Health technology assessment : HTA
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Health Technol Assess · Apr 2008
Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study.
To review UK guidelines regarding the use of financial incentives for healthcare professionals to become involved in clinical trials, and to survey perceptions and current practice. ⋯ The ethical stances outlined in Good Clinical Practice in research were widely endorsed by the three groups interviewed. These allow reasonable payments to clinicians, subject to disclosure of any possible conflicts of interest. The potential for incentivising clinicians to recruit was limited as any payments should be based on the cost of inputs and should not be made to individuals but to their host organisation. NHS professionals were concerned that payments could damage the quality of research and also considered full disclosure to patients as challenging. Patients and members of the public favoured full disclosure and payment of expenses to patients involved in research. Pharmaceutical company interviewees viewed payment to the NHS for all research activities as normal and highly regulated. They complained that the prices charged were high and so variable that they required benchmarking. Considerable scope exists for compiling data on the factors that help and hinder the progress of clinical trials and also for experimenting with different incentives to encourage involvement in clinical research. Further research should focus on improved reporting of those organisational aspects of trials that are known to affect recruitment; retrospective analysis of the factors associated with different levels of recruitment to RCTs; prospective comparative research on trial recruitment; qualitative research on participants' experiences of being involved in different kinds of trials, and proposals to include within trials experiments with payments methods.
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Health Technol Assess · Apr 2008
Review Meta AnalysisCyclooxygenase-2 selective non-steroidal anti-inflammatory drugs (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis and rheumatoid arthritis: a systematic review and economic evaluation.
To review the clinical effectiveness and cost-effectiveness of cyclooxygenase-2 (COX-2) selective non-steroidal anti-inflammatory drugs (NSAIDs) (etodolac, meloxicam, celecoxib, rofecoxib, etoricoxib, valdecoxib and lumiracoxib) for osteoarthritis (OA) and rheumatoid arthritis (RA). ⋯ The COX-2 selective NSAIDs examined were found to be similar to non-selective NSAIDs for the symptomatic relief of RA and OA and to provide superior GI tolerability (the majority of evidence is in patients with OA). Although COX-2 selective NSAIDs offer protection against serious GI events, the amount of evidence for this protective effect varied considerably across individual drugs. The volume of trial evidence with regard to cardiovascular safety also varied substantially between COX-2 selective NSAIDs. Increased risk of MI compared to non-selective NSAIDs was observed among those drugs with greater volume of evidence in terms of exposure in patient-years. Economic modelling shows a wide range of possible costs per QALY gained in patients with OA and RA. Costs per QALY also varied if individual drugs were used in 'standard' or 'high'-risk patients, the choice of non-selective NSAID comparator and whether that NSAID was combined with a PPI. With reduced costs of PPIs, future primary research needs to compare the effectiveness and cost-effectiveness of COX-2 selective NSAIDs relative to non-selective NSAIDs with a PPI. Direct comparisons of different COX-2 selective NSAIDs, using equivalent doses, that compare GI and MI risk are needed. Pragmatic studies that include a wider range of people, including the older age groups with a greater burden of arthritis, are also necessary to inform clinical practice.
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Health Technol Assess · Apr 2008
ReviewStapled haemorrhoidectomy (haemorrhoidopexy) for the treatment of haemorrhoids: a systematic review and economic evaluation.
To determine the safety, clinical effectiveness and cost-effectiveness of circular stapled haemorrhoidopexy (SH) for the treatment of haemorrhoids. ⋯ SH was associated with less pain in the immediate postoperative period, but a higher rate of residual prolapse, prolapse in the longer term and reintervention for prolapse. There was no clear difference in the rate or type of complications associated with the two techniques and the absolute and relative rates of recurrence and reintervention for both are still uncertain. CH and SH had very similar costs and QALYs, the cost of the staple gun being offset by savings in hospital stay. Should the price of the gun change, the conclusions of the economic analysis may also change. Some training may be required in the use of the staple gun; this is not expected to have major resource implications. Given the currently available clinical evidence and the results of the economic analysis, the decision as to whether SH or CH is conducted could primarily be based on the priorities and preferences of the patient and surgeon. An adequately powered, good-quality RCT is required, comparing SH with CH, recruiting patients with second, third and fourth degree haemorrhoids, and having a minimum follow-up period of 5 years to ensure an adequate evaluation of the reintervention rate. Other areas for research are the effectiveness of SH in patients with fourth degree haemorrhoids and patients with co-morbid conditions, the reintervention rates for all treatments for haemorrhoids, utilities of patients up to 6 months postoperatively, the trade-offs of patients for short-term pain versus long-term outcomes, and the ability of SH to reduce hospital stays in a real practice setting.
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Health Technol Assess · Apr 2008
ReviewThe clinical effectiveness and cost-effectiveness of central venous catheters treated with anti-infective agents in preventing bloodstream infections: a systematic review and economic evaluation.
To assess the clinical effectiveness and cost-effectiveness of central venous catheters (CVCs) treated with anti-infective agents in preventing catheter-related bloodstream infection (CRBSI). ⋯ Overall, AI-CVCs are clinically effective and relatively inexpensive and therefore their integration into clinical practice can be justified. However, the use of these anti-infective catheters without the appropriate use of other practical care initiatives will have only a limited success on the prevention of CRBSIs. Comparative trials are required to determine which, if any, of the treated catheters is the most effective. Pragmatic research related to the effectiveness of bundles of care that may reduce rates of CRBSI is also warranted.
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Health Technol Assess · Apr 2008
The use of economic evaluations in NHS decision-making: a review and empirical investigation.
To determine the extent to which health economic information is used in health policy decision-making in the UK, and to consider factors associated with the utilisation of such research findings. ⋯ This study suggests that research is needed into structures, processes and mechanisms by which technology coverage decisions can and should be made in healthcare. Further development of 'resource centres' may be useful to provide independent published analyses in order to support local decision-makers. Improved methods of economic analyses and of their presentation, which take account of the concerns of their users, are needed. Finally, the findings point to the need for further assessment of the feasibility and value of a formal process of clarification of the objectives that we seek from investments in healthcare.