Community consultation in emergency neurotrauma research: results from a pre-protocol survey

Clark, David; Kolias, Angelos G.; Corteen, Elizabeth A.; Ingham, S. C.; Piercy, James; Crick, Simon J.; Menon, David; Hutchinson, Peter J.

doi:10.1007/s00701-013-1748-3

Cited by 16 publications

(10 citation statements)

References 18 publications

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“…A survey conducted as part of community consultation for a trial evaluating a pre-hospital intervention for seizures found that 78 % (n = 1901) of respondents supported the concept of third-party consent, and 65 % indicated willingness to be enrolled with the consent of a family member even if there was no direct benefit to themselves [ 44 ]. A community consultation for a neurosurgical trial found 91 % (n = 171) of participants were accepting of surrogate consent by a doctor independent of the trial [ 45 ].…”

Section: Resultsmentioning

confidence: 99%

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Gobat

Gal

Francis

et al. 2015

Trials

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BackgroundA rigorous research response is required to inform clinical and public health decision-making during an epi/pandemic. However, the ethical conduct of such research, which often involves critically ill patients, may be complicated by the diminished capacity to consent and an imperative to initiate trial therapies within short time frames. Alternative approaches to taking prospective informed consent may therefore be used. We aimed to rapidly review evidence on key stakeholder (patients, their proxy decision-makers, clinicians and regulators) views concerning the acceptability of various approaches for obtaining consent relevant to pandemic-related acute illness research.MethodsWe conducted a rapid evidence review, using the Internet, database and hand-searching for English language empirical publications from 1996 to 2014 on stakeholder opinions of consent models (prospective informed, third-party, deferred, or waived) used in acute illness research. We excluded research on consent to treatment, screening, or other such procedures, non-emergency research and secondary studies. Papers were categorised, and data summarised using narrative synthesis.ResultsWe screened 689 citations, reviewed 104 full-text articles and included 52. Just one paper related specifically to pandemic research. In other emergency research contexts potential research participants, clinicians and research staff found third-party, deferred, and waived consent to be acceptable as a means to feasibly conduct such research. Acceptability to potential participants was motivated by altruism, trust in the medical community, and perceived value in medical research and decreased as the perceived risks associated with participation increased. Discrepancies were observed in the acceptability of the concept and application or experience of alternative consent models. Patients accepted clinicians acting as proxy-decision makers, with preference for two decision makers as invasiveness of interventions increased. Research regulators were more cautious when approving studies conducted with alternative consent models; however, their views were generally under-represented.ConclusionsThird-party, deferred, and waived consent models are broadly acceptable to potential participants, clinicians and/or researchers for emergency research. Further consultation with key stakeholders, particularly with regulators, and studies focused specifically on epi/pandemic research, are required. We highlight gaps and recommendations to inform set-up and protocol development for pandemic research and institutional review board processes.PROSPERO protocol registration numberCRD42014014000Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1110-6) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Gobat

Gal

Francis

et al. 2015

Trials

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“…While this is a good starting point, we should highlight that each of those studies related to the use of potential treatment that may have had direct benefit to the subject. In fact, the Corticoid Randomization after Significant Head Injury (CRASH) Trial [35] evaluated tranexamic acid in TBI; Clark et al [36] was evaluating the role of decompressive craniectomy for evacuation of an acute subdural haematoma, and Scotton et al [37] was evaluating a subdural evacuating port system as a minimally invasive alternative to burr-hole evacuation. On the contrary, the study outlined in our surveys, although not influencing our standard of care, might not necessary lead to any direct benefit for the participants.…”

Section: Discussionmentioning

confidence: 99%

Defining New Research Questions and Protocols in the Field of Traumatic Brain Injury through Public Engagement: Preliminary Results and Review of the Literature

Hasan

Chari

Ganau

et al. 2019

Emergency Medicine International

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Traumatic brain injury (TBI) is the most common cause of death and disability in the age group below 40 years. The financial cost of loss of earnings and medical care presents a massive burden to family, society, social care, and healthcare, the cost of which is estimated at £1 billion per annum (about brain injury (online)). At present, we still lack a full understanding on the pathophysiology of TBI, and biomarkers represent the next frontier of breakthrough discoveries. Unfortunately, many tenets limit their widespread adoption. Brain tissue sampling is the mainstay of diagnosis in neuro-oncology; following on this path, we hypothesise that information gleaned from neural tissue samples obtained in TBI patients upon hospital admission may correlate with outcome data in TBI patients, enabling an early, accurate, and more comprehensive pathological classification, with the intent of guiding treatment and future research. We proposed various methods of tissue sampling at opportunistic times: two methods rely on a dedicated sample being taken; the remainder relies on tissue that would otherwise be discarded. To gauge acceptance of this, and as per the guidelines set out by the National Research Ethics Service, we conducted a survey of TBI and non-TBI patients admitted to our Trauma ward and their families. 100 responses were collected between December 2017 and July 2018, incorporating two redesigns in response to patient feedback. 75.0% of respondents said that they would consent to a brain biopsy performed at the time of insertion of an intracranial pressure (ICP) bolt. 7.0% replied negatively and 18.0% did not know. 70.0% would consent to insertion of a jugular bulb catheter to obtain paired intracranial venous samples and peripheral samples for analysis of biomarkers. Over 94.0% would consent to neural tissue from ICP probes, external ventricular drains (EVD), and lumbar drains (LD) to be salvaged, and 95.0% would consent to intraoperative samples for further analysis.

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“…The pilot highlighted the need to promote this and train sites about appropriate use of IHP consent. There is evidence from a public opinion survey on patient inclusion in severe traumatic brain injury (TBI) clinical trials that 91% of respondents would be happy for an independent doctor to assent 48 . Despite this, we have found there is persistent institutional reluctance to use such proxy consent processes, which is only likely to be overcome by continued adoption into trials where appropriate.…”

Section: Discussionmentioning

confidence: 99%

Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase

Edlmann

Thelin

Caldwell

et al. 2019

Sci Rep

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The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.

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Community consultation in emergency neurotrauma research: results from a pre-protocol survey

Abstract: Our community consultation survey shows that the proposed trial is acceptable to the public. In addition, the results suggest high levels of acceptability of surrogate consent by next of kin or independent doctor amongst our community.

Cited by 16 publications

References 18 publications

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

Defining New Research Questions and Protocols in the Field of Traumatic Brain Injury through Public Engagement: Preliminary Results and Review of the Literature

Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase

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