Health technology assessment : HTA
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Health Technol Assess · Apr 2006
Review Randomized Controlled TrialRandomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial).
To establish the cost-effectiveness of surgery and sclerotherapy for the treatment of varicose veins. ⋯ Standard surgical treatment of varicose veins by saphenofemoral ligation, stripping and multiple phlebectomies is a clinically effective and cost-effective treatment for varicose veins, with an ICER well below the threshold normally considered appropriate for the funding of treatments within the NHS. Injection sclerotherapy also appears to be cost-effective, but produces less overall benefit, with a higher ICER than surgery for patients with superficial venous reflux. In minor varicose veins without reflux, sclerotherapy is likely to provide a small average benefit with acceptable cost-effectiveness. Research is needed into methods for accurate and acceptable utility evaluations for conditions with relatively minor effect on HRQoL and also for a validated and standardised method of classification for varicose veins.
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Health Technol Assess · Apr 2006
Review Comparative StudyScreening for thrombophilia in high-risk situations: systematic review and cost-effectiveness analysis. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) study.
To assess the risk of clinical complications associated with thrombophilia in three high-risk patient groups: women using oral oestrogen preparations, women during pregnancy and patients undergoing major orthopaedic surgery. To assess the effectiveness of prophylactic treatments in preventing venous thromboembolism (VTE) and adverse pregnancy outcomes in women with thrombophilia during pregnancy and VTE in patients with thrombophilia, undergoing major orthopaedic surgery. To evaluate the relative cost-effectiveness of universal and selective VTE history-based screening for thrombophilia compared with no screening in the three high-risk patient groups. ⋯ Thrombophilia is associated with increased risks of VTE in women taking oral oestrogen preparations and patients undergoing major elective orthopaedic surgery, and of VTE and adverse pregnancy outcomes in women with thrombophilia during pregnancy. There is considerable difference in the magnitude of the risks among different patient groups with different thrombophilic defects. In women who are on combined oral contraceptives, the OR of VTE among those who are carriers of the FVL mutation was 15.62 (95% confidence interval 8.66 to 28.15). However, in view of the prevalence of thrombophilia and the low prevalence of VTE in non-users of combined oral contraceptives, the absolute risk remains low. Significant risks for VTE and adverse pregnancy outcomes have been established with individual thrombophilic defects. Thrombophilic defects including FVL, high plasma factor VIIIc levels and prothrombin G20210A are associated with the occurrence of postoperative VTE in elective hip or knee replacement therapy. These associations are observed in patients who were given preoperative thromboprophylaxis and are, therefore, of clinical significance. Universal thrombophilia screening in women prior to prescribing oral oestrogen preparations, in women during pregnancy and in patients undergoing major orthopaedic surgery is not supported by current evidence. The findings from this study show that selective screening based on prior VTE history is more cost-effective than universal screening. Large prospective studies should be undertaken to refine the risks and establish the associations of thrombophilias with VTE among hormone users and in patients undergoing orthopaedic surgery. The relative value of a thrombophilia screening programme to other healthcare programmes needs to be established.
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Health Technol Assess · Apr 2006
ReviewA series of systematic reviews to inform a decision analysis for sampling and treating infected diabetic foot ulcers.
To review systematically the evidence on the performance of diagnostic tests used to identify infection in diabetic foot ulcers (DFUs) and of interventions to treat infected DFUs. To use estimates derived from the systematic reviews to create a decision analytic model in order to identify the most effective method of diagnosing and treating infection and to identify areas of research that would lead to large reductions in clinical uncertainty. ⋯ The available evidence is too weak to be able to draw reliable implications for practice. This means that, in terms of diagnosis, infection in DFUs cannot be reliably identified using clinical assessment. This has implications for determining which patients need formal diagnostic testing for infection, on whether empirical treatment with antibiotics (before the results of diagnostic tests are available) leads to better outcomes, and on identifying the optimal methods of diagnostic testing. With respect to treatment, it is not known whether treatment with systemic or local antibiotics leads to better outcomes or whether any particular agent is more effective. Limited evidence suggests that both G-CSF and cadexomer iodine dressings may be less expensive than 'standard' care, that ampicillin/sulbactam may be less costly than imipenem/cilastatin, and that an unlicensed cream (pexiganan) may be as effective as oral ofloxacin. Further research is needed to ascertain the characteristics of infection in people with DFUs that influence healing and amputation outcomes, to determine whether detecting infection prior to treatment offers any benefit over empirical therapy, and to establish the most effective and cost-effective methods for detecting infection, as well as the relative effectiveness and cost-effectiveness of antimicrobial interventions for DFU infection.
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Health Technol Assess · Apr 2006
Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients.
To evaluate selected molecular tests in diagnosis and screening of cytomegalovirus (CMV) infection in immunosuppressed patients. ⋯ The study findings offer some evidence that a CMV screening regime is more cost-effective than diagnostic testing alone, based on the cost per true positive detected and interim outcome such as changes in patient management. However, the study was unable to demonstrate any benefits in terms of longer term patient outcomes. If CMV screening is introduced, the use of antigenaemia pp65 is clearly less cost-effective than the use of molecular tests. The study identified the optimum test for CMV screening as an in-house molecular test (single-round PCR test). This test was less costly to perform and also resulted in lower costs linked to false positives and negatives than other tests. The in-house, semi-quantitative test was two to three times more cost-effective than the commercial molecular tests assessed; however changes to European Union legislation may mean that it may not be feasible to use in-house tests. The use of targeted screening (limiting CMV screening to high-risk transplants) as opposed to universal screening offers a significant improvement in the cost-effectiveness ratio for haematology transplant patients, but has limited impact in the case of renal transplants. Economic analyses could be expanded to model the cost-effectiveness of more frequent screening tests (as reported nationally), and screening in other "at risk" groups. Subgroup specific disease groups should be investigated across a larger population to allow more accurate modelling of the impact of CMV screening on disease progression. Further studies of CMV screening programmes should address a range of outcome measures, including patient outcomes.