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

Clinical Decision Support Work Group

Maturity Level: 1

Trial Use

Use Context: Country: World

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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: 2024-11-07T14:43:37.879Z

Profile: Shareable CodeSystem

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

Lvl	Code	Display	Definition	Copy
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, preventive or screening method or intervention) is evaluated for effects on health-related biomedical or behavioral processes and/or outcomes.
3	SEVCO:01041	Pragmatic clinical trial	A clinical trial conducted under conditions of routine clinical practice.
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.
3	SEVCO:01030	Phase 1 trial	A clinical trial to gather initial evidence in humans to support further investigation of an intervention.
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).
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.
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.
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.
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.
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.
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.
2	SEVCO:01037	Post-Marketing Surveillance study	An observational study to identify adverse events related to the use of an approved clinical intervention.
1	SEVCO:01010	Comparative study design	A study design in which two or more groups are compared.
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.
2	SEVCO:01012	Crossover cohort design	A comparative study design in which participants receive two or more alternative exposures during separate periods of time.
3	SEVCO:01024	Controlled crossover cohort design	A crossover cohort design in which two or more cohorts have different orders of exposures.
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.
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).
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.
3	SEVCO:01020	Family study design	A matched study design in which related or non-related family members are compared.
4	SEVCO:01021	Twin study design	A family study design in which twin siblings are compared.
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.
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.
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).
2	SEVCO:01017	Case report	A non-comparative study design in which a single participant is evaluated.
1	SEVCO:01022	Population-based design	A study design in which the unit of observation is a population or community.
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.
1	SEVCO:01027	Cross sectional data collection	A study design process in which data is collected at a single point in time.
1	SEVCO:01028	Longitudinal data collection	A study design process in which data is collected at two or more points in time.
2	SEVCO:01018	Time series design	A longitudinal data collection which includes a set of time-ordered observations.
3	SEVCO:01019	Before and after comparison	A time series design which includes comparisons of observations before and after an event or exposure.
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.
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.
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.
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.
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.
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.
3	SEVCO:01046	Real world data collection from monitoring procedures	Real world data collection from data obtained routinely for a purpose of repeated testing.
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.
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.
1	SEVCO:01051	Multisite data collection	A study design process in which data are collected from two or more geographic locations.
1	SEVCO:01086	Quantitative analysis	A study design process in which data are analyzed with mathematical or statistical methods and formulas.
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.
1	SEVCO:01060	Blinding of study participants	A study design process in which study participants are not informed of their intervention assignment.
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.
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.
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.
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.
1	SEVCO:01043	Multicentric	A study design feature in which two or more institutions are responsible for the conduct of the study.
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.
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.
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.
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.
1	SEVCO:01089	Study Goal	A study design feature specifying the intent of the study.
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.
2	SEVCO:01097	Derivation Goal	A study goal with the intent to generate a predictive algorithm.
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.
2	SEVCO:01088	Comparison Goal	A study design feature in which the study intent is to compare two or more interventions or exposures.
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.
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.
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.
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.
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.
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.

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