Contemporary clinical trials
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Contemp Clin Trials · Sep 2012
Randomized Controlled TrialA randomized controlled trial of the efficacy and cost-effectiveness of a brief intensified cognitive behavioral therapy and/or pharmacotherapy for mood and anxiety disorders: design and methods.
Anxiety and mood disorders involve a high disease burden and are associated with high economic costs. A stepped-care approach intervention and abbreviated diagnostic method are assumed to increase effectiveness and efficiency of the mental healthcare and are expected to reduce economic costs. ⋯ Since few studies have investigated both the clinical and cost effectiveness of a stepped-care approach intervention and a shortened diagnostic ROM method in both anxiety and/or mood disorders within secondary mental health care, the results of this study might contribute to the improvement of (cost)-effective treatment options and diagnostic methods for these disorders.
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Contemp Clin Trials · Sep 2012
The prevalence and influence of self-reported conflicts of interest by editorial authors of phase III cancer trials.
To assess the frequency with which editorial authors report personal conflict of interest and investigate a possible association between the presence of such conflicts and favorable opinion. ⋯ Besides the high proportion of conflict of interest among editorial authors discussing phase III clinical trials, study interpretation may be influenced by their financial relationships with industry.
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Contemp Clin Trials · Jul 2012
ReviewEarly phase drug development for treatment of chronic pain--options for clinical trial and program design.
Due to high prevalence and unmet medical need, chronic pain has become an important area for development of new medicines. Chronic pain disorders are heterogeneous with regard to pathophysiological mechanisms and clinical presentation. While a mechanism-based classification of pain is generally advocated, it is not yet applicable for diagnostic use. ⋯ We have reviewed characteristics of three alternative design options from an early (Phase 2) drug development perspective; enriched enrolment, dose titration and adaptive dosing. The advantages and disadvantages of each type of study design were analyzed and discussed from a clinical development program perspective. It is concluded that these designs can be useful in addressing different types of issues in early development of novel analgesic drugs for chronic pain.
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Contemp Clin Trials · Jul 2012
Randomized Controlled TrialGroup interventions for co-morbid insomnia and osteoarthritis pain in primary care: the lifestyles cluster randomized trial design.
Six weekly sessions of group cognitive-behavioral therapy for insomnia and osteoarthritis pain (CBT-PI), and for osteoarthritis pain alone (CBT-P) were compared to an education only control (EOC). Basic education about pain and sleep was comparable, so EOC controlled for information and group participation. Active interventions differed from EOC in training pain coping skills (CBT-P and CBT-PI) and sleep enhancement techniques (CBT-PI). ⋯ The trial was executed in 6 primary clinics, randomizing 367 participants, with 93.2% of randomized patients attending at least 4 group sessions. Response rates for post-intervention and 9 month assessments were 96.7% and 92.9% respectively. This hybrid efficacy-effectiveness trial design evaluates whether interventions yield specific benefits for clinical and behavioral outcomes relative to an education only control when implemented in a primary care setting.
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Contemp Clin Trials · Jul 2012
Randomized Controlled TrialDesign and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial.
Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. ⋯ We will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care.