study-design
type: CodeSystem
node role: treeRoot
id:
  v: study-design
text:
  status:
    v: generated
  div:
    v: This code system http://hl7.org/fhir/study-design defines the following codes: Lvl Code Display Definition 1 SEVCO:01001 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). 2 SEVCO:01003 randomized assignment An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups. 3 SEVCO:01006 simple randomization A randomized assignment in which each participant has the same prespecified likelihood of being assigned to a group as all other participants, independent of the assignment of any other participant. 3 SEVCO:01007 stratified randomization A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups 3 SEVCO:01008 block randomization A randomized assignment in which a pre-specified number of subjects is assigned to a block containing the same pre-specified ratio of group assignments in random order. 3 SEVCO:01009 adaptive randomization A randomized assignment in which a participant’s group assignment probability is adjusted based on any factor such that the likelihood of assignment is not the same for all participants. 2 SEVCO:01005 Non-randomized assignment An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by methods other than random chance to separate groups. 3 SEVCO:01004 Quasi-Randomized assignment An interventional study design with a method of allocation that is not limited to random chance but is intended to produce similar baseline groups for experimentation. 2 SEVCO:01029 Clinical trial Interventional research in which one or more healthcare-related actions (i.e., a diagnostic, prognostic, therapeutic, pr…
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 1
extension:
  extension:
    url:
      v: packageId
      l: packageId
    value: Id
      v: hl7.fhir.uv.xver-r5.r4
  extension:
    url:
      v: version
      l: version
    value: String
      v: 0.1.0
  extension:
    url:
      v: uri
      l: uri
    value: Uri
      v: http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r4
      l: hl7.fhir.uv.xver-r5.r4
  url:
    v: http://hl7.org/fhir/StructureDefinition/package-source
    l: package-source
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: cds
url:
  v: http://hl7.org/fhir/study-design
  l: study-design
version:
  v: 5.0.0
name:
  v: StudyDesign
title:
  v: Study Design
status:
  v: active
experimental:
  v: false
date:
  v: 2020-12-27T23:55:11-06:00
publisher:
  v: Clinical Decision Support
contact:
  name:
    v: Clinical Decision Support
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/dss
description:
  v: This is a set of terms for study design characteristics.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
case sensitive:
  v: true
value set:
  v: http://hl7.org/fhir/ValueSet/study-design
  l: study-design
hierarchy meaning:
  v: is-a
content:
  v: complete
concept:
  code:
    v: SEVCO:01001
  display:
    v: Interventional research
  definition:
    v: 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).
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Interventional study
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Interventional study design
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: interventional primary research
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: international method of research
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: experimental research
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: experimental study
  concept:
    code:
      v: SEVCO:01003
    display:
      v: randomized assignment
    definition:
      v: An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups.
    designation:
      value:
        v: Interventional research with randomized assignment
    designation:
      value:
        v: Randomized trial
    designation:
      value:
        v: Randomized controlled trial
    designation:
      value:
        v: RCT
    concept:
      code:
        v: SEVCO:01006
      display:
        v: simple randomization
      definition:
        v: A randomized assignment in which each participant has the same prespecified likelihood of being assigned to a group as all other participants, independent of the assignment of any other participant.
    concept:
      code:
        v: SEVCO:01007
      display:
        v: stratified randomization
      definition:
        v: A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups
    concept:
      code:
        v: SEVCO:01008
      display:
        v: block randomization
      definition:
        v: A randomized assignment in which a pre-specified number of subjects is assigned to a block containing the same pre-specified ratio of group assignments in random order.
    concept:
      code:
        v: SEVCO:01009
      display:
        v: adaptive randomization
      definition:
        v: A randomized assignment in which a participant’s group assignment probability is adjusted based on any factor such that the likelihood of assignment is not the same for all participants.
  concept:
    code:
      v: SEVCO:01005
    display:
      v: Non-randomized assignment
    definition:
      v: An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by methods other than random chance to separate groups.
    designation:
      value:
        v: Interventional research with non-randomized assignment
    concept:
      code:
        v: SEVCO:01004
      display:
        v: Quasi-Randomized assignment
      definition:
        v: An interventional study design with a method of allocation that is not limited to random chance but is intended to produce similar baseline groups for experimentation.

v: Alternative term

v: Alternative term

v: Alternative term

v: Alternative term

display:
  v: Alternative term

v: Unrestricted Randomization

v: Alternative term

code:
  v: SEVCO:01029
display:
  v: Clinical trial
definition:
  v: Interventional research in which one or more healthcare-related actions (i.e., a diagnostic, prognostic, therapeutic, preventive or screening method or intervention) is evaluated for effects on health-related biomedical or behavioral processes and/or outcomes.
concept:
  code:
    v: SEVCO:01041
  display:
    v: Pragmatic clinical trial
  definition:
    v: A clinical trial conducted under conditions of routine clinical practice.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Pragmatic trial
concept:
  code:
    v: SEVCO:01038
  display:
    v: Expanded Access study
  definition:
    v: A clinical trial that provides a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Compassionate use trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Compassionate use study
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Expanded access trial
concept:
  code:
    v: SEVCO:01030
  display:
    v: Phase 1 trial
  definition:
    v: A clinical trial to gather initial evidence in humans to support further investigation of an intervention.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase I trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase 1 study
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: phase I clinical trial
  concept:
    code:
      v: SEVCO:01031
    display:
      v: Exploratory investigational new drug study
    definition:
      v: A clinical trial that is conducted early in phase 1, involves very limited human exposure, and has no therapeutic or diagnostic intent (e.g., screening studies, microdose studies).
    designation:
      value:
        v: Phase 0 study
    designation:
      value:
        v: Pre-clinical trial
    designation:
      value:
        v: Exploratory IND study
concept:
  code:
    v: SEVCO:01032
  display:
    v: Phase 1/Phase 2 trial
  definition:
    v: A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of phase 2 trial.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase I/II trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase 1-2 trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase 1/2 trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Trial phase 1-2
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Trial phase 1/2
concept:
  code:
    v: SEVCO:01033
  display:
    v: Phase 2 trial
  definition:
    v: A clinical trial to gather evidence of effectiveness and safety for an intervention in patients with the disease or condition under study, but not intended to provide an adequate basis for regulatory approval for clinical use.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase II trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: phase 2 study
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Exploratory clinical study
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: phase II clinical trial
concept:
  code:
    v: SEVCO:01034
  display:
    v: Phase 2/Phase 3 trial
  definition:
    v: A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of phase 3 trial.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase II/III trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase 2-3 trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase 2/3 trial
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Trial phase 2-3
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Trial phase 2/3
concept:
  code:
    v: SEVCO:01035
  display:
    v: Phase 3 Trial
  definition:
    v: A clinical trial to gather the evidence of effectiveness and safety of an intervention, intended to provide an adequate basis for regulatory approval for clinical use.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Phase III trial

v: Alternative term

v: Alternative term

v: Alternative term

use:
  display:
    v: Alternative term
value:
  v: phase 3 study

use:
  display:
    v: Alternative term
value:
  v: Confirmatory clinical study

use:
  display:
    v: Alternative term
value:
  v: phase III clinical trial

code:
  v: SEVCO:01036
display:
  v: Post-marketing study
definition:
  v: A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Phase IV trial
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Phase 4 trial
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Phase 4 study
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Trial phase 4
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Post-approval study

code:
  v: SEVCO:01002
display:
  v: Observational research
definition:
  v: A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Observational Study
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Observational Study Design
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Observational primary research
designation:
  use:
    display:
      v: Alternative term
  value:
    v: observational method of research
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Non-interventional research
concept:
  code:
    v: SEVCO:01037
  display:
    v: Post-Marketing Surveillance study
  definition:
    v: An observational study to identify adverse events related to the use of an approved clinical intervention.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Postmarketing evaluation study

code:
  v: SEVCO:01010
display:
  v: Comparative study design
definition:
  v: A study design in which two or more groups are compared.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Comparative research
concept:
  code:
    v: SEVCO:01011
  display:
    v: Parallel cohort design
  definition:
    v: A comparative study design in which the groups are compared concurrently and participants are expected to remain in the groups being compared for the entire duration of participation in the study.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Concurrent cohort study
concept:
  code:
    v: SEVCO:01012
  display:
    v: Crossover cohort design
  definition:
    v: A comparative study design in which participants receive two or more alternative exposures during separate periods of time.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Crossover study
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Crossover trial
  concept:
    code:
      v: SEVCO:01024
    display:
      v: Controlled crossover cohort design
    definition:
      v: A crossover cohort design in which two or more cohorts have different orders of exposures.
  concept:
    code:
      v: SEVCO:01025
    display:
      v: Single-arm crossover design
    definition:
      v: A crossover cohort design in which all participants are in a single cohort with the same order of exposures.
concept:
  code:
    v: SEVCO:01013
  display:
    v: Case control design
  definition:
    v: A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).
concept:
  code:
    v: SEVCO:01014
  display:
    v: Matching for comparison
  definition:
    v: A comparative study design in which individual participants in different groups being compared are paired or matched into sets based on selected attributes for within-set analysis.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Matched study design
  concept:
    code:
      v: SEVCO:01020
    display:
      v: Family study design
    definition:
      v: A matched study design in which related or non-related family members are compared.
    designation:
      value:
        v: Familial study
    designation:
      value:
        v: Family study
    designation:
      value:
        v: Family based study
    concept:
      code:
        v: SEVCO:01021
      display:
        v: Twin study design
      definition:
        v: A family study design in which twin siblings are compared.
concept:
  code:
    v: SEVCO:01015
  display:
    v: Cluster as unit of allocation
  definition:
    v: A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Clustering for comparison

v: Alternative term

v: Alternative term

v: Alternative term

code:
  v: SEVCO:01023
display:
  v: Non-comparative study design
definition:
  v: A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Non-comparative research
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Descriptive study
concept:
  code:
    v: SEVCO:01016
  display:
    v: Uncontrolled cohort design
  definition:
    v: A non-comparative study design in which two or more participants are evaluated in a single group (or cohort).
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Single cohort design
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Case series design
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Non-controlled cohort design
concept:
  code:
    v: SEVCO:01017
  display:
    v: Case report
  definition:
    v: A non-comparative study design in which a single participant is evaluated.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Case study

code:
  v: SEVCO:01022
display:
  v: Population-based design
definition:
  v: A study design in which the unit of observation is a population or community.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Population study
concept:
  code:
    v: SEVCO:01044
  display:
    v: Ecological design
  definition:
    v: A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Ecologic study

code:
  v: SEVCO:01027
display:
  v: Cross sectional data collection
definition:
  v: A study design process in which data is collected at a single point in time.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Cross-sectional study

code:
  v: SEVCO:01028
display:
  v: Longitudinal data collection
definition:
  v: A study design process in which data is collected at two or more points in time.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Longitudinal study
concept:
  code:
    v: SEVCO:01018
  display:
    v: Time series design
  definition:
    v: A longitudinal data collection which includes a set of time-ordered observations.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Multiple time point comparison
  concept:
    code:
      v: SEVCO:01019
    display:
      v: Before and after comparison
    definition:
      v: A time series design which includes comparisons of observations before and after an event or exposure.
    designation:
      value:
        v: Before and After design
    designation:
      value:
        v: Pre-Post Design
    designation:
      value:
        v: Before-After Comparison

v: Alternative term

v: Alternative term

v: Alternative term

code:
  v: SEVCO:01045
display:
  v: Primary data collection
definition:
  v: A study design process in which the data are recorded and collected during the study for the purpose of the same study.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Study-generated data collection

code:
  v: SEVCO:01026
display:
  v: Real world data collection
definition:
  v: 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.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: RWD collection
concept:
  code:
    v: SEVCO:01039
  display:
    v: Real world data collection from healthcare records
  definition:
    v: Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: RWD collection from clinical care records
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: RWD from health care records
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: RWD from healthcare delivery records
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Real world data collection from medical records
concept:
  code:
    v: SEVCO:01050
  display:
    v: Real world data collection from personal health records
  definition:
    v: Real world data collection from data obtained routinely for a purpose of recording data related to personal health in a record controlled by the person, guardian, or caretaker.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Real world data collection from personal care records
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: RWD collection from personal medical records
concept:
  code:
    v: SEVCO:01040
  display:
    v: Real world data collection from healthcare financing records
  definition:
    v: Real world data collection from data obtained routinely for a purpose of recording healthcare financing.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: RWD collection from healthcare financing records
concept:
  code:
    v: SEVCO:01048
  display:
    v: Real world data collection from testing procedures
  definition:
    v: Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: RWD collection from testing procedures
  concept:
    code:
      v: SEVCO:01046
    display:
      v: Real world data collection from monitoring procedures
    definition:
      v: Real world data collection from data obtained routinely for a purpose of repeated testing.
    designation:
      value:
        v: RWD collection from monitoring procedures

v: Alternative term

code:
  v: SEVCO:01049
display:
  v: Secondary data collection from prior research
definition:
  v: A study design process in which the data are collected from data obtained during a different study than the current study.

code:
  v: SEVCO:01042
display:
  v: Secondary data collection from a registry
definition:
  v: 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.

code:
  v: SEVCO:01051
display:
  v: Multisite data collection
definition:
  v: A study design process in which data are collected from two or more geographic locations.

code:
  v: SEVCO:01086
display:
  v: Quantitative analysis
definition:
  v: A study design process in which data are analyzed with mathematical or statistical methods and formulas.

code:
  v: SEVCO:01087
display:
  v: Qualitative analysis
definition:
  v: 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.

code:
  v: SEVCO:01060
display:
  v: Blinding of study participants
definition:
  v: A study design process in which study participants are not informed of their intervention assignment.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Masking of study participants

code:
  v: SEVCO:01061
display:
  v: Blinding of intervention providers
definition:
  v: A study design process in which the people administering the intervention are not informed of the intervention assignment.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Masking of intervention providers
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Blinding of intervention deliverers
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Masking of intervention deliverers

code:
  v: SEVCO:01062
display:
  v: Blinding of outcome assessors
definition:
  v: A study design process in which the people determining the outcome are not informed of the intervention assignment.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Masking of outcome assessors

code:
  v: SEVCO:01063
display:
  v: Blinding of data analysts
definition:
  v: A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Masking of data analysts

code:
  v: SEVCO:01064
display:
  v: Allocation concealment
definition:
  v: 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.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Blinding of randomization assignment
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Masking of randomization assignment

code:
  v: SEVCO:01043
display:
  v: Multicentric
definition:
  v: A study design feature in which two or more institutions are responsible for the conduct of the study.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Multi-institutional study
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Multicenter trial
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Multicenter study

code:
  v: SEVCO:01052
display:
  v: Includes patient-reported outcome
definition:
  v: A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: PRO
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes patient-reported outcomes

code:
  v: SEVCO:01053
display:
  v: Includes patient-centered outcome
definition:
  v: 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.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes patient-oriented outcome
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes patient-important outcome
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes patient-relevant outcome
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes clinical outcome
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes patient-centered outcome measure
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes clinical outcome measure

code:
  v: SEVCO:01054
display:
  v: Includes disease-oriented outcome
definition:
  v: 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.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes disease-oriented outcome measure
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes surrogate outcome
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes surrogate outcome measure

code:
  v: SEVCO:01085
display:
  v: Includes process measure
definition:
  v: A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes process outcome
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Includes process outcome measure

code:
  v: SEVCO:01089
display:
  v: Study Goal
definition:
  v: A study design feature specifying the intent of the study.
designation:
  use:
    display:
      v: Alternative term
  value:
    v: Study Aim
concept:
  code:
    v: SEVCO:01096
  display:
    v: Evaluation Goal
  definition:
    v: A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Evaluation Study Goal
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Evaluation Aim
concept:
  code:
    v: SEVCO:01097
  display:
    v: Derivation Goal
  definition:
    v: A study goal with the intent to generate a predictive algorithm.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Derivation Study Goal
concept:
  code:
    v: SEVCO:01098
  display:
    v: Validation Goal
  definition:
    v: A study goal with the intent to determine the reliability and/or performance of a procedure for a specific predictive, classification, measurement, or communication purpose.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Validation Study Goal
concept:
  code:
    v: SEVCO:01088
  display:
    v: Comparison Goal
  definition:
    v: A study design feature in which the study intent is to compare two or more interventions or exposures.
  designation:
    use:
      display:
        v: Alternative term
    value:
      v: Comparative Analysis Goal
  concept:
    code:
      v: SEVCO:01091
    display:
      v: Comparative Effectiveness Goal
    definition:
      v: A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms.
    concept:
      code:
        v: SEVCO:01090
      display:
        v: Comparative Efficacy Goal
      definition:
        v: A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.
    concept:
      code:
        v: SEVCO:01092
      display:
        v: Comparative Safety Goal
      definition:
        v: A study design feature in which the study intent is to compare two or more interventions with respect to harms.
  concept:
    code:
      v: SEVCO:01093
    display:
      v: Equivalence Goal
    definition:
      v: A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is within a prespecified range representing absence of a meaningful difference.
  concept:
    code:
      v: SEVCO:01094
    display:
      v: Non-inferiority Goal
    definition:
      v: A study goal with the intent to compare two or more interventions or exposures and determine that any difference in effects is below a prespecified value representing a threshold between a meaningful difference and absence of a meaningful difference.
  concept:
    code:
      v: SEVCO:01095
    display:
      v: Superiority Goal
    definition:
      v: A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects.
    designation:
      value:
        v: Superiority study goal

v: Alternative term