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Randomized study of two different consent procedures on recall: a study within a digital alcohol intervention trial
Linköping University, Sweden.
RISE Research Institutes of Sweden, Bioeconomy and Health, Material and Surface Design. Linköping University, Sweden.ORCID iD: 0000-0002-4730-6328
University of York, UK.
Linköping University, Sweden.
2024 (English)In: Trials, E-ISSN 1745-6215, Vol. 25, no 1, article id 5Article in journal (Refereed) Published
Abstract [en]

Introduction: Individuals’ comprehension of the information provided in consent forms should fundamentally influence whether to participate initially in a study and later whether to remain a participant. Existing evidence, however, suggests that participants do not thoroughly read, comprehend, or recall the information in consent forms. This study aimed to better understand how well participants recalled trial procedure information in the consent materials they received prior to taking part in a trial of a digital alcohol intervention. Method: This study was nested within an online effectiveness trial. The study included a contrast between two layout approaches to present the trial procedure information: one where all materials were shown on the same page (One page) and one where participants had to click on links to get materials for certain parts of the study information (Active request). Recall of trial procedures was measured 2 months post-randomization with four questions. Participants were also asked to leave a comment after each question. Result: Of the 2437 individuals who registered interest in the parent trial, 1197 were randomized to One page and 1240 were randomized to Active request. Approximately 90% consented to participate and 53% of the participants responded to the recall questionnaire. Contrasting the consent layout showed no marked differences between groups in three out of the four questions on recall of trial procedures. There was, however, evidence that recall of aspects of how personal data would be handled during the trial did differ between the two groups, with the Active request group reporting less recall than the One page group. Free-text comments were used to give nuance to the quantitative analysis. Conclusion: Participants exposed to different layouts of trial procedure information exhibited varying levels of information recall 2 months after consenting. The findings highlight the influence of the presentation of consent forms, which should be given attention when designing trials. Trial registration: ISRCTN ISRCTN48317451. Registered 6 December 2018, https://www.isrctn.com/ISRCTN48317451. 

Place, publisher, year, edition, pages
BioMed Central Ltd , 2024. Vol. 25, no 1, article id 5
Keywords [en]
Consent Forms, Humans, Informed Consent, Mental Recall, Research Design, Surveys and Questionnaires, adult, article, attention, controlled study, female, human, identifiable information, intervention study, quantitative analysis, questionnaire, randomized controlled trial, recall, methodology
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:ri:diva-71931DOI: 10.1186/s13063-023-07855-3Scopus ID: 2-s2.0-85181233599OAI: oai:DiVA.org:ri-71931DiVA, id: diva2:1841049
Funder
Forte, Swedish Research Council for Health, Working Life and Welfare, 2022-00193
Note

 This study was conducted under the auspices of the Alcohol Research Council of the Swedish Alcohol Retailing Monopoly (grant numbers 2019-0056 and 2020-0043) and the Swedish Research Council for Health, Working Life, and Welfare (grant number 2022-00193)

Available from: 2024-02-27 Created: 2024-02-27 Last updated: 2024-02-27Bibliographically approved

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Collier, Elizabeth S

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