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.

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.

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).

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.

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.

Incident atrial fibrillation and adverse clinical outcomes during extended follow-up of participants recruited to the remote heart rhythm sampling using the AliveCor heart monitor to screen for atrial fibrillation: the REHEARSE-AF study.

Aims: Atrial fibrillation (AF) is an important risk factor for stroke, which is commonly asymptomatic, particularly in older patients, and often undetected until cardiovascular events occur. Development of novel technology has helped to improve detection of AF. However, the longer-term benefit of systematic electrocardiogram (ECG) screening on cardiovascular outcomes is unclear. Methods and results: In the original REHEARSE-AF study, patients were randomized to twice-weekly portable electrocardiogram (iECG) assessment or routine care. After discontinuing the trial portable iECG assessment, electronic health record data sources provided longer-term follow-up analysis. Cox regression was used to provide unadjusted and adjusted hazard ratios (HR) [95% confidence intervals (CI)] for clinical diagnosis, events, and anticoagulant prescriptions during the follow-up period. Over the median 4.2-year follow-up, although a greater number of patients were diagnosed with AF in the original iECG group (43 vs. 31), this was not significant (HR 1.37, 95% CI 0.86-2.19). No differences were seen in the number of strokes/systemic embolisms or deaths between the two groups (HR 0.92, 95% CI 0.54-1.54; HR 1.07, 95% CI 0.66-1.73). Findings were similar when restricted to those with CHADS-VASc ≥ 4. Conclusion: A 1-year period of home-based, twice-weekly screening for AF increased diagnoses of AF for the screening period but did not lead to increased diagnoses of AF or a reduction in cardiovascular-related events or all-cause death over a median of 4.2 years, even in those at highest risk of AF. These results suggest that benefits of regular ECG screening over a 1-year period are not maintained after cessation of the screening protocol.

A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol.

BACKGROUND: Antibiotic associated diarrhoea complicates 5-39% of courses of antibiotic treatment. Major risk factors are increased age and admission to hospital. Of particular importance is C. difficile associated diarrhoea which occurs in about 4% of antibiotic courses and may result in severe illness, death and high healthcare costs. The emergence of the more virulent 027 strain of C. difficile has further heightened concerns. Probiotics may prevent antibiotic associated diarrhoea by several mechanisms including colonization resistance through maintaining a healthy gut flora. METHODS: This study aims to test the hypothesis that administration of a probiotic comprising two strains of lactobacilli and two strains of bifidobacteria alongside antibiotic treatment prevents antibiotic associated diarrhoea. We have designed a prospective, parallel group trial where people aged 65 years or more admitted to hospital and receiving one or more antibiotics are randomly allocated to receive either one capsule of the probiotic or a matching placebo daily for 21 days. The primary outcomes are the frequency of antibiotic associated and C. difficile diarrhoea during 8-12 weeks follow-up. To directly inform routine clinical practice, we will recruit a sufficient number of patients to demonstrate a 50% reduction in the frequency of C. difficile diarrhoea with a power of 80%. To maximize the generalizability of our findings and in view of the well-established safety record of probiotics, we will recruit a broad range of medical and surgical in-patients from two different health regions within the UK. DISCUSSION: Antibiotic associated diarrhoea constitutes a significant health burden. In particular, current measures to prevent and control C. difficile diarrhoea are expensive and disrupt clinical care. This trial may have considerable significance for the prevention of antibiotic associated diarrhoea in hospitals. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number Register ISRCTN70017204.

Making the economic case for prevention--a view from Wales.

BACKGROUND: It is widely acknowledged that adverse lifestyle behaviours in the population now will place an unsustainable burden on health service resources in the future. It has been estimated that the combined cost to the NHS in Wales of overweight and obesity, alcohol and tobacco is in excess of £540 million.In the current climate of financial austerity, there can be a tendency for the case for prevention efforts to be judged on the basis of their scope for cost savings. This paper was prompted by discussion in Wales about the evidence for the cost savings from prevention and early intervention and a resulting concern that these programmes were thus being evaluated in policy terms using an incorrect metric. Following a review of the literature, this paper contributes to the discussion of the potential role that economics can play in informing decisions in this area. DISCUSSION: This paper argues that whilst studies of the economic burden of diseases provide information about the magnitude of the problem faced, they should not be used as a means of priority setting. Similarly, studies discussing the likelihood of savings as a result of prevention programmes may be distorting the arguments for public health.Prevention spend needs to be considered purposefully, resulting in a strategic commitment to spending. The role of economics in this process is to provide evidence demonstrating that information and support can be provided cost effectively to individuals to change their lifestyles thus avoiding lifestyle related morbidity and mortality. There is growing evidence that prevention programmes represent value for money using the currently accepted techniques and decision making metrics such as those advocated by NICE. SUMMARY: The issue here is not one of arguing that the economic evaluation of prevention and early intervention should be treated differently, although in some instances that may be appropriate, rather it is about making the case for these interventions to be treated and evaluated to the same standard. The difficulty arises when a higher standard of cost saving may be expected from prevention and public health programmes.The paper concludes that it is of vital importance that during times of budget constraints, as currently faced, the public health budgets are not eroded to fund secondary care budget shortfalls, which are more easily identifiable. To do so would diminish any possibility of reducing the future burden faced by the NHS of lifestyle-related illnesses.

The cost effectiveness of NHS physiotherapy support for occupational health (OH) services.

BACKGROUND: Musculoskeletal pain is detrimental to quality of life (QOL) and disruptive to activities of daily living. It also places a major economic burden on healthcare systems and wider society. In 2006, the Welsh Assembly Government (WAG) established a three tiered self-referral Occupational Health Physiotherapy Pilot Project (OHPPP) comprising: 1.) telephone advice and triage, 2.) face-to-face physiotherapy assessment and treatment if required, and 3.) workplace assessment and a return-to-work facilitation package as appropriate. This study aimed to evaluate the feasibility and cost-effectiveness of the pilot service. METHODS: A pragmatic cohort study was undertaken, with all OHPPP service users between September 2008 and February 2009 being invited to participate. Participants were assessed on clinical status, yellow flags, sickness absence and work performance at baseline, after treatment and at 3 month follow up. Cost-effectiveness was evaluated from both top-down and bottom-up perspectives and cost per Quality Adjusted Life Year (cost/QALY) was calculated. The cost-effectiveness analysis assessed the increase in service cost that would be necessary before the cost-effectiveness of the service was compromised. RESULTS: A total of 515 patients completed questionnaires at baseline. Of these, 486 were referred for face to face assessment with a physiotherapist and were included in the analysis for the current study. 264 (54.3%) and 199 (40.9%) were retained at end of treatment and 3 month follow up respectively. An improvement was observed at follow up in all the clinical outcomes assessed, as well as a reduction in healthcare resource usage and sickness absence, and improvement in self-reported work performance. Multivariate regression indicated that baseline and current physical health were associated with work-related outcomes at follow up. The costs of the service were £194-£360 per service user depending on the method used, and the health gains contributed to a cost/QALY of £1386-£7760, which would represent value for money according to current UK thresholds. Sensitivity analyses demonstrated that the service would remain cost effective until the service costs were increased to 160% per user. CONCLUSIONS: This pragmatic evaluation of the OHPPP indicated that it was likely to be feasible in terms of service usage and could potentially be cost effective in terms of QALYs. Further, the study confirmed that improving physical health status for musculoskeletal pain patients is important in reducing problems with work capacity and related costs. This study suggests that this type of service could be potentially be useful in reducing the burden of pain and should be further investigated, ideally via randomised controlled trials assessing effectiveness and cost-effectiveness.

HERALD (health economics using routine anonymised linked data).

BACKGROUND: Health economic analysis traditionally relies on patient derived questionnaire data, routine datasets, and outcomes data from experimental randomised control trials and other clinical studies, which are generally used as stand-alone datasets. Herein, we outline the potential implications of linking these datasets to give one single joined up data-resource for health economic analysis. METHOD: The linkage of individual level data from questionnaires with routinely-captured health care data allows the entire patient journey to be mapped both retrospectively and prospectively. We illustrate this with examples from an Ankylosing Spondylitis (AS) cohort by linking patient reported study dataset with the routinely collected general practitioner (GP) data, inpatient (IP) and outpatient (OP) datasets, and Accident and Emergency department data in Wales. The linked data system allows: (1) retrospective and prospective tracking of patient pathways through multiple healthcare facilities; (2) validation and clarification of patient-reported recall data, complementing the questionnaire/routine data information; (3) obtaining objective measure of the costs of chronic conditions for a longer time horizon, and during the pre-diagnosis period; (4) assessment of health service usage, referral histories, prescribed drugs and co-morbidities; and (5) profiling and stratification of patients relating to disease manifestation, lifestyles, co-morbidities, and associated costs. RESULTS: Using the GP data system we tracked about 183 AS patients retrospectively and prospectively from the date of questionnaire completion to gather the following information: (a) number of GP events; (b) presence of a GP 'drug' read codes; and (c) the presence of a GP 'diagnostic' read codes. We tracked 236 and 296 AS patients through the OP and IP data systems respectively to count the number of OP visits; and IP admissions and duration. The results are presented under several patient stratification schemes based on disease severity, functions, age, sex, and the onset of disease symptoms. CONCLUSION: The linked data system offers unique opportunities for enhanced longitudinal health economic analysis not possible through the use of traditional isolated datasets. Additionally, this data linkage provides important information to improve diagnostic and referral pathways, and thus helps maximise clinical efficiency and efficiency in the use of resources.

The impact and burden of chronic pain in the workplace: a qualitative systematic review.

BACKGROUND: Chronic pain (CP) poses a diverse and substantial burden for employees, employers, and society. The deleterious consequences of CP in the workplace are frequently underestimated. OBJECTIVE: To estimate the burden of CP in the European workplace. METHODS: A systematic review following PRISMA statement guidelines was conducted to identify studies reporting work-related outcomes for people with CP. EMBASE, MEDLINE, EconLit, and Cochrane Library databases were searched up to 18th August 2010. RESULTS: We identified 91 observational studies. Few were specifically designed to investigate the association between CP, productivity, and employment. The focus for this review was studies clearly reporting outcomes relating to the burden of CP on employment status (n = 37), sickness absence (absenteeism, n = 47), and loss of productivity because of reduced ability at work (presenteeism, n = 8). CONCLUSION: The body of evidence identified from the systematic review indicates that CP has a substantial negative impact on work-related outcomes, supporting the importance of interventions to reduce the burden of CP. Well-designed prospective studies specifically assessing the direct consequences of CP on employment are needed to confirm these findings.

Healthcare resource utilisation and cost analysis associated with opioid analgesic use for non-cancer pain: A case-control, retrospective study between 2005 and 2015.

Objective: To examine differences in healthcare utilisation and costs associated with opioid prescriptions for non-cancer pain issued in primary care. Method: A longitudinal, case-control study retrospectively examined Welsh healthcare data for the period 1 January 2005-31 December 2015. Data were extracted from the Secure Anonymised Information Linkage (SAIL) databank. Subjects, aged 18 years and over, were included if their primary care record contained at least one of six overarching pain diagnoses during the study period. Subjects were excluded if their record also contained a cancer diagnosis in that time or the year prior to the study period. Case subjects also received at least one prescription for an opioid analgesic. Controls were matched by gender, age, pain-diagnosis and socioeconomic deprivation. Healthcare use included primary care visits, emergency department (ED) and outpatient (OPD) attendances, inpatient (IP) admissions and length of stay. Cost analysis for healthcare utilisation used nationally derived unit costs for 2015. Differences between case and control subjects for resource use and costs were analysed and further stratified by gender, prescribing persistence (PP) and deprivation. Results: Data from 3,286,215 individuals were examined with 657,243 receiving opioids. Case subjects averaged 5 times more primary care visits, 2.8 times more OPD attendances, 3 times more ED visits and twice as many IN admissions as controls. Prescription persistence over 6 months and greater deprivation were associated with significantly greater utilisation of healthcare resources. Opioid prescribing was associated with 69% greater average healthcare costs than in control subjects. National Health Service (NHS) healthcare service costs for people with common, pain-associated diagnoses, receiving opioid analgesics were estimated to be £0.9billion per year between 2005 and 2015. Conclusion: Receipt of opioid prescriptions was associated with significantly greater healthcare utilisation and accompanying costs in all sectors. Extended prescribing durations are particularly important to address and should be considered at the point of initiation.

Exploration of mentor and mentee perspectives of a mentored clinical practice programme to improve patient outcomes in musculoskeletal physiotherapy.

BACKGROUND: A recent randomised controlled trial has demonstrated the impact on practice of an educational programme for clinicians. Mentored clinical practice in musculoskeletal physiotherapy resulted in clinically significant improvements in both physiotherapist performance and patient outcomes. The objectives of this study were to explore mentor and mentee perceptions of a mentored clinical practice programme, in order to identify key factors in the process to improve patient outcomes. METHODS: Employing a case study design of a mentoring programme that led to improved patient outcomes, mentored clinical practice was explored from multiple perspectives using a grounded theory strategy of enquiry to derive a theory of mentored clinical practice grounded in the views of the participants. Semi-structured interviews with a purposive sample of mentors and mentees were employed along with qualitative observations of mentored clinical practice. Data analysis and collection were concurrent, with analysis an iterative process deriving inductive analytical categories from the data through constant comparison. FINDINGS: Highly informative themes of how the complex interaction between mentor, mentee, patient and environment worked successfully were identified from the data. The mentors' knowledge, additional perspectives, critical analysis and facilitatory style were enabling factors, as were mentees' motivation, openness to criticism and commitment to reflect on practice. Themes around potential threats to the mentees' development were also identified. Overloading or contradictory feedback and lack of relationship with mentees were barriers that mentors could bring; fear, defensiveness, routine working, people-pleasing and lack of experience were potential mentee barriers. A model emerges from the data demonstrating how these themes interact, providing guidance to mentors and mentees to optimise the effectiveness of mentored clinical practice. CONCLUSION: This study provides a sound basis for future mentored clinical practice, producing a model from key themes from a case study where impact on clinician performance and patient outcomes are established.

SCOPE1: a randomised phase II/III multicentre clinical trial of definitive chemoradiation, with or without cetuximab, in carcinoma of the oesophagus.

BACKGROUND: Chemoradiotherapy is the standard of care for patients with oesophageal cancer unsuitable for surgery due to the presence of co-morbidity or extent of disease, and is a standard treatment option for patients with squamous cell carcinoma of the oesophagus. Modern regimens of chemoradiotherapy can lead to significant long-term survival. However the majority of patients will die of their disease, most commonly with local progression/recurrence of their tumours. Cetuximab may overcome one of the principal mechanisms of tumour radio-resistance, namely tumour repopulation, in patients treated with chemoradiotherapy.The purpose of this research is first to determine whether the addition of cetuximab to definitive chemoradiotherapy for treatment of patients with non-metastatic carcinoma of the oesophagus is active (in terms of failure-free rate), safe, and feasible within the context of a multi-centre randomised controlled trial in the UK. If the first stage is successful then the trial will continue to accrue sufficient patients to establish whether the addition of cetuximab to the standard treatment improves overall survival. METHODS/DESIGN: SCOPE1 is a two arm, open, randomised multicentre Phase II/III trial. Eligible patients will have histologically confirmed carcinoma of the oesophagus and have been chosen to receive definitive chemoradiotherapy by an accredited multidisciplinary team including a specialist Upper GI surgeon. 420 patients will be randomised to receive definitive chemoradiotherapy with or without cetuximab using a 1:1 allocation ratio.During Phase II of the study, the trial will assess safety (toxicity), activity (failure-free rate) and feasibility (recruitment rate and protocol dose modifications/delays) in 90 patients in the experimental arm. If the experimental arm is found to be active, safe, and feasible by the Independent Data Monitoring Committee then recruitment will continue into Phase III. This second stage will recruit a further 120 patients into each arm and compare the overall survival of both groups.All patients randomised into Phase II will contribute to the Phase III comparison of overall survival. In addition to overall survival, Phase III of the study will also assess toxicity, health related quality of life and cost effectiveness. A detailed radiotherapy protocol and quality assurance procedure has been incorporated into this trial. TRIAL REGISTRATION: ISRCTN: ISRCTN47718479.

Preventing bath water scalds: a cost-effectiveness analysis of introducing bath thermostatic mixer valves in social housing.

AIMS: To assess the cost-effectiveness of installing thermostatic mixer valves (TMVs) in reducing risks of bath water scalds and estimate the costs of avoiding bath water scalds. METHODS: The evaluation was undertaken from the perspective of the UK public sector, and conducted in conjunction with a randomised control trial of TMVs installed in social housing in Glasgow. Installation costs were borne by the social housing organisation, while support materials were provided by the UK NHS. Effectiveness was represented by the number of families with at-risk bath water temperatures pre- and post-installation, and the number of bath scalds avoided as a result of installation. Differences in the number of families with at-risk temperatures between groups were derived from the RCT. Cost-effectiveness was assessed and a series of one-way sensitivity analyses were conducted. RESULTS: Unit costs associated with installation were calculated to be £13.68, while costs associated with treating bath water scalds ranged from £25,226 to £71,902. The cost of an avoided bath water scald ranged from net savings to public purse of £1887 to £75,520 and at baseline produced a net saving of £3,229,008; that is, £1.41 saved for every £1 spent. CONCLUSION: It is very likely that installing TMVs as standard in social housing in new buildings and major refurbishments accompanied by educational information represents value for money.

Exploring the role of economics in prioritization in public health: what do stakeholders think?

BACKGROUND: Debates surrounding the use of conventional approaches in public health and the existence of perceived barriers to using the results of economic evaluations have led to questions posed as to how to establish priorities within public health schemes. The aims of this study were therefore to explore the feasibility and validity of economic evaluation techniques in developing priorities within public health programmes and consider the extent to which different presentational approaches are likely to be incorporated into decision-making, from perspectives of relevant stakeholders. METHODS: An advisory board, representative of potential users of economic evaluations, was set up to identify preferences for how findings from economic evaluations might be presented to decision makers and to test the impact of different approaches, different outputs and different presentational styles. The board was divided into two groups, each of which was given three hypothetical 'scenarios' to consider. The scenarios comprised descriptions of methods and outputs, with costs, effects, target population and context of intervention constant across all scenarios. RESULTS: The perceived validity of estimates of effectiveness was vitally important, along with sufficient information to gauge whether designs were appropriate and to assess implementation practicalities. Cost-benefit analysis and cost-utility analysis were the preferred approaches despite their complexity, although participants required benchmarks to place net-benefit estimates from cost-benefit analyses into context. CONCLUSION: Further research is required to substantiate and build on these preliminary findings and collaborations between economists and policy makers are needed to develop clear, rigorous and standard guidance relating to economic evaluation, recognizing the diversity of public health strategies.

Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response.

BACKGROUND: Clinical trials in chronic pain often collect information about interference with work as answers to component questions of commonly used questionnaires but these data are not normally analysed separately. METHODS: We performed a meta-analysis of individual patient data from four large trials of pregabalin for fibromyalgia lasting 8-14 weeks. We analysed data on interference with work, inferred from answers to component questions of Fibromyalgia Impact Questionnaire (FIQ), Short Form 36 Health Survey, Sheehan Disability Scale, and Multidimensional Assessment of Fatigue, including "How many days in the past week did you miss work, including housework, because of fibromyalgia?" from FIQ. Analyses were performed according to randomised treatment group (pregabalin 150-600 mg daily or placebo), pain improvement (0-10 numerical pain rating scale scores at trial beginning vs. end), and end of trial pain state (100 mm visual analogue pain scale [VAS]). RESULTS: Comparing treatment group average outcomes revealed modest improvement over the duration of the trials, more so with active treatment than with placebo. For the 'work missed' question from FIQ the change for patients on placebo was from 2.2 (standard deviation [SD] 2.3) days of work lost per week at trial beginning to 1.9 (SD 2.1) days lost at trial end (p < 0.01). For patients on 600 mg pregabalin the change was from 2.1 (SD 2.2) days to 1.6 (SD 2.0) days (p < 0.001). However, the change in days of work lost was substantial in patients with a good pain response: from 2.0 (SD 2.2) days to 0.97 (SD 1.6) days (p < 0.0001) for those experiencing >/= 50% pain improvement and from 1.9 (SD 2.2) days to 0.73 (SD 1.4) days (p < 0.0001) for those achieving a low level of pain at trial end (<30 mm on the VAS). Patients achieving both >/= 50% pain improvement and a pain score <30 mm on the VAS had the largest improvement, from 2.0 (SD 2.2) days to 0.60 (SD 1.3) days (p < 0.0001). Analysing answers to the other questions yielded qualitatively similar results. CONCLUSIONS: Effective pain treatment goes along with benefit regarding work. A reduction in time off work >1 day per week can be achieved in patients with good pain responses.