Department of Vascular and Endovascular Surgery, University Hospital College Galway, Galway, Ireland.
School of Medicine, National University of Ireland Galway, Galway, Ireland.
J Evid Based Med. 2020 Feb;13(1):81-84. doi: 10.1111/jebm.12375. Epub 2020 Feb 15.
The impact of reduced adherence in randomized clinical trials is well documented in the literature. Nonadherence can negatively affect the trial sample size and estimation of the treatment effect. This protocol aims to evaluate the effects of a telephone call reminder on the adherence rates of participants to interventions in a cardiovascular randomized trial. This is a study within a trial (SWAT). The host trial is evaluating the effectiveness of a multidisciplinary 16-wk cardiovascular disease prevention program on risk factor profile among patients with carotid artery stenosis. Simultaneously, this SWAT will evaluate the effectiveness of telephone call reminders on the participants' adherence to the host trial intervention. The primary outcome is adherence to the protocol of the host trial. Secondary outcomes are level of adherence, number of dropouts, and time to drop out from the host trial.
文献中充分记录了随机临床试验中依从性降低的影响。不依从可能会对试验样本量和治疗效果的估计产生负面影响。本方案旨在评估电话提醒对心血管随机试验中干预措施参与者依从率的影响。这是一项试验内研究（SWAT）。主体试验评估了多学科 16 周心血管疾病预防计划对颈动脉狭窄患者危险因素谱的有效性。同时，本 SWAT 将评估电话提醒对参与者依从主体试验干预的效果。主要结局是对主体试验方案的依从性。次要结局是依从水平、脱落人数以及从主体试验中脱落的时间。
