Showing papers in "Controlled Clinical Trials in 1995"

TL;DR: An annotated bibliography of scales and checklists developed to assess quality is presented, giving readers a quantitative index of the likelihood that the reported methodology and results are free of bias.

TL;DR: The study is expected to determine whether or not treatment with hydroxyurea can offer significant clinical benefit to patients with the most common hereditary disorder among African-Americans in the United States.

TL;DR: A flexible method of extending a study based on conditional power, where the significance of the treatment difference at the planned end is used to determine the number of additional observations needed and the critical value necessary after accruing those additional observations.

TL;DR: The PCPT design is described with reference to alternatives that were considered and the chosen design depends on five critical assumptions that must be monitored closely throughout the 9-year trial.

TL;DR: The quality assurance and monitoring program is an integral and continuing part of study operations and can be met only when the coordinating center staff understand data quality goals and are up to date with all phases of data management and reporting.

TL;DR: SIZE as discussed by the authors is a comprehensive computer program for calculating sample size, power, and duration of study in clinical trials with time-dependent rates of event, crossover, and loss to follow-up.

TL;DR: This paper describes some statistical considerations for the Child and Adolescent Trial for Cardiovascular Health (CATCH), a large-scale community health trial sponsored by the National Heart, Lung, and Blood Institute.

TL;DR: It is concluded that the CCS design is only justified under extraordinary circumstances and results on the external validity of the treatment effects estimated in the randomized patients by means of Cox's proportional hazards model are presented.

TL;DR: This paper argues that the requirement that the need for a subjectively determined prior distribution, likelihood, and loss function be explicitly stated is a distinct Bayesian advantage.

TL;DR: The reasons why economic data collection and analysis are being considered in clinical trials are described, various designs and methods for gathering economic trial data are identified, and the strengths and limitations of different methods for providing sound data for decision making on appropriate use of health care interventions are evaluated.

TL;DR: It is concluded that the Vermont-Oxford Trials Network Database is reliable and data keying errors have been reduced by the introduction of additional quality control measures.

TL;DR: The PEPI trial as mentioned in this paper was designed to test whether estrogen and estrogen-progestin therapy is efficacious in the prevention of cardiovascular disease, as a much larger trial with clinical disease outcomes is needed to answer that question.

TL;DR: The rationale and operational model for the DSMB may be a useful example for the development of similar review processes in other HIV clinical trial settings and the responsibility, organization, and operating procedures are presented and illustrated.

TL;DR: A prospective randomized trial is being undertaken at Southern California Kaiser Permanente, a large health maintenance organization, to compare the effectiveness and costs of two alternative approaches to the treatment of hypercholesterolemia.

TL;DR: Response rates were similar between the methods of addressing envelopes and among the three vehicles for the message, suggesting that the least costly method of mailing should be used.

TL;DR: A placebo run-in would have had little effect on the outcome of the CRISP study and would have substantially increased recruitment difficulties, while lower educated persons were more likely to be excluded and the effect of therun-in on follow-up adherence was stronger in less educated participants.

TL;DR: PEPI was not designed to test whether estrogen and estrogen-progestin therapy is efficacious in the prevention of cardiovascular disease, as a much larger trial with clinical disease outcomes is needed to answer that question.

TL;DR: A benefit-risk ratio is proposed that quantifies for a new therapy how many therapeutic events will be achieved for each adverse event incurred and is illustrated using data from the GUSTO trial comparing tissue plasminogen activator and streptokinase in the management of patients with acute myocardial infarction.

TL;DR: Following the least-significant-difference approach proposed by Makuch and Simon, sample size formulas are derived by working with the logrank test and proportional hazards model directly and ensures the type I error rate to be the nominal value when the global null hypothesis is true.

TL;DR: A cumulative meta-analysis of 12 trials performed shortly before the end of CSP #207 raised the issue as to whether the meta- analysis, if done earlier, would have changed the conduct of the trial and could be useful as an adjunct in the planning, conduct, and final analysis of a clinical trial.