Health Literacy in Clinical Research Practice and Impact: Proceedings of a Workshop (2020) / Chapter Skim
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2 Health Literacy as an Ethical Imperative in Clinical Trials
2 Health Literacy as an Ethical Imperative in Clinical Trials
Pages 5-22
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Bierer, professor of medicine and faculty co-director of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center) , offered her perspective on why health literacy matters.
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According to Bierer, those stakeholders include pharmaceutical companies, contract research organizations, academicians, patients, patient advocates, regulatory folks, and others. "We work to create actionable, ethical, and practical solutions," she said, "and the MRCT Center works to deliver practical tools and resources that individuals can use." Bierer noted that the MRCT Center has been focusing on improving health literacy in clinical trials for about 1.5 years, but that the idea actually started several years before that, when the MRCT Center was focused on returning individual and aggregate summary results to participants.
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When Bierer began working on the health literacy in clinical research project at the MRCT Center, about 50 people volunteered to participate. Bierer explained that the volunteers adopted a "multidimensional" definition of health literacy: This is not only about plain language.
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Health Literacy in the Clinical Trial Life Cycle Bierer said that at the MRCT Center, they think that [the clinical trial life cycle] goes from discovery, from access to education, all the way through to the end of the study and communication, and clear communication is essential throughout.
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Existing Tools to Improve Health Literacy in Clinical Trials Bierer highlighted some of the work the MRCT Center had done that focused on access, education, and developing patient-facing materials and resources. Participant Brochures Harvard Catalyst has developed 25 brochures for potential clinical trial participants, in 15 languages, which "are all health literate and all reviewed by IRBs and have gone through health-literate sorts of revisions by [patient advocacy]
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She added that she has seen a rising appreciation of patient participation, of how patient engagement can make clinical trials more patient-centric, and of how patient voices in developing clinical trials matter. She continued, "If you work with the community and use their language, by default you are more likely to be health literate in your communications." Potential Systems Changes to Improve Health Literacy in Clinical Trials Bierer emphasized that health literacy is a responsibility of the entire system, and it is not up to the communicator or patient alone.
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, and https://store.samhsa.gov/system/files/ sma13-4775.pdf (accessed October 16, 2019) for more information about traumatic stress.
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Collyar emphasized that she believes there are myriad opportunities to engage and inform patients about clinical research and clinical trials throughout their diagnosis and treatment experience. But common problems that add to the mistrust of the medical community include medical professionals that • misdiagnose patients, • treat patients as data repositories, • fail to consider what is in it for the patient, and • fail to consider the significant costs for patients and their families.
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down? " Environment "Patient-controlled" "External forces" Community "Nonacademic center" "Where I live" Medical advance "Incremental adjustment" "A cure" SOURCE: Adapted from a presentation by Deborah Collyar at the workshop Health Literacy in Clinical Trials: Practice and Impact on April 11, 2019.
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We have to do a better job of explaining what those terms actually mean." Collyar noted that she served as co-chair on the Cancer and Leukemia Group B's Committee on Advocacy, Research Communications, Ethics, and Disparities (CARE) from 1998 through 2010, and helped them create better clinical trials with better results, especially for patients.
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• What is going to happen to me after the trial is over? SOURCE: Adapted from a presentation by Deborah Collyar at the workshop Health Literacy in Clinical Trials: Practice and Impact on April 11, 2019.
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. What Clinical Trials Should Really Be About Collyar said crossover designs are just one example of clinical researchers rethinking clinical trial design.
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At best, this can cause confusion within a PCP's office, and, at worst, it causes medical complications or mistreatment. He wondered why there were not handouts given to trial participants to share with their PCPs and how to encourage specialists who enroll participants to communicate with PCPs about their patients participating in clinical trials.
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"My dream," she added, "is that we actually are able to use clinical trial results in a way that makes our new trials better (including adaptive clinical trial design) , so that we're raising the bar on better designs and helping to build better results and impacts for patient communities as new drugs are developed." Bierer added that not enough is known about stakeholder engagement, particularly in trial design.
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Bierer added that cultural competence should be prioritized among researchers, including having adequate translation and interpretation services, and developing culturally appropriate educational materials. Collyar noted that therapeutic misconception is also a hurdle when it comes to informed consent.
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"Are they friends of those of us who are advocates of health literacy? Could they be recruited to be more helpful?
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From page 21... ...
Applied Clinical Trials, July 1, 2007. http://www.appliedclinicaltrialsonline.com/survey-survivors (accessed October 17, 2019)
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