Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level

Kim, Eun Jin; Kim, Su Hyun

doi:10.1177/1740774515571139

Cited by 56 publications

(43 citation statements)

References 17 publications

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“…Studies have found that use of a simplified consent form—one using figures and plain language—can improve understanding (Dunn & Jeste, 2001; Kim & Kim, 2015). Others have found that an iterative process of assessing understanding, identifying areas of misunderstanding, and providing corrective feedback can lead to significant improvements in the understanding and appreciation of information (DuBois, Bante, & Hadley, 2011; Nishimura et al, 2013).…”

Section: Discussionmentioning

confidence: 99%

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities

Prusaczyk

Cherney

Carpenter

et al. 2016

Clinical Gerontologist

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Introduction Due to issues related to informed research consent, older adults with cognitive impairments are often excluded from high-quality studies that are not directly related to cognitive impairment, which has led to a dearth of evidence for this population. The challenges to including cognitively impaired older adults in research and the implications of their exclusion are a transdisciplinary issue. Discussion The ethical challenges and logistical barriers to conducting research with cognitively impaired older adults are addressed from the perspectives of three different fields – social work, emergency medicine, and orthopaedic surgery. Issues related to funding, study design, intervention components, and outcomes are discussed through the unique experiences of three different providers. Clinical Implications A fourth perspective – medical research ethics – provides alternatives to exclusion when conducting research with cognitively impaired older adults such as timing, corrective feedback and plain language, and capacity assessment and proxy appointments. Given the increasing aging population and the lack of evidence on cognitively impaired older adults, it is critical that researchers, funders, and institutional review boards not be dissuaded from including this population in research studies.

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Section: Discussionmentioning

confidence: 99%

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities

Prusaczyk

Cherney

Carpenter

et al. 2016

Clinical Gerontologist

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“…Educational research demonstrates that information perceived as attractive increases its potential and readability [ 10 , 20 ]. Plain language, short sentences, diagrams, pictures and bullet points have also recently in a randomized study been shown to effectively enhance understanding of consent forms irrespective of health literacy level [ 21 ]. Collaboration between investigators and patient representatives has been suggested to improve participant comprehension and satisfaction [ 6 ].…”

Section: Discussionmentioning

confidence: 99%

Patient representatives’ views on patient information in clinical cancer trials

Dellson

Nilbert

Carlsson

2015

BMC Health Serv Res

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BackgroundPatient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives’ views and perceptions on the written trial information used in clinical cancer trials.MethodsWritten patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis.ResultsTwo major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms.ConclusionsThe emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

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“…Research on ethical CT presentation highlights the need to enhance patients’ autonomy by meeting ethical obligations and reforming informed consent processes so that they are an ongoing interactive process that prioritizes patients’ privacy as well as creates opportunities for patients to interact with their social network . Understanding how patient's autonomy is enacted is significant to the broader CT participation literature as it can inform efforts that seek to optimize trial enrolment among patients with cancer.…”

Section: Introductionmentioning

confidence: 99%

“Ultimately, mom has the call”: Viewing clinical trial decision making among patients with ovarian cancer through the lens of relational autonomy

Asiedu

Ridgeway

Carroll

et al. 2018

Health Expectations

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ObjectiveThis study employs the concept of relational autonomy to understand how relational encounters with family members (FMs) and care providers may shape decisions around ovarian cancer patients’ clinical trial (CT) participation. The study also offers unique insights into how FMs view patients’ decision making.MethodsIn‐depth interviews were conducted with 33 patients with ovarian cancer who had been offered a CT and 39 FMs. Data were inductively analysed using a thematic approach and deductively informed by constructs derived from the theory of relational autonomy (RA).ResultsPatients’ relationships, experiences and social status were significant resources that shaped their decisions. Patients did not give equal weight to all relationships and created boundaries around whom to include in decision making. Doctors’ recommendations and perceived enthusiasm were described as influential in CT decisions. Both patients with ovarian cancer and their FMs maintained that patients have the “final say,” indicating an individualistic autonomy. However, maintaining the “final say” in the decision‐making process is constitutive of patients’ relationships, emphasizing a relational approach to autonomy. FMs support patients’ autonomy and they do so particularly when they believe the patient is capable of making the right choices.ConclusionsAlthough ethical principles underlying informed consent for CT participation emphasize individual autonomy, greater attention to relational autonomy is warranted for a more comprehensive understanding of CT decision making.

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Simplification improves understanding of informed consent information in clinical trials regardless of health literacy level

Abstract: Simplified informed consent was effective in enhancing participant's subjective and objective understanding regardless of health literacy.

Cited by 56 publications

References 17 publications

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities

Informed Consent to Research with Cognitively Impaired Adults: Transdisciplinary Challenges and Opportunities

Patient representatives’ views on patient information in clinical cancer trials

“Ultimately, mom has the call”: Viewing clinical trial decision making among patients with ovarian cancer through the lens of relational autonomy

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