Scotton William J, Kolias Angelos G, Ban Vin Shen, Crick Simon J, Sinha Rohitashwa, Gardner Andrew, Massey Kate, Minett Thais, Santarius Thomas, Hutchinson Peter J
Division of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK.
Br J Neurosurg. 2013 Oct;27(5):590-4. doi: 10.3109/02688697.2013.793291. Epub 2013 Jun 14.
Chronic subdural haematoma (CSDH) is one of the most common neurosurgical disorders and is especially prevalent in old age. The subdural evacuating port system (SEPS) has emerged in the last few years as a minimally invasive alternative to the standard procedure of burr-hole evacuation. NHS practice is evidence-driven and evidence from high-quality clinical studies is required prior to implementation of any changes. In the UK, the National Research Ethics Service (NRES) advises community consultation prior to starting a clinical trial, where the patient is unlikely to have capacity to consent to enrolment in the trial. To prepare for a trial comparing minimally invasive (SEPS) versus burr-hole evacuation for evacuation of a CSDH, we have designed and undertaken a pre-protocol community consultation survey to examine potential patient participation. MATERIAL(S) AND METHODS: The study population consisted of patients, family members and carers/friends in neurosurgical clinic waiting rooms and wards at Addenbrooke's Hospital, Cambridge, who individually completed a questionnaire (n = 215).
Most respondents were willing to participate in the proposed randomised clinical trial (77%; 165/215). Moreover, 80% (171/215) and 74% (159/215) were willing to allow their next of kin and an independent consultant neurosurgeon to give surrogate consent, respectively.
The results of our pre-protocol community consultation showed that not only would most respondents be willing to participate in the proposed trial, but also would be happy for either next of kin or an independent consultant neurosurgeon to give surrogate consent if they lacked capacity to consent themselves. The advantages of this type of survey are twofold: they increase patient and public involvement in the research process and allow researchers to design study protocols that are acceptable to the community.
