTAIN减肥维持试验中,在基线、第14、26、42和56周收集现场体重数据。获取研究期间EHR中的所有可用体重数据。
平均而言,在Log2Lose试验中,手机秤测量的体重比现场体重低0.6千克(95%置信区间:-2.9,2.2);在MAINTAIN试验中,EHR体重比现场体重高2.8千克(标准误差:-0.5,6.0)。两项研究中使用实用方法和研究秤估算的体重变化方向相同,幅度相似。
在可接受的变异性范围内,这两种方法均可作为具有成本效益的现实世界替代方法用于金标准。
NCT02691260;NCT01357551。