How to Achieve Informed Consent for Research from Spanish-Speaking Individuals with Low Literacy: A Qualitative Report

Cortés, Dharma E.; Drainoni, Mari-Lynn; Henault, Lori

doi:10.1080/10810730.2010.499990

Cited by 23 publications

(14 citation statements)

References 19 publications

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“…As in our study, other research has found (Cortes et al 2010)—and indeed there seems to be consensus (Lorell et al 2015)—that the leading problem regarding informed consent is the length and amount of information included in informed consent documents. However, much of this information is critical.…”

Section: Discussionsupporting

confidence: 85%

“…Consent forms could be made shorter, but ultimately, a solely text-based delivery system has significant limitations. Our participants noted, as in other studies, that they often felt rushed during the informed consent process (Hallinan et al 2016; Cortes et al 2010). Multimedia formats have numerous benefits for presenting information in more user-friendly ways; they allow individuals to absorb information at their own pace through their own preferred means of delivery (Shneerson et al 2013).…”

Section: Discussionsupporting

confidence: 82%

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Improving informed consent: Stakeholder views

Anderson

Newman

Matthews

2017

AJOB Empirical Bioethics

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Purpose Innovation will be required to improve the informed consent process in research. We aimed to obtain input from key stakeholders—research participants and those responsible for obtaining informed consent—to inform potential development of a multimedia informed consent “app.” Methods This descriptive study used a mixed-methods approach. Five 90-minute focus groups were conducted with volunteer samples of former research participants and researchers/research staff responsible for obtaining informed consent. Participants also completed a brief survey that measured background information and knowledge and attitudes regarding research and the use of technology. Established qualitative methods were used to conduct the focus groups and data analysis. Results We conducted five focus groups with 41 total participants: three groups with former research participants (total n = 22), and two groups with researchers and research coordinators (total n = 19). Overall, individuals who had previously participated in research had positive views regarding their experiences. However, further discussion elicited that the informed consent process often did not meet its intended objectives. Findings from both groups are presented according to three primary themes: content of consent forms, experience of the informed consent process, and the potential of technology to improve the informed consent process. A fourth theme, need for lay input on informed consent, emerged from the researcher groups. Conclusions Our findings add to previous research that suggests that the use of interactive technology has the potential to improve the process of informed consent. However, our focus-group findings provide additional insight that technology cannot replace the human connection that is central to the informed consent process. More research that incorporates the views of key stakeholders is needed to ensure that multimedia consent processes do not repeat the mistakes of paper-based consent forms.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionsupporting

confidence: 82%

Improving informed consent: Stakeholder views

Anderson

Newman

Matthews

2017

AJOB Empirical Bioethics

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“…Teach-back has been studied in the informed consent literature 22,23 , where it has been shown to increase recall. 24 Teach-back has been estimated to add an estimated additional 5 minutes is required to the informed consent process.…”

Section: Discussionmentioning

confidence: 99%

“Like a dialogue”: Teach-back in the emergency department

Samuels‐Kalow

Hardy

Rhodes

et al. 2016

Patient Education and Counseling

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Objective Teach-back may improve communication, but has not been well studied in the emergency setting. The goal of this study was to characterize perceptions of teach-back in the emergency department (ED) by health literacy. Methods We conducted an in-depth interview study the ED discharge process teach-back techniques in two tertiary care centers (adult and pediatric), using asthma as a model system for health communication. Participants were screened for health literacy, and purposive sampling was used to balance the sample between literacy groups. Interviews were conducted until thematic saturation was reached for each literacy group at each site; audiotaped, transcribed, coded, and analyzed using a modified grounded theory approach. Results Fifty-one interviews were completed (31 parents; 20 patients). Across all groups, participants felt that teach-back would help them confirm learning, avoid forgetting key information, and improve doctor-patient communication. Participants with limited health literacy raised concerns about teach-back being condescending, but suggested techniques for introducing the technique to avoid this perception. Conclusion Most participants were supportive of teach-back techniques, but many were concerned about perceived judgment from providers. Practice Implications Future investigations should focus on feasibility and efficacy of teach-back in the ED and using participant generated wording to introduce teach-back

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“…User-centered design principles enabled us to prototype a tool, receive feedback from potential end users, and quickly make substantial improvements to the next iteration. This process is critical for our objectives, given that many research and informed consent concepts are particularly difficult for people to understand [3, 10, 11]. This design process also illuminated additional research concepts in need of attention, such as standard of care, personal identifiers linked to samples, and distrust of the randomization process.…”

Section: Discussionmentioning

confidence: 99%

“…Data suggest that research participants only understand between 30% to 81% of the information presented to them and not all the concepts essential for true informed consent [10, 11]. Particularly difficult research concepts include: the experimental nature of trials, risks and benefits, alternatives to treatment, voluntarism, and randomization [10, 12, 13].…”

Section: Introductionmentioning

confidence: 99%

The Development of a Communication Tool to Facilitate the Cancer Trial Recruitment Process and Increase Research Literacy among Underrepresented Populations

et al. 2015

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Despite increasing need to boost the recruitment of underrepresented populations into cancer trials and biobanking research, few tools exist for facilitating dialogue between researchers and potential research participants during the recruitment process. In this paper, we describe the initial processes of a user-centered design cycle to create a standardized research communication tool prototype for enhancing research literacy among individuals from underrepresented populations considering enrollment in cancer research and biobanking studies. We present qualitative feedback and recommendations on the prototype's design and content from potential end users: five clinical trial recruiters and ten potential research participants recruited from an academic medical center. Participants were given the prototype (a set of laminated cards) and were asked to provide feedback about the tool's content, design elements, and word choices during semi-structured, in-person interviews. Results suggest that the prototype was well received by recruiters and patients alike. They favored the simplicity, lay language, and layout of the cards. They also noted areas for improvement, leading to card refinements that included: addressing additional topic areas, clarifying research processes, increasing the number of diverse images, and using alternative word choices. Our process for refining user interfaces and iterating content in early phases of design may inform future efforts to develop tools for use in clinical research or biobanking studies to increase research literacy.

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How to Achieve Informed Consent for Research from Spanish-Speaking Individuals with Low Literacy: A Qualitative Report

Cited by 23 publications

References 19 publications

Improving informed consent: Stakeholder views

Improving informed consent: Stakeholder views

“Like a dialogue”: Teach-back in the emergency department

The Development of a Communication Tool to Facilitate the Cancer Trial Recruitment Process and Increase Research Literacy among Underrepresented Populations

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