182 resultados para Randomized controlled trials
Resumo:
Objective. To improve understanding of barriers to participation in community-based arthritis self-management programmes and patient preferences for self-management education.
Methods. Individuals with hip or knee OA referred to orthopaedic surgeons or rheumatologists at six public and private hospitals in Victoria, Australia, were recruited for a randomized controlled trial (RCT) of the Stanford Arthritis Self-Management Programme (ASMP). As part of the study design, potential participants were asked during the screening and recruitment process about reasons for being unable to attend the course, reasons for not participating in the study and individual preferences for course scheduling.
Results. Of 1125 individuals assessed, 216 (19%) were unable to attend six ASMP sessions. This was commonly due to physical limitations, including illness, restricted mobility and pain (22%), difficulty getting to or from courses (22%), work commitments (22%), the time commitment required (17%) and family roles (12%). Among those who did not want to participate in the study (n = 258), the overwhelming reason was disinterest (74%). Specific preferences for course scheduling were frequent, confirming the practical challenges faced in organizing courses for the RCT.
Conclusion. Incorporating patients from public and private settings, this study has elicited new insights into barriers to ASMP participation. Many people with hip or knee OA have limited capacity and motivation to attend community-based group programmes. Future self-management programmes and research should include more accessible options for those who cannot attend group-based programmes.
Resumo:
This paper presents findings on parent anxiety and attachment relationship style from the Deakin Family Options (DFO) pilot study, a randomized controlled pilot study comparing a family-based treatment (BEST Plus), versus a youth only treatment (CBT) versus a group who received both of these treatments (COMBINED). Eligible participants were families with a young person (aged 12 - 25 years) with a high prevalence mental health problem. Youth from participating families scored in the clinical or subclinical range for depression, anxiety and/or substance misuse symptoms on standardized measures during the initial assessment. The collected sample was drawn from regional and urban centers in Victoria, Australia and allocated to treatment condition using a simple randomization procedure (parallel design). It was hypothesized that families receiving the BEST Plus would experience greater reductions in youth and parent mental health symptoms, and improved parent-child relationships, compared with those in the CBT condition. This paper describes and discusses changes in parent anxiety and parent attachment, according to whether the parent participated in a treatment (BEST Plus) or did not (NONBEST Plus). Participants were blind to the study hypotheses. In total 71 parent participants returned pre data and were allocated to a treatment group. In this paper, data from parent participants who completed pre and post measures (n = 48) and pre, post, and 6-month follow-up measures (n = 28) on anxiety and attachment were analyzed by group (BEST Plus versus NONBEST Plus). The results of this study suggest that parent anxiety decreased significantly more following parent involvement in a group treatment, than for parents that did not receive treatment. Unexpectedly, avoidant attachment increased in the no treatment group, but remained relatively stable following the BEST Plus group. There were no significant findings in relation to compulsive traits and anxious attachment. These findings are discussed in light of the study limitations.
Resumo:
Attention deficit hyperactivity disorder (ADHD) is a common psychiatric disorder in children and adolescents. Stimulants are commonly prescribed for ADHD management. There is clinical trial evidence that some medications with noradrenergic properties such as atomoxetine are effective. It is of theoretical and practical importance if other agents with noradrenergic properties display a comparable pattern of efficacy.
This paper is a systematic review of the efficacy and safety of venlafaxine for treating children and adolescents with ADHD. MEDLINE, Google scholar, Scopus, and Web of science (ISI) databases were electronically searched in July 2012, updated on November 2012. Time and language of publication were not exclusion criteria. Efficacy outcomes were assessed by a valid and reliable parent- and/or teacher-reported instrument to evaluate clinical symptoms. Adverse effects were also evaluated.
There were three uncontrolled trials and only two double blind controlled clinical trials. Venlafaxine appeared effective for treating ADHD. The rates of some adverse effects of venlafaxine were less than those documented for methylphenidate.
While one of the two small controlled trials did not find difference between venlafaxine ad methylphenidate, the other trial reported lower efficacy for venlafaxine. Headache, insomnia, and nausea were among the most common adverse effects.
This systematic review provides preliminary support that venlafaxine may have short term utility in treating ADHD in children and adolescents. However, before recommending venlafaxine for treatment, more robust and larger clinical trials, in particular providing evidence of its long-term efficacy, safety and tolerability are required.
Resumo:
Background: Substantial numbers of cancer patients use complementary medicine therapies, even without a supportive evidence base. This study aimed to evaluate in a randomized controlled trial, the use of Medical Qigong (MQ) compared with usual care to improve the quality of life (QOL) of cancer patients. Patients and methods: One hundred and sixty-two patients with a range of cancers were recruited. QOL and fatigue were measured by Functional Assessment of Cancer Therapy—General and Functional Assessment of Cancer Therapy—Fatigue, respectively, and mood status by Profile of Mood State. The inflammatory marker serum C-reactive protein (CRP) was monitored serially. Results: Regression analysis indicated that the MQ group significantly improved overall QOL (t144 = −5.761, P < 0.001), fatigue (t153 = −5.621, P < 0.001), mood disturbance (t122 =2.346, P = 0.021) and inflammation (CRP) (t99 = 2.042, P < 0.044) compared with usual care after controlling for baseline variables. Conclusions: This study indicates that MQ can improve cancer patients’ overall QOL and mood status and reduce specific side-effects of treatment. It may also produce physical benefits in the long term through reduced inflammation.
Resumo:
Objectives: To investigate the efficacy and tolerability of transdermal estrogen patches for the adjunctive treatment of aggressive behavior in male patients with advanced dementia. Methods: The study was designed as an 8-week, randomized, controlled trial in acute aged psychiatry inpatient units and specialized nursing homes in Melbourne, Australia, between 1998 and 1999. The participants were 27 men with established dementia, identified as displaying aggressive behavior not responding to treatment for at least 2 weeks prior to referral. The instruments used to measure aggressive behavior were the Rating Scale for Aggressive Behavior in the Elderly (RAGE), the Cornell Scale for Depression in Dementia (CSDD) and the Mini-mental State Examination (MMSE). Physical examination was performed and biochemistry and serum hormone concentrations were measured at baseline and at 8 weeks. Concomitant psychotropic medication use was recorded and analyzed. Results: There was no significant difference in aggressive behavior at 8 weeks, but significant “rebound” in aggressive behavior (change in scores between week 8 and week 10, p<0.009) and benzodiazepine use in the estrogen group (p<0.03), following removal of the patches. Only behavioral items of the CSDD improved in the experimental group (p=0.031). The use of patches was associated with a significant rise in serum estrogen (p<0.001) but not with a significant decrease in serum testosterone (p=0.077). There were no adverse effects associated with their use. Conclusions: The use of transdermal estrogen yielding up to 100μg per day was not associated with discernable improvement in aggressive behavior in men with advanced dementia. Small subject numbers, multiple variables and a lack of statistical power impair interpretation of these results. However, the tolerability and apparent rebound effect on removal of patches indicate the need for larger studies in this area.
Resumo:
Background
Neck of femur fractures (NOFFs) are a common cause of morbidity and mortality in our community. Minimally displaced intracapsular fractures are treated with internal fixation by a two-hole dynamic hip screw (DHS) or three partially threaded cancellous screws. Data to support the superiority of one are limited. This prospective randomized controlled trial compares outcomes with these two fixation methods.
Methods
We prospectively recruited patients over 50 years, with an acute fracture subcapital NOFF, who walked and lived independently, and were cognitively intact. They were randomized into DHS or cancellous screw groups and followed up for 2 years (overall 75.9%). Outcomes of mortality, revision, loss of fixation, avascular necrosis, surgical complications, WOMAC, Harris hip score and SF-12 were measured.
Results
We recruited 62 patients (31 DHS, 29 cancellous screws, 2 failed consent). Six deaths (19.3%) were seen in each group. A total of 3.2% of DHS (1 out of 31) and 10.3% (3 out of 29) of cancellous screw patients required re-operation (P = 0.272). There was no statistical significant difference in patient satisfaction, quality of life (QoL), radiological union or osteonecrosis. There are trends towards better functional scores and QoL in cancellous screws, particularly at 1 year (P = 0.0061), but with a higher re-operation rate. There was a combined mortality and transition to institutional care of 40.0% (24 out of 60) at 2 years.
Conclusions
This study found no difference in outcomes between DHS and cancellous screws in the treatment of subcapital NOFFs in a fit, independent population, but we found a high level of physical decline in previously fit, independently ambulating patients. A large, multicentre trial will be required to differentiate between these two fixation methods.
Resumo:
Objective To systematically evaluate the effects of physical activity in adult patients after completion of main treatment related to cancer. Design Meta-analysis of randomised controlled trials with data extraction and quality assessment performed independently by two researchers. Data sources Pubmed, CINAHL, and Google Scholar from the earliest possible year to September 2011. References from meta-analyses and reviews. Study selection Randomised controlled trials that assessed the effects of physical activity in adults who had completed their main cancer treatment, except hormonal treatment. Results There were 34 randomised controlled trials, of which 22 (65%) focused on patients with breast cancer, and 48 outcomes in our meta-analysis. Twenty two studies assessed aerobic exercise, and four also included resistance or strength training. The median duration of physical activity was 13 weeks (range 3-60 weeks). Most control groups were considered sedentary or were assigned no exercise. Based on studies on patients with breast cancer, physical activity was associated with improvements in insulin-like growth factor-I, bench press, leg press, fatigue, depression, and quality of life. When we combined studies on different types of cancer, we found significant improvements in body mass index (BMI), body weight, peak oxygen consumption, peak power output, distance walked in six minutes, right handgrip strength, and quality of life. Sources of study heterogeneity included age, study quality, study size, and type and duration of physical activity. Publication bias did not alter our conclusions. Conclusions Physical activity has positive effects on physiology, body composition, physical functions, psychological outcomes, and quality of life in patients after treatment for breast cancer. When patients with cancer other than breast cancer were also included, physical activity was associated with reduced BMI and body weight, increased peak oxygen consumption and peak power output, and improved quality of life.
Resumo:
Objective:
Method:
A cluster randomized controlled design was used to compare the referral rates for residents in seven facilities randomly allocated into one of three conditions: staff training, staff training plus a screening and referral protocol and wait-list control. Participants were 216 aged care residents (M age = 87 years), who agreed to a 12-month audit of their facility file.
Results:
Staff training on its own did not increase the rate of referrals for depression; however, staff training plus the screening protocol and referral guidelines did lead to a significant increase in the number of residents who were referred to a medical practitioner for further assessment. However, this increase in care staff referrals did not result in substantial changes in the treatment prescribed for residents.
Conclusion:
Staff training in depression, supplemented with a protocol for routine screening and guidelines on referring residents, can improve pathways to care. However, strategies to overcome barriers to appropriate subsequent treatment of depression are required for staff-focused initiatives to translate into better outcomes for depressed older adults. Methodological limitations of this study are discussed.
Resumo:
Background:
Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals.
Methods/Design:
The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups.
Discussion:
This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population.
Resumo:
Background
There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services.
Methods/Design
The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention.
