Health technology assessment : HTA
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Health Technol Assess · Jul 2006
Randomized Controlled Trial Multicenter StudyPressure relieving support surfaces: a randomised evaluation.
To determine differences between alternating pressure overlays and alternating pressure replacement mattresses with respect to the development of new pressure ulcers, healing of existing pressure ulcers, patient acceptability and cost-effectiveness of the different pressure-relieving surfaces. Also to investigate the specific additional impact of pressure ulcers on patients' well-being. ⋯ There is no difference between alternating pressure mattress replacements and overlays in terms of the proportion of patients developing new pressure ulcers; however, alternating pressure mattress replacements are more likely to be cost-saving. The results suggest that when renewing alternating pressure surfaces or ordering equipment within a rental contract, mattress replacements should be specified; however, overlays are acceptable if no replacement mattress is available. Similarly, patient preferences can be supported, without any great increase in risk, if individual patients request an overlay rather than a replacement mattress. Further research could include a randomised controlled trial comparing alternating pressure mattress replacements and high-specification foam mattresses in patients at moderate to high risk; an accurate costing study to understand better how much pressure ulcers cost health and social services in the UK; and trials in higher risk groups of patients. Also future trials should measure time to ulceration as the primary end-point, since this is more informative economically and possibly also from a patient and clinical perspective.
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Health Technol Assess · May 2006
Randomized Controlled Trial Multicenter StudyRandomised controlled trials of conventional antipsychotic versus new atypical drugs, and new atypical drugs versus clozapine, in people with schizophrenia responding poorly to, or intolerant of, current drug treatment.
To determine the clinical and cost-effectiveness of different classes of antipsychotic drug treatment in people with schizophrenia responding inadequately to, or having unacceptable side-effects from, their current medication. ⋯ For band 1, there is no disadvantage in terms of quality of life and symptoms, or associated costs of care, over 1 year in commencing conventional antipsychotic drugs rather than new atypical drugs. Conventional drugs were associated with non-significantly better outcomes and lower costs. Drug costs represented a small proportion of the overall costs of care (<5%). For band 2, there is a statistically significant advantage in terms of symptoms but not quality of life over 1 year in commencing clozapine rather than new atypical drugs, but with increased associated costs of care. The results suggest that conventional antipsychotic drugs, which are substantially cheaper, still have a place in the treatment of patients unresponsive to, or intolerant of, current medication. Further analyses of this data set are planned and further research is recommended into areas such as current antipsychotic treatment guidance, valid measures of utility in serious mental illness, low-dose 'conventional' treatment in first episode schizophrenia, QLS validity and determinants of QLS score in schizophrenia, and into the possible financial and other mechanisms of rewarding clinician participation in trials.
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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.
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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.