scholarly journals Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients

2016 ◽  
Vol 109 (3) ◽  
pp. djw233 ◽  
Author(s):  
Janice L. Krieger ◽  
Jordan M. Neil ◽  
Yulia A. Strekalova ◽  
Melanie A. Sarge
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Low Health Literacy ◽  
Linguistic Strategies

Increasing Health Literacy to Improve Clinical Trial Recruitment

2018 ◽  
pp. 94-108
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Trial Recruitment ◽  
Negative Perception ◽  
Consent Forms ◽  
Clinical Trial Recruitment ◽  
And Training

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

Trends of Informed Consent forms for industry-sponsored clinical trials in rheumatology over a 17-year period: Readability, and assessment of patients’ health literacy and perceptions

2018 ◽  
Vol 48 (3) ◽  
pp. 547-552 ◽  
Author(s):  
Hector de la Mora-Molina ◽  
Aldo Barajas-Ochoa ◽  
Leon Sandoval-Garcia ◽  
Martha Navarrete-Lorenzon ◽  
Edgar A. Castañeda-Barragan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Consent Forms

scholarly journals 2030

2017 ◽  
Vol 1 (S1) ◽  
pp. 52-53
Author(s):  
Tina Moore ◽  
Laura P. James ◽  
Jennifer Holland ◽  
Edith Paal ◽  
Kristie Hadden
Keyword(s):  
Informed Consent ◽  
Health Literacy ◽  
Focus Group ◽  
Retrospective Analysis ◽  
Plain Language ◽  
Research Subjects ◽  
Regulatory Requirements ◽  
Post Intervention ◽  
10Th Grade ◽  
Low Health Literacy

OBJECTIVES/SPECIFIC AIMS: Develop a plain language informed consent template that met IRB and regulatory requirements. Evaluate the effectiveness of the template at improving the readability of informed consents. Field test the informed consent with low health literacy. METHODS/STUDY POPULATION: We conducted a retrospective analysis of over 200 UAMS IRB approved, investigator initiated informed consents from 2013 to 2015 to determine the readability before intervention. The mean grade level readabilities were derived from the results of 3 readability formulas (Flesch-Kincaid, SMOG, and Fry) using open-source readability tools. A plain language informed consent template that meets IRB and regulatory requirements was developed, adhering to health literacy best practices for written communication. The template was made available to investigators as an optional resource, and IRB committees were trained on use of the template. In addition, a focus group will be conducted to qualitatively assess understandability of the template with study participants identified as having inadequate health literacy. Data analysis will include readability assessment of IRB approved informed consents post intervention with and without use of the plain language template, as well as qualitative feedback from focus group participants. RESULTS/ANTICIPATED RESULTS: The retrospective analysis revealed a mean readability of 10th grade for IRB approved informed consents from 2013 to 2015 (n=217). The readability of the developed plain language template was 5th grade. Preliminary post-intervention results show adoption of the template by investigators (n=16) resulted in informed consents with a mean readability of 7th grade (range 6–9th grade), compared to a mean of 10th grade (range 7–11th grade) for the comparator (“no adoption” group, n=24). Data collection will continue through May 2017. The focus group is forthcoming and results will be included in the poster. DISCUSSION/SIGNIFICANCE OF IMPACT: Low health literacy is common in individuals with healthcare disparities and can limit their participation in clinical research. Few studies have examined interventions to address this barrier to research. Preliminary results of this study support the utilization of a plain language informed consent template in investigator-initiated research. Moreover, this study demonstrates the importance of stakeholder engagement among CTSA leadership, health literacy experts, the institutional review board, investigators, and research subjects in the development and testing of this intervention to make informed consents “understandable to the subject” while containing all required elements.

Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

2021 ◽  
Vol 10 (1) ◽  
pp. 33-36
Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practices ◽  
Situational Awareness ◽  
Implantable Devices ◽  
Wearable Device ◽  
Sleep Habits ◽  
Privacy Issues ◽  
Trial Participants ◽  
Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy

2002 ◽  
Vol 28 (4) ◽  
pp. 361-408
Author(s):  
Lars Noah
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Patient Autonomy ◽  
College Campuses ◽  
Human Experimentation ◽  
Experimental Therapy ◽  
Academic Literature ◽  
Medical Experimentation ◽  
Disclosure Rules ◽  
Near Unanimity

A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

scholarly journals Mental health, compliance with measures and health prospects during the COVID-19 epidemic: the role of health literacy

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Lize Hermans ◽  
Stephan Van den Broucke ◽  
Lydia Gisle ◽  
Stefaan Demarest ◽  
Rana Charafeddine
Keyword(s):  
Mental Health ◽  
At Risk ◽  
Health Literacy ◽  
Prevalence Ratio ◽  
Physical Distance ◽  
Poor Mental Health ◽  
Infection Prevalence ◽  
Cross Sectional ◽  
Normal Life ◽  
Low Health Literacy

Abstract Background The importance of health literacy in dealing with the COVID-19 epidemic has been emphasized but scarcely addressed empirically. In this study, the association of health literacy with mental health, compliance with COVID-19 preventive measures and health prospects was assessed in a Belgian context. Methods Data were extracted from the third of a series of cross-sectional online COVID-related surveys (n = 32,794). Data collection took place for 1 week starting the 28th of May 2020. People residing in Belgium and aged 18 years or older could participate. Data were collected on sociodemographic background, health literacy, multimorbidity, mental health (depression, anxiety, sleeping disorder, vitality), knowledge about COVID-19, compliance with COVID-19 measures (hygiene, physical distance, covering mouth and nose on public transport and in places where physical distance cannot be respected), and health prospects (risk for health when returning to normal life and possibility of infection). Prevalence Ratio (PR) of poor mental health, non-compliance with the measures and health prospects in relation to health literacy were calculated using Poisson regressions. Results People showing sufficient health literacy were less likely to suffer from anxiety disorders (PR = 0.47, 95% CI = [0.42–0.53]), depression (PR = 0.46, 95% CI = [0.40–0.52]) and sleeping disorders (PR = 0.85, 95% CI = [0.82–0.87]), and more likely to have optimal vitality (PR = 2.41, 95% CI = [2.05–2.84]) than people with low health literacy. They were less at risk of not complying with the COVID-19 measures (PR between 0.60 and 0.83) except one (covering mouth and nose in places where physical distance cannot be respected). Finally, they were less likely to perceive returning to normal life as threatening (PR = 0.70, 95% CI = [0.65–0.77]) and to consider themselves at risk of an infection with COVID-19 (PR = 0.75, 95% CI = [0.67–0.84]). The associations remained significant after controlling for COVID-19 knowledge and multimorbidity. Conclusions These results suggest that health literacy is a crucial factor in managing the COVID-19 epidemic and offer a perspective for future studies that target health literacy in the context of virus outbreaks.

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