Evidence map›Paper›PMID 37925488›Full record

Trial reportProstate cancer and prostatic diseases2024

Digital informed consent for urological surgery - randomized controlled study comparing multimedia-supported vs. traditional paper-based informed consent concerning satisfaction, anxiety, information gain and time efficiency.

Maximilian Haack, Nikita D Fischer, Lisa Frey, Peter Sparwasser, Robert Dotzauer, Gregor Duwe, Axel Haferkamp, Hendrik Borgmann

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Prostate cancer and prostatic diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

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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

8 authors.

Maximilian HaackDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany. Maximilian.Haack@unimedizin-mainz.de.ORCID 0000-0003-0957-2219
Nikita D FischerDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.
Lisa FreyDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.
Peter SparwasserDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.
Robert DotzauerDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.
Gregor DuweDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.
Axel HaferkampDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.
Hendrik BorgmannDepartment of Urology and Pediatric Urology, University Medical Center, Mainz, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDue to a lack of time and staff, informed consent (IC) in clinical practice often lacks clarity, comprehensibility and scope of information. Digital media offer great potential to enhance IC. Aim of this study is to evaluate the effectiveness of multimedia-supported compared to traditional paper-based IC.

methodsIn the randomized, controlled, three-arm DICon (Digital Informed Consent for urological surgery) study 70 patients with an indication for prostate biopsy were randomized 1:1:1 to receive traditional paper-based IC vs. multimedia-supported information before IC vs. multimedia-supported information during IC. Patient satisfaction, anxiety and information gain were measured by validated questionnaires 2 weeks and directly before the procedure and time efficiency was recorded. Statistical analysis was performed using Kruskal-Wallis and Dunn's test (one-way ANOVA) and two-way ANOVA (with bonferroni post-test).

resultsMultimedia information prior to the consultation saved 32.9% time compared to paper-based (5.3 min. vs. 9.5 min; p < 0.05) and 60.4% time compared to shared multimedia information (5.3 min. vs. 13.9 min.; p < 0.001), with no difference in satisfaction (62.6 vs. 62.7 vs. 68.6 of max. 80; p = 0.07), anxiety (8 vs. 8.1 vs. 7 of max. 16; p = 0.35), or information gain (6.5 vs. 5.7 vs. 6.7 of max. 10; p = 0.23). Results on satisfaction (56.6 vs. 62.6 vs. 66; p = 0.06), anxiety (7.2 vs. 7.2 vs. 6.8; p = 0.84), and information gain (7 vs. 6.4 vs. 5.9; p = 0.43) remained stable over time.

conclusionsMultimedia-supported IC prior to consultation provided improved time efficiency (33% gain) compared to traditional paper-based IC, with comparable satisfaction, anxiety and information gain. Multimedia-supported information materials should therefore be used more frequently in patient education.

Indexed as

AnxietyInformed ConsentMultimediaPatient SatisfactionAgedHumansMaleMiddle AgedPatient Education as TopicProstatic NeoplasmsSurveys and QuestionnairesUrologic Surgical Procedures

Identifiers

PMID37925488
PMCPMC11543590

What Socratic holds

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LicenceCC BY
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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 Socratic graph.