Health technology assessment : HTA
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Health Technol Assess · Mar 2006
ReviewTopotecan, pegylated liposomal doxorubicin hydrochloride and paclitaxel for second-line or subsequent treatment of advanced ovarian cancer: a systematic review and economic evaluation.
To examine the clinical effectiveness and cost-effectiveness of intravenous formulations of topotecan monotherapy, pegylated liposomal doxorubicin hydorocholoride (PLDH) monotherapy and paclitaxel used alone or in combination with a platinum-based compound for the second-line or subsequent treatment of advanced ovarian cancer. ⋯ For participants with platinum-resistant disease there was a low probability of response to treatment with PLDH, topotecan or paclitaxel. Furthermore, there was little difference between the three comparators in relation to overall survival. The comparators did, however, differ considerably in their toxicity profiles. Given the low survival times and response rates, it appears that the maintenance of quality of life and the control of symptoms and toxicity are paramount in this patient group. As the three comparators differed significantly in terms of their toxicity profiles, patient and physician choice is also an important element that should be addressed when decisions are made regarding second-line therapy. It can also be suggested that this group of patients may benefit from being included in further clinical trials of new drugs. For participants with platinum-sensitive disease there was a considerable range of median survival times observed across the trials. The most favourable survival times and response rates were observed for paclitaxel and platinum combination therapy. This suggests that treatment with combination therapy may be more beneficial than treatment with a single-agent chemotherapeutic regimen. In terms of single-agent compounds, the evidence suggests that PLDH is more effective than topotecan. Evidence from a further trial that compared PLDH and paclitaxel suggests that there is no significant difference between these two comparators in this trial. The three comparators did, however, differ significantly in terms of their toxicity profiles across the trials. Although treatment with PLDH may therefore be more beneficial than that with topotecan, patient and physician choice as to the potential toxicities associated with each of the comparators and the patient's ability and willingness to tolerate these are of importance. Assuming the NHS is willing to pay up to pound 20,000-40,000 per additional QALY, PLDH appears to be cost-effective compared with topotecan and paclitaxel monotherapy, in terms of the overall patient population and the main subgroups considered. The cost-effectiveness results for the base-case analysis were sensitive to the inclusion of additional trial data. Incorporating the results of additional trial data gave less favourable estimates for the ICER for PLDH versus paclitaxel monotherapy, compared with the base-case results. Although the ICER of PLDH compared with paclitaxel monotherapy was less favourable, PLDH was still cost-effective compared with topotecan and paclitaxel monotherapy. For platinum-sensitive patients, the combination of paclitaxel and platinum appears to be cost-effective. On the strength of the evidence reviewed here, it can be suggested that participants with platinum-resistant disease may benefit from being included in further clinical trials of new drugs. To assess the effectiveness of combination therapy against a single-agent non-platinum-based compound, it can be suggested that a trial that compared paclitaxel in combination with a platinum-based therapy versus single-agent PLDH would be a reasonable option.
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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 · 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
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 · Jan 2006
Randomized Controlled Trial Multicenter Study Comparative StudyFOOD: a multicentre randomised trial evaluating feeding policies in patients admitted to hospital with a recent stroke.
To determine whether routine oral nutritional supplementation of a normal hospital diet improves outcome after stroke (Trial 1); whether early tube feeding improves the outcomes of dysphagic stroke patients (Trial 2); and if tube feeding via a percutaneous endoscopic gastrostomy (PEG) results in better outcomes than that via a nasogastric tube (NG) (Trial 3). ⋯ The results of Trial 1 would be compatible with oral supplementation being associated with a 1-2% absolute benefit or harm, but do not support routine supplementation of hospital diet for unselected stroke patients who are predominantly well nourished on admission. In Trial 2, the data suggest that a policy of early tube feeding may substantially reduce the risk of dying after stroke and it is very unlikely that the alternative policy of avoiding early tube feeding would significantly improve survival. Improved survival may be at the expense of increasing the proportion surviving with poor outcome. These data might usefully inform the difficult discussions about whether or not to feed a patient with a severe stroke. In Trial 3, the data suggest that in the first 2-3 weeks after acute stroke, better functional outcomes result from feeding via NG tube than PEG tube, although there was no major difference in survival. These data do not support a policy of early initiation of PEG feeding in dysphagic stroke patients. Future research might be focused on making NG tube feeding safer and more effective, also studies need to confirm the increased risk of gastrointestinal haemorrhage associated with tube feeding and, if confirmed, establish whether any interventions might reduce this risk. Future work might also aim to establish why worse functional outcomes occurred in PEG-fed patients because patients with prolonged dysphagia or intolerance of an NG tube are inevitably fed via a PEG tube.