Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study
Research Article
Linda Brubaker, J Eric Jelovsek, Emily S Lukacz, Sunil Balgobin, Alicia Ballard, Alison C Weidner, Marie G Gantz, Ryan Whitworth, Donna Mazloomdoost
Clinical Trials, 26 July 2019
Abstract
Background/aims
In this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone.
Methods
Individuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student’s t-test (continuous) and chi-square or Fisher’s exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p < 0.05.
Results
Of the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being “very satisfied” overall with study information (97.7% vs 88.5%, p = 0.01); “strong agreement” for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being “very important” (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group.
Conclusion
The extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.
Month: August 2019
Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction
Oxford Video Informed Consent Tool (OxVIC): a pilot study of informed video consent in spinal surgery and preoperative patient satisfaction
Research
Gerard Mawhinney, Chrishan Thakar, Victoria Williamson, Dominique A Rothenfluh, Jeremy Reynolds
BMJ Open, 24 July 2019; 9(7)
Open Access
Abstract
Objectives
The British Association of Spinal Surgeons recently called for updates in consenting practice. This study investigates the utility and acceptability of a personalised video consent tool to enhance patient satisfaction in the preoperative consent giving process.
Design
A single-centre, prospective pilot study using questionnaires to assess acceptability of video consent and its impacts on preoperative patient satisfaction.
Setting
A single National Health Service centre with individuals undergoing surgery at a regional spinal centre in the UK.
Outcome measure
As part of preoperative planning, study participants completed a self-administered questionnaire (CSQ-8), which measured their satisfaction with the use of a video consent tool as an adjunct to traditional consenting methods.
Participants
20 participants with a mean age of 56 years (SD=16.26) undergoing spinal surgery.
Results
Mean patient satisfaction (CSQ-8) score was 30.2/32. Median number of video views were 2–3 times. Eighty-five per cent of patients watched the video with family and friends. Eighty per cent of participants reported that the video consent tool helped to their address preoperative concerns. All participants stated they would use the video consent service again. All would recommend the service to others requiring surgery. Implementing the video consent tool did not endure any significant time or costs.
Conclusions
Introduction of a video consent tool was found to be a positive adjunct to traditional consenting methods. Patient–clinician consent dialogue can now be documented. A randomised controlled study to further evaluate the effects of video consent on patients’ retention of information, preoperative and postoperative anxiety, patient reported outcome measures as well as length of stay may be beneficial.
Obtaining Informed Consent Using Patient Specific 3D Printing Cerebral Aneurysm Model
Obtaining Informed Consent Using Patient Specific 3D Printing Cerebral Aneurysm Model
Pil Soo Kim, Chang Hwa Choi, In Ho Han, Jung Hwan Lee, Hyuk Jin Choi, Jae Il Lee
Journal of Korean Neurosurgical Society, 1 July 2019; 62(4) pp 398-404
Open Access
Abstract
Objective
Recently, three-dimensional (3D) printed models of the intracranial vascular have served as useful tools in simulation and training for cerebral aneurysm clipping surgery. Precise and realistic 3D printed aneurysm models may improve patients’ understanding of the 3D cerebral aneurysm structure. Therefore, we created patient-specific 3D printed aneurysm models as an educational and clinical tool for patients undergoing aneurysm clipping surgery. Herein, we describe how these 3D models can be created and the effects of applying them for patient education purpose.
Methods
Twenty patients with unruptured intracranial aneurysm were randomly divided into two groups. We explained and received informed consent from patients in whom 3D printed models-(group I) or computed tomography angiography-(group II) was used to explain aneurysm clipping surgery. The 3D printed intracranial aneurysm models were created based on time-offlight magnetic resonance angiography using a 3D printer with acrylonitrile-butadiene-styrene resin as the model material. After describing the model to the patients, they completed a questionnaire about their understanding and satisfaction with aneurysm clipping surgery.
Results
The 3D printed models were successfully made, and they precisely replicated the actual intracranial aneurysm structure of the corresponding patients. The use of the 3D model was associated with a higher understanding and satisfaction of preoperative patient education and consultation. On a 5-point Likert scale, the average level of understanding was scored as 4.7 (range, 3.0–5.0) in group I. In group II, the average response was 2.5 (range, 2.0–3.0).
Conclusion
The 3D printed models were accurate and useful for understanding the intracranial aneurysm structure. In this study, 3D printed intracranial aneurysm models were proven to be helpful in preoperative patient consultation.
Ethical Tensions Resulting from Interpreter Involvement in the Consent Process
Ethical Tensions Resulting from Interpreter Involvement in the Consent Process
Amelia Barwise, Richard Sharp, and Jessica Hirsch
Ethics & Human Research, July 2019; 41(4) pp 31-35
Open Access
Abstract
We describe how our institution responded when an interpreter who participated in the consent process involving an individual with limited English proficiency refused to cosign consent documents attesting that the individual enrolling in the study understood the consent information and that her consent to enroll was voluntary. In developing our approach, our institution took into account ethical tensions between the Belmont principles of respect for persons, beneficence, and justice that apply to the protection of research participants and the professional principles of beneficence, fidelity, and respect for the importance of culture that are outlined in ethical guidelines for medical interpreters.
Editor’s note: The Belmont principles referred to above can be found in the Belmont Report here.
Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent
Evaluation of a REDCap-based Workflow for Supporting Federal Guidance for Electronic Informed Consent
Cindy Chen, Scott P. Turner, Evan T. Sholle, Scott W. Brown, Vanessa L.I. Blau, Julianna P. Brouwer, Alicia N. Lewis, Curtis L. Cole, David M. Nanus, Manish A. Shah, John P. Leonard, Thomas R. Campion, Jr.
AMIA Joint Summits on Translational Science Proceedings, 6 May 2019; pp 163–172
Open Access
Abstract
Adoption of electronic informed consent (eConsent) for research remains low despite evidence of improved patient comprehension, usability, and workflow processes compared to paper. At our institution, we implemented an eConsent workflow using REDCap, a widely used electronic data capture system. The goal of this study was to evaluate the extent to which the REDCap eConsent solution adhered to federal guidance for eConsent. Of 29 requirements derived from sixteen recommendations from the United States Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA), the REDCap eConsent solution supported 24 (86%). To the best of our knowledge, this is among the first studies to evaluate an eConsent approach’s support for federal guidance. Findings suggest use of REDCap may help other institutions overcome barriers to eConsent adoption, and that OHRP and FDA expand guidance to recommend eConsent solutions integrate with enterprise clinical and research information systems.
Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys
Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys
Original Investigation
William B. Feldman, Spencer P. Hey, Jessica M. Franklin, Aaron S. Kesselheim
JAMA Network Open, 24 July 2019; 2(7)
Open Access
Abstract
Importance
The US Food and Drug Administration (FDA) created the exception from informed consent (EFIC) pathway in 1996 to allow some emergency trials to enroll patients without informed consent. To protect individual autonomy and preserve public trust, the FDA requires that EFIC trial investigators consult with community members before a trial may begin.
Objectives
To analyze data from surveys conducted as part of community consultation ahead of EFIC trials and assess levels of public approval.
Data Sources
All trials granted an EFIC must submit documentation of compliance with EFIC regulations to a publicly available docket at the FDA. Submissions between November 1, 1996, and October 23, 2017, were reviewed.
Study Selection
Trials with survey data were included.
Data Extraction and Synthesis
Data were extracted between January 2018 and June 2018 and were analyzed between June 2018 and August 2018. The quality and validity of data were assessed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A random-effects metaregression was used to assess the association of demographic characteristics with EFIC approval.
Main Outcomes and Measures
The primary study outcome was EFIC approval.
Results
The FDA docket contained 15 958 pages of material with survey data for 42 448 individuals submitted by 27 trials. Public approval of EFIC varied by question type, with more people willing to approve initiation of EFIC trials in their community (86.5%) than personal enrollment (73.0%), enrollment of a family member (68.6%), or the principle of enrollment without consent (58.4%) (P < .001 for all comparisons). In the United States, African American individuals made up 29.3% of those enrolled in EFIC trials that reported data on race (5064 of 17 302) but only 16.7% of those surveyed as part of community consultation. In the United States and Canada, men made up 42.9% of the surveyed population but 65.6% of those eventually enrolled in EFIC trials (29 961 of 45 694). Groups surveyed with higher proportions of African American and male respondents had lower rates of EFIC approval.
Conclusions and Relevance
Public approval of EFIC trials varied by question type and by the respondents’ reported race and sex. The demographic characteristics of those surveyed did not match the demographic characteristics of EFIC enrollees. The FDA could strengthen community consultation by standardizing survey instruments and reporting, requiring broader inclusion of African American and male respondents, clarifying the function of surveys in the development and modification of trial protocols, and building more public consensus around the acceptable use of EFIC.
How Should We Apply the Wisdom of the Crowd to Clinical Trials With Exception From Informed Consent?
How Should We Apply the Wisdom of the Crowd to Clinical Trials With Exception From Informed Consent?
Invited Commentary
Michael J. Lanspa, Eddy Fan, Alan H. Morris
JAMA Network Open, 24 July 2019; 2(7)
Open Access
Excerpt
In emergency trials applying for an exception from informed consent (EFIC), the US Food and Drug Administration (FDA) requires transparency, achieved through consultation with community members, before clinical investigators can enroll patients without informed consent. Feldman et al1 provide a review of surveys intended to achieve these consultations. Their results contribute to the literature by indicating the persistent gap between our goals and the imperfect surveys that have been reported…
Public Deliberation as a Novel Method for an Exception from Informed Consent Community Consultation
Public Deliberation as a Novel Method for an Exception from Informed Consent Community Consultation
Original Contribution
Patricia E. Powers, Karen K. Shore, Susan Perez, Dominique Ritley, Nathan Kuppermann, James F. Holmes, Leah S Tzimenatos, Hiwote Shawargga, Daniel K. Nishijima
Academic Emergency Medicine, 4 July 2019
Abstract
Objectives
Community consultation is required for clinical trials considering federal exception from informed consent (EFIC) procedures. Questions remain about the value of the community consult process and whether it adds intended protections to study subjects. Public deliberation methods that provide baseline participant education and elicit values and opinions about consent options is a novel approach for community consultation. This study evaluated the use of structured public deliberation methods to assess a community’s values and opinions about informed consent procedures for a pediatric trauma trial.
Methods
This was a mixed‐methods descriptive study of public deliberation sessions assessing participants’ opinions about informed consent procedures for a pediatric trauma randomized controlled trial (RCT). Participants from communities with high rates of pediatric trauma were recruited via community‐based organizations and social media. Deliberation focused on three consent options for a proposed RCT: 1) enrollment using EFIC procedures with no attempt to obtain informed consent; 2) enrollment using EFIC procedures after attempting to reach a parent; or 3) enrollment only with informed consent. Participant demographic data and their opinions about the proposed study and deliberative session were also collected.
Results
There were 102 participants across eight sessions (range of 9 to 15/session, average of 13). Most participants were female (n=78, 76%) and a plurality black (n=48, 47%). The majority of participants preferred enrollment using EFIC procedures only after an attempt was made to reach a parent and informed consent was not possible (n=56, 55%), followed by enrollment using EFIC procedures with no attempt to obtain informed consent (n=32, 32%), and enrollment only with written informed consent (n=13, 13%). One participant declined all options. 84 participants (82%) agreed or strongly agreed that the RCT was important to do, and 79 participants (77%) said the sessions provided enough information to make an informed decision about the proposed RCT.
Conclusions
Structured public deliberation is an effective approach when consulting communities for trials considering EFIC procedures. Future studies are needed to evaluate whether public deliberation methods provide participants with enhanced understanding of clinical trials compared to other community consultation methods.
The impact of central IRB’s on informed consent readability and trial adherence in SPRINT
The impact of central IRB’s on informed consent readability and trial adherence in SPRINT
Leonardo Tamariz, Mitscher Gajardo, Carolyn H.Still, Lisa H.Gren, Elizabeth Clark, Sandy Walsh, Jeff Whittle, John Nord, Thomas Ramsey, Gabriel Contreras
Contemporary Clinical Trials Communications, September 2019; 15
Open Access
Abstract
Background
Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and participant trial adherence compared to those regulated by local IRBs.
Methods
We conducted a cohort study using the SPRINT clinical trial. We collected the IRB of record from the stamped and approved 2012 informed consents from each of the sites. We defined CIRB as an IRB for more than one SPRINT site. Our outcomes were informed consent readability measured using the Flesch-Kincaid readability scale and trial adherence defined as a loss to follow-up, consent withdrawal, and missed last 3-month visit.
Results
Sixty-one percent of all SPRINT sites used a CIRB as their IRB of record. The adjusted mean grade reading level for CIRB consents was 13.4 (95% CI 12.6–13.8) compared to 12.3 (95% CI 12.1–13.1) for non CIRB consents (p = 0.07). CIRB sites had similar rates of withdrawal of consent and loss to follow-up as non-CIRB sites; subjects missing the last appointment of the study were more likely to come from sites regulated by a CIRB. The Veterans Affairs CIRB had the lowest rate of withdrawal of consent (1.9%) and the lowest rate of missed appointments (1.9%) among CIRBs.
Conclusions
Niether CIRB-regulated sites nor IRB regulated sites enforce the recommended readability level of the informed consent documents. Sites regulated by both IRBs had similar participant trial adherence.
Editor’s note: SPRINT refers to the Systolic Blood Pressure Intervention Trial (SPRINT), a multisite randomized controlled trial.
What are research nurses’ experiences of obtaining consent from or for patients participating in emergency care research? A qualitative review
What are research nurses’ experiences of obtaining consent from or for patients participating in emergency care research? A qualitative review
Review
Pauline Brown, Alistair Hewison, Roger Newham
Journal of Clinical Nursing, 26 June 2019
Abstract
Introduction
If studies are to be valid, recruitment of representative samples is essential. In 2012, 28% of UK emergency departments met the 80% standard for recruitment to trials set by the National Institute for Health Research. Research nurses play a vital role in the conduct of high‐quality research, and it has been argued that dedicated research nurses are needed if clinical trials are to recruit successfully to target.
Review question
What are research nurses’ experiences of obtaining consent from or for patients participating in emergency care research? A qualitative evidence review.
Methods
A qualitative integrative literature review with a narrative synthesis of the evidence. PRISMA guidelines for reporting systematic qualitative reviews (Appendix S1) were followed. A search of five electronic databases was performed in December 2018 along with a hand search which yielded 125 citations: 10 papers and one PhD thesis met the review eligibility criteria. Methodological quality of the selected studies was evaluated, and data were extracted and synthesised.
Results
Three themes were identified: Access, Organisation and Timing. Research nurses encountered both general and specific barriers when seeking to obtain consent for participation in research. In particular, it was found there was lack of experience among staff of working in emergency research and with securing deferred consent. The distinction between nurse researchers with a clinical role and those dedicated to solely to research only is often not clear and warrants further investigation.
Conclusion
Nurse researchers with and without a clinical role can make a positive difference in recruitment to trials in emergency care. The involvement of dedicated research nurses in the consent process can increase recruitment to emergency care research. Experience of recruiting to clinical trials in nonemergency settings does not seem to help when recruiting for trials in emergency care.
Relevance to clinical practice
There is a need for greater understanding of the experiences of dedicated research nurses in emergency care settings and in particular with regard to deferred consent.
Center for Informed Consent Integrity 