Showing papers in "Controlled Clinical Trials in 1996"

TL;DR: An instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research is described and its use to determine the effect of rater blinding on the assessments of quality is described.

TL;DR: It is shown that values of median follow-up may differ substantially depending on the method used, and standard analytical methods for survival data, such as the log-rank test 121, the generalized Wilcoxon test, or the proportional hazards model 141, estimate average effects for the observed response times and test those effects for significance.

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TL;DR: A detailed overview of the rationale for key aspects of the protocol of the Digitalis Investigation Group (DIG) trial is provided, including the simplicity of the design, broad eligibility criteria, essential data collection, and inclusion of various types of centers.

TL;DR: The AASK Pilot Study evaluated the feasibility of conducting a long-term clinical trial to compare the effects of two levels of blood pressure control and three different antihypertensive drug regimens on the rate of decline in glomerular filtration rate (GFR) in African Americans with clinically diagnosed hypertensive renal disease.

TL;DR: On current evidence EPO is of little value in the management of premenstrual syndrome and hence a rigorous meta-analysis inappropriate.

TL;DR: In this paper, the authors compare monitoring therapeutic trials with monitoring prevention trails and argue that in monitoring prevention trials one should place more emphasis on formally defined global measures of health, not simply on a single targeted disease.

TL;DR: These simulated meta-analyses demonstrate the main point, which is that the time of first significance, however parameterized, is itself a random variable with error variance.

TL;DR: The results of ten clinical trials suggest that supplemental calcium may prevent preeclampsia, but none of the trials has reported the outcome of systematic surveillance for urolithiasis, a potential complication of calcium supplementation.

TL;DR: Although numerous single institution studies showed increased CR rates and improved local control, the efficacy of HT as an adjunct to RT should be assessed with well-designed multi-institutional randomized clinical trials.

TL;DR: Enrollment was higher for those who read and understood the informed consent and those who were initially recruited after hospital discharge, particularly nondepressed patients and it may be a greater challenge to motivate patients to enroll in future clinical trials if health care reform improves access to medical insurance coverage.

TL;DR: The one-stage modified CRM II and CRM III designs perform well and avoid the criticisms of the original CRM by reducing the average number of cohorts and toxicity incidences, while estimating the MTD more accurately than does the standard design.

TL;DR: This report summarizes the demographic, biochemical, and clinical characteristics of the randomized patients at the time of entry into the ABCD trial and evaluates the balance between the treatment groups within each population.

TL;DR: A positive correlation to patient accrual was found for several attitudes held by the participating physicians, including their perception of the importance of a quality-of-life study in the protocol, their conception of the simplicity of the study Protocol, their frequency of participation in investigators' meetings, and their awareness of cost and reimbursement levels for entered patients.

TL;DR: This commentary deals with RCTs to establish the efficacy of a treatment-what are often categorized as phase III trials in the U.S. Food and Drug Administration (FDA) regulatory setting.

TL;DR: A statistical framework is presented for examining cost and effect data on competing interventions obtained from an RCT or from an observational study, and several new c-e measures are proposed that utilize the linkage between costs and effects on the patient level.

TL;DR: The design of an economic evaluation integrated into the Flolan International Randomized Survival Trial (FIRST) was reported on, considered a critical component of the assessment of this therapy given the resources required to administer epoprostenol (Flolan).

TL;DR: It is concluded that selected dimensions of quality of life improved during the AASK Pilot Study only in participants randomized to the usual mean arterial blood pressure goal group.

TL;DR: For the development of a graphical user interface in network-based information system for use in multi-institutional clinical trials, HTTP/HTML has several advantages over an ordinary client-server model.

TL;DR: The results suggest that clinic-based screening is an effective approach for recruitment of African Americans with hypertension and renal insufficiency into clinical trials and that enrollment of African American women in such studies is a special challenge.

TL;DR: It is concluded that willingness to participate in vaccine trials varies systematically with some of their characteristics, and where there are design alternatives for identified negative components, these should be considered.

TL;DR: Data obtained on myocardial perfusion changes (99 patients underwent initial PET), special lipid particles, and coagulation factors may help define which patients with CHD and relatively low LDL cholesterol will benefit from lipid-lowering treatment.

TL;DR: The study found that the most highly rated trial benefit was the perception of potential colon cancer prevention; the trial barrier reported to be the most troublesome was inappropriate or mistaken billing for study visits.

TL;DR: The reporting of adverse reactions in clinical trials is inadequate in both the United States and Japanese literature, and clinical research into drug safety in both countries could be improved through the adoption of simple standards of clarity and consistency in the monitoring and reporting of drug adverse effects.

TL;DR: Although AASK Pilot Study participants maintained excellent attendance, their pill counts were lower than previously reported among clinical trial participants and goal blood pressure levels were difficult to achieve during the short period of follow-up.

TL;DR: Some of the practical issues concerning modifying or closing randomized clinical trials, including what data and analyses could be helpful to the data monitoring committee in their deliberations are discussed.