2.0
The scientific conclusions that are supported by the results of this study
Conclusion Details
Secondary Study
Additional investigation pertaining the same interventions as the primary study.
Clinical Rule
Kaplan Meier Time Point
Non Concurrent Situations
Pair of non-concurrent situations in which the duration between situations may be described.
Some Kind Of Drug
The withholding of any treatment
No Treatment
Trial Design
Primary Outcome
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.
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.
Data Extraction Management
Search Methods
Some Second Kind Of Drug
Selective Reporting Risk
Drug Step
A discrete unit of administration of a drug treatment that ends after a specified time or when a specified state is reached.
Treatment not under investigation that is administered concomitantly with the treatment being tested
CoIntervention
Method used to quality adjust life years, if applicable.
Life Year
Blinding Risk
Description of what is retracted, if not the entire paper
Retraction Details
Subgroup
Definition of a subgroup, with pointers to the subgroups defined in each study arm population.
Condition that must be met for participation in the trial
Inclusion Rule
Highest & Lowest range allowed in study.
Age Gender Rule
Usual Care
The treatment administered before enrollment in the trial and continued during the trial.
Allocation Risk
Selection Of Studies
The method used to apply the selection criteria. Whether they are applied independently by more than one author should be stated, along with how any disagreements are resolved.
Concept
Design concept
Device
Condition that, if met, precludes participation in the trial.
Exclusion Rule
How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules
Sample Size Calculation
Data Point Population
The numerators and denominators of the results of an outcome assessed at a particular timepoint. The denominators reflect the degree of followup and outcome assessment achieved in this trial. This class is used for both main and subgroup populations. Crossover population datapoints should use DATAPOINT-OF-CROSSOVER-POP
Outcome Not Assessed
Smallest Unit
Description of the smallest unit that is being analyzed to assess intervention effects (e.g., individual, group, or community)
Study Outcome
Regularly Recurring Event
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
Missing Statistics
Follow Up Compliance
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.
Assesment Risk Bias
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.
Procedure
Execution of a surgical or other invasive action
Data collection analysis
Event Entity
Electronic Searching
Sensitivity Analysis
This should describe analyses aimed at determining whether conclusions are robust to decisions made during the review process, such as inclusion/exclusion of particular studies from a meta-analysis, imputing missing data or choice of a method for analysis.
Restriction
Method used to assign units to study conditions, including details of any restriction (e.g., blocking, stratification, minimization)
Special Variable Information
Hypothesis Concept
The actual number of people in this blindee group who did not guess at the study population's assigned treatment.
Blinding Efficacy Data Point
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.
Side Effect
The lower confidence interval for this summary. The % interval is in confidence-interval-percent in STATISTICAL-ANALYSIS-AND-RESULTS for this outcome.
Summary Data Point
Category
Stopping Details
When and why study was stopped.
State
Methods to Minimize Bias
Inclusion of aspects employed to help minimize potential bias induced due to nonrandomization (e.g., matching)
Clinical Heterogeneity
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 secondary interest for the trial to show efficacy of the experimental treatment.
Secondary Outcome
The number of people in this population taking this cointervention.
Cointervention Data Point
Scored Instrument
Summary of other analyses performed, including subgroup or restricted analyses, indicating which are prespecified or exploratory
Ancilliary Outcome
Background Details
Potential Sources Bias Risk
Trial Details
Protocol Change
Amendment of the original objective(s), design, methodology, statistical analysis, or organization of the trial.
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).
Intervention Step
Result Entity
Drug With Some Bad Effect
Not Enrolled
the unit being assigned to study condition, e.g., individual, group, community
Unit Of Assignment
The categories for the categorical variable, assumed to be in the order in which they were entered.
Categorical
Single Time X Comparison
Pointers to the data for each group for this timepoint and this outcome, as well as to the ITT and efficacy analysis summaries (e.g., OR and 95% c.i.)
Missing Participants
how were subjects grouped during delivery?
Unit of delivery
Withdrawal Reason
Why a group of participants withdrew from the trial.
Random Effects Model
Descriptions of two or more situations that are concurrent
Concurrent Situations
Range
Heterogeneity
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
Miscellaneous Outcome Entity
Population Concept
Adjusting Different in Units
If the unit of analysis differs from the unit of assignment, the analytical method used to account for this (e.g., adjusting the standard error estimates by the design effect or using multilevel analysis)
Recruited Population
Data Collection Description
Baseline
A characteristic of the study population evaluated at the beginning of the trial.
Cost
Description of the references used to define an outcome variable of type cost.
Data Point Entity
Activities to Increase Compliance
Activities to increase compliance or adherence (e.g., incentives)
Statistical Heterogeneity
Content
what was given?
who delivered the intervention?
Deliverer
Blinding Efficacy
The method used to determine how efficacious intervention blinding was, among various study subject and investigator groups.
The process of assigning participants to interventions, also called treatment allocation.
Treatment Assignment
Primary Hypothesis
Correction Details
Complete description of previous data, what is changed, and source (who provided and/or authorized this change)
A point in time defined as a combination of day, month and year.
Situation
The actual value of this baseline characteristic for this population.
Baseline Data Point
Rate
Not Eligible
Missing Data
A discrete unit of administration of a non-drug treatment that ends after a specified time or when a specified state is reached.
Non Drug Intervention Step
Setting
where was the intervention delivered?
Secondary Hypothesis
Time Span
how long was it intended to take to deliver the intervention to each unit?
Survival Analysis And Results Entity
Site Enrollment
The number of trial participants enrolled at a site and the start and end date of enrollment.
Protocol Concept
Hand Searching
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.
Single or Irregular Event
Fixed Effect Model
Rule Concept
Reason
Primary Recruitment Flow Chart
A representation of the number of (potential) participants in each phase of the primary trial, from screening, to enrollment, to randomization to analysis.
Generic Concept
Statistical Analysis And Results
Action(s) carried out by qualified personnel to verify and evaluate trial participants' adherence and response to experimental and comparison treatments.
Follow Up Activity
Analyzed Population
Blinding Concept
Text statement of study objective
Study Objective
Settings and locations where the data were collected
Recruitment Setting
Intervention
Delivery Method
how was the content given?
Blinding
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
Excluded Population
Kaplan Meier Data Point
Population
Subgroup Regression
Intervention Concept
Drug
ClinicalIntervention
All Comparisons At Time X
The results in each study population group (e.g., control arm) for a particular outcome at a particular time, e.g., death at six months. If the duration from the reference timepoint is zero, then these are baseline data.
Off Assigned Intervention
Outcome Concept
Outcome Type
Data Synthesis
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.
how many sessions or episodes or events were intended to be delivered? How long were they intended to last?
Exposure Quantity and Duration
Incomplete Data Risk
Outcome Value Entity
Follow Up
Information about followup in this study, including the date of last followup of a subject (|complete-fu-date|) for any trial-related activity, and the maximum duration of followup in the whole trial. The |follow-up-activity| slot points to one or more descriptions of activities, e.g,. N-ECHO if all groups undergo the same echo followup , or N-ENDOSCOPY-CONTROL and N-ENDOSCOPY-EXPERIMENTAL if the experimental and control groups have a different schedule of endoscopy followup.
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
Blinding Methods
This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar
This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar
This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar