Data processing in the DMagic cluster randomised controlled trial.

Data processing in the DMagic cluster randomised controlled trial.
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DMagic 集群随机对照试验中的数据处理。

DOI:
10.1016/s2213-8587(22)00014-6
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发表时间:
2022
期刊:
The lancet. Diabetes & endocrinology
影响因子:
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通讯作者:
Fottrell E
Fottrell E
中科院分区:
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文献类型:
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作者:
Fottrell E

文献摘要

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内分泌学为移动健康和参与式学习与行动(PLA)社区动员干预措施在降低孟加拉国农村人口水平的中高血糖和2型糖尿病患病率以及2型糖尿病发病率方面的有效性提供了证据。这些主要结果是在30岁及以上成年人的空腹和2小时血糖的大型随机抽样调查中测量的。与对照组相比,PLA社区动员的患病率和发病率降低60%以上的观察结果对敏感性分析是稳健的,包括使用不同的任意禁食和2小时血糖临界值来分类中度高血糖或糖尿病。我们报告,我们的试验主要结局是基于WHO对血糖分为正常血糖、中度高血糖和糖尿病的分类,空腹血糖低于6.1 mmol/L用于将个体分类为正常血糖。2我们最近发现了一个数据处理错误,即空腹血糖读数恰好为6.1 mmol/L的个体被错误地归类为读数低于6.1 mmol/L的个体,从而偏离了标准的WHO定义。该误差影响了随机人群样本中的11375名个体中的317名(2.8%),以及我们的中度高血糖个体队列中的2094名个体中的61名(2.9%)。这些错误分类的病例分布在所有试验组中。这种错误分类的后果
Endocrinology provides evidence on the effectiveness of mHealth and Participatory Learning and Action (PLA) community mobilisation interventions for reducing populationlevel prevalence of intermediate hyperglycaemia and type 2 diabetes and the incidence of type 2 diabetes in rural Bangladesh. These primary outcomes were measured in large random sample surveys of fasting and 2-h blood glucose among adults aged 30 years and older. The observed effects of a greater than 60% reduction in prevalence and incidence outcomes in the PLA community mobilisation compared with control was robust to sensitivity analysis, including use of different arbitrary fasting and 2-h blood glucose cutoffs for classifications of intermediate hyperglycaemia or diabetes. 1We report that our trial primary outcome is based on WHO categorisations of blood glucose into normoglycaemia, intermediate hyperglycaemia and diabetes, with fasting blood glucose of less than 6· 1 mmol/L used to classify individuals as having normal blood glucose. 2 We recently identified a data processing error, whereby individuals with fasting blood glucose readings of exactly 6· 1 mmol/L were misclassified as having readings of less than 6· 1 mmol/L, thus deviating from the standard WHO definition. This error affects 317 (2· 8%) of 11 375 individuals from our random population sample, and 61 (2· 9%) of 2094 individuals in our cohort of individuals with intermediate hyperglycaemia. These cases of misclassification are distributed across all trial groups. The consequence of this misclassification