scholarly journals Optimizing Communication of Emergency Response Adaptive Randomization Clinical Trials to Potential Participants

2016 ◽  
Author(s):  
Bredan McEvoy ◽  
David Haidar ◽  
Jason Tehranisa ◽  
William J. Meurer
Keyword(s):  
Clinical Trial ◽  
Interactive Video ◽  
Clinical Trial Design ◽  
Altered Mental Status ◽  
Future Research ◽  
Correct Identification ◽  
Cross Sectional ◽  
Absolute Increase ◽  
Adaptive Randomization ◽  
Allocation Method

AbstractIntroductionAcute clinical stroke trials are challenging to communicate to patients and families considering participation. Response adaptive randomization (RAR) is a technique that alters the proportion of trial subjects receiving active treatment, based on the outcomes of previous subjects. We aimed to determine how well interactive videos would improve understanding of a simulated acute stroke trial scenario that incorporated a design with RAR.MethodsWe performed a cross-sectional study of emergency department patients who were without stroke, altered mental status, or critical illness. Subjects viewed a hypothetical stroke and clinical trial scenario. They were randomized into one of four groups with either an RAR or fixed randomization clinical trial design and with either a standard consent video, or an interactive video.Results:We enrolled 720 participants. In the RAR group with interactive video, 128 out of 149 (85.9%) of the subjects were able to correctly identify the allocation method, compared to the 172 out of 285 (61.6%) in the RAR group with the uninterrupted video for an absolute increase of 25.6% (95% Cl 17-33%). The RAR group with interactive video had a higher odds of correct identification of allocation method (O.R. 2.767, 95% Cl [1.011 – 7.570] while controlling for age, sex, ethnicity, education, self-reported understanding of protocol, stroke awareness and agreement to participate in trial.Conclusions:The interactive video increased participant understanding of an RAR design in a simulated stroke scenario. Future research should focus on whether acute trial recruitment can be enhanced using similar techniques.

Abstract 128: Can Response Adaptive Randomization Increase Participation in Acute Stroke Trials?

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Jason Tehranisa ◽  
William J Meurer
Keyword(s):  
Clinical Trial ◽  
Acute Stroke ◽  
Research Participation ◽  
Cross Sectional Survey ◽  
Multivariable Logistic Regression Model ◽  
Cross Sectional ◽  
Absolute Increase ◽  
Adaptive Randomization ◽  
The Impact ◽  
Stroke Trial

Introduction: Acute stroke trials may be improved by using response-adaptive randomization (RAR) because it works in favor of the trial population on average. With RAR, the ratio of participants assigned to each trial arm is adjusted to favor the better performing treatment using outcome information from earlier participants in the clinical trial. Hypothesis: When presented a hypothetical acute stroke trial, more patients would agree to a RAR versus a standard clinical trial with all other aspects of trial held constant. Methods: This cross-sectional survey included adult ED patients presenting without stroke or other critical illness. A standardized protocol was used and subjects were randomized to view either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. Adequacy of the informed consent process was measured by ICQ-4. A multivariable logistic regression model was fitted to estimate the impact of RAR, while controlling for demographic factors and patient understanding of the design. Results: A total of 418 subjects (210 standard 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% CI: 3.7 to 22.2%). The trials were generally well understood by the participants (Table); however standard randomization appeared to be better understood. The RAR group had a higher odds ratio of agreeing to research (O.R. 1.89, 95% CI [1.2 - 2.9]), while adjusting for patient level factors. Conclusion: The RAR trial attracted more research participation than standard randomization and has potential to increase recruitment and offer benefit to future trial participants.

Abstract T P213: An Interactive Video Improves the Understanding of a Hypothetical Adaptive Acute Stroke Trial

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Brendan McEvoy ◽  
Jason Tehranisa ◽  
William J Meurer
Keyword(s):  
Acute Stroke ◽  
Interactive Video ◽  
Research Participation ◽  
Consent Process ◽  
Trial Participation ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Absolute Increase ◽  
Video Group ◽  
Stroke Trial

BACKGROUND AND PURPOSE: The communication of adaptive clinical trials can be more difficult due to the increased complexity of the design itself, especially in an emergent, time-sensitive setting such as with acute stroke patients. We hypothesized that introducing brief, comprehension questions into a video explaining a hypothetical acute stroke trial would improve the understanding of the trial allocation procedure and increase patient participation. METHODS: We conducted a cross-sectional survey of adult patients presenting to the emergency department. After obtaining verbal consent, patients were randomized to one of four groups: They watched a video with either an RAR or a standard hypothetical acute stroke trial, with or without the addition of interactive comprehension questions. These questions addressed research procedures relevant to the consent process and operation of the trial. Subjects were asked whether they would consent to the trial and if they could identify the method of randomization and allocation used. RESULTS: A total of 720 patients were enrolled. A significantly higher proportion of individuals in the RAR interactive video group (85.9%) correctly identified the trial allocation method assigned versus the RAR uninterrupted video group (60.4%), absolute increase: 25.5% (95% confidence interval, 17-33%). Additionally, there was significantly higher trial participation in the RAR interactive video group (table). CONCLUSIONS: Integrating structured comprehension questions into the consent process of a hypothetical acute stroke trial increased understanding of the RAR trial design and further attracted more research participation. Improving the communication of the trial procedures within a simulated situation that mimics the rapid discussion regarding an emergency research trial is beneficial and should be incorporated into future acute stroke trials

scholarly journals Clinical trial recruiters’ experiences working with trial eligibility criteria: results of an exploratory, cross-sectional, online survey in the UK

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
William J. Cragg ◽  
Kathryn McMahon ◽  
Jamie B. Oughton ◽  
Rachel Sigsworth ◽  
Christopher Taylor ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Online Survey ◽  
Strong Support ◽  
Clinical Trial Design ◽  
Research Unit ◽  
Free Text ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Protocol Development ◽  
The Uk

Abstract Background Eligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants’ safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters’ experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed. Methods Our survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes. Results A total of 823 eligible respondents participated. In total, 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%), and suitability (14%). In total, 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea of recruiter review of eligibility criteria earlier in the protocol development process. Conclusions Our survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria.

EXPRESS: What is the Median Volume of Intracerebral Hemorrhage and is it Changing?

2021 ◽  
pp. 174749302110325
Author(s):  
David Robinson ◽  
Carson Van Sanford ◽  
Soo Young Kwon ◽  
Elisheva Coleman ◽  
Padmini Sekar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intracerebral Hemorrhage ◽  
Temporal Trends ◽  
Clinical Trial Design ◽  
Population Level ◽  
Population Based ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Risk Factor Management ◽  
Median Volume

Abstract: Objectives: Population-level estimates of the median intracerebral hemorrhage (ICH) volume would allow for the evaluation of clinical trial external validity and determination of temporal trends. We previously reported the median ICH volume in 1988. However, differences in risk factor management, neuroimaging and demographics may have affected ICH volumes. The goal of this study was to determine the median volume of ICH within a population-based cross-sectional study, including whether it has changed over time. Methods: The Genetic and Environmental Risk Factors for Hemorrhagic Stroke study was a population-based study of ICH among residents of the Greater Cincinnati/Northern Kentucky region from 2008 through 2012. The current study utilizes those data and compares with ICH cases from the same region in 1988. Initial CT images of the head were reviewed, and ICH volumes were calculated using consistent methodology. Results: From 2008 through 2012, we identified 1117 cases of ICH. The median volume of ICH was 14.0 mL and was lower in black (11.6) than in white (15.5) patients. Median volumes of lobar and deep ICH were 28·8 mL and 9.8 mL, respectively. Median ICH volume changed significantly from 1988 to 2008-2012, with age-and-race adjusted volume decreasing from 18.3 mL to 13.76 mL (p=0.025). Conclusions: Median volume of ICH was 13.76 mL, and this should be considered in clinical trial design. Median ICH volume has apparently decreased from 1988 to 2008-2012.

scholarly journals DEFORMATION BASED MORPHOMETRY STUDY OF LONGITUDINAL MRI CHANGES IN BEHAVIORAL VARIANT FRONTOTEMPORAL DEMENTIA

2019 ◽  
Author(s):  
Ana L. Manera ◽  
Mahsa Dadar ◽  
D. Louis Collins ◽  
Simon Ducharme ◽  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Disease Progression ◽  
Frontotemporal Dementia ◽  
Trial Design ◽  
Clinical Trial Design ◽  
Cross Sectional ◽  
One Year ◽  
Deformation Based Morphometry

ABSTRACTObjectiveTo objectively quantify how cerebral volume loss could assist with clinical diagnosis and clinical trial design in the behavioural variant of frontotemporal dementia (bvFTD).MethodsWe applied deformation-based morphometric analyses with robust registration to precisely quantify the magnitude and pattern of atrophy in patients with bvFTD as compared to cognitively normal controls (CNCs), to assess the progression of atrophy over one year follow up and to generate clinical trial sample size estimates to detect differences for the structures most sensitive to change. This study included 203 subjects - 70 bvFTD and 133 CNCs - with a total of 482 timepoints from the Frontotemporal Lobar Degeneration Neuroimaging Initiative.ResultsDeformation based morphometry (DBM) revealed significant atrophy in the frontal lobes, insula, medial and anterior temporal regions bilaterally in bvFTD subjects compared to controls with outstanding subcortical involvement. We provide detailed information on regional changes per year. In both cross-sectional analysis and over a one-year follow-up period, ventricle expansion was the most prominent differentiator of bvFTD from controls and a sensitive marker of disease progression.ConclusionsAutomated measurement of ventricular expansion is a sensitive and reliable marker of disease progression in bvFTD to be used in clinical trials for potential disease modifying drugs, as well as possibly to implement in clinical practice. Ventricular expansion measured with DBM provides the lowest published estimated sample size for clinical trial design to detect significant differences over one and two years.

scholarly journals Clinical Trial Recruiters’ Experiences Working With Trial Eligibility Criteria: Results of an Exploratory, Cross-sectional, Online Survey

2021 ◽  
Author(s):  
William Cragg ◽  
Kathryn McMahon ◽  
Jamie B Oughton ◽  
Rachel Sigsworth ◽  
Christopher Taylor ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Online Survey ◽  
Strong Support ◽  
Clinical Trial Design ◽  
Research Unit ◽  
Free Text ◽  
Eligibility Criteria ◽  
Cross Sectional ◽  
Protocol Development ◽  
Mailing Lists

Abstract BackgroundEligibility criteria are a fundamental element of clinical trial design, defining who can and who should not participate in a trial. Problems with the design or application of criteria are known to occur and pose risks to participants' safety and trial integrity, sometimes also negatively impacting on trial recruitment and generalisability. We conducted a short, exploratory survey to gather evidence on UK recruiters' experiences interpreting and applying eligibility criteria and their views on how criteria are communicated and developed.MethodsOur survey included topics informed by a wider programme of work at the Clinical Trials Research Unit, University of Leeds, on assuring eligibility criteria quality. Respondents were asked to answer based on all their trial experience, not only on experiences with our trials. The survey was disseminated to recruiters collaborating on trials run at our trials unit, and via other mailing lists and social media. The quantitative responses were descriptively analysed, with inductive analysis of free-text responses to identify themes.ResultsA total of 823 eligible respondents participated. 79% of respondents reported finding problems with eligibility criteria in some trials, and 9% in most trials. The main themes in the types of problems experienced were criteria clarity (67% of comments), feasibility (34%) and suitability (14%). 27% of those reporting some level of problem said these problems had led to patients being incorrectly included in trials; 40% said they had led to incorrect exclusions. Most respondents (56%) reported accessing eligibility criteria mainly in the trial protocol. Most respondents (74%) supported the idea that they might review eligibility criteria earlier in the protocol development process.ConclusionsOur survey corroborates other evidence about the existence of suboptimal trial eligibility criteria. Problems with clarity were the most often reported, but the number of comments on feasibility and suitability suggest some recruiters feel eligibility criteria and associated assessments can hinder recruitment to trials. Our proposal for more recruiter involvement in protocol development has strong support and some potential benefits, but questions remain about how best to implement this. We invite other trialists to consider our other suggestions for how to assure quality in trial eligibility criteria.

scholarly journals 038 Tremor: a clinical and neurophysiological study

2019 ◽  
Vol 90 (e7) ◽  
pp. A13.2-A13
Author(s):  
Alessandro Fois ◽  
Neil Mahant ◽  
Steve Vucic ◽  
Victor SC Fung
Keyword(s):  
Essential Tremor ◽  
Upper Limb ◽  
Temporal Discrimination ◽  
Clinical Trial Design ◽  
Clinical Problem ◽  
Future Research ◽  
Cross Sectional ◽  
Clinical Criteria ◽  
Dystonic Tremor ◽  
Neurophysiological Studies

IntroductionTremor is a common clinical problem seen in a number of diseases. Robust classification and diagnosis of tremor remains controversial due to overlap in clinical features and lack of established biomarkers. This hampers effective research including therapeutic trials. We present our research protocol for a cross-sectional study which aims to find more robust methods of tremor classification and diagnosis.MethodsAdults with upper limb tremor of varying aetiologies, diagnosed using current clinical criteria (including essential tremor, Parkinsonian tremor, and dystonic tremor), and age-matched controls are eligible for recruitment. Participants undergo a clinical and neurophysiological assessment, including accelerometry, surface electromyography, long-latency stretch reflexes, temporal discrimination, and tonic vibration reflexes. Data will be analysed using a cluster analysis to identify robust tremor syndromes and biomarkers associated with them. We aim to recruit 100 participants prior to analysis.ResultsAt time of writing, 13 participants with upper limb tremor have been studied (6 with essential tremor, 5 with dystonic tremor, and 2 with indeterminate tremor; mean age 66 years, range 18–85). Participants tolerated the clinical and neurophysiological studies well with 100% completion rate after recruitment. With current rates of recruitment we anticipate completion of recruitment and commencement of data analysis in October 2019.ConclusionsOur protocol aims to identify robust tremor phenotypes and biomarkers for them. This will allow patients with tremor to be classified into more biologically homogeneous diagnostic categories, aiding future research into the mechanism of tremor and more rational clinical trial design.

A Silenced Population

Crisis ◽  
2017 ◽  
Vol 38 (6) ◽  
pp. 433-442 ◽  
Author(s):  
Kim Gryglewicz ◽  
Melanie Bozzay ◽  
Brittany Arthur-Jordon ◽  
Gabriela D. Romero ◽  
Melissa Witmeier ◽  
...  
Keyword(s):  
At Risk ◽  
Depressive Symptomatology ◽  
The United States ◽  
Future Research ◽  
At Risk Youth ◽  
Peer Relationship ◽  
Student Records ◽  
Cross Sectional ◽  
Increased Risk ◽  
Method Student

Abstract. Background: Given challenges that exceed the normal developmental requirements of adolescence, deaf and hard-of-hearing (DHH) youth are believed to be at elevated risk for engaging in suicide-related behavior (SRB). Unfortunately, little is known about the mechanisms that put these youth potentially at risk. Aims: To determine whether peer relationship difficulties are related to increased risk of SRB in DHH youth. Method: Student records (n = 74) were retrieved from an accredited educational center for deaf and blind students in the United States. Results: Peer relationship difficulties were found to be significantly associated with engagement in SRB but not when accounting for depressive symptomatology. Limitations: The restricted sample limits generalizability. Conclusions regarding risk causation cannot be made due to the cross-sectional nature of the study. Conclusion: These results suggest the need for future research that examines the mechanisms of the relationship between peer relationship difficulties, depression, and suicide risk in DHH youth and potential preventive interventions to ameliorate the risks for these at-risk youth.

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