The effect of participating in MedEx Wellness, a community-based chronic disease exercise rehabilitation programme, on physical, clinical and psychological health: A study protocol for a cohort trial.

BACKGROUND: Community-based exercise rehabilitation programmes for chronic disease are an effective alternative to traditional hospital-based programmes. MedEx Wellness is a novel community-based exercise rehabilitation programme that integrates a range of chronic diseases. The aim of this trial was to investigate the effect of participating in MedEx Wellness on physical, clinical and psychological health. METHODS: A prospective cohort study was conducted. Participants were recruited at induction to the MedEx Wellness programme following referral from healthcare professionals. Participants underwent a baseline assessment before commencing the exercise programme and repeat assessments at 3, 6 and 12 months. The primary outcome was cardiorespiratory fitness (6 minute- time trial) at 12 months. Secondary outcomes included health-related quality of life (EuroQoL-5D, Satisfaction with Life Scale, Warwick Edinburgh Mental Wellbeing Scale, Patient Health Questionnaire8, Functional Assessment of Cancer Therapy Questionnaire), free living activity behavior (accelerometer) and healthcare utilization (recall questionnaire). Tertiary outcomes included blood pressure (24 h), biomarkers (lipids, glucose and C-reactive protein), other components of physical fitness, including strength (handgrip test, sit-to-stand test), flexibility (sit-and-reach test), body composition (body mass index and waist-to-hip ratio), and falls risk (timed up and go test), and claudication time (incremental treadmill walking test), cognitive function, including attention (Attention Network Task), memory (Luck & Vogel Visual Working Memory Task) and cognitive reserve. Exploratory outcomes included psychosocial determinants of physical activity (self-efficacy, social support, intentions). DISCUSSION: This trial will evaluate whether participation in the MedEx Wellness programme has positive effects on physical, clinical and psychological health in individuals with a range of chronic diseases. TRIAL REGISTRATION: ISRCTN Registry ISRCTN10351412.

Repeatability of transient elastography in children.

BACKGROUND: Poorly performing diagnostic tests can impact patient safety. Clinical investigations must have good precision and diagnostic accuracy before widespread use in clinical practice. Transient elastography (TE) measures liver stiffness, a surrogate marker of liver fibrosis in adults and children. Studies to evaluate its repeatability and reproducibility (precision) in children are limited. Our aim was to determine (i) the normal range of TE measurements and (ii) the repeatability and reproducibility of TE in healthy children. METHODS: TE was performed in 257 healthy children, of whom 235 (91%, mean age 11.7 years, standard deviation (SD) 2.51, 107 were males (45.5%)) had two valid TE measurements performed, at least 24 h apart, by two operators under similar circumstances. High-quality TE images were obtained for each examination. RESULTS: The normal range of TE was 2.88-6.52 kPa. The mean difference between paired measurements was 0.044 (SD 0.4). The 95% limits of agreement ranged from -0.8 to +0.76 kPa for repeat measurements. There was a difference of >1 kPa between measurements in 61/235 (25.9%) children. The lack of precision was similar across all age groups. CONCLUSIONS: This study demonstrates that TE does not have acceptable precision in healthy children, because random measurement variation results in the lack of agreement between paired measurements. IMPACT: The precision and diagnostic accuracy of a new technology must be determined before it is deployed in children in order to ensure that appropriate clinical decisions are made, and healthcare resources are not wasted. TE is widely used to diagnose liver disease in children without adequate evaluation of the precision (repeatability) of TE either in healthy children or children with liver disease. This study demonstrates that TE does not have adequate precision in children. This study was performed in accordance with methods previously published for children. Refinements to the test protocol, such as duration of fasting or probe size, will have to be evaluated for their impact on precision and accuracy before the test is deployed in research studies or clinical practice.

Ketamine Versus Midazolam for Depression Relapse Prevention Following Successful Electroconvulsive Therapy: A Randomized Controlled Pilot Trial.

OBJECTIVE: Depression relapse after electroconvulsive therapy (ECT) is common (40% at 6 months). Ketamine has a robust antidepressant effect, but there are no reported studies of ketamine for depression relapse prevention. This pilot trial (NCT02414932) was designed to assess feasibility of the proposed trial protocol, including examining reasons for nonrecruitment, nonrandomization, and dropout. METHODS: Patients with unipolar depression referred for ECT were monitored weekly for therapeutic response, using the 24-item Hamilton Rating Scale for Depression (monitoring phase). Those who met standard response criteria were invited to be randomized to a course of 4 once-weekly infusions of ketamine (0.5 mg/kg) or the active comparator, midazolam (0.045 mg/kg), over 40 minutes to examine trial processes (treatment phase). Participants were followed up for 6 months after ECT to assess for relapse. RESULTS: One hundred seventy-five referrals were screened over 18 months, and 68% of eligible participants (n = 43) were recruited to the monitoring phase; 60.5% of participants met ECT response criteria (n = 26), but only 26% (6) of these consented to take part in the treatment phase. These were randomized (3 to ketamine and 3 to midazolam), and no participant completed the 4-week treatment protocol. Information was gathered on reasons for nonrecruitment, nonrandomization, and dropout, which included practical aspects of infusions and lack of interest in further treatment after response to ECT. CONCLUSIONS: The proposed treatment protocol is not suitable for a definitive trial in our center. Information collected on reasons for dropout may inform future clinical trials of intravenous ketamine. TRIAL REGISTRATION: www.clinicaltrials.gov NCT02414932.

Nilvadipine in mild to moderate Alzheimer disease: A randomised controlled trial.

BACKGROUND: This study reports the findings of the first large-scale Phase III investigator-driven clinical trial to slow the rate of cognitive decline in Alzheimer disease with a dihydropyridine (DHP) calcium channel blocker, nilvadipine. Nilvadipine, licensed to treat hypertension, reduces amyloid production, increases regional cerebral blood flow, and has demonstrated anti-inflammatory and anti-tau activity in preclinical studies, properties that could have disease-modifying effects for Alzheimer disease. We aimed to determine if nilvadipine was effective in slowing cognitive decline in subjects with mild to moderate Alzheimer disease. METHODS AND FINDINGS: NILVAD was an 18-month, randomised, placebo-controlled, double-blind trial that randomised participants between 15 May 2013 and 13 April 2015. The study was conducted at 23 academic centres in nine European countries. Of 577 participants screened, 511 were eligible and were randomised (258 to placebo, 253 to nilvadipine). Participants took a trial treatment capsule once a day after breakfast for 78 weeks. Participants were aged >50 years, meeting National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's disease Criteria (NINCDS-ADRDA) for diagnosis of probable Alzheimer disease, with a Standardised Mini-Mental State Examination (SMMSE) score of ≥12 and <27. Participants were randomly assigned to 8 mg sustained-release nilvadipine or matched placebo. The a priori defined primary outcome was progression on the Alzheimer's Disease Assessment Scale Cognitive Subscale-12 (ADAS-Cog 12) in the modified intention-to-treat (mITT) population (n = 498), with the Clinical Dementia Rating Scale sum of boxes (CDR-sb) as a gated co-primary outcome, eligible to be promoted to primary end point conditional on a significant effect on the ADAS-Cog 12. The analysis set had a mean age of 73 years and was 62% female. Baseline demographic and Alzheimer disease-specific characteristics were similar between treatment groups, with reported mean of 1.7 years since diagnosis and mean SMMSE of 20.4. The prespecified primary analyses failed to show any treatment benefit for nilvadipine on the co-primary outcome (p = 0.465). Decline from baseline in ADAS-Cog 12 on placebo was 0.79 (95% CI, -0.07-1.64) at 13 weeks, 6.41 (5.33-7.49) at 52 weeks, and 9.63 (8.33-10.93) at 78 weeks and on nilvadipine was 0.88 (0.02-1.74) at 13 weeks, 5.75 (4.66-6.85) at 52 weeks, and 9.41 (8.09-10.73) at 78 weeks. Exploratory analyses of the planned secondary outcomes showed no substantial effects, including on the CDR-sb or the Disability Assessment for Dementia. Nilvadipine appeared to be safe and well tolerated. Mortality was similar between groups (3 on nilvadipine, 4 on placebo); higher counts of adverse events (AEs) on nilvadipine (1,129 versus 1,030), and serious adverse events (SAEs; 146 versus 101), were observed. There were 14 withdrawals because of AEs. Major limitations of this study were that subjects had established dementia and the likelihood that non-Alzheimer subjects were included because of the lack of biomarker confirmation of the presence of brain amyloid. CONCLUSIONS: The results do not suggest benefit of nilvadipine as a treatment in a population spanning mild to moderate Alzheimer disease. TRIAL REGISTRATION: Clinicaltrials.gov NCT02017340, EudraCT number 2012-002764-27.

Recall of structured radiology reports is significantly superior to that of unstructured reports.

OBJECTIVE: To measure recall of structured compared with unstructured radiology reports. METHODS: Institutional review board approval was obtained. Four hypothetical radiology reports, two structured and two unstructured reports, were created for the purposes of this study by an experienced consultant radiologist. The reports, each followed immediately by a multiple-choice questionnaire listing possible diagnoses from the report, were distributed to the members of two national physician associations using a web-based survey tool. Based on the number of correct responses, correct critical findings and incorrect responses, rates per number of potential diagnoses were calculated for each individual and averaged. The paired sign test compared results between structured and unstructured reports. RESULTS: 148 respondents completed the survey, 126 (85.1%) of whom were physicians. The mean percentage of incorrect diagnoses was 4.5% for structured reports compared with 16.7% for unstructured reports (p < 0.001). The average rate of critical diagnosis recall was 82.7% for structured reports and 65.1% for unstructured reports (p < 0.001). The average percentage of all diagnoses detected for structured compared with unstructured reports was 64.3 and 59.0%, respectively (p = 0.007). CONCLUSION: Recall of structured radiology reports is significantly superior to recall of unstructured reports immediately after reading the report. Advances in knowledge: A structured radiology report format can positively impact the referring clinician's ability to recall the critical findings with statistically significance.

Ketamine for depression relapse prevention following electroconvulsive therapy: protocol for a randomised pilot trial (the KEEP-WELL trial).

BACKGROUND: Major depressive disorder is a common debilitating illness that is the second leading contributor to the global burden of disease. Unfortunately, about 30 % of patients do not respond to adequate trials of antidepressants and/or psychotherapies. About 45-60 % of such treatment-resistant patients will remit with electroconvulsive therapy (ECT). However, relapse rates are high following ECT-38 % after 6 months. There is a need for better relapse prevention strategies. One possibility is to use ketamine, a competitive glutamate receptor antagonist used for anaesthesia. A recent paradigm shift in treating depression and understanding its biology has been the finding that ketamine has a robust, rapid-onset, though short-lived, antidepressant effect that is possibly mediated through neuroplastic effects. However, ketamine has not previously been reported on for relapse prevention. METHODS/DESIGN: The main objective of this study is to conduct a randomised controlled pilot trial (n = 40) of a 4-week course of once-weekly ketamine infusions for relapse prevention following ECT for depression to assess trial procedures that will inform a future definitive trial. Participants with unipolar depression will be recruited prior to commencing ECT and be assessed weekly during the ECT course using the primary clinical outcome, the 24-item Hamilton Rating Scale for Depression (HRSD-24). Those who meet standard response criteria will be invited, on completing ECT, to be randomised in a 1:1 ratio to a course of four once-weekly infusions of ketamine or an active comparator midazolam, which mimics some of the effects of ketamine and may improve blinding over inactive placebo. Participants will be followed up over 6 months using the HRSD-24 to assess for relapse. DISCUSSION: This is the first registered trial (NCT02414932, https://clinicaltrials.gov/ct2/show/NCT02414932) of ketamine for depression relapse prevention, an important possible use of this agent. The primary focus of the pilot trial is on feasibility. However, a 95 % confidence interval will be determined for the difference between ketamine and midazolam groups in 6-month relapse rates to help inform a future definitive trial. TRIAL REGISTRATION: https://clinicaltrials.gov/ NCT02414932 Secondary Identifying numbers: EudraCT number: 2014-000339-18 Sponsors' Reference, Sponsor: St. Patrick's Mental Health Services: 05/14 Research Ethics Committee Reference, Joint REC of St James' and Tallaght Hospitals, Dublin: 2014-08-19.

European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease-the substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow.

INTRODUCTION: In conjunction with the NILVAD trial, a European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild-to-Moderate Alzheimer's disease (AD), there are four NILVAD substudies in which eligible NILVAD patients are also invited to participate. The main NILVAD protocol was previously published in BMJ Open (2014). The objectives of the NILVAD substudies are to determine whether frailty, cerebrospinal fluid (CSF), blood biomarker profile and Apolipoprotein E (APOE) status predict response to Nilvadipine, and to investigate the effect of Nilvadipine on cerebral blood flow and blood biomarkers. METHODS AND ANALYSIS: All participants who fulfil criteria for the main NILVAD study are eligible for participation in the NILVAD substudies. Participation is subject to informed consent and whether the substudy is available at a particular NILVAD study site. Each substudy entails extra measurements during the course of the main NILVAD study. For example, in the blood and genetic biomarkers substudy, extra blood (30 mL) will be collected at week 0, week 13, week 52 and week 78, while in the cerebral blood flow substudy, participants will receive an MRI and transcranial Doppler measurements at week 0, week 26 and week 78. In the CSF substudy, 10 mL CSF is collected at week 0 and week 78. ETHICS AND DISSEMINATION: All NILVAD substudies and all subsequent amendments have received ethical approval within each participating country, according to national regulations. Each participant provides written consent to participate. All participants remain anonymised throughout and the results of each substudy will be published in an international peer reviewed journal. TRIAL REGISTRATION NUMBER: EUDRACT 2012-002764-27; Pre-results.

Synthetic folic acid intakes and status in children living in Ireland exposed to voluntary fortification.

BACKGROUND: In the context of mandatory and voluntary folic acid fortification, the exposure of children to folic acid has been a focus of concern, particularly regarding the possibility of whether any potentially adverse effects will emerge in the future. OBJECTIVE: We explored concentrations of fasting unmetabolized folic acid (UFA) in the circulation of children living in Ireland who were exposed to the voluntary folic acid-fortification regimen in place in Ireland. DESIGN: Healthy children who were attending Our Lady's Children's Hospital, Crumlin, for routine minor surgery were recruited to provide a fasting 3-mL blood sample that was taken while a general anesthetic was administered. The samples were analyzed for plasma folate, red blood cell folate, and UFA concentrations. A short dietary questionnaire that captured recent and habitual intakes of folic acid, both as supplements and as fortified foods, was completed face to face with parents. RESULTS: We collected fasting samples (n = 68) and completed questionnaires that captured recent and habitual daily folic acid intakes of children grouped as follows: 0-5 y of age: 6 girls and 21 boys (27 children total); 6-10 y of age: 10 girls and 10 boys (20 children total); and 11-16 y of age: 10 girls and 11 boys (21 children total). UFA was detected in 10.3% of the samples tested (range: 0.5-1.3 nmol/L). Mean plasma folate and red blood cell folate concentrations were 35.1 nmol/L (range: 21-47 nmol/L) and 956 nmol/L (range: 305-2319 nmol/L), respectively. Mean daily intake of folic acid from fortified foods and supplements was 109 µg (range: 0-767 µg). CONCLUSIONS: We showed that there was UFA in the plasma of just >10% of the children sampled after an overnight fast. These findings should be considered by policy makers who are responsible for folic acid fortification. This trial was registered at www.isrctn.com as ISRCTN90038765.

Yoga and Emotion Regulation in High School Students: A Randomized Controlled Trial.

Middle adolescents (15-17 years old) are prone to increased risk taking and emotional instability. Emotion dysregulation contributes to a variety of psychosocial difficulties in this population. A discipline such as yoga offered during school may increase emotion regulation, but research in this area is lacking. This study was designed to evaluate the impact of a yoga intervention on the emotion regulation of high school students as compared to physical education (PE). In addition, the potential mediating effects of mindful attention, self-compassion, and body awareness on the relationship between yoga and emotion regulation were examined. High school students were randomized to participate in a 16-week yoga intervention (n = 19) or regular PE (n = 18). Pre-post data analyses revealed that emotion regulation increased significantly in the yoga group as compared to the PE group (F (1,32) = 7.50, p = .01, and eta(2) = .19). No significant relationship was discovered between the changes in emotion regulation and the proposed mediating variables. Preliminary results suggest that yoga increases emotion regulation capacities of middle adolescents and provides benefits beyond that of PE alone.

Supervised walking in comparison with fitness training for chronic back pain in physiotherapy: results of the SWIFT single-blinded randomized controlled trial (ISRCTN17592092).

Effectiveness of brief/minimal contact self-activation interventions that encourage participation in physical activity (PA) for chronic low back pain (CLBP >12 weeks) is unproven. The primary objective of this assessor-blinded randomized controlled trial was to investigate the difference between an individualized walking programme (WP), group exercise class (EC), and usual physiotherapy (UP, control) in mean change in functional disability at 6 months. A sample of 246 participants with CLBP aged 18 to 65 years (79 men and 167 women; mean age ± SD: 45.4 ± 11.4 years) were recruited from 5 outpatient physiotherapy departments in Dublin, Ireland. Consenting participants completed self-report measures of functional disability, pain, quality of life, psychosocial beliefs, and PA were randomly allocated to the WP (n = 82), EC (n = 83), or UP (n = 81) and followed up at 3 (81%; n = 200), 6 (80.1%; n = 197), and 12 months (76.4%; n = 188). Cost diaries were completed at all follow-ups. An intention-to-treat analysis using a mixed between-within repeated-measures analysis of covariance found significant improvements over time on the Oswestry Disability Index (Primary Outcome), the Numerical Rating Scale, Fear Avoidance-PA scale, and the EuroQol EQ-5D-3L Weighted Health Index (P < 0.05), but no significant between-group differences and small between-group effect sizes (WP: mean difference at 6 months, 6.89 Oswestry Disability Index points, 95% confidence interval [CI] -3.64 to -10.15; EC: -5.91, CI: -2.68 to -9.15; UP: -5.09, CI: -1.93 to -8.24). The WP had the lowest mean costs and the highest level of adherence. Supervised walking provides an effective alternative to current forms of CLBP management.

Outcome in patients with cystic fibrosis liver disease.

BACKGROUND: Liver disease is an important complication in CF. AIMS: To determine if CFLD is a risk factor for mortality in CF, and which baseline characteristics predict all-cause mortality. METHODS: Irish children with CFLD, and their age and gender matched controls were enrolled at baseline and reviewed after 10years to determine which characteristics predict mortality. RESULTS: 72/84 (85.71%) participants were followed, (mean age Cases 21.71yrs SD 6.5, CF controls 23.62 SD 5.6, 22 (61%) males), with no difference in duration of follow-up. Nineteen participants (26.4%) died, 38.9% (14/36) with CFLD and 13.89% (5/36) CF controls (Odds Ratio (OR) 3.94 95% CI:1.23-12.56 p=0.005). In logistic regression, liver disease (OR 4.28 95% CI 1.07-17.16) female gender (OR 12.25 95% CI 2.37-63.24), reduced pulmonary function, (OR 5.11 95% CI 1.09-23.81) were each independent risk factors for mortality in CF. CONCLUSIONS: Liver disease is an independent risk factor for mortality in CF.

Acute hospital, community, and indirect costs of stroke associated with atrial fibrillation: population-based study.

BACKGROUND AND PURPOSE: No economic data from population-based studies exist on acute or late hospital, community, and indirect costs of stroke associated with atrial fibrillation (AF-stroke). Such data are essential for policy development, service planning, and cost-effectiveness analysis of new therapeutic agents. METHODS: In a population-based prospective study of incident and recurrent stroke treated in hospital and community settings, we investigated direct (healthcare related) and indirect costs for a 2-year period. Survival, disability, poststroke residence, and healthcare use were determined at 90 days, 1 year, and 2 years. Acute hospital cost was determined using a case-mix approach, and other costs using a bottom-up approach (2007 prices). RESULTS: In 568 patients ascertained in 1 year (2006), the total estimated 2-year cost was $33.84 million. In the overall sample, AF-stroke accounted for 31% (177) of patients, but a higher proportion of costs (40.5% of total and 45% of nursing home costs). On a per-patient basis compared with non-AF-stroke, AF-stroke was associated with higher total (P<0.001) and acute hospital costs (P<0.001), and greater nursing home (P=0.001) and general practitioner (P<0.001) costs among 90-day survivors. After stratification by stroke severity in survivors, AF was associated with 2-fold increase in costs in patients with mild-moderate (National Institutes of Health Stroke Scale, 0-15) stroke (P<0.001) but not in severe stroke (National Institutes of Health Stroke Scale ≥16; P=0.7). CONCLUSIONS: In our population study, AF-stroke was associated with substantially higher total, acute hospital, nursing home, and general practitioner costs per patient. Targeted programs to identify AF and prevent AF-stroke may have significant economic benefits, in addition to health benefits.

NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease.

INTRODUCTION: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82 weeks with a treatment period of 78 weeks. METHODS AND ANALYSIS: Adult patients, males and females over 50 years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria, will be included in the study. It aims to recruit a total of 500 patients with AD; 250 in the nilvadipine group and 250 in the placebo group. Participants will be randomised to receive nilvadipine, an 8 mg overencapsulated, sustained release capsule, or a matching overencapsulated placebo (sugar pill) for a period of 78 weeks of treatment. The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer's disease Assessment Scale (ADAS-Cog 12) from baseline to the end of treatment duration (78 weeks). There are two key secondary outcome measures, the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and the Disability Assessment for Dementia (DAD). If a statistically significant effect is seen in the primary outcome, CDR-sb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis. ETHICS AND DISSEMINATION: The study and all subsequent amendments have received ethical approval within each participating country according to national regulations. Each participant will provide written consent to participate in the study. All participants will remain anonymised throughout and the results of the study will be published in an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: EUDRACT Reference Number: 2012-002764-27.

A Randomised Controlled Trial Comparing the Impact of Yoga and Physical Education on the Emotional and Behavioural Functioning of Middle School Children.

BACKGROUND: Yoga programs geared for school children have become more widespread, but research regarding its impact on children is lacking. Several studies have reported positive outcomes, though there is a need for more randomised controlled trials. OBJECTIVES: To determine the effects of yoga on children's emotional and behavioural functioning when compared with physical education (PE) classes. METHODS: Thirty middle school children were randomised to participate in either a school-based Ashtanga-informed yoga or PE class three times a week for 12 weeks. Emotional (i.e. affect, self-perceptions) and behavioural (i.e. internalising and externalising problems, aggression) functioning were measured pre and post-intervention. RESULTS: There were no significant changes between groups in self-reported positive affect, global self-worth, aggression indices or parent reports of their children's externalising and internalising problems. However, negative affect increased for those children participating in yoga when compared to the PE program. CONCLUSIONS: In general, findings suggest that yoga and PE classes do not differentially impact on middle school children's emotional and behavioural functioning. However, children reported experiencing increased negative emotions after receiving yoga while children in the PE group reported a decrease in these feelings. Implications of these results and potential directions for future research on children's yoga are discussed.

Frequent mental distress (FMD) in Irish Travellers: discrimination and bereavement negatively influence mental health in the All Ireland Traveller Health Study.

Travellers are an indigenous minority group in Ireland, with poorer life expectancy and health status than the general population. Recent data have shown that Travellers are at increased risk of poor mental health and sequelae from same. We aimed to examine the associations between sociodemographic and lifestyle factors with poor mental health in Irish Travellers. A census survey of all Travellers was undertaken, with 8,492 enumerated families (80% response rate). A random subset of 1,796 adults completed an adult health survey. Traveller peer researchers employed a novel oral-visual computer-aided data collection tool. Frequent mental distress (FMD) was defined as 14 or more days of poor mental health in the preceding 1 month. Prevalence ratios for typical associates of FMD were estimated using a Poisson regression model, adjusted for age and sex. FMD was present in 11.9% of Traveller respondents, and prevalence increased with age. After age and sex adjustment, FMD was more prevalent in those whose quality of life was impaired by physical health, by those who were recently bereaved of a friend or family member, and by those who had greater experiences of discrimination. This study shows that Travellers experience discrimination and bereavement, which negatively influence their mental health. The findings have implications for the mental healthcare needs of indigenous ethnic minorities worldwide.

Physiotherapy for sleep disturbance in people with chronic low back pain: results of a feasibility randomized controlled trial.

OBJECTIVE: To determine the feasibility of a randomized controlled trial investigating the effectiveness of physiotherapy for sleep disturbance in chronic low back pain (CLBP) (≥12wks). DESIGN: Randomized controlled trial with evaluations at baseline, 3 months, and 6 months. SETTING: Outpatient physiotherapy department in an academic teaching hospital. PARTICIPANTS: Participants with CLBP were randomly assigned to a walking program (n=20; mean age ± SD, 46.4±13.8y), supervised exercise class (n=20; mean age ± SD, 41.3±11.9y), or usual physiotherapy (n=20; mean age ± SD, 47.1±14.3y). The 3-month evaluation was completed by 44 participants (73%), and 42 (70%) participants completed the 6-month evaluation. INTERVENTIONS: Participants received a physiotherapy-delivered 8-week walking program, an 8-week group supervised exercise class (1 class/wk), or 1-to-1 usual physiotherapy (advice, manual therapy, and exercise). MAIN OUTCOME MEASURES: Sleep was assessed by the self-reported Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Pittsburgh Sleep Diary, and objective actigraphy. RESULTS: Groups were comparable at baseline. Most (95%, n=57) of the participants had sleep disturbance. The acceptability of actigraphy was excellent at baseline (58 of 60 participants), but dropped at 3 months (26 of 44 participants). There were improvements on the PSQI and ISI in all groups at 3 and 6 months, with predominantly medium effect sizes (Cohen d=0.2-0.5). CONCLUSIONS: The high prevalence of sleep disturbance indicated the feasibility of good recruitment in future trials. The PSQI would be a suitable screening tool and outcome measure alongside an objective nonobtrusive sleep outcome measure. The effectiveness of physiotherapy for sleep disturbance in CLBP warrants investigation in a fully powered randomized controlled trial.

A randomized controlled trial on the effects of yoga on stress reactivity in 6th grade students.

There is an increasing interest in developing school programs that improve the ability of children to cope with psychosocial stress. Yoga may be an appropriate intervention as it has demonstrated improvements in the ability of children to manage psychosocial stress. Yoga is thought to improve the control of reactivity to stress via the regulation of the autonomic nervous system. The current study examined the effects of yoga compared to a physical education class on physiological response (blood pressure (BP) and heart rate (HR)) to behavioral stressor tasks (mental arithmetic and mirror tracing tasks). Data analysis of BP and HR was performed using a 2 × 2 × 4 repeated measures ANOVA (time × group × stressor time points). 30 (17 male) 6th graders participated in the study. Yoga did not provide significant differences in stress reactivity compared to a physical education class (group × time: systolic (F(1,28) = .538, P = .470); diastolic (F(1,28) = .1.061, P = .312); HR (F(1,28) = .401, P = .532)). The lack of significant differences may be due to the yoga intervention failing to focus on stress management and/or the stressor tasks not adequately capturing attenuation of stressor response.

Disparities in fatal and non-fatal injuries between Irish travellers and the Irish general population are similar to those of other indigenous minorities: a cross-sectional population-based comparative study.

OBJECTIVES: To assess recent disparities in fatal and non-fatal injury between travellers and the general population in Ireland. DESIGN: A cross-sectional population-based comparative study. SETTING: Republic of Ireland. PARTICIPANTS: Population census and retrospective mortality data were collected from 7042 traveller families, travellers being those identified by themselves and others as members of the traveller community. Retrospective injury incidence was estimated from a survey of a random sample of travellers in private households, aged 15 years or over (702 men and 961 women). Comparable general population data were obtained from official statistical reports, while retrospective incidence was estimated from the Survey of Lifestyle, Attitude and Nutrition 2002, a random sample of 5992 adults in private households aged 18 years or over. OUTCOME MEASURES: Potential Years of Life Lost (PYLL), Standardised Mortality Ratios (SMR), Standardised Incidence Ratios (SIR) and Case Fatality Ratios (CFR). RESULTS: Injury accounted for 36% of PYLL among travellers, compared with 13% in the general population. travellers were more likely to die of unintentional injury than the general population (SMR=454 (95% CI 279 to 690) in men and 460 (95% CI 177 to 905) in women), with a similar pattern for intentional injury (SMR=637 (95% CI 367 to 993) in men and 464 (95% CI 107 to 1204 in women). They had a lower incidence of unintentional injury but those aged 65 years or over were about twice as likely to report an injury. Travellers had a higher incidence of intentional injuries (SIR=181 (95% CI 116 to 269) in men and 268 (95% CI 187 to 373) in women). Injury CFR were consistently higher among travellers. CONCLUSIONS: Irish travellers continue to bear a disproportionate burden of injury, which calls for scaling up injury prevention efforts in this group. Prevention and further research should focus on suicide, alcohol misuse and elderly injury among Irish travellers.

Social inequalities in health expectancy and the contribution of mortality and morbidity: the case of Irish Travellers.

BACKGROUND: The health expectancy of Irish Travellers, a disadvantaged indigenous minority group in Ireland has not been previously estimated. This study aimed to examine health expectancy inequalities between Irish Travellers and the general population. METHODS: We used Sullivan's life table method to construct healthy life expectancy (HLE) and disability-free life expectancy (DFLE). The All-Ireland Traveller Health Study provided Irish Traveller population's mortality and health data. Vital registration, census and comparable national survey health data were used for the general population. We calculated the absolute and relative life expectancy, HLE and DFLE gaps between Irish Travellers and the general population and decomposed the HLE and DFLE gaps into mortality and morbidity contributions. RESULTS: Irish Travellers had consistently lower HLE and DFLE than the general population. The health expectancy gap displayed notable age and gender variations and was wider than the life expectancy gap. Mortality contributed more than morbidity to the health expectancy gap in men but not in women. CONCLUSIONS: This study illustrated the true extent of health inequalities experienced by an indigenous minority in Europe, clarifying the importance of reducing the burden of non-fatal disabling conditions for addressing these inequalities. The health expectancy measure used has application for other similar indigenous minorities elsewhere.