982 resultados para Controlled-trial
Resumo:
Low dietary intakes of the n-3 long-chain PUFA (LCPUFA) EPA and DHA are thought to be associated with increased risk for a variety of adverse outcomes, including some psychiatric disorders. Evidence from observational and intervention studies for a role of n-3 LCPUFA in depression is mixed, with some support for a benefit of EPA and/or DHA in major depressive illness. The present study was a double-blind randomised controlled trial that evaluated the effects of EPA+DHA supplementation (1.5 g/d) on mood and cognitive function in mild to moderately depressed individuals. Of 218 participants who entered the trial, 190 completed the planned 12 weeks intervention. Compliance, confirmed by plasma fatty acid concentrations, was good, but there was no evidence of a difference between supplemented and placebo groups in the primary outcome - namely, the depression subscale of the Depression Anxiety and Stress Scales at 12 weeks. Mean depression score was 8.4 for the EPA+DHA group and 9.6 for the placebo group, with an adjusted difference of - 1.0 (95 % CI - 2.8, 0.8; P = 0.27). Other measures of mood, mental health and cognitive function, including Beck Depression Inventory score and attentional bias toward threat words, were similarly little affected by the intervention. In conclusion, substantially increasing EPA+DHA intake for 3 months was found not to have beneficial or harmful effects on mood in mild to moderate depression. Adding the present result to a meta-analysis of previous relevant randomised controlled trial results confirmed an overall negligible benefit of n-3 LCPUFA supplementation for depressed mood.
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Background: In Australia and internationally, there is concern about the growing proportion of women giving birth by caesarean section. There is evidence of increased risk of placenta accreta and percreta in subsequent pregnancies as well as decreased fertility; and significant resource implications. Randomised controlled trials (RCTs) of continuity of midwifery care have reported reduced caesareans and other interventions in labour, as well as increased maternal satisfaction, with no statistically significant differences in perinatal morbidity or mortality. RCTs conducted in the UK and in Australia have largely measured the effect of teams of care providers (commonly 6–12 midwives) with very few testing caseload (one-to-one) midwifery care. This study aims to determine whether caseload (one-to-one) midwifery care for women at low risk of medical complications decreases the proportion of women delivering by caesarean section compared with women receiving 'standard' care. This paper presents the trial protocol in detail.
Methods/design: A two-arm RCT design will be used. Women who are identified at low medical risk will be recruited from the antenatal booking clinics of a tertiary women's hospital in Melbourne, Australia. Baseline data will be collected, then women randomised to caseload midwifery or standard low risk care. Women allocated to the caseload intervention will receive antenatal, intrapartum and postpartum care from a designated primary midwife with one or two antenatal visits conducted by a 'back-up' midwife. The midwives will collaborate with obstetricians and other health professionals as necessary. If the woman has an extended labour, or if the primary midwife is unavailable, care will be provided by the back-up midwife. For women allocated to standard care, options include midwifery-led care with varying levels of continuity, junior obstetric care and community based general medical practitioner care. Data will be collected at recruitment (self administered survey) and at 2 and 6 months postpartum by postal survey. Medical/obstetric outcomes will be abstracted from the medical record. The sample size of 2008 was calculated to identify a decrease in caesarean birth from 19 to 14% and detect a range of other significant clinical differences. Comprehensive process and economic evaluations will be conducted.
Trial registration: Australian New Zealand Clinical Trials Registry ACTRN012607000073404.
Resumo:
BACKGROUND/PURPOSE: The effectiveness and costs of very early rehabilitation after stroke are unknown. This study assessed the cost effectiveness of very early mobilisation in addition to standard care (VEM) compared with standard care alone (SC). METHODS: Cost-effectiveness analysis alongside a phase II, multi-centre, randomised controlled trial (RCT) with blinded outcome assessments. Less than 24 h after stroke, patients were recruited from two stroke units and randomised to receive VEM or SC. The intervention continued until discharge or 14 days, whichever was sooner. The efficacy measure was a dichotomised modified Rankin Scale (mRS) at 3 months with mRS < or =2 representing good outcome. Costs were determined from medical records and patient interviews at 3, 6 and 12 months. National average (where available) or local costs were applied for the reference year 2004. Differences in mean total costs at 3 and 12 months were tested using t test assuming unequal variances. An incremental cost-effectiveness ratio was calculated and probabilistic uncertainty analysis was undertaken. RESULTS: The sample consisted of 38 VEM and 33 SC patients. A trend for good outcome with VEM compared to SC was found (adjusted OR 4.10, 95% CI 0.99-16.88, p = 0.051). Patients receiving VEM incurred significantly less costs at 3 months (AUD 13,559) compared with SC (AUD 21,860; p = 0.02). This difference in mean per patient total cost persisted at the 12-month assessment (VEM: AUD 17,564; SC: AUD 29,750; p = 0.03). VEM was found to be a 'dominant' (more effective, less cost) intervention when compared to SC at 3 months. CONCLUSION: These findings provide preliminary evidence that VEM is likely to be cost-effective. A large RCT is currently underway to confirm the cost effectiveness of VEM.
Resumo:
Summary We examined the independent and combined effects of a multi-component exercise program and calcium–vitamin-D3-fortified milk on bone mineral density (BMD) in older men. Exercise resulted in a 1.8% net gain in femoral neck BMD, but additional calcium–vitamin D3 did not enhance the response in this group of older well-nourished men.
Introduction This 12-month randomised controlled trial assessed whether calcium–vitamin-D3-fortified milk could enhance the effects of a multi-component exercise program on BMD in older men.
Methods Men (n = 180) aged 50–79 years were randomised into: (1) exercise + fortified milk; (2) exercise; (3) fortified milk; or (4) controls. Exercise consisted of high intensity progressive resistance training with weight-bearing impact exercise. Men assigned to fortified milk consumed 400 mL/day of low fat milk providing an additional 1,000 mg/day calcium and 800 IU/day vitamin D3. Femoral neck (FN), total hip, lumbar spine and trochanter BMD and body composition (DXA), muscle strength 25-hydroxyvitamin D and parathyroid hormone (PTH) were assessed.
Results There were no exercise-by-fortified milk interactions at any skeletal site. Exercise resulted in a 1.8% net gain in FN BMD relative to no-exercise (p < 0.001); lean mass (0.6 kg, p < 0.05) and muscle strength (20–52%, p < 0.001) also increased in response to exercise. For lumbar spine BMD, there was a net 1.4–1.5% increase in all treatment groups relative to controls (all p < 0.01). There were no main effects of fortified milk at any skeletal site.
Conclusion A multi-component community-based exercise program was effective for increasing FN BMD in older men, but additional calcium–vitamin D3 did not enhance the osteogenic response.
Resumo:
Objective To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making.
Design A cluster randomised controlled trial.
Setting Primary health care.
Population Women in early pregnancy consulting a GP.
Methods GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting.
Main outcome measures Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post.
Findings Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14–3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79–6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI −0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes.
Conclusion A tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values.
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Objective. Patellar tendinopathy (PT) is a common and significant clinical condition for which there are few established interventions. One intervention that is currently being used clinically to manage PT symptoms is the introduction of low-intensity pulsed ultrasound (LIPUS). The aim of this study was to investigate the clinical efficacy of LIPUS in the management of PT symptoms.
Methods. A randomized, double-blind, placebo-controlled study was conducted. Volunteers with clinically and radiologically confirmed PT were randomly allocated to either an active-LIPUS (treatment) or inactive-LIPUS (placebo) group. LIPUS was self-administered by participants for 20 min/day, 7 days/week for 12 weeks. All participants also completed a daily, standardized eccentric exercise programme based on best practice. Primary outcomes were change in pain during the participant's most aggravating activity in the preceding week, measured on 10 cm visual analogue scales for both usual (VAS-U) and worst (VAS-W) tendon pain.
Results. Out of 156 individuals who volunteered, 37 met the eligibility criteria and were randomized to either active-LIPUS (n = 17) or inactive-LIPUS (n = 20). Using an intention-to-treat analysis, VAS-U and VAS-W for the entire cohort decreased by 1.6 ± 1.9 cm (P < 0.01) and 2.5 ± 2.4 cm (P < 0.01), respectively. There were no differences between the active- and inactive-LIPUS groups for change in VAS-U (–0.2 cm; 95% CI, –1.5, 1.1 cm) (P = 0.74) or VAS-W (–0.5 cm; 95% CI, –2.1, 1.1 cm) (P = 0.57). A per-protocol analysis provided similar results.
Conclusions. These findings suggest that LIPUS does not provide any additional benefit over and above placebo in the management of symptoms associated with PT.
Resumo:
Background: Panic disorder (PD) is one of the most common anxiety disorders seen in general practice, but provision of evidence-based cognitive-behavioural treatment (CBT) is rare. Many Australian GPs are now trained to deliver focused psychological strategies, but in practice this is time consuming and costly.
Objective: To evaluate the efficacy of an internet-based CBT intervention (Panic Online) for the treatment of PD supported by general practitioner (GP)-delivered therapeutic assistance.
Design: Panic Online supported by GP-delivered face-to-face therapy was compared to Panic Online supported by psychologist-delivered email therapy.
Methods: Sixty-five people with a primary diagnosis of PD (78% of whom also had agoraphobia) completed 12 weeks of therapy using Panic Online and therapeutic assistance with his/her GP (n = 34) or a clinical psychologist (n = 31). The mean duration of PD for participants allocated to these groups was 59 months and 58 months, respectively. Participants completed a clinical diagnostic interview delivered by a psychologist via telephone and questionnaires to assess panic-related symptoms, before and after treatment.
Results: The total attrition rate was 20%, with no group differences in attrition frequency. Both treatments led to significant improvements in panic attack frequency, depression, anxiety, stress, anxiety sensitivity and quality of life. There were no statistically significant differences in the two treatments on any of these measures, or in the frequency of participants with clinically significant PD at post assessment.
Conclusions: When provided with accessible online treatment protocols, GPs trained to deliver focused psychological strategies can achieve patient outcomes comparable to efficacious treatments delivered by clinical psychologists. The findings of this research provide a model for how GPs may be assisted to provide evidence-based mental healthcare successfully.
Resumo:
Background : Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour) from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT) aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups) and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy.
Methods/Design : This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group.
Discussion : The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups promotes healthy eating, physical activity and reduced sedentary behaviours. If proven to be effective, INFANT may protect children from the development of obesity and its associated social and economic costs.
Resumo:
Objective: The aim of the present study was to assess the impact of attending targeted clinical education on borderline personality disorder on the attitudes of health clinicians towards working with deliberate self-harm behaviours commonly exhibited by patients diagnosed with this complex disorder. Comparisons of clinicians across service settings, occupational fields, and other demographic areas were also made.
Method: A purpose-designed demographic questionnaire and the Attitudes Towards Deliberate Self-Harm Questionnaire were used to collect the demographic information and assess the attitudes of 99 mental health and emergency medicine practitioners across two Australian health services and a New Zealand health service, both before and after education attendance.
Results: Statistically significant improvements in attitude ratings were found for both emergency medicine clinicians and mental health clinicians in working with deliberate self-harm behaviours in borderline personality disorder, following attendance at the education program with a medium affect size (t(32)=−3.45, p=0.002, d=0.43 and t(65)=−5.12, p=0.000, d=0.42, respectively). Clinicians across occupational areas of nursing, allied health, and medical fields demonstrated equivocal levels of improvement in their attitude ratings.
Conclusions: Results are discussed in terms of the necessity of providing regular access to targeted clinical education for health professionals working with patients diagnosed with borderline personality disorder.
