Evidence map›Paper›PMID 28352847›Full record

ArticleOpen medicine (Warsaw, Poland)2016

Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy.

Alessandro Borello, Alessia Ferrarese, Roberto Passera, Alessandra Surace, Silvia Marola, Claudio Buccelli, Massimo Niola, Pierpaolo Di Lorenzo, Maurizio Amato, Lorenza Di Domenico and 2 more

Abstract read
In one paragraph

Article in Open medicine (Warsaw, Poland), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review.Medical decision making : an international journal of the Society for Medical Decision Making · 2020
    Pooled it
  2. Review
  3. Article
  4. Article
  5. Genetic Testing: Ethical Aspects.Open medicine (Warsaw, Poland) · 2018
    Article
  6. Article
  7. Article
  8. 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

12 authors.

Alessandro BorelloUniversity of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
Alessia FerrareseDepartment of Oncology, University of Turin, Section of General Surgery, San Luigi Gonzaga University Hospital, Regione Gonzole 10, 10043 Orbassano, Turin, Italy ,.
Roberto PasseraCittà della Salute e della Scienza Hospital, Section of Nuclear Medicine, Turin, Italy.
Alessandra SuraceUniversity of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
Silvia MarolaUniversity of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
Claudio BuccelliDepartment of Advanced Biomedical Sciences, Naples, Italy, University "Federico II" of Naples. Via Sergio Pansini 5, 80131, Naples, Italy.
Massimo NiolaDepartment of Advanced Biomedical Sciences, Naples, Italy, University "Federico II" of Naples. Via Sergio Pansini 5, 80131, Naples, Italy.
Pierpaolo Di LorenzoDepartment of Advanced Biomedical Sciences, Naples, Italy, University "Federico II" of Naples. Via Sergio Pansini 5, 80131, Naples, Italy.
Maurizio AmatoDepartment of Neuroscience, Naples, Italy. Fellow in General Surgery at University of Naples, Naples, Italy.
Lorenza Di DomenicoDepartment of Neuroscience, Naples, Italy. Fellow in Anestesiology at University of Naples, Naples, Italy.
Mario SolejUniversity of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.
Valter MartinoUniversity of Turin, Department of Oncology, School of Medicine, San Luigi Gonzaga University Hospital, Section of General Surgery, Orbassano, Turin, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSurgical informed consent forms can be complicated for patients to read and understand. We created a consent form with key information presented in bulleted texts and diagrams combined in a graphical format to facilitate the understanding of information during the verbal consent discussion.

methodsThis prospective, randomized study involved 70 adult patients awaiting cholecystectomy for gallstones. Consent was obtained after standard verbal explanation using either a graphically formatted (study group, n=33) or a standard text document (control group, n=37). Comprehension was evaluated with a 9-item multiple-choice questionnaire administered before surgery and factors affecting comprehension were analyzed.

resultsComparison of questionnaire scores showed no effect of age, sex, time between consent and surgery, or document format on understanding of informed consent. Educational level was the only predictor of comprehension.

conclusionsSimplified surgical consent documents meet the goals of health literacy and informed consent. Educational level appears to be a strong predictor of understanding.

Indexed as

Informed consentLaparoscopic cholecystectomy

Identifiers

PMID28352847
PMCPMC5329879

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.