Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials
Susan M. Abdel-Rahman
Pediatric Drugs, 17 July 2019; pp 1-10
Abstract
Individuals approached to participate in human subjects research, irrespective of age, must be completely apprised of the study, and researchers must ensure that the information is understood to the fullest extent possible, prior to decision making. However, evolving regulatory and institutional requirements have led to permission/assent/consent (PAC) forms that are unnecessarily complex, serving only to exacerbate the challenges associated with communicating this important information to prospective participants. At greatest risk are children and other individuals with low literacy, limited English proficiency, and diminished mental capacity, populations all too often neglected in clinical research. This paper examines various strategies that have been evaluated to facilitate informed PAC, drawing on experiences across a broad array of populations whose needs overlap with those of children. These strategies range from simplifying PAC forms for readability and creating multimedia PAC delivery tools to actively engaging participants on their understanding of PAC elements by leveraging testing, rewards, and third-party communications. Notably, the findings from strategies that have been explored in more than one setting are uniformly mixed with respect to their ability to improve comprehension, underscoring the challenges that persist in designing, implementing, and objectively examining strategies intended to facilitate informed PAC. However, these studies do serve to highlight efforts that may reduce anxiety around, and increase the satisfaction of participants with, the PAC process. Ultimately, accommodating a diverse participant pool will require the consideration, and continual refinement, of various PAC strategies along with the engagement of team members who are intimately familiar with these populations.
Consent in paediatric neurosurgery: adequacy of documentation and parental perspectives
Consent in paediatric neurosurgery: adequacy of documentation and parental perspectives
Adikarige H. D. Silva, Haren Wijesinghe, Nilesh Mundil, William Lo, A. Richard Walsh, Guirish A. Solanki, Desiderio Rodrigues
Child’s Nervous System, 9 July 2019; pp 1–7
Original Article
Abstract
Introduction
Consenting paediatric patients for surgical procedures remains inherently unique in that it is underpinned by principles such as parental responsibility, assessment of the child’s capacity to consent, and adherence to national/legal guidelines. Quality record keeping is an important objective evidence to demonstrate the highest standards of medical care provided to our patients. The consent form is a crucial medical record encapsulating the attainment of informed consent from a parent/guardian for performing a procedure on their child. We aimed to prospectively evaluate the consenting process in our department to assess adequacy of documentation and parental perspectives.
Methods
A prospective study using qualitative descriptive design was conducted with parents of 50 children requiring neurosurgical procedures over a 3-month period.
Results
All patients understood the primary diagnosis and type of surgery. Procedure-specific risks were understood by 98% and 84% could remember the mentioning of general risks of surgery. Only a minority of parents (24%) could recollect that alternative options of management including no treatment were discussed. In cases where relevant, laterality was only documented in 56% of consent forms. All patients felt that an informed decision regarding consent to surgery was made. However, 12% suggested areas where further improvement could be made in the timing of consent and the way information could be better provided.
Discussion
Consent is more than a signature on a form. It provides objective evidence of a shared decision-making process between the surgeon, patient, and their parent/guardian. Our initial study highlights multiple areas for improvement.
Informed consent and ethical reporting of research in clinical trials recruiting participants with psychotic disorders
Informed consent and ethical reporting of research in clinical trials recruiting participants with psychotic disorders
Guy M. Weissinger, Connie M. Ulrich
Contemporary Clinical Trials, 24 June 2019
Abstract
Informed consent is the foundation of modern biomedical research and it is vital for assuring the safety of vulnerable individuals, like those with psychotic disorders (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, etc.). All individuals who are involved in clinical research must have consented to participate or had surrogate consent from a representative. As individuals with psychotic disorders may not always have capacity to consent, assessment of capacity before research participation is vital but there is little research on how these assessments are conducted in clinical research. The authors conducted a systematic review of high-risk trials, defined as randomized medication or device trials that specifically recruited individuals with psychotic disorders, to understand the use of capacity to consent assessment and their reporting. A total of 646 articles, which mostly recruited participants with schizophrenia and were medication trials, were coded using a standardized questionnaire on consent practices and ethical reporting of research. Only 34 (5.3%) of the studies reported an assessment of capacity to provide informed consent and less than half of those used a standardized assessment. Sixty-four (9.9%) of the articles had capacity to provide informed consent in the study inclusion/exclusion criteria. Additionally, 66 (10.2%) of the articles did not have a statement about IRB approval and 134 (20.7%) had no statements about potential conflicts of interest. Though limitations to the review exist, it is clear that both in conducting high-risk research with individuals with psychotic disorders and when reporting research findings, there are ethical issues that must be addressed.
Use of multimedia during informed consent: novelty or necessity
Use of multimedia during informed consent: novelty or necessity
Henry H. Chill, Uri Dior, David Shveiky
International Urogynecology Journal, 13 July 2019; pp 1–3
Abstract
The process of informed consent is an integral part of the preoperative encounter. In theory, it has the potential to educate patients, enabling them to reach a true autonomous decision regarding the treatment offered. Unfortunately, in recent years informed consent has become overly complicated for the average patient. Questions have been raised regarding the ability of the process, as practiced nowadays, to actually increase knowledge and achieve its goals. In search of new ways to increase patient comprehension, researchers have suggested use of multimedia during the process of informed consent. Visualization of complex ideas, interactive learning and tailoring the procedure to fit patient needs are all advantages presented by use of multimedia during the process. Several randomized prospective trials have looked into this topic and have presented promising data in favor of multimedia use. Informed consent is a process with unfulfilled potential, and use of multimedia may be part of the solution. In our opinion, it is time to change the way we educate patients.
Electronic informed consent: the need to redesign the consent process for the digital age
Electronic informed consent: the need to redesign the consent process for the digital age
Personal Viewpoint
Helen Lunt, Saxon Connor, Helen Skinner, Greg Brogden
International Medicine Journal, 11 July 2019
Abstract
The delivery of healthcare, which includes the informed consent process, is moving to a digital environment. This change in informed consent delivery will be associated with opportunities, risks and also unintentional consequences. Physicians are well placed to contribute to the ongoing dialogue about what is needed to make the informed consent process fit for purpose, in the digital age.
Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study
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.
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.
Center for Informed Consent Integrity 