Assessing cost-effectiveness in the management of multiple sclerosis

Multiple sclerosis (MS) is one of the most common causes of neurological disability in young and middle-aged adults, with current prevalence rates estimated to be 30 per 100,000 populations. Women are approximately twice as susceptible as males, but males are more likely to have progressive disease. The onset of the disease normally occurs between 20 and 40 years of age, with a peak incidence during the late twenties and early thirties, resulting in many years of disability for a large proportion of patients, many of whom require wheelchairs and some nursing home or hospital care. The aim of this study is to update a previous review which considered the cost-effectiveness of disease-modifying drugs (DMDs), such as interferons and glatiramer acetate, with more up to date therapies, such as mitaxantrone hydrochloride and natalizumab in the treatment of MS. The development and availability of new agents has been accompanied by an increased optimism that treatment regimens for MS would be more effective; that the number, severity and duration of relapses would diminish; that disease progression would be delayed; and that disability accumulation would be reduced. However, doubts have been expressed about the effectiveness of these treatments, which has only served to compound the problems associated with endeavors to estimate the relative cost-effectiveness of such interventions

Linked routine data to enhance health-economics analysis

<a href="http://dx.doi.org/10.7175/fe.v14i2.677">http://dx.doi.org/10.7175/fe.v14i2.677</a><br /

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>Trial registration</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/ISRCTN47718479">ISRCTN47718479</a></p

Systematic Review and Meta-Analysis of Randomised Trials to Ascertain Fatal Gastrointestinal Bleeding Events Attributable to Preventive Low-Dose Aspirin: No Evidence of Increased Risk.

BACKGROUND: Aspirin has been shown to lower the incidence and the mortality of vascular disease and cancer but its wider adoption appears to be seriously impeded by concerns about gastrointestinal (GI) bleeding. Unlike heart attacks, stroke and cancer, GI bleeding is an acute event, usually followed by complete recovery. We propose therefore that a more appropriate evaluation of the risk-benefit balance would be based on fatal adverse events, rather than on the incidence of bleeding. We therefore present a literature search and meta-analysis to ascertain fatal events attributable to low-dose aspirin. METHODS: In a systematic literature review we identified reports of randomised controlled trials of aspirin in which both total GI bleeding events and bleeds that led to death had been reported. Principal investigators of studies in which fatal events had not been adequately described were contacted via email and asked for further details. A meta-analyses was then performed to estimate the risk of fatal gastrointestinal bleeding attributable to low-dose aspirin. RESULTS: Eleven randomised trials were identified in the literature search. In these the relative risk (RR) of 'major' incident GI bleeding in subjects who had been randomised to low-dose aspirin was 1.55 (95% CI 1.33, 1.83), and the risk of a bleed attributable to aspirin being fatal was 0.45 (95% CI 0.25, 0.80). In all the subjects randomised to aspirin, compared with those randomised not to receive aspirin, there was no significant increase in the risk of a fatal bleed (RR 0.77; 95% CI 0.41, 1.43). CONCLUSIONS: The majority of the adverse events caused by aspirin are GI bleeds, and there appears to be no valid evidence that the overall frequency of fatal GI bleeds is increased by aspirin. The substantive risk for prophylactic aspirin is therefore cerebral haemorrhage which can be fatal or severely disabling, with an estimated risk of one death and one disabling stroke for every 1,000 people taking aspirin for ten years. These adverse effects of aspirin should be weighed against the reductions in vascular disease and cancer

Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

Background: Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology - hand-held computers with computerised clinical decision support (CCDS) software - to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services. Methods/Design: Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters') at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial. Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders. The primary outcome is the interval to the first subsequent reported fall (or death). We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically. Discussion: Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services. In conclusion this complex emergency care trial will provide rigorous evidence on the clinical and cost effectiveness of CCDS for paramedics in the care of older people who have fallen

Improving mental health through the regeneration of deprived neighbourhoods: a prospective controlled quasi-experimental study

AbstractBACKGROUND Policy makers often target deprived neighbourhoods for regeneration with the expectation that population health will improve, since housing and neighbourhoods of low quality, as well as the social and economic determinants of poor health, are concentrated in the most deprived areas. Our aim was to examine the eff ects of Communities First, a Welsh Assembly Government community-led programme of neighbourhood regeneration targeted at the 100 most deprived electoral wards in Wales on mental health. METHODS Information on Communities First regeneration activities in 35 intervention lower super output areas (LSOAs) (n=4197) and 75 control LSOAs (6695) were linked to data from the eCATALyST study, a prospective cohort study, in 2001 (before regeneration) and 2008 (after regeneration) within the Secure Anonymised Information Linkage (SAIL) databank. Communities First was delivered through multiagency partnership boards in all 22 local authorities. Boards worked with residents to identify and secure funding for regeneration activities. The primary outcome was the change in Mental Health Inventory (MHI) score (a population-based measure of anxiety and depressive symptoms) between 2001 and 2008 recorded in eCATALyST. We examined the changes in mental health in intervention LSOAs compared with control LSOAs using propensity score matching (1:1 ratio) to balance the level of socioeconomic disadvantage across groups. Sensitivity analysis examined the impact of length of residence in an intervention area and six types of regeneration activity. FINDINGS 1500 regeneration projects were funded from 2001 to 2008. Before regeneration, mental health was worse in the intervention than in the control group (mean MHI score 66·6, SD 22·3 vs 71·0, SD 20·8). After propensity score matching, regeneration was associated with an improvement in the mental health of intervention compared with control group residents (β=1·54, 95% CI 0·50–2·59), suggesting that inequalities in mental health narrowed. We found evidence of a dose–response association between length of residence and improvements in mental health (ptrend=0·05). We could not attribute improvements to any one type of regeneration activity. Interpretation Targeted regeneration directed by the residents of deprived urban communities can help reduce inequalities in mental health. FUNDING This study was funded by a grant from the National Institute for Social Care and Health Research (RFS-12-05) and undertaken with the support of the Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (MR/KO232331/1) and the Farr Institute of Health Informatics Research