Evidence map›Paper›PMID 29523129›Full record

Trial reportBMC medical ethics2018

Educational video-assisted versus conventional informed consent for trauma-related debridement surgery: a parallel group randomized controlled trial.

Yen-Ko Lin, Chao-Wen Chen, Wei-Che Lee, Yuan-Chia Cheng, Tsung-Ying Lin, Chia-Ju Lin, Leiyu Shi, Yin-Chun Tien, Liang-Chi Kuo

Registry-linked trialAbstract readComparative StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medical ethics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01338480 (Improving Informed Consent Process for Trauma Patients in the Emergency Department), which is not on this map. Cited by 36 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 6 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.

NCT01338480 nacompletednot on this map

Improving Informed Consent Process for Trauma Patients in the Emergency Department

TypeinterventionalSponsorKaohsiung Medical University Chung-Ho Memorial HospitalRan2009 to 2014Enrolled172ConditionsTrauma, SurgeryArmsvideo
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  5. 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
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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

9 authors.

Yen-Ko LinDivision of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Chao-Wen ChenDivision of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Wei-Che LeeDivision of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Yuan-Chia ChengDivision of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Tsung-Ying LinDivision of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Chia-Ju LinCollege of Nursing, Kaohsiung Medical University, Kaohsiung, 807, Taiwan. chiaju@kmu.edu.tw.
Leiyu ShiDepartment of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
Yin-Chun TienDepartment of Orthopedics, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Liang-Chi KuoDivision of Trauma and Surgical Critical Care, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe investigated whether, in the emergency department (ED), educational video-assisted informed consent is superior to the conventional consent process, to inform trauma patients undergoing surgery about the procedure, benefits, risks, alternatives, and postoperative care.

methodsWe conducted a prospective randomized controlled trial, with superiority study design. All trauma patients scheduled to receive trauma-related debridement surgery in the ED of Kaohsiung Medical University Hospital were included. Patients were assigned to one of two education protocols. Participants in the intervention group watched an educational video illustrating informed consent information, whereas those in the control group read an informed consent document. The primary outcome was knowledge scores and the secondary outcome was assessment of patient satisfaction. A multivariable regression model, with predefined covariates, was used to analyze differences in knowledge scores and patient satisfaction levels between the groups.

resultsA total of 142 patients were enrolled, with 70 and 72 assigned to the intervention and control groups, respectively. Mean knowledge scores were higher in the intervention (72.57 ± 16.21 (SD)) than in the control (61.67 ± 18.39) group. By multivariate analysis, the intervention group had significantly greater differences in knowledge scores (coefficient: 7.646, 95% CI: 3.381-11.911). Age, injury severity score, and baseline knowledge score significantly affected the differences in knowledge scores. Significant improvements were observed in patients' perception of statements addressing comprehension of the information provided, helpfulness of the supplied information for decision making, and satisfaction with the informed consent process. Multivariate analysis showed significant correlations between video education and patient satisfaction.

conclusionsBoth the educational approach and severity of injury may have an impact on patient understanding during the informed consent process in an emergency environment. Video-assisted informed consent may improve the understanding of surgery and satisfaction with the informed consent process for trauma patients in the ED. Institutions should develop structured methods and other strategies to better inform trauma patients, facilitate treatment decisions, and improve patient satisfaction.

trial registrationThe ClinicalTrials.gov Identifier is NCT01338480 . The date of registration was April 18, 2011 (retrospectively registered).

Indexed as

DebridementEmergency Service, HospitalHealth Knowledge, Attitudes, PracticeInformed ConsentPatient Education as TopicPatient SatisfactionAdultAgedComprehensionConsent FormsDecision MakingDelivery of Health CareEmergency Medical ServicesEthics, ClinicalFemaleHumansEmergency departmentInformed consentPatient knowledgePatient satisfactionTrauma

Identifiers

PMID29523129
PMCPMC5845218

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.