Health technology assessment : HTA
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Health Technol Assess · May 2007
ReviewThe clinical effectiveness and cost-effectiveness of gemcitabine for metastatic breast cancer: a systematic review and economic evaluation.
To assess the clinical effectiveness and cost-effectiveness of gemcitabine, used in combination with paclitaxel, as a second-line treatment for people with metastatic breast cancer who have relapsed following treatment with anthracycline-based chemotherapy. ⋯ The review of clinical effectiveness is based on data from a single RCT that has not yet been fully published. While only tentative conclusions can be drawn from this, the evidence may indicate that treatment with gemcitabine and paclitaxel confers an improved outcome for patients in terms of survival and disease progression, but at the cost of increased toxicity. An economic model developed for this review reflects high costs per QALY for this treatment combination. The base-case analysis shows high ICERs, with costs per QALY gained close to 60,000 pounds. Adopting a more realistic treatment protocol, with chemotherapy limited to a maximum of six cycles, gives a more favourable cost-effectiveness estimate. However, this was still higher than would usually be considered to be a cost-effective treatment from the NHS's perspective. Future research recommendations include an update of this review in 12-18 months' time, by which time the included RCT should be fully published. It would also be useful to compare gemcitabine with currently used treatments for metastatic breast cancer, including capecitabine and vinorelbine.
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Health Technol Assess · May 2007
Randomized Controlled Trial Multicenter StudyAdditional therapy for young children with spastic cerebral palsy: a randomised controlled trial.
To investigate whether, in the short and medium term, additional support by (a) a physiotherapy assistant improved physical function in young children with spastic cerebral palsy and (b) a family support worker improved family functioning. ⋯ The findings of this study provide support for the current literature that there was no evidence that additional intervention (in this case by a physiotherapy assistant or family support worker) helped the motor or general development of young children with spastic cerebral palsy. Nor was there any quantitative evidence that providing extra family support helped levels of parental stress and family needs. The implication was that the provision of extra physical therapy does not necessarily improve the motor function of a young child with cerebral palsy and additional family support should not automatically be assumed to be beneficial. In addition, no significant association was found between the intensity of the local services provided and any outcome measure, other than a slight association with lowered family needs. The provision of local services was related to the severity of the child's impairments and not to family difficulties. A small group of families with complex family problems needed more service input. There was a wide range in the costs of services. Research is needed to examine what 'sufficient' levels of provision or therapy might be for which children and which families. A time series of different levels of input and outcomes would provide valuable information for practitioners. It is also recommended that future assessments of therapies of this type adopt a similar multifaceted approach, which is likely to be more suitable than a simple RCT for the evaluation of clinical interventions where the effects are complex. The most appropriate measures of outcome should be used, including assessment of provision of information and emotional support for families.
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Health Technol Assess · May 2007
ReviewScreening for type 2 diabetes: literature review and economic modelling.
To reconsider the aims of screening for undiagnosed diabetes, and whether screening should be for other abnormalities of glucose metabolism such as impaired glucose tolerance (IGT), or the 'metabolic syndrome'. Also to update the previous review for the National Screening Committee (NSC) on screening for diabetes, including reviewing choice of screening test; to consider what measures would be taken if IGT and impaired fasting glucose (IFG) were identified by screening, and in particular to examine evidence on treatment to prevent progression to diabetes in these groups; to examine the cost-effectiveness of screening; and to consider groups at higher risk at which screening might be targeted. ⋯ The case for screening for undiagnosed diabetes is probably somewhat stronger than it was at the last review, because of the greater options for reduction of CVD, principally through the use of statins, and because of the rising prevalence of obesity and hence type 2 diabetes. However, there is also a good case for screening for IGT, with the aim of preventing some future diabetes and reducing CVD. Further research is needed into the duration of undiagnosed diabetes, and whether the rise in blood glucose levels is linear throughout or whether there may be a slower initial phase followed by an acceleration around the time of clinical diagnosis. This has implications for the interval after which screening would be repeated. Further research is also needed into the natural history of IGT, and in particular what determines progression to diabetes. An RCT of the type required by NSC criterion 13 is under way but will not report for about 7 years.
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Health Technol Assess · May 2007
ReviewA systematic review of duplex ultrasound, magnetic resonance angiography and computed tomography angiography for the diagnosis and assessment of symptomatic, lower limb peripheral arterial disease.
To determine the diagnostic accuracy and cost-effectiveness of duplex ultrasound (DUS), magnetic resonance angiography (MRA), and computed tomography angiography (CTA), as alternatives to contrast angiography (CA), for the assessment of lower limb peripheral arterial disease (PAD). ⋯ The results of the review suggest that CE MRA has a better overall diagnostic accuracy than CTA or DUS, and that CE MRA is generally preferred by patients over CA. Where available, CE MRA may be a viable alternative to CA. The only controlled trial suggested that the results of DUS were comparable to those of CA, in terms of surgical planning and outcome. This finding conflicts with the results of diagnostic accuracy studies, which reported poor estimates of accuracy for DUS in comparison with CA. There was insufficient evidence to evaluate the usefulness of CTA for the assessment of PAD, particularly newer techniques. The results of the economic modelling suggest that for PAD patients for whom the whole leg is evaluated by a preoperative diagnostic test, DUS dominates the other alternatives by presenting higher effectiveness at a lower cost per QALY. However, when the analysis of stenosis is limited to a section of the leg, either above the knee or below the knee, 2D TOF MRA appears to be the most cost-effective preoperative diagnostic strategy. Further research is needed into a number of areas including the relative clinical effectiveness of the available imaging tests, in terms of surgical planning and postoperative outcome.