scholarly journals Health literacy and informed consent for clinical trials: a systematic review and implications for nurses

2019 ◽  
Vol Volume 9 ◽  
pp. 31-40 ◽  
Author(s):  
Allison C Burks ◽  
Jessica Keim-Malpass
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy

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.

scholarly journals Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

2009 ◽  
Vol 10 (1) ◽  
pp. 13-24 ◽  
Author(s):  
Andrea L. Ciaranello ◽  
Rochelle P. Walensky ◽  
Paul E. Sax ◽  
Yuchiao Chang ◽  
Kenneth A. Freedberg ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Medical Care ◽  
Trial Protocols ◽  
Hiv Clinical Trials

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

scholarly journals Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis

2015 ◽  
Vol 93 (3) ◽  
pp. 186-198H ◽  
Author(s):  
Nguyen Thanh Tam ◽  
Nguyen Tien Huy ◽  
Le Thi Bich Thoa ◽  
Nguyen Phuoc Long ◽  
Nguyen Thi Huyen Trang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Meta Analysis

scholarly journals Patient reported measures of informed consent for clinical trials: A systematic review

PLoS ONE ◽  
2018 ◽  
Vol 13 (6) ◽  
pp. e0199775 ◽  
Author(s):  
Katie Gillies ◽  
Alexander Duthie ◽  
Seonaidh Cotton ◽  
Marion K. Campbell
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Patient Reported ◽  
Patient Reported Measures

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 Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Angela De Pretto-Lazarova ◽  
Domnita Oana Brancati-Badarau ◽  
Christian Burri
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Decision Maker ◽  
Secondary Analysis ◽  
Decision Makers ◽  
Sub Saharan Africa ◽  
Study Protocols ◽  
Sub Saharan

Abstract Background Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases. Methods We conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed. Results None of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently. Conclusions Reporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents. Study registration CRD42018074220.

Sign in / Sign up

Export Citation Format

Share Document