Controlled clinical trials
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Control Clin Trials · Aug 1998
Randomized Controlled Trial Multicenter Study Clinical TrialSystemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations (SCCOPE): rationale and design of an equivalence trial. Veterans Administration Cooperative Trials SCCOPE Study Group.
The Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations Trial (SCCOPE) was a randomized, double-blind, placebo-controlled, multicenter trial sponsored by the U. S. Department of Veterans Affairs Cooperative Studies Program. ⋯ The primary endpoint of the study was treatment failure, defined as death, intubation with mechanical ventilation, hospital readmission for COPD, or intensification of pharmacologic therapy. Secondary endpoints included length of hospital stay, changes in FEV1, and changes in dyspnea score. We also evaluated possible adverse effects from systemic corticosteroids.
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Control Clin Trials · Aug 1998
Randomized Controlled Trial Multicenter Study Clinical TrialRationale and design for the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial.
The Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) Trial is a randomized, prospective, double-blind, parallel-group, two-arm, actively controlled, multicenter, international 5-year clinical trial involving 15,000 patients. CONVINCE will compare the incidence of fatal or nonfatal myocardial infarction (MI), fatal or nonfatal stroke, or cardiovascular-disease-related death in two antihypertensive treatment regimens. One treatment arm begins with controlled onset-extended release (COER)-verapamil, which has its major antihypertensive effect 6-12 hours after administration. ⋯ Although most patients switch from an established antihypertensive medication to randomized treatment, untreated patients with stages I-III hypertension (SBP between 140 and 190 or DBP between 90 and 110 mm Hg) are eligible. Outcomes are monitored by an independent Data and Safety Monitoring Board. Enrollment began during the third quarter of 1996, and follow-up is to be completed in the third quarter of 2002.
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Control Clin Trials · Feb 1998
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialStroke prevention trial in sickle cell anemia.
Stroke occurs in 7-8% of children with Sickle Cell Disease (Hb SS) and is a major cause of morbidity. Rates of recurrence have been reduced from 46-90% to less than 10% through chronic blood transfusions. Prevention of first stroke, however, would be preferable because even one stroke can cause irreversible brain injury. ⋯ The sample size is sufficient to detect 70% reduction in the primary endpoint at 90% power. This trial will determine if transfusion is effective in the primary prevention of stroke. Secondary aims may further the understanding of the effects of transfusion on the brain and guide future research into cerebrovascular disease in Hb SS.
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Control Clin Trials · Feb 1997
Randomized Controlled Trial Clinical TrialOutcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group.
Considerable effort is often expended to adjudicate outcomes in clinical trials, but little has been written on the administration of the adjudication process and its possible impact on study results. As a case study, we describe the function and performance of an adjudication committee in a large randomized trial of two diagnostic approaches to potentially operable lung cancer. Up to five independent adjudicators independently determined two primary outcomes: tumor status at death or at final follow-up and the cause of death. ⋯ This level of effort could be substantially reduced by using fewer adjudicators with little impact on the results. Thus, we suggest that when high observer agreement is demonstrated or anticipated, adjudication committees should consist of no more than three members. Further work is needed to evaluate if smaller committees are adequate to detect small but important treatment effects or if they compromise validity when the level of adjudicator agreement is lower.
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Control Clin Trials · Feb 1995
Randomized Controlled Trial Multicenter Study Clinical TrialThe SvO2 study: general design and results of the feasibility phase of a multicenter, randomized trial of three different hemodynamic approaches and two monitoring techniques in the treatment of critically ill patients. The SvO2 Collaborative Group.
Although the attainment of normal hemodynamic values has always been assumed to be the therapeutic target for critically ill patients, recent studies reported increased values in oxygen transport variables in survivors of high-risk surgery. It has been supposed that the higher values observed in survivors might indicate a physiological compensation for the increased metabolic requirements due to disease. ⋯ Two different monitoring systems are used to maintain the target: conventional Swan-Ganz catheter with scheduled samples of mixed venous O2 saturation, and optical catheter with continuous SvO2 evaluation. The aim of the study is to answer three questions regarding the hypothesis reported above: (1) Are results in postoperative patients applicable to other pathological groups? (2) Does continuous monitoring of SvO2 provide advantages over conventional hemodynamic monitoring? (3) Is a normal SvO2 rather than a supranormal CI a good and predictable therapeutic goal? We report herein the protocol of the study and the results of the pilot phase, which was conducted in 98 critically ill patients enrolled by 56 participating centers to evaluate the safety and feasibility of the proposed trial.