Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review.
ABSTRACT BACKGROUND: Inadequate health literacy may impair research subjects' ability to participate adequately in the informed consent (IC) process. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects. METHODS: We performed a MEDLINE database search (1966 to November 2011) supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations. Study design, quality criteria, population, interventions and outcomes for each trial were extracted. The main outcome evaluated was comprehension, measured using a written test or verbal comprehension. RESULTS: Our search strategy yielded 281 studies, of which only six met our eligibility criteria. The six studies included 1620 research participants. The studies predominantly included populations that were older (median age 61, range 48-64), ethnic minority, and with literacy level of 8th grade or below. Only one study had a randomized design. The specific intervention differed in each study. Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects. CONCLUSIONS: The evidence supporting interventions to improve the informed consent process in low literacy populations is extremely limited. Among the interventions evaluated, having a study team member spend more time talking one-on-one to study participants was the most effective strategy for improving informed consent understanding; however, this finding is based on the results of a single study.
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ABSTRACT: PurposeEvidence indicates that research participants often do not fully understand the studies for which they have volunteered. The aim of this systematic review was to examine the relationship between the process of obtaining informed consent for research and participant comprehension and satisfaction with the research.DesignSystematic review of published research on informed consent and participant comprehension of research for which they volunteer using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement as a guide.Methods PubMed, Cumulative Index for Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trails, and Cochrane Database of Systematic Reviews were used to search the literature for studies meeting the following inclusion criteria: (a) published between January 1, 2006, and December 31, 2013, (b) interventional or descriptive quantitative design, (c) published in a peer-reviewed journal, (d) written in English, and (e) assessed participant comprehension or satisfaction with the research process. Studies were assessed for quality using seven indicators: sampling method, use of controls or comparison groups, response rate, description of intervention, description of outcome, statistical method, and health literacy assessment.FindingsOf 176 studies identified, 27 met inclusion criteria: 13 (48%) were randomized interventional designs and 14 (52%) were descriptive. Three categories of studies included projects assessing (a) enhanced consent process or form, (b) multimedia methods, and (c) education to improve participant understanding. Most (78%) used investigator-developed tools to assess participant comprehension, did not assess participant health literacy (74%), or did not assess the readability level of the consent form (89%). Researchers found participants lacked basic understanding of research elements: randomization, placebo, risks, and therapeutic misconception.Conclusions Findings indicate (a) inconsistent assessment of participant reading or health literacy level, (b) measurement variation associated with use of nonstandardized tools, and (c) continued therapeutic misconception and lack of understanding among research participants of randomization, placebo, benefit, and risk. While the Agency for Healthcare and Quality and National Quality Forum have published informed consent and authorization toolkits, previously published validated tools are underutilized.Clinical RelevanceInformed consent requires the assessment of health literacy, reading level, and comprehension of research participants using validated assessment tools and methods.Journal of Nursing Scholarship 08/2014; · 1.61 Impact Factor
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ABSTRACT: Little research has examined the association of health literacy and numeracy with patients' preferred involvement in the problem-solving and decision-making process in the hospital. Using a sample of 1,249 patients hospitalized with cardiovascular disease from the Vanderbilt Inpatient Cohort Study (VICS), we assessed patients' preferred level of involvement using responses to two scenarios of differing symptom severity from the Problem-Solving Decision-Making Scale. Using multivariable modeling, we determined the relationship of health literacy, subjective numeracy, and other patient characteristics with preferences for involvement in decisions, and how this differed by scenario. The authors found that patients with higher levels of health literacy desired more participation in the problem-solving and decision-making process, as did patients with higher subjective numeracy skills, greater educational attainment, female gender, less perceived social support, or greater health care system distrust (p < .05 for each predictor in multivariable models). Patients also preferred to participate more in the decision-making process when the hypothetical symptom they were experiencing was less severe (i.e., they deferred more to their physician when the hypothetical symptom was more severe). These findings underscore the role that patient characteristics, especially health literacy and numeracy, play in decisional preferences among hospitalized patients.Journal of Health Communication 10/2014; 19 Suppl 2:29-43. · 1.61 Impact Factor
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ABSTRACT: The current emphasis on broad sharing of human genomic data generated in research in order to maximize utility and public benefit is a significant legacy of the Human Genome Project. Concerns about privacy and discrimination have led to policy responses that restrict access to genomic data as the means for protecting research participants. Our research and experience show, however, that a considerable number of research participants agree to open access sharing of their genomic data when given the choice. General policies that limit access to all genomic data fail to respect the autonomy of these participants and, at the same time, unnecessarily limit the utility of the data. We advocate instead a more balanced approach that allows for individual choice and encourages informed decision making, while protecting against the misuse of genomic data through enhanced legislation.Genes. 09/2014; 5(3):739-747.