A systematic review of randomized controlled trials on the theraputic effect of intravenous sodium valproate in status epilepticus.

Controlled Clinical Trials As Topic

Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.

Randomized Controlled Trials As Topic

Clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.

Intention To Treat Analysis

Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.

Medicare Payment Advisory Commission

The Commission was created by the Balanced Budget Act of 1997 under Title XVIII. It is specifically charged to review the effect of Medicare+Choice under Medicare Part C and to review payment policies under Parts A and B. It is also generally charged to evaluate the effect of prospective payment policies and their impact on health care delivery in the US. The former Prospective Payment Assessment Commission (ProPAC) and the Physician Payment Review Commission (PPRC) were merged to form MEDPAC.

Clinical Trials Data Monitoring Committees

Committees established to review interim data and efficacy outcomes in clinical trials. The findings of these committees are used in deciding whether a trial should be continued as designed, changed, or terminated. Government regulations regarding federally-funded research involving human subjects (the "Common Rule") require (45 CFR 46.111) that research ethics committees reviewing large-scale clinical trials monitor the data collected using a mechanism such as a data monitoring committee. FDA regulations (21 CFR 50.24) require that such committees be established to monitor studies conducted in emergency settings.