Health technology assessment : HTA
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To consider the effects of contamination on the magnitude and statistical significance (or precision) of the estimated effect of an educational intervention, to investigate the mechanisms of contamination, and to consider how contamination can be avoided. ⋯ The probability, nature and process of contamination should be considered when designing and analysing controlled trials of educational interventions in health. Cluster randomisation may or may not be appropriate and should not be uncritically assumed always to be a solution. Complier Average Causal Effect models are an appropriate way to adjust for contamination if it can be measured. When conducting such trials in future, it is a priority to report the extent, nature and effects of contamination.
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Health Technol Assess · Oct 2007
Review Meta AnalysisClinical effectiveness and cost-effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling.
To examine the clinical effectiveness and cost-effectiveness of self-testing and self-management of oral anticoagulation treatment compared with clinic-based monitoring. ⋯ For selected and successfully trained patients, self-monitoring is effective and safe for long-term oral anticoagulation therapy. In general, patient self-management (PSM) is unlikely to be more cost-effective than the current specialised anticoagulation clinics in the UK; self-monitoring may enhance the quality of life for some patients who are frequently away from home, who are in employment or education, or those who find it difficult to travel to clinics. Further research is needed into alternative dosing regimes, the clinical effectiveness and cost-effectiveness of patient education and training in long-term oral anticoagulation therapy, UK-relevant cost-effectiveness, the effectiveness of PSM in children, and the potential future developments of near-patient testing devices.
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Health Technol Assess · Oct 2007
ReviewOverview of the clinical effectiveness of positron emission tomography imaging in selected cancers.
To assess the clinical effectiveness of positron emission tomography (PET) using 2-[18F]-fluoro-2-deoxy-D-glucose (FDG) in breast, colorectal, head and neck, lung, lymphoma, melanoma, oesophageal and thyroid cancers. Management decisions relating to diagnosis, staging/restaging, recurrence, treatment response and radiotherapy (RT) planning were evaluated separately. ⋯ The strongest evidence for the clinical effectiveness of FDG-PET is in staging NSCLC, restaging HL, staging/restaging colorectal cancer and detection of SPN. Some of these may still require clinical audit to augment the evidence base. Other management decisions require further research to show the impact of FDG-PET on patient management or added value in the diagnostic pathway. It is likely that capital investment will be in the newer PET/CT technology, for which there is less evidence. However, as this technology appears to be slightly more accurate than PET/CT, the PET clinical effectiveness results presented here can be extrapolated to cover PET/CT. PET research could be undertaken on FDG-PET or FDG-PET/CT, using a standard cancer work-up process on typical patients who are seen within the NHS in England. For treatment response and RT planning, the need for larger studies using consistent methods across the UK is highlighted as a priority for all cancers. For all studies, consideration should be given to collaboration across sites nationally and internationally, taking cognisance of the work of the National Cancer Research Institute.
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Health Technol Assess · Oct 2007
ReviewA systematic review and economic model of the clinical effectiveness and cost-effectiveness of interventions for preventing relapse in people with bipolar disorder.
To determine the clinical effectiveness and cost-effectiveness of pharmacological and/or psychosocial interventions for the prevention of relapse in people with bipolar disorder. ⋯ Lithium, valproate, lamotrigine and olanzapine are effective as maintenance therapy for the prevention of relapse in bipolar disorder. Olanzapine and lithium are efficacious for the prevention of manic relapses and valproate, lamotrigine and imipramine for the prevention of depressive relapse. There is some evidence that CBT, group psychoeducation and family therapy might be beneficial as adjuncts to pharmacological maintenance treatments. Insufficient information is available regarding the relative tolerability of the treatments or their relative effects on suicide rate and mortality. For patients with a recent depressive episode, valproate, lithium monotherapy and the combination of lithium and imipramine are potentially cost-effective. For patients with a recent manic episode, olanzapine and lithium monotherapy are potentially cost-effective. The cost-effectiveness estimates in both groups of patients were shown to be sensitive to the assumption of a reduced suicidal risk associated with lithium-based strategies. Further research is needed into the adverse effects of all treatments and the differential effects of agents. Good-quality trials of valproate, of combination therapy, e.g. lithium plus a selective serotonin reuptake inhibitor antidepressant, of psychosocial interventions and of the disorder in children are also required.
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Health Technol Assess · Oct 2007
ReviewTaxanes for the adjuvant treatment of early breast cancer: systematic review and economic evaluation.
To estimate the clinical effectiveness and cost-effectiveness of docetaxel and paclitaxel compared with non-taxane, anthracycline-containing chemotherapy regimens, for the adjuvant treatment of women with early-stage breast cancer. ⋯ There is a large degree of heterogeneity in the evidence base for the effectiveness of taxane- compared with non-taxane-containing regimens in terms of the interventions, comparators and populations. Eight of the 11 trials providing effectiveness data reported a significant improvement in DFS or TTR for taxanes over comparator regimens. The remaining three trials found no significant differences between the groups in DFS/TTR. The cost-effectiveness results suggest that the cost per quality-adjusted life-year for taxane- compared with non-taxane-containing chemotherapy varies between 12,000 pounds and 43,000 pounds, depending on the taxane under consideration and the specific trial used as the basis of the analysis. However, the comparators used in these trials do not conform to current standard care in the UK. More research is needed, comparing taxanes used in line with their current UK marketing authorisation and with anthracycline-containing regimens commonly used in the UK. The on-going TACT trial is expected to provide useful data. There are currently few data on the effectiveness of taxanes for the over-70s. Further research is required into the long-term outcomes of taxane therapy, such as whether there are any long-term adverse events that significantly impact on overall survival or quality of life and whether the increases in DFS will translate into increases in overall survival.