Contemporary clinical trials
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Contemp Clin Trials · Sep 2013
Clinical TrialThe Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE): method and design considerations.
Due to the concentration of individuals at-risk for suicide, an emergency department visit represents an opportune time for suicide risk screening and intervention. ⋯ While 'classic' randomized control trials (RCT) are typically selected over quasi-experimental designs, ethical and methodological issues may make an RCT a poor fit for complex interventions in an applied setting, such as the ED. ED-SAFE represents an innovative approach to examining the complex public health issue of suicide prevention through a multi-phase, quasi-experimental design embedded in 'real world' clinical settings.
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Contemp Clin Trials · Jul 2013
Randomized Controlled TrialA pilot study of Biotene OralBalance® gel for oral care in mechanically ventilated preterm neonates.
Neonatal ventilator-associated pneumonia (VAP) is associated with increased morbidity and mortality. In adults on mechanical ventilation, timed oral care decreases the frequency of VAP, but this approach has not been studied in neonates. ⋯ The results of this pilot study support the feasibility of a randomized trial of timed oral care with Biotene OralBalance® gel for prevention of VAP in mechanically ventilated neonates.
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Contemp Clin Trials · Jul 2013
ReviewA systematic review of the factors influencing African Americans' participation in cancer clinical trials.
This systematic review was conducted to synthesize the existing evidence regarding key considerations influencing African Americans' participation in cancer clinical trials (CCTs). ⋯ Existing research underscores the importance of social support from family and friends, cultural appropriateness and sensitivity from physicians and in the design of the CCT, and enhanced education among African Americans in decision-making processes. As African Americans are underrepresented in CCTs, targeted strategies to enhance recruitment efforts and improve cancer treatment outcomes are essential.
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Contemp Clin Trials · Jul 2013
Methodology of clinical research in rare diseases: development of a research program in juvenile neuronal ceroid lipofuscinosis (JNCL) via creation of a patient registry and collaboration with patient advocates.
Juvenile neuronal ceroid lipofuscinosis (JNCL; Batten disease) is a rare, inherited, fatal lysosomal storage childhood disorder. True for many rare diseases, there are no treatments that impact the course of JNCL. The University of Rochester Batten Center's (URBC) mission is to find treatments to slow, halt, or prevent JNCL. ⋯ The registry and BDSRA collaboration have enabled development of a clinical rating scale, natural history and neuropsychological studies, and genetic studies for disease confirmation. This work highlights an approach for preparatory natural history research and infrastructure development needed to facilitate efficient implementation of clinical trials in rare diseases.
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Contemp Clin Trials · Jul 2013
Randomized Controlled TrialChronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): design and methods.
Treatment of COPD requires multiple pharmacological and non-pharmacological intervention strategies. One target is physical inactivity because it leads to disability and contributes to poor physical and mental health. Unfortunately, less than 1% of eligible patients have access to gold-standard pulmonary rehabilitation. ⋯ This theory driven self-management lifestyle physical activity intervention is designed to reach patients unable to complete center-based pulmonary rehabilitation. Results will advance knowledge and methods for dissemination of a potentially cost-effective program for patients with COPD.