Health technology assessment : HTA
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Health Technol Assess · Aug 2005
Randomized Controlled Trial Multicenter StudyCost-effectiveness and safety of epidural steroids in the management of sciatica.
To investigate the clinical effectiveness of epidural steroid injections (ESIs) in the treatment of sciatica with an adequately powered study and to identify potential predictors of response to ESIs. Also, to investigate the safety and cost-effectiveness of lumbar ESIs in patients with sciatica. ⋯ Although ESIs appear relatively safe, it was found that they confer only transient benefit in symptoms and self-reported function in a small group of patients with sciatica at substantial costs. ESIs do not provide good value for money if NICE recommendations are followed. Additional research is suggested into the epidemiology of radicular pain, producing a register of all ESIs, possible subgroups who may benefit from ESIs, the use of radiological imaging, optimal early interventions, analgesic agents and nerve root injections, the use of cognitive behavioural therapy in rehabilitation, improved methods of assessment, a comparative cost-utility analysis between various treatment strategies, and methods to reduce the effect of scarring and inflammation.
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Health Technol Assess · Jul 2005
ReviewImatinib for the treatment of patients with unresectable and/or metastatic gastrointestinal stromal tumours: systematic review and economic evaluation.
To assess the clinical and cost-effectiveness of imatinib in the treatment of unresectable and/or metastatic, KIT-positive, gastrointestinal stromal tumours (GISTs), relative to current standard treatments. ⋯ Evidence from uncontrolled studies indicates that the treatment with imatinib brings about clinically significant shrinkage of tumour mass in about half of patients with unresectable and/or metastatic, KIT-positive GIST. Results of modelling based on data from uncontrolled studies suggest that imatinib treatment improves survival in patients with unresectable and/or metastatic GIST. The economic evaluation modelling suggests that the cost per QALY gained ranges from 51,515 to 98,889 UK pounds after 2 years, from 27,331 to 44,236 UK pounds after 5 years, and from 21,404 to 33,976 UK pounds after 10 years. Further research is needed into quality of life within trials involving patients with advanced malignancy, and long-term follow-up of adverse events is needed. Subgroup analysis of which, if any, patient types have a better or worse response to imatinib is also required. Analysis of individual patient data may be a good way of exploring these issues. There are many uncertainties surrounding imatinib prescription, such as the length of time patients should be on imatinib, the dose, drug resistance and the optimum time-point in the disease course at which to give the drug. Secondary research such as an update of this systematic review and a reassessment of the model is highly recommended when ongoing trials reach completion.
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Health Technol Assess · Jul 2005
Review Comparative StudyThe effectiveness and cost-effectiveness of pimecrolimus and tacrolimus for atopic eczema: a systematic review and economic evaluation.
To consider the effectiveness and cost-effectiveness of pimecrolimus for mild to moderate atopic eczema and tacrolimus for moderate to severe atopic eczema compared with current standard treatment in adults and children. ⋯ There is limited evidence from a small number of randomised controlled trials (RCTs) that pimecrolimus is more effective than placebo treatment in controlling mild to moderate atopic eczema. Although greater than for pimecrolimus, the evidence base for tacrolimus in moderate to severe atopic eczema is also limited. At both 0.1% and 0.03% potencies, tacrolimus appears to be more effective than the placebo treatment and mild topical corticosteroids. However, these are not the most clinically relevant comparators. Compared with potent topical corticosteroids, no significant difference was shown. Short-term adverse effects with both immunosuppressants are relatively common, but appear to be mild. Experience of long-term use of the agents is lacking so the risk of rare but serious adverse effects remains unknown. No conclusions can be confidently drawn about the cost-effectiveness of pimecrolimus or tacrolimus compared with active topical corticosteroid comparators. Areas for further research should focus on the effectiveness and safety of the treatments through good-quality RCTs and further economic analysis.
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To survey the frequency of use of indirect comparisons in systematic reviews and evaluate the methods used in their analysis and interpretation. Also to identify alternative statistical approaches for the analysis of indirect comparisons, to assess the properties of different statistical methods used for performing indirect comparisons and to compare direct and indirect estimates of the same effects within reviews. ⋯ Direct evidence from good-quality RCTs should be used wherever possible. Without this evidence, it may be necessary to look for indirect comparisons from RCTs. However, the results may be susceptible to bias. When making indirect comparisons within a systematic review, an adjusted indirect comparison method should ideally be used employing the random effects model. If both direct and indirect comparisons are possible within a review, it is recommended that these be done separately before considering whether to pool data. There is a need to evaluate methods for the analysis of indirect comparisons for continuous data and for empirical research into how different methods of indirect comparison perform in cases where there is a large treatment effect. Further study is needed into when it is appropriate to look at indirect comparisons and when to combine both direct and indirect comparisons. Research into how evidence from indirect comparisons compares to that from non-randomised studies may also be warranted. Investigations using individual patient data from a meta-analysis of several RCTs using different protocols and an evaluation of the impact of choosing different binary effect measures for the inverse variance method would also be useful.
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Health Technol Assess · Jul 2005
ReviewAn evaluation of the costs, effectiveness and quality of renal replacement therapy provision in renal satellite units in England and Wales.
To survey of the structure, processes and organisation of renal satellite units (RSUs) in England and Wales (Phase 1), and to compare the effectiveness, acceptability, accessibility and economic impact of chronic haemodialysis performed in RSUs compared to main renal units (MRUs) (Phase 2). ⋯ This study has shown that RSUs are an effective alternative to MRU HD for a wide spectrum of patients. They improve geographic access for more dispersed areas and reduce patients' travel time, and are generally more acceptable to patients on several criteria. There does not seem to be an adverse impact of care in the RSUs although comparative long-term prospective data are lacking. The evidence suggests that satellite development could be successfully expanded; not all MRUs have any satellites and many have only a few. No single RSU model can be recommended but key factors would include local geography, the likely catchment population and the type of patients to be treated. There is a need for more basic budgetary information linking activity and expenditure to be available and more transparent, to perform at least an insightful top-down costing of the two care settings. Other areas suggested for further research include: a comparison of adverse events occurring in MRUs and RSUs with longer duration and larger numbers to identify more severe events, along with the more research into the scope for preventing such events, and a study into the patients deemed ineligible for satellite care. International comparisons of satellite care would also be useful.