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 collection analysis
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.
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
Condition that must be met for participation in the trial
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).
Concept
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.
A representation of the number of (potential) participants in each phase of the primary trial, from screening, to enrollment, to randomization to analysis.
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
Complete description of previous data, what is changed, and source (who provided and/or authorized this change)
Treatment not under investigation that is administered concomitantly with the treatment being tested
Highest & Lowest range allowed in study.
Definition of a subgroup, with pointers to the subgroups defined in each study arm population.
Design concept
The method used to determine how efficacious intervention blinding was, among various study subject and investigator groups.
Execution of a surgical or other invasive action
A point in time defined as a combination of day, month and year.
The number of trial participants enrolled at a site and the start and end date of enrollment.
Pair of non-concurrent situations in which the duration between situations may be described.
Description of what is retracted, if not the entire paper
The scientific conclusions that are supported by the results of this study
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.
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.
Condition that, if met, precludes participation in the trial.
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
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
Descriptions of two or more situations that are concurrent
This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar