Contemporary clinical trials
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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.
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Contemp Clin Trials · Sep 2012
Dose escalation with overdose control using a quasi-continuous toxicity score in cancer Phase I clinical trials.
Escalation with overdose control (EWOC) is a Bayesian adaptive design for selecting dose levels in cancer Phase I clinical trials while controlling the posterior probability of exceeding the maximum tolerated dose (MTD). EWOC has been used by clinicians to design many cancer Phase I clinical trials, see e.g. [1-4]. However, this design treats the toxicity response as a binary indicator of dose limiting toxicity (DLT) and does not account for the number and specific grades of toxicities experienced by patients during the trial. ⋯ We call the design escalation with overdose control using normalized equivalent toxicity score (EWOC-NETS). Simulation results show that this design has good operating characteristics and improves the accuracy of MTD, trial efficiency, therapeutic effect, and overdose control relative to EWOC which is used as a representative of designs treating toxicity response as a binary indicator of DLT. We illustrate the performance of this design using real trial data in identifying the Phase II dose.
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Contemp Clin Trials · Sep 2012
ReviewDoes the reporting of randomized clinical trials published in Chinese pediatrics journals improve after the CONSORT Statement is adopted?
There is no systematic assessment whether the quality of reporting has been improved since the CONSORT Statement was introduced into China in 1997. The aim of this study is to determine whether the use of the CONSORT Statement is associated with improved quality of reporting of RCTs published in Chinese pediatrics journals. ⋯ The quality of reporting of RCTs has not significantly improved since the CONSORT Statement was introduced into China. The reporting remains poor, and often inadequate for assessment of the rigor of studies. Chinese pediatrics journals should reinforce the use of the CONSORT Statement in the reporting of trials.
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Contemp Clin Trials · Sep 2012
Randomized Controlled Trial Multicenter StudyLongitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle (FACE): design and methods.
As life expectancy increases for adolescents ever diagnosed with AIDS due to treatment advances, the optimum timing of advance care planning is unclear. Left unprepared for end-of-life (EOL) decisions, families may encounter miscommunication and disagreements, resulting in families being charged with neglect, court battles and even legislative intervention. Advanced care planning (ACP) is a valuable tool rarely used with adolescents. ⋯ The mediating and moderating effects of threat appraisal, HAART adherence, and spiritual struggle on the relationships among FACE and quality of life and hospitalization/dialysis use will also be assessed. This study will be the first longitudinal study of an AIDS-specific model of ACP with adolescents. If successful, this intervention could quickly translate into clinical practice.