Prehospital Tranexamic Acid for Severe Trauma.

BACKGROUND: Whether prehospital administration of tranexamic acid increases the likelihood of survival with a favorable functional outcome among patients with major trauma and suspected trauma-induced coagulopathy who are being treated in advanced trauma systems is uncertain. METHODS: We randomly assigned adults with major trauma who were at risk for trauma-induced coagulopathy to receive tranexamic acid (administered intravenously as a bolus dose of 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital) or matched placebo. The primary outcome was survival with a favorable functional outcome at 6 months after injury, as assessed with the use of the Glasgow Outcome Scale-Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 ("upper good recovery" [no injury-related problems]). We defined survival with a favorable functional outcome as a GOS-E level of 5 ("lower moderate disability") or higher. Secondary outcomes included death from any cause within 28 days and within 6 months after injury. RESULTS: A total of 1310 patients were recruited by 15 emergency medical services in Australia, New Zealand, and Germany. Of these patients, 661 were assigned to receive tranexamic acid, and 646 were assigned to receive placebo; the trial-group assignment was unknown for 3 patients. Survival with a favorable functional outcome at 6 months occurred in 307 of 572 patients (53.7%) in the tranexamic acid group and in 299 of 559 (53.5%) in the placebo group (risk ratio, 1.00; 95% confidence interval [CI], 0.90 to 1.12; P = 0.95). At 28 days after injury, 113 of 653 patients (17.3%) in the tranexamic acid group and 139 of 637 (21.8%) in the placebo group had died (risk ratio, 0.79; 95% CI, 0.63 to 0.99). By 6 months, 123 of 648 patients (19.0%) in the tranexamic acid group and 144 of 629 (22.9%) in the placebo group had died (risk ratio, 0.83; 95% CI, 0.67 to 1.03). The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between the groups. CONCLUSIONS: Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo. (Funded by the Australian National Health and Medical Research Council and others; PATCH-Trauma ClinicalTrials.gov number, NCT02187120.).

Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial.

INTRODUCTION: Haemorrhage causes most preventable prehospital trauma deaths and about a third of in-hospital trauma deaths. Tranexamic acid (TXA), administered soon after hospital arrival in certain trauma systems, is an effective therapy in preventing or managing acute traumatic coagulopathy. However, delayed administration of TXA appears to be ineffective or harmful. The effectiveness of prehospital TXA, incidence of thrombotic complications, benefit versus risk in advanced trauma systems and the mechanism of benefit remain uncertain. METHODS AND ANALYSIS: The Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH-Trauma study) is comparing TXA, initiated prehospital and continued in hospital over 8 hours, with placebo in patients with severe trauma at risk of acute traumatic coagulopathy. We present the trial protocol and an overview of the statistical analysis plan. There will be 1316 patients recruited by prehospital clinicians in Australia, New Zealand and Germany. The primary outcome will be the eight-level Glasgow Outcome Scale Extended (GOSE) at 6 months after injury, dichotomised to favourable (GOSE 5-8) and unfavourable (GOSE 1-4) outcomes, analysed using an intention-to-treat (ITT) approach. Secondary outcomes will include mortality at hospital discharge and at 6 months, blood product usage, quality of life and the incidence of predefined adverse events. ETHICS AND DISSEMINATION: The study was approved by The Alfred Hospital Research and Ethics Committee in Victoria and also approved in New South Wales, Queensland, South Australia, Tasmania and the Northern Territory. In New Zealand, Northern A Health and Disability Ethics Committee provided approval. In Germany, Witten/Herdecke University has provided ethics approval. The PATCH-Trauma study aims to provide definitive evidence of the effectiveness of prehospital TXA, when used in conjunction with current advanced trauma care, in improving outcomes after severe injury. TRIAL REGISTRATION NUMBER: NCT02187120.

Interventions for managing skeletal muscle spasticity following traumatic brain injury.

BACKGROUND: Skeletal muscle spasticity is a major physical complication resulting from traumatic brain injury (TBI), which can lead to muscle contracture, joint stiffness, reduced range of movement, broken skin and pain. Treatments for spasticity include a range of pharmacological and non-pharmacological interventions, often used in combination. Management of spasticity following TBI varies from other clinical populations because of the added complexity of behavioural and cognitive issues associated with TBI. OBJECTIVES: To assess the effects of interventions for managing skeletal muscle spasticity in people with TBI. SEARCH METHODS: In June 2017, we searched key databases including the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE (Ovid), Embase (Ovid) and others, in addition to clinical trials registries and the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cross-over RCTs evaluating any intervention for the management of spasticity in TBI. Only studies where at least 50% of participants had a TBI (or for whom separate data for participants with TBI were available) were included. The primary outcomes were spasticity and adverse effects. Secondary outcome measures were classified according to the World Health Organization International Classification of Functioning, Disability and Health including body functions (sensory, pain, neuromusculoskeletal and movement-related functions) and activities and participation (general tasks and demands; mobility; self-care; domestic life; major life areas; community, social and civic life). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Data were synthesised narratively; meta-analysis was precluded due to the paucity and heterogeneity of data. MAIN RESULTS: We included nine studies in this review which involved 134 participants with TBI. Only five studies reported between-group differences, yielding outcome data for 105 participants with TBI. These five studies assessed the effects of a range of pharmacological (baclofen, botulinum toxin A) and non-pharmacological (casting, physiotherapy, splints, tilt table standing and electrical stimulation) interventions, often in combination. The studies which tested the effect of baclofen and tizanidine did not report their results adequately. Where outcome data were available, spasticity and adverse events were reported, in addition to some secondary outcome measures.Of the five studies with results, three were funded by governments, charities or health services and two were funded by a pharmaceutical or medical technology company. The four studies without useable results were funded by pharmaceutical or medical technology companies.It was difficult to draw conclusions about the effectiveness of these interventions due to poor reporting, small study size and the fact that participants with TBI were usually only a proportion of the overall total. Meta-analysis was not feasible due to the paucity of data and heterogeneity of interventions and comparator groups. Some studies concluded that the intervention they tested had beneficial effects on spasticity, and others found no difference between certain treatments. The most common adverse event was minor skin damage in people who received casting. We believe it would be misleading to provide any further description of study results given the quality of the evidence was very low for all outcomes. AUTHORS' CONCLUSIONS: The very low quality and limited amount of evidence about the management of spasticity in people with TBI means that we are uncertain about the effectiveness or harms of these interventions. Well-designed and adequately powered studies using functional outcome measures to test the interventions used in clinical practice are needed.

Title and Abstract Screening and Evaluation in Systematic Reviews (TASER): a pilot randomised controlled trial of title and abstract screening by medical students.

BACKGROUND: The production of high quality systematic reviews requires rigorous methods that are time-consuming and resource intensive. Citation screening is a key step in the systematic review process. An opportunity to improve the efficiency of systematic review production involves the use of non-expert groups and new technologies for citation screening. We performed a pilot study of citation screening by medical students using four screening methods and compared students' performance to experienced review authors. METHODS: The aims of this pilot randomised controlled trial were to provide preliminary data on the accuracy of title and abstract screening by medical students, and on the effect of screening modality on screening accuracy and efficiency. Medical students were randomly allocated to title and abstract screening using one of the four modalities and required to screen 650 citations from a single systematic review update. The four screening modalities were a reference management software program (EndNote), Paper, a web-based systematic review workflow platform (ReGroup) and a mobile screening application (Screen2Go). Screening sensitivity and specificity were analysed in a complete case analysis using a chi-squared test and Kruskal-Wallis rank sum test according to screening modality and compared to a final set of included citations selected by expert review authors. RESULTS: Sensitivity of medical students' screening decisions ranged from 46.7% to 66.7%, with students using the web-based platform performing significantly better than the paper-based group. Specificity ranged from 93.2% to 97.4% with the lowest specificity seen with the web-based platform. There was no significant difference in performance between the other three modalities. CONCLUSIONS: Medical students are a feasible population to engage in citation screening. Future studies should investigate the effect of incentive systems, training and support and analytical methods on screening performance. SYSTEMATIC REVIEW REGISTRATION: Cochrane Database CD001048.

Quality of guidelines for cognitive rehabilitation following traumatic brain injury.

INTRODUCTION: Cognitive rehabilitation following traumatic brain injury can aid in optimizing function, independence, and quality of life by addressing impairments in attention, executive function, cognitive communication, and memory. This study aimed to identify and evaluate the methodological quality of clinical practice guidelines for cognitive rehabilitation following traumatic brain injury. METHODS: Systematic searching of databases and Web sites was undertaken between January and March 2012 to identify freely available, English language clinical practice guidelines from 2002 onward. Eligible guidelines were evaluated using the validated Appraisal of Guidelines for Research and Evaluation II instrument. RESULTS: The 11 guidelines that met inclusion criteria were independently rated by 4 raters. Results of quality appraisal indicated that guidelines generally employed systematic search and appraisal methods and produced unambiguous, clearly identifiable recommendations. Conversely, only 1 guideline incorporated implementation and audit information, and there was poor reporting of processes for formulating, reviewing, and ensuring currency of recommendations and incorporating patient preferences. Intraclass correlation coefficients for agreement between raters showed high agreement (intraclass correlation coefficient > 0.80) for all guidelines except for 1 (moderate agreement; intraclass correlation coefficient = 0.76). CONCLUSION: Future guidelines should address identified limitations by providing implementation information and audit criteria, along with better reporting of guideline development processes and stakeholder engagement.

Self-management education programmes for osteoarthritis.

BACKGROUND: Self-management education programmes are complex interventions specifically targeted at patient education and behaviour modification. They are designed to encourage people with chronic disease to take an active self-management role to supplement medical care and improve outcomes. OBJECTIVES: To assess the effectiveness of self-management education programmes for people with osteoarthritis. SEARCH METHODS: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PyscINFO, SCOPUS and the World Health Organization (WHO) International Clinical Trial Registry Platform were searched, without language restriction, on 17 January 2013. We checked references of reviews and included trials to identify additional studies. SELECTION CRITERIA: Randomised controlled trials of self-management education programmes in people with osteoarthritis were included. Studies with participants receiving passive recipients of care and studies comparing one type of programme versus another were excluded. DATA COLLECTION AND ANALYSIS: In addition to standard methods we extracted components of the self-management interventions using the eight domains of the Health Education Impact Questionnaire (heiQ), and contextual and participant characteristics using PROGRESS-Plus and the Health Literacy Questionnaire (HLQ). Outcomes included self-management of osteoarthritis, participant's positive and active engagement in life, pain, global symptom score, self-reported function, quality of life and withdrawals (including dropouts and those lost to follow-up). We assessed the quality of the body of evidence for these outcomes using the GRADE approach. MAIN RESULTS: We included twenty-nine studies (6,753 participants) that compared self-management education programmes to attention control (five studies), usual care (17 studies), information alone (four studies) or another intervention (seven studies). Although heterogeneous, most interventions included elements of skill and technique acquisition (94%), health-directed activity (85%) and self-monitoring and insight (79%); social integration and support were addressed in only 12%. Most studies did not provide enough information to assess all PROGRESS-Plus items. Eight studies included predominantly Caucasian, educated female participants, and only four provided any information on participants' health literacy. All studies were at high risk of performance and detection bias for self-reported outcomes; 20 studies were at high risk of selection bias, 16 were at high risk of attrition bias, two were at high risk of reporting bias and 12 were at risk of other biases. We deemed attention control as the most appropriate and thus the main comparator.Compared with attention control, self-management programmes may not result in significant benefits at 12 months. Low-quality evidence from one study (344 people) indicates that self-management skills were similar in active and control groups: 5.8 points on a 10-point self-efficacy scale in the control group, and the mean difference (MD) between groups was 0.4 points (95% confidence interval (CI) -0.39 to 1.19). Low-quality evidence from four studies (575 people) indicates that self-management programmes may lead to a small but clinically unimportant reduction in pain: the standardised mean difference (SMD) between groups was -0.26 (95% CI -0.44 to -0.09); pain was 6 points on a 0 to 10 visual analogue scale (VAS) in the control group, treatment resulted in a mean reduction of 0.8 points (95% CI -0.14 to -0.3) on a 10-point scale, with number needed to treat for an additional beneficial outcome (NNTB) of 8 (95% CI 5 to 23). Low-quality evidence from one study (251 people) indicates that the mean global osteoarthritis score was 4.2 on a 0 to 10-point symptom scale (lower better) in the control group, and treatment reduced symptoms by a mean of 0.14 points (95% CI -0.54 to 0.26). This result does not exclude the possibility of a clinically important benefit in some people (0.5 point reduction included in 95% CI). Low-quality evidence from three studies (574 people) showed no signficant difference in function between groups (SMD -0.19, 95% CI -0.5 to 0.11); mean function was 1.29 points on a 0 to 3-point scale in the control group, and treatment resulted in a mean improvement of 0.04 points with self-management (95% CI -0.10 to 0.02). Low-quality evidence from one study (165 people) showed no between-group difference in quality of life (MD -0.01, 95% CI -0.03 to 0.01) from a control group mean of 0.57 units on 0 to 1 well-being scale. Moderate-quality evidence from five studies (937 people) shows similar withdrawal rates between self-management (13%) and control groups (12%): RR 1.11 (95% CI 0.78 to 1.57). Positive and active engagement in life was not measured.Compared with usual care, moderate-quality evidence from 11 studies (up to 1,706 participants) indicates that self-management programmes probably provide small benefits up to 21 months, in terms of self-management skills, pain, osteoarthritis symptoms and function, although these are of doubtful clinical importance, and no improvement in positive and active engagement in life or quality of life. Withdrawal rates were similar. Low to moderate quality evidence indicates no important differences in self-management , pain, symptoms, function, quality of life or withdrawal rates between self-management programmes and information alone or other interventions (exercise, physiotherapy, social support or acupuncture). AUTHORS' CONCLUSIONS: Low to moderate quality evidence indicates that self-management education programmes result in no or small benefits in people with osteoarthritis but are unlikely to cause harm.Compared with attention control, these programmes probably do not improve self-management skills, pain, osteoarthritis symptoms, function or quality of life, and have unknown effects on positive and active engagement in life. Compared with usual care, they may slightly improve self-management skills, pain, function and symptoms, although these benefits are of unlikely clinical importance.Further studies investigating the effects of self-management education programmes, as delivered in the trials in this review, are unlikely to change our conclusions substantially, as confounding from biases across studies would have likely favoured self-management. However, trials assessing other models of self-management education programme delivery may be warranted. These should adequately describe the intervention they deliver and consider the expanded PROGRESS-Plus framework and health literacy, to explore issues of health equity for recipients.

Non-surgical interventions for the management of type 2 dens fractures: a systematic review.

BACKGROUND: Non-surgical immobilization strategies for type 2 odontoid fractures vary considerably, with some surgeons preferring rigid collars, halothoracic bracing or the Minerva brace. Choice of device should be informed by the effectiveness in achieving union, whilst minimizing mortality and complications. OBJECTIVES: Perform a systematic review evaluating the efficacy of non-surgical interventions for type 2 odontoid fractures. DATA SOURCES: MEDLINE (OvidSP), EMBASE (OvidSP) and The Cochrane Library, ClinicalTrials.gov, Current Controlled Trials. METHODS: We conducted a systematic review of studies directly comparing the halothoracic brace and cervical collars or the Minerva brace for union, mortality and complications. Studies were appraised for quality and bias, and results were pooled for analysis. RESULTS: Our search identified 1794 citations, 13 of which met inclusion criteria. There were no randomized or prospective studies. All studies were small, retrospective and observational. Our results demonstrate a greater likelihood of developing stable union (osseous and fibrous); relative risk (RR) 1.27 (95% confidence intervals (CI) 1.03 to 1.57; P = 0.03); and airway complications; RR 7.52 (95% CI 1.39 to 40.83; P = 0.02) with halothoracic bracing compared with cervical collar. In patients >65, there was a greater risk of airway complications; RR 7.50 (0.96-58.36; P = 0.05). No other significant differences were identified. CONCLUSION: Evidence to support selection of non-surgical immobilization in type 2 odontoid fractures is poor. Osseous union has traditionally been the benchmark for 'successful' treatment; however, evidence of association between union and improved outcomes is lacking. We highlight the need for a randomized study to promote evidence-based decision-making in the non-surgical management of this injury.

Safety and efficacy of pharmacologic thromboprophylaxis following blunt head injury: a systematic review.

BACKGROUND: Patients with blunt head injury are at high risk of venous thromboembolism. However, pharmacologic thromboprophylaxis (PTP) may cause progression of intracranial hemorrhage, and clinicians must often weigh up the risks and benefits. This review aimed to determine whether adding PTP to mechanical prophylaxis confers net benefit or harm and the optimal timing, dose, and agent for PTP in patients with blunt head injury. METHODS: We searched MEDLINE, EMBASE, The Cochrane Library Central Register of Controlled Trials (CENTRAL), and www.clinicaltrials.gov on April 24, 2013, to identify controlled studies and ongoing trials that assessed the efficacy or safety of thromboprophylaxis interventions in the early management of head-injured patients. Studies were classified based on types of interventions and comparisons, and the quality of included studies was assessed using Cochrane risk-of-bias tool and the Newcastle-Ottawa Quality Assessment Scale. We intended to undertake a meta-analysis if studies were sufficiently similar. RESULTS: Sixteen studies met the inclusion criteria, including four randomized controlled trials. At least two randomized controlled trials were at high risk of bias owing to inadequate randomization and concealment of allocation, and observational studies were potentially confounded by substantial differences between comparison groups. Heterogeneity of included studies precluded meta-analysis. Results were mixed, with some studies supporting and others refuting addition of PTP to mechanical interventions. Little evidence was available about dose or choice of agent. The safety and efficacy of early PTP in patients without early progression of hemorrhage is unclear. CONCLUSION: There is currently insufficient evidence to guide thromboprophylaxis in patients with blunt head injury. Standardized definitions and outcome measurements would facilitate comparison of outcomes across future studies. Studies in mixed populations should report head-injured specific subgroup data. Future randomized controlled trials should investigate the efficacy and safety of early pharmacologic prophylaxis in addition to mechanical intervention. LEVEL OF EVIDENCE: Systematic review, level IV.

Reporting of allocation method and statistical analyses that deal with bilaterally affected wrists in clinical trials for carpal tunnel syndrome.

The authors aimed to describe how often the allocation method and the statistical analyses that deal with bilateral involvement are reported in clinical trials for carpal tunnel syndrome and to determine whether reporting has improved over time. Forty-two trials identified from recently published systematic reviews were assessed. Information about allocation method and statistical analyses was obtained from published reports and trialists. Only 15 trialists (36%) reported the method of random sequence generation used, and 6 trialists (14%) reported the method of allocation concealment used. Of 25 trials including participants with bilateral carpal tunnel syndrome, 17 (68%) reported the method used to allocate the wrists, whereas only 1 (4%) reported using a statistical analysis that appropriately dealt with bilateral involvement. There was no clear trend of improved reporting over time. Interventions are needed to improve reporting quality and statistical analyses of these trials so that these can provide more reliable evidence to inform clinical practice.

Consumer-providers of care for adult clients of statutory mental health services.

BACKGROUND: In mental health services, the past several decades has seen a slow but steady trend towards employment of past or present consumers of the service to work alongside mental health professionals in providing services. However the effects of this employment on clients (service recipients) and services has remained unclear.We conducted a systematic review of randomised trials assessing the effects of employing consumers of mental health services as providers of statutory mental health services to clients. In this review this role is called 'consumer-provider' and the term 'statutory mental health services' refers to public services, those required by statute or law, or public services involving statutory duties. The consumer-provider's role can encompass peer support, coaching, advocacy, case management or outreach, crisis worker or assertive community treatment worker, or providing social support programmes. OBJECTIVES: To assess the effects of employing current or past adult consumers of mental health services as providers of statutory mental health services. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2012, Issue 3), MEDLINE (OvidSP) (1950 to March 2012), EMBASE (OvidSP) (1988 to March 2012), PsycINFO (OvidSP) (1806 to March 2012), CINAHL (EBSCOhost) (1981 to March 2009), Current Contents (OvidSP) (1993 to March 2012), and reference lists of relevant articles. SELECTION CRITERIA: Randomised controlled trials of current or past consumers of mental health services employed as providers ('consumer-providers') in statutory mental health services, comparing either: 1) consumers versus professionals employed to do the same role within a mental health service, or 2) mental health services with and without consumer-providers as an adjunct to the service. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. We contacted trialists for additional information. We conducted analyses using a random-effects model, pooling studies that measured the same outcome to provide a summary estimate of the effect across studies. We describe findings for each outcome in the text of the review with considerations of the potential impact of bias and the clinical importance of results, with input from a clinical expert. MAIN RESULTS: We included 11 randomised controlled trials involving 2796 people. The quality of these studies was moderate to low, with most of the studies at unclear risk of bias in terms of random sequence generation and allocation concealment, and high risk of bias for blinded outcome assessment and selective outcome reporting.Five trials involving 581 people compared consumer-providers to professionals in similar roles within mental health services (case management roles (4 trials), facilitating group therapy (1 trial)). There were no significant differences in client quality of life (mean difference (MD) -0.30, 95% confidence interval (CI) -0.80 to 0.20); depression (data not pooled), general mental health symptoms (standardised mean difference (SMD) -0.24, 95% CI -0.52 to 0.05); client satisfaction with treatment (SMD -0.22, 95% CI -0.69 to 0.25), client or professional ratings of client-manager relationship; use of mental health services, hospital admissions and length of stay; or attrition (risk ratio 0.80, 95% CI 0.58 to 1.09) between mental health teams involving consumer-providers or professional staff in similar roles.There was a small reduction in crisis and emergency service use for clients receiving care involving consumer-providers (SMD -0.34 (95%CI -0.60 to -0.07). Past or present consumers who provided mental health services did so differently than professionals; they spent more time face-to-face with clients, and less time in the office, on the telephone, with clients' friends and family, or at provider agencies.Six trials involving 2215 people compared mental health services with or without the addition of consumer-providers. There were no significant differences in psychosocial outcomes (quality of life, empowerment, function, social relations), client satisfaction with service provision (SMD 0.76, 95% CI -0.59 to 2.10) and with staff (SMD 0.18, 95% CI -0.43 to 0.79), attendance rates (SMD 0.52 (95% CI -0.07 to 1.11), hospital admissions and length of stay, or attrition (risk ratio 1.29, 95% CI 0.72 to 2.31) between groups with consumer-providers as an adjunct to professional-led care and those receiving usual care from health professionals alone. One study found a small difference favouring the intervention group for both client and staff ratings of clients' needs having been met, although detection bias may have affected the latter. None of the six studies in this comparison reported client mental health outcomes.No studies in either comparison group reported data on adverse outcomes for clients, or the financial costs of service provision. AUTHORS' CONCLUSIONS: Involving consumer-providers in mental health teams results in psychosocial, mental health symptom and service use outcomes for clients that were no better or worse than those achieved by professionals employed in similar roles, particularly for case management services.There is low quality evidence that involving consumer-providers in mental health teams results in a small reduction in clients' use of crisis or emergency services. The nature of the consumer-providers' involvement differs compared to professionals, as do the resources required to support their involvement. The overall quality of the evidence is moderate to low. There is no evidence of harm associated with involving consumer-providers in mental health teams.Future randomised controlled trials of consumer-providers in mental health services should minimise bias through the use of adequate randomisation and concealment of allocation, blinding of outcome assessment where possible, the comprehensive reporting of outcome data, and the avoidance of contamination between treatment groups. Researchers should adhere to SPIRIT and CONSORT reporting standards for clinical trials.Future trials should further evaluate standardised measures of clients' mental health, adverse outcomes for clients, the potential benefits and harms to the consumer-providers themselves (including need to return to treatment), and the financial costs of the intervention. They should utilise consistent, validated measurement tools and include a clear description of the consumer-provider role (eg specific tasks, responsibilities and expected deliverables of the role) and relevant training for the role so that it can be readily implemented. The weight of evidence being strongly based in the United States, future research should be located in diverse settings including in low- and middle-income countries.

Therapeutic ultrasound for carpal tunnel syndrome.

BACKGROUND: Therapeutic ultrasound may be offered to people experiencing mild to moderate symptoms of carpal tunnel syndrome (CTS). The effectiveness and duration of benefit of this non-surgical intervention remain unclear. OBJECTIVES: To review the effects of therapeutic ultrasound compared with no treatment, placebo or another non-surgical intervention in people with CTS. SEARCH METHODS: On 27 November 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2012, Issue 11 in The Cochrane Library), MEDLINE (January 1966 to November 2012), EMBASE (January 1980 to November 2012), CINAHL Plus (January 1937 to November 2012), and AMED (January 1985 to November 2012). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing any regimen of therapeutic ultrasound with no treatment, a placebo or another non-surgical intervention in people with CTS. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data and assessed the risk of bias in the included studies. We calculated risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CIs) for primary and secondary outcomes. We pooled results of clinically homogenous trials in a meta-analysis using a random-effects model, where possible, to provide estimates of the effect. MAIN RESULTS: We included 11 studies including 414 participants in the review. Two trials compared therapeutic ultrasound with placebo, two compared one ultrasound regimen with another, two compared ultrasound with another non-surgical intervention, and six compared ultrasound as part of a multi-component intervention with another non-surgical intervention (for example, exercises and splint). The risk of bias was low in some studies and unclear or high in other studies, with only two reporting that the allocation sequence was concealed and six reporting that participants were blinded. Overall, there is insufficient evidence that one therapeutic ultrasound regimen is more efficacious than another. Only two studies reported the primary outcome of interest, short-term overall improvement (any measure in which patients indicate the intensity of their complaints compared with baseline, for example, global rating of improvement, satisfaction with treatment, within three months post-treatment). One low quality trial with 68 participants found that when compared with placebo, therapeutic ultrasound may increase the chance of experiencing short-term overall improvement at the end of seven weeks treatment (RR 2.36; 95% CI 1.40 to 3.98), although losses to follow-up and failure to adjust for the correlation between wrists in participants with bilateral CTS in this study suggest that this data should be interpreted with caution. Another low quality trial with 60 participants found that at three months post-treatment therapeutic ultrasound plus splint increased the chance of short-term overall improvement (patient satisfaction) when compared with splint alone (RR 3.02; 95% CI 1.36 to 6.72), but decreased the chance of short-term overall improvement when compared with low-level laser therapy plus splint (RR 0.87; 95% CI 0.57 to 1.33), though participants were not blinded to treatment, it was unclear if the random allocation sequence was adequately concealed, and there was a potential unit of analysis error. Differences between groups receiving different frequencies and intensities of ultrasound, and between ultrasound as part of a multi-component intervention versus other non-surgical interventions, were generally small and not statistically significant for symptoms, function, and neurophysiologic parameters. No studies reported any adverse effects of therapeutic ultrasound, but this outcome was only measured in three studies. More adverse effects data are required before any firm conclusions on the safety of therapeutic ultrasound can be made. AUTHORS' CONCLUSIONS: There is only poor quality evidence from very limited data to suggest that therapeutic ultrasound may be more effective than placebo for either short- or long-term symptom improvement in people with CTS. There is insufficient evidence to support the greater benefit of one type of therapeutic ultrasound regimen over another or to support the use of therapeutic ultrasound as a treatment with greater efficacy compared to other non-surgical interventions for CTS, such as splinting, exercises, and oral drugs. More methodologically rigorous studies are needed to determine the effectiveness and safety of therapeutic ultrasound for CTS.

Haemorrhage control in severely injured patients.

Most surgeons have adopted damage control surgery for severely injured patients, in which the initial operation is abbreviated after control of bleeding and contamination to allow ongoing resuscitation in the intensive-care unit. Developments in early resuscitation that emphasise rapid control of bleeding, restrictive volume replacement, and prevention or early management of coagulopathy are making definitive surgery during the first operation possible for many patients. Improved topical haemostatic agents and interventional radiology are becoming increasingly useful adjuncts to surgical control of bleeding. Better understanding of trauma-induced coagulopathy is paving the way for the replacement of blind, unguided protocols for blood component therapy with systemic treatments targeting specific deficiencies in coagulation. Similarly, treatments targeting dysregulated inflammatory responses to severe injury are under investigation. As point-of-care diagnostics become more suited to emergency environments, timely targeted intervention for haemorrhage control will result in better patient outcomes and reduced demand for blood products. Our Series paper describes how our understanding of the roles of the microcirculation, inflammation, and coagulation has shaped new and emerging treatment strategies.

Improving the care of people with traumatic brain injury through the Neurotrauma Evidence Translation (NET) program: protocol for a program of research.

The Neurotrauma Evidence Translation (NET) program was funded in 2009 to increase the uptake of research evidence in the clinical care of patients who have sustained traumatic brain injury. This paper reports the rationale and plan for this five-year knowledge translation research program. The overarching aims of the program are threefold: to improve outcomes for people with traumatic brain injury; to create a network of neurotrauma clinicians and researchers with expertise in knowledge translation and evidence-based practice; and to contribute knowledge to the field of knowledge translation research. The program comprises a series of interlinked projects spanning varying clinical environments and disciplines relevant to neurotrauma, anchored within four themes representing core knowledge translation activities: reviewing research evidence; understanding practice; developing and testing interventions for practice change; and building capacity for knowledge translation in neurotrauma. The program uses a range of different methods and study designs, including: an evidence fellowship program; conduct of and training in systematic reviews; mixed method study designs to describe and understand factors that influence current practices (e.g., semi-structured interviews and surveys); theory-based methods to develop targeted interventions aiming to change practice; a cluster randomised trial to test the effectiveness of a targeted theory-informed intervention; stakeholder involvement activities; and knowledge translation events such as consensus conferences.

Splinting for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a condition where one of two main nerves in the wrist is compressed, which can lead to pain in the hand, wrist and sometimes arm, and numbness and tingling in the thumb, index and long finger. Splinting is usually offered to people with mild to moderate symptoms. However, the effectiveness and duration of the benefit of splinting for this condition remain unknown. OBJECTIVES: To compare the effectiveness of splinting for carpal tunnel syndrome with no treatment, placebo or another non-surgical intervention. SEARCH METHODS: We searched the Cochrane Neuromuscular Disease Group Specialized Register (10 January 2011), CENTRAL, NHSEED and DARE (The Cochrane Library 2011, Issue 4), MEDLINE (January 1966 to December 2011), EMBASE (January 1980 to January 2012), AMED (January 1985 to January 2012), and CINAHL Plus (January 1937 to January 2012), using no time limits. We searched the reference lists of all included trials and relevant reviews for further relevant studies. SELECTION CRITERIA: All randomised and quasi-randomised trials comparing splinting with no treatment (or a placebo) or with other non-surgical treatments were eligible for inclusion. We also included studies comparing one splint type or regimen versus another. We excluded studies comparing splinting with surgical treatment. There were no language restrictions. We included all patients diagnosed with carpal tunnel syndrome unless they had undergone surgical release. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, and performed data extraction. Two authors also independently performed the assessment of risk of bias. We calculated measures of effect as risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI) reported and statistical significance set at P < 0.05 for all outcome comparisons. MAIN RESULTS: The review included 19 studies randomising 1190 participants with carpal tunnel syndrome. Two studies compared splinting with no treatment, five compared different splint designs, one compared different splint-wearing regimens, seven compared splint delivered as a single intervention with another non-surgical intervention, and five compared splint delivered alongside other non-surgical interventions with another non-surgical intervention. Only three studies reported concealing the allocation sequence, and only one reported blinding of participants. Three studies measured the primary outcome, short-term overall improvement at three months or less. One low quality study with 80 wrists found that compared to no treatment, splints worn at night more than tripled the likelihood of reporting overall improvement at the end of four weeks of treatment (RR 3.86, 95% CI 2.29 to 6.51). However, the lack of patient blinding and unclear allocation concealment suggests this result should be interpreted with caution. A very low quality quasi-randomised trial with 90 wrists found that wearing a neutral splint more than doubled the likelihood of reporting 'a lot or complete relief' at the end of two weeks of treatment compared with an extension splint (RR 2.43, 95% CI 1.12 to 5.28). The third study which measured short-term overall improvement did not report outcome data separately per group. Nine studies measured adverse effects of splinting and all found either no or few participants reporting discomfort or swelling due to splinting; however, the precision of all RRs was very low. Differences between groups in the secondary outcomes - symptoms, function, and neurophysiologic parameters - were most commonly small with 95% CIs incorporating effects in either direction. AUTHORS' CONCLUSIONS: Overall, there is limited evidence that a splint worn at night is more effective than no treatment in the short term, but there is insufficient evidence regarding the effectiveness and safety of one splint design or wearing regimen over others, and of splint over other non-surgical interventions for CTS. More research is needed on the long-term effects of this intervention for CTS.

Exercise and mobilisation interventions for carpal tunnel syndrome.

BACKGROUND: Non-surgical treatment, including exercises and mobilisation, has been offered to people experiencing mild to moderate symptoms arising from carpal tunnel syndrome (CTS). However, the effectiveness and duration of benefit from exercises and mobilisation for this condition remain unknown. OBJECTIVES: To review the efficacy and safety of exercise and mobilisation interventions compared with no treatment, a placebo or another non-surgical intervention in people with CTS. SEARCH METHODS: We searched the Cochrane Neuromuscular Disease Group Specialised Register (10 January 2012), CENTRAL (2011, Issue 4), MEDLINE (January 1966 to December 2011), EMBASE (January 1980 to January 2012), CINAHL Plus (January 1937 to January 2012), and AMED (January 1985 to January 2012). SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing exercise or mobilisation interventions with no treatment, placebo or another non-surgical intervention in people with CTS. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed searches and selected trials for inclusion, extracted data and assessed risk of bias of the included studies. We calculated risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CIs) for primary and secondary outcomes of the review. We collected data on adverse events from included studies. MAIN RESULTS: Sixteen studies randomising 741 participants with CTS were included in the review. Two compared a mobilisation regimen to a no treatment control, three compared one mobilisation intervention (for example carpal bone mobilisation) to another (for example soft tissue mobilisation), nine compared nerve mobilisation delivered as part of a multi-component intervention to another non-surgical intervention (for example splint or therapeutic ultrasound), and three compared a mobilisation intervention other than nerve mobilisation (for example yoga or chiropractic treatment) to another non-surgical intervention. The risk of bias of the included studies was low in some studies and unclear or high in other studies, with only three explicitly reporting that the allocation sequence was concealed, and four reporting blinding of participants. The studies were heterogeneous in terms of the interventions delivered, outcomes measured and timing of outcome assessment, therefore, we were unable to pool results across studies. Only four studies reported the primary outcome of interest, short-term overall improvement (any measure in which patients indicate the intensity of their complaints compared to baseline, for example, global rating of improvement, satisfaction with treatment, within three months post-treatment). However, of these, only three fully reported outcome data sufficient for inclusion in the review. One very low quality trial with 14 participants found that all participants receiving either neurodynamic mobilisation or carpal bone mobilisation and none in the no treatment group reported overall improvement (RR 15.00, 95% CI 1.02 to 220.92), though the precision of this effect estimate is very low. One low quality trial with 22 participants found that the chance of being 'satisfied' or 'very satisfied' with treatment was 24% higher for participants receiving instrument-assisted soft tissue mobilisation compared to standard soft tissue mobilisation (RR 1.24, 95% CI 0.89 to 1.75), though participants were not blinded and it was unclear if the allocation sequence was concealed. Another very low-quality trial with 26 participants found that more CTS-affected wrists receiving nerve gliding exercises plus splint plus activity modification had no pathologic finding on median and ulnar nerve distal sensory latency assessment at the end of treatment than wrists receiving splint plus activity modification alone (RR 1.26, 95% CI 0.69 to 2.30). However, a unit of analysis error occurred in this trial, as the correlation between wrists in participants with bilateral CTS was not accounted for. Only two studies measured adverse effects, so more data are required before any firm conclusions on the safety of exercise and mobilisation interventions can be made. In general, the results of secondary outcomes of the review (short- and long-term improvement in CTS symptoms, functional ability, health-related quality of life, neurophysiologic parameters, and the need for surgery) for most comparisons had 95% CIs which incorporated effects in either direction. AUTHORS' CONCLUSIONS: There is limited and very low quality evidence of benefit for all of a diverse collection of exercise and mobilisation interventions for CTS. People with CTS who indicate a preference for exercise or mobilisation interventions should be informed of the limited evidence of effectiveness and safety of this intervention by their treatment provider. Until more high quality randomised controlled trials assessing the effectiveness and safety of various exercise and mobilisation interventions compared to other non-surgical interventions are undertaken, the decision to provide this type of non-surgical intervention to people with CTS should be based on the clinician's expertise in being able to deliver these treatments and patient's preferences.

Therapeutic ultrasound for carpal tunnel syndrome.

BACKGROUND: Therapeutic ultrasound may be offered to people experiencing mild to moderate symptoms of carpal tunnel syndrome (CTS). The effectiveness and duration of benefit of this non-surgical intervention remain unclear. OBJECTIVES: To review the effects of therapeutic ultrasound compared with no treatment, placebo or another non-surgical intervention in people with CTS. SEARCH METHODS: We searched the Cochrane Neuromuscular Disease Group Specialized Register (22 February 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2011, Issue 1), MEDLINE (January 1966 to February 2011), EMBASE (January 1980 to February 2011), CINAHL Plus (January 1937 to February 2011), and AMED (January 1985 to February 2011). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing any regimen of therapeutic ultrasound with no treatment, a placebo or another non-surgical intervention in people with CTS. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, extracted data and assessed the risk of bias in the included studies. We calculated risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CIs) for primary and secondary outcomes. We pooled results of clinically homogenous trials in a meta-analysis using a random-effects model, where possible, to provide estimates of the effect. MAIN RESULTS: We included 11 studies randomising 443 patients in the review. Two trials compared therapeutic ultrasound with placebo, two compared one ultrasound regimen with another, two compared ultrasound with another non-surgical intervention, and six compared ultrasound as part of a multi-component intervention with another non-surgical intervention (for example, exercises and splint). The risk of bias was low in some studies and unclear or high in other studies, with only three reporting that the allocation sequence was concealed and six reporting that participants were blinded. Overall, there is insufficient evidence that one therapeutic ultrasound regimen is more efficacious than another. Only two studies reported the primary outcome of interest, short-term overall improvement (any measure in which patients indicate the intensity of their complaints compared with baseline, for example, global rating of improvement, satisfaction with treatment, within three months post-treatment). One low quality trial with 68 participants found that when compared with placebo, therapeutic ultrasound may increase the chance of experiencing short-term overall improvement at the end of seven weeks treatment (RR 2.36; 95% CI 1.40 to 3.98), although losses to follow-up in this study suggest that these data should be interpreted with caution. Another low quality trial with 60 participants found that at three months, post-treatment therapeutic ultrasound plus splint increased the chance of short-term overall improvement (patient satisfaction) when compared with splint alone (RR 3.02; 95% CI 1.36 to 6.72), but decreased the chance of short-term overall improvement when compared with low-level laser therapy plus splint (RR 0.87; 95% CI 0.57 to 1.33), though participants were not blinded to treatment and it was unclear if the random allocation sequence was adequately concealed. Differences between groups receiving different frequencies and intensities of ultrasound, and between ultrasound as part of a multi-component intervention versus other non-surgical interventions, were generally small and not statistically significant for symptoms, function, and neurophysiologic parameters. Only four studies measured adverse effects, none of which identified adverse effects due to therapeutic ultrasound. However, more data on this outcome are required before any firm conclusions on the safety of this intervention can be made. AUTHORS' CONCLUSIONS: There is only poor quality evidence from very limited data to suggest that therapeutic ultrasound may be more effective than placebo for either short- or long-term symptom improvement in people with CTS. There is insufficient evidence to support the greater benefit of one type of therapeutic ultrasound regimen over another or to support the use of therapeutic ultrasound as a treatment with greater efficacy compared to other non-surgical interventions for CTS, such as splinting, exercises, and oral drugs. More methodologically rigorous studies are needed to determine the effectiveness and safety of this intervention for CTS.

An overview of published research about the acute care and rehabilitation of traumatic brain injured and spinal cord injured patients.

Knowledge of the breadth, nature, and volume of traumatic brain injury (TBI) and spinal cord injury (SCI) research can aid in research planning. This study aimed to provide an overview of existing TBI and SCI research to inform identification of knowledge translation (KT), systematic review (SR), and primary research opportunities. Topics and relevant articles from three large neurotrauma evidence resources were synthesized: the Global Evidence Mapping (GEM) Initiative (129 topics and 1644 articles), the Acquired Brain Injury Evidence-Based Review (ERABI; 152 topics and 732 articles), and the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Project (297 topics and 1650 articles). A de-duplicated dataset of SRs, randomized controlled trials (RCTs), and other studies identified by these projects was created. In all, 145 topics were identified (66 TBI and 79 SCI), yielding 3466 research articles (1256 TBI and 2210 SCI). Topics with KT potential included cognitive therapies for TBI and prevention/management of urinary tract problems post-SCI, which accounted for 17% and 18%, respectively, of the TBI and SCI yield. Topics that may require SR included management of raised intracranial pressure in TBI, and ventilation and intermittent positive pressure interventions following SCI. Topics for which primary research may be needed included pharmacological therapies for neurological recovery post-TBI, and management of sleep-disordered breathing post-SCI. There was a larger volume of non-intervention (epidemiological) studies in SCI than in TBI. This comprehensive overview of TBI and SCI research can aid funding agencies, researchers, clinicians, and other stakeholders in prioritizing and planning TBI and SCI research.

Quality and consistency of guidelines for the management of mild traumatic brain injury in the emergency department.

OBJECTIVES: The objective was to provide an overview of the recommendations and quality of evidence-based clinical practice guidelines (CPGs) for the emergency management of mild traumatic brain injury (mTBI), with a view to informing best practice and improving the consistency of recommendations. METHODS: Electronic searches of health databases (MEDLINE, EMBASE, The Cochrane Library, PsycINFO), CPG clearinghouse websites, CPG developer websites, and Internet search engines up to January 2010 were conducted. CPGs were included if 1) they were published in English and freely accessible, 2) their scope included the management of mTBI in the emergency department (ED), 3) the date of last search was within the past 10 years (2000 onward), 4) systematic methods were used to search for evidence, and 5) there was an explicit link between the recommendations and the supporting evidence. Four authors independently assessed the quality of the included CPGs using the Appraisal of Guidelines, Research and Evaluation (AGREE) Instrument. The authors extracted and categorized recommendations according to initial clinical assessment, imaging, management, observation, discharge planning, and patient information and follow-up. RESULTS: The search identified 18 potential CPGs, of which six met the inclusion criteria. The included CPGs varied in scope, target population, size, and guideline development processes. Four CPGs were assessed as "strongly recommended." The majority of CPGs did not provide information about the level of stakeholder involvement (mean AGREE standardized domain score = 57%, range = 25% to 81%), nor did they address the organizational/cost implications of applying the recommendations or provide criteria for monitoring and review of recommendations in practice (mean AGREE standardized domain score = 46.6%, range = 19% to 94%). Recommendations were mostly consistent in terms of the use of the Glasgow Coma Scale (GCS) score (adult and pediatric) to assess the level of consciousness, initial assessment criteria, the use of computed tomography (CT) scanning as imaging investigation of choice, and the provision of patient information. The CPGs defined mTBI in a variety of ways and described different rules to determine the need for CT scanning and therefore used different criteria to identify high-risk patients. CONCLUSIONS: Higher-quality CPGs for mTBI are consistent in their recommendations about assessment, imaging, and provision of patient information. There is not, however, an agreed definition of mTBI, and the quality of future CPGs could be improved with better reporting of stakeholder involvement, procedures for updating, and greater consideration of the applicability of the recommendations (cost implications, monitoring procedures). Nevertheless, guideline developers may benefit from adapting existing CPGs to their local context rather than investing in developing CPGs de novo.

The effect of provider case volume on cancer mortality: systematic review and meta-analysis.

The authors systematically reviewed the association between provider case volume and mortality in 101 publications involving greater than 1 million patients with esophageal, gastric, hepatic, pancreatic, colon, or rectal cancer, of whom more than 70,000 died. The majority of studies addressed the relation between hospital surgical case volume and short-term perioperative mortality. Few studies addressed surgeon case volume or evaluated long-term survival outcomes. Common methodologic limitations were failure to control for potential confounders, post hoc categorization of provider volume, and unit of analysis errors. A significant volume effect was evident for the majority of gastrointestinal cancers; with each doubling of hospital case volume, the odds of perioperative death decreased by 0.1 to 0.23. The authors calculated that between 10 and 50 patients per year, depending on cancer type, needed to be moved from a "low-volume" hospital to a "high-volume" hospital to prevent 1 additional volume-associated perioperative death. Despite this, approximately one-third of all analyses did not find a significant volume effect on mortality. The heterogeneity of results from individual studies calls into question the validity of case volume as a proxy for care quality, and leads the authors to conclude that more direct quality measures and the validity of their use to inform policy should also be explored.