Parent class: Study-outcome
Subclasses:
Documentation: "A characteristic of the study population evaluated at one or more time points during the trial that is expected to change in response to the experimental treatment and whose evaluation is of primary interest for the trial to show efficacy of the experimental treatment."
Template Slots | |||||
Slot name | Documentation | Type | Allowed Values/Classes | Cardinality | Default |
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