Health technology assessment : HTA
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Health Technol Assess · Oct 2004
ReviewProvision, uptake and cost of cardiac rehabilitation programmes: improving services to under-represented groups.
To estimate UK need for outpatient cardiac rehabilitation, current provision and identification of patient groups not receiving services. To conduct a systematic review of literature on methods to improve uptake and adherence to cardiac rehabilitation. To estimate cost implications of increasing uptake of cardiac rehabilitation. ⋯ Provision of outpatient cardiac rehabilitation in the UK is low and little is known about the capacity of cardiac rehabilitation centres to increase this provision. There is an uncoordinated approach to audit data collection and few interventions aimed at improving the situation have been formally evaluated. Motivational communications and trained lay volunteers may improve uptake of cardiac rehabilitation, as may self-management techniques. Experience of low-cost interventions and good practice exists within rehabilitation centres, although cost information frequently is not reported. Increased provision of outpatient cardiac rehabilitation will require extra resources. Further trials are required to compare the cost-effectiveness of comprehensive multidisciplinary rehabilitation with simpler outpatient programmes, also research is needed into economic and patient preference studies of the effects of different methods of using increased funding for cardiac rehabilitation. An evaluation of a range of interventions to promote attendance in all patients and under-represented groups would also be useful. The development of standards is suggested for audit methods and for eligibility criteria, as well as regular and comprehensive data collection to estimate the need for and provision of cardiac rehabilitation. Further areas for intervention could be identified through qualitative studies, and the extension of low-cost interventions and good practice within rehabilitation centres. Regularly updated systematic reviews of relevant literature would also be useful.
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Health Technol Assess · Oct 2004
Review Comparative StudyClopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation.
To review systematically the clinical effectiveness and the cost-effectiveness of clopidogrel used in combination with standard therapy including aspirin, compared with standard therapy alone for the treatment of non-ST-segment elevation acute coronary syndromes (ACS). ⋯ The results of the CURE trial indicate that clopidogrel in combination with aspirin was significantly more effective than placebo combined with aspirin in a wide range of patients with ACS. This benefit was largely related to a reduction in Q-wave myocardial infarction. There was no statistically significant benefit in relation to mortality. The trial data suggested that a substantial part of the benefit derived from clopidogrel is achieved by 3 months, with a further small benefit over the remaining 9 months of chronic treatment. The results from the base-case model suggest that treatment with clopidogrel as an adjunct to standard therapy (including aspirin) for 12 months, compared with standard therapy alone, is cost-effective in non-ST elevation ACS patients as long as the health service is willing to pay GBP6078 per additional QALY. However, although treatment with clopidogrel for 12 months remained cost-effective for the overall cohort, provisional findings indicate that the shorter treatment durations may be more cost-effective in patients at low risk. To estimate the exact length of time that clopidogrel in addition to standard therapy should be prescribed for patients with non-ST-segment ACS would require a prospective trial that randomised patients to various durations of therapy. This would accurately assess whether a 'rebound' phenomenon occurs in patients if clopidogrel were stopped after 3 months of treatment.
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To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. ⋯ Effective strategies for South Asian recruitment to clinical trials include: using multi-recruitment strategies; defining the demographic and social profiles of the population to be included; using focus groups to identify any potential barriers; consulting representative community members to provide assistance in the study; ensuring eligibility criteria are set as wide as possible; developing educational and recruitment approaches to attract ethnic minority health professionals; ensuring health professionals are adequately trained in culturally and ethnically orientated service provision; determining the most effective mass media to use in study promotion and recruitment; and targeting inner-city, single-handed practices likely to have high ethnic minority populations. Future research should consider: responses when invited to participate; the role of methodological and organisational barriers to recruitment; the complexities of recruitment from a health professional perspective; developing culturally sensitive research methods; the magnitude of the problem of under-recruitment; strategies to encourage inner-city, single-handed GP participation; and other factors affecting trial inclusion, such as age, gender, educational level and socio-cultural background.
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Health Technol Assess · Oct 2004
ReviewPegylated interferon alpha-2a and -2b in combination with ribavirin in the treatment of chronic hepatitis C: a systematic review and economic evaluation.
To assess the clinical-effectiveness and cost-effectiveness of pegylated interferon-alpha combined with ribavirin in the treatment of chronic hepatitis C. ⋯ Well-designed RCTs show that patients treated with pegylated interferon, both as dual therapy and as monotherapy, experience higher sustained viral response rates than those treated with non-pegylated interferon. Patients with genotypes 2 and 3 experience the highest response, with rates in excess of 80%. Patients with the harder to treat genotype 1 nevertheless benefit, with up to 46% of patients experiencing an SVR in one of the trials. Pegylated interferon also appears to be relatively cost-effective in both monotherapy and dual therapy, with cost per QALY estimates remaining generally under 30,000 pounds sterling. The most favourable estimates were for patients with genotypes 2 and 3. Pegylated interferon is a relatively new intervention in the treatment of hepatitis C and therefore there are areas where further research is needed. These include: efficacies of therapy with PEG-alpha-2a vs PEG-alpha-2b; retreatment of previous non-responders using pegylated interferon; efficacy of treatments and long-term outcomes in patients who have other co-morbidities; prospective tests of rules governing stopping treatment; treating patients with acute hepatitis C; problems that may occur in a minority of patients with hepatitis C, such as cryoglobulinaemia and vasculitis; additional psychological effects on quality of life due to hepatitis C and also on the treatment of children and adolescents with hepatitis C.
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Health Technol Assess · Sep 2004
ReviewReview of guidelines for good practice in decision-analytic modelling in health technology assessment.
To identify existing guidelines and develop a synthesised guideline plus accompanying checklist. In addition to provide guidance on key theoretical, methodological and practical issues and consider the implications of this research for what might be expected of future decision-analytic models. ⋯ The review of current guidelines showed that although authors may provide a consistent message regarding some aspects of modelling, in other areas conflicting attributes are presented in different guidelines. In general, the checklist appears to perform well, in terms of identifying those aspects of the model that should be of particular concern to the reader. The checklist cannot, however, provide answers to the appropriateness of the model structure and structural assumptions, as these may be seen as a general problem with generic checklists and do not reflect any shortcoming with the synthesised guidance and checklist developed here. The assessment of the checklist, as well as feedback from the EAG, indicated the importance of its use in conjunction with a more general checklist or guidelines on economic evaluation. Further methods research into the following areas would be valuable: the quantification of selection bias in non-controlled studies and in controlled observational studies; the level of bias in the different non-RCT study designs; a comparison of results from RCTs with those from other non-randomised studies; assessment of the strengths and weaknesses of alternative ways to adjust for bias in a decision model; and how to prioritise searching for parameter estimates.