Health technology assessment : HTA
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Health Technol Assess · Mar 2006
ReviewThe clinical effectiveness and cost-effectiveness of newer drugs for children with epilepsy. A systematic review.
To examine the clinical effectiveness and cost-effectiveness of newer antiepileptic drugs (AEDs) for epilepsy in children: gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate and vigabatrin. ⋯ The prognosis for children diagnosed with epilepsy is generally good, with a large proportion responding well to the first treatment given. A substantial proportion, however, will not respond well to treatment, and for these patients the clinical goal is to find an optimal balance between the benefits and side-effects of any treatment given. For the newly, or recently, diagnosed population, the key question for the newer drugs is how soon they should be tried. The cost-effectiveness of using these agents early, in place of one of the older agents, will depend on the effectiveness and tolerability of these agents compared with the older agents; the evidence from the available trial data so far suggests that the newer agents are no more effective but may be somewhat better tolerated than the older agents, and so the cost-effectiveness for early use will depend on the trade-off between effectiveness and tolerability, both in terms of overall (long-term) treatment retention and overall utility associated with effects on seizure rate and side-effects. There are insufficient data available to estimate accurately the nature of this trade off either in terms of long-term treatment retention or utility. Better information is required from RCTs before any rational evidence-based prescribing strategy could be developed. Ideally, RCTs should be conducted from a 'public health' perspective, making relevant comparisons and incorporating outcomes of interest to clinicians and patients, with sufficiently long-term follow-up to determine reliably the clinical utility of different treatments, particularly with respect to treatment retention and the balance between effectiveness and tolerability. RCTs should mirror clinical practice with respect to diagnosis, focusing on defined syndromes or, where no syndrome is identified, on groups defined by specific seizure type(s) and aetiology. Epilepsy in children is a complex disease, with a variety of distinct syndromes and many alternative treatment options and outcomes. Diagnosis-specific decision-analytic models are required; further research may be required to inform parameter values adequately with respect to epidemiology and clinical practice.
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Health Technol Assess · Feb 2006
ReviewSystematic review and evaluation of methods of assessing urinary incontinence.
To identify and synthesise studies of diagnostic processes of urinary incontinence and to construct an economic model to examine the cost-effectiveness of simple, commonly used primary care tests. ⋯ This is the first systematic review of methods for diagnosing urinary incontinence. As reporting of the primary studies was poor, clinical interpretation was often difficult because few studies could be synthesised and conclusions made. The report found that a large proportion of women with USI can be correctly diagnosed in primary care from clinical history alone. On the basis of diagnosis the diary appears to be the most cost-effective of the three primary care tests (diary, pad test and validated scales) used in addition to clinical history. Ultrasound imaging may offer a valuable alternative to urodynamic investigation. The clinical stress test is effective in the diagnosis of USI. Adaptation of such a test so that it could be performed in primary care with a naturally filled bladder may prove clinically useful. If a patient is to undergo an invasive urodynamic procedure, multichannel urodynamics is likely to give the most accurate result in a secondary care setting. There is a dearth of literature on the diagnosis of urinary incontinence in men, with no studies meeting the study criteria for data extraction in the diagnosis of bladder outlet obstruction. There is a need for large-scale, high-quality primary studies evaluating the use of a number of diagnostic methods in a primary care setting to be undertaken so that the results of this systematic review can be verified or not. Such studies should include not only an assessment of clinical effectiveness, in this case diagnostic accuracy, but also an assessment of costs and quality of life/satisfaction to inform future health policy decisions. Studies carried out should be reported to a better standard. The recommendations of the Standards for Reporting Diagnostic Accuracy (STARD) initiative should be followed to ensure the accuracy and completeness of reporting design and results.
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Health Technol Assess · Feb 2006
Review Case Reports Comparative StudyComparison of conference abstracts and presentations with full-text articles in the health technology assessments of rapidly evolving technologies.
To assess the extent of use of data from conference abstracts and presentations in health technology assessments (HTAs) provided as part of the National Institute for Health and Clinical Excellence (NICE) appraisal process. Also to assess the methodological quality of trials from conference abstracts and presentations, the consistency of reporting major outcomes between these sources and subsequent full-length publications, the effect of inclusion or exclusion of data from these sources on the meta-analysis pooled effect estimates, and the timeliness of availability of data from these sources and full articles in relation to the development of technology assessment reviews (TARs). ⋯ There are variations in policy and practice across TAR groups regarding searching for and inclusion of studies available as conference abstracts/presentations. There is also variation in the level of detail reported in TARs regarding the use of abstracts/presentations. Therefore, TAR teams should be encouraged to state explicitly their search strategies for identifying conference abstracts and presentations, their methods for assessing these for inclusion, and where appropriate how the data were used and their effect on the results. Comprehensive searching for trials available as conference abstracts/presentations is time consuming and may be of questionable value. However, there may be a case for searching for and including abstract/presentation data if, for example, other sources of data are limited. If conference abstracts/presentations are to be included, the TAR teams need to allocate additional time for searching and managing data from these sources. Incomplete reporting in conference abstracts and presentations limits the ability of reviewers to assess confidently the methodological quality of trials. Where conference abstracts and presentations are considered for inclusion in the review, the TAR teams should increase their efforts to obtain further study details by contacting trialists. Where abstract/presentation data are included, reviewers should discuss the effect of including data from these sources. Any data discrepancies identified across sources in TARs should be highlighted and their impact discussed in the review. In addition, there is a need to carry out, for example, a sensitivity analysis with and without abstract/presentation data in the analysis. There is a need for research into the development of search strategies specific to identification of studies available as conference abstracts and presentations in TARs. Such strategies may include guidance with regard to identification of relevant electronic databases and appropriate conference sites relevant to certain clinical areas. As there are limited case studies included in this report, analyses should be repeated as more TARs accrue, or include the work of other international HTA groups.
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Health Technol Assess · Feb 2006
ReviewA systematic review of the effectiveness and cost-effectiveness of neuroimaging assessments used to visualise the seizure focus in people with refractory epilepsy being considered for surgery.
To review the effectiveness and/or accuracy, cost-effectiveness, and predictive value of neuroimaging of the cerebral cortex to visualise the seizure focus in people with refractory epilepsy being considered for surgery. ⋯ Due to the limitations of the included studies, the results of this review do little to inform clinical practice, with insufficient evidence regarding effectiveness and cost-effectiveness of imaging techniques in the work-up for epilepsy surgery. Given the inadequacy of existing data, there is a pressing need for studies investigating the utility of imaging techniques in the work up for epilepsy surgery. The most reliable method to achieve this is the RCT, which could examine the single tests or combinations of tests on patient outcome. The authors suggest that it is important that clinicians, patient groups, policy makers and healthcare/research funders meet and debate the most appropriate way to investigate these technologies.
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Health Technol Assess · Jan 2006
ReviewThe clinical and cost-effectiveness of donepezil, rivastigmine, galantamine and memantine for Alzheimer's disease.
To provide an update review of the best quality evidence for the clinical effectiveness and cost-effectiveness of donepezil, rivastigmine and galantamine for mild to moderately severe Alzheimer's disease (AD) and of memantine for moderately severe to severe AD. ⋯ Although results from the clinical effectiveness review suggest that these treatments may be beneficial, a number of issues need to be considered when assessing the results of the present review, such as the characteristics of the participants included in the individual trials, the outcome measures used, the length of study duration, the effects of attrition and the relationship between statistical significance and clinical significance. Many included trials were sponsored by industry. For donepezil, rivastigmine and galantamine, the cost savings associated with reducing the mean time spent in full-time care do not offset the cost of treatment sufficiently to bring estimated cost-effectiveness to levels generally considered acceptable by NHS policy makers. It is difficult to draw conclusions on the cost-effectiveness of memantine; it is suggested that further amendments to the potentially optimistic industry model (measure of effect) would offer higher cost per QALY estimates. Future research should include: information on the quality of the outcome measures used; development of quality of life instruments for patients and carers; studies assessing the effects of these interventions of durations longer than 12 months; comparisons of benefits between interventions; and research on the prediction of disease progression.