Class BASELINE

Parent class: Outcome

Subclasses:

Documentation: "A characteristic of the study population evaluated at the beginning of the trial."

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
baseline-subgroups "Points to subgroups within this baseline characteristic. e.g., of those with CHF, those with EF <35% and those with EF >35%." Instance Baseline    
outcomes-followup "Points to class with number of subjects off their assigned intervention at this timepoint, for each study-arm-population, with the reasons for their withdrawal." Instance Outcomes-followup    
baseline-datapoints "The value of this baseline characteristic among different study populations." Instance Baseline-datapoint    
p-value "Enter as ('=' '0.975')" FLOAT   0:1  
unit "The unit of the outcome value, e.g., feet or mmHg. Should come from a controlled vocabulary." STRING   0:1  
comment-on-efficacy-results   STRING   0:1  
outcome-assessment "Details about the assessment of this outcome." Instance Outcome-assessment 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:*  
special-variable-information "Points to additional information relevant to special classes of variables (e.g., discount rate for cost variables)" Instance Special-variable-information 0:1  
comment-on-outcome "Comment on selection, importance, etc. of outcome." STRING   0:1  
comment-on-itt-subgroup-results   STRING   0:1  
name "A 'pretty name' for referring to this entity." STRING   0:1  
statistical-analyses-and-results "Pointer to the description of how this outcome will be statistically analyzed." Instance Statistical-analysis-and-results    
type-of-outcome   SYMBOL Continuous Categorical Proportion Rate Count Cost Life-Years Scored Instrument 0:1  
comment-on-itt-results   STRING   0:1  
comment-on-efficacy-subgroup-results   STRING   0:1  
description-of-outcome "Text definition of this outcome." 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