Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial

Lattuca, Benoît; Barber‐Chamoux, Nicolas; Alos, Benjamin; Sfaxi, Anis; Mulliez, Aurélien; Miton, Noelie; Levasseur, Thomas; Servoz, Clément; Dérimay, François; Hachet, Olivier; Motreff, Pascal; Metz, Damien; Lairez, Olivier; Mewton, Nathan; Belle, Loïc; Akodad, Mariama; Mathivet, Thomas; Ecarnot, Fiona; Pollet, Justine; Danchin, Nicolás; Steg, P. Gabriel; Juillière, Yves; Bouleti, Claire

doi:10.1016/j.ahj.2018.03.006

Cited by 39 publications

(63 citation statements)

References 28 publications

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“…34–36 Most (41/52) addressed informed consent for surgical procedures, 9 for medical procedures, and 2 for a mixture of medical and surgical procedures. Seven studies specified that interventions took place in the outpatient setting, 37–43 6 in the inpatient setting, 44–49 and 1 in the emergency department. 50 The remaining 38 studies did not specify the setting.…”

Section: Resultsmentioning

confidence: 99%

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

et al. 2020

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Background. Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension. Purpose. An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent. Data Sources. Systematic searches of MEDLINE and EMBASE (2008–2018). Study Selection. We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent. Data Extraction. Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus. Data Synthesis. Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity. Limitations. Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome. Conclusions. Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.

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Section: Resultsmentioning

confidence: 99%

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

et al. 2020

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“…Therefore, it is important to explore other formats of transmitting key messages of a clinical trial using pictures, videos or even theaters. Previous studies have shown that, for example, the use of videos significantly increases participants' comprehension when compared to a standard informed consent procedure [20][21][22]. Another potential explanation for the poor understanding of caregivers might be related to the concept of "authority of knowledge", i.e.…”

Section: Discussionmentioning

confidence: 99%

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

et al. 2020

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Background: In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant's true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania. Methods: A total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65). Results: In contrast to the pamphlet, attending an information session significantly increased caregivers' knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures). Conclusions: In conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.

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“…Using video or multimedia modalities to educate patients and assist informed consent seems to produce satisfactory results. Several studies have shown that using a video-assisted method to educate patients resulted in better patient satisfaction and improved patient knowledge of procedures and risks [74, 77, 83, 84]. Some studies also found that the use of educational videos can reduce physician counseling time [75, 85].…”

Section: Discussionmentioning

confidence: 99%

How to effectively obtain informed consent in trauma patients: a systematic review

et al. 2019

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BackgroundObtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients.MethodsWe conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed (1961–August 2018) that had experimental or observational study design and involved adult trauma patients. Studies involving informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach.ResultsA total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information.ConclusionsMany articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients.Electronic supplementary materialThe online version of this article (10.1186/s12910-019-0347-0) contains supplementary material, which is available to authorized users.

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Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial

Cited by 39 publications

References 28 publications

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

Informed consent procedure in a double blind randomized anthelminthic trial on Pemba Island, Tanzania: do pamphlet and information session increase caregivers knowledge?

How to effectively obtain informed consent in trauma patients: a systematic review

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