Evidence map›Paper›PMID 36397108›Full record

ArticleBMC medical informatics and decision making2022

Using provocative design to foster electronic informed consent innovation.

Evelien De Sutter, Stef Verreydt, Koen Yskout, David Geerts, Pascal Borry, An Outtier, Marc Ferrante, Corinne Vandermeulen, Nele Vanmechelen, Bart Van der Schueren and 1 more

Abstract read
In one paragraph

Article in BMC medical informatics and decision making, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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.

Evelien De SutterClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium. evelien.desutter@kuleuven.be.
Stef VerreydtDistributed and Secure Software (DistriNet), Department of Computer Science, KU Leuven, Leuven, Belgium.
Koen YskoutDistributed and Secure Software (DistriNet), Department of Computer Science, KU Leuven, Leuven, Belgium.
David GeertsKU Leuven Digital Society Institute, KU Leuven, Leuven, Belgium.
Pascal BorryCentre for Biomedical Ethics and Law, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
An OuttierDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Marc FerranteDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Corinne VandermeulenLeuven University Vaccinology Centre, Department of Public Health and Primary Care, KU Leuven, Leuven, Belgium.
Nele VanmechelenDepartment of Endocrinology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Bart Van der SchuerenDepartment of Endocrinology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
Isabelle HuysClinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Funding

European Union's Horizon 2020 research and innovation programme 825903
6 · The paper itself

Abstract

backgroundThe development of technological applications in clinical research, such as electronic informed consent (eIC), is on the rise. The involvement of end users throughout the design process of eIC is of utmost importance to improve the current informed consent process.

methodsUsing a provocative design, we conducted interviews with 30 clinical research participants. Provotypes were used as a starting base to discuss various aspects relevant to eIC. By providing a medium to encourage divergent thinking, participants' views and concerns were solicited. Thematic analysis was undertaken using NVivo.

resultsThe majority of participants placed trust in the principal investigator or the hospital to perform the role of eIC hosting party. Differing opinions were reported on the amount of information required related to stakeholders' access to an eIC system, and thus, to participants' personal data, to enable trust in an eIC system. Nevertheless, this study indicates a general willingness of participants to share personal data with physicians and pharmaceutical companies on an international level, and to receive requests for new research studies via an eIC system. Participants suggested to tailor an eIC system based upon their preferences, for example, regarding whom they want to share their personal data with. Moreover, they expressed a desire to choose how they can contact the research team, and to indicate which study-related information they would like to receive electronically. In addition, positive opinions were voiced on the integration of a test to assess participants' understanding before providing their eIC.

conclusionsFollowing a research through design approach, insights have been generated which inform the design of eIC. Provotypes were designed to help participants think beyond what is familiar to them. Study findings revealed that not all situations were perceived as provocative, because of participants' motivation to advance scientific research and the trust they place in the research team. Nevertheless, the use of provocative design resulted in additional insights, generated by clinical research participants, which could be considered in the further design of eIC.

Indexed as

AttitudeInformed ConsentElectronicsHumansTechnologyTrustClinical studyDigital consentEthicsHuman-centered designProvotypesQualitative researchUser interface

Identifiers

PMID36397108
PMCPMC9669523

What OpenQuestion holds

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Registered trials

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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.