Release 5

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4.4.1.431 ValueSet http://hl7.org/fhir/ValueSet/study-design

Clinical Decision Support icon Work Group Maturity Level: 1Trial Use Use Context: Country: World, Not yet ready for Production use
Official URL: http://hl7.org/fhir/ValueSet/study-design Version: 5.0.0
draft as of 2022-08-24 Computable Name: StudyDesign
Flags: Experimental, Immutable OID: 2.16.840.1.113883.4.642.3.3045

This value set is used in the following places:

This is a set of terms for study design characteristics.


 

This expansion generated 26 Mar 2023


This value set contains 72 concepts

Expansion based on Study Design v5.0.0 (CodeSystem)

LevelCodeSystemDisplayDefinition
1  SEVCO:01001http://hl7.org/fhir/study-designInterventional 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:01003http://hl7.org/fhir/study-designrandomized 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:01006http://hl7.org/fhir/study-designsimple 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:01007http://hl7.org/fhir/study-designstratified randomization

A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups

3      SEVCO:01008http://hl7.org/fhir/study-designblock 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:01009http://hl7.org/fhir/study-designadaptive 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:01005http://hl7.org/fhir/study-designNon-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:01004http://hl7.org/fhir/study-designQuasi-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:01029http://hl7.org/fhir/study-designClinical trial

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.

3      SEVCO:01041http://hl7.org/fhir/study-designPragmatic clinical trial

A clinical trial conducted under conditions of routine clinical practice.

3      SEVCO:01038http://hl7.org/fhir/study-designExpanded Access study

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.

3      SEVCO:01030http://hl7.org/fhir/study-designPhase 1 trial

A clinical trial to gather initial evidence in humans to support further investigation of an intervention.

4        SEVCO:01031http://hl7.org/fhir/study-designExploratory investigational new drug study

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).

3      SEVCO:01032http://hl7.org/fhir/study-designPhase 1/Phase 2 trial

A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of phase 2 trial.

3      SEVCO:01033http://hl7.org/fhir/study-designPhase 2 trial

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.

3      SEVCO:01034http://hl7.org/fhir/study-designPhase 2/Phase 3 trial

A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of phase 3 trial.

3      SEVCO:01035http://hl7.org/fhir/study-designPhase 3 Trial

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.

3      SEVCO:01036http://hl7.org/fhir/study-designPost-marketing study

A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use.

1  SEVCO:01002http://hl7.org/fhir/study-designObservational research

A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.

2    SEVCO:01037http://hl7.org/fhir/study-designPost-Marketing Surveillance study

An observational study to identify adverse events related to the use of an approved clinical intervention.

1  SEVCO:01010http://hl7.org/fhir/study-designComparative study design

A study design in which two or more groups are compared.

2    SEVCO:01011http://hl7.org/fhir/study-designParallel cohort design

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.

2    SEVCO:01012http://hl7.org/fhir/study-designCrossover cohort design

A comparative study design in which participants receive two or more alternative exposures during separate periods of time.

3      SEVCO:01024http://hl7.org/fhir/study-designControlled crossover cohort design

A crossover cohort design in which two or more cohorts have different orders of exposures.

3      SEVCO:01025http://hl7.org/fhir/study-designSingle-arm crossover design

A crossover cohort design in which all participants are in a single cohort with the same order of exposures.

2    SEVCO:01013http://hl7.org/fhir/study-designCase control design

A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).

2    SEVCO:01014http://hl7.org/fhir/study-designMatching for comparison

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.

3      SEVCO:01020http://hl7.org/fhir/study-designFamily study design

A matched study design in which related or non-related family members are compared.

4        SEVCO:01021http://hl7.org/fhir/study-designTwin study design

A family study design in which twin siblings are compared.

2    SEVCO:01015http://hl7.org/fhir/study-designCluster as unit of allocation

A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.

1  SEVCO:01023http://hl7.org/fhir/study-designNon-comparative study design

A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.

2    SEVCO:01016http://hl7.org/fhir/study-designUncontrolled cohort design

A non-comparative study design in which two or more participants are evaluated in a single group (or cohort).

2    SEVCO:01017http://hl7.org/fhir/study-designCase report

A non-comparative study design in which a single participant is evaluated.

1  SEVCO:01022http://hl7.org/fhir/study-designPopulation-based design

A study design in which the unit of observation is a population or community.

2    SEVCO:01044http://hl7.org/fhir/study-designEcological design

A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings.

1  SEVCO:01027http://hl7.org/fhir/study-designCross sectional data collection

A study design process in which data is collected at a single point in time.

1  SEVCO:01028http://hl7.org/fhir/study-designLongitudinal data collection

A study design process in which data is collected at two or more points in time.

2    SEVCO:01018http://hl7.org/fhir/study-designTime series design

A longitudinal data collection which includes a set of time-ordered observations.

3      SEVCO:01019http://hl7.org/fhir/study-designBefore and after comparison

A time series design which includes comparisons of observations before and after an event or exposure.

1  SEVCO:01045http://hl7.org/fhir/study-designPrimary data collection

A study design process in which the data are recorded and collected during the study for the purpose of the same study.

1  SEVCO:01026http://hl7.org/fhir/study-designReal 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.

2    SEVCO:01039http://hl7.org/fhir/study-designReal world data collection from healthcare records

Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional.

2    SEVCO:01050http://hl7.org/fhir/study-designReal world data collection from personal health records

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.

2    SEVCO:01040http://hl7.org/fhir/study-designReal world data collection from healthcare financing records

Real world data collection from data obtained routinely for a purpose of recording healthcare financing.

2    SEVCO:01048http://hl7.org/fhir/study-designReal world data collection from testing procedures

Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination.

3      SEVCO:01046http://hl7.org/fhir/study-designReal world data collection from monitoring procedures

Real world data collection from data obtained routinely for a purpose of repeated testing.

1  SEVCO:01049http://hl7.org/fhir/study-designSecondary 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.

1  SEVCO:01042http://hl7.org/fhir/study-designSecondary 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.

1  SEVCO:01051http://hl7.org/fhir/study-designMultisite data collection

A study design process in which data are collected from two or more geographic locations.

1  SEVCO:01086http://hl7.org/fhir/study-designQuantitative analysis

A study design process in which data are analyzed with mathematical or statistical methods and formulas.

1  SEVCO:01087http://hl7.org/fhir/study-designQualitative 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.

1  SEVCO:01060http://hl7.org/fhir/study-designBlinding of study participants

A study design process in which study participants are not informed of their intervention assignment.

1  SEVCO:01061http://hl7.org/fhir/study-designBlinding of intervention providers

A study design process in which the people administering the intervention are not informed of the intervention assignment.

1  SEVCO:01062http://hl7.org/fhir/study-designBlinding of outcome assessors

A study design process in which the people determining the outcome are not informed of the intervention assignment.

1  SEVCO:01063http://hl7.org/fhir/study-designBlinding 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.

1  SEVCO:01064http://hl7.org/fhir/study-designAllocation 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.

1  SEVCO:01043http://hl7.org/fhir/study-designMulticentric

A study design feature in which two or more institutions are responsible for the conduct of the study.

1  SEVCO:01052http://hl7.org/fhir/study-designIncludes 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.

1  SEVCO:01053http://hl7.org/fhir/study-designIncludes 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.

1  SEVCO:01054http://hl7.org/fhir/study-designIncludes 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.

1  SEVCO:01085http://hl7.org/fhir/study-designIncludes process measure

A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.

1  SEVCO:01089http://hl7.org/fhir/study-designStudy Goal

A study design feature specifying the intent of the study.

2    SEVCO:01096http://hl7.org/fhir/study-designEvaluation Goal

A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.

2    SEVCO:01097http://hl7.org/fhir/study-designDerivation Goal

A study goal with the intent to generate a predictive algorithm.

2    SEVCO:01098http://hl7.org/fhir/study-designValidation Goal

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.

2    SEVCO:01088http://hl7.org/fhir/study-designComparison Goal

A study design feature in which the study intent is to compare two or more interventions or exposures.

3      SEVCO:01091http://hl7.org/fhir/study-designComparative Effectiveness Goal

A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms.

4        SEVCO:01090http://hl7.org/fhir/study-designComparative Efficacy Goal

A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.

4        SEVCO:01092http://hl7.org/fhir/study-designComparative Safety Goal

A study design feature in which the study intent is to compare two or more interventions with respect to harms.

3      SEVCO:01093http://hl7.org/fhir/study-designEquivalence Goal

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.

3      SEVCO:01094http://hl7.org/fhir/study-designNon-inferiority Goal

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.

3      SEVCO:01095http://hl7.org/fhir/study-designSuperiority Goal

A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects.

 

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LvlA few code lists that FHIR defines are hierarchical - each code is assigned a level. For value sets, levels are mostly used to organize codes for user convenience, but may follow code system hierarchy - see Code System for further information
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