BACKGROUND Randomized trials are designed to evaluate the effects of health care interventions. The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered research that will not adequately answer the original research question. AIM We aim to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial. METHODS This SWAT is designed as an observational study. However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease. For this trial and SWAT, same-day consent is defined as the patient giving consent on the same day, after the investigator has fully explained the predesigned information leaflet for the host trial. Delayed consent is defined as the patient feeling they still need further time to consider their decision to participate or not. SWAT REGISTRATION The SWAT was registered on the Northern Ireland Network for Trials Methodology Research.

中文翻译：

---

试验方案内的研究：随机试验中的当天同意与延迟同意。


背景随机试验旨在评估医疗保健干预措施的效果。随机试验的招募过程可能具有挑战性。招募不当可能会对分配的预算和研究的预计完成日期产生负面影响，并可能导致研究动力不足，无法充分回答最初的研究问题。目的 我们的目标是进行试验内研究 (SWAT)，以评估当日同意或延迟同意对宿主试验中招募和保留的影响。方法 本 SWAT 旨在作为一项观察性研究。然而，宿主试验是一项随机对照试验，评估强化生活方式改变计划对外周动脉疾病患者的有效性。对于本试验和 SWAT，当天同意被定义为在研究​​者充分解释了为主试验预先设计的信息传单后，患者在当天给予同意。延迟同意被定义为患者感觉他们仍然需要更多时间来考虑是否参与的决定。 SWAT 注册 SWAT 在北爱尔兰试验方法研究网络上注册。