Truly robust evidence to support the surgical management of IFP pathology requires randomised controlled trials; however the expenses involved to design such trials means that they are unlikely to be undertaken for this uncommon disorder. Consequently well-designed and well-reported case series need to be undertaken to improve our current understanding that includes recording quantitative measures such as range of knee motion, VAS Pain scores and a validated scoring system.
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 No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment.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.
ObjectivesPostoperative mortality is a widely used quality indicator, but it may be unreliable when procedure numbers and/or mortality rates are low, due to insufficient statistical power. The objective was to investigate the statistical validity of postoperative 30-day mortality as a quality metric for neurosurgical practice across healthcare providers.DesignRetrospective cohort study.SettingHospital Episode Statistics data from all neurosurgical units in England.ParticipantsPatients who underwent neurosurgical procedures between April 2013 and March 2018. Procedures were grouped using the National Neurosurgical Audit Programme classification.Outcomes measuredNational 30-day postoperative mortality rates were calculated for elective and non-elective neurosurgical procedural groups. The study estimated the proportion of neurosurgeons and NHS trusts in England that performed sufficient procedures in 3-year and 5-year periods to detect unusual performance (defined as double the national rate of mortality). The actual difference in mortality rates that could be reliably detected based on procedure volumes of neurosurgeons and units over a 5-year period was modelled.ResultsThe 30-day mortality rates for all elective and non-elective procedures were 0.4% and 6.1%, respectively. Only one neurosurgeon in England achieved the minimum sample size (n=2402) of elective cases in 5 years needed to detect if their mortality rate was double the national average. All neurosurgical units achieved the minimum sample sizes for both elective (n=2402) and non-elective (n=149) procedures. In several neurosurgical subspecialties, approximately 80% of units (or more) achieved the minimum sample sizes needed to detect if their mortality rate was double the national rate, including elective neuro-oncology (baseline mortality rate=2.3%), non-elective neuro-oncology (rate=5.7%), neurovascular (rate=6.7%) and trauma (rate=11%).ConclusionPostoperative mortality lacks statistical power as a measure of individual neurosurgeon performance. Neurosurgical units in England performed sufficient procedure numbers overall and in several subspecialty areas to support the use of mortality as a quality indicator.
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