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

Clinical Decision Support icon Work Group Maturity Level: 1Trial Use Use Context: Not yet ready for Production use, Not yet ready for Production use

This is a value set defined by the FHIR project.

Summary

Defining URL:http://hl7.org/fhir/ValueSet/study-design
Version:5.0.0-ballot
Name:StudyDesign
Title:Study Design
Status:draft
Definition:

This is a set of terms for study design characteristics.

Committee:Clinical Decision Support icon Work Group
OID:2.16.840.1.113883.4.642.3.3045 (for OID based terminology systems)
Flags:Experimental, Immutable

This value set is used in the following places:


 

This expansion generated 10 Sep 2022


This value set contains 72 concepts

Expansion based on ResearchStudy Classifiers Code System v5.0.0-ballot (CodeSystem)

LevelCodeSystemDisplayDefinition
1  SEVCO:01001http://hl7.org/fhir/research-study-classifiersInterventional 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/research-study-classifiersrandomized 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/research-study-classifierssimple 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/research-study-classifiersstratified 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/research-study-classifiersblock 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/research-study-classifiersadaptive 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/research-study-classifiersNon-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/research-study-classifiersQuasi-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/research-study-classifiersClinical 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/research-study-classifiersPragmatic clinical trial

A clinical trial conducted under conditions of routine clinical practice.

3      SEVCO:01038http://hl7.org/fhir/research-study-classifiersExpanded 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/research-study-classifiersPhase 1 trial

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

4        SEVCO:01031http://hl7.org/fhir/research-study-classifiersExploratory 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/research-study-classifiersPhase 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/research-study-classifiersPhase 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/research-study-classifiersPhase 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/research-study-classifiersPhase 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/research-study-classifiersPost-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/research-study-classifiersObservational 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/research-study-classifiersPost-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/research-study-classifiersComparative study design

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

2    SEVCO:01011http://hl7.org/fhir/research-study-classifiersParallel 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/research-study-classifiersCrossover 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/research-study-classifiersControlled crossover cohort design

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

3      SEVCO:01025http://hl7.org/fhir/research-study-classifiersSingle-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/research-study-classifiersCase 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/research-study-classifiersMatching 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/research-study-classifiersFamily study design

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

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

A family study design in which twin siblings are compared.

2    SEVCO:01015http://hl7.org/fhir/research-study-classifiersCluster 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/research-study-classifiersNon-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/research-study-classifiersUncontrolled 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/research-study-classifiersCase report

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

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

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

2    SEVCO:01044http://hl7.org/fhir/research-study-classifiersEcological 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/research-study-classifiersCross sectional data collection

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

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

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

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

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

3      SEVCO:01019http://hl7.org/fhir/research-study-classifiersBefore 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/research-study-classifiersPrimary 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/research-study-classifiersReal 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/research-study-classifiersReal 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/research-study-classifiersReal 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/research-study-classifiersReal 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/research-study-classifiersReal 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/research-study-classifiersReal 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/research-study-classifiersSecondary 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/research-study-classifiersSecondary 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/research-study-classifiersMultisite data collection

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

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

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

1  SEVCO:01087http://hl7.org/fhir/research-study-classifiersQualitative 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/research-study-classifiersBlinding of study participants

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

1  SEVCO:01061http://hl7.org/fhir/research-study-classifiersBlinding 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/research-study-classifiersBlinding 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/research-study-classifiersBlinding 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/research-study-classifiersAllocation 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/research-study-classifiersMulticentric

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

1  SEVCO:01052http://hl7.org/fhir/research-study-classifiersIncludes 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/research-study-classifiersIncludes 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/research-study-classifiersIncludes 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/research-study-classifiersIncludes 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/research-study-classifiersStudy Goal

A study design feature specifying the intent of the study.

2    SEVCO:01096http://hl7.org/fhir/research-study-classifiersEvaluation 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/research-study-classifiersDerivation Goal

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

2    SEVCO:01098http://hl7.org/fhir/research-study-classifiersValidation 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/research-study-classifiersComparison 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/research-study-classifiersComparative 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/research-study-classifiersComparative 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/research-study-classifiersComparative 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/research-study-classifiersEquivalence 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/research-study-classifiersNon-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/research-study-classifiersSuperiority Goal

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

 

See the full registry of value sets defined as part of FHIR.


Explanation of the columns that may appear on this page:

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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