Estimating the cost consequence of the early use of botulinum toxin in post-stroke spasticity: Secondary analysis of a randomised controlled trial.

OBJECTIVE: To estimate the cost-consequence of treating spasticity early with botulinum toxin in the acute stroke unit. DESIGN: Secondary cost-consequence analysis, using data from a double-blind randomised-controlled trial. SETTING: Single-centre specialised stroke unit. SUBJECTS AND INTERVENTIONS: Patients with Action Research Arm Test grasp-score of <2 and who developed spasticity within six weeks of a first stroke were randomised to receive injections of: 0.9% sodium-chloride solution (placebo) or onabotulinumtoxin-A (treatment). MAIN MEASURES: Resource use costs were calculated for the study. Mean contracture costs for each group were calculated. The Barthel Index and Action Research Arm Test were used to generate a cost per unit of improvement. RESULTS: There were no significant differences associated with early treatment use. The mean contracture cost for the treatment group was £817 and for the control group was £2298 (mean difference = -£1481.1(95% CI -£2893.5, -£68.7) (p = 0.04). The cost per unit of improvement for the Barthel Index was -£1240 indicating that the intervention costs less and is more effective. The cost per unit of improvement for the Action Research Arm Test was -£450 indicating that the intervention costs less and is more effective. CONCLUSIONS: Treating spasticity early in stroke patients at risk of contractures with botulinum toxin leads to a significant reduction in contracture costs. The cost per improvement of Barthel and Action Research Arm Test indicates that the intervention costs less and is more effective. TRIAL REGISTRATION DATA: EudraCT(2010-021257-39) and ClinicalTrials.gov-Identifier:NCT01882556.

Impact of the COVID-19 pandemic on provision of antimicrobial stewardship education and training in UK health service sites.

The impact of the COVID-19 pandemic on antimicrobial stewardship is a cause for serious concern. There is evidence of increased antibiotic usage in many settings and fears of over-use, especially of broad-spectrum antibiotics in patients with COVID-19, raising concerns about potential impact on antimicrobial resistance globally. At the same time, the pandemic has impacted the provision of education and training throughout the health and education sectors, during a period when health services and staff were under unprecedented pressure. All-Wales Antimicrobial Resistance Educators (AWARE) is an interprofessional network of healthcare professionals whose roles include provision of antimicrobial stewardship education in National Health Service health boards across Wales. The aim of this report was to use AWARE project data to study the impact of the pandemic on the provision of antimicrobial stewardship education and training in healthcare settings in Wales in 2020, compared to 2019. Overall, the number of staff reached by education increased by 10%, despite the number of educational sessions falling by 26% and the number of hours of teaching by 43%. Rapid switch to virtual education allowed fewer, shorter, educational sessions, allowing more staff to be reached.

Cost of managing patients with venous leg ulcers.

The aim of this study was to estimate costs associated with the management of patients with venous leg ulcers (VLUs) from the perspective of the UK National Health Service (NHS). The analysis was undertaken through the Secure Anonymised Information Linkage Databank which brings together and anonymously links a wide range of person-based data from around 75% of general practitioner (GP) practices within Wales (population coverage ~2.5 million). The data covered an 11-year period from 2007 to 2017. All patients linked to the relevant codes were tracked through primary care settings, recording the number of GP practice visits (number of days with an event recorded), and wound treatment utilisation (eg, dressings, bandages, etc.) Resources were valued in monetary terms (£ sterling) and the costs were determined from national published sources of unit costs. This is the first attempt to estimate the costs of managing of VLUs using routine data sources. The direct costs to the Welsh NHS are considerable and represent 1.2% of the annual budget. Nurse visits are the main cost driver with annual estimates of £67.8 million. At a UK level, these costs amount to £1.98 billion. Dressings and compression bandages are also major cost drivers with annual Welsh estimates of £828 790. The direct cost of managing patients with VLUs is £7706 per patient per annum, which translates to an annual cost of over £2 billion, when extrapolated to the UK population. The primary cost driver is the number of district nurse visits. Initiatives to reduce healing times through improving accuracy of initial diagnosis, and improved evidence-based treatment pathways would result in major financial savings.

Opportunistic screening for alcohol use problems in adolescents attending emergency departments: an evaluation of screening tools.

OBJECTIVE: To estimate and compare the optimal cut-off score of Alcohol Use Disorders Identification Test (AUDIT) and AUDIT-C in identifying at-risk alcohol consumption, heavy episodic alcohol use, ICD-10 alcohol abuse and alcohol dependence in adolescents attending ED in England. DESIGN: Opportunistic cross-sectional survey. SETTING: 10 emergency departments across England. PARTICIPANTS: Adolescents (n = 5377) aged between their 10th and 18th birthday who attended emergency departments between December 2012 and May 2013. MEASURES: Scores on the AUDIT and AUDIT-C. At-risk alcohol consumption and monthly episodic alcohol consumption in the past 3 months were derived using the time-line follow back method. Alcohol abuse and alcohol dependence was assessed in accordance with ICD-10 criteria using the MINI-KID. FINDINGS: AUDIT-C with a score of 3 was more effective for at-risk alcohol use (AUC 0.81; sensitivity 87%, specificity 97%), heavy episodic use (0.84; 76%, 98%) and alcohol abuse (0.98; 91%, 90%). AUDIT with a score of 7 was more effective in identifying alcohol dependence (0.92; 96%, 94%). CONCLUSIONS: The 3-item AUDIT-C is more effective than AUDIT in screening adolescents for at-risk alcohol use, heavy episodic alcohol use and alcohol abuse. AUDIT is more effective than AUDIT-C for the identification of alcohol dependence.

Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study.

BACKGROUND: Asymptomatic atrial fibrillation (AF) is increasingly common in the aging population and implicated in many ischemic strokes. Earlier identification of AF with appropriate anticoagulation may decrease stroke morbidity and mortality. METHODS: We conducted a randomized controlled trial of AF screening using an AliveCor Kardia monitor attached to a WiFi-enabled iPod to obtain ECGs (iECGs) in ambulatory patients. Patients ≥65 years of age with a CHADS-VASc score ≥2 free from AF were randomized to the iECG arm or routine care (RC). iECG participants acquired iECGs twice weekly over 12 months (plus additional iECGs if symptomatic) onto a secure study server with overread by an automated AF detection algorithm and by a cardiac physiologist and/or consultant cardiologist. Time to diagnosis of AF was the primary outcome measure. The overall cost of the devices, ECG interpretation, and patient management were captured and used to generate the cost per AF diagnosis in iECG patients. Clinical events and patient attitudes/experience were also evaluated. RESULTS: We studied 1001 patients (500 iECG, 501 RC) who were 72.6±5.4 years of age; 534 were female. Mean CHADS-VASc score was 3.0 (heart failure, 1.4%; hypertension, 54%; diabetes mellitus, 30%; prior stroke/transient ischemic attack, 6.5%; arterial disease, 15.9%; all CHADS-VASc risk factors were evenly distributed between groups). Nineteen patients in the iECG group were diagnosed with AF over the 12-month study period versus 5 in the RC arm (hazard ratio, 3.9; 95% confidence interval=1.4-10.4; P=0.007) at a cost per AF diagnosis of $10 780 (£8255). There was a similar number of stroke/transient ischemic attack/systemic embolic events (6 versus 10, iECG versus RC; hazard ratio=0.61; 95% confidence interval=0.22-1.69; P=0.34). The majority of iECG patients were satisfied with the device, finding it easy to use without restricting activities or causing anxiety. CONCLUSIONS: Screening with twice-weekly single-lead iECG with remote interpretation in ambulatory patients ≥65 years of age at increased risk of stroke is significantly more likely to identify incident AF than RC over a 12-month period. This approach is also highly acceptable to this group of patients, supporting further evaluation in an appropriately powered, event-driven clinical trial. CLINICAL TRIAL REGISTRATION: URL: https://www.isrctn.com. Unique identifier: ISRCTN10709813.

Pragmatic RAndomised controlled trial of a trauma-focused guided self-help Programme versus InDividual trauma-focused cognitive Behavioural therapy for post-traumatic stress disorder (RAPID): trial protocol.

BACKGROUND: There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. However, they are not always feasible to deliver due a shortage of trained therapists and demands on the patient. An online trauma-focused Guided Self-Help (GSH) programme which could overcome these barriers has shown promise in a pilot study. This study will be the first to evaluate GSH against standard face-to-face therapy to assess its suitability for use in the NHS. METHODS: The study is a large-scale multi-centre pragmatic randomised controlled non-inferiority trial, with assessors masked to treatment allocation. One hundred and ninety-two participants will be randomly allocated to receive either face-to-face trauma-focused cognitive behaviour therapy (TFCBT) or trauma-focused online guided self-help (GSH). The primary outcome will be the severity of symptoms of PTSD over the previous week as measured by the Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks post-randomisation. Secondary outcome measures include PTSD symptoms over the previous month as measured by the CAPS-5 at 52 weeks plus the Impact of Event Scale - revised (IES-R), Work and Social Adjustment Scale (WSAS), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Alcohol Use Disorders Test (AUDIT-O), Multidimensional Scale for Perceived Social Support (MSPSS), short Post-Traumatic Cognitions Inventory (PTCI), Insomnia Severity Index (ISI) and General Self Efficacy Scale (GSES) measured at 16 and 52 weeks post-randomisation. Changes in health-related quality of life will be measured by the EQ-5D and the level of healthcare resource utilisation for health economic analysis will be determined by an amended version of the Client Socio-Demographic and Service Receipt Inventory European Version. The Client Satisfaction Questionnaire (CSQ) will be collected at 16 weeks post-randomisation to evaluate treatment satisfaction. DISCUSSION: This study will be the first to compare online GSH with usual face-to-face therapy for PTSD. The strengths are that it will test a rigorously developed intervention in a real world setting to inform NHS commissioning. The potential challenges of delivering such a pragmatic study may include participant recruitment, retention and adherence, therapist retention, and fidelity of intervention delivery. TRIAL REGISTRATION: ISRCTN13697710 registered on 20/12/2016.

Low-Dose Intravenous Immunoglobulin Treatment for Long-Standing Complex Regional Pain Syndrome: A Randomized Trial.

BACKGROUND: Two small trials suggest that low-dose intravenous immunoglobulin (IVIg) may improve the symptoms of complex regional pain syndrome (CRPS), a rare posttraumatic pain condition. OBJECTIVE: To confirm the efficacy of low-dose IVIg compared with placebo in reducing pain during a 6-week period in adult patients who had CRPS from 1 to 5 years. DESIGN: 1:1 parallel, randomized, placebo-controlled, multicenter trial for 6 weeks, with an optional 6-week open extension. Patients were randomly assigned to 1 of 2 study groups between 27 August 2013 and 28 October 2015; the last patient completed follow-up on 21 March 2016. Patients, providers, researchers, and outcome assessors were blinded to treatment assignment. (ISRCTN42179756). SETTING: 7 secondary and tertiary care pain management centers in the United Kingdom. PARTICIPANTS: 111 patients with moderate or severe CRPS of 1 to 5 years' duration. INTERVENTION: IVIg, 0.5 g/kg of body weight, or visually indistinguishable placebo of 0.1% albumin in saline on days 1 and 22 after randomization. MEASUREMENTS: The primary outcome was 24-hour average pain intensity, measured daily between days 6 and 42, on an 11-point (0- to 10-point) rating scale. Secondary outcomes were pain interference and quality of life. RESULTS: The primary analysis sample consisted of 108 eligible patients, 103 of whom had outcome data. Mean (average) pain scores were 6.9 points (SD, 1.5) for placebo and 7.2 points (SD, 1.3) for IVIg. The adjusted difference in means was 0.27 (95% CI, -0.25 to 0.80; P = 0.30), which excluded the prespecified, clinically important difference of -1.2. No statistically significant differences in secondary outcomes were found between the groups. In the open extension, 12 of the 67 patients (18%) who received 2 IVIg infusions had pain reduction of at least 2 points compared with their baseline score. Two patients in the blinded phase (1 in the placebo and 1 in the IVIg group) and 4 in the open IVIg phase had serious events. LIMITATIONS: Results do not apply to patients who have had CRPS for less than 1 year or more than 5 years and do not extend to full-dose treatment (for example, 2 g/kg). The study was inadequately powered to detect subgroup effects. CONCLUSION: Low-dose immunoglobulin treatment for 6 weeks was not effective in relieving pain in patients with moderate to severe CRPS of 1 to 5 years' duration. PRIMARY FUNDING SOURCE: Medical Research Council/National Institute for Health Research Efficacy and Mechanism Evaluation Program, Pain Relief Foundation, and Biotest United Kingdom.

Improving Mental Health Through the Regeneration of Deprived Neighborhoods: A Natural Experiment.

Neighborhood-level interventions provide an opportunity to better understand the impact of neighborhoods on health. In 2001, the Welsh Government, United Kingdom, funded Communities First, a program of neighborhood regeneration delivered to the 100 most deprived of the 881 electoral wards in Wales. In this study, we examined the association between neighborhood regeneration and mental health. Information on regeneration activities in 35 intervention areas (n = 4,197 subjects) and 75 control areas (n = 6,695 subjects) was linked to data on mental health from a cohort study with assessments made in 2001 (before regeneration) and 2008 (after regeneration). Propensity score matching was used to estimate the change in mental health in intervention neighborhoods versus control neighborhoods. Baseline differences between intervention and control areas were of similar magnitude as produced by paired randomization of neighborhoods. Regeneration was associated with an improvement in the mental health of residents in intervention areas compared with control neighborhoods (ß = 1.54, 95% confidence interval: 0.50, 2.59), suggesting a reduction in socioeconomic inequalities in mental health. There was a dose-response relationship between length of residence in regeneration neighborhoods and improvements in mental health (P-trend = 0.05). These results show that targeted regeneration of deprived neighborhoods can improve mental health.

Paramedic Assessment of Older Adults After Falls, Including Community Care Referral Pathway: Cluster Randomized Trial.

STUDY OBJECTIVE: We aim to determine clinical and cost-effectiveness of a paramedic protocol for the care of older people who fall. METHODS: We undertook a cluster randomized trial in 3 UK ambulance services between March 2011 and June 2012. We included patients aged 65 years or older after an emergency call for a fall, attended by paramedics based at trial stations. Intervention paramedics could refer the patient to a community-based falls service instead of transporting the patient to the emergency department. Control paramedics provided care as usual. The primary outcome was subsequent emergency contacts or death. RESULTS: One hundred five paramedics based at 14 intervention stations attended 3,073 eligible patients; 110 paramedics based at 11 control stations attended 2,841 eligible patients. We analyzed primary outcomes for 2,391 intervention and 2,264 control patients. One third of patients made further emergency contacts or died within 1 month, and two thirds within 6 months, with no difference between groups. Subsequent 999 call rates within 6 months were lower in the intervention arm (0.0125 versus 0.0172; adjusted difference -0.0045; 95% confidence interval -0.0073 to -0.0017). Intervention paramedics referred 8% of patients (204/2,420) to falls services and left fewer patients at the scene without any ongoing care. Intervention patients reported higher satisfaction with interpersonal aspects of care. There were no other differences between groups. Mean intervention cost was $23 per patient, with no difference in overall resource use between groups at 1 or 6 months. CONCLUSION: A clinical protocol for paramedics reduced emergency ambulance calls for patients attended for a fall safely and at modest cost.

Implementation of a Cooking Bus intervention to support cooking in schools in Wales, UK.

PURPOSE: The teaching of cooking is an important aspect of school-based efforts to promote healthy diets among children, and is frequently done by external agencies. Within a limited evidence base relating to cooking interventions in schools, there are important questions about how interventions are integrated within school settings. The purpose of this paper is to examine how a mobile classroom (Cooking Bus) sought to strengthen connections between schools and cooking, and drawing on the concept of the sociotechnical network, theorise the interactions between the Bus and school contexts. DESIGN/METHODOLOGY/APPROACH: Methods comprised a postal questionnaire to 76 schools which had received a Bus visit, and case studies of the Bus' work in five schools, including a range of school sizes and urban/rural locations. Case studies comprised observation of Cooking Bus sessions, and interviews with school staff. FINDINGS: The Cooking Bus forged connections with schools through aligning intervention and schools' goals, focussing on pupils' cooking skills, training teachers and contributing to schools' existing cooking-related activities. The Bus expanded its sociotechnical network through post-visit integration of cooking activities within schools, particularly teachers' use of intervention cooking kits. RESEARCH LIMITATIONS/IMPLICATIONS: The paper highlights the need for research on the long-term impacts of school cooking interventions, and better understanding of the interaction between interventions and school contexts. ORIGINALITY/VALUE: This paper adds to the limited evidence base on school-based cooking interventions by theorising how cooking interventions relate to school settings, and how they may achieve integration.

The epidemiology, healthcare and societal burden and costs of asthma in the UK and its member nations: analyses of standalone and linked national databases.

BACKGROUND: There are a lack of reliable data on the epidemiology and associated burden and costs of asthma. We sought to provide the first UK-wide estimates of the epidemiology, healthcare utilisation and costs of asthma. METHODS: We obtained and analysed asthma-relevant data from 27 datasets: these comprised national health surveys for 2010-11, and routine administrative, health and social care datasets for 2011-12; 2011-12 costs were estimated in pounds sterling using economic modelling. RESULTS: The prevalence of asthma depended on the definition and data source used. The UK lifetime prevalence of patient-reported symptoms suggestive of asthma was 29.5 % (95 % CI, 27.7-31.3; n = 18.5 million (m) people) and 15.6 % (14.3-16.9, n = 9.8 m) for patient-reported clinician-diagnosed asthma. The annual prevalence of patient-reported clinician-diagnosed-and-treated asthma was 9.6 % (8.9-10.3, n = 6.0 m) and of clinician-reported, diagnosed-and-treated asthma 5.7 % (5.7-5.7; n = 3.6 m). Asthma resulted in at least 6.3 m primary care consultations, 93,000 hospital in-patient episodes, 1800 intensive-care unit episodes and 36,800 disability living allowance claims. The costs of asthma were estimated at least £1.1 billion: 74 % of these costs were for provision of primary care services (60 % prescribing, 14 % consultations), 13 % for disability claims, and 12 % for hospital care. There were 1160 asthma deaths. CONCLUSIONS: Asthma is very common and is responsible for considerable morbidity, healthcare utilisation and financial costs to the UK public sector. Greater policy focus on primary care provision is needed to reduce the risk of asthma exacerbations, hospitalisations and deaths, and reduce costs.

Estimating the costs associated with the management of patients with chronic wounds using linked routine data.

Chronic wounds are known to represent a significant burden to patients and National Health Service (NHS) alike. However, previous attempts to estimate the costs associated with the management of chronic wounds have been based on literature studies or broad estimates derived from incidence rates and extrapolations from relatively small-scale studies. The aim of this study is therefore to determine the extent of resource utilisation by patients classed as having chronic wounds within Wales using linked routine data - available through the Secure Anonymised Information Linkage (SAIL) database - to estimate the costs associated with the management of these patients by the NHS in Wales. The SAIL database brings together, and anonymously links, a wide range of person-based data from general practitioner (GP) practices within Wales, which includes primary and secondary care consultations to create an encrypted anonymised linking field for each individual. This linkage allows the patient pathway to be tracked through the NHS system both retrospectively and prospectively from a specific reference date. The estimated costs were derived by extrapolating to an all-Wales level from the results gleaned from the SAIL database using the respective READ codes to capture relevant patients with chronic wounds. The number of patients identified as having chronic wounds within the SAIL database was 78 090, which equates to 190 463 across Wales as a whole and a prevalence of 6% of the Welsh population. The total cost of managing patients with chronic wounds in Wales amounted to £328·8 million - an average cost of £1727 per patient and 5·5% of total expenditure on the health service in Wales. A relatively few READ codes represented a significant proportion of expenditure, with diabetic foot ulcers, leg ulcers, foot ulcers, varicose eczema, bed sores and postoperative wound care constituting 93% of total expenditure. When a more conservative perspective was used in relation to classification of chronic wounds, the total cost amounted to £303 million. However, these are likely to be underestimates because of the lack of information for patients with treatments lasting over 6 months and not including patients who might have entered the health care system of wound management elsewhere - such as patients contracting pressure ulcers in hospitals and having surgical wound infections.

Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies.

OBJECTIVE: To estimate the prevalence of inadequate pain relief (IPR) among patients with symptomatic knee OA prescribed analgesic therapy and to characterize patients with IPR. METHODS: Patients ≥50 years old with physician-diagnosed knee OA who had taken topical or oral pain medication for at least 14 days were recruited for this prospective non-interventional study in six European countries. Pain and function were assessed using the Brief Pain Inventory (BPI) and the WOMAC; quality of life (QoL) was assessed using the 12-item short form. IPR was defined as an average pain score of >4 out of 10 on BPI question 5. RESULTS: Of 1187 patients enrolled, 68% were female and the mean age was 68 years (s.d. 9); 639 (54%) met the definition of IPR. Patient responses for the BPI average pain question were well correlated with responses on the WOMAC pain subscale (Spearman r = 0.64, P < 0.001). In multivariate logistic regression, patients with IPR had greater odds of being female [adjusted odds ratio (adjOR) 1.90 (95% CI 1.46, 2.48)] and having OA in both knees [adjOR 1.48 (95% CI 1.15, 1.90)], higher BMI, longer OA duration, depression or diabetes. Patients with IPR (vs non-IPR) were more likely to have worse QoL, greater function loss and greater pain interference. CONCLUSION: IPR is common among patients with knee OA requiring analgesics and is associated with large functional loss and impaired QoL. Patients at particular risk of IPR, as characterized in this study, may require greater attention towards their analgesic treatment options. TRIAL REGISTRATION: https://clinicaltrials.gov/ (NCT01294696).

Linked randomised controlled trials of face-to-face and electronic brief intervention methods to prevent alcohol related harm in young people aged 14-17 years presenting to Emergency Departments (SIPS junior).

BACKGROUND: Alcohol is a major global threat to public health. Although the main burden of chronic alcohol-related disease is in adults, its foundations often lie in adolescence. Alcohol consumption and related harm increase steeply from the age of 12 until 20 years. Several trials focusing upon young people have reported significant positive effects of brief interventions on a range of alcohol consumption outcomes. A recent review of reviews also suggests that electronic brief interventions (eBIs) using internet and smartphone technologies may markedly reduce alcohol consumption compared with minimal or no intervention controls. Interventions that target non-drinking youth are known to delay the onset of drinking behaviours. Web based alcohol interventions for adolescents also demonstrate significantly greater reductions in consumption and harm among 'high-risk' drinkers; however changes in risk status at follow-up for non-drinkers or low-risk drinkers have not been assessed in controlled trials of brief alcohol interventions. DESIGN AND METHODS: The study design comprises two linked randomised controlled trials to evaluate the effectiveness and cost-effectiveness of two intervention strategies compared with screening alone. One trial will focus on high-risk adolescent drinkers attending Emergency Departments (Eds) and the other will focus on those identified as low-risk drinkers or abstinent from alcohol but attending the same ED. Our primary (null) hypothesis is similar for both trials: Personalised Feedback and Brief Advice (PFBA) and Personalised Feedback plus electronic Brief Intervention (eBI) are no more effective than screening alone in alcohol consumed at 12 months after randomisation as measured by the Time-Line Follow-Back 28-day version. Our secondary (null) hypothesis relating to economics states that PFBA and eBI are no more cost-effective than screening alone. In total 1,500 participants will be recruited into the trials, 750 high-risk drinkers and 750 low-risk drinkers or abstainers. Participants will be randomised with equal probability, stratified by centre, to either a screening only control group or one of the two interventions: single session of PFBA or eBI. All participants will be eligible to receive treatment as usual in addition to any trial intervention. Individual participants will be followed up at 6 and 12 months after randomisation. DISCUSSION: The protocol represents an ambitious innovative programme of work addressing alcohol use in the adolescent population. TRIAL REGISTRATION: ISRCTN45300218. Registered 5th July 2014.

Cost analysis of the Communication and Low Mood (CALM) randomised trial of behavioural therapy for stroke patients with aphasia.

OBJECTIVE: To evaluate the cost effectiveness of a behavioural therapy intervention shown to be clinically effective in comparison with usual care for stroke patients with aphasia. DESIGN: Randomised controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. SETTING: Community. PARTICIPANTS: Participants identified as having low mood on either the Visual Analog Mood Scale sad item (≥50) or Stroke Aphasic Depression Questionnaire Hospital version 21 (SADQH21) (≥6) were recruited. INTERVENTIONS: Participants were randomly allocated to behavioural therapy or usual care using internet-based randomisation generated in advance of the study by a clinical trials unit. MAIN MEASURES: Outcomes were assessed at six months after randomisation, blind to group allocation. The costs were assessed from a service use questionnaire. Effectiveness was defined as the change in SADQH21 scores and a cost-effectiveness analysis was performed comparing the behavioural group with the usual care control group. The cost analysis was undertaken from the perspective of the UK NHS and Social Services. RESULTS: The greatest difference was in home help costs where there was a saving of £56.20 in the intervention group compared to an increase of £61.40 in the control group. At six months the SADQH21 score for the intervention group was 17.3 compared to the control group value of 20.4. This resulted in a mean increase of 0.7 in the control group, compared to a mean significant different decrease of 6 in the intervention group (P = 0.003). The Incremental Cost-Effectiveness Ratio indicated that the cost per point reduction on the SADQH21 was £263. CONCLUSION: Overall the behavioural therapy was found to improve mood and resulted in some encouraging savings in resource utilisation over the six months follow-up.

Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10-14 UK (SFP 10-14 UK).

BACKGROUND: Prevention of alcohol, drug and tobacco misuse by young people is a key public health priority. There is a need to develop the evidence base through rigorous evaluations of innovative approaches to substance misuse prevention. The Strengthening Families Programme 10-14 is a universal family-based alcohol, drugs and tobacco prevention programme, which has achieved promising results in US trials, and which now requires cross-cultural assessment. This paper therefore describes the protocol for a randomised controlled trial of the UK version of the Strengthening Families Programme 10-14 (SFP 10-14 UK). METHODS/DESIGN: The trial comprises a pragmatic cluster randomised controlled effectiveness trial with families as the unit of randomisation, with embedded process and economic evaluations. Participating families will be randomised to one of two treatment groups - usual care with full access to existing services (control group), or usual care plus SFP 10-14 UK (intervention group). The trial has two primary outcomes - the number of occasions that young people report having drunk alcohol in the last 30 days, and drunkenness during the last 30 days, both dichotomised as 'never' and '1-2 times or more'. The main follow-up is at 2 years past baseline, and short-term and intermediate outcomes are also measured at 9 and 15 months. DISCUSSION: The results from this trial will provide evidence on the effectiveness and cost-effectiveness of an innovative universal family-based substance misuse prevention programme in a UK context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63550893.

The costs and consequences of adequately managed chronic non-cancer pain and chronic neuropathic pain.

BACKGROUND: Chronic pain is distressing for patients and a burden on healthcare systems and society. Recent research demonstrates different aspects of the negative impact of chronic pain and the positive impact of successful treatment, making an overview of the costs and consequences of chronic pain appropriate. OBJECTIVE: To examine recent literature on chronic noncancer and neuropathic pain prevalence, impact on quality and quantity of life, societal and healthcare costs, and impact of successful therapy. METHODS: Systematic reviews (1999 to February 2012) following PRISMA guidelines were conducted to identify studies reporting appropriate outcomes. RESULTS: Chronic pain has a weighted average prevalence in adults of 20%; 7% have neuropathic pain, and 7% have severe pain. Chronic pain impeded activities of daily living, work and work efficiency, and reduced quality and quantity of life. Effective pain therapy (pain intensity reduction of at least 50%) resulted in consistent improvements in fatigue, sleep, depression, quality of life, and work. CONCLUSION: Strenuous efforts should be put into obtaining good levels of pain relief for people in chronic pain, including the opportunity for multiple drug switching, using reliable, validated, and relatively easily applied patient-centered outcomes. Detailed, thoughtful and informed decision analytic policy modeling would help understand the key elements in organizational change or service reengineering to plan the optimum pain management strategy to maximize pain relief and its stream of benefits against budgetary and other constraints. This paper contains the information on which such models can be based.

Pharmacist-Led Antimicrobial Stewardship Programme in Two Tertiary Hospitals in Malawi.

The ultimate goal of antimicrobial stewardship (AMS) programmes is to decrease the occurrence and spread of antimicrobial resistance (AMR). In response to this, a pharmacist partnership was established between Malawi and Wales (UK) with the aim of strengthening antimicrobial stewardship (AMS) activities in Malawi, with the initial project focusing on two tertiary referral hospitals. The Global Point Prevalence Survey (GPPS) was undertaken for the first time in Malawi at these sites and demonstrated a prescribing rate slightly lower than the African average, with ceftriaxone indicated for almost every bacterial infection. An educational intervention was also delivered, with a train-the-trainer approach upskilling pharmacists at the two sites, who then cascaded co-produced training sessions to an additional 120 multidisciplinary health professionals. A toolkit to support AMS at an individual patient level was also developed and disseminated to provide an ongoing reference to refer to. Both the trainings and toolkit were well received. Over the course of this project, significant progress has been made with the AMS programmes at the two sites, with local staff empowered to implement AMS activities. These interventions could be easily replicated and scaled and support the delivery of some of the AMS elements of the Malawi Ministry of Health National Action Plan for Antimicrobial Resistance.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

OBJECTIVE: To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. DESIGN: Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. SETTING: Community. PARTICIPANTS: People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. INTERVENTIONS: Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. MAIN MEASURES: Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. RESULTS: Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. CONCLUSION: In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

A systematic review and meta-analysis of biological treatments targeting tumour necrosis factor α for sciatica.

PURPOSE: Systematic review comparing biological agents, targeting tumour necrosis factor α, for sciatica with placebo and alternative interventions. METHODS: We searched 21 electronic databases and bibliographies of included studies. We included randomised controlled trials (RCTs), non-RCTs and controlled observational studies of adults who had sciatica treated by biological agents compared with placebo or alternative interventions. RESULTS: We pooled the results of six studies (five RCTs and one non-RCT) in meta-analyses. Compared with placebo biological agents had: better global effects in the short-term odds ratio (OR) 2.0 (95 % CI 0.7-6.0), medium-term OR 2.7 (95 % CI 1.0-7.1) and long-term OR 2.3 [95 % CI 0.5 to 9.7); improved leg pain intensity in the short-term weighted mean difference (WMD) -13.6 (95 % CI -26.8 to -0.4), medium-term WMD -7.0 (95 % CI -15.4 to 1.5), but not long-term WMD 0.2 (95 % CI -20.3 to 20.8); improved Oswestry Disability Index (ODI) in the short-term WMD -5.2 (95 % CI -14.1 to 3.7), medium-term WMD -8.2 (95 % CI -14.4 to -2.0), and long-term WMD -5.0 (95 % CI -11.8 to 1.8). There was heterogeneity in the leg pain intensity and ODI results and improvements were no longer statistically significant when studies were restricted to RCTs. There was a reduction in the need for discectomy, which was not statistically significant, and no difference in the number of adverse effects. CONCLUSIONS: There was insufficient evidence to recommend these agents when treating sciatica, but sufficient evidence to suggest that larger RCTs are needed.