Parent class: Intervention-concept

Subclasses: Comparison-arm    Experimental-arm   

Documentation: "Arm-intervention: What is done to subjects in a randomized group for the duration of a trial. May consist of one or more interventions, whose effects are the object of investigation."

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
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