Effect of waivers of consent on recruitment in acute stroke trials: A systematic review.
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SUBMITTER: Feldman WB
PROVIDER: S-EPMC4836887 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and purposeImaging biomarkers are increasingly used to provide a better understanding of the pathophysiology of acute ischemic stroke. However, this approach of routinely using imaging biomarkers to inform treatment decisions has yet to be translated into successful randomized trials. The aim of this study was to systematically review the use of imaging biomarkers in randomized controlled trials in patients with acute ischemic stroke, exploring the purposes for which the imaging biomarkers were used.Materials and methodsWe performed a systematic review of imaging biomarkers used in randomized controlled trials of acute ischemic stroke, in which a therapeutic intervention was trialed within 48 hours of symptom onset. Data bases searched included MEDLINE, EMBASE, strokecenter.org, and the Virtual International Stroke Trials Archive (1995-2014).ResultsEighty-four studies met the criteria, of which 49 used imaging to select patients; 31, for subgroup analysis; and 49, as an outcome measure. Imaging biomarkers were broadly used for 8 purposes. There was marked heterogeneity in the definitions and uses of imaging biomarkers and significant publication bias among post hoc analyses.ConclusionsImaging biomarkers offer the opportunity to refine the trial cohort by minimizing participant variation, to decrease sample size, and to personalize treatment approaches for those who stand to benefit most. However, within imaging modalities, there has been little consistency between stroke trials. Greater effort to prospectively use consistent imaging biomarkers should help improve the development of novel treatment strategies in acute stroke and improve comparison between studies.
| S-EPMC5524169 | biostudies-literature
Project description:INTRODUCTION:Randomised controlled trials (RCTs) that fail to meet their recruitment target risk increasing research waste. Acute stroke RCTs experience notable recruitment issues. The efficiency of recruitment to stroke rehabilitation RCTs has not been explored. AIMS AND OBJECTIVES:To explore recruitment efficiency and the trial features associated with efficient recruitment to stroke rehabilitation RCTs. METHODS:A systematic review of stroke rehabilitation RCTs published between 2005 and 2015 identified in a search of the Cochrane Stroke Group (CSG) Trials Register from 35 electronic databases (e.g. Medline, CINAHL; EMBASE), clinical trial registers, and hand-searching. Inclusion criteria are stroke rehabilitation intervention, delivered by a member of the rehabilitation team, and clinically relevant environment. We extracted data on recruitment efficiency and trial features. RESULTS:We screened 12,939 titles, 1270 abstracts and 788 full texts, before extracting data from 512 included RCTs (n = 28,804 stroke survivor participants). This is the largest systematic review of recruitment to date. A third of stroke survivors screened consented to participate (median 34% (IQR 14-61), on average sites recruited 1.5 participants per site per month (IQR 0.71-3.22), and one in twenty (6% (IQR 0-13) dropped out during the RCT. Almost half (48%) of those screened in the community were recruited compared to hospital settings (27%). Similarly, almost half (47%) those screened at least 6 months after stroke participated, compared to 23% of stroke survivors screened within a month of stroke. When one recruiter screened multiple sites, a median of one stroke survivor was recruited every 2 months compared to more than two per month when there was a dedicated recruiter per site. RCT recruitment was significantly faster per site, with fewer dropouts, for trials conducted in Asia (almost three stroke survivors monthly; 2% dropout) compared to European trials (approximately one stroke survivor monthly; 7% dropout). CONCLUSIONS:One third of stroke survivors screened were randomised to rehabilitation RCTs at a rate of between one and two per month, per site. One in twenty did not complete the trial. Our findings will inform recruitment plans of future stroke rehabilitation RCTs. Limited reporting of recruitment details restricted the subgroup analysis performed. TRIAL REGISTRATION:Prospective Register of Systematic Reviews, registration number CRD42016033067.
| S-EPMC6954526 | biostudies-literature
Project description:Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients' and surrogates' experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context-sensitive approaches to consent is important.
| S-EPMC6497349 | biostudies-literature
Project description:Background and purposeSlow recruitment in acute stroke trials hampers the evaluation of new therapies and delays the adoption of effective therapies into clinical practice. This systematic review evaluates whether recruitment efficiency and rates have increased in acute stroke trials from 1990 to 2014.MethodsAcute stroke trials from 2010 to 2014 were identified by a search of PubMed, Medline, the Cochrane Database of Research in Stroke, and the Stroke Trials Registry. These trials were compared to a previously published data set of trials conducted from 1990 to 2004.ResultsThe median recruitment efficiency of trials from 1990 to 2004 was 0.41 participants/site/month compared with 0.26 participants/site/month from 2010 to 2014 (P=0.14). The median recruitment rate of trials from 1990 to 2004 was 26.8 participants/month compared with 19.0 participants/month from 2010 to 2014 (P=0.13).ConclusionsFor acute stroke trials, neither recruitment efficiency nor recruitment rates have increased over the past 25 years and, if anything, have declined.
| S-EPMC5330837 | biostudies-literature
Project description:INTRODUCTION:The subjective assessment of the adequacy of informed consent for clinical trials, and the potential difficulties associated with it, has led several studies to develop objective measures of informed consent for clinical trials. These objective measures of informed consent are often specific to a particular population or clinical condition and largely focus on understanding of (some or all of) the key elements of informed consent. Many of the developed tools are study-specific, but some validated measures exist. Of these validated measures, those which are reported by participants are of particular interest. Whether these objective tools conceptualize and measure informed consent in the same way is not known. As such, it is not clear whether meta-analyzing data from studies reporting different tools is worthwhile. The aim of this systematic review was to critically appraise the evidence on the overall conceptualisation and item content of validated patient reported measures of informed consent for clinical trials, and to identify core domains of potential importance for informed consent. METHODS:A systematic search of the literature was conducted to identify relevant articles that described the development, and/or validation, of patient-reported measures of adequacy of informed consent for randomised controlled trials. Data was synthesised by classifying the items identified into domains and sub-domains which were determined by the nomenclature reported in included studies. Both for descriptions of included studies and of the instruments reported in those studies, descriptive statistics were used to describe general information and instrument detail. A narrative synthesis of the instruments and their inter-related domains and subdomains was conducted to identify areas of both convergence and divergence. RESULTS:The search identified 8193 citations. After screening titles and abstracts, 29 full text articles were retrieved for further assessment. Of these 29, 14 complied with our pre-specified inclusion criteria with 15 not being eligible. Of the 14 instruments, three explicitly reported a theoretical or conceptual framework underpinning their development, a further three implicitly referred to the 'conceptual dimensions of informed consent' or 'principles of research ethics' as informing their development and eight reported no guiding theoretical framework. Only three of the 14 studies reported patient or public involvement in the development of the tool. One hundred and seventy nine items were included across the 14 instruments. The primary focus of the instruments was on understanding. Five core domains were identified which included: Autonomy; Consequences; Expectations; Purpose; and Individualisation. There was substantial variability in the coverage of different domains across measures. CONCLUSIONS:This study demonstrated the variability in the theoretical underpinning, development and domain coverage of existing patient-reported measures of informed consent for clinical trials. The conceptualisation of informed consent could benefit from being extended from a narrow focus on understanding to include broader considerations of decision-making. Meaningful involvement of potential trial participants during development of measures critical for tool relevance is also lacking. The identification of the key domains relevant to all stakeholders which could be measured to assess the informed consent process for clinical trials is needed.
| S-EPMC6021104 | biostudies-literature
Project description:Objectives:We evaluated 300 paediatric trials to determine: the consent and recruitment strategies used, who trial information was targeted to, how incentives were used and if they achieved their recruitment targets. Methods:For this cross-sectional evaluation, we searched the Cochrane Central Register of Controlled Trials for paediatric trials published in 2012 and randomly selected 300 that reported on outcomes for participants aged ?21 years. We collected data on consent and recruitment procedures for each trial and undertook descriptive analyses in SPSS statistics V.23. Results:All but one trial (99.7%) used a standard recruitment strategy. Most (92%) trials reported that consent was obtained but only 13% reported who obtained consent. Two-thirds (65%) of trials included school-aged participants, and of these 68% reported obtaining assent. Half (50%) of the trials reported who the trial information was targeted to. Most trials (75%) of school-aged participants targeted information towards children or children and their parents. Fourteen per cent of trials reported using incentives, half (50%) of which were in the form of compensation. Only 48% of trials reported sufficient data to determine if their recruitment targets were achieved. Of these, 70% achieved their targets. Conclusions:Notable reporting shortcomings included: how families were recruited into the trial, who obtained consent and/or assent and how, who trial information was directed to, whether incentives were used and sufficient data to determine if the recruitment target was achieved. Forthcoming paediatric-specific reporting standards may improve reporting in this priority area. Our data provide a baseline for ongoing monitoring of the state of the research.
| S-EPMC6267313 | biostudies-literature
Project description:BackgroundRecruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs.Methods and findingsA systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00-2.18], attendance at an education session [RR 1.14, 95% CI 1.01-1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14-1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11-2.74), and also monetary incentives (RR1.39, 95% CI 1.13-1.64 to RR 1.53, 95% CI 1.28-1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007.ConclusionRecruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis. Please see later in the article for the Editors' Summary.
| S-EPMC2976724 | biostudies-literature
Project description:Importance. Oncology trials often entail high-stakes interventions where potential for morbidity and fatal side effects, and for life-prolongation or cure, intensify bioethical issues surrounding informed consent. These challenges are compounded in multistage randomized trials, which are prevalent in oncology. Objective. We sought to elucidate the major barriers to informed consent in high-stakes oncology trials in general and the best consent practices for multistage randomized trials. Evidence Review. We queried PubMed for original studies published from January 1, 1990, to April 5, 2018, that focused on readability, quality, complexity or length of consent documents, motivation and sickness level of participants, or interventions and enhancements that influence informed consent for high-stakes oncologic interventions. Exclusion criteria included articles focused on populations outside industrialized countries, minors or other vulnerable populations, physician preferences, cancer screening and prevention, or recruitment strategies. Additional articles were identified through comprehensive bibliographic review. Findings. Twenty-seven articles were retained; 19 enrolled participants and 8 examined samples of consent documents. Methodologic quality was variable. This body of literature identified certain challenges that can be readily remedied. For example, the average length of the consent forms has increased 10-fold from 1987 to 2010, and patient understanding was shown to be inversely proportional to page count; shortening forms, or providing a concise summary as mandated by the revised Common Rule, might help. However, barriers to understanding that stem from deeply ingrained and flawed sociocultural perceptions of medical research seem more difficult to surmount. Although no studies specifically addressed problems posed by multiple sequential randomizations (such as change in risk-benefit ratio due to time-varying treatment responses or organ toxicities), the findings are likely applicable and especially relevant in that context. Concrete suggestions for improvement are proposed.
| S-EPMC6440043 | biostudies-literature
Project description:OBJECTIVE:To systematically evaluate and compare the diagnostic accuracy of CT perfusion (CTP), non-enhanced computed tomography (NCCT) and computed tomography angiography (CTA) in detecting acute ischemic stroke. METHODS:We searched seven databases and screened the reference lists of the included studies. The risk of bias in the study quality was assessed using QUADASII. We produced paired forest plots in RevMan to show the variation of the sensitivity and specificity estimates together with their 95% CI. We used a hierarchical summary ROC model to summarize the sensitivity and specificity of CTP in detecting ischemic stroke. RESULTS:We identified 27 studies with a total of 2168 patients. The pooled sensitivity of CTP for acute ischemic stroke was 82% (95% CI 75-88%), and the specificity was 96% (95% CI 89-99%). CTP was more sensitive than NCCT and had a similar accuracy with CTA. There were no statistically significant differences in the sensitivity and specificity between patients who underwent CTP within 6 hours of symptom onset and beyond 6 hours after symptom onset. No adverse events were reported in the included studies. CONCLUSIONS:CTP is more accurate than NCCT and has similar accuracy to CTA in detecting acute ischemic stroke. However, the evidence is not strong. There is potential benefit of using CTP to select stroke patients for treatment, but more high-quality evidence is needed to confirm this result.
| S-EPMC5435168 | biostudies-literature
Project description:IntroductionInformed consent is essential to clinical research, though obtaining informed consent for participation in research for emergency conditions is challenging. Adapted consent methods include consent from a substitute-decision maker, deferral of consent and waiver of consent. A novel approach is to use advanced consent, where a potential participant provides consent in the present in the event that they become eligible for enrolment into a future study. This scoping review will map and synthesise the literature on the use of advanced consent for participation and enrolment in randomised control trials for emergency conditions.Methods and analysisGuided by Arksey and O'Malley's scoping review methodology framework, we will search electronic databases (Medline, Embase, Web of Science and the Cochrane Register of Clinical Trials), the grey literature sources and reference lists of relevant studies. Eligible studies will include English language articles that discuss, examine or employ the use of advanced consent for enrolment in randomised control trials, specifically related to emergency conditions or emergency treatment. Diverse types of articles will be eligible for inclusion, including peer-reviewed qualitative and quantitative studies such as randomised control trials, observational studies, surveys, systematic reviews, as well as narrative reviews and ethics papers. Studies will be screened by two independent reviewers to determine eligibility for inclusion. Data on bibliographic information, study characteristics and methodology, and reported results, specifically author disposition, will be extracted and described using qualitative analysis.Ethics and disseminationFormal ethics review is not required as primary data will not be collected. The findings of this study will be disseminated through a peer-reviewed publication. The findings of this study will help identify knowledge gaps that may guide areas for future research and may aid in the design of future clinical trials using advanced consent.
| S-EPMC7569993 | biostudies-literature