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.

Model-based economic evaluation of the effectiveness of "'Hypos' can strike twice", a leaflet-based ambulance clinician referral intervention to prevent recurrent hypoglycaemia.

"'Hypos' can strike twice" (HS2) is a pragmatic, leaflet-based referral intervention designed for administration by clinicians of the emergency medical services (EMS) to people they have attended and successfully treated for hypoglycaemia. Its main purpose is to encourage the recipient to engage with their general practitioner or diabetic nurse in order that improvements in medical management of their diabetes may be made, thereby reducing their risk of recurrent hypoglycaemia. Herein we build a de novo economic model for purposes of incremental analyses to compare, in 2018-19 prices, HS2 against standard care for recurrent hypoglycaemia in the fortnight following the initial attack from the perspective of the UK National Health Service (NHS). We found that per patient NHS costs incurred by people receiving the HS2 intervention over the fortnight following an initial hypoglycaemia average £49.79, and under standard care costs average £40.50. Target patient benefit assessed over that same period finds the probability of no recurrence of hypoglycaemia averaging 42.4% under HS2 and 39.4% under standard care, a 7.6% reduction in relative risk. We find that implementing HS2 will cost the NHS an additional £309.36 per episode of recurrent hypoglycaemia avoided. Contrary to the favourable support offered in Botan et al., we conclude that in its current form the HS2 intervention is not a cost-effective use of NHS resources when compared to standard NHS care in reducing the risk of hypoglycaemia recurring within a fortnight of an initial attack that was resolved at-scene by EMS ambulance clinicians.

"It's like a swan, all nice and serene on top, and paddling like hell underneath": community first responders' practices in attending patients and contributions to rapid emergency response in rural England, United Kingdom-a qualitative interview study.

BACKGROUND: Community First Responder (CFR) schemes are a long-established service supplementing ambulance trusts in their local community in the United Kingdom. CFRs are community members who volunteer to respond to people with life-threatening conditions. Previous studies highlighted the motivations for becoming CFRs, their training, community (un)awareness and implications of their work on themselves and others. The practices of CFRs in prehospital care remain underexplored. Therefore, we aimed to explore real-world practice of Community First Responders and their contribution to prehospital emergency care. METHODS: We conducted 47 interviews with CFRs (21), CFR leads (15), ambulance clinicians (4), commissioners (2) and patients and relatives (5) from six ambulance services and regions of England, United Kingdom. Thematic analysis enabled identification of themes and subthemes, with subsequent interpretation built on the theory of practice wisdom. RESULTS: Our analysis revealed the embeddedness of the concept of doing the right thing at the right time in CFR practice. CFRs' work consisted of a series of sequential and interconnected activities which included: identifying patients' signs, symptoms and problems; information sharing with the ambulance control room on the patient's condition; providing a rapid emergency response including assessment and care; and engaging with ambulance clinicians for patient transfer. The patient care sequence began with recognising patients' signs and symptoms, and validation of patient information provided by the ambulance control room. The CFRs shared patient information with ambulance control who in turn notified the ambulance crew en-route. The practices of CFRs also included delivery of emergency care before ambulance clinicians arrived. Following the delivery of a rapid emergency response, CFRs engaged with the ambulance crew to facilitate patient transfer to the nearest medical facility. CONCLUSION: The sequential CFR practices supported ambulance services in delivering prehospital and emergency care in rural areas. CFR practices were founded on the principle of practice wisdom where CFRs constructed their practice decisions based on the patient's condition, their training, availability of equipment and medications and their scope of practice.

Community First Responders' Contribution to Emergency Medical Service Provision in the United Kingdom.

STUDY OBJECTIVE: We aimed to investigate community first responders' contribution to emergency care provision in terms of number, rate, type, and location of calls and characteristics of patients attended. METHODS: We used a retrospective observational design analyzing routine data from electronic clinical records from 6 of 10 ambulance services in the United Kingdom during 2019. Descriptive statistics, including numbers and frequencies, were used to illustrate characteristics of incidents and patients that the community first responders attended first in both rural and urban areas. RESULTS: The data included 4.5 million incidents during 1 year. The community first responders first attended a higher proportion of calls in rural areas compared with those in urban areas (3.90% versus 1.48 %). In rural areas, the community first responders also first attended a higher percentage of the most urgent call categories, 1 and 2. The community first responders first attended more than 9% of the total number of category 1 calls and almost 5% of category 2 calls. The community first responders also attended a higher percentage of the total number of cardiorespiratory and neurological/endocrine conditions. They first attended 6.5% of the total number of neurological/endocrine conditions and 5.9% of the total number of cardiorespiratory conditions. Regarding arrival times in rural areas, the community first responders attended higher percentages (more than 6%) of the total number of calls that had arrival times of less than 7 minutes or more than 60 minutes. CONCLUSION: In the United Kingdom, community first responders contribute to the delivery of emergency medical services, particularly in rural areas and especially for more urgent calls. The work of community first responders has expanded from their original purpose-to attend to out-of-hospital cardiac arrests. The future development of community first responders' schemes should prioritize training for a range of conditions, and further research is needed to explore the contribution and potential future role of the community first responders from the perspective of service users, community first responders' schemes, ambulance services, and commissioners.

Strengthening Mental Abilities with Relational Training (SMART) in multiple sclerosis (MS): study protocol for a feasibility randomised controlled trial.

BACKGROUND: Multiple sclerosis (MS) is a chronic condition of the central nervous system, affecting around 1 in every 600 people in the UK, with 130 new diagnoses every week. Cognitive difficulties are common amongst people with MS, with up to 70% experiencing deficits in higher-level brain functions-such as planning and problem-solving, attention, and memory. Cognitive deficits make it difficult for people with MS to complete everyday tasks and limit their abilities to work, socialise, and live independently. There is a clear need-and recognised research priority-for treatments that can improve cognitive functioning in people with MS. The absence of effective cognitive interventions exacerbates burdens on the services accessed by people with MS-requiring these services to manage sequelae of untreated cognitive deficits, including reduced quality of life, greater disability and dependence, and poorer adherence to disease-modifying treatments. Our planned research will fill the evidence gap through developing-and examining the feasibility of trialling-a novel online cognitive rehabilitation programme for people with MS (SMART). The SMART programme directly trains relational skills (the ability to flexibly relate concepts to one another) based on theory that these skills are critical to broader cognitive functioning. METHODS: The primary objective of this study aims to conduct a feasibility study to inform the development of a definitive trial of SMART for improving cognitive functioning in people with MS. The secondary objective is to develop the framework for a cost-effectiveness analysis alongside a definitive trial, and the exploratory objective is to assess the signal of efficacy. DISCUSSION: As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial-and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation-improving service delivery and optimising support with limited additional resources. TRIAL REGISTRATION: Registration ID: ClnicalTrials.gov: NCT04975685-registered on July 23rd, 2021. PROTOCOL VERSION: 2.0, 25 November 2021.

Can dog-assisted and relaxation interventions boost spatial ability in children with and without special educational needs? A longitudinal, randomized controlled trial.

Children's spatial cognition abilities are a vital part of their learning and cognitive development, and important for their problem-solving capabilities, the development of mathematical skills and progress in Science, Technology, Engineering and Maths (STEM) topics. As many children have difficulties with STEM topic areas, and as these topics have suffered a decline in uptake in students, it is worthwhile to find out how learning and performance can be enhanced at an early age. The current study is the first to investigate if dog-assisted and relaxation interventions can improve spatial abilities in school children. It makes a novel contribution to empirical research by measuring longitudinally if an Animal-Assisted Intervention (AAI) or relaxation intervention can boost children's development of spatial abilities. Randomized controlled trials were employed over time including dog intervention, relaxation intervention and no treatment control groups. Interventions were carried out over 4 weeks, twice a week for 20 min. Children were tested in mainstream schools (N = 105) and in special educational needs (SEN) schools (N = 64) before and after interventions, after 6 weeks, 6 months and 1 year. To assess intervention type and to provide advice for subsequent best practice recommendations, dog-assisted interventions were run as individual or small group interventions. Overall, children's spatial abilities improved over the year with highest increases in the first 4 months. In Study 1, typically developing children showed higher scores and more continuous learning overall compared to children with special educational needs. Children in the dog intervention group showed higher spatial ability scores immediately after interventions and after a further 6 weeks (short-term). Children in the relaxation group also showed improved scores short-term after relaxation intervention. In contrast, the no treatment control group did not improve significantly. No long-term effects were observed. Interestingly, no gender differences could be observed in mainstream school children's spatial skills. In study 2, children in SEN schools saw immediate improvements in spatial abilities after relaxation intervention sessions. No changes were seen after dog interventions or in the no treatment control group. Participants' pet ownership status did not have an effect in either cohort. These are the first findings showing that AAI and relaxation interventions benefit children's spatial abilities in varied educational settings. This research represents an original contribution to Developmental Psychology and to the field of Human-Animal Interaction (HAI) and is an important step towards further in-depth investigation of how AAI and relaxation interventions can help children achieve their learning potential, both in mainstream schools and in schools for SEN.

Evaluation of the effectiveness and costs of inhaled methoxyflurane versus usual analgesia for prehospital injury and trauma: non-randomised clinical study.

BACKGROUND: We aimed to investigate clinical benefits and economic costs of inhaled methoxyflurane when used by ambulance staff for prehospital emergency patients with trauma. Comparison is to usual analgesic practice (UAP) in the UK in which patient records were selected if treatment had been with Entonox® or intravenous morphine or intravenous paracetamol. METHODS: Over a 12-month evaluation period, verbal numerical pain scores (VNPS) were gathered from adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with methoxyflurane. Control VNPS were obtained from ambulance database records of UAP in similar patients for the same period. Statistical modelling enabled comparisons of methoxyflurane to UAP, where we employed an Ordered Probit panel regression model for pain, linked by observational rules to VNPS. RESULTS: Overall, 96 trained paramedics and technicians from the East Midlands Ambulance Service NHS Trust (EMAS) prepared 510 doses of methoxyflurane for administration to a total of 483 patients. Comparison data extracted from the EMAS database of UAP episodes involved: 753 patients using Entonox®, 802 patients using intravenous morphine, and 278 patients using intravenous paracetamol. Modelling results included demonstration of faster pain relief with inhaled methoxyflurane (all p-values < 0.001). Methoxyflurane's time to achieve maximum pain relief was estimated to be significantly shorter: 26.4 min (95%CI 25.0-27.8) versus Entonox® 44.4 min (95%CI 39.5-49.3); 26.5 min (95%CI 25.0-27.9) versus intravenous morphine 41.8 min (95%CI 38.9-44.7); 26.5 min (95%CI 25.1-28.0) versus intravenous paracetamol 40.8 (95%CI 34.7-46.9). Scenario analyses showed that durations spent in severe pain were significantly less for methoxyflurane. Costing scenarios showed the added benefits of methoxyflurane were achieved at higher cost, eg versus Entonox® the additional cost per treated patient was estimated to be £12.30. CONCLUSION: When administered to adults with moderate or severe pain due to trauma inhaled methoxyflurane reduced pain more rapidly and to a greater extent than Entonox® and parenteral analgesics. Inclusion of inhaled methoxyflurane to the suite of prehospital analgesics provides a clinically useful addition, but one that is costlier per treated patient.

Can dogs reduce stress levels in school children? effects of dog-assisted interventions on salivary cortisol in children with and without special educational needs using randomized controlled trials.

Prolonged or excessive stress negatively affects learning, behavior and health across the lifespan. To alleviate adverse effects of stress in school children, stressors should be reduced, and support and effective interventions provided. Animal-assisted interventions (AAI) have shown beneficial effects on health and wellbeing, however, robust knowledge on stress mediation in children is lacking. Despite this, AAIs are increasingly employed in settings world-wide, including schools, to reduce stress and support learning and wellbeing. This study is the first randomized controlled trial to investigate dog-assisted interventions as a mediator of stress in school children with and without special educational needs (SEN) over the school term. Interventions were carried out individually and in small groups twice a week for 20 minutes over the course of 4 weeks. We compared physiological changes in salivary cortisol in a dog intervention group with a relaxation intervention group and a no treatment control group. We compared cortisol level means before and after the 4 weeks of interventions in all children as well as acute cortisol in mainstream school children. Dog interventions lead to significantly lower stress in children with and without special educational needs compared to their peers in relaxation or no treatment control groups. In neurotypical children, those in the dog interventions showed no baseline stress level increases over the school term. In addition, acute cortisol levels evidenced significant stress reduction following the interventions. In contrast, the no treatment control group showed significant rises in baseline cortisol levels from beginning to end of school term. Increases also occurred in the relaxation intervention group. Children with SEN showed significantly decreased cortisol levels after dog group interventions. No changes occurred in the relaxation or no treatment control groups. These findings provide crucial evidence that dog interventions can successfully attenuate stress levels in school children with important implications for AAI implementation, learning and wellbeing.

People with diabetes and ambulance staff perceptions of a booklet-based intervention for diabetic hypoglycaemia, "Hypos can strike twice": a mixed methods process evaluation.

BACKGROUND: Hypoglycaemia is a potentially serious condition, characterised by lower-than-normal blood glucose levels, common in people with diabetes (PWD). It can be prevented and self-managed if expert support, such as education on lifestyle and treatment, is provided. Our aim was to conduct a process evaluation to investigate how ambulance staff and PWD perceived the "Hypos can strike twice" booklet-based ambulance clinician intervention, including acceptability, understandability, usefulness, positive or negative effects, and facilitators or barriers to implementation. METHODS: We used an explanatory sequential design with a self-administered questionnaire study followed by interviews of people with diabetes and ambulance staff. We followed the Medical Research Council framework for process evaluations of complex interventions to guide data collection and analysis. Following descriptive analysis (PWD and staff surveys), exploratory factor analysis was conducted to identify staff questionnaire subscales and multiple regression models were fitted to identify demographic predictors of overall and subscale scores. RESULTS: 113 ambulance staff members and 46 PWD completed the survey. We conducted interviews with four ambulance staff members and five PWD who had been attended by an ambulance for a hypoglycaemic event. Based on surveys and interviews, there were positive attitudes to the intervention from both ambulance staff and PWD. Although the intervention was not always implemented, most staff members and PWD found the booklet informative, easy to read and to use or explain. PWD who completed the survey reported that receiving the booklet reminded and/or encouraged them to test their blood glucose more often, adjust their diet, and have a discussion/check up with their diabetes consultant. Interviewed PWD felt that the booklet intervention would be more valuable to less experienced patients or those who cannot manage their diabetes well. Overall, participants felt that the intervention could be beneficial, but were uncertain about whether it might help prevent a second hypoglycaemic event and/or reduce the number of repeat ambulance attendances. CONCLUSIONS: The 'Hypos may strike twice' intervention, which had demonstrable reductions in repeat attendances, was found to be feasible, acceptable to PWD and staff, prompting reported behaviour change and help-seeking from primary care. TRIAL REGISTRATION: Registered with ClinicalTrials.gov: NCT04243200 on 27 January 2020.

Usability and acceptability of a cognitive training intervention (SMART) for people with multiple sclerosis (MS): A prefeasibility formative evaluation.

Background: Multiple sclerosis (MS) is a chronic autoimmune, inflammatory neurological disease of the central nervous system (CNS), increasing in incidence and prevalence across both developed and developing countries. Cognitive difficulties are common in MS sufferers with 70% experiencing difficulties in higher-level brain functioning such as planning, attention, problem solving, and memory. Computerised cognitive training programmes may hold promise as a treatment option for improving cognitive function in people with MS, subject to exploring and addressing potential barriers to usability and acceptability. Methods: This study aimed to test the usability and acceptability of a computerised cognitive training intervention-Strengthening Mental Abilities Through Relational Training (SMART) -for people with MS, through a mostly qualitative prefeasibility design ( n= 12). There were two phases of testing: (1) initial usability testing via a think-aloud protocol ( n= 6) and (2) alpha-testing to assess experienced acceptability over a four-week period of engagement ( n= 6). Data from the two phases were subjected to Framework Analysis, wherein we deductively applied the Health IT Usability Evaluation Model and Theoretical Framework of Acceptability to assess usability and acceptability, respectively. Results: Results show SMART to have satisfactory usability with participants reacting positively to the formatting, visuality, and process of the interface. Minor suggestions were made on how best to adapt SMART for people with MS, but the programme and facilitative support were generally perceived to be acceptable, with participants expressing positive feelings about taking part in the intervention, despite associated burdens. Conclusions: This prefeasibility study provides preliminary evidence of the usability and acceptability of SMART as a computerised cognitive training programme for people with MS. We conclude that we can now move forward with a feasibility trial of SMART, with the intention of proceeding to a definitive trial with cost-effectiveness analysis.

AIMS: We are developing a new 'brain training' treatment to help people with multiple sclerosis (MS) who have problems with thinking skills ( e.g., problem-solving, attention, and memory). This study aimed to test whether the training (called 'Strengthening Mental Abilities Through Relational Training' ['SMART']) is suitable for people with MS. Specifically, we assessed whether SMART was easy to use and acceptable for use in their everyday lives. BACKGROUND: MS is a long-term condition that affects the nervous system, with the number of cases increasing in both developed and developing countries. MS affects an individual's thinking skills, which can affect their ability to go about their everyday lives. Brain training has potential for improving thinking skills in people with MS, provided ease of use and factors impacting willingness to use the training are explored. Design and methods used: This study used a mix of methods, such as scores from objective tests and verbal feedback, to explore whether SMART is easy to use and acceptable for people with MS. The study had two phases: think-aloud interviews (participants provided feedback on whether the training interface and guidance were easy to use) and then the alpha-testing phase (participants tested the training over time, and then gave feedback on acceptability). Common and salient themes were identified in both phases. RESULTS: Participants found SMART to be suitably easy to use and acceptable for use by people with MS. Participants thought that the interface was visually appealing, and easy to operate and navigate. Participants made minor suggestions for improving the intervention, but feedback was generally positive, despite demands on time and energy. DISCUSSION: SMART appears to be suitable for people with MS. We conclude that we can go ahead with the next phase of testing SMART, as a possible treatment for improving thinking skills in people with MS.

Clinical effectiveness and costs of pre-hospital inhaled methoxyflurane for acute pain in trauma in adults: non-randomised control group study.

AIMS: Inhaled methoxyflurane, newly licensed in Europe for acute trauma pain in adults, has limited evidence of effectiveness in the pre-hospital setting. We aimed to investigate the clinical effectiveness and costs of methoxyflurane delivered when administered by ambulance staff compared with usual analgesic practice (UAP) for adults with trauma. METHODS: A non-randomised control group design was used to compare methoxyflurane versus Entonox® or parenteral analgesics. Verbal numerical pain scores (VNPS) were gathered over time in adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with methoxyflurane. Comparator VNPS were obtained from database records of UAP in similar patients. Clinical efficacy was tested using an Ordered Probit panel regression model of pain intensity linked by observational rules to VNPS. Scenario analyses were used to compare durations under analgesia spent in severe pain, and costs. RESULTS: Over the 12-month evaluation period, 96 trained paramedics and technicians prepared 510 doses of methoxyflurane for administration to a grand total of 483 patients. Thirty-two patients reported side effects, 19 of whom discontinued early. Thirteen patients, 10 aged over 75 years, were nonadherent to instructions given on inhaler use. Modelling results included demonstration of statistically significant clinical effectiveness of methoxyflurane over each comparator (all p-values <0.001). Methoxyflurane's time to achieve maximum pain relief was significantly faster (all p-values <0.001): 25.7 mins (95%CI 24.4-27.0) versus Entonox® 44.4 (39.5-49.3); 25.8 (24.5-27.1) versus IV paracetamol 40.7 (34.6-46.9); 25.7 (24.4-27.0) versus IV morphine sulfate 41.9 (38.9-44.8). Scenario analyses of time spent in severe pain (VNPS on administration just scoring 10 reducing to a score of 7) were significantly less for methoxyflurane (all difference p-values <0.001): 7.6 mins (95%CI 6.5-8.7) versus Entonox® 24.6 (20.1-29.0); 6.7 (5.6-7.7) versus IV paracetamol 23.0 (17.9-28.0); 6.9 (5.9-7.9) versus IV morphine sulfate 14.9 (13.3-16.6). Costing scenarios compared single-dose use of methoxyflurane versus Entonox® and versus parenteral analgesics (80-20% weighted episode mix of morphine sulfate and paracetamol). In both scenarios, the benefits of methoxyflurane were achieved at higher cost: the additional cost per treated patient was £8.77 versus Entonox® and £9.69 versus parenteral analgesics. The BNF list price for one vial containing a 3 mL dose of methoxyflurane for vaporisation in a Penthrox® inhaler is £17.89 per pack. CONCLUSION: Methoxyflurane administered by ambulance clinicians reduced moderate or severe pain due to trauma in adults more rapidly compared to Entonox® or parenteral drugs. Methoxyflurane provides a useful addition to pre-hospital analgesia.

The effects of a leaflet-based intervention, 'Hypos can strike twice', on recurrent hypoglycaemic attendances by ambulance services: A non-randomised stepped wedge study.

AIMS: We aimed to investigate the effect of an intervention in which ambulance personnel provided advice supported by a booklet-'Hypos can strike twice'-issued following a hypoglycaemic event to prevent future ambulance attendances. METHODS: We used a non-randomised stepped wedge-controlled design. The intervention was introduced at different times (steps) in different areas (clusters) of operation within East Midlands Ambulance Service NHS Trust (EMAS). During the first step (T0), no clusters were exposed to the intervention, and during the last step (T3), all clusters were exposed. Data were analysed using a general linear mixed model (GLMM) and an interrupted-time series analysis (ITSA). RESULTS: The study included 4825 patients (mean age 65.42 years, SD 19.42; 2,166 females) experiencing hypoglycaemic events attended by EMAS. GLMM indicated a reduction in the number of unsuccessful attendances (i.e., attendance followed by a repeat attendance) in the final step of the intervention when compared to the first (odds ratio OR: 0.50, 95%CI: 0.33-0.76, p = 0.001). ITSA indicated a significant decrease in repeat ambulance attendances for hypoglycaemia-relative to the pre-intervention trend (p = 0.008). Furthermore, the hypoglycaemia care bundle was delivered in 66% of attendances during the intervention period, demonstrating a significant level of practice change (p < 0.001). CONCLUSION: The 'Hypos can strike twice' intervention had a positive effect on reducing numbers of repeat attendances for hypoglycaemia and in achieving the care bundle. The study supports the use of information booklets by ambulance clinicians to prevent future attendances for recurrent hypoglycaemic events.

Surgical Trial In Traumatic intraCerebral Haemorrhage (STITCH): a randomised controlled trial of Early Surgery compared with Initial Conservative Treatment.

BACKGROUND: While it is accepted practice to remove extradural (EDH) and subdural haematomas (SDH) following traumatic brain injury, the role of surgery in parenchymal traumatic intracerebral haemorrhage (TICH) is controversial. There is no evidence to support Early Surgery in this condition. OBJECTIVES: There have been a number of trials investigating surgery for spontaneous intracerebral haemorrhage but none for TICH. This study aimed to establish whether or not a policy of Early Surgery for TICH improves outcome compared with a policy of Initial Conservative Treatment. DESIGN: This was an international multicentre pragmatic parallel group trial. Patients were randomised via an independent telephone/web-based randomisation service. SETTING: Neurosurgical units in 59 hospitals in 20 countries registered to take part in the study. PARTICIPANTS: The study planned to recruit 840 adult patients. Patients had to be within 48 hours of head injury with no more than two intracerebral haematomas greater than 10 ml. They did not have a SDH or EDH that required evacuation or any severe comorbidity that would mean they could not achieve a favourable outcome if they made a complete recovery from their head injury. INTERVENTIONS: Patients were randomised to Early Surgery within 12 hours or to Initial Conservative Treatment with delayed evacuation if it became clinically appropriate. MAIN OUTCOME MEASURES: The Extended Glasgow Outcome Scale (GOSE) was measured at 6 months via a postal questionnaire. The primary outcome was the traditional dichotomised split into favourable outcome (good recovery or moderate disability) and unfavourable outcome (severe disability, vegetative, dead). Secondary outcomes included mortality and an ordinal assessment of Glasgow Outcome Scale and Rankin Scale. RESULTS: Patient recruitment began in December 2009 but was halted by the funding body because of low UK recruitment in September 2012. In total, 170 patients were randomised from 31 centres in 13 countries: 83 to Early Surgery and 87 to Initial Conservative Treatment. Six-month outcomes were obtained for 99% of 168 eligible patients (82 Early Surgery and 85 Initial Conservative Treatment patients). Patients in the Early Surgery group were 10.5% more likely to have a favourable outcome (absolute benefit), but this difference did not quite reach statistical significance because of the reduced sample size. Fifty-two (63%) had a favourable outcome with Early Surgery, compared with 45 (53%) with Initial Conservative Treatment [odds ratio 0.65; 95% confidence interval (CI) 0.35 to 1.21; p = 0.17]. Mortality was significantly higher in the Initial Conservative Treatment group (33% vs. 15%; absolute difference 18.3%; 95% CI 5.7% to 30.9%; p = 0.006). The Rankin Scale and GOSE were significantly improved with Early Surgery using a trend analysis (p = 0.047 and p = 0.043 respectively). CONCLUSIONS: This is the first ever trial of surgery for TICH and indicates that Early Surgery may be a valuable tool in the treatment of TICH, especially if the Glasgow Coma Score is between 9 and 12, as was also found in Surgical Trial In spontaneous intraCerebral Haemorrhage (STICH) and Surgical Trial In spontaneous lobar intraCerebral Haemorrhage (STICH II). Further research is clearly warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN 19321911. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 70. See the NIHR Journals Library website for further project information.

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 Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial.

Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, -4.4-25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed.

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.

Long-term incidence of depression and predictors of depressive symptoms in older stroke survivors.

BACKGROUND: Depression is common and an important consequence of stroke but there is limited information on the longer-term relationship between these conditions. AIMS: To identify the prevalence, incidence and predictors of depression in a secondary-care-based cohort of stroke survivors aged over 75 years, from 3 months to up to 10 years post-stroke. METHOD: Depression was assessed annually by three methods: major depression by DSM-IV criteria, the self-rated Geriatric Depression Scale (GDS) and the observer-rated Cornell scale. RESULTS: We found the highest rates, 31.7% baseline prevalence, of depressive symptoms with the GDS compared with 9.7% using the Cornell scale and 1.2% using DSM-IV criteria. Incidence rates were 36.9, 5.90 and 4.18 episodes per 100 person years respectively. Baseline GDS score was the most consistent predictor of depressive symptoms at all time points in both univariate and multivariate analyses. Other predictors included cognitive impairment, impaired activities of daily living and in the early period, vascular risk factor burden and dementia. CONCLUSIONS: Our results emphasise the importance of psychiatric follow-up for those with early-onset post-stroke depression and long-term monitoring of mood in people who have had a stroke and remain at high risk of depression.

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.