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Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the (...) non-digital Informed Consent process. Methods We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio–video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia, non-interactive multimedia, and videos, and most studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures and clinical research. For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact. (shrink)

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BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/ucla Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, (...) ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/ucla method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process. (shrink)

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From an epidemiological perspective, the practice of universal vaccination of girls and young women in order to prevent human papilloma virus (HPV) infection and potential development of cervical cancer is widely accepted even though it may lead to the neglect of other preventive strategies against cervical cancer.

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Background Several authors have shown that children and adolescents have limited understanding of critical elements of the research studies in which they are participating. The inclusion of graphic elements is a promising approach to increase the understandability of assent forms of clinical trials. Objectives To design a new assent form in comic strip format for minors participating in clinical trials and to compare the comprehension of this new document with a traditional assent form. Methods This study included an assessment of (...) the readability of standard informed assents, the evaluation of the comprehension of one of these documents, the development of a new (comic format) informed assent from the original document previously evaluated, and the analysis of readability and comprehension of the new informed assent. The readability of the documents was assessed using previously validated formulas, whereas comprehension analyses were performed through a questionnaire taken by two groups of 12-year-old students of secondary schools. Ethical considerations: All procedures involving human participants were in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments. Findings Compared with the original document, the comic assent form improved the grammatical readability of the “Aims, Risks and Benefits and How to Get More Information” sections, the comprehension scores in the Aims and Procedure sections, the understanding of ideas, and the formation of macro-ideas. The benefits of the comic strip format were more noticeable among participants in the lower percentiles of the comprehension score. Conclusions Our results show that the comic assent form has high readability and comprehensibility compared with its original form, particularly in the domains of knowledge-based inferences and macro-ideas formation. The use of forms that combine text and comic strips may help the comprehension of minors participating of a clinical trial, supporting their autonomy in decision-making. (shrink)

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