An evaluation of the implementation, adoption, and uptake of a model of remote e-consent within the PRE-DX study

Abstract

Abstract Background: Remote electronic consent (e-consent) is an area of growing interest but questions remain about how to successfully implement this in clinical research. There are potential benefits from adopting remote e-consent, but uncertainty exists regarding the barriers and facilitators to wider use. PRE-DX is a randomised controlled trial, comparing the effect of changing the time point when the Oncotype DX genomic assay is ordered on the patient management pathway in early-stage breast cancer. In this paper, we evaluated the implementation, adoption, and uptake of a model of remote e-consent and explored the impact of patient demographics, method of e-consent and site research staff training on successful implementation. Methods: Remote e-consent was the primary consent method in PRE-DX, with remote postal consent and face-to-face consent available as alternatives. At the mid-point of recruitment, virtual researcher meetings were held to facilitate site recruitment during which polls using Microsoft teams and open discussions about staff’s experience of the e-consent process were conducted. Demographic information collected as part of PRE-DX was used to describe the characteristics of participants for each consent method. Continuous variable of age for each consent method and overall are described according to mean, standard deviation, median, interquartile range, and minimum and maximum values. Categorical variables of consent methods, gender and ethnicity and poll results from the researcher meetings are reported as frequencies and percentages. Results: Three hundred and forty-one participants were recruited to PRE-DX. The predominant consent method was e-consent (n=213), followed by face-to-face consent (n=119) and postal (n=9). The comparison of patient demographics showed that the age of participants was similar across groups (e-consent: mean 57.7 ± 10.2 years, median 59.0 (13) years; postal: mean 55.8 ± 11.9 years, median 52 (17.5) years; face-to face: mean 58.5 ± 10.4 years, median 57 (14) years). No concerns regarding the e-consent method were expressed during the researcher meetings, but uptake varied across sites. Conclusion: Remote e-consent can be successfully implemented for recruitment of patients of different ages and is acceptable to site research teams. Alternative consent methods should be available to maximise recruitment. Trial Registration: PRE-DX (ISRCTN14337451), registered 16th August 2022.