Health technology assessment : HTA
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Health Technol Assess · Jul 2004
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialVenUS I: a randomised controlled trial of two types of bandage for treating venous leg ulcers.
To compare the clinical and cost-effectiveness of two different compression bandages for the healing of venous leg ulcers. ⋯ The 4LB, which is currently the UK standard compression bandage for people with venous leg ulcers, was more clinically and cost-effective than the SSB. The bandage costs were less important than the costs of treatment visits, and patients in SSBs required more treatment overall. Generally, this trial supports the use of the 4LB in preference to the SSB. Recommendations for future research include: exploration of the relationship between bandager skill, application technique and ulcer healing; the relative cost-effectiveness of community leg ulcer clinics; and the study of nurse decision-making in venous ulcer management.
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Health Technol Assess · Jul 2004
A pilot study on the use of decision theory and value of information analysis as part of the NHS Health Technology Assessment programme.
To demonstrate the benefits of using appropriate decision-analytic methods and value of information analysis (DA-VOI). Also to establish the feasibility and implications of applying these methods to inform the prioritisation process of the NHS Health Technology Assessment (HTA) programme, and possibly extending their use therein. ⋯ The pilot study showed that, even with very short timelines, it is possible to undertake DA-VOI that can feed into the priority-setting process that has been developed for the HTA programme. There are however a number of areas that need to be established at the beginning of the process, such as clarification of the nature of the decision problem for which additional research is being considered, explicitness about which existing data should be used and how data that exhibit particular weaknesses should be down-weighted in the analysis. Other areas, including optimum application of researcher time, integrating the vignette (a summary of the clinical problem and existing evidence) and the use of DA-VOI, training, use of sensitivity analyses, and deployment of clinical expertise, are also considered in terms of the potential implementation of DA-VOI within the HTA programme. Recommendations for further research include how literature searching should focus on those variables to which the model's results are most sensitive and with the highest expected value of perfect information; methods of evidence synthesis (multiple parameter synthesis) to consider the evidence surrounding multiple comparators and networks of evidence; and ways in which the value of sample information can be used by the NHS HTA programme and other research funders to decide on the most efficient design of new evaluative research. There is also a need for an analytical framework to be developed that can jointly address the question of whether additional resources would better be devoted to additional research or interventions to change clinical practice.
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Health Technol Assess · Jun 2004
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialEVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy.
To test the null hypothesis of no significant difference between laparoscopic hysterectomy (LH), abdominal hysterectomy (AH) and vaginal hysterectomy (VH) with regard to each of the outcome measures of the trial, and also to assess the cost-effectiveness of the alternatives. ⋯ ALH is associated with a significantly higher risk of major complications and takes longer to perform than AH. ALH is, however, associated with less pain, quicker recovery and better short-term QoL after surgery than AH. The cost-effectiveness of ALH is finely balanced and is also influenced by the choice of reusable versus disposable equipment. Individual surgeons must decide between patient-orientated benefits and the risk of severe complications. VLH was not cost-effective relative to VH. Recommendations for future research include the application and relevance of QoL measures following hysterectomy, and long-term follow-up; patient preferences; reducing complication rates; improving gynaecological surgical training; surgeon effect in surgery trials; care pathways for hysterectomy; additional pathology identification in LH and meta-analysis/further trial of VH versus LH.
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Health Technol Assess · Jun 2004
ReviewDevelopment and validation of methods for assessing the quality of diagnostic accuracy studies.
To develop a quality assessment tool which will be used in systematic reviews to assess the quality of primary studies of diagnostic accuracy. ⋯ This project produced an evidence-based quality assessment tool to be used in systematic reviews of diagnostic accuracy studies. Through the various stages of the project the current lack of such a tool and the need for a systematically developed validated tool were demonstrated. Further work to validate the tool continues beyond the scope of this project. The further development of the tool by the addition of design- and topic-specific criteria is proposed.
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Health Technol Assess · Jun 2004
Review Comparative StudyNewer hypnotic drugs for the short-term management of insomnia: a systematic review and economic evaluation.
To assess the clinical and cost-effectiveness of zaleplon, zolpidem and zopiclone (Z-drugs) compared with benzodiazepines. ⋯ The short-acting drugs seem equally effective and safe with minor differences that may lead a prescriber to favour one over another in different patients. There is no evidence that one is more cost-effective than any other. Analysis of the additional costs to the NHS, depending on the rate of change from benzodiazepine prescriptions to Z-drug prescriptions, at current levels of hypnotic prescribing, range from GBP2 million to GBP17 million per year. There are clear research needs in this area; in particular, none of the existing trials adequately compare these medications. It is suggested that further consideration should be given to a formal trial to allow head-to-head comparison of some of the key drugs in a double-blind RCT lasting at least 2 weeks, and of sufficient size to draw reasonable conclusions. We would also recommend that any such trial should include a placebo arm. It should also collect good-quality data around sleep outcomes and in particular quality of life and daytime drowsiness. We do not believe that any formal study of risk of dependency is feasible at present. Finally, the management of long-term insomnia is suggested for further investigation: considering the frequency of this symptom and its recurring course, the short-term trial of medication and lack of long-term follow-up undermine attempts to develop evidence-based guidelines for the use of hypnotics in this condition, or indeed for its whole management.