435 resultados para Screening trial


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Objective: The Brief Michigan Alcoholism Screening Test (bMAST) is a 10-item test derived from the 25-item Michigan Alcoholism Screening Test (MAST). It is widely used in the assessment of alcohol dependence. In the absence of previous validation studies, the principal aim of this study was to assess the validity and reliability of the bMAST as a measure of the severity of problem drinking. Method: There were 6,594 patients (4,854 men, 1,740 women) who had been referred for alcohol-use disorders to a hospital alcohol and drug service who voluntarily participated in this study. Results: An exploratory factor analysis defined a two-factor solution, consisting of Perception of Current Drinking and Drinking Consequences factors. Structural equation modeling confirmed that the fit of a nine-item, two-factor model was superior to the original one-factor model. Concurrent validity was assessed through simultaneous administration of the Alcohol Use Disorders Identification Test (AUDIT) and associations with alcohol consumption and clinically assessed features of alcohol dependence. The two-factor bMAST model showed moderate correlations with the AUDIT. The two-factor bMAST and AUDIT were similarly associated with quantity of alcohol consumption and clinically assessed dependence severity features. No differences were observed between the existing weighted scoring system and the proposed simple scoring system. Conclusions: In this study, both the existing bMAST total score and the two-factor model identified were as effective as the AUDIT in assessing problem drinking severity. There are additional advantages of employing the two-factor bMAST in the assessment and treatment planning of patients seeking treatment for alcohol-use disorders. (J. Stud. Alcohol Drugs 68: 771-779,2007)

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Background: Ambiguity remains about the effectiveness of wearing surgical face masks. The purpose of this study was to assess the impact on surgical site infections when non-scrubbed operating room staff did not wear surgical face masks. Design: Randomised controlled trial. Participants: Patients undergoing elective or emergency obstetric, gynecological, general, orthopaedic, breast or urological surgery in an Australian tertiary hospital. Intervention: 827 participants were enrolled and complete follow-up data was available for 811 (98.1%) patients. Operating room lists were randomly allocated to a ‘Mask roup’ (all non-scrubbed staff wore a mask) or ‘No Mask group’ (none of the non-scrubbed staff wore masks). Primary end point: Surgical site infection (identified using in-patient surveillance; post discharge follow-up and chart reviews). The patient was followed for up to six weeks. Results: Overall, 83 (10.2%) surgical site infections were recorded; 46/401 (11.5%) in the Masked group and 37/410 (9.0%) in the No Mask group; odds ratio (OR) 0.77 (95% confidence interval (CI) 0.49 to 1.21), p = 0.151. Independent risk factors for surgical site infection included: any pre-operative stay (adjusted odds ratio [aOR], 0.43 (95% CI, 0.20; 0.95), high BMI aOR, 0.38 (95% CI, 0.17; 0.87), and any previous surgical site infection aOR, 0.40 (95% CI, 0.17; 0.89). Conclusion: Surgical site infection rates did not increase when non-scrubbed operating room personnel did not wear a face mask.

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Objective: During hospitalisation older people often experience functional decline which impacts on their future independence. The objective of this study was to evaluate a multifaceted transitional care intervention including home-based exercise strategies for at-risk older people on functional status, independence in activities of daily living, and walking ability. Methods: A randomised controlled trial was undertaken in a metropolitan hospital in Australia with 128 patients (64 intervention, 64 control) aged over 65 years with an acute medical admission and at least one risk factor for hospital readmission. The intervention group received an individually tailored program for exercise and follow-up care which was commenced in hospital and included regular visits in hospital by a physiotherapist and a Registered Nurse, a home visit following discharge, and regular telephone follow-up for 24 weeks following discharge. The program was designed to improve health promoting behaviours, strength, stability, endurance and mobility. Data were collected at baseline, then 4, 12 and 24 weeks following discharge using the Index of Activities of Daily Living (ADL), Instrumental Index of Activities of Daily Living (IADL), and the Walking Impairment Questionnaire (Modified). Results: Significant improvements were found in the intervention group in IADL scores (p<.001), ADL scores (p<.001), and WIQ scale scores (p<.001) in comparison to the control group. The greatest improvements were found in the first four weeks following discharge. Conclusions: Early introduction of a transitional model of care incorporating a tailored exercise program and regular telephone follow-up for hospitalised at-risk older adults can improve independence and functional ability.

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BACKGROUND Parenting-skills training may be an effective age-appropriate child behavior-modification strategy to assist parents in addressing childhood overweight. OBJECTIVE Our goal was to evaluate the relative effectiveness of parenting-skills training as a key strategy for the treatment of overweight children. DESIGN The design consisted of an assessor-blinded, randomized, controlled trial involving 111 (64% female) overweight, prepubertal children 6 to 9 years of age randomly assigned to parenting-skills training plus intensive lifestyle education, parenting-skills training alone, or a 12-month wait-listed control. Height, BMI, and waist-circumference z score and metabolic profile were assessed at baseline, 6 months, and 12 months (intention to treat). RESULTS After 12 months, the BMI z score was reduced by ∼10% with parenting-skills training plus intensive lifestyle education versus ∼5% with parenting-skills training alone or wait-listing for intervention. Waist-circumference z score fell over 12 months in both intervention groups but not in the control group. There was a significant gender effect, with greater reduction in BMI and waist-circumference z scores in boys compared with girls. CONCLUSION Parenting-skills training combined with promoting a healthy family lifestyle may be an effective approach to weight management in prepubertal children, particularly boys. Future studies should be powered to allow gender subanalysis.

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Objective: To determine whether bifocal and prismatic bifocal spectacles could control myopia in children with high rates of myopic progression. ---------- Methods: This was a randomized controlled clinical trial. One hundred thirty-five (73 girls and 62 boys) myopic Chinese Canadian children (myopia of 1.00 diopters [D]) with myopic progression of at least 0.50 D in the preceding year were randomly assigned to 1 of 3 treatments: (1) single-vision lenses (n = 41), (2) +1.50-D executive bifocals (n = 48), or (3) +1.50-D executive bifocals with a 3–prism diopters base-in prism in the near segment of each lens (n = 46). ---------- Main Outcome Measures: Myopic progression measured by an automated refractor under cycloplegia and increase in axial length (secondary) measured by ultrasonography at 6-month intervals for 24 months. Only the data of the right eye were used. ---------- Results: Of the 135 children (mean age, 10.29 years [SE, 0.15 years]; mean visual acuity, –3.08 D [SE, 0.10 D]), 131 (97%) completed the trial after 24 months. Myopic progression averaged –1.55 D (SE, 0.12 D) for those who wore single-vision lenses, –0.96 D (SE, 0.09 D) for those who wore bifocals, and –0.70 D (SE, 0.10 D) for those who wore prismatic bifocals. Axial length increased an average of 0.62 mm (SE, 0.04 mm), 0.41 mm (SE, 0.04 mm), and 0.41 mm (SE, 0.05 mm), respectively. The treatment effect of bifocals (0.59 D) and prismatic bifocals (0.85 D) was significant (P < .001) and both bifocal groups had less axial elongation (0.21 mm) than the single-vision lens group (P < .001). ---------- Conclusions: Bifocal lenses can moderately slow myopic progression in children with high rates of progression after 24 months.

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Background: The two-stage Total Laparoscopic Hysterectomy (TLH) versus Total Abdominal Hysterectomy (TAH) for stage I endometrial cancer (LACE) randomised controlled trial was initiated in 2005. The primary objective of stage 1 was to assess whether TLH results in equivalent or improved QoL up to 6 months after surgery compared to TAH. The primary objective of stage 2 was to test the hypothesis that disease-free survival at 4.5 years is equivalent for TLH and TAH. Results addressing the primary objective of stage 1 of the LACE trial are presented here. Methods: The first 361 LACE participants (TAH n= 142, TLH n=190) were enrolled in the QoL substudy at 19 centres across Australia, New Zealand and Hong Kong, and 332 completed the QoL analysis. Randomisation was performed centrally and independently from other study procedures via a computer generated, web-based system (providing concealment of the next assigned treatment) using stratified permuted blocks of 3 and 6, and assigned patients with histologically confirmed stage 1 endometrioid endometrial adenocarcinoma and ECOG performance status <2 to TLH or TAH stratified by histological grade and study centre. No blinding of patients or study personnel was attempted. QoL was measured at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The primary endpoint was the difference between the groups in QoL change from baseline at early and late time points (a 5% difference was considered clinically significant). Analysis was performed according to the intention-to-treat principle using generalized estimating equations on differences from baseline for the early and late QoL recovery. The LACE trial is registered with clinicaltrials.gov (NCT00096408) and the Australian New Zealand Clinical Trials Registry (CTRN12606000261516). Patients for both stages of the trial have now been recruited and are being followed up for disease-specific outcomes. Findings: The proportion of missing values at the 5%, 10% 15% and 20% differences in the FACT-G scale was 6% (12/190) in the TLH and 14% (20/142) in the TAH group. There were 8/332 conversions (2.4%, 7 of which were from TLH to TAH). In the early phase of recovery, patients undergoing TLH reported significantly greater improvement of QoL from baseline compared to TAH in all subscales except the emotional and social well-being subscales. Improvements in QoL up to 6 months post-surgery continued to favour TLH except for the emotional and social well-being of the FACT and the visual analogue scale of the EuroQoL five dimensions (EuroQoL-VAS). Length of operating time was significantly longer in the TLH group (138±43 mins), than in the TAH group at (109±34 mins; p=0.001). While the proportion of intraoperative adverse events was similar between the treatment groups (TAH 8/142, 5.6%; TLH 14/190, 7.4%; p=0.55), postoperatively, twice as many patients in the TAH group experienced adverse events of CTC grade 3+ than in the TLH group (33/142, 23.2% and 22/190, 11.6%, respectively; p=0.004). Postoperative serious adverse events occurred more frequently in patients who had a TAH (27/142, 19.0%) than a TLH (15/190, 7.9%) (p=0.002). Interpretation: QoL improvements from baseline during early and later phases of recovery, and the adverse event profile significantly favour TLH compared to TAH for patients treated for Stage I endometrial cancer.