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Significant Treatment Differences (significant + treatment_difference)
Selected AbstractsEstablishing Efficacy of a New Experimental Treatment in the ,Gold Standard' DesignBIOMETRICAL JOURNAL, Issue 6 2005Dieter Hauschke Abstract Provided that there are no ethical concerns, the comparison of an active drug with placebo in a randomized two-arm clinical trial provides the most convincing way to demonstrate the efficacy of a new experimental treatment. However, in a placebo-controlled clinical trial it is not sufficient to demonstrate merely a statistically significant treatment difference. Regulatory authorities strongly recommend to assess additionally whether the observed treatment difference is also of clinical relevance. The inherent issue is the necessity of the a priori definition of what constitutes a clinically relevant difference in efficacy. This problem can be solved in a three-arm study by including an active control group. We address the necessary conditions in the gold standard design which allow the claim of efficacy for the new treatment with particular focus on assay sensitivity. (© 2005 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim) [source] Acute cholecystokinin effects on event-related potentials in healthy volunteersHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2002Verner J. Knott Abstract This study investigated the effects of a continuous slow infusion of cholecystokinin tetrapeptide (CCK-4), a neuropeptide with panicogenic properties, on brain event-related potentials (ERPs) in healthy adults. Twenty-four volunteers, 15 females and 9 males, were assigned to infusion with either placebo or CCK-4 in a randomized, double-blind, parallel group design. ERPs, elicited within a standard auditory odd-ball paradigm requiring the counting of rare (20%) occurring ,deviant' tones interspersed among more frequent (80%) occurring ,standard' tones, were assessed once before infusion, and at 10,min and 40,min after the onset of infusion. Compared with the placebo, CCK-4 delayed the latencies of N100 and P200 components elicited by ,deviant' stimuli. No significant treatment differences were observed with respect to N200, P300b, mood or adverse symptoms. These preliminary findings suggest that CCK-4 may interfere with information processing relating to the selection of significant stimuli and as such, may be of relevance to mechanisms underlying panic disorder. Copyright © 2002 John Wiley & Sons, Ltd. [source] Effects of three PTSD treatments on anger and guilt: Exposure therapy, eye movement desensitization and reprocessing, and relaxation training,JOURNAL OF TRAUMATIC STRESS, Issue 1 2006Jennifer A. Stapleton This study sought to investigate the efficacy of prolonged exposure, eye movement desensitization and reprocessing, and relaxation training on trait anger and guilt and on trauma-related anger and guilt within the context of posttraumatic stress disorder (PTSD) treatment. Fifteen PTSD patients completed each treatment and were assessed at posttreatment and at 3-month follow-up. All three treatments were associated with significant reductions in all measures of anger and guilt, with gains maintained at follow-up. There were no significant treatment differences in efficacy or in the proportion of patients who worsened on anger or guilt measures over the course of treatment. Between-treatment effect sizes were generally very small. Results suggest that all three treatments are associated with reductions in anger and guilt, even for patients who initially have high levels of these emotions. However, these PTSD therapies may not be sufficient for treating anger and guilt; additional interventions may be required. [source] Improvement in health-related quality of life with fluticasone propionate compared with budesonide or beclomethasone dipropionate in adults with severe asthmaRESPIROLOGY, Issue 3 2003Carolyn RUTHERFORD Objective: Changes in health-related quality of life (HRQoL) were evaluated in adults with severe asthma following inhaled corticosteroid treatment with high-dose beclomethasone dipropionate or budesonide (BDP/BUD) and compared with fluticasone propionate taken at approximately half the dose of BDP/BUD. Methodology: HRQoL was assessed as part of an open, multicentre, randomized, parallel-group study in Australia evaluating the safety and efficacy of switching to fluticasone propionate (FP) 1000,2000 µg/day (n = 67) compared with remaining on BDP/BUD ,1750 µg/day (n = 66) for 6 months. Patients completed two HRQoL questionnaires, the Asthma Quality of Life Questionnaire (AQLQ) and the Medical Outcomes Study Short Form-36 (SF-36), at baseline and at weeks 12 and 24. A change in AQLQ score of ,0.5 was considered to be clinically meaningful. Results: There were significant improvements in HRQoL with FP on four of the eight dimensions on the SF-36 (i.e. physical functioning, general health, role-emotional, and mental health), while there were no significant improvements in HRQoL in the BDP/BUD group. Overall, patients in the FP group experienced significantly greater improvement (P < 0.001) in AQLQ scores at weeks 12 and 24 compared with the BDP/BUD group. On the individual domains of the AQLQ, there were significant treatment differences (P < 0.01) in favour of FP in three of the four domains (activity limitations [0.92], symptoms [0.73], and emotional function [1.02]). Mean differences between groups for overall score and these three domains were also clinically meaningful. Conclusion: Patients with severe asthma who received FP (at approximately half the dose of BDP/BUD) experienced statistically significant, as well as clinically meaningful, improvements in their HRQoL. [source] Age and comorbidity impact surgical therapy in older bladder carcinoma patients,,CANCER, Issue 8 2005A population-based study Abstract BACKGROUND Bladder carcinoma often occurs in older patients who also may have other comorbid conditions that could influence the administration of surgical therapy. The current study was conducted to describe the distribution of comorbid conditions in patients with bladder carcinoma and ascertain whether these conditions, as grouped by the American Society of Anesthesiologists physical status classification, affected the choice of surgical therapy. METHODS The authors examined six population-based cancer registries from the National Cancer Institute's Surveillance, Epidemiology, and End Results Program in 1992. A total of 820 individuals age 55 years and older was found. A random sample of newly diagnosed bladder carcinoma patients were stratified according to registry, age group (ages 55,64 yrs, ages 65,74 yrs, and age 75 yrs and older), and gender. Data regarding comorbid conditions were abstracted from the medical records and merged with routinely collected cancer registry data. The main outcome measures were the prevalence and distribution of comorbid conditions, American Society of Anesthesiologists physical status classification, and the receipt of cystectomy in patients with muscle invasion. RESULTS Hypertension, chronic pulmonary disease, arthritis, and heart disease were found to affect at least 15% of the study population. Approximately 38% of patients were current or former smokers. Greater than 90% of patients with superficial disease were treated with transurethral resection alone. Among those patients with muscle invasion, only 55% of those ages 55,59 years underwent cystectomy; this percentage dropped to 4% in patients age 85 years and older. Among patients with an American Society of Anesthesiologists physical status classification of 0,2, the cystectomy rate ranged from 53% in those ages 55,59 years to 9% in those age 85 years and older. CONCLUSIONS There were no significant treatment differences noted with regard to age among patients with superficial disease. Among those patients with muscle invasion, those age 75 years and older were less likely to undergo radical cystectomy (14%) compared with patients ages 55,64 years (48%) and those ages 65,74 years (43%). Patient age may contribute to treatment decisions in patients with muscle-invasive disease, even when comorbidity is taken into account. Cancer 2005. © 2005 American Cancer Society. 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