Informed Consent: The Rate-Limiting Step in Acute Stroke Trials

Rose, David Z.; Kasner, Scott E.

doi:10.3389/fneur.2011.00065

Cited by 37 publications

(39 citation statements)

References 46 publications

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“…Consenting patients with stroke were included which resulted in a population representative of those in the local stroke population other than in terms of early mortality, reflecting the difficulty in gaining consent or assent from very sick patients. 15 Because only half the potentially eligible patients were recruited, it is possible that our results may have been skewed towards shorter time to CT scan and a higher proportion of thrombolysed patients compared to the total population. Although an attempt was made to sample all patients with stroke, our recruitment was limited by the practicalities of engaging with people presenting 24 h a day, 7 days a week.…”

Section: Discussionmentioning

confidence: 98%

The association between prehospital care and in-hospital treatment decisions in acute stroke: a cohort study

et al. 2013

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BackgroundHospital prealerting in acute stroke improves the timeliness of subsequent treatment, but little is known about the impact of prehospital assessments on in-hospital care.ObjectiveExamine the association between prehospital assessments and notification by emergency medical service staff on the subsequent acute stroke care pathway.MethodsThis was a cohort study of linked patient medical records. Consenting patients with a diagnosis of stroke were recruited from two urban hospitals. Data from patient medical records were extracted and entered into a Cox regression analysis to investigate the association between time to CT request and recording of onset time, stroke recognition (using the Face Arm Speech Test (FAST)) and sending of a prealert message.Results151 patients (aged 71±15 years) travelled to hospital via ambulance and were eligible for this analysis. Time of symptom onset was recorded in 61 (40%) cases, the FAST test was positive in 114 (75%) and a prealert message was sent in 65 (44%). Following adjustment for confounding, patients who had time of onset recorded (HR 0.73, 95% CI 0.52 to 1.03), were FAST-positive (HR 0.54, 95% CI 0.37 to 0.80) or were prealerted (HR 0.26, 95% CI 0.18 to 0.38), were more likely to receive a timely CT request in hospital.ConclusionsThis study highlights the importance of hospital prealerting, accurate stroke recognition, and recording of onset time. Those not recognised with stroke in a prehospital setting appear to be excluded from the possibility of rapid treatment in hospital, even before they have been seen by a specialist.

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Section: Discussionmentioning

confidence: 98%

The association between prehospital care and in-hospital treatment decisions in acute stroke: a cohort study

et al. 2013

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“…Models of informed consent differ strongly between countries - and in the case of Germany, even between federal states. An emergency clause for including patients unable to give consent exists in some countries, rendering new treatments more available than in other countries [12,13]. This holds true for stroke and also for other diseases, especially in emergency care.…”

Section: Discussionmentioning

confidence: 99%

Impact of Selection Criteria on Recruitment in an Interventional Stroke Trial

Hotter

Jegzentis²,

Steinbrink³

et al. 2013

Cerebrovasc Dis

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Background: Randomized controlled clinical trials are the gold standard for scientific evaluation of clinical diagnostic and treatment concepts. Frequently, recruitment of participants is slower than expected, especially in acute conditions with a short time frame for inclusion. Simple prediction models have been proposed to extrapolate recruitment rates. We hypothesized a significant overestimation of recruitment when ignoring interdependence of selection criteria, leading to an insufficient representation of reality by available models. We proposed that slight modifications to inclusion criteria might augment recruitment without causing selection bias. Methods: We analyzed recruitment in an acute intervention trial of acute ischemic stroke initiated by our facility. Frequencies of selection criteria were recorded and analyzed individually as well as cumulatively. We then amended the trial protocol by moderate modifications to the selection criteria. The main outcome criterion was the rate of recruited over screened patients, with the goal of increasing recruitment fourfold without adding unacceptable selection bias. A previously presented prediction model was applied to our trial and compared with actual recruitment. Data were compared between screening periods at recruitment prior to and after the implementation of the amendments. Results: The impact of typical as well as novel inclusion criteria such as age limits, imaging-based definition of pathology, time between onset and presentation as well as inability to consent were quantified. Age restriction, definition of index event and late arrival after ictus were identified as the most challenging modifiable selection criteria. Amending those criteria increased recruitment by a factor of 4.1. Inability to consent was a significant exclusion criterion gaining impact with the target population. The selection criteria had a cumulative rather than separate recruitment-limiting impact. A previously presented model did not predict recruitment sufficiently. Conclusion: We describe frequencies of selection criteria in a typical cohort of patients suffering from acute cerebrovascular events, and their cumulative impact. These data may help to better understand recruitment limitations and allow designing future trials more effectively. Ability to consent especially is a major contributor to trial exclusion, strongly interfering with the targeted trial population of ischemic stroke. Tentative prescreening phases before site or trial initiation should be considered. No predictive statistical models of recruitment have been established so far.

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“…A long‐standing debate in stroke trials is the issue of consent particularly for patients with cognitive deficit . Our results report the opinions of individuals interviewed, who expressed that opportunity to participate should be equitably available to all, regardless of their cognitive capacity.…”

Section: Discussionmentioning

confidence: 86%

PERSPECTIVES: Stroke survivors' views on the design of an early‐phase cell therapy trial for patients with chronic ischaemic stroke

Nagpal

Hillier

Milton

et al. 2019

Health Expectations

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BackgroundStem cell research holds the potential for a paradigm shift in the management of diseases such as stroke. Patient and public involvement in research (PPIR) can bring a focus to issues of clinical relevance and accelerate translation to real‐world clinical practice.ObjectiveA qualitative thematic analysis of the perspectives of stroke survivors regarding the conduct and design aspects of a proposed phase I clinical cell therapy study in stroke.DesignTwelve stroke survivors were purposively recruited in July 2016–August 2017 and participated in semi‐structured, face‐to‐face interviews for input into the design of a proposed phase I clinical study of autologous dental pulp stem cells. Concurrent thematic analysis was conducted until data saturation was achieved.Discussion and conclusionsParticipants conveyed that the most relevant outcomes to them were regaining participation, decreased dependence on caregivers and improvement in cognition, memory, mood, pain and fatigue. The perception of risk vs. benefit was likely influenced by the time elapsed since stroke, with participants being more willing to accept a higher level of risk early in the post‐stroke disease course. They believed that all stroke survivors should be given an opportunity to participate in research, irrespective of their cognitive capacity. A relatively small sample population of 12 stroke survivors was studied as thematic saturation was achieved. PERSPECTIVES study applied principles of PPIR to early‐phase cell research. Incorporation of outcomes relevant to patients' need within the study design is critical to generate data that will enable personalized application of regenerative medicine in stroke.

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Informed Consent: The Rate-Limiting Step in Acute Stroke Trials

Cited by 37 publications

References 46 publications

The association between prehospital care and in-hospital treatment decisions in acute stroke: a cohort study

The association between prehospital care and in-hospital treatment decisions in acute stroke: a cohort study

Impact of Selection Criteria on Recruitment in an Interventional Stroke Trial

PERSPECTIVES: Stroke survivors' views on the design of an early‐phase cell therapy trial for patients with chronic ischaemic stroke

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