Contemporary clinical trials
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Contemp Clin Trials · Mar 2012
Randomized Controlled Trial Multicenter Study Comparative StudyCognitive behavioural therapy as an adjunct to pharmacotherapy for treatment resistant depression in primary care: the CoBalT randomised controlled trial protocol.
Antidepressants are often the first-line treatment for depression but only one third of patients respond fully to pharmacotherapy. This paper describes the protocol for a randomised controlled trial (RCT) designed to evaluate the clinical and cost effectiveness of cognitive behavioural therapy (CBT) as an adjunct to pharmacotherapy for patients with treatment resistant depression in primary care. ⋯ The CoBalT trial will provide evidence on the clinical and cost effectiveness of CBT as an adjunct to antidepressant medication in the treatment of depression that has not responded to pharmacotherapy. Given the move to widen access to 'talking therapies', the results of this study will be timely.
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Contemp Clin Trials · Mar 2012
Exact two-stage designs for phase II activity trials with rank-based endpoints.
Features common to phase II clinical trials include limited knowledge of the experimental treatment being evaluated, design components reflecting ethical considerations, and small to moderate sample sizes as a result of resource constraints. It is for these reasons that there exist many two-stage designs proposed in the literature for use in this context. ⋯ We present exact two-stage Mann-Whitney designs in the context of two-arm randomized clinical trials. In addition to describing the designs, we present tables of decision rules under a variety of assumed realities for use in trial planning.
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Contemp Clin Trials · Mar 2012
Randomized Controlled Trial Multicenter Study Comparative StudyClinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial.
The NHLBI-sponsored Sickle Cell Disease Clinical Research Network (SCDCRN) conducted a multi-center, acute intervention randomized clinical trial of two methods of Patient Controlled Analgesia for acute pain. This trial was terminated early due to low enrollment. We analyzed the perceived barriers and recruitment difficulties as reported by the coordinators and principal investigators. ⋯ We identified multiple barriers to patient accrual including short duration of enrollment period, protocol design, complex dosing schedule, requirement for staff availability during week-end and after hours, multiple departments' involvement, protocol acceptance, eligibility criteria, competing protocols, and limited staff. Each of these areas should be targeted for intervention in order to plan and conduct successful future clinical trials.
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Contemp Clin Trials · Mar 2012
Randomized Controlled Trial Comparative StudyThe design and methods of the aging successfully with pain study.
Chronic low back pain (CLBP) is widespread among older adults (≥ 65 years) and is often treated inadequately. With a rapidly growing aging population, CLBP will increase and so will the demand for treatment. We believe that mind-body therapies can help to meet this demand. ⋯ We will measure self-reported and objectively measured physical function and include a variety of measures to assess pain intensity and pain interference and psychological function. Our primary hypothesis is that the MBSR program will be more effective than the 10 Keys program in increasing function and decreasing pain. The proposed study represents the first large, well-controlled, comprehensive examination of the effects of a mind-body program on older adults with chronic pain.
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Contemp Clin Trials · Mar 2012
Multicenter Study Comparative StudyIf you build a rare disease registry, will they enroll and will they use it? Methods and data from the National Registry of Myotonic Dystrophy (DM) and Facioscapulohumeral Muscular Dystrophy (FSHD).
Registries are becoming increasingly important for rare diseases as experimental therapies develop. This report describes the methodology behind the National Registry of Myotonic Dystrophy (DM) and Facioscapulohumeral Muscular Dystrophy (FSHD) Patients and Family Members to facilitate the development of other rare disease registries. We also highlight data about the pathophysiology and select burdens of DM and FSHD reported at baseline and longitudinally. ⋯ Strengths of the Registry include large sample sizes, stringent review of clinical and molecular data, annually updated information, and regular interactions between patients and investigators. Registry data provide new insights into the burdens of DM and FSHD, such as, psychological problems and reduced employment. Opportunities abound for investigators to utilize Registry resources to assess the impact of these and other burdens on health care costs, progression of symptoms, and quality of life.