Testing an Alternate Informed Consent Process

Yates, Bernice C.; Dodendorf, Diane M.; Lane, Judy; LaFramboise, Louise; Pozehl, Bunny; Duncan, Kathleen; Knodel, Kendra

doi:10.1097/nnr.0b013e31818c3df5

Cited by 12 publications

(11 citation statements)

References 15 publications

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“…Supplemental educational material can provide information about the underlying disease, available therapies, and prognosis as well as study-related information. Supplemental education materials may allow for shortening of the consent form while improving patient understanding of the research study (27,28). Alternate methods of consenting patients through web-based informed consents for minimal risk studies may promote enrollment and participation in internet-based studies, such as registries or surveys.…”

Section: Study Design and Proceduresmentioning

confidence: 99%

Optimizing Enrollment of Patients into Nephrology Research Studies

Selewski

Herreshoff

Gipson

2016

Clinical Journal of the American Society of Nephrology

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Advances in medical care and biomedical research depend on the participation of human subjects. Poor patient enrollment in research has limited past clinical and translational research endeavors in nephrology. Simultaneously, patients and their caregivers are seeking better diagnostic, monitoring, and therapeutic approaches to improve or restore kidney and overall health. This manuscript will discuss a framework and strategies to optimize patient enrollment within nephrology research and provide examples of success from existing nephrology research programs.

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Section: Study Design and Proceduresmentioning

confidence: 99%

Optimizing Enrollment of Patients into Nephrology Research Studies

Selewski

Herreshoff

Gipson

2016

Clinical Journal of the American Society of Nephrology

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“…Instead, a low-tech approach was pursued; key informed consent concepts were identified, and NIH artists prepared 11 illustrative storyboards 33 . Large-scale copies were hung in a 25-seat meeting room at Redemption.…”

Section: Introductionmentioning

confidence: 99%

Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency

Larson

Baseler

Hoover³

et al. 2017

The American Society of Tropical Medicine and Hygiene

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Abstract.Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity. The setting in Liberia was especially problematic due to an infrastructure still badly damaged following a lengthy civil war and a very fragile health-care system that was further devastated by the EVD outbreak. The Partnership for Research on Vaccines in Liberia I EVD vaccine trial was planned and implemented in less than 3 months by a Liberian and U.S. research partnership, and its Phase II substudy was fully enrolled 3 months later. Contrasting conventional wisdom with trial outcomes offers an opportunity to compare early assumptions, barriers encountered, and adaptive strategies used, with end results. Understanding what was learned can inform future trial responses when disease outbreaks, especially in resource-poor locations with minimal infrastructure, pose a significant threat to public health.

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“…Video methods have been shown to increase participant’s knowledge and positive attitude towards clinical trial participation (3, 4). Furthermore, video may be beneficial in improving participation while helping potential participants have a better understanding of the studies (5). Prior studies examining the willingness to consider future trials and the effectiveness of audio-visual interventions on increasing enrollment rates are limited to hypothetical studies using video to educate participants on a particular medical condition instead of including participants with the specific condition being studied (5, 6).…”

Section: Introductionmentioning

confidence: 99%

“…Furthermore, video may be beneficial in improving participation while helping potential participants have a better understanding of the studies (5). Prior studies examining the willingness to consider future trials and the effectiveness of audio-visual interventions on increasing enrollment rates are limited to hypothetical studies using video to educate participants on a particular medical condition instead of including participants with the specific condition being studied (5, 6). Other studies are limited to the measure of attitudes associated with participation without actually measuring the impact of these methods on the study enrollment decision (3, 4).…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of an informational video method to improve enrollment and retention of a pediatric cohort

Gesualdo

Ide

Rewers

et al. 2012

Contemporary Clinical Trials

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Objective The Environmental Determinants of Diabetes in the Young (TEDDY), a multinational epidemiological study, is designed to identify environmental exposures triggering autoimmunity and type 1 diabetes (T1D) in children at increased genetic risk. The objective of this analysis was to evaluate the use of an informational video in the enrollment and retention of eligible participants at the Colorado TEDDY clinical center. Study Design and Setting Eligible participants were divided into two groups based on the inclusion of the video in the enrollment materials: the No-Video Group (n=449) did not receive the video and were contacted between 7/1/07 and 6/30/08. The Video Group (n=494) received the video and were contacted between 7/1/08 and 6/30/09. Multiple logistic regression compared the enrollment rates (percent of eligible subjects deciding to enroll) of those who received the video compared to those who did not. Kaplan-Meier survival analysis and a multivariate Cox proportional hazards model compared the differences in study retention, as defined by active participation fifteen months after the baseline visit at three months of age. Results Both groups were demographically similar. The enrollment rate was significantly higher for the Video Group (56.9%) compared to the No-Video Group (49.9%). Differences remained significant with adjustment for other known factors. A difference in retention between the two groups was not observed. Conclusion Methods and materials increasing understanding and more accurately informing participants of what is involved in participation may increase enrollment in a prospective observational study.

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Testing an Alternate Informed Consent Process

Abstract: Participation rates could be enhanced in future clinical trials by using a visual presentation to explain and describe the study as part of the informed consent process. More research is needed to test alternate methods of obtaining informed consent.

Cited by 12 publications

References 15 publications

Optimizing Enrollment of Patients into Nephrology Research Studies

Optimizing Enrollment of Patients into Nephrology Research Studies

Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency

Effectiveness of an informational video method to improve enrollment and retention of a pediatric cohort

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