Health technology assessment : HTA
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Health Technol Assess · Mar 2010
Randomized Controlled Trial Multicenter StudyMulticentre randomised controlled trial of the clinical and cost-effectiveness of a bypass-surgery-first versus a balloon-angioplasty-first revascularisation strategy for severe limb ischaemia due to infrainguinal disease. The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial.
To compare a 'bypass-surgery-first' with a 'balloon-angioplasty-first' revascularisation strategy in patients with severe limb ischaemia (SLI) due to infrainguinal disease requiring immediate/early revascularisation. ⋯ The findings of our study suggest that in patients with SLI due to infrainguinal disease the decision whether to perform bypass surgery or balloon angioplasty first appears to depend upon anticipated life expectancy. Patients expected to live less than 2 years should usually be offered balloon angioplasty first as it is associated with less morbidity and cost, and such patients are unlikely to enjoy the longer-term benefits of surgery. By contrast, those patients expected to live beyond 2 years should usually be offered bypass surgery first, especially where a vein is available as a conduit. Many patients who could not undergo a vein bypass would probably have been better served by a first attempt at balloon angioplasty than prosthetic bypass. The failure rate of angioplasty in SLI is high (c. 25%) and patients who underwent bypass after failed angioplasty fared significantly worse than those who underwent surgery as their first procedure. The interests of a significant proportion of BASIL patients may have been best served by primary amputation followed by high-quality rehabilitation. Further research is required to confirm or refute the BASIL findings and recommendations; validate the BASIL survival prediction model in a separate cohort of patients with SLI; examine the clinical and cost-effectiveness of new endovascular techniques and devices; and compare revascularisation with primary amputation and with best medical and nursing care in those SLI patients with the poorest survival prospects.
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Health Technol Assess · Mar 2010
Randomized Controlled TrialNorth of England and Scotland Study of Tonsillectomy and Adeno-tonsillectomy in Children(NESSTAC): a pragmatic randomised controlled trial with a parallel non-randomised preference study.
To examine the clinical effectiveness and cost-effectiveness of tonsillectomy/adeno-tonsillectomy in children aged 4-15 years with recurrent sore throats in comparison with standard non-surgical management. ⋯ Children and parents exhibited strong preferences for the surgical management of recurrent sore throats. The health of all children with recurrent sore throat improves over time, but trial participants randomised to surgical management tended to experience better outcomes than those randomised to medical management. The limitations of the study due to poor response at follow-up support the continuing careful use of 'watchful waiting' and medical management in both primary and secondary care in line with current clinical guidelines until clear-cut evidence of clinical effectiveness and cost-effectiveness is available.
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Health Technol Assess · Mar 2010
Randomized Controlled Trial Multicenter Study Comparative StudyA randomised controlled multicentre trial of treatments for adolescent anorexia nervosa including assessment of cost-effectiveness and patient acceptability - the TOuCAN trial.
To evaluate the clinical effectiveness and cost-effectiveness of inpatient compared with outpatient treatment and general (routine) treatment in Child and Adolescent Mental Health Services (CAMHS) against specialist treatment for young people with anorexia nervosa. In addition, to determine young people's and their carers' satisfaction with these treatments. ⋯ Poor adherence to randomisation (despite initial consent to it), limits the assessment of the treatment effect of inpatient care. However, this study provides little support for lengthy inpatient psychiatric treatment on clinical or health economic grounds. These findings are broadly consistent with existing guidelines on the treatment of anorexia nervosa, which suggest that outpatient treatments should be offered to the majority, with inpatient treatment offered in rare cases, though our findings lend little support to a stepped-care approach in which inpatient care is offered to outpatient non-responders. Outpatient care, supported by brief (medical) inpatient management for correction of acute complications may be a preferable approach. The health economic analysis and user views both support NICE guidelines, which suggest that anorexia nervosa should be managed in specialist services that have experience and expertise in its management. Comprehensive general CAMHS might, however, be well placed to manage milder cases. Further research should focus on the specific components of outpatient psychological therapies. Although family-based treatments are well established, trials have not established their effectiveness compared with good-quality individual psychological therapies and the combination of individual and family approaches is untested. Further research is needed to establish which patients (if any) might respond to inpatient psychiatric treatment when unresponsive to outpatient care, the positive and negative components of it and the optimum length of stay.