Decompressive Craniectomy versus Craniotomy for Acute Subdural Hematoma.

BACKGROUND: Traumatic acute subdural hematomas frequently warrant surgical evacuation by means of a craniotomy (bone flap replaced) or decompressive craniectomy (bone flap not replaced). Craniectomy may prevent intracranial hypertension, but whether it is associated with better outcomes is unclear. METHODS: We conducted a trial in which patients undergoing surgery for traumatic acute subdural hematoma were randomly assigned to undergo craniotomy or decompressive craniectomy. An inclusion criterion was a bone flap with an anteroposterior diameter of 11 cm or more. The primary outcome was the rating on the Extended Glasgow Outcome Scale (GOSE) (an 8-point scale, ranging from death to "upper good recovery" [no injury-related problems]) at 12 months. Secondary outcomes included the GOSE rating at 6 months and quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L). RESULTS: A total of 228 patients were assigned to the craniotomy group and 222 to the decompressive craniectomy group. The median diameter of the bone flap was 13 cm (interquartile range, 12 to 14) in both groups. The common odds ratio for the differences across GOSE ratings at 12 months was 0.85 (95% confidence interval, 0.60 to 1.18; P = 0.32). Results were similar at 6 months. At 12 months, death had occurred in 30.2% of the patients in the craniotomy group and in 32.2% of those in the craniectomy group; a vegetative state occurred in 2.3% and 2.8%, respectively, and a lower or upper good recovery occurred in 25.6% and 19.9%. EQ-5D-5L scores were similar in the two groups at 12 months. Additional cranial surgery within 2 weeks after randomization was performed in 14.6% of the craniotomy group and in 6.9% of the craniectomy group. Wound complications occurred in 3.9% of the craniotomy group and in 12.2% of the craniectomy group. CONCLUSIONS: Among patients with traumatic acute subdural hematoma who underwent craniotomy or decompressive craniectomy, disability and quality-of-life outcomes were similar with the two approaches. Additional surgery was performed in a higher proportion of the craniotomy group, but more wound complications occurred in the craniectomy group. (Funded by the National Institute for Health and Care Research; RESCUE-ASDH ISRCTN Registry number, ISRCTN87370545.).

Volume reduction with surgery for ICH: when is it effective? Analysis of the CT scans from the STICH II trial.

BACKGROUND: The surgical trial of lobar intracerebral haemorrhage (STICH II) was a randomised controlled trial evaluating early surgical removal of a clot. This paper investigates volume change in both arms of the trial with respect to Extended Glasgow Outcome Scale (GOSE) groups. METHODS: Patients randomised into STICH II had an initial diagnostic CT and a second CT 5 days after randomisation. Each scan was anonymously assessed by at least two central readers. An analysis of agreement between the two readers was conducted using kappa tests and intraclass correlation. The change in volume in both the early surgery (ES) and the initial conservative treatment (ICT) arms were analysed with respect to the six-month GOSE outcome. RESULTS: Of the 597 patients randomised in the trial there were 582 pre-randomisation scans and 566 5-day scans available for analysis of agreement. There was good agreement between the assessors for the radiological inclusion criteria including volume (ICC = 0.87) and this was better than the agreement between the assessor and local investigator (ICC = 0.73). There were 526 patients with two scans available for analysis of change in volume measurement. The median percentage change in volume for the ES group was a reduction of 92.4% (IQR 75.6%, 99.0%) while for the ICT group, in which some cases crossed over to delayed surgery, it was only 5.7% (IQR 16.4% increase, 29.5% reduction). ES patients with almost complete removal (99-100%) had the best outcome with only 30% dead or lower severely disabled. For the ICT group outcome was related to the final volume: the smaller the final volume the better the outcome. CONCLUSIONS: This analysis provides evidence for central assessments of scans in exploratory analyses and further information regarding the potential advantage of early and more complete clot removal on outcome in ICH and should inform the planning of future trials.Clinical trials registration: ISRCTN22153967.

Lumbar disc disease: the effect of inversion on clinical symptoms and a comparison of the rate of surgery after inversion therapy with the rate of surgery in neurosurgery controls.

[Purpose] We have previously shown inversion therapy to be effective in a small prospective randomised controlled trial of patients with lumbar disc protrusions. Our purpose now was to measure symptoms and to compare the surgery rate following inversion for 85 participants with the surgery rate in 3 control groups. [Participants and Methods] Each of the 85 inverted participants acted as their own control for the "symptomatic" part of the study. In the "Need for surgery" part of the study, one control group was made up of similar patients with leg pain and sciatica who were referred to the same clinic in the same year. Two additional control groups were examined: the original control group from the pilot trial and the lumbar disc surgery waiting list patients. [Results] Inversion therapy relieved symptoms: there were improvements in the Visual Analogue Score, Roland Morris and Oswestry Disease indices and Health Utility Score compared with their pre-treatment status. Also, the 2 year surgery rate in the inversion participants in the registry (21%) was significantly lower than in the matched control group (39% at two years and 43% at four years). It was also lower than the surgery rate in the other 2 control groups. [Conclusion] Inversion therapy relieved symptoms and avoided surgery.

Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial.

BACKGROUND: Acute stroke due to supratentorial intracerebral haemorrhage is associated with high morbidity and mortality. Open craniotomy haematoma evacuation has not been found to have any benefit in large randomised trials. We assessed whether minimally invasive catheter evacuation followed by thrombolysis (MISTIE), with the aim of decreasing clot size to 15 mL or less, would improve functional outcome in patients with intracerebral haemorrhage. METHODS: MISTIE III was an open-label, blinded endpoint, phase 3 trial done at 78 hospitals in the USA, Canada, Europe, Australia, and Asia. We enrolled patients aged 18 years or older with spontaneous, non-traumatic, supratentorial intracerebral haemorrhage of 30 mL or more. We used a computer-generated number sequence with a block size of four or six to centrally randomise patients to image-guided MISTIE treatment (1·0 mg alteplase every 8 h for up to nine doses) or standard medical care. Primary outcome was good functional outcome, defined as the proportion of patients who achieved a modified Rankin Scale (mRS) score of 0-3 at 365 days, adjusted for group differences in prespecified baseline covariates (stability intracerebral haemorrhage size, age, Glasgow Coma Scale, stability intraventricular haemorrhage size, and clot location). Analysis of the primary efficacy outcome was done in the modified intention-to-treat (mITT) population, which included all eligible, randomly assigned patients who were exposed to treatment. All randomly assigned patients were included in the safety analysis. This study is registered with ClinicalTrials.gov, number NCT01827046. FINDINGS: Between Dec 30, 2013, and Aug 15, 2017, 506 patients were randomly allocated: 255 (50%) to the MISTIE group and 251 (50%) to standard medical care. 499 patients (n=250 in the MISTIE group; n=249 in the standard medical care group) received treatment and were included in the mITT analysis set. The mITT primary adjusted efficacy analysis estimated that 45% of patients in the MISTIE group and 41% patients in the standard medical care group had achieved an mRS score of 0-3 at 365 days (adjusted risk difference 4% [95% CI -4 to 12]; p=0·33). Sensitivity analyses of 365-day mRS using generalised ordered logistic regression models adjusted for baseline variables showed that the estimated odds ratios comparing MISTIE with standard medical care for mRS scores higher than 5 versus 5 or less, higher than 4 versus 4 or less, higher than 3 versus 3 or less, and higher than 2 versus 2 or less were 0·60 (p=0·03), 0·84 (p=0·42), 0·87 (p=0·49), and 0·82 (p=0·44), respectively. At 7 days, two (1%) of 255 patients in the MISTIE group and ten (4%) of 251 patients in the standard medical care group had died (p=0·02) and at 30 days, 24 (9%) patients in the MISTIE group and 37 (15%) patients in the standard medical care group had died (p=0·07). The number of patients with symptomatic bleeding and brain bacterial infections was similar between the MISTIE and standard medical care groups (six [2%] of 255 patients vs three [1%] of 251 patients; p=0·33 for symptomatic bleeding; two [1%] of 255 patients vs 0 [0%] of 251 patients; p=0·16 for brain bacterial infections). At 30 days, 76 (30%) of 255 patients in the MISTIE group and 84 (33%) of 251 patients in the standard medical care group had one or more serious adverse event, and the difference in number of serious adverse events between the groups was statistically significant (p=0·012). INTERPRETATION: For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons. FUNDING: National Institute of Neurological Disorders and Stroke and Genentech.

Surgical Decision Making in Brain Hemorrhage.

Background and Purpose- The STICH (Surgical Trial in Lobar Intracerebral Haemorrhage) I and II trials randomized patients with spontaneous intracerebral hemorrhage (ICH) to early surgery or initial conservative treatment. Both were nonsignificant; possibly because surgery has minimal effect on recovery, or because surgery benefits some and harms others. We introduce a new nonparametric method of analysis. The method is then applied to data from a third trial, STITCH(Trauma) (Surgical Trial in Traumatic Intracerebral Haemorrhage), which addressed a similar surgical question in head-injured patients. Methods- Data from 1541 patients from the STICH trials were analyzed using (1) standard meta-analysis of prognosis-based dichotomized outcome and prespecified standard subgroups of Glasgow Coma Scale (GCS): 3-8, 9-12, and 13-15; (2) new nonparametric regression of ranked Extended Glasgow Outcome Scale against ranked GCS and ranked volume; and (3) analysis (1) repeated using categories identified by analysis (2). Results- Standard meta-analysis showed more favorable outcomes, although nonsignificant, with surgery if presenting GCS was 9-12 (spontaneous ICH odds ratio, 0.70 [95% CI, 0.48-1.03; P=0.07]; traumatic odds ratio, 0.48 [95% CI, 0.18-1.26; P=0.14]). Ranked analysis showed a similar pattern of results for both spontaneous and traumatic ICH. Surgery was harmful for small lesions with increasing benefit for larger volumes. With GCS, surgery had little effect at either ends of the spectrum but suggested a beneficial effect in the range 10 to 13 (identified graphically). Repeating the meta-analysis with this categorization showed significant benefit for surgery (spontaneous odds ratio, 0.71 [95% CI, 0.51-1.00; P=0.05]; traumatic odds ratio, 0.16 [95% CI, 0.05-0.51; P=0.002]). Conclusions- The nonsignificant results observed in the STICH trials are because of mixing patients who benefit from surgery with those who are harmed. Patients with a GCS 10-13 or a large ICH are likely to benefit from surgery. Our analysis showed a similar effect on traumatic ICH/contusion data and promises to be a valuable tool. Clinical Trial Registration- URL: http://www.isrctn.com/ . Unique identifiers: ISRCTN19976990 (STITCH), ISRCTN22153967 (STICH II), and ISRCTN19321911 (STITCH[Trauma]).

Retrospective Methods Analysis of Semiautomated Intracerebral Hemorrhage Volume Quantification From a Selection of the STICH II Cohort (Early Surgery Versus Initial Conservative Treatment in Patients With Spontaneous Supratentorial Lobar Intracerebral Haematomas).

BACKGROUND AND PURPOSE: The ABC/2 method for calculating intracerebral hemorrhage (ICH) volume has been well validated. However, the formula, derived from the volume of an ellipse, assumes the shape of ICH is elliptical. We sought to compare the agreement of the ABC/2 formula with other methods through retrospective analysis of a selection of the STICH II cohort (Early Surgery Versus Initial Conservative Treatment in Patients With Spontaneous Supratentorial Lobar Intracerebral Haematomas). METHODS: From 390 patients, 739 scans were selected from the STICH II image archive based on the availability of a CT scan compatible with OsiriX DICOM viewer. ICH volumes were calculated by the reference standard semiautomatic segmentation in OsiriX software and compared with calculated arithmetic methods (ABC/2, ABC/2.4, ABC/3, and 2/3SC) volumes. Volumes were compared by difference plots for specific groups: randomization ICH (n=374), 3- to 7-day postsurgical ICH (n=206), antithrombotic-associated ICH (n=79), irregular-shape ICH (n=703) and irregular-density ICH (n=650). Density and shape were measured by the Barras ordinal shape and density groups (1-5). RESULTS: The ABC/2.4 method had the closest agreement to the semiautomatic segmentation volume in all groups, except for the 3- to 7-day postsurgical ICH group where the ABC/3 method was superior. CONCLUSIONS: Although the ABC/2 formula for calculating elliptical ICH is well validated, it must be used with caution in ICH scans where the elliptical shape of ICH is a false assumption. We validated the adjustment of the ABC/2.4 method in randomization, antithrombotic-associated, heterogeneous-density, and irregular-shape ICH. CLINICAL TRIAL REGISTRATION: URL: http://www.isrctn.com/ISRCTN22153967. Unique identifier: ISRCTN22153967.

Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial.

BACKGROUND: Intraventricular haemorrhage is a subtype of intracerebral haemorrhage, with 50% mortality and serious disability for survivors. We aimed to test whether attempting to remove intraventricular haemorrhage with alteplase versus saline irrigation improved functional outcome. METHODS: In this randomised, double-blinded, placebo-controlled, multiregional trial (CLEAR III), participants with a routinely placed extraventricular drain, in the intensive care unit with stable, non-traumatic intracerebral haemorrhage volume less than 30 mL, intraventricular haemorrhage obstructing the 3rd or 4th ventricles, and no underlying pathology were adaptively randomly assigned (1:1), via a web-based system to receive up to 12 doses, 8 h apart of 1 mg of alteplase or 0·9% saline via the extraventricular drain. The treating physician, clinical research staff, and participants were masked to treatment assignment. CT scans were obtained every 24 h throughout dosing. The primary efficacy outcome was good functional outcome, defined as a modified Rankin Scale score (mRS) of 3 or less at 180 days per central adjudication by blinded evaluators. This study is registered with ClinicalTrials.gov, NCT00784134. FINDINGS: Between Sept 18, 2009, and Jan 13, 2015, 500 patients were randomised: 249 to the alteplase group and 251 to the saline group. 180-day follow-up data were available for analysis from 246 of 249 participants in the alteplase group and 245 of 251 participants in the placebo group. The primary efficacy outcome was similar in each group (good outcome in alteplase group 48% vs saline 45%; risk ratio [RR] 1·06 [95% CI 0·88-1·28; p=0·554]). A difference of 3·5% (RR 1·08 [95% CI 0·90-1·29], p=0·420) was found after adjustment for intraventricular haemorrhage size and thalamic intracerebral haemorrhage. At 180 days, the treatment group had lower case fatality (46 [18%] vs saline 73 [29%], hazard ratio 0·60 [95% CI 0·41-0·86], p=0·006), but a greater proportion with mRS 5 (42 [17%] vs 21 [9%]; RR 1·99 [95% CI 1·22-3·26], p=0·007). Ventriculitis (17 [7%] alteplase vs 31 [12%] saline; RR 0·55 [95% CI 0·31-0·97], p=0·048) and serious adverse events (114 [46%] alteplase vs 151 [60%] saline; RR 0·76 [95% CI 0·64-0·90], p=0·002) were less frequent with alteplase treatment. Symptomatic bleeding (six [2%] in the alteplase group vs five [2%] in the saline group; RR 1·21 [95% CI 0·37-3·91], p=0·771) was similar. INTERPRETATION: In patients with intraventricular haemorrhage and a routine extraventricular drain, irrigation with alteplase did not substantially improve functional outcomes at the mRS 3 cutoff compared with irrigation with saline. Protocol-based use of alteplase with extraventricular drain seems safe. Future investigation is needed to determine whether a greater frequency of complete intraventricular haemorrhage removal via alteplase produces gains in functional status. FUNDING: National Institute of Neurological Disorders and Stroke.

Spinal meningioma: relationship between degree of cord compression and outcome.

BACKGROUND: The aim of this study was to find the relationships between the degree of cord compression as seen on MRIs with persisting cord atrophy after decompression and patient outcomes in spinal meningiomas. METHOD: We undertook a retrospective analysis of 31 patients' pre- and postoperative MRIs, preoperative functional status and their outcomes at follow-up. The following metrics were analysed; percentage cord area at maximum compression, percentage tumour occupancy and percentage cord occupancy. These were then compared with outcome as measured by the Nurick scale. RESULTS: Of the 31 patients, 27 (87%) had thoracic meningiomas, 3 (10%) cervical and 1 (3%) cervicothoracic. The meningiomas were pathologically classified as grade 1 (29) or grade 2 (2) according to the WHO classification. The average remaining cord cross-sectional area was 61% of the estimated original value. The average tumour occupancy of the canal was 72%. The average cord occupancy of the spinal canal at maximum compression was 20%. No correlation between cord cross-section area and Nurick Scale was seen. On the postoperative scan, the average cord area had increased to 84%. No correlation was seen between this value and outcome. CONCLUSION: We found that cross-section area measurements on MRI scans have no obvious relationship with function before or after surgery. This is a base for future research into the mechanism of cord recovery and other compressive cord conditions.

Attitudes in 2013 to Monitoring Intracranial Pressure for Traumatic Intracerebral Haemorrhage.

INTRODUCTION: Recent research has been equivocal regarding the usefulness of intracranial pressure (ICP) monitoring for traumatic intracerebral haemorrhage (ICH). We aimed to investigate attitudes of clinicians from as wide an international audience as possible. MATERIALS AND METHODS: A SurveyMonkey® questionnaire was distributed to individuals, including members of the Society of British Neurological Surgeons, the European Brain Injury Consortium, the Euroacademia Multidisciplinaria Neurotraumatologica and the neurotrauma committee of the World Federation of Neurosurgical Societies. RESULTS: Ninety-eight participants from at least 25 different countries completed the survey (86 surgeons). ICP was routinely monitored by 76 % and would be monitored by 5 % more if they had equipment. ICP monitoring was valued (0 = not at all important, 10 = critically important) as 10 by 21 % (median = 8; Q1 = 7, Q3 = 9). Responders were aware of 16 trials that investigated the value of ICP monitoring in neurotrauma, including BEST TRIP (n = 35), Rescue ICP (n = 13) and DECRA (n = 8). Other results are discussed. DISCUSSION: Despite equivocation in the literature, we found that ICP monitoring continues to be routinely performed and is highly valued. Interestingly, only 36 % of responders were aware of the BEST TRIP trial, which found no difference in outcome between patients with a head injury managed with or without ICP monitoring.

Decompressive craniectomy following traumatic brain injury: developing the evidence base.

In the context of traumatic brain injury (TBI), decompressive craniectomy (DC) is used as part of tiered therapeutic protocols for patients with intracranial hypertension (secondary or protocol-driven DC). In addition, the bone flap can be left out when evacuating a mass lesion, usually an acute subdural haematoma (ASDH), in the acute phase (primary DC). Even though, the principle of "opening the skull" in order to control brain oedema and raised intracranial pressure has been practised since the beginning of the 20th century, the last 20 years have been marked by efforts to develop the evidence base with the conduct of randomised trials. This article discusses the merits and challenges of this approach and provides an overview of randomised trials of DC following TBI. An update on the RESCUEicp study, a randomised trial of DC versus advanced medical management (including barbiturates) for severe and refractory post-traumatic intracranial hypertension is provided. In addition, the rationale for the RESCUE-ASDH study, the first randomised trial of primary DC versus craniotomy for adult head-injured patients with an ASDH, is presented.

Characteristics of traumatic intracerebral haemorrhage: An assessment of screening logs from the STITCH(Trauma) Trial.

INTRODUCTION: In undertaking international neurosurgical trials it is useful to understand international patient demographics and potential patient populations that study results will apply to. The STITCH(Trauma) trial included 59 centres from 20 countries, which were requested to screen all patients with traumatic intracerebral haemorrhage. This paper reviews these data. MATERIALS AND METHODS: Demographic, clinical and exclusion reason data were analysed. Comparisons were made between patients who were included in the trial and patients who were potentially eligible (but not included in the trial) and patients who were not potentially eligible. RESULTS: Screening evidence was returned for 1735 patients, 11% of these may potentially have been eligible, of whom 52% were not included because consent could not be gained. By country, median age per centre ranged from 26 years (Egypt) to 67 years (Germany), median time from injury to screening ranged from 5 h (Germany and Nepal) to 16 h (India), median intracerebral haemorrhage (ICH) volume ranged from 5 ml (Germany) to 30 ml (China), the proportion of male patients ranged from 56% (Egypt) to 91% (Canada) and the proportion of patients with both pupils reactive ranged from 68% (China) to 98% (Nepal). The most common exclusion reasons were ICH volume < 10 ml (49%) and presence of subdural haemorrhage/extradural haemorrhage or SDH/EDH requiring surgery (20%). CONCLUSION: Data presented here including international patient demographics and reasons for patient ineligibility will be useful for future traumatic ICH studies.

Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial.

BACKGROUND: The balance of risk and benefit from early neurosurgical intervention for conscious patients with superficial lobar intracerebral haemorrhage of 10-100 mL and no intraventricular haemorrhage admitted within 48 h of ictus is unclear. We therefore tested the hypothesis that early surgery compared with initial conservative treatment could improve outcome in these patients. METHODS: In this international, parallel-group trial undertaken in 78 centres in 27 countries, we compared early surgical haematoma evacuation within 12 h of randomisation plus medical treatment with initial medical treatment alone (later evacuation was allowed if judged necessary). An automatic telephone and internet-based randomisation service was used to assign patients to surgery and initial conservative treatment in a 1:1 ratio. The trial was not masked. The primary outcome was a prognosis-based dichotomised (favourable or unfavourable) outcome of the 8 point Extended Glasgow Outcome Scale (GOSE) obtained by questionnaires posted to patients at 6 months. Analysis was by intention to treat. This trial is registered, number ISRCTN22153967. FINDINGS: 307 of 601 patients were randomly assigned to early surgery and 294 to initial conservative treatment; 298 and 291 were followed up at 6 months, respectively; and 297 and 286 were included in the analysis, respectively. 174 (59%) of 297 patients in the early surgery group had an unfavourable outcome versus 178 (62%) of 286 patients in the initial conservative treatment group (absolute difference 3·7% [95% CI -4·3 to 11·6], odds ratio 0·86 [0·62 to 1·20]; p=0·367). INTERPRETATION: The STICH II results confirm that early surgery does not increase the rate of death or disability at 6 months and might have a small but clinically relevant survival advantage for patients with spontaneous superficial intracerebral haemorrhage without intraventricular haemorrhage. FUNDING: UK Medical Research Council.

What does it take to deliver an international neurosurgical trial? Experiences from STICH II.

BACKGROUND AND PURPOSE: When undertaking multicentre randomised controlled trials some obstacles cause a slower than required recruitment rate. This article discusses factors that affected the completion of the international neurosurgical trial STICH II, which took almost 6 years. METHODS: We reviewed the following factors: recruitment of participating sites, patient recruitment, patient screening, trial fatigue and maintenance of profile and maintenance of quality and standards. We discuss the practical strategies employed by the STICH II team to address these factors and optimise patient recruitment. CONCLUSION: Although STICH II attained its final recruitment target, it took longer to complete than anticipated. Publishing and sharing the experiences of the STICH II trial team is an important step towards ensuring that other potential neurosurgical triallists are aware of the issues that can slow patient recruitment and strategies that can help to overcome them.

Attitudes to intracranial pressure monitoring of traumatic intracerebral haemorrhage.

INTRODUCTION: Recent research has been equivocal regarding the usefulness of intracranial pressure (ICP) monitoring for traumatic intracerebral haemorrhage (ICH). We aimed to investigate attitudes of clinicians from as wide an international audience as possible. MATERIALS AND METHODS: A SurveyMonkey(®) questionnaire was distributed to individuals, including members of the Society of British Neurological Surgeons, the European Brain Injury Consortium, the neurotrauma committee of the Euroacademia Multidisciplinaria Neurotraumatologica and the World Federation of Neurosurgical Societies. RESULTS: N = 98 completed the survey (surgeons n = 86) from at least 25 different countries. ICP was routinely monitored by 76% and would be monitored by 5% more if they had equipment. ICP monitoring was valued (0 = not at all important, 10 = critically important) as 10 by 21% (median = 8, Q1 = 7, Q3 = 9). Triggers to begin ICP monitoring included midline shift (n = 48), contusion (n = 47), ICH (n = 46), subdural haemorrhage (n = 42), Glasgow coma scale reduction of median 2 for eye, verbal or motor, and one reactive pupil (30%). Responders stated that intervention would begin for adults with an ICP median of 25 mmHg and for children 20 mmHg. Most favourable treatments of raised ICP included Mannitol and ventriculostomy, which were ranked as most favourable (out of 10) by n = 31 each. Responders claimed to be aware of 16 different trials that investigated the value of ICP monitoring in neurotrauma, including BEST TRIP (n = 35), Rescue ICP (n = 13) and DECRA (n = 8). CONCLUSION: ICP monitoring continues to be a highly valued and clinically desirable technique for managing traumatic ICH patients.

Proposal for a prospective multi-centre audit of chronic subdural haematoma management in the United Kingdom and Ireland.

BACKGROUND. Chronic subdural haematoma (CSDH) is a common condition that increases in incidence with rising age. Evacuation of a CSDH is one of the commonest neurosurgical procedures; however the optimal peri-operative management, surgical technique, post-operative care and the role of adjuvant therapies remain controversial. AIM. We propose a prospective multi-centre audit in order to establish current practices, outcomes and national benchmarks for future studies. METHODS. Neurosurgical units (NSU) in the United Kingdom and Ireland will be invited to enrol patients to this audit. All adult patients aged 16 years and over with a primary or recurrent CSDH will be eligible for inclusion. OUTCOME MEASURES AND ANALYSIS. The proposed outcome measures are (1) clinical recurrence requiring re-operation within 60 days; (2) modified Rankin scale (mRS) score at discharge from NSU; (3) morbidity and mortality in the NSU; (4) destination at discharge from NSU and (5) length of stay in the NSU. Audit standards have been derived from published systematic reviews and a recent randomised trial. The proposed standards are clinical recurrence rate < 20%; unfavourable mRS (4-6) at discharge from NSU < 30%; mortality rate in NSU < 5%; morbidity rate in NSU < 10%. Data will be submitted directly into a secure online database and analysed by the study's management group. CONCLUSIONS. The audit will determine the contemporary management and outcomes of patients with CSDH in the United Kingdom and Ireland. It will inform national guidelines, clinical practice and future studies in order to improve the outcome of patients with CSDH.

Cost-effectiveness of craniotomy versus decompressive craniectomy for UK patients with traumatic acute subdural haematoma.

OBJECTIVE: To estimate the cost-effectiveness of craniotomy, compared with decompressive craniectomy (DC) in UK patients undergoing evacuation of acute subdural haematoma (ASDH). DESIGN: Economic evaluation undertaken using health resource use and outcome data from the 12-month multicentre, pragmatic, parallel-group, randomised, Randomised Evaluation of Surgery with Craniectomy for Patients Undergoing Evacuation-ASDH trial. SETTING: UK secondary care. PARTICIPANTS: 248 UK patients undergoing surgery for traumatic ASDH were randomised to craniotomy (N=126) or DC (N=122). INTERVENTIONS: Surgical evacuation via craniotomy (bone flap replaced) or DC (bone flap left out with a view to replace later: cranioplasty surgery). MAIN OUTCOME MEASURES: In the base-case analysis, costs were estimated from a National Health Service and Personal Social Services perspective. Outcomes were assessed via the quality-adjusted life-years (QALY) derived from the EuroQoL 5-Dimension 5-Level questionnaire (cost-utility analysis) and the Extended Glasgow Outcome Scale (GOSE) (cost-effectiveness analysis). Multiple imputation and regression analyses were conducted to estimate the mean incremental cost and effect of craniotomy compared with DC. The most cost-effective option was selected, irrespective of the level of statistical significance as is argued by economists. RESULTS: In the cost-utility analysis, the mean incremental cost of craniotomy compared with DC was estimated to be -£5520 (95% CI -£18 060 to £7020) with a mean QALY gain of 0.093 (95% CI 0.029 to 0.156). In the cost-effectiveness analysis, the mean incremental cost was estimated to be -£4536 (95% CI -£17 374 to £8301) with an OR of 1.682 (95% CI 0.995 to 2.842) for a favourable outcome on the GOSE. CONCLUSIONS: In a UK population with traumatic ASDH, craniotomy was estimated to be cost-effective compared with DC: craniotomy was estimated to have a lower mean cost, higher mean QALY gain and higher probability of a more favourable outcome on the GOSE (though not all estimated differences between the two approaches were statistically significant). ETHICS: Ethical approval for the trial was obtained from the North West-Haydock Research Ethics Committee in the UK on 17 July 2014 (14/NW/1076). TRIAL REGISTRATION NUMBER: ISRCTN87370545.

Decompressive craniectomy as a second/third-tier intervention in traumatic brain injury: A multicenter observational study.

OBJECTIVES: RESCUEicp studied decompressive craniectomy (DC) applied as third-tier option in severe traumatic brain injury (TBI) patients in a randomized controlled setting and demonstrated a decrease in mortality with similar rates of favorable outcome in the DC group compared to the medical management group. In many centers, DC is being used in combination with other second/third-tier therapies. The aim of the present study is to investigate outcomes from DC in a prospective non-RCT context. METHODS: This is a prospective observational study of 2 patient cohorts: one from the University Hospitals Leuven (2008-2016) and one from the Brain-IT study, a European multicenter database (2003-2005). In thirty-seven patients with refractory elevated intracranial pressure who underwent DC as a second/third-tier intervention, patient, injury and management variables including physiological monitoring data and administration of thiopental were analysed, as well as Extended Glasgow Outcome score (GOSE) at 6 months. RESULTS: In the current cohorts, patients were older than in the surgical RESCUEicp cohort (mean 39.6 vs. 32.3; p < 0.001), had higher Glasgow Motor Score on admission (GMS < 3 in 24.3% vs. 53.0%; p = 0.003) and 37.8% received thiopental (vs. 9.4%; p < 0.001). Other variables were not significantly different. GOSE distribution was: death 24.3%; vegetative 2.7%; lower severe disability 10.8%; upper severe disability 13.5%; lower moderate disability 5.4%; upper moderate disability 2.7%, lower good recovery 35.1%; and upper good recovery 5.4%. The outcome was unfavorable in 51.4% and favorable in 48.6%, as opposed to 72.6% and 27.4% respectively in RESCUEicp (p = 0.02). CONCLUSION: Outcomes in DC patients from two prospective cohorts reflecting everyday practice were better than in RESCUEicp surgical patients. Mortality was similar, but fewer patients remained vegetative or severely disabled and more patients had a good recovery. Although patients were older and injury severity was lower, a potential partial explanation may be in the pragmatic use of DC in combination with other second/third-tier therapies in real-life cohorts. The findings underscore that DC maintains an important role in managing severe TBI.

Individual patient data subgroup meta-analysis of surgery for spontaneous supratentorial intracerebral hemorrhage.

BACKGROUND AND PURPOSE: By 2010 there had been 14 published trials of surgery for intracerebral hemorrhage reported in systematic reviews or to the authors, but the role and timing of operative intervention remain controversial and the practice continues to be haphazard. This study attempted to obtain individual patient data from each of the 13 studies published since 1985 to better define groups of patients that might benefit from surgery. METHODS: Authors of identified published articles were approached by mail, e-mail, and at conferences and invited to take part in the study. Data were obtained from 8 studies (2186 cases). Individual patient data included patient's age, Glasgow Coma Score at presentation, volume and site of hematoma, presence of intraventricular hemorrhage, method of evacuation, time to randomization, and outcome. RESULTS: Meta-analysis indicated that there was improved outcome with surgery if randomization was [corrected] undertaken within 8 hours of ictus (P=0.003), or the volume of the hematoma was 20 to 50 mL (P=0.004), or the Glasgow Coma Score was between 9 and 12 (P=0.0009), or the patient was aged between 50 and 69 years (P=0.01). In addition, there was some evidence that more superficial hematomas with no intraventricular hemorrhage might also benefit (P=0.09). CONCLUSIONS: There is evidence that surgery is of benefit if undertaken early before the patient deteriorates. This work identifies areas for further research. Ongoing studies in subgroups of patients such as the Surgical Trial in Lobar Intracerebral Hemorrhage (STICH II) will confirm whether these interpretations can be replicated.

Telephone logs of neurosurgery specialty trainees: a time study.

PURPOSE: With a constant debate on working hours and improved patient outcomes, time studies are crucial to obtain and analyse timelines and work components. This includes time spent on communication. The aim of this study was to assess the magnitude and patterns of telephone call episodes in the work schedule of neurosurgery trainees. METHODS: Logs of handheld telephone sets assigned to neurosurgery specialty trainees in a British regional neurosurgical centre were obtained from the hospital switchboard for a 6-month period. This formed the primary data. Ringtime was added to the talktime for outgoing calls. Monday to Friday, 8 am-5 pm was considered as regular hours and the rest as other hours. The outcome measures used were number and duration of telephone episodes (individual and collective) and the timing of these episodes. RESULTS: During the study period of 6 months, there were 12071 incoming calls and 10712 outgoing calls (total calls-22783). The maximum number of incoming calls/ day/ trainee was in the range of 39-78 while the range for outgoing calls was 36-102. On an average, the on-call trainee made and received 33 and 36 calls respectively in a 24-hour period (mean call duration was 1.7 minutes) which meant that a telephone call intruded into the schedule almost once every 21 minutes. Typically, the on-call trainee spent 138 minutes on the telephone (69 calls) in 24 hours, while on an off-call day it was significantly less at 25 minutes (18 calls). Of the calls, 67% happened out of regular hours. CONCLUSIONS: Time spent on the telephone is a significant work component and would have a bearing on timelines.