School of Medicine, University of Galway, University Road, Galway, Ireland.
Department of Vascular and Endovascular Surgery, University College Hospital, Galway (UCHG), Newcastle Road, Galway, Ireland.
Trials. 2023 Oct 25;24(1):691. doi: 10.1186/s13063-023-07727-w.
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 study. We aimed 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.
This SWAT is designed as a prospective cohort design. The host trial was a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification programme in participants with peripheral arterial disease. Researchers screened the participants for inclusion and exclusion criteria. Informed consents were obtained from the participants who were willing to participate in the study on a standardized consent form. Participants were given the option to consent on the same day or to delay their consent. Following the consent, the participants were allocated to two groups (same-day consent vs. delayed consent) based on pre-determined criteria for SWAT. One hundred sixteen participants were consented to take part in the host trial. Seventy-five participants were randomized to the host trial. The primary outcome was the proportion of participants who withdrew consent at the recruitment phase. Secondary outcomes were reasons for consent withdrawal and dropout, attrition rate, and adherence with the host trial intervention.
There was a significantly lower consent-withdrawal rate in same-day consent (17.4%, n = 8/46), compared to the delayed consent group (47.1%, n = 33/70), p = 0.001. There was a significantly lower dropout rate in participants randomized following same-day consent (10.5%, n = 4/38), compared to those randomized after delayed consent (29.7%, n = 11/37), p = 0.038. Transport was the main reason mentioned for consent withdrawal and dropout. In participants randomized to the host trial intervention arm, there was a significant difference in adherence (percentage of the 12-week programme completed) between same-day consent (96.7% ± 4.9) and delayed consent participants (86.4% ± 11.2), p = 0.003, as well as number of weeks completed (mean difference = - 1.547, 95% confidence intervals (- 2.237 to - 0.85)), p = 0.02.
This SWAT found evidence that participants who gave consent on the same day seemed to have better adherence and fewer-withdrawal and dropout rates.
The SWAT was registered on the Northern Ireland Network for Trials Methodology Research, SWAT 84.
随机试验的招募过程可能具有挑战性。招募不力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，并可能导致研究效力不足。我们旨在进行一项试验内研究（SWAT），以评估同日同意或延迟同意对招募和保留的影响。
该 SWAT 设计为前瞻性队列设计。主体试验是一项随机对照试验，评估了强化生活方式改变方案对周围动脉疾病患者的有效性。研究人员根据纳入和排除标准筛选参与者。愿意参加研究的参与者在标准化同意书中获得知情同意。参与者可以选择当天同意或延迟同意。在同意后，根据预先确定的 SWAT 标准，将参与者分配到两组（同日同意组和延迟同意组）。有 116 名参与者同意参加主体试验。75 名参与者被随机分配到主体试验。主要结局是招募阶段退出同意的参与者比例。次要结局是同意退出和脱落的原因、失访率以及对主体试验干预的依从性。
同日同意组的同意撤回率明显较低（17.4%，n=8/46），而延迟同意组的同意撤回率较高（47.1%，n=33/70），p=0.001。在随机分配到同日同意的参与者中，脱落率明显较低（10.5%，n=4/38），而在随机分配到延迟同意的参与者中，脱落率较高（29.7%，n=11/37），p=0.038。交通是同意退出和脱落的主要原因。在随机分配到主体试验干预组的参与者中，在对主体试验干预的依从性（完成 12 周方案的百分比）方面，同日同意组（96.7%±4.9）和延迟同意组参与者之间存在显著差异（86.4%±11.2），p=0.003，以及完成的周数（平均差异=−1.547，95%置信区间（−2.237 至−0.85）），p=0.02。
这项 SWAT 发现，当天同意的参与者似乎具有更好的依从性和较低的退出和脱落率。
SWAT 注册：SWAT 在北爱尔兰试验方法学研究网络上进行了注册，SWAT 84。
