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

Clinical Decision Support icon Work Group  Maturity Level: 1 Trial Use Use Context: Country: World, Not yet ready for Production use
Official URL: http://hl7.org/fhir/ValueSet/study-design Version: 6.0.0-ballot2
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.


Generated Narrative: ValueSet study-design

Last updated: 2024-11-12T02:57:08Z

Profile: Shareable ValueSet

 

This expansion generated 12 Nov 2024


Generated Narrative: ValueSet

Last updated: 2024-11-12T02:57:08Z

Profile: Shareable ValueSet

Expansion based on codesystem Study Design v6.0.0-ballot2 (CodeSystem)

This value set contains 72 concepts

LevelCodeSystemDisplayDefinition
1   SEVCO:01001 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design 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 http://hl7.org/fhir/study-design Clinical 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:01041 http://hl7.org/fhir/study-design Pragmatic clinical trial

A clinical trial conducted under conditions of routine clinical practice.

3       SEVCO:01038 http://hl7.org/fhir/study-design Expanded 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:01030 http://hl7.org/fhir/study-design Phase 1 trial

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

4         SEVCO:01031 http://hl7.org/fhir/study-design Exploratory 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:01032 http://hl7.org/fhir/study-design Phase 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:01033 http://hl7.org/fhir/study-design Phase 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:01034 http://hl7.org/fhir/study-design Phase 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:01035 http://hl7.org/fhir/study-design Phase 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:01036 http://hl7.org/fhir/study-design Post-marketing study

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

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

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

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

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

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

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

2     SEVCO:01011 http://hl7.org/fhir/study-design Parallel 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:01012 http://hl7.org/fhir/study-design Crossover cohort design

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

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

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

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

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

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

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

2     SEVCO:01014 http://hl7.org/fhir/study-design Matching 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:01020 http://hl7.org/fhir/study-design Family study design

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

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

A family study design in which twin siblings are compared.

2     SEVCO:01015 http://hl7.org/fhir/study-design Cluster 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:01023 http://hl7.org/fhir/study-design Non-comparative study design

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1   SEVCO:01045 http://hl7.org/fhir/study-design 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.

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

2     SEVCO:01039 http://hl7.org/fhir/study-design Real 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:01050 http://hl7.org/fhir/study-design Real 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:01040 http://hl7.org/fhir/study-design Real world data collection from healthcare financing records

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

2     SEVCO:01048 http://hl7.org/fhir/study-design Real 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:01046 http://hl7.org/fhir/study-design Real world data collection from monitoring procedures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1   SEVCO:01085 http://hl7.org/fhir/study-design Includes 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:01089 http://hl7.org/fhir/study-design Study Goal

A study design feature specifying the intent of the study.

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

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

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

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

2     SEVCO:01098 http://hl7.org/fhir/study-design Validation 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:01088 http://hl7.org/fhir/study-design Comparison Goal

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

3       SEVCO:01091 http://hl7.org/fhir/study-design Comparative 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:01090 http://hl7.org/fhir/study-design Comparative 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:01092 http://hl7.org/fhir/study-design Comparative Safety Goal

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

3       SEVCO:01093 http://hl7.org/fhir/study-design Equivalence 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:01094 http://hl7.org/fhir/study-design Non-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:01095 http://hl7.org/fhir/study-design Superiority 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:

Lvl A 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
Source The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance). If the code is in italics, this indicates that the code is not selectable ('Abstract')
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code