Contemporary clinical trials
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Contemp Clin Trials · Jan 2013
Randomized Controlled Trial Comparative StudyDose-response effects of exercise on abdominal obesity and risk factors for cardiovascular disease in adults: study rationale, design and methods.
Although progress has been made to elucidate the effects of exercise as a strategy for reducing obesity and related cardiometabolic risk factors, the specific exercise exposures required to achieve optimal benefit continue to be the source of considerable uncertainty and debate. Despite the inference of a dose-dependent relationship between exercise and health benefit, absent from the literature are randomized trials that, without alteration in caloric intake, examine the separate effects of exercise dose and intensity on obesity and associated cardiometabolic risk. We will perform a randomized, controlled trial designed to study the separate effects of habitual exercise differing in dose (energy expenditure, kcal/session) and intensity (relative to VO(2)peak) on abdominal obesity and selected cardiometabolic risk factors. ⋯ Duration of all treatments will be 6 months. The findings from this study may help resolve the following unanswered questions, "For a given exercise dose does higher exercise intensity result in greater health benefits?" "For a given exercise intensity does higher exercise dose result in greater health benefits?". Identification of the separate effects of exercise dose and intensity on obesity and related cardiometabolic risk factors under controlled conditions is important for development of optimal, lifestyle-based strategies that can subsequently be tested in long-term effectiveness trials.
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Contemp Clin Trials · Jan 2013
Identifying and collecting pertinent medical records for centralized abstraction in a multi-center randomized clinical trial: the model used by the American College of Radiology arm of the National Lung Screening Trial.
In clinical trials and epidemiologic studies, information on medical care utilization and health outcomes is often obtained from medical records. For multi-center studies, this information may be gathered by personnel at individual sites or by staff at a central coordinating center. We describe the process used to develop a HIPAA-compliant centralized process to collect medical record information for a large multi-center cancer screening trial. ⋯ We designed a successful centralized medical record abstraction process that may be generalized to other research settings, including observational studies. The coordinating center received no identifying data. The process satisfied requirements imposed by the Health Insurance Portability and Accountability Act and concerns of site institutional review boards with respect to protected health information.
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Contemp Clin Trials · Jan 2013
Randomized Controlled TrialProgressive resistance versus relaxation training for breast cancer patients during adjuvant chemotherapy: design and rationale of a randomized controlled trial (BEATE study).
Cancer-related fatigue is a common severe symptom in breast cancer patients, especially during chemotherapy. Exercise appears to be promising in prevention or treatment of fatigue. Resistance training as an accompanying treatment to chemotherapy has been minimally investigated, yet might counteract muscle degradation and inflammation caused by many chemotherapeutics, and thus forestall or reduce fatigue. Previous exercise trials mostly compared the intervention with 'usual care'. Therefore, it is unclear to what extent the observed effects on fatigue are based on physical adaptations by exercise itself, or rather on psycho-social factors linked to the group support or attention by the trainer. ⋯ Strengths of the BEATE study include the investigation of progressive resistance training parallel with chemotherapy, the choice of a control group that enables an evaluation of the physiological effects of exercise beyond potential psycho-social effects, and the comprehensive and high-quality assessment of physiological factors and biomarkers potentially related to fatigue.
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Contemp Clin Trials · Nov 2012
Randomized Controlled Trial Multicenter StudyStatistical considerations for the HPTN 052 Study to evaluate the effectiveness of early versus delayed antiretroviral strategies to prevent the sexual transmission of HIV-1 in serodiscordant couples.
The HIV Prevention Trial Network (HPTN) 052 Study is a Phase III, two-arm, controlled, open-labeled, randomized clinical trial designed to determine whether early antiretroviral therapy (ART) can prevent the sexual transmission of human immunodeficiency virus type 1 (HIV-1). A total of 1763 couples in which one partner was HIV-1-positive and the other was HIV-1-negative were enrolled in four continents, nine countries and thirteen study sites. The HIV-1-positive partner was randomly assigned to either of the two arms: "immediate" (early) therapy with ART initiated upon enrollment plus HIV primary care, or "delayed" therapy with HIV primary care but ART initiated when the index case would have two consecutive measurements of a CD4+ cell count within or below the range of 200-250 cells/mm(3), or develop an AIDS-defining illness. ⋯ Despite that the observed event rates were lower than expected, which might have compromised the study power, an early release of the trial results in May 2011 showed an overwhelming 96% risk reduction for the immediate therapy in the prevention of genetically linked HIV-1 incident transmissions. Nevertheless, the durability of its long-term effectiveness is yet to be assessed. The HPTN 052 Study is still ongoing and will not complete till 2015.
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Contemp Clin Trials · Nov 2012
Randomized Controlled TrialDevelopment and evaluation of an interprofessional communication intervention to improve family outcomes in the ICU.
The intensive care unit (ICU), where death is common and even survivors of an ICU stay face the risk of long-term morbidity and re-admissions to the ICU, represents an important setting for improving communication about palliative and end-of-life care. Communication about the goals of care in this setting should be a high priority since studies suggest that the current quality of ICU communication is often poor and is associated with psychological distress among family members of critically ill patients. This paper describes the development and evaluation of an intervention designed to improve the quality of care in the ICU by improving communication among the ICU team and with family members of critically ill patients. ⋯ The facilitators are trained using three specific content areas: a) evidence-based approaches to improving clinician-family communication in the ICU, b) attachment theory allowing clinicians to adapt communication to meet individual family member's communication needs, and c) mediation to facilitate identification and resolution of conflict including clinician-family, clinician-clinician, and intra-family conflict. The outcomes assessed in this randomized trial focus on psychological distress among family members including anxiety, depression, and post-traumatic stress disorder at 3 and 6 months after the ICU stay. This manuscript also reports some of the lessons that we have learned early in this study.