Evidence map›Paper›PMID 33639926›Full record

SynthesisBMC medical ethics2021

Digital tools in the informed consent process: a systematic review.

Francesco Gesualdo, Margherita Daverio, Laura Palazzani, Dimitris Dimitriou, Javier Diez-Domingo, Jaime Fons-Martinez, Sally Jackson, Pascal Vignally, Caterina Rizzo, Alberto Eugenio Tozzi

Abstract readSystematic Review
In one paragraph

Synthesis in BMC medical ethics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 3 pooled it
–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

74 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  12. 'A No-Brainer, but Not a Simple Decision': A Qualitative Study of Patient Experiences of Tissue Donation for Research in Rare Craniospinal Tumour Pathways.Health expectations : an international journal of public participation in health care and health policy · 2026
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  18. [Relevance of eHealth Literacy (eHL) for health services research and practice - Part II].Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) · 2026
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14 more citing papers are in PubMed but not listed here.

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

10 authors.

Francesco GesualdoOspedale Pediatrico Bambino Gesù (OPBG), Piazza di Sant'Onofrio, 4, 00165, Rome, Italy. francesco.gesualdo@opbg.net.ORCID 0000-0002-9087-4398
Margherita DaverioLibera Università Maria Ss. Assunta (LUMSA), Via della Traspontina, 21, 00193, Rome, Italy.
Laura PalazzaniLibera Università Maria Ss. Assunta (LUMSA), Via della Traspontina, 21, 00193, Rome, Italy.
Dimitris DimitriouAND Consulting Group SPRL, Place Marcel Broodthaers, 8, 1060, Brussels, Belgium.
Javier Diez-DomingoThe Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO), Avda. de Catalunya, 21, 46020, Valencia, Spain.
Jaime Fons-MartinezThe Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO), Avda. de Catalunya, 21, 46020, Valencia, Spain.
Sally JacksonOspedale Pediatrico Bambino Gesù (OPBG), Piazza di Sant'Onofrio, 4, 00165, Rome, Italy.
Pascal VignallyOspedale Pediatrico Bambino Gesù (OPBG), Piazza di Sant'Onofrio, 4, 00165, Rome, Italy.
Caterina RizzoOspedale Pediatrico Bambino Gesù (OPBG), Piazza di Sant'Onofrio, 4, 00165, Rome, Italy.
Alberto Eugenio TozziOspedale Pediatrico Bambino Gesù (OPBG), Piazza di Sant'Onofrio, 4, 00165, Rome, Italy.

Funding

European Commission Horizon 2020 SwafS-17-2016 741856
6 · The paper itself

Abstract

backgroundProviding understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients' autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.

methodsWe searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.

resultsOur search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes.

conclusionsDigital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.

Indexed as

Informed ConsentMultimediaAdultHumansResearch DesignDigital toolsInformed consentInnovationMultimediaRCTSystematic reviewVideo

Identifiers

PMID33639926
PMCPMC7913441

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.