Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures

Bowers, Nicolas; Eisenberg, Eric L.; Montbriand, Janice; Jaskolka, Jeffrey D.; Roche-Nagle, Graham

doi:10.1016/j.surge.2015.09.001

Cited by 51 publications

(54 citation statements)

References 22 publications

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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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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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“…Wir haben in einer eigenen Studie an 21 Probanden evaluiert, ob die Verwendung von 3D-Modellen zur Aufklärung vor einem endovaskulären Eingriff (EVAR) bei AAA von Nutzen für Verständnis und Zufriedenheit der Befragten sein kann. Für die Befragung unserer Probanden haben wir auf das Design einer ähnlichen Studie zurückgegriffen [19] und die verwendeten Fragen inhaltlich angepasst an das von uns untersuchte Krankheitsbild des AAA und die Verwendung eines 3D-Modells. Hierbei ist zu bemerken, dass aufgrund des Studiendesigns potenziell die Möglichkeit eines Bias besteht, da der Patient eine abgestufte Aufklärung erfährt.…”

Section: Patientenaufklärungunclassified

“…Hierbei ist zu bemerken, dass aufgrund des Studiendesigns potenziell die Möglichkeit eines Bias besteht, da der Patient eine abgestufte Aufklärung erfährt. Im Gegensatz dazu hätte die komplette Trennung in 2 Studienkohorten (mit und ohne 3D-Modell) wiederum den Nachteil, dass für den einzelnen Patienten kein intraindividueller Vergleich (vor/ nach 3D-Modell) möglich gewesen wäre, sodass wir uns für ersteres Studiendesign entschieden haben, das bereits in der Publikation von Bowers et al [19] evaluiert worden war. Die Datenerhebung erfolgte anhand von 4 Fragebögen mit den Themen- komplexen "Erwartung an eine Aufklärung" (max.…”

Section: Patientenaufklärungunclassified

Gefäßmedizin in der Zukunft – Möglichkeiten mit 3D-Druckverfahren

et al. 2019

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ZusammenfassungDie Digitalisierung der Chirurgie ist eine der richtungsweisenden Herausforderungen der aktuellen und kommenden Chirurgengenerationen. Für das Gebiet der Gefäßmedizin steht mit dem 3D-Druck eine digitale Technologie zur Verfügung, deren Implementierungsmöglichkeit interessante Perspektiven bietet und evaluiert werden muss. Die 3D-Drucktechnologie erlaubt neben dem Einsatz zu Aufklärungs-, Trainings- und Simulationszwecken auch die Herstellung von patientenindividuellen OP-Schablonen und Implantaten. In unserer Klinik wird diese Technologie derzeit in den Bereichen Operationsplanung bei komplexer Gefäßmorphologie, Patientenaufklärung und zu Trainingszwecken verwendet. Die aktuellen industriellen Weiterentwicklungen hinsichtlich Softwarelösungen, Materialpalette und Druckereigenschaften lassen eine deutliche Vereinfachung des Herstellungsprozesses von patientenindividuellen 3D-Modellen und eine Expansion der Anwendungsmöglichkeiten erwarten.

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“…Therefore, in our opinion, alternative methods of information that contribute to a better understanding of information in iPSC research should be adopted. These could incorporate the use of multimedia (i.e., information videos or computerized presentations) and interactive tools (i.e., examination of information provided during the information process in the form of a questionnaire with subsequent feedback) [56]. This could allow to estimate the level of actual understanding.…”

Section: Discussionmentioning

confidence: 99%

Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

Orzechowski¹,

Schochow²,

Kühl

et al. 2020

Stem Cell Res Ther

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Background: The discovery of induced pluripotent stem cells (iPSCs) opened the possibilities for reprogramming cells back to a pluripotent state. Because of no apparent ethical issues connected with donation and derivation of biomaterial, iPSCs are considered as a research alternative to ethically highly disputed human embryonic stem cells (hESCs). However, the unique character of iPSCs leads to numerous ethical considerations, which mainly concern the issue of donor information and consent for the use of biospecimen in research and drug evaluation. Methods: For the purpose of this analysis, we conducted a review of the literature in the PubMed/MEDLINE and Web of Science databases. The search algorithm led to the identification of 1461 results. After removing duplicates and screening of title and abstract, 90 articles were found to be relevant to the study's objective. Full texts of these articles were apprised and 62 articles were excluded at this step for not properly addressing the study's objective. In the final step, 28 articles were included in the analysis. Analyzed were both research and non-research manuscripts published in peer-reviewed journals. Results: In the case of iPSC research, the information process should be guided by general frameworks established for research on human subjects but also by specific characteristics of iPSCs. We determined four main domains and 12 thematic subdomains that should be included in donor information. Our results show that majority of authors agree to the content of information with regard to the areas of general information, storage of cells, and protection of privacy. Two main issues that are discussed in the literature are donor's consent for use in future studies and the process of donor information. Conclusions: Given the unique character of iPSCs and the possibility of their various uses in the future, the content of donor information should contain specific information central to iPSC research. Effective methods of communicating information to donors should combine written and oral information with the possible use of multimedia.

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Using a multimedia presentation to improve patient understanding and satisfaction with informed consent for minimally invasive vascular procedures

Cited by 51 publications

References 22 publications

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

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

Gefäßmedizin in der Zukunft – Möglichkeiten mit 3D-Druckverfahren

Donor information in research and drug evaluation with induced pluripotent stem cells (iPSCs)

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