AI Article Synopsis
- Randomized trials face challenges in recruiting participants, impacting the study's budget and overall effectiveness.
- This study aims to assess how same-day versus delayed consent affects participant recruitment and retention in a larger trial focused on lifestyle changes for peripheral arterial disease patients.
- The SWAT is an observational study, registered with Northern Ireland's research network, to explore the consent process within the context of the main randomized controlled trial.
Article Abstract
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.
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| http://dx.doi.org/10.1111/jebm.12392 | DOI Listing |
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