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Predictors of Adherence in the Women’s Health Initiative Calcium and Vitamin D Trial

机译:妇女健康计划钙和维生素D试验中依从性的预测指标

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摘要

The authors analyzed data from the Women’s Health Initiative (WHI) Calcium and Vitamin D Supplementation Trial (CaD) to learn more about factors affecting adherence to clinical trial study pills (both active and placebo). Most participants (36,282 postmenopausal women aged 50–79 years) enrolled in CaD 1 year after joining either a hormone trial or the dietary modification trial of WHI. The WHI researchers measured adherence to study pills by weighing the amount of remaining pills at an annual study visit; adherence was primarily defined as taking ≥ 80% of the pills. The authors in this study examined a number of behavioral, demographic, procedural, and treatment variables for association with study pill adherence. They found that relatively simple procedures (ie, phone contact early in the study [4 weeks post randomization] and direct social contact) later in the trial may improve adherence. Also, at baseline, past pill-use experiences, personal supplement use, and relevant symptoms may be predictive of adherence in a supplement trial.
机译:作者分析了来自妇女健康倡议(WHI)钙和维生素D补充试验(CaD)的数据,以了解更多有关影响临床试验研究药物(活性药物和安慰剂)依从性的因素。加入WHI的激素试验或饮食改良试验1年后,大多数参与者(36,282名50-79岁的绝经后妇女)入选了CaD。 WHI的研究人员通过在年度研究访问中称量剩余药量来衡量对研究药的依从性。依从性主要定义为服用≥80%的药丸。本研究的作者检查了许多与研究药依从性相关的行为,人口统计学,程序和治疗变量。他们发现,试验后期相对简单的程序(即研究初期(随机分配后4周)电话联系和直接的社会联系)可以改善依从性。同样,在基线时,过去的药物使用经验,个人补充剂使用和相关症状可能是补充剂试验中依从性的预测。

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