Contemporary clinical trials
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Contemp Clin Trials · Jul 2014
Randomized Controlled Trial Multicenter StudyRationale and design of a multicenter randomized clinical trial with memantine and dextromethorphan in ketamine-responder patients.
The N-methyl-D-aspartate receptor plays an important role in central sensitization of neuropathic pain and N-methyl-D-aspartate receptor antagonists, such as ketamine, memantine and dextromethorphan may be used for persistent pain. However, ketamine cannot be repeated too often because of its adverse events. A drug relay would be helpful in the outpatient to postpone or even cancel the next ketamine infusion. ⋯ Data analysis is performed using mixed models and the tests are two-sided, with a type I error set at α=0.05. This study will explore if oral memantine and/or dextromethorphan may be a beneficial relay in ketamine responders and may diminish ketamine infusion frequency. Preservation of cognitive function and quality of life is also a central issue that will be analyzed in these vulnerable patients.
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Contemp Clin Trials · Jul 2014
ReviewImprovement in the quality of abstracts in major clinical journals since CONSORT extension for abstracts: a systematic review.
We sought to determine if the publication of the Consolidated Standards of Reporting Trials (CONSORT)(1) extension for abstracts in 2008 had led to an improvement in reporting abstracts of randomized controlled trials (RCTs).(2) METHODS: We searched PubMed for RCTs published in 2007 and 2012 in top-tier general medicine journals. A random selection of 100 trial abstracts was obtained for each year. Data were extracted in duplicate on the adherence to the CONSORT extension for abstracts. The primary outcome was the mean number of items reported and the secondary outcome was the odds of reporting each item. We also estimated incidence rate ratios (IRRs).(3) RESULTS: Significantly more checklist items were reported in 2012 than in 2007: adjusted mean difference was 2.91 (95% confidence interval [CI](4) 2.35, 3.41; p<0.001). In 2012 there were significant improvements in reporting the study as randomized in the title, describing the trial design, the participants, and objectives and blinding. In the Results section, trial status and numbers analyzed were also reported better. The IRRs were significantly higher for 2012 (IRR 1.32; 95% CI 1.25, 1.39; p<0.001) and in multisite studies compared to single site studies (IRR 1.08; 95% CI 1.03, 1.15; p=0.006). ⋯ There was a significant improvement in the reporting of abstracts of RCTs in 2012 compared to 2007. However, there is still room for improvement as some items remain under-reported.
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Contemp Clin Trials · Jul 2014
Randomized Controlled TrialFlexible and extended dosing of nicotine replacement therapy or varenicline in comparison to fixed dose nicotine replacement therapy for smoking cessation: rationale, methods and participant characteristics of the FLEX trial.
Quitting smoking is the single most effective strategy to reduce morbidity and premature mortality in smokers. Research has demonstrated the effectiveness of pharmacotherapy in smoking cessation, but few studies have directly compared varenicline and monotherapy nicotine replacement therapy (NRT) and none have examined varenicline and combinations of NRT products. The majority of smoking cessation trials involve carefully circumscribed populations, making their results less generalizable to those with severe medical conditions or psychiatric comorbidities. ⋯ Smokers (N=737) were randomly assigned to one of three treatment conditions, and were scheduled to attend 8 follow-up appointments over 12 months. All participants received 6-15 minute practical counseling sessions with nurse counselors experienced in treating tobacco dependence. We expect that the results will lead to an enhanced understanding of the efficacy of these pharmacotherapies, including those with a history of psychiatric illness.
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Contemp Clin Trials · Jul 2014
Randomized Controlled TrialA randomized trial of diet in men with early stage prostate cancer on active surveillance: rationale and design of the Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]).
Diet may substantially alter prostate cancer initiation and progression. However, large-scale clinical trials of diet modification have yet to be performed for prostate cancer. The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) is investigating the effect of increased vegetable consumption on clinical progression in men with localized prostate cancer. ⋯ The MEAL Study is assessing the effectiveness of a high-vegetable diet intervention for preventing clinical progression in men with localized prostate cancer on active surveillance.
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Contemp Clin Trials · Jul 2014
Randomized Controlled TrialDevelopment and implementation of a telehealth-enhanced intervention for pain and symptom management.
Managing chronic pain effectively is often challenging for health care providers and patients. Telehealth technologies can bridge geographic distance and improve patients' quality of care in communities where access to pain specialists has previously been unavailable. This paper describes the development and evaluation of a telehealth intervention (TelePain) designed to address the need for pain specialist consultation regarding pain and symptom management issues in non-academic medical centers. ⋯ Symptom management recommendations for each patient case are made by a panel of pain specialists representing internal medicine, addiction medicine, rehabilitation medicine, anesthesiology, psychiatry, and nursing. The outcomes assessed in this randomized trial focus on pain intensity, pain's interference on function and sleep, and anxiety, depression, and cost-effectiveness. Some of the challenges and lessons that we have learned early in implementing the TelePain intervention are also reported.