Contemporary clinical trials
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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
A Bayesian adaptive design for multi-dose, randomized, placebo-controlled phase I/II trials.
We present a design for a randomized controlled trial (RCT) featuring two simultaneous iterative processes, dose escalation and cohort expansion. In this design, patient enrollment does not need to stop when transitioning from the evaluation of the dose safety and tolerability to the assessment of its efficacy. The cohort expansion used in dose-finding is adaptive, based on the interim comparisons between each dose and placebo. ⋯ Simulation studies also demonstrated that this proposed adaptive design controls the false positive error rate at the specified level and provides adequate statistical power to detect the treatment effect. Compared to the conventional approach, our proposed adaptive design removes ineffective doses, reduces the total sample size, and maintains adequate power for dose-finding. The proposed design has been implemented in an ongoing study and software for trial simulation is available at http://odin.mdacc.tmc.edu/~yuanj/soft.html.
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Contemp Clin Trials · Jul 2012
Randomized Controlled TrialAn online randomised controlled trial to assess the feasibility, acceptability and potential effectiveness of 'Living with Bipolar': a web-based self-management intervention for bipolar disorder: trial design and protocol.
Bipolar Disorder (BD) is a common and severe form of mental illness. Pharmacotherapy is the main treatment offered, but has limited effectiveness, and there is increasing evidence that people with BD respond well to psychological interventions. Inequalities in access to face-to-face psychological interventions mean many people seek support outside of routine health services. ⋯ The results of this trial will inform a definitive trial; and the implementation phase will aim to assess the potential for use within the NHS.
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Contemp Clin Trials · Jul 2012
Comparative StudyDose-finding designs in pediatric phase I clinical trials: comparison by simulations in a realistic timeline framework.
Usual dose-finding methods in oncology are sequential. Accrual is suspended after each group of patients to assess toxicity before increasing the dose. An adapted Continual Reassessment Method (CRM) and Rolling 6 (R6) method, designed to avoid this suspension of accrual in pediatric oncology, are compared with the traditional 3+3 design. ⋯ These new methods can reduce the number of skipped patients, but only provide limited gain in terms of ability to select the right dose. New designs are needed.
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Contemp Clin Trials · May 2012
Randomized Controlled TrialComparative study on the pharmacodynamics of cisatracurium: continuous infusion or intermittent bolus injection.
To explore a better administration way through comparison of the pharmacodynamics of cisatracurium administered by continuous infusion or intermittent bolus injection. ⋯ Although cisatracurium consumption was significantly lower in continuous infusion than in intermittent bolus injection, continuous infusion can obtain more stable neuromuscular blockade than intermittent bolus injection.