Contemporary clinical trials
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Contemp Clin Trials · Nov 2012
Randomized Controlled Trial Multicenter StudyEthical considerations and rationale of the MAKI trial: a multicenter double-blind randomized placebo-controlled trial into the preventive effect of palivizumab on recurrent wheezing associated with respiratory syncytial virus infection in children with a gestational age of 33-35 weeks.
Respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) is the most frequent cause of bronchiolitis during infancy. Long-term airway morbidity with recurrent post bronchiolitis wheezing (PBW) episodes, which are probably associated with respiratory infections, occurs in 30 to 70% of infants that were hospitalised with RSV LRTI. ⋯ The Institutional review board (IRB) concluded the study has high clinical relevance because the benefit of 50% chance of protection by palivizumab outweighs the risk of side adverse events due to intramuscular administration of placebo.
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Contemp Clin Trials · Nov 2012
Randomized Controlled Trial Multicenter StudyThe MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features.
This paper presents the rationale and design features of the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research; Clinical Trials.gov NCT00597012). MeTeOR is an NIH-funded seven-center prospective randomized controlled trial (RCT) designed to establish the efficacy of arthroscopic partial meniscectomy combined with a standardized physical therapy program as compared with a standardized physical therapy program alone in patients with a symptomatic meniscal tear in the setting of mild to moderate knee osteoarthritic change (OA). The design and execution of a trial that compares surgery with a nonoperative treatment strategy presents distinctive challenges. The goal of this paper is to provide the clinical rationale for MeTeOR and to highlight salient design features, with particular attention to those that present clinical and methodologic challenges.
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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.