Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial.
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ABSTRACT:
SUBMITTER: Rothwell E
PROVIDER: S-EPMC7486234 | biostudies-literature | 2020 Oct
REPOSITORIES: biostudies-literature
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Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial.
Rothwell Erin E Johnson Erin E Wong Bob B Goldenberg Aaron A Tarini Beth A BA Riches Naomi N Stark Louisa A LA Pries Christina C Langbo Carrie C Langen Elizabeth E Botkin Jeffrey J
Journal of empirical research on human research ethics : JERHRE 20200403 4
Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet "app") with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowle ...[more]
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Project description:BackgroundSince the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women.ObjectiveThe aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies.MethodsThis review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing.ResultsConsistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted.ConclusionsThis review advocates the importance of participant informedness in a novel and largely unregulated research setting.
| S-EPMC5597795 | biostudies-literature
Project description:OBJECTIVES:This study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea. METHODS:Through purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1:1 in-depth interviews and analysed the data by framework analysis. RESULTS:Themes raised throughout the interviews were categorised into 'disclosure' and 'understanding' of clinical information and 'decision'. Provider-centred information, both verbal and written, was delivered to each participant. There were few tools that the research staff might evaluate study participants' level of understanding of the provided information during the clinical trial. Although participants did not understand basic clinical trial concepts as much as desired, they may not seek to solve difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent. CONCLUSION:There is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.
| S-EPMC6532870 | biostudies-literature
Project description: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.
| S-EPMC7197014 | biostudies-literature
Project description:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.None.Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.
| S-EPMC3939835 | biostudies-literature
Project description:BackgroundThe use of research evidence to underpin public health policy is strongly promoted. However, its implementation has not been straightforward. The objectives of this systematic review were to synthesise empirical evidence on the use of research evidence by public health decision makers in settings with universal health care systems.MethodsTo locate eligible studies, 13 bibliographic databases were screened, organisational websites were scanned, key informants were contacted and bibliographies of included studies were scrutinised. Two reviewers independently assessed studies for inclusion, extracted data and assessed methodological quality. Data were synthesised as a narrative review.Findings18 studies were included: 15 qualitative studies, and three surveys. Their methodological quality was mixed. They were set in a range of country and decision making settings. Study participants included 1063 public health decision makers, 72 researchers, and 174 with overlapping roles. Decision making processes varied widely between settings, and were viewed differently by key players. A range of research evidence was accessed. However, there was no reliable evidence on the extent of its use. Its impact was often indirect, competing with other influences. Barriers to the use of research evidence included: decision makers' perceptions of research evidence; the gulf between researchers and decision makers; the culture of decision making; competing influences on decision making; and practical constraints. Suggested (but largely untested) ways of overcoming these barriers included: research targeted at the needs of decision makers; research clearly highlighting key messages; and capacity building. There was little evidence on the role of research evidence in decision making to reduce inequalities.ConclusionsTo more effectively implement research informed public health policy, action is required by decision makers and researchers to address the barriers identified in this systematic review. There is an urgent need for evidence to support the use of research evidence to inform public health decision making to reduce inequalities.
| S-EPMC3144216 | biostudies-literature
Project description:IntroductionDrugs for rare diseases (DRDs) offer important health benefits, but challenge traditional health technology assessment, reimbursement, and pricing processes due to limited effectiveness evidence. Recently, modified processes to address these challenges while improving patient access have been proposed in Canada. This review examined processes in 12 jurisdictions to develop recommendations for consideration during formal government-led multi-sectoral discussions currently taking place in Canada.Methods(i) A scoping review of DRD reimbursement processes, (ii) key informant interviews, (iii) a case study of evaluations for and the reimbursement status of a set of 7 DRDs, and (iv) a virtual, multi-stakeholder consultation retreat were conducted.ResultsOnly NHS England has a process specifically for DRDs, while Italy, Scotland, and Australia have modified processes for eligible DRDs. Almost all consider economic evaluations, budget impact analyses, and patient-reported outcomes; but less than half accept surrogate measures. Disease severity, lack of alternatives, therapeutic value, quality of evidence, and value for money are factors used in all decision-making process; only NICE England uses a cost-effectiveness threshold. Budget impact is considered in all jurisdictions except Sweden. In Italy, France, Germany, Spain, and the United Kingdom, specific factors are considered for DRDs. However, in all jurisdictions opportunities for clinician/patient input are the same as those for other drugs. Of the 7 DRDs included in the case study, the number that received a positive reimbursement recommendation was highest in Germany and France, followed by Spain and Italy. No relationship between recommendation type and specific elements of the pricing and reimbursement process was found.ConclusionsBased on the collective findings from all components of the project, seven recommendations for possible action in Canada are proposed. These focus on defining "appropriate access", determining when a "full" HTA may not be needed, improving coordination among stakeholder groups, developing a Canadian framework for Managed Access Plans, creating a pan-Canadian DRD/rare disease data infrastructure, genuine and continued engagement of patient groups and clinicians, and further research on different decision and financing options, including MAPs.
| S-EPMC9264608 | biostudies-literature
Project description:BackgroundTotal knee arthroplasty (TKA) is an option for the treatment of knee osteoarthritis (OA). Patients have high expectations regarding the benefits of the actual operation. Patients can seek a second opinion on the indication for TKA. In a study, less than half of recommended TKAs were confirmed by the second opinion and conservative treatments are not fully utilized. Informed consent forms that are used in Germany usually do not meet the requirements to support informed decision-making. Our aim was to describe the process from the diagnosis of knee OA through the decision-making process to the informed consent process for TKA, and to understand when, how, and by whom decisions are made. Moreover, we wanted to describe patients' information needs and preferences about knee OA and its treatment, including TKA, and find out what information is provided. We also wanted to find out what information was important for decision-making and identify barriers and facilitators for the optimal use of evidence-based informed consent forms in practice.MethodsWe chose a qualitative approach and conducted semi-structured interviews with patients who were going to receive, have received, or have declined TKA, and with general practitioners (GP), office-based as well as orthopaedists and anaesthesiologists in clinics who obtain informed consent. The interviews were audio-recorded, transcribed and analysed using qualitative content analysis.ResultsWe conducted interviews with 13 patients, three GPs, four office-based orthopaedists and seven doctors in clinics who had obtained informed consent. Information needs were modelled on subjective disease theory and information conveyed by the doctors. Patients in this sample predominantly made their decisions without having received sufficient information. Trust in doctors and experiences seemed to be more relevant in this sample than fact-based information. Office-based (GPs, orthopaedists) and orthopaedists in clinics had different understandings of their roles and expectations in terms of providing information.ConclusionsWe were able to identify structural barriers and assumptions that hinder the implementation of evidence-based informed consent forms.
| S-EPMC10494361 | biostudies-literature
Project description:BackgroundInformed consent is an integral part of pre-operative counseling. However, information discussed can be variable. Recent studies have explored the use of multimedia in providing informed consent for rhinologic surgery.ObjectiveTo measure impact of an educational video (Video) compared to verbal informed consent (Verbal) on knowledge gained, alleviation of concerns, and efficiency.MethodsPatients undergoing endoscopic sinus surgery (ESS), septoplasty, or ESS+septoplasty were prospectively enrolled and randomized to receive Video or Verbal consent. The Video group watched an educational video; the Verbal group received standard verbal consent from an Otolaryngology resident per institutional protocol. Both groups had the opportunity to discuss questions or concerns with their attending surgeon. Prior to, and after, consent was signed, both groups completed surveys regarding knowledge of purpose, risks, and benefits of surgery as well as surgical concerns. Decision regret and patient satisfaction were also assessed post-operatively.Results77 patients were enrolled (39 Video, 38 Verbal). Demographics were not significantly different between groups. Overall knowledge significantly improved (p < 0.005) and concerns significantly decreased (p < 0.001) following consent in both groups. Improvements in these metrics were equivalent between groups (p < 0.02). Furthermore, resident time to complete consent, patient satisfaction, and decision regret were not significantly different between groups.ConclusionUse of an educational video was equivalent to standard verbal informed consent for patients undergoing rhinologic surgery. Otolaryngologists can consider developing procedure-specific videos to allow allocation of time to other tasks, standardized education of patients, and streamlining of the informed consent process.
| S-EPMC9793427 | biostudies-literature
Project description:In modeling the human affective system and applying lessons learned to human-robot interaction, the challenge is to handle ambiguous emotional states of an agency (whether human or artificial), probabilistic decisions, and freedom of choice in affective and behavioral patterns. Moreover, many cognitive processes seem to run in parallel whereas seriality is the standard in conventional computation. Representation of contextual aspects of behavior and processes and of self-directed neuroplasticity are still wanted and so we attempt a quantum-computational construction of robot affect, which theoretically should be able to account for indefinite and ambiguous states as well as parallelism. Our Quantum Coppélia (Q-Coppélia) is a translation into quantum logics of the fuzzy-based Silicon Coppélia system, which simulates the progression of a robot's attitude towards its user. We show the entire circuitry of the Q-Coppélia framework, aiming at contemporary descriptions of (neuro)psychological processes. Arguably, our work provides a system for simulating and handling affective interactions among various agencies from an understanding of the relations between quantum algorithms and the fundamental nature of psychology.
| S-EPMC9705568 | biostudies-literature
Project description:A key question within systems neuroscience is how the brain translates physical stimulation into a behavioral response: perceptual decision making. To answer this question, it is important to dissociate the neural activity underlying the encoding of sensory information from the activity underlying the subsequent temporal integration into a decision variable. Here, we adopted a decoding approach to empirically assess this dissociation in human magnetoencephalography recordings. We used a functional localizer to identify the neural signature that reflects sensory-specific processes, and subsequently traced this signature while subjects were engaged in a perceptual decision making task. Our results revealed a temporal dissociation in which sensory processing was limited to an early time window and consistent with occipital areas, whereas decision-related processing became increasingly pronounced over time, and involved parietal and frontal areas. We found that the sensory processing accurately reflected the physical stimulus, irrespective of the eventual decision. Moreover, the sensory representation was stable and maintained over time when it was required for a subsequent decision, but unstable and variable over time when it was task-irrelevant. In contrast, decision-related activity displayed long-lasting sustained components. Together, our approach dissects neuro-anatomically and functionally distinct contributions to perceptual decisions.
| S-EPMC4678878 | biostudies-literature