Contemporary clinical trials
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Contemp Clin Trials · May 2011
Hospital training program increases awareness of Good Clinical Practice (GCP).
To develop an in-house training program of Good Clinical Practice (GCP) for the whole clinical team and to evaluate the effect of the program on the personnel's knowledge on GCP. ⋯ A simple in-house training program is easy to implement and may help to improve GCP compliance.
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Contemp Clin Trials · Mar 2011
Randomized Controlled TrialA study design to investigate the effect of short-form Sun-style Tai Chi in improving functional exercise capacity, physical performance, balance and health related quality of life in people with Chronic Obstructive Pulmonary Disease (COPD).
The effectiveness of exercise training in people with COPD is well established. However, alternative methods of training such as Tai Chi have not been widely evaluated. This paper describes the study design of a clinical trial which aims to determine if short form Sun-style Tai Chi improves exercise capacity and quality of life in people with COPD. ⋯ If short form Sun-style Tai Chi improves exercise capacity, physical performance and quality of life in people with COPD, this would provide an alternate form of exercise training which does not require exercise equipment thus making effective exercise training more accessible for the large numbers of people with COPD.
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Contemp Clin Trials · Mar 2011
The blind leading the blind: use and misuse of blinding in randomized controlled trials.
The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. ⋯ We address herein the concept of blinding, propose standard definitions for the consistent use of these terms, and detail when different types of blinding should be utilized. Standardizing the definition of blinding and utilizing proper blinding methods will improve the quality and clarity of reporting in RCTs.
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Contemp Clin Trials · Mar 2011
Randomized Controlled TrialDesign, recruitment and start up of a primary care weight loss trial targeting African American and Hispanic adults.
Primary care offices are critical access points for obesity treatment, but evidence for approaches that can be implemented within these settings is limited. The Think Health! (¡Vive Saludable!) Study was designed to assess the feasibility and effectiveness of a behavioral weight loss program, adapted from the Diabetes Prevention Program, for implementation in routine primary care. Recruitment of clinical sites targeted primary care practices serving African American and Hispanic adults. ⋯ A total of 412 patients were pre-screened, of whom 284 (68.9%) had baseline assessments and 261 were randomized, with the following characteristics: 65% African American; 16% Hispanic American; 84% female; mean (SD) age of 47.2 (11.7) years; mean (SD) BMI of 37.2(6.4) kg/m(2); 43.7% with high blood pressure; and 18.4% with diabetes. This study will provide insights into the potential utility of moderate-intensity lifestyle counseling delivered by motivated primary care clinicians and their staff. The study will have particular relevance to African Americans and women.