Parent class: Study-outcome


Documentation: "A characteristic of the study population evaluated at one or more time points during the trial that may change in response to the experimental treatment and whose evaluation is of interest for the trial to show safety of the experimental treatment. Side effects cannot be of type cost, functional status, or life years: characteristics of those types are predefined study outcomes."

Template Slots
Slot name Documentation Type Allowed Values/Classes Cardinality Default
event-type "Side effects are known problems that some subjects encounter from the intervention. Adverse events are unexpected events or effects." SYMBOL Side Effect Adverse Event 0:1  
side-effect-comment "Any comments on this side effect or adverse event." STRING   0:1  
reason-for-post-hoc-definition "If this outcome was specified post-hoc, describe why this outcome was defined post-hoc." STRING   0:1  
survival-analysis-and-results   Instance Survival-analysis-and-results 0:1  
regression-analyses-and-results "Details about the regression analysis done on this outcome." Instance Regression-analysis-and-results    
specification-time   SYMBOL A-priori Post-hoc 0:1  
timepoint-comments "Comments on the definition of timepoints, e.g., how 'hospital discharge' was defined." STRING   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