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

摘要

Background: Uncertainty remains as to the role of decompressive craniectomy (DC) for primary evacuation of an acute subdural haematoma (ASDH). In 2011, a collaborative group of neurosurgeons, neuro-intensive care physicians and trial methodologists was formed in the UK with the aim of answering the following question: "What is the clinical- and cost-effectiveness of DC, in comparison to simple craniotomy for adult patients undergoing primary evacuation of an ASDH?" The proposed RESCUE-ASDH trial (Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma) is a multi-centre, pragmatic, parallel group randomised trial of DC versus simple craniotomy for adult head-injured patients with an ASDH. Clinical trials in the emergency setting face the problem that potential participants may be incapacitated and their next of kin initially unavailable. As a result, consent and enrolment of participants can often be difficult. Method: In the current study, we aimed to assess public opinion regarding participation in the RESCUE-ASDH trial and acceptability of surrogate consent by conducting a pre-protocol community consultation survey. Results: One hundred and seventy-one subjects completed the survey. Eighty-four percent of participants responded positively when asked if they would participate in the proposed trial. Ninety-six percent and 91 % answered positively when asked if they found surrogate consent by their next of kin and an independent doctor acceptable, respectively. None of the characteristics of the study population were found to affect the decision to participate or the acceptability of surrogate consent by the next of kin. Being religious showed a trend towards higher acceptability of surrogate consent by a doctor. Conversely, an education to degree level and above showed a trend towards reduced acceptability of surrogate consent by a doctor. Conclusions: 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.