Evidence map›Paper›PMID 39107860›Full record

Trial reportTrials2024

Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial.

Ngoc H Tan, Melvin Lafeber, Roos S G Sablerolles, Isabelle Veerman Roders, Anna van de Hoef, Karenin van Grafhorst, Leo G Visser, Douwe F Postma, Abraham Goorhuis, Wim J R Rietdijk and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05471440 (SWITCH ON), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05471440 naunknown statusnot on this map

SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in Healthcare Workers. A Multicenter, Randomised, Controlled Trial

TypeinterventionalSponsorErasmus Medical CenterRan2022 to 2023Enrolled431ConditionsCovid-19 VaccinationArmsDirect boost mRNA, Direct boost adeno, Post-poned boost mRNA, Post-poned boost adeno
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Ngoc H TanDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.ORCID http://orcid.org/0000-0002-8238-951X
Melvin LafeberDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.
Roos S G SablerollesDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.
Isabelle Veerman RodersDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.
Anna van de HoefDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.
Karenin van GrafhorstDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.
Leo G VisserDepartment of Infectious Diseases, Leiden University Medical Center, Leiden, the Netherlands.
Douwe F PostmaDepartment of Internal Medicine and Infectious Diseases, University Medical Center Groningen, Groningen, the Netherlands.
Abraham GoorhuisCenter of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam University Medical Centers, Amsterdam, the Netherlands.
Wim J R RietdijkDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands.
P Hugo M van der KuyDepartment of Hospital Pharmacy, Erasmus Medical Center, Rotterdam, the Netherlands. h.vanderkuy@erasmusmc.nl.

Funding

ZonMw 2021/22006/ZONMW
6 · The paper itself

Abstract

backgroundElectronic informed consent (eConsent) usage has expanded in recent years in Europe, especially during the pandemic. Slow recruitment rate and limitations in participant outreach are the challenges often faced in clinical research. Given the benefits of eConsent and group counselling reported in the literature, group eConsent was implemented in recruitment for the SWITCH-ON study. We aim to explore the experience of participants who attended group eConsent for the SWITCH-ON study and evaluate its potential for future use.

methodsSWITCH-ON study aims to analyse the immunogenicity of a healthy population following bivalent COVID-19 booster vaccination. Four hundred thirty-four healthcare workers aged 18-65 were successfully recruited and sent a questionnaire about their experience with group eConsent. Out of 399 completed questionnaires (response rate 92%), 39 participants did not join group eConsent. The remaining 360 responses were included in the final analysis. Quantitative and qualitative data were reported using descriptive statistical analysis and thematic analysis respectively.

resultsParticipants found that group eConsent was an efficient method that it allowed them to hear each other's questions and concerns and created a sense of togetherness. However, limited privacy, barriers to asking questions in a group, and peer pressure can limit the use of group eConsent. One hundred sixty-five (46%) participants thought that group eConsent was suitable to recruit participants with diseases or conditions, while 87 (24%) reported limitations with this method. The remaining participants suggested that applicability of group eConsent depended on the diseases or conditions of the study population, and one-to-one conversation should always be available. Participants who had experienced both one-to-one and group eConsent shared different preferred consent formats for future studies.

conclusionGroup eConsent was positively evaluated by the participants of a low-risk vaccination study. Participants advised using webinars to provide general information about the study, followed by an individual session for each participant, would retain the benefits of group eConsent and minimise the limitations it posed. This proposed setting addresses privacy questions and makes group eConsent easier to implement.

trial registrationClinicalTrials.gov NCT05471440 (registered on 22nd of July, 2022).

Indexed as

COVID-19COVID-19 VaccinesInformed ConsentAdolescentAdultAgedCommunicationFemaleHealth PersonnelHumansImmunization, SecondaryMaleMiddle AgedSurveys and QuestionnairesVaccinationYoung AdultCOVID-19 VaccineseConsentGroupInformed consent

Identifiers

PMID39107860
PMCPMC11304818

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.