StudyDesign

Study Design

activecomplete72 conceptsv5.0.0

This is a set of terms for study design characteristics.

Metadata

hl7.org/fhir
Canonical URL
http://hl7.org/fhir/study-design
All-Codes Value Set
http://hl7.org/fhir/ValueSet/study-design
ID
study-design
Version
5.0.0
Publisher
HL7 (FHIR Project)
Case Sensitive
Yes
Hierarchy Meaning
is-a
In the unified registry

Concepts (72)

SEVCO:01001(3)
Interventional research
A study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by the investigator to evaluate a response in the dependent variable (an effect or outcome).
SEVCO:01002(1)
Observational research
A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.
SEVCO:01010(5)
Comparative study design
A study design in which two or more groups are compared.
SEVCO:01023(2)
Non-comparative study design
A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.
SEVCO:01022(1)
Population-based design
A study design in which the unit of observation is a population or community.
SEVCO:01027
Cross sectional data collection
A study design process in which data is collected at a single point in time.
SEVCO:01028(1)
Longitudinal data collection
A study design process in which data is collected at two or more points in time.
SEVCO:01045
Primary data collection
A study design process in which the data are recorded and collected during the study for the purpose of the same study.
SEVCO:01026(4)
Real world data collection
A study design process in which the study data are obtained from a source of data collected during a routine process in the natural environment rather than using a process designed or controlled by the researcher.
SEVCO:01049
Secondary data collection from prior research
A study design process in which the data are collected from data obtained during a different study than the current study.
SEVCO:01042
Secondary data collection from a registry
A study design process in which the data are collected from a system organized to obtain and maintain uniform data for discovery and analysis, and this system is organized prior to the current study.
SEVCO:01051
Multisite data collection
A study design process in which data are collected from two or more geographic locations.
SEVCO:01086
Quantitative analysis
A study design process in which data are analyzed with mathematical or statistical methods and formulas.
SEVCO:01087
Qualitative analysis
A study design process in which data are analyzed, without primary reliance on mathematical or statistical techniques, by coding and organizing data to provide interpretation or understanding of experiences or hypotheses.
SEVCO:01060
Blinding of study participants
A study design process in which study participants are not informed of their intervention assignment.
SEVCO:01061
Blinding of intervention providers
A study design process in which the people administering the intervention are not informed of the intervention assignment.
SEVCO:01062
Blinding of outcome assessors
A study design process in which the people determining the outcome are not informed of the intervention assignment.
SEVCO:01063
Blinding of data analysts
A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment.
SEVCO:01064
Allocation concealment
A study design process in which all parties influencing study enrollment and allocation to study groups are unaware of the group assignment for the study participant at the time of enrollment and allocation.
SEVCO:01043
Multicentric
A study design feature in which two or more institutions are responsible for the conduct of the study.
SEVCO:01052
Includes patient-reported outcome
A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.
SEVCO:01053
Includes patient-centered outcome
A study design feature in which one or more measures are outcomes that patients directly care about, i.e. outcomes that are directly related to patients' experience of their life.
SEVCO:01054
Includes disease-oriented outcome
A study design feature in which one or more measures are outcomes that relate to a health or illness condition but are not outcomes which patients directly care about.
SEVCO:01085
Includes process measure
A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.
SEVCO:01089(4)
Study Goal
A study design feature specifying the intent of the study.