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Open Access 01-12-2023 | Peripheral Arterial Disease | Methodology

SWAT 84: effects of same-day consent vs delayed consent on the recruitment and retention of trial participants—an observational SWAT

Authors: M. Elfghi, F. Jordan, S. Sultan, W. Tawfick

Published in: Trials | Issue 1/2023

Abstract

Background and aim

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.

Methods

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.

Results

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.

Conclusion

This SWAT found evidence that participants who gave consent on the same day seemed to have better adherence and fewer-withdrawal and dropout rates.

SWAT registration

The SWAT was registered on the Northern Ireland Network for Trials Methodology Research, SWAT 84.

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Title: SWAT 84: effects of same-day consent vs delayed consent on the recruitment and retention of trial participants—an observational SWAT
Authors: M. Elfghi
F. Jordan
S. Sultan
W. Tawfick
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Peripheral Arterial Disease
Peripheral Arterial Disease
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07727-w

Keynote webinar | Spotlight on medication adherence

Springer Medicine

SWAT 84: effects of same-day consent vs delayed consent on the recruitment and retention of trial participants—an observational SWAT

Abstract

Background and aim

Methods

Results

Conclusion

SWAT registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background and aim

Methods

Results

Conclusion

SWAT registration

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