Health technology assessment : HTA
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Health Technol Assess · Sep 2004
ReviewReview of guidelines for good practice in decision-analytic modelling in health technology assessment.
To identify existing guidelines and develop a synthesised guideline plus accompanying checklist. In addition to provide guidance on key theoretical, methodological and practical issues and consider the implications of this research for what might be expected of future decision-analytic models. ⋯ The review of current guidelines showed that although authors may provide a consistent message regarding some aspects of modelling, in other areas conflicting attributes are presented in different guidelines. In general, the checklist appears to perform well, in terms of identifying those aspects of the model that should be of particular concern to the reader. The checklist cannot, however, provide answers to the appropriateness of the model structure and structural assumptions, as these may be seen as a general problem with generic checklists and do not reflect any shortcoming with the synthesised guidance and checklist developed here. The assessment of the checklist, as well as feedback from the EAG, indicated the importance of its use in conjunction with a more general checklist or guidelines on economic evaluation. Further methods research into the following areas would be valuable: the quantification of selection bias in non-controlled studies and in controlled observational studies; the level of bias in the different non-RCT study designs; a comparison of results from RCTs with those from other non-randomised studies; assessment of the strengths and weaknesses of alternative ways to adjust for bias in a decision model; and how to prioritise searching for parameter estimates.
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Health Technol Assess · Sep 2004
Randomized Controlled Trial Comparative Study Clinical TrialEvaluation of abnormal uterine bleeding: comparison of three outpatient procedures within cohorts defined by age and menopausal status.
To compare three outpatient methods of endometrial evaluation in terms of performance, patient acceptability and cost-effectiveness. ⋯ Decision-making about investigation would be clarified if postmenopausal women were studied separately from premenopausal women with menstrual bleeding problems. For postmenopausal women exclusion of cancer is a main objective, so once investigation has been completed discharge follows, but in the woman with abnormal menstrual bleeding, even if serious pathology is excluded, the original presenting symptoms require management. About 60% of premenopausal women with abnormal bleeding reported that their symptoms were not 'much improved' at 10 months. Research is needed to understand this phenomenon, and to explore ways to integrate patient factors into optimising evaluation and treatment. The significance of benign pathologies in this group also requires clarification. Given the relatively small differences observed in cost-effectiveness, there is justification for allowing other issues (such as clinician preferences and women's perspectives) to influence decisions as to the investigation method. There is scope to make better use of patient factors to inform decisions as to the most efficient and acceptable method of investigation for an individual woman. Additional analyses, using data available as a result of this study, will contribute to this agenda.
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Health Technol Assess · Sep 2004
ReviewRituximab (MabThera) for aggressive non-Hodgkin's lymphoma: systematic review and economic evaluation.
To determine the clinical and cost-effectiveness of adding rituximab to the CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy regime for adult patients with diffuse large B-cell lymphoma (DLBCL). ⋯ In the short term, the addition of rituximab to the CHOP regimen increased the likelihood of a complete-response by 20% without a significant rise in the risk of a serious adverse event in people aged 60 years or older. Over a 2-year follow-up period, the intervention reduced the risk of death, progression or relapse by 45% and reduced the risk of death by 47% in this population. There is no direct evidence for the clinical effectiveness of adding rituximab to CHOP in the treatment of DLBCL in those aged 18-59 years, although data from phase I and II trials confirm its safety and efficacy in a preclinical setting. The cost-effectiveness modelling presented here has shown that rituximab in combination with CHOP chemotherapy regimen is likely to be considered a cost-effective treatment for DLBCL when compared with the current standard treatment, CHOP chemotherapy only. Analysis of quality of life (QoL) in the area of NHL is limited and only one cost-utility analysis for the treatment of CHOP in NHL was identified. Both the SCHARR and the manufacturer's models utilised QoL utility scores from an unpublished data source. Further research within this area would help to improve the robustness of QoL utility analysis within DLBCL and also NHL as a whole. Further clinical trials might also establish whether R-CHOP may replace peripheral blood stem cell transplant in high-risk patients and whether the doses of chemotherapy in the elderly may be reduced if rituximab is added to less intensive regimens.
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Health Technol Assess · Sep 2004
Review Comparative StudyCoronary artery stents: a rapid systematic review and economic evaluation.
To assess the effectiveness and cost-effectiveness of the use of coronary artery stents in patients with coronary heart disease (CHD). ⋯ DES might be considered cost-effective if the additional cost (compared with ordinary stents) was substantially reduced, the outcome benefits from the use of DES were much improved, and/or its use were targeted on the subgroups of patients with the highest risks of requiring reintervention. Long-term clinical studies are needed that focus on significant outcomes such as mortality. Further research should consider: the differences among plain stents; head-to-head comparisons within DES, CABG compared with DES; and the evaluation of newer non-DES against DES. Evaluation of the effects of revascularisation procedures and especially repeat revascularisation procedures on the patient's quality of life would also be useful, as would the development and testing of risk assessment tools to identify patients likely to need further revascularisations.