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4.3.2.413 CodeSystem http://hl7.org/fhir/study-design

Clinical Decision Support icon Work Group  Maturity Level: 1 Trial Use Use Context: Country: World
Official URL: http://hl7.org/fhir/study-design Version: 6.0.0-ballot2
active as of 2020-12-28 Computable Name: StudyDesign
Flags: CaseSensitive, Complete. All codes ValueSet: Study Design OID: TBD

This Code system is used in the following value sets:

  • ValueSet: Study Design (This is a set of terms for study design characteristics.)

4.3.2.413.1 Definition

This is a set of terms for study design characteristics.

4.3.2.413.2 Content

Generated Narrative: CodeSystem study-design

Last updated: 2024-08-12T16:52:12.437+08:00

Profile: Shareable CodeSystem

This case-sensitive code system http://hl7.org/fhir/study-design defines the following codes in a Is-A hierarchy:

LvlCodeDisplayDefinitionCopy
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). btn btn
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. btn btn
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. btn btn
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 btn btn
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. btn btn
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. btn btn
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. btn btn
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. btn btn
2   SEVCO:01029 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. btn btn
3     SEVCO:01041 Pragmatic clinical trial A clinical trial conducted under conditions of routine clinical practice. btn btn
3     SEVCO:01038 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. btn btn
3     SEVCO:01030 Phase 1 trial A clinical trial to gather initial evidence in humans to support further investigation of an intervention. btn btn
4       SEVCO:01031 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). btn btn
3     SEVCO:01032 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. btn btn
3     SEVCO:01033 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. btn btn
3     SEVCO:01034 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. btn btn
3     SEVCO:01035 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. btn btn
3     SEVCO:01036 Post-marketing study A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use. btn btn
1 SEVCO:01002 Observational research A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator. btn btn
2   SEVCO:01037 Post-Marketing Surveillance study An observational study to identify adverse events related to the use of an approved clinical intervention. btn btn
1 SEVCO:01010 Comparative study design A study design in which two or more groups are compared. btn btn
2   SEVCO:01011 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. btn btn
2   SEVCO:01012 Crossover cohort design A comparative study design in which participants receive two or more alternative exposures during separate periods of time. btn btn
3     SEVCO:01024 Controlled crossover cohort design A crossover cohort design in which two or more cohorts have different orders of exposures. btn btn
3     SEVCO:01025 Single-arm crossover design A crossover cohort design in which all participants are in a single cohort with the same order of exposures. btn btn
2   SEVCO:01013 Case control design A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control). btn btn
2   SEVCO:01014 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. btn btn
3     SEVCO:01020 Family study design A matched study design in which related or non-related family members are compared. btn btn
4       SEVCO:01021 Twin study design A family study design in which twin siblings are compared. btn btn
2   SEVCO:01015 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. btn btn
1 SEVCO:01023 Non-comparative study design A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes. btn btn
2   SEVCO:01016 Uncontrolled cohort design A non-comparative study design in which two or more participants are evaluated in a single group (or cohort). btn btn
2   SEVCO:01017 Case report A non-comparative study design in which a single participant is evaluated. btn btn
1 SEVCO:01022 Population-based design A study design in which the unit of observation is a population or community. btn btn
2   SEVCO:01044 Ecological design A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings. btn btn
1 SEVCO:01027 Cross sectional data collection A study design process in which data is collected at a single point in time. btn btn
1 SEVCO:01028 Longitudinal data collection A study design process in which data is collected at two or more points in time. btn btn
2   SEVCO:01018 Time series design A longitudinal data collection which includes a set of time-ordered observations. btn btn
3     SEVCO:01019 Before and after comparison A time series design which includes comparisons of observations before and after an event or exposure. btn btn
1 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. btn btn
1 SEVCO:01026 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. btn btn
2   SEVCO:01039 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. btn btn
2   SEVCO:01050 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. btn btn
2   SEVCO:01040 Real world data collection from healthcare financing records Real world data collection from data obtained routinely for a purpose of recording healthcare financing. btn btn
2   SEVCO:01048 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. btn btn
3     SEVCO:01046 Real world data collection from monitoring procedures Real world data collection from data obtained routinely for a purpose of repeated testing. btn btn
1 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. btn btn
1 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. btn btn
1 SEVCO:01051 Multisite data collection A study design process in which data are collected from two or more geographic locations. btn btn
1 SEVCO:01086 Quantitative analysis A study design process in which data are analyzed with mathematical or statistical methods and formulas. btn btn
1 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. btn btn
1 SEVCO:01060 Blinding of study participants A study design process in which study participants are not informed of their intervention assignment. btn btn
1 SEVCO:01061 Blinding of intervention providers A study design process in which the people administering the intervention are not informed of the intervention assignment. btn btn
1 SEVCO:01062 Blinding of outcome assessors A study design process in which the people determining the outcome are not informed of the intervention assignment. btn btn
1 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. btn btn
1 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. btn btn
1 SEVCO:01043 Multicentric A study design feature in which two or more institutions are responsible for the conduct of the study. btn btn
1 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. btn btn
1 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. btn btn
1 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. btn btn
1 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. btn btn
1 SEVCO:01089 Study Goal A study design feature specifying the intent of the study. btn btn
2   SEVCO:01096 Evaluation Goal A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment. btn btn
2   SEVCO:01097 Derivation Goal A study goal with the intent to generate a predictive algorithm. btn btn
2   SEVCO:01098 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. btn btn
2   SEVCO:01088 Comparison Goal A study design feature in which the study intent is to compare two or more interventions or exposures. btn btn
3     SEVCO:01091 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. btn btn
4       SEVCO:01090 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. btn btn
4       SEVCO:01092 Comparative Safety Goal A study design feature in which the study intent is to compare two or more interventions with respect to harms. btn btn
3     SEVCO:01093 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. btn btn
3     SEVCO:01094 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. btn btn
3     SEVCO:01095 Superiority Goal A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects. btn btn

 

See the full registry of code systems defined as part of FHIR.

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. 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