The Effectiveness of the Mitchell Method Relaxation Technique for the Treatment of Fibromyalgia Symptoms: A Three-Arm Randomized Controlled Trial

Objective: To evaluate the effectiveness of the Mitchell Method Relaxation Technique (MMRT) in reducing symptoms of fibromyalgia. Design: A randomised controlled trial was used to compare the effectiveness of self-administered MMRT (n= 67) with attention control (n = 66) and usual care (n = 56) groups. Main Outcome Measures: Primary outcomes included self-reported fatigue, pain, and sleep. Secondary outcomes were daily functioning, quality of life, depression, and coping, anxiety and perceived stress. Outcomes were assessed at baseline, post-intervention (four weeks) and followup (eight weeks). Results: A significant combined improvement on outcomes (p<.005), specific significant effects for sleep problems (d=0.29, p<.05), sleep inadequacy (d=0.20, p<.05), and fatigue (d=0.47, p<.05) were present in the MMRT group. At the follow-up, fatigue did not differ to the post-intervention score (p=.25) indicating short-term sustainability of the effect. The effects on sleep problems and sleep inadequacy were not sustained. The pain levels decreased when the MMRT was practiced three times a week (p<.001). Conclusion: MMRT was effective in reducing pain, sleep problems, and fatigue. High rates of relative risk reduction for fatigue (37%) and pain (42.8%) suggest clinical significance

Sports-related brain injury in the general population: An epidemiological study

Objectives To determine the incidence, nature and severity of all sports-related brain injuries in the general population. Design Population-based epidemiological incidence study. Methods Data on all traumatic brain injury events sustained during a sports-related activity were extracted from a dataset of all new traumatic brain injury cases (both fatal and non-fatal), identified over a one-year period in the Hamilton and Waikato districts of New Zealand. Prospective and retrospective case ascertainment methods from multiple sources were used. All age groups and levels of traumatic brain injury severity were included. Details of the registering injuries and recurrent injuries sustained over the subsequent year were obtained through medical/accident records and assessment interviews with participants. Results Of 1369 incident traumatic brain injury cases, 291 were identified as being sustained during a sports-related activity (21% of all traumatic brain injuries) equating to an incidence rate of 170 per 100,000 of the general population. Recurrent injuries occurred more frequently in adults (11%) than children (5%). Of the sports-related injuries 46% were classified as mild with a high risk of complications. Injuries were most frequently sustained during rugby, cycling and equestrian activities. It was revealed that up to 19% of traumatic brain injuries were not recorded in medical notes. Conclusions Given the high incidence of new and recurrent traumatic brain injury and the high risk of complications following injury, further sport specific injury prevention strategies are urgently needed to reduce the impact of traumatic brain injury and facilitate safer engagement in sports activities. The high levels of ‘missed’ traumatic brain injuries, highlights the importance in raising awareness of traumatic brain injury during sports-related activity in the general population

Bridging the gap between goal intentions and actions: a systematic review in patient populations.

To evaluate the evidence for the effectiveness of if-then implementation intentions (if-then plans) in adult patient populations. Outcomes of interest included adherence, goal pursuit and physical health outcomes.Keywords were used to search electronic databases without date or language restrictions (up to 30 April 2014). Studies were included if they (1) concerned a patient population; (2) used if-then plans as a sole intervention or as part of treatment, therapy or rehabilitation; (3) if they were randomised controlled trials. The PEDro scale was used to evaluate study quality. Guidance as set out by the Cochrane Collaboration was used. Two reviewers independently extracted data, discrepancies were discussed and if required referred to a third reviewer.In total, 18 of the 2141 articles were identified as potentially relevant and four studies of people with epilepsy, chronic back pain, stroke and obesity met the inclusion criteria. People who form if-then plans achieved better outcomes on epilepsy and stroke medication adherence and physical capacity than controls.Of the four studies that used an if-then plan, only one (people with epilepsy) looked at the intervention as a stand-alone strategy. Further research needs to explore if this simple approach improves rehabilitation outcomes and is a helpful and feasible strategy for people experiencing disabilities. Implications for Rehabilitation Steps involved in achieving goals, such as doing exercises or completing other goal related tasks, can be compromised for people with chronic health conditions particularly resulting from difficulties in self-regulating behaviour. If-then plans are implementation intention tools aimed at supporting people to deal more effectively with self-regulatory problems that might undermine goal striving and goal attainment, and have been found to be effective in health promotion and health behaviour change. This systematic literature review identified four studies completed with patient populations, with three demonstrating effectiveness. If-then plans provide an opportunity for clinicians to develop better ways of implementing rehabilitation

A Comparison of Cognitive Function in Former Rugby Union Players Compared with Former Non-Contact-Sport Players and the Impact of Concussion History

Aim: This study investigated differences in cognitive function between former rugby and non-contact-sport players, and assessed the association between concussion history and cognitive function. Methods: Overall, 366 former players (mean ± standard deviation [SD] age 43.3 ± 8.2 years) were recruited from October 2012 to April 2014. Engagement in sport, general health, sports injuries and concussion history, and demographic information were obtained from an online self-report questionnaire. Cognitive functioning was assessed using the online CNS Vital Signs neuropsychological test battery. Cohen’s d effect size statistics were calculated for comparisons across player groups, concussion groups (one or more self-reported concussions versus no concussions) and between those groups with CNS Vital Signs age-matched norms (US norms). Individual differences within groups were represented as SDs. Results: The elite-rugby group (n = 103) performed worse on tests of complex attention, processing speed, executive functioning, and cognitive flexibility than the non-contact-sport group (n = 65), and worse than the community-rugby group (n = 193) on complex attention. The community-rugby group performed worse than the non-contact group on executive functioning and cognitive flexibility. Compared with US norms, all three former player groups performed worse on verbal memory and reaction time; rugby groups performed worse on processing speed, cognitive flexibility and executive functioning; and the community-rugby group performed worse on composite memory. The community-rugby group and non-contact-sport group performed slightly better than US norms on complex attention, as did the elite-rugby group for motor speed. All three player groups had greater individual differences than US norms on composite memory, verbal memory and reaction time. The elite-rugby group had greater individual differences on processing speed and complex attention, and the community-rugby group had greater individual differences on psychomotor speed and motor speed. The average number of concussions recalled per player was greater for elite rugby and community rugby than non-contact sport. Former players who recalled one or more concussions (elite rugby, 85 %; community rugby, 77 %; non-contact sport, 23 %) had worse scores on cognitive flexibility, executive functioning, and complex attention than players who did not recall experiencing a concussion. Conclusions: Past participation in rugby or a history of concussion were associated with small to moderate neurocognitive deficits (as indicated by worse CNS Vital Signs scores) in athletes post retirement from competitive sport

The feasibility of using pattern recognition software to measure the influence of computer use on the consultation

BACKGROUND: A key feature of a good general practice consultation is that it is patient-centred. A number of verbal and non-verbal behaviours have been identified as important to establish a good relationship with the patient. However, the use of the computer detracts the doctor's attention away from the patient, compromising these essential elements of the consultation. Current methods to assess the consultation and the influence of the computer on them are time consuming and subjective. If it were possible to measure these quantitatively, it could provide the basis for the first truly objective way of studying the influence of the computer on the consultation. The aim was to assess whether pattern recognition software could be used to measure the influence and pattern of computer use in the consultation. If this proved possible it would provide, for the first time, an objective quantitative measure of computer use and a measure of the attention and responsiveness of the general practitioner towards the patient. METHODS: A feasibility study using pattern recognition software to analyse a consultation was conducted. A web camera, linked to a data-gathering node was used to film a simulated consultation in a standard office. Members of the research team enacted the role of the doctor and the patient, using pattern recognition software to try and capture patient-centred, non-verbal behaviour. As this was a feasibility study detailed results of the analysis are not presented. RESULTS: It was revealed that pattern recognition software could be used to analyse certain aspects of a simulated consultation. For example, trigger lines enabled the number of times the clinician's hand covered the keyboard to be counted and wrapping recorded the number of times the clinician nodded his head. It was also possible to measure time sequences and whether the movement was brief or lingering. CONCLUSION: Pattern recognition software enables movements associated with patient-centredness to be recorded. Pattern recognition software has the potential to provide an objective, quantitative measure of the influence of the computer on the consultation

How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study

Background The European Union (EU) aims to optimize patient protection and efficiency of health-care research by harmonizing procedures across Member States. Nonetheless, further improvements are required to increase multicenter research efficiency. We investigated IRB procedures in a large prospective European multicenter study on traumatic brain injury (TBI), aiming to inform and stimulate initiatives to improve efficiency. Methods We reviewed relevant documents regarding IRB submission and IRB approval from European neurotrauma centers participating in the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI). Documents included detailed information on IRB procedures and the duration from IRB submission until approval(s). They were translated and analyzed to determine the level of harmonization of IRB procedures within Europe. Results From 18 countries, 66 centers provided the requested documents. The primary IRB review was conducted centrally (N = 11, 61%) or locally (N = 7, 39%) and primary IRB approval was obtained after one (N = 8, 44%), two (N = 6, 33%) or three (N = 4, 23%) review rounds with a median duration of respectively 50 and 98 days until primary IRB approval. Additional IRB approval was required in 55% of countries and could increase duration to 535 days. Total duration from submission until required IRB approval was obtained was 114 days (IQR 75-224) and appeared to be shorter after submission to local IRBs compared to central IRBs (50 vs. 138 days, p = 0.0074). Conclusion We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.Peer reviewe

Tracheal intubation in traumatic brain injury: a multicentre prospective observational study

Background We aimed to study the associations between pre- and in-hospital tracheal intubation and outcomes in traumatic brain injury (TBI), and whether the association varied according to injury severity. Methods Data from the international prospective pan-European cohort study, Collaborative European NeuroTrauma Effectiveness Research for TBI (CENTER-TBI), were used (n=4509). For prehospital intubation, we excluded self-presenters. For in-hospital intubation, patients whose tracheas were intubated on-scene were excluded. The association between intubation and outcome was analysed with ordinal regression with adjustment for the International Mission for Prognosis and Analysis of Clinical Trials in TBI variables and extracranial injury. We assessed whether the effect of intubation varied by injury severity by testing the added value of an interaction term with likelihood ratio tests. Results In the prehospital analysis, 890/3736 (24%) patients had their tracheas intubated at scene. In the in-hospital analysis, 460/2930 (16%) patients had their tracheas intubated in the emergency department. There was no adjusted overall effect on functional outcome of prehospital intubation (odds ratio=1.01; 95% confidence interval, 0.79–1.28; P=0.96), and the adjusted overall effect of in-hospital intubation was not significant (odds ratio=0.86; 95% confidence interval, 0.65–1.13; P=0.28). However, prehospital intubation was associated with better functional outcome in patients with higher thorax and abdominal Abbreviated Injury Scale scores (P=0.009 and P=0.02, respectively), whereas in-hospital intubation was associated with better outcome in patients with lower Glasgow Coma Scale scores (P=0.01): in-hospital intubation was associated with better functional outcome in patients with Glasgow Coma Scale scores of 10 or lower. Conclusion The benefits and harms of tracheal intubation should be carefully evaluated in patients with TBI to optimise benefit. This study suggests that extracranial injury should influence the decision in the prehospital setting, and level of consciousness in the in-hospital setting. Clinical trial registration NCT02210221

Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): A Prospective Longitudinal Observational Study

BACKGROUND: Current classification of traumatic brain injury (TBI) is suboptimal, and management is based on weak evidence, with little attempt to personalize treatment. A need exists for new precision medicine and stratified management approaches that incorporate emerging technologies. OBJECTIVE: To improve characterization and classification of TBI and to identify best clinical care, using comparative effectiveness research approaches. METHODS: This multicenter, longitudinal, prospective, observational study in 22 countries across Europe and Israel will collect detailed data from 5400 consenting patients, presenting within 24 hours of injury, with a clinical diagnosis of TBI and an indication for computed tomography. Broader registry-level data collection in approximately 20 000 patients will assess generalizability. Cross sectional comprehensive outcome assessments, including quality of life and neuropsychological testing, will be performed at 6 months. Longitudinal assessments will continue up to 24 months post TBI in patient subsets. Advanced neuroimaging and genomic and biomarker data will be used to improve characterization, and analyses will include neuroinformatics approaches to address variations in process and clinical care. Results will be integrated with living systematic reviews in a process of knowledge transfer. The study initiation was from October to December 2014, and the recruitment period was for 18 to 24 months. EXPECTED OUTCOMES: Collaborative European NeuroTrauma Effectiveness Research in TBI should provide novel multidimensional approaches to TBI characterization and classification, evidence to support treatment recommendations, and benchmarks for quality of care. Data and sample repositories will ensure opportunities for legacy research. DISCUSSION: Comparative effectiveness research provides an alternative to reductionistic clinical trials in restricted patient populations by exploiting differences in biology, care, and outcome to support optimal personalized patient management

Brain death and postmortem organ donation: Report of a questionnaire from the CENTER-TBI study

Background: We aimed to investigate the extent of the agreement on practices around brain death and postmortem organ donation. Methods: Investigators from 67 Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study centers completed several questionnaires (response rate: 99%). Results: Regarding practices around brain death, we found agreement on the clinical evaluation (prerequisites and neurological assessment) for brain death determination (BDD) in 100% of the centers. However, ancillary tests were required for BDD in 64% of the centers. BDD for nondonor patients was deemed mandatory in 18% of the centers before withdrawing life-sustaining measures (LSM). Also, practices around postmortem organ donation varied. Organ donation after circulatory arrest was forbidden in 45% of the centers. When withdrawal of LSM was contemplated, in 67% of centers the patients with a ventricular drain in situ had this removed, either sometimes or all of the time. Conclusions: This study showed both agreement and some regional differences regarding practices around brain death and postmortem organ donation. We hope our results help quantify and understand potential differences, and provide impetus for current dialogs toward further harmonization of practices around brain death and postmortem organ donation

Predictors of Access to Rehabilitation in the Year Following Traumatic Brain Injury : A European Prospective and Multicenter Study

Background Although rehabilitation is beneficial for individuals with traumatic brain injury (TBI), a significant proportion of them do not receive adequate rehabilitation after acute care. Objective Therefore, the goal of this prospective and multicenter study was to investigate predictors of access to rehabilitation in the year following injury in patients with TBI. Methods Data from a large European study (CENTER-TBI), including TBIs of all severities between December 2014 and December 2017 were used (N = 4498 patients). Participants were dichotomized into those who had and those who did not have access to rehabilitation in the year following TBI. Potential predictors included sociodemographic factors, psychoactive substance use, preinjury medical history, injury-related factors, and factors related to medical care, complications, and discharge. Results In the year following traumatic injury, 31.4% of patients received rehabilitation services. Access to rehabilitation was positively and significantly predicted by female sex (odds ratio [OR] = 1.50), increased number of years of education completed (OR = 1.05), living in Northern (OR = 1.62; reference: Western Europe) or Southern Europe (OR = 1.74), lower prehospital Glasgow Coma Scale score (OR = 1.03), higher Injury Severity Score (OR = 1.01), intracranial (OR = 1.33) and extracranial (OR = 1.99) surgery, and extracranial complication (OR = 1.75). On contrast, significant negative predictors were lack of preinjury employment (OR = 0.80), living in Central and Eastern Europe (OR = 0.42), and admission to hospital ward (OR = 0.47; reference: admission to intensive care unit) or direct discharge from emergency room (OR = 0.24). Conclusions Based on these findings, there is an urgent need to implement national and international guidelines and strategies for access to rehabilitation after TBI.Peer reviewe