Health technology assessment : HTA
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Health Technol Assess · Jan 2000
Randomized Controlled Trial Comparative Study Clinical TrialRandomised controlled trial of non-directive counselling, cognitive-behaviour therapy and usual general practitioner care in the management of depression as well as mixed anxiety and depression in primary care.
The aim of this study was to determine both the clinical and cost-effectiveness of usual general practitioner (GP) care compared with two types of brief psychological therapy (non-directive counselling and cognitive-behaviour therapy) in the management of depression as well as mixed anxiety and depression in the primary care setting. ⋯ At 4 months, both psychological therapies had reduced depressive symptoms to a significantly greater extent than usual GP care. Patients in the psychological therapy groups exhibited mean scores on the Beck Depression Inventory that were 4-5 points lower than the mean score of patients in the usual GP care group, a difference that was also clinically significant. These differences did not generalize to other measures of outcome. There was no significant difference in outcome between the two psychological therapies when they were compared directly using all 260 patients randomised to a psychological therapy by either randomised allocation method. At 12 months, the patients in all three groups had improved to the same extent. The lack of a significant difference between the treatment groups at this point resulted from greater improvement of the patients in the GP care group between the 4- and 12-month follow-ups. At 4 months, patients in both psychological therapy groups were more satisfied with their treatment than those in the usual GP care group. However, by 12 months, patients who had received non-directive counselling were more satisfied than those in either of the other two groups. There were few differences in the baseline characteristics of patients who were randomised or expressed a treatment preference, and no differences in outcome between these patients. Similar outcomes were found for patients who chose either psychological therapy. Again, there were no significant differences between the two groups at 4 or 12 months. Patients who chose counselling were more satisfied with treatment than those who chose c
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Health Technol Assess · Jan 2000
Randomized Controlled Trial Clinical TrialEarly asthma prophylaxis, natural history, skeletal development and economy (EASE): a pilot randomised controlled trial.
(1) To establish recruitment rates of newly presenting asthmatic children. (2) To establish acceptability of study protocols. (3) To pilot age-specific quality of life (QoL) assessment. (4) To assess short-term (6 months) outcomes of inhaled corticosteroids (ICS) treatment. (5) To refine sample size calculations for a definitive study. ⋯ Most (96%) of the proposed sample was recruited, and the low drop-out rate (8%) demonstrated acceptability of the study protocol. Most children first presenting with symptoms suggestive of asthma were < 6 years old and represented a group biased towards mild to moderate asthma, or virally induced wheeze. The caregiver's QoL questionnaire was found to better reflect a child's symptom changes than a child-centred instrument. In the short term, no adverse effects were seen on growth, but ICS treatment significantly reduced bone metabolism. Most of the young children with asthma/wheeze improved over time with ss2-agonist treatment alone, and clinical benefits of early ICS intervention amongst these children were not detected; however, there was inadequate power in this pilot study to establish this. (AB
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Health Technol Assess · Jan 2000
Randomized Controlled Trial Clinical TrialA randomised controlled trial of prehospital intravenous fluid replacement therapy in serious trauma.
In total 1309 patients were entered in the study: 699 (53.4%) were treated by paramedics operating protocol A and 610 (46.6%) were treated by paramedics operating protocol B. The randomisation worked well and there were no significant differences between treatment groups in incident characteristics, ambulance performance times, or patient or injury characteristics, apart from slightly more moderate or severe head injuries in the protocol A group (25.3% versus 20.3%). Protocol compliance was poor, with only 31% of protocol A patients receiving prehospital fluids and only 80% of protocol B patients not given fluids. The estimated odds ratio for being given prehospital fluids when treated by protocol A compared to protocol B was 2.09 (95% confidence interval (CI), 1.53 to 2.81). ⋯ In the prehospital and immediate-care phase (including A&E treatment), the mean costs of the protocol A and protocol B groups were ¿419 and ¿416, respectively. This small difference reflects two small and offsetting effects of protocol B: reduced on-scene time (p = 0.08) and increased use of blood in the A&E department (p = 0.03). There were no other statistically significant differences in costs, with the mean total costs being ¿2706 and ¿2678 in the protocol A and protocol B groups, respectively (p = 0.52). (ABSTRACT TRUNCA
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Health Technol Assess · Jan 2000
Randomized Controlled Trial Clinical TrialA randomised controlled trial to evaluate the effectiveness and cost-effectiveness of counselling patients with chronic depression.
To examine the effectiveness and cost-effectiveness of short-term counselling in general practice for patients with chronic depression or combined depression and anxiety, compared with general practitioner (GP) care alone. ⋯ Although patients were generally appreciative of the counselling received, there was only limited evidence of improved outcomes in those referred to counselling. Stricter referral criteria to exclude the severely depressed may have yielded more conclusive results. It is also difficult to estimate the effect of recruitment by screening rather than GP referral, which may limit the applicability of the results to routine clinical practice, and may have interfered with the normal working alliance established between the GP, patient and counsellor. A patient preference trial may, therefore, have been more appropriate. The results indicated that there were similar improvements for both CBT and psychodynamic counselling, but a