Evidence map›Paper›PMID 41392053›Full record

Trial reportAesthetic plastic surgery2026

Effect of a Multimedia-Assisted Informed Consent Procedure on the Information Gain of Patients Undergoing Mastectomy and Implant-Based Reconstruction.

Francesca De Lorenzi, Riccardo Carbonaro, Chiara Marzorati, Eleonora Pagan, Sergio Miranda, Vincenzo Bagnardi, Claudia Sangalli, Mara Negri, Gabriella Pravettoni, Paolo Veronesi

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Aesthetic plastic surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Francesca De LorenziDivision of Plastic and Reconstructive Surgery, IEO, European Institute of Oncology, IRCCS, Milan, Italy.
Riccardo CarbonaroDivision of Plastic and Reconstructive Surgery, IEO, European Institute of Oncology, IRCCS, Milan, Italy. carbonaro.doc@gmail.com.ORCID 0000-0003-2137-5007
Chiara MarzoratiApplied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy.
Eleonora PaganDepartment of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Sergio MirandaDivision of Plastic and Reconstructive Surgery, IEO, European Institute of Oncology, IRCCS, Milan, Italy.
Vincenzo BagnardiDepartment of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
Claudia SangalliClinical Trial Office, European Institute of Oncology IRCCS, Milan, Italy.
Mara NegriClinical Trial Office, European Institute of Oncology IRCCS, Milan, Italy.
Gabriella PravettoniApplied Research Division for Cognitive and Psychological Science, European Institute of Oncology, IRCCS, Milan, Italy.
Paolo VeronesiUniversità degli Studi di Milano, Via Festa del Perdono 7, 20122, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionImplant-based reconstruction is the most frequent procedure after mastectomy. Effective preoperative counseling and a thorough informed consent process are crucial for informing patients about oncologic surgery, reconstruction options, and expected cosmetic outcomes. Recent studies indicate that a multimedia video-assisted informed consent procedure may enhance patient information retention compared to traditional methods. This study aims to compare the conventional informed consent process, supplemented with a written informational brochure, to a multimedia video-assisted approach. MATERIALS AND

methodsFrom January to June 2024, 265 consecutive breast cancer patients scheduled for mastectomy and implant-based reconstruction at the European Institute of Oncology in Milan, Italy, were enrolled in this controlled randomized prospective study. Of these, 200 patients completed evaluation questionnaires assessing information retention and anxiety. A six-minute video featuring simple schematic illustrations and automated text-to-speech narration in Italian was developed to enhance understanding of the risks, benefits, and alternatives of the surgical treatment. Patients were randomly assigned to two groups: Group A received the video presentation along with evaluation questionnaires via email, while Group B received only the questionnaires.

resultsPatients in the multimedia video-assisted group demonstrated significantly higher overall comprehension compared to those in the control group. Although scores from the Spielberger State/Trait Anxiety Inventory (STAI) and the Decisional Conflict Scale (DCS) indicated greater anxiety and decisional conflict in the standard group, these differences were not statistically significant.

conclusionsThe multimedia video-assisted informed consent process is an effective tool for enhancing patient knowledge and awareness regarding implant-based breast reconstruction. This method improves information uptake and retention, suggesting its superiority over traditional communication techniques in preoperative counseling. These findings support the integration of multimedia resources in patient education to facilitate better-informed decision-making. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Indexed as

Breast ImplantationBreast NeoplasmsInformed ConsentMastectomyMultimediaPatient Education as TopicAdultAgedBreast ImplantsFemaleHumansItalyMiddle AgedProspective StudiesSurveys and QuestionnairesBreastInformationInformed consentMultimedia

Identifiers

PMID41392053
PMCPMC13102937

What OpenQuestion holds

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LicenceCC BY
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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.