Parent class: Intervention-arm


Documentation: "The regimen of intervention(s) used as control in the trial. The regimen may include placebo or standard therapy (treatment that experts agree is appropriate, accepted, and widely used) or no intervention."

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
justification "Rational for why it was reasonable to use this comparison intervention, especially if the comparison is a placebo or sham intervention, or if the comparison was to no treatment or usual care." STRING   0:1  
interventions "Pointers to one or more interventions received by subjects assigned to this arm." Instance Intervention 1:*  
intervention-arm-execution-notes "Notes on how intervention arm was executed, not strictly compliance or results. e.g., door-to-thrombolysis time." STRING   0:1  
multiple-interventions-p "Whether this arm involves more than one intervention (e.g., triple therapy for H. Pylori)." SYMBOL TRUE FALSE 0:1  
regimens "Pointer to the regimen administered to the the clusters/individuals at the level of randomization below. The unit of randomization is at the top level. This slot contains data only if the trial is cluster-randomized." Instance Intervention-arm 0:1  
repetition-expression "The s-expression that captures the intervention arm sequence of intervention elements that are repeated in a cycle." SYMBOL   1:*  
delay-after-randomization "Description of any delay between randomization and treatment." STRING   0:1  
description-of-intervention-arm "Description of this intervention arm as a whole. Descriptions of the individual intervention(s) of this arm are provided separately for that intervention." STRING   0:1  
name "A 'pretty name' for referring to this entity." STRING   0:1  
intervention-arm-expression "The s-expression that captures the intervention arm sequence of intervention elements." SYMBOL   1:*  
compliance-details "Details of compliance checking, encouragement, and compliance rates and definitions." Instance Compliance-details 0:1  
repetition-rule "The condition that regulates the repetition of treatment cycles." Instance Clinical-rule 0:1  
term-information "Pointer to a UMLS preferred term or terms, if available, that capture the major clinical concepts in this data class (e.g, diabetes mellitus)." Instance Term-information 1:*  
intervention-arm-compliance-comment "Comments on compliance with this intervention arm." STRING   0:1  
protocol-changes   Instance Protocol-change    
roles "Tells which class and slot will take instances of this class depending on the role of the instance. The format is (role OWNER-CLASS |owner-slot|) e.g., if this class is DATE and the instance's role is recruitment-start-date, (recruitment-start-date RECRUITMENT |start-date|) tells us that this instance of date should be the value of the slot |start-date| in an instance of class RECRUITMENT." SYMBOL   0:1  

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Generated on Mon Dec 15 11:40:40 2008