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The benefit of statins in patients with acute aneurysmal subarachnoid haemorrhage is unclear. We aimed to determine whether simvastatin 40 mg could improve the long-term outcome in patients with this disorder. In this international, multicentre, randomised, double-blind trial, we enrolled patients aged 18–65 years with confirmatory evidence of an aneurysmal subarachnoid haemorrhage and presenting less than 96 h from ictus from 35 acute neurosurgical centres in nine countries. Patients were randomly allocated (1:1) to receive either simvastatin 40 mg or placebo once a day for up to 21 days. We used a computer-generated randomisation code to randomise patients in every centre by blocks of ten (five simvastatin, five placebo). Participants and investigators were masked to treatment assignment. The primary outcome was the distribution of modified Rankin Scale (mRS) score obtained by questionnaire at 6 months. Analyses were done on the intention-to-treat population. This trial has been completed and is registered with Current Controlled Trials, number ISRCTN75948817. Between Jan 6, 2007, and Feb 1, 2013, apart from the period between May 15, 2009, and Feb 8, 2011, when recruitment was on hold, 803 patients were randomly assigned to receive either simvastatin 40 mg (n=391) or placebo (n=412). All patients were included in the intention-to-treat population. 782 (97%) patients had outcome data recorded at 6 months, of whom 560 (72%) were classed as having a favourable outcome, mRS 0–2 (271 patients in the simvastatin group vs 289 in the placebo group). The primary ordinal analysis of the mRS, adjusted for age and World Federation of Neurological Surgeons grade on admission, gave a common odds ratio (OR) of 0·97, 95% CI 0·75–1·25; p=0·803. At 6 months, we recorded 37 (10%) deaths in the simvastatin group compared with 35 (9%) in the placebo group (log-rank p=0·592). 70 (18%) serious adverse events were reported in the simvastatin group compared with 74 (18%) in the placebo group. No suspected unexpected serious adverse reactions were reported. The STASH trial did not detect any benefit in the use of simvastatin for long-term or short-term outcome in patients with aneurysmal subarachnoid haemorrhage. Despite demonstrating no safety concerns, we conclude that patients with subarachnoid haemorrhage should not be treated routinely with simvastatin during the acute stages. British Heart Foundation.

BACKGROUND:There remains a proportion of patients with unfavorable outcomes after aneurysmal subarachnoid hemorrhage, of particular relevance in those who present with a good clinical grade. A forewarning of those at risk provides an opportunity towards more intensive monitoring, investigation, and prophylactic treatment prior to the clinical manifestation of advancing cerebral injury. OBJECTIVE:To assess whether biochemical markers sampled in the first days after the initial hemorrhage can predict poor outcome. METHODS:All patients recruited to the multicenter Simvastatin in Aneurysmal Hemorrhage Trial (STASH) were included. Baseline biochemical profiles were taken between time of ictus and day 4 post ictus. The t-test compared outcomes, and a backwards stepwise binary logistic regression was used to determine the factors providing independent prediction of an unfavorable outcome. RESULTS:Baseline biochemical data were obtained in approximately 91% of cases from 803 patients. On admission, 73% of patients were good grade (World Federation of Neurological Surgeons grades 1 or 2); however, 84% had a Fisher grade 3 or 4 on computed tomographic scan. For patients presenting with good grade on admission, higher levels of C-reactive protein, glucose, and white blood cells and lower levels of hematocrit, albumin, and hemoglobin were associated with poor outcome at discharge. C-reactive protein was found to be an independent predictor of outcome for patients presenting in good grade. CONCLUSION:Early recording of C-reactive protein may prove useful in detecting those good grade patients who are at greater risk of clinical deterioration and poor outcome. ABBREVIATIONS:ALP, alkaline phosphataseALT, alanine aminotransferaseCK, creatine kinaseCRP, C-reactive proteinEVD, external ventricular drainageICH GCP, International Conference on Harmonisation guidelines for good clinical practicemRS, modified Rankin ScaleSAH, subarachnoid hemorrhageSTASH, Simvastatin in Aneurysmal Subarachnoid Hemorrhage TrialWBC, white blood cellsWFNS, World Federation of Neurological Surgeons

The plethora of studies in chronic subdural hematoma (CSDH) has not resulted in the development of an evidence-based treatment strategy, largely due to heterogeneous outcome measures that preclude cross-study comparisons and guideline development. This study aimed to identify and quantify the heterogeneity of outcome measures reported in the CSDH literature and to build a case for the development of a consensus-based core outcome set. This systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and was registered with the PROSPERO international prospective register of systematic reviews (CRD42014007266). All full-text English language studies with >10 patients (prospective) or >100 patients (retrospective) published after 1990 examining clinical outcomes in CSDH were eligible for inclusion. One hundred two eligible studies were found. There were 14 (13.7%) randomized controlled trials, one single arm trial (1.0%), 25 (24.5%) cohort comparison studies, and 62 (60.8%) prospective or retrospective cohort studies. Outcome domains reported by the studies included mortality (63.8% of included studies), recurrence (94.1%), complications (48.0%), functional outcomes (40.2%), and radiological (38.2%) outcomes. There was significant heterogeneity in the definitions of the outcome measures, as evidenced by the seven different definitions of the term “recurrence,” with no definition given in 19 studies. The time-points of assessment for all the outcome domains varied greatly from inpatient/hospital discharge to 18 months. This study establishes and quantifies the heterogeneity of outcome measure reporting in CSDH and builds the case for the development of a robust consensus-based core outcome set for future studies to adhere to as part of the Core Outcomes and Common Data Elements in CSDH (CODE-CSDH) project.

Patients with post-subarachnoid haemorrhage hydrocephalus and progressive cognitive decline in the weeks after a subarachnoid haemorrhage are rare.1 Prolonged therapy with simvastatin is, therefore, unlikely to yield a difference in outcome when compared with the results of the STASH trial, with respect to cognition or otherwise.

Background The incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the 6-month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate. Methods and design Dex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a 2-week course of dexamethasone following a CSDH. Seven hundred fifty patients were randomised to either dexamethasone or placebo. The primary outcome is the modified Rankin Scale at 6 months which is dichotomised to favourable (a score of 0–3) versus unfavourable (a score of 4–6). Conclusions This paper and the accompanying additional material describe the statistical analysis plan for the trial. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810 . EudraCT, 2014-004948-35. Registered on 20 March 2015.

Core outcome sets (COSs) are important and necessary as they help standardize reporting in research studies. Cranioplasty following traumatic brain injury (TBI) or stroke is becoming increasingly common, leading to an ever-growing clinical and research interest, especially regarding the optimal material, cost-effectiveness, and timing of cranioplasty concerning neurological recovery and complications. Consequently, heterogeneous reporting of outcomes from such diverse studies has led to limited meta-analysis ability and an ongoing risk of outcome reporting bias. This study aims to define a standardized COS for reporting in all future TBI and stroke cranioplasty studies. This study has four aims: (1) undertake a systematic review to collate the most current outcome measures used within the cranioplasty literature; (2) undertake a qualitative study to understand better the views of clinicians, patients' relatives, and allied health professionals regarding clinical outcomes following cranioplasty; (3) undertake a Delphi survey as part of the process of gaining consensus for the COS; and (4) finalize consensus through a consensus meeting resulting in the COS. An international steering committee has been formed to guide the development of the COS. In addition, recommendations from other clinical initiatives such as COMET (Core Outcomes and Effectiveness Trials) and OMERACT (Outcome Measures in Rheumatology) have been adhered to. Phase 1 is data collection through a systematic review and qualitative study. Phase 2 is the COS development through a Delphi survey and consensus meetings with consensus definitions decided and agreed upon before the Delphi survey begins to avoid bias. Phase 1 started at the end of 2019, following ethical approval in December 2019, and the project completion date is planned for the end of 2022 or beginning of 2023. This study should result in a consensus on a COS for cranioplasty, following TBI or stroke, to help standardize outcome reporting for future studies, which can be applied to future research and clinical services, help align future studies, build an increased understanding of cranioplasty and its impact on a patient's function and recovery, and help standardize the evidence base. DERR1-10.2196/37442.

Abstract INTRODUCTION: Prevention of cerebral vasospasm is the target of modern drug therapy, candidates of which include statins. The results of phase 11 studies have shown promise in this arena. STASH is an international multicentre randomised controlled phase 111 trial designed to assess the effects of Simvastatin 40 mg on the long and short term outcome of patients who have suffered from an acute aneurysmal subarachnoid haemorrhage (SAH). METHODS: All grades of SAH patients with a radiological proven aneurysm were eligible. Patients were randomized to receive Simvastatin 40 mg or placebo for up to 21 days. Primary outcome was the modified Rankin Disability Score (mRS) at 6 months. Secondary outcome measures included the SF-36 short form questionnaire at 6 months, the incidence and duration of delayed ischemic deficit (DID) and associated rescue therapy, the incidence and severity of sepsis, length of intensive care and total acute hospital stay, and discharge destination. Primary analysis was an ordinal regression of the mRS following the intention to treat (ITT) principle. RESULTS: Eight hundred three patients (252 male, 551 female) were recruited with mean age 50 years (range 21 67). Six hundred seventy-six (85%) from UK centres and 127 (15%) from non-UK centres. Five hundred eighty-eight patients (73%) were WFNS grade 1-2 on admission and 84% had a CT scan Fisher Grade 3 or 4. Five hundred fifteen patients (64%) were coiled. 6 month outcome data is available for 782 (97%) of which 560 (72%) were mRS 0-2 at 6 months. DID was confirmed in 131 (16.3%), and the overall mortality at 6 months was 9% (n = 72). Mean length of hospital stay was 20 days and ITU stay 12 days. Four hundred seventy-one (59%) were discharged directly home and 102 (13%) were discharged to rehabilitation centres. CONCLUSION: Primary outcome, secondary outcome measures and subgroup analyses will be presented from the ITT population.

Most of today's 1.7 million women veterans obtain all or most of their medical care outside the VA health care system, where their veteran status is rarely recognized or acknowledged. Several aspects of women's military service have been associated with adverse psychologic and physical outcomes, and failure to assess women's veteran status, their deployment status, and military trauma history could delay identifying or treating such conditions. Yet few clinicians know of women's military history--or of military service's impact on women's subsequent health and well being. Because an individual's military service may be best understood within the historical context in which it occurred, we provide a focused historical overview of women's military contributions and their steady integration into the Armed Forces since the War for Independence. We then describe some of the medical and psychiatric conditions associated with military service.

After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled.After publication of the original article [1], the authors notified that that one of the BNTRC institutional collaborator names was misspelled.