Health technology assessment : HTA
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Health Technol Assess · Oct 2005
Randomized Controlled Trial Multicenter Study Comparative StudyDisplaced intracapsular hip fractures in fit, older people: a randomised comparison of reduction and fixation, bipolar hemiarthroplasty and total hip arthroplasty.
To compare internal fixation, bipolar hemiarthroplasty and total hip arthroplasty for the management of displaced subcapital fracture of the hip in previously fit patients of 60 years or older. ⋯ In fit, older patients the results of the study show a clear advantage for arthroplasty over fixation; arthroplasty was more clinically effective and probably less costly over a 2-year period postsurgery. The results suggest that total hip replacement has long-term advantages over bipolar hemiarthroplasty, but these findings are less definite. This study provided support for the use of total hip replacement to treat displaced intracapsular hip fractures in fit, older patients. A larger trial comparing total versus hemiarthroplasty for these fractures could help to verify these findings. It would also be useful to know whether the findings of this study apply to patients aged 60 years or less who are usually treated with reduction and fixation. A clinical trial comparing arthroplasty versus fixation in patients older than 40 years would be a logical extension of the current study.
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Health Technol Assess · Oct 2005
Randomized Controlled Trial Multicenter Study Comparative StudyIs hydrotherapy cost-effective? A randomised controlled trial of combined hydrotherapy programmes compared with physiotherapy land techniques in children with juvenile idiopathic arthritis.
To compare the effects of combined hydrotherapy and land-based physiotherapy (combined) with land-based physiotherapy only (land) on cost, health-related quality of life (HRQoL) and outcome of disease in children with juvenile idiopathic arthritis (JIA). Also to determine the cost-effectiveness of combined hydrotherapy and land-based physiotherapy in JIA. ⋯ JIA is a disease in which a cure is not available. This research demonstrates a beneficial effect from both combined hydrotherapy and land-based physiotherapy treatment and land-based physiotherapy treatment alone in JIA without any exacerbation of disease, indicating that treatments are safe. The caveat to the results of the cost-effectiveness and clinical efficacy analysis is that the restricted sample size could have prevented a true difference being detected between the groups. Nevertheless, there appears to be no evidence to justify the costs of building pools or initiating new services specifically for use in this disease. However, this conclusion may not apply to patients with unremitting active disease who could not be entered into the trial because of specified exclusion criteria. For this group, hydrotherapy or combined treatment may still be the only physiotherapy option. Further research is suggested into: the investigation and development of appropriate and sensitive outcome measures for use in future hydrotherapy and physiotherapy trials of JIA; preliminary studies of methodologies in complex interventions such as physiotherapy and hydrotherapy to improve recruitment and ensure protocol is acceptable to patients and carers; hydrotherapy in the most common paediatric user group, children with neurological dysfunction, ensuring appropriate outcome measures are available and methodologies previously tried; patient satisfaction and compliance in land-based physiotherapy and hydrotherapy and European studies of hydrotherapy in rare disorders such as JIA.
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Health Technol Assess · Oct 2005
Randomized Controlled Trial Multicenter StudyA randomised controlled trial and cost-effectiveness study of systematic screening (targeted and total population screening) versus routine practice for the detection of atrial fibrillation in people aged 65 and over. The SAFE study.
To determine the most cost-effective method of screening for atrial fibrillation (AF) in the population aged 65 years and over, as well as its prevalence and incidence in this age group. Also to evaluate the relative cost-effectiveness of different methods of recording and interpreting the electrocardiogram (ECG) within a screening programme. ⋯ The results of the study indicated that in terms of a screening programme for atrial fibrillation in patients 65 and over, the only strategy that improved on routine practice was opportunistic screening, model-based analyses indicated that there was a probability of approximately 60% of annual opportunistic screening being cost effective. It is suggested that the following topics are worthy of further investigation: the effect of the implementation of a screening programme for AF on the uptake and maintenance of anticoagulation in patients aged 65 years and over; an evaluation of the role of CDSS in the diagnosis of cardiac arrythmias; the best method for routinely detecting paroxysmal AF; ways of improving healthcare professionals' performance in ECG interpretation; development of a robust economic model to incorporate data on new therapeutic agents for use as thromboprophylactic agents for patients with AF, and an evaluation of the relative risk of stroke for patients with incident as opposed to prevalent AF.
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Health Technol Assess · Sep 2005
Randomized Controlled Trial Multicenter Study Comparative StudyThe British Rheumatoid Outcome Study Group (BROSG) randomised controlled trial to compare the effectiveness and cost-effectiveness of aggressive versus symptomatic therapy in established rheumatoid arthritis.
To examine the effectiveness and cost-effectiveness of symptomatic versus aggressive treatment in patients with established, stable rheumatoid arthritis (RA). ⋯ This trial showed no benefit of aggressive treatment in patients with stable established RA. However, it was difficult to persuade the rheumatologist and/or the patient to change treatment if the evidence of disease activity was minimal. Patients in the symptomatic arm were able to initiate changes of therapy when their symptoms deteriorated, without frequent hospital assessment. Approximately one-third of current clinic attenders with stable RA could be managed in a shared care setting with annual review by a rheumatologist and regular contact with a rheumatologist nurse. Further research is needed into disease progression and the use of biological agents, minimum disease activity level below which disease progression does not occur, cost-effectiveness through shared care modelling, the development of a robust and fail-safe system of primary-care based disease-modifying anti-rheumatic drug (DMARD) monitoring, and predicting response to DMARDs.
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Health Technol Assess · Sep 2005
ReviewConceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials.
To develop a conceptual framework of preferences for interventions in the context of randomised controlled trials (RCTs), as well as to examine the extent to which preferences affect recruitment to RCTs and modify the measured outcome in RCTs through a systematic review of RCTs that incorporated participants' and professionals' preferences. Also to make recommendations on the role of participants' and professionals' preferences in the evaluation of health technologies. ⋯ Although patients and physicians often have intervention preferences, our review gives less support to the hypothesis that preferences significantly compromise the internal and external validity of trials. This review adds to the growing evidence that when preferences based on informed expectations or strong ethical objections to an RCT exist, observational methods are a valuable alternative. All RCTs in which participants and/or professionals cannot be masked to treatment arms should attempt to estimate participants' preferences. In this way, the amount of evidence available to answer questions about the effect of treatment preferences within and outwith RCTs could be increased. Furthermore, RCTs should routinely attempt to report the proportion of eligible patients who refused to take part because of their preferences for treatment. The findings also indicate a number of approaches to the design, conduct and analysis of RCTs that take account of participants' and/or professionals' preferences. This is referred to as a methodological tool kit for undertaking RCTs that incorporate some consideration of patients' or professionals' preferences. Future research into the amount and source of information available to patients about interventions in RCTs could be considered, with special emphasis on the relationship between sources inside and outside the RCT context. Qualitative research undertaken as part of ongoing RCTs might be especially useful. The processes by which this information leads to preferences in order to develop or extend the proposed expectancy--value framework could also be examined. Other areas for consideration include: how information about interventions changes participants' preferences; a comparison of the feasibility and effectiveness of different informed consent procedures; how strength of preference varies for different interventions within the same RCT and how these differences can be taken account of in the analysis; the differential effects of patients' and professionals' preferences on evidence arising from RCTs; and whether the standardised measurement of preferences within all RCTs (and analysis of the effect on outcome) would allow the rapid development of a significant evidence base concerning patient preferences, albeit in relation to a single preference design.