RCTOntology.owl
type: Ontology
version info: 2.0

Data Synthesis
type: Class
disjoint with: Data Extraction Management
disjoint with: Missing Data
disjoint with: Heterogeneity
disjoint with: Assesment Risk Bias
subclass of: Data collection analysis
comment: The choice of meta-analysis method should be stated, including whether a fixed-effect or a random-effects model is used. If meta-analyses are not undertaken, systematic approaches to synthesizing the findings of multiple studies should be described.

Data Extraction Management
type: Class
comment: The method used to extract or obtain data from published reports or from the original researchers (for example, using a data collection form). Whether data are extracted independently by more than one author should be stated, along with how any disagreements are resolved. If relevant, methods for processing data in preparation for analysis should be described.
disjoint with: Heterogeneity
disjoint with: Missing Data
disjoint with: Assesment Risk Bias
disjoint with: Data Synthesis
subclass of: Data collection analysis

Missing Data
type: Class
disjoint with: Heterogeneity
disjoint with: Data Extraction Management
disjoint with: Data Synthesis
disjoint with: Assesment Risk Bias
disjoint with: Search Methods
disjoint with: TypeOfStudy
subclass of: Data Collection Analysis

Heterogeneity
type: Class
comment: Approaches to addressing clinical heterogeneity should be described, along with how the authors will determine whether a meta-analysis is considered appropriate. Methods for identifying statistical heterogeneity should be stated
disjoint with: Data Extraction Management
disjoint with: Data Synthesis
disjoint with: Missing Data
disjoint with: Assesment Risk Bias
subclass of: Data collection analysis

Assesment Risk Bias
type: Class
disjoint with: Data Synthesis
disjoint with: Heterogeneity
disjoint with: Data Extraction Management
disjoint with: Missing Data
comment: The method used to assess risk of bias (or methodological quality). Whether methods are applied independently by more than one author should be stated, along with how any disagreements are resolved. The tool(s) used should be described or referenced, with an indication of how the results are incorporated into the interpretation of the results.
subclass of: Data collection analysis

Data collection analysis
type: Class
subclass of: Design concept
disjoint with: Hypothesis Concept
disjoint with: Search Methods
disjoint with: Data Collection Analysis

Random Effects Model
type: Class
disjoint with: Fixed Effect Model
subclass of: Data Synthesis

Fixed Effect Model
type: Class
subclass of: Data Synthesis
disjoint with: Random Effects Model

Design concept
type: Class
disjoint with: Intervention Concept
disjoint with: Generic Concept
disjoint with: Population Concept
disjoint with: Hypothesis Concept
disjoint with: StatisticalMethods
subclass of: Concept

Hypothesis Concept
type: Class
disjoint with: Search Methods
subclass of: Concept
disjoint with: Population Concept
disjoint with: Generic Concept
disjoint with: Intervention Concept
disjoint with: Design concept
disjoint with: Data collection analysis
disjoint with: StatisticalMethods
disjoint with: Data Collection Analysis

Search Methods
type: Class
disjoint with: Hypothesis Concept
disjoint with: Data collection analysis
disjoint with: Data Collection Analysis
disjoint with: Missing Data
disjoint with: TypeOfStudy
subclass of: Data Collection Analysis

Data Collection Analysis
type: Class
subclass of: Design concept
disjoint with: Data collection analysis
disjoint with: Search Methods
disjoint with: Hypothesis Concept

Event Entity
type: Class
disjoint with: Concurrent Situations
disjoint with: State
disjoint with: Non Concurrent Situations
subclass of: Situation

Concurrent Situations
type: Class
subclass of: Situation
comment: Descriptions of two or more situations that are concurrent
disjoint with: State
disjoint with: Event Entity
disjoint with: Non Concurrent Situations

State
type: Class
disjoint with: Event Entity
disjoint with: Concurrent Situations
disjoint with: Non Concurrent Situations
subclass of: Situation

Non Concurrent Situations
type: Class
comment: Pair of non-concurrent situations in which the duration between situations may be described.
disjoint with: Event Entity
disjoint with: Concurrent Situations
disjoint with: State
subclass of: Situation
subclass of: diagont resource:arc0fb7b12

Situation
type: Class
subclass of: Generic Concept
disjoint with: Rule Concept
disjoint with: TimeEntity

Regularly Recurring Event
type: Class
disjoint with: Single or Irregular Event
subclass of: diagont resource:arc0fb7b1
subclass of: Event Entity
subclass of: diagont resource:arc0fb7b2
comment: If the events are not exactly the same, the events must be described separately as single event. If the events are identical but the recurrence is irregular, then irregular interval between events can be individually described using NON-CONCURRENT-SITUATIONS. Alternatively, separate events occurring at specified times can be defined

Single or Irregular Event
type: Class
comment: A single event that occurs either in reference to a single (relative or absolute) timepoint or a single- or double-anchored interval, as modified by |time-operator| as necessary. Also can be an event that occurs at irregular intervals, each of which is described as a timepoint or interval.
disjoint with: Regularly Recurring Event
subclass of: diagont resource:arc0fb7b15
subclass of: Event Entity

Inclusion Rule
type: Class
disjoint with: Exclusion Rule
comment: Condition that must be met for participation in the trial
subclass of: Clinical Rule

Exclusion Rule
type: Class
subclass of: Clinical Rule
disjoint with: Inclusion Rule
comment: Condition that, if met, precludes participation in the trial.

Clinical Rule
type: Class
disjoint with: Age Gender Rule
subclass of: Rule Concept

Trial Details
type: Class
disjoint with: Concept
subclass of: Concept

Concept
type: Class
disjoint with: Trial Details

Missing Participants
type: Class
subclass of: Missing Data

Trial
type: Class
subclass of: diagont resource:arc0fb7b3
subclass of: Concept
comment: A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).

TimePoint
type: Class
comment: A point in time, defined directly here in text, or as an event-defined-timepoint, or a date-defined-timepoint. Alternatively, this timepoint can be defined in reference to a reference timepoint, by some duration before or after that reference timepoint.
subclass of: diagont resource:arc0fb7b4
subclass of: TimeEntity

Date
type: Class
disjoint with: TimeRange
comment: A point in time defined as a combination of day, month and year.
subclass of: TimeEntity

Primary Recruitment Flow Chart
type: Class
subclass of: diagont resource:arc0fb7b5
subclass of: diagont resource:arc0fb7b6
subclass of: diagont resource:arc0fb7b7
subclass of: Population Concept
comment: A representation of the number of (potential) participants in each phase of the primary trial, from screening, to enrollment, to randomization to analysis.

Recruited Population
type: Class
subclass of: Population
disjoint with: Site Enrollment
disjoint with: Excluded Population
disjoint with: Analyzed Population

Analyzed Population
type: Class
subclass of: Population
disjoint with: Excluded Population
disjoint with: Site Enrollment
disjoint with: Recruited Population

Excluded Population
type: Class
subclass of: Population
disjoint with: Site Enrollment
disjoint with: Recruited Population
disjoint with: Analyzed Population

Population Concept
type: Class
disjoint with: Intervention Concept
disjoint with: Generic Concept
disjoint with: Design concept
disjoint with: Hypothesis Concept
disjoint with: StatisticalMethods
subclass of: Concept

Age Gender Rule
type: Class
comment: Highest & Lowest range allowed in study.
subclass of: Rule Concept
disjoint with: Clinical Rule

Rule Concept
type: Class
disjoint with: TimeEntity
disjoint with: Situation
subclass of: Generic Concept

Generic Concept
type: Class
subclass of: Concept
disjoint with: Intervention Concept
disjoint with: Population Concept
disjoint with: Design concept
disjoint with: Hypothesis Concept
disjoint with: StatisticalMethods

Intervention Concept
type: Class
disjoint with: Population Concept
disjoint with: Generic Concept
disjoint with: Design concept
disjoint with: Hypothesis Concept
disjoint with: StatisticalMethods
subclass of: Concept

Hand Searching
type: Class
subclass of: Search Methods
disjoint with: Electronic Searching

Electronic Searching
type: Class
subclass of: Search Methods
disjoint with: Hand Searching

Population
type: Class
subclass of: diagont resource:arc0fb7b16
subclass of: Population Concept
disjoint with: Subgroup

Site Enrollment
type: Class
subclass of: diagont resource:arc0fb7b11
subclass of: Population Concept
disjoint with: Excluded Population
disjoint with: Analyzed Population
disjoint with: Recruited Population
comment: The number of trial participants enrolled at a site and the start and end date of enrollment.

Correction Details
type: Class
disjoint with: Stopping Details
disjoint with: Fraud Details
disjoint with: Retraction Details
disjoint with: Conclusion Details
disjoint with: Background Details
comment: Complete description of previous data, what is changed, and source (who provided and/or authorized this change)
subclass of: diagont resource:arc0fb7b8
subclass of: Trial Details

Stopping Details
type: Class
disjoint with: Conclusion Details
disjoint with: Fraud Details
disjoint with: Retraction Details
disjoint with: Background Details
disjoint with: Correction Details
subclass of: Trial Details
comment: When and why study was stopped.

Fraud Details
type: Class
disjoint with: Retraction Details
disjoint with: Background Details
disjoint with: Correction Details
disjoint with: Conclusion Details
subclass of: diagont resource:arc0fb7b13
comment: Date and source of fraud verification
disjoint with: Stopping Details
subclass of: Trial Details

Retraction Details
type: Class
comment: Description of what is retracted, if not the entire paper
disjoint with: Conclusion Details
subclass of: diagont resource:arc0fb7b14
disjoint with: Correction Details
disjoint with: Stopping Details
disjoint with: Background Details
disjoint with: Fraud Details
subclass of: Trial Details

Conclusion Details
type: Class
disjoint with: Correction Details
disjoint with: Background Details
disjoint with: Retraction Details
disjoint with: Fraud Details
disjoint with: Stopping Details
comment: The scientific conclusions that are supported by the results of this study
subclass of: Trial Details

Background Details
type: Class
subclass of: Trial Details
disjoint with: Fraud Details
disjoint with: Retraction Details
disjoint with: Stopping Details
disjoint with: Conclusion Details
disjoint with: Correction Details

CoIntervention
type: Class
comment: Treatment not under investigation that is administered concomitantly with the treatment being tested
disjoint with: Blinding Concept
subclass of: Intervention Concept

Blinding Concept
type: Class
subclass of: Intervention Concept
disjoint with: CoIntervention

Secondary Hypothesis
type: Class
disjoint with: Primary Hypothesis
subclass of: Hypothesis Concept

Primary Hypothesis
type: Class
disjoint with: Secondary Hypothesis
subclass of: Hypothesis Concept

Subgroup
type: Class
subclass of: diagont resource:arc0fb7b9
subclass of: Population Concept
subclass of: diagont resource:arc0fb7b10
comment: Definition of a subgroup, with pointers to the subgroups defined in each study arm population.
disjoint with: Population

Blinding Efficacy
type: Class
subclass of: Blinding Concept
disjoint with: Blinding
disjoint with: Blinding Methods
comment: The method used to determine how efficacious intervention blinding was, among various study subject and investigator groups.

Blinding
type: Class
disjoint with: Blinding Methods
disjoint with: Blinding Efficacy
comment: Whether an investigator, or person collecting or analyzing trial data, or otherwise affecting conduct of the trial, knows about the subjects' assigned intervention or interim trial results
subclass of: Blinding Concept

Blinding Methods
type: Class
disjoint with: Blinding
disjoint with: Blinding Efficacy
comment: How an investigator, or person collecting or analyzing trial data, or otherwise affecting conduct of the trial, is prevented from knowing the subjects' assigned intervention or interim results
subclass of: Blinding Concept

Missing Statistics
type: Class
subclass of: Missing Data

Procedure
type: Class
subclass of: Intervention Concept
comment: Execution of a surgical or other invasive action

Device
type: Class
subclass of: Trial Details

hasCheckpointDate
type: DatatypeProperty
domain: Trial
comment: This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar
range: date

hasStartDate
type: DatatypeProperty
range: date
domain: Trial
comment: This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar
type: FunctionalProperty

hasEndDate
type: DatatypeProperty
range: date
comment: This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar
domain: Trial
type: FunctionalProperty