Development of a Plain Language Decision Support Tool for Cancer Clinical Trials: Blending Health Literacy, Academic Research, and Minority Patient Perspectives
Aisha T. Langford, Sarah T. Hawley, Sue Stableford, Jamie L. Studts, Margaret M. Byrne
Journal of Cancer Education, 9 February 2019; pp 1–8
Abstract
Despite the promise of clinical trials for improving cancer care, less than 5% of all cancer patients participate. Racial/ethnic minorities continue to be underrepresented in cancer clinical trials (CCTs). To address this gap, we developed a plain language, web-based decision support tool (CHOICES DST) in English and Spanish to support decision-making about CCTs among Blacks and Hispanics. In phase 1 (information collection), we conducted qualitative interviews with 45 cancer patients, completed a thorough literature review, and reviewed results from a telephone survey of 1100 cancer patients. In phase 2 (content generation), we created the first iteration of the CHOICES DST. In phase 3 (usability testing), we gathered user experience and acceptability data from a small sample of cancer survivors (n = 9). The Knowledge, Empowerment, and Values Clarification (KEV) model of decision-making was developed based on data from phase 1. The KEV model and other phase 1 data allowed us to create the CHOICES DST platform. Usability testing of the CHOICES DST showed highly favorable responses from users, satisfaction with content, ease of navigation, and a desire to use the tool. Qualitative results identified addressable points that would benefit from content and navigation-related alterations. The final version of the CHOICES DST was well received and understood by Black and Hispanic participants, and adheres to the mandates for plain language communication. This research provides preliminary data that CHOICES DST holds promise for improving knowledge of CCTs and potentially improving informed decision-making about participation in trials.
Month: March 2019
The Role of Informed Consent in Biobanks after the General Data Protection Regulation [THESIS]
The Role of Informed Consent in Biobanks after the General Data Protection Regulation [THESIS]
Nina Savolainen
University of Turku, 2019
Abstract
This Thesis evaluates the role of informed consent in biobank research and the impact of the General Data Protection Regulation (GDPR) for the informed consent procedure when providing biological and related data to biobanks. Aim of the research is to assess especially two derogations which offer relief for the demand of obtaining an informed consent from a sample donor; Recital 33 which allows the use of a broad consent in the field of scientific research, and the research exemption provided in the Article 9(2)(j), which allows re-purposing personal data for scientific purposes without asking a consent from the person whom the data originates from. The applicability and relevance of those provisions will be examined from the perspective of biobank sample donor’s right to privacy and right to data protection. This Thesis suggests the derogations provided in the GDPR will modify the meaning of informed consent in the field of biomedical research. The main findings are that the GDPR did not improve the data autonomy of individuals who participate in biobank research. Instead, the derogations provided are made in favor of the researcher: the aim of the GDPR was to empower individuals control over their data processing, but it seems that scientific research is an acceptable reason to exclude decisional power form individuals.
Clinical Trials Informed Consent: An educational intervention to improve nurses’ knowledge and communications skills
Clinical Trials Informed Consent: An educational intervention to improve nurses’ knowledge and communications skills
Eileen Regan
Clinical Journal of Oncology Nursing, December 2018; 22(6):E152–E158
Background
Teach-back is an evidence-based tool recommended for use during informed consent (IC) discussions. The nurses’ role in the IC process is important, particularly for patient education and advocacy.
Objectives
The aim was to initiate and evaluate an educational program for nurses to improve knowledge and communication skills used in IC for cancer clinical trials.
Methods
An educational program was presented to nurses. Anonymous pre-, post-, and one-month postprogram surveys measured nurses’ knowledge of research and the importance of and confidence using teach-back during IC discussions.
Findings
Nurses had high research knowledge scores and statistically significant improvement in pre- and post-test scores of conviction and confidence using teach-back. Nurses employed essential elements of teach-back before the program but had greater recognition of elements after the program.
Informed Consent, Fraud and Confidentiality in Psycho-Pedagogic Research Activity
Informed Consent, Fraud and Confidentiality in Psycho-Pedagogic Research Activity
Corina Iurea
Jus et Civitas, 2018
Abstract
This paper analyses the ethical character of the interactions between researchers and the subjects of the psycho-pedagogic research, a topic that has attracted more and more interest. The research activity needs to be ethical, show consideration towards the interests and needs of the participants and of those affected by the research results. While researching, we need t be honest, opened, and have a critical approach about who, what and why we perform the research. Researchers need to avoid any activity that could impact their credibility, objectivity, and impartiality.
Readability of consent forms in veterinary clinical research
Readability of consent forms in veterinary clinical research
Josey Sobolewski1, Jeffrey N. Bryan, Dawn Duval, Allison O’Kell, Deborah J. Tate, Tracy Webb, Sarah Moore
Journal of Veterinary Internal Medicine, 6 February 2019
Background
“Readability” of consent forms is vital to the informed consent process. The average human hospital consent form is written at a 10th grade reading level, whereas the average American adult reads at an 8th grade level. Limited information currently exists regarding the readability of veterinary general medical or clinical research consent forms.
Hypothesis/Objectives
The goal of this study was to assess the readability of veterinary clinical trial consent forms from a group of veterinary referral centers recently involved in a working group focused on veterinary clinical trial review and consent. We hypothesized that consent forms would not be optimized for client comprehension and would be written above the National Institutes of Health-recommended 6th grade reading level.
Animals
None.
Methods
This was a prospective study assessing a convenience sample of veterinary clinical trial consent forms. Readability was assessed using 3 methods: the Flesch-Kincaid (F-K) Grade Level, Flesch Reading Ease Score (FRES), and the Readability Test Tool (RTT). Results were reported as mean (±SD) and compared across specialties.
Results
Fifty-three consent forms were evaluated. Mean FRES was 37.5 ± 6.0 (target 60 or higher). Mean F-K Grade Level was 13.0 ± 1.2 and mean RTT grade level was 12.75 ± 1.1 (target 6.0 or lower). There was substantial agreement between F-K and RTT grade level scores (intraclass correlation coefficient 0.8).
Conclusions and Clinical Importance
No form evaluated met current health literacy recommendations for readability. A simple and readily available F-K Microsoft-based approach for evaluating grade level was in substantial agreement with other methods, suggesting that this approach might be sufficient for use by clinicians and administrators drafting forms for future studies.
Center for Informed Consent Integrity 