Arthritis Research UK and Medical Research Council.
SummaryBackgroundEvidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals.MethodsIn this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232.FindingsBetween Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were −3·26 kg (brief intervention), −4·75 kg (12-week programme), and −6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference −2·71 kg, 95% CI −3·86 to −1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (−2·14 kg, −3·05 to −1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY)....
Objective To determine the clinical and cost effectiveness of booklet based vestibular rehabilitation with and without telephone support for chronic dizziness, compared with routine care.Design Single blind, parallel group, pragmatic, randomised controlled trial. Setting 35 general practices across southern England between October 2008 and January 2011.Participants Patients aged 18 years or over with chronic dizziness (mean duration >five years) not attributable to non-vestibular causes (confirmed by general practitioner) and that could be aggravated by head movement (confirmed by patient).Interventions Participants randomly allocated to receive routine medical care, booklet based vestibular rehabilitation only, or booklet based vestibular rehabilitation with telephone support. For the booklet approach, participants received self management booklets providing comprehensive advice on undertaking vestibular rehabilitation exercises at home daily for up to 12 weeks and using cognitive behavioural techniques to promote positive beliefs and treatment adherence. Participants receiving telephone support were offered up to three brief sessions of structured support from a vestibular therapist.Main outcome measures Vertigo symptom scale-short form and total healthcare costs related to dizziness per quality adjusted life year (QALY). ResultsOf 337 randomised participants, 276 (82%) completed all clinical measures at the primary endpoint, 12 weeks, and 263 (78%) at one year follow-up. We analysed clinical effectiveness by intention to treat, using analysis of covariance to compare groups after intervention, controlling for baseline symptom scores. At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference −1.79 (95% confidence interval −3.69 tο 0.11), P=0.064). At one year, both intervention groups improved significantly relative to routine care (telephone support −2.52 (−4.52 to −0.51), P=0.014; booklet only −2.43 (−4.27 to −0.60), P=0.010). Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488; $1932). Using the booklet approach with telephone support, five (three to 12) patients would need to be treated for one patient to report subjective improvement at one year.Conclusions Booklet based vestibular rehabilitation for chronic dizziness is a simple and cost effective means of improving patient reported outcomes in primary care. Trial registration ClinicalTrials.gov NCT00732797.Correspondence to: L Yardley L.Yardley@soton.ac.uk Extra material supplied by the author (see http://www.bmj.com/content/344/bmj.e2237?tab=related#webextra) RESEARCH IntroductionDizziness associated with vestibular dysfunction is a very common condition, especia...
Objective To review the clinical effectiveness of oseltamivir and zanamivir for the treatment and prevention of influenza A and B. Design Systematic review and meta-analyses of randomised controlled trials. Data sources Published studies were retrieved from electronic bibliographic databases; supplementary data were obtained from the manufacturers. Selection of studies Randomised controlled, double blind trials that were published in English, had data available before 31 December 2001, evaluated treatment or prevention of naturally occurring influenza with zanamivir or oseltamivir (if given using the formulation and dosage licensed for clinical use), and reported at least one end point of relevance. Review methods The main outcome measures were the median time to the alleviation of symptoms (for treatment trials) and number of flu episodes avoided (for prevention trials). Three population groups were defined: children aged 12 years and under; otherwise healthy individuals aged 12 to 65 years; and "high risk" individuals (those with certain chronic medical conditions or aged 65 years and older). Results Seventeen treatment trials and seven prevention trials identified met the inclusion criteria. All trials included compared one of the drugs against placebo or standard care. Treatment of children, otherwise healthy individuals, and high risk populations with zanamivir reduced the median duration of symptoms in days respectively by 1.0 (95% confidence interval 0.5 to 1.5), 0.8 (0.3 to 1.3), and 0.9 ( − 0.1 to 1.9) for the intention to treat population. The corresponding results, in days, for oseltamivir were 0.9 (0.3 to 1.5), 0.9 (0.3 to 1.4), and 0.4 ( − 0.7 to 1.4). The effect of giving zanamivir and oseltamivir prophylactically resulted in a relative reduction of 70-90% in the odds of developing flu, depending on the strategy adopted and the population studied. Conclusions Evidence from randomised controlled trials consistently supports the view that both oseltamivir and zanamivir are clinically effective for treating and preventing flu. However, evidence is limited for the treatment of certain populations and for all prevention strategies.
National Research Register N0484094184 ISRCTN: 03525333.
BackgroundExercise has been shown to be effective in treating depression, but trials testing the effect of exercise for depressed adolescents utilising mental health services are rare. The aim of this study was to determine the effectiveness of a preferred intensity exercise intervention on the depressive symptoms of adolescents with depression.MethodsWe randomly assigned 87 adolescents who were receiving treatment for depression to either 12 sessions of aerobic exercise at preferred intensity alongside treatment as usual or treatment as usual only. The primary outcome was depressive symptom change using the Children’s Depression Inventory 2nd Version (CDI-2) at post intervention. Secondary outcomes were health-related quality of life and physical activity rates. Outcomes were taken at baseline, post intervention and at six month follow up.ResultsCDI-2 score reduction did not differ significantly between groups at post-intervention (est. 95 % CI −6.82, 1.68, p = 0.23). However, there was a difference in CDI-2 score reduction at six month follow-up in favour of the intervention of −4.81 (est. 95 % CI −9.49, −0.12, p = 0.03). Health-related quality of life and physical activity rates did not differ significantly between groups at post-intervention and follow-up.ConclusionsThere was no additional effect of preferred intensity exercise alongside treatment as usual on depressive reduction immediately post intervention. However, effects were observed at six months post-intervention, suggesting a delayed response. However, further trials, with larger samples are required to determine the validity of this finding.Trial registrationClinicalTrials.gov NCT01474837, March 16 2011
PURPOSE Vestibular rehabilitation is an effective intervention for dizziness due to vestibular dysfunction, but is seldom provided. We aimed to determine the effectiveness of an Internet-based vestibular rehabilitation program for older adults experiencing dizziness in primary care. METHODSWe undertook a single-center, single-blind randomized controlled trial comparing an Internet-based vestibular rehabilitation intervention (Balance Retraining, freely available from https://balance.lifeguidehealth.org) with usual primary care in patients from 54 primary care practices in southern England. Patients aged 50 years and older with current dizziness exacerbated by head movements were enrolled. Those in the intervention group accessed an automated Internet-based program that taught vestibular rehabilitation exercises and suggested cognitive behavioral management strategies. Dizziness was measured by the Vertigo Symptom Scale-Short Form (VSS-SF) at baseline, 3 months, and 6 months. The primary outcome was VSS-SF score at 6 months. RESULTS A total of 296 patients were randomized in the trial; 66% were female, and the median age was 67 years. The VSS-SF was completed by 250 patients (84%) at 3 months and 230 patients (78%) at 6 months. Compared with the usual care group, the Internet-based vestibular rehabilitation group had less dizziness on the VSS-SF at 3 months (difference, 2.75 points; 95% CI, 1.39-4.12; P <.001) and at 6 months (difference, 2.26 points; 95% CI, 0.39-4.12; P = .02, respectively). Dizziness-related disability was also lower in the Internet-based vestibular rehabilitation group at 3 months (difference, 6.15 points; 95% CI, 2.81-9.49; P <.001) and 6 months (difference, 5.58 points; 95% CI, 1.19-10.0; P = .01).CONCLUSIONS Internet-based vestibular rehabilitation reduces dizziness and dizziness-related disability in older primary care patients without requiring clinical support. This intervention has potential for wide application in community settings. Ann Fam Med 2017;15:209-216. https://doi.org/10.1370/afm.2070. INTRODUCTIOND izziness is a highly prevalent symptom 1,2 responsible for nearly 7 million consultations per year in the United States. 3 In primary care, the majority of dizziness is caused by vestibular dysfunction, including benign paroxysmal positional vertigo. 4 Dizziness in older adults is associated with falls, fear of falling, anxiety, and depression, contributing to substantial disability, increased frailty, and loss of independence. 5,6 With a growing aging population, the health burden will steadily increase. 7Although dizziness has higher prevalence in older adults, more than 1 in 10 people of working age experience dizziness that causes dysfunction or leads to medical consultations. 8 Often going untreated, dizziness can become chronic; in a recent primary care trial including adults of all ages, the mean duration of symptoms was 5.5 years.9 Medical and surgical interventions offer limited benefit 10 ; however, there is evidence that vestibular rehabilitation exercises are ...
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