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