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Random allocation software for parallel group randomized trials

DOI: 10.1186/1471-2288-4-26

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Abstract:

The program has different settings for: simple and blocked randomizations; length, format and ordering of generated unique identifiers; type and format of program output; and saving sessions for future use. A formatted random list generated by this program can be used directly (without further formatting) by the coordinator of the research team to prepare and encode different drugs or instruments necessary for the parallel group trial.Random Allocation Software enables users to control different attributes of the random allocation sequence and produce qualified lists for parallel group trials.An important aspect of any trial that should be clearly stated in the final report is the method used to assign treatments (or other interventions) to participants [1]. In the final report of the trial, authors should specify the method of sequence generation, i.e. whether they have used mechanical means, a computer generated random list or random number table. After preparing a random sequence, subjects will be allocated to the trial groups using an implementation method such as numbered containers, central telephone line, or allocation by a person who is not involved in the main research and patient care (the encoder). During the process of allocation each subject will be given a unique identification code (Unique Identifier, UI). This UI will be used as a label to uniquely identify the patient's group after completion of the study. During the study period this UI will be given to the main researchers together with the necessary treatment (e.g. drug or placebo). Usually these treatments are prepared by the encoder with the same physical characteristics (shape, color, size, etc), differing only by the UI labels to blind the main researchers about the actual patient group. Following enrollment of all subjects into the study, these UIs are decoded to determine the patient group. Depending on the preference of the researchers or facilities of the research environment, subjects ar

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