Generated Narrative: ValueSet study-design Last updated: 2022-05-12 12:40:00+0000 Profile: Shareable ValueSet Include these codes as defined in https://fevir.net/sevco version ?2.0 Code Display Definition Definition (core metadata concept) Synonym (core metadata concept) 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). 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). experimental study 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. An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups. RCT 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. 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. unrestricted randomization 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 A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups 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. 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. 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. 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. 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. 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. interventional research with non-randomized assignment 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. 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. 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. 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. SEVCO:01041 pragmatic clinical trial A clinical trial conducted under conditions of routine clinical practice. A clinical trial conducted under conditions of routine clinical practice. pragmatic trial 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. 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. expanded access trial SEVCO:01030 phase 1 trial A clinical trial to gather initial evidence in humans to support further investigation of an intervention. A clinical trial to gather initial evidence in humans to support further investigation of an intervention. phase I clinical trial 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). 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). exploratory ind study 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. A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of phase 2 trial. trial phase 1/2 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. 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. phase II clinical trial 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. A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of phase 3 trial. trial phase 2/3 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. 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. phase III clinical trial 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. A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use. post-approval study SEVCO:01002 observational research A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator. A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator. non-interventional research SEVCO:01037 post-marketing surveillance study An observational study to identify adverse events related to the use of an approved clinical intervention. An observational study to identify adverse events related to the use of an approved clinical intervention. postmarketing evaluation study SEVCO:01010 comparative study design A study design in which two or more groups are compared. A study design in which two or more groups are compared. comparative research 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. 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. concurrent cohort study SEVCO:01012 crossover cohort design A comparative study design in which participants receive two or more alternative exposures during separate periods of time. A comparative study design in which participants receive two or more alternative exposures during separate periods of time. crossover trial SEVCO:01024 controlled crossover cohort design A crossover cohort design in which two or more cohorts have different orders of exposures. A crossover cohort design in which two or more cohorts have different orders of exposures. 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. A crossover cohort design in which all participants are in a single cohort with the same order of exposures. SEVCO:01013 case control design A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control). A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control). 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. 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. matched study design SEVCO:01020 family study design A matched study design in which related or non-related family members are compared. A matched study design in which related or non-related family members are compared. family based study SEVCO:01021 twin study design A family study design in which twin siblings are compared. A family study design in which twin siblings are compared. 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. A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments. clustering for comparison 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. A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes. descriptive study SEVCO:01016 uncontrolled cohort design A non-comparative study design in which two or more participants are evaluated in a single group (or cohort). A non-comparative study design in which two or more participants are evaluated in a single group (or cohort). non-controlled cohort design SEVCO:01017 case report A non-comparative study design in which a single participant is evaluated. A non-comparative study design in which a single participant is evaluated. case study SEVCO:01022 population-based design A study design in which the unit of observation is a population or community. A study design in which the unit of observation is a population or community. population study 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. A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings. ecologic study SEVCO:01027 cross sectional data collection A study design process in which data is collected at a single point in time. A study design process in which data is collected at a single point in time. cross-sectional study SEVCO:01028 longitudinal data collection A study design process in which data is collected at two or more points in time. A study design process in which data is collected at two or more points in time. longitudinal study SEVCO:01018 time series design A longitudinal data collection which includes a set of time-ordered observations. A longitudinal data collection which includes a set of time-ordered observations. multiple time point comparison SEVCO:01019 before and after comparison A time series design which includes comparisons of observations before and after an event or exposure. A time series design which includes comparisons of observations before and after an event or exposure. before-after comparison 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. A study design process in which the data are recorded and collected during the study for the purpose of the same study. study-generated data collection 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. 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. RWD collection 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. Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional. real world data collection from medical records 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. 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. RWD collection from personal medical records 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. Real world data collection from data obtained routinely for a purpose of recording healthcare financing. RWD collection from healthcare financing records 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. Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination. RWD collection from testing procedures SEVCO:01046 real world data collection from monitoring procedures Real world data collection from data obtained routinely for a purpose of repeated testing. Real world data collection from data obtained routinely for a purpose of repeated testing. RWD collection from monitoring procedures 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. A study design process in which the data are collected from data obtained during a different study than the current study. 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. 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. SEVCO:01051 multisite data collection A study design process in which data are collected from two or more geographic locations. A study design process in which data are collected from two or more geographic locations. SEVCO:01086 quantitative analysis A study design process in which data are analyzed with mathematical or statistical methods and formulas. A study design process in which data are analyzed with mathematical or statistical methods and formulas. 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. 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. SEVCO:01060 blinding of study participants A study design process in which study participants are not informed of their intervention assignment. A study design process in which study participants are not informed of their intervention assignment. masking of study participants SEVCO:01061 blinding of intervention providers A study design process in which the people administering the intervention are not informed of the intervention assignment. A study design process in which the people administering the intervention are not informed of the intervention assignment. masking of intervention deliverers SEVCO:01062 blinding of outcome assessors A study design process in which the people determining the outcome are not informed of the intervention assignment. A study design process in which the people determining the outcome are not informed of the intervention assignment. masking of outcome assessors 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. A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment. masking of data analysts 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. 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. masking of randomization assignment SEVCO:01043 multicentric A study design feature in which two or more institutions are responsible for the conduct of the study. A study design feature in which two or more institutions are responsible for the conduct of the study. multicenter study 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. A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher. PRO 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. 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. includes clinical outcome measure 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. 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. includes surrogate outcome measure 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. A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team. includes process outcome measure SEVCO:01089 study goal A study design feature specifying the intent of the study. A study design feature specifying the intent of the study. study aim SEVCO:01096 evaluation goal A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment. A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment. evaluation aim SEVCO:01097 derivation goal A study goal with the intent to generate a predictive algorithm. A study goal with the intent to generate a predictive algorithm. derivation study goal 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. 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. validation study goal SEVCO:01088 comparison goal A study design feature in which the study intent is to compare two or more interventions or exposures. A study design feature in which the study intent is to compare two or more interventions or exposures. comparative analysis goal 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. A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms. 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. A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions. 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. A study design feature in which the study intent is to compare two or more interventions with respect to harms. 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. 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. 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. 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. SEVCO:01095 superiority goal A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects. A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects. superiority study goal SEVCO:01100 allocation ratio A study design feature describing the intended relative proportion of assignment across groups. A study design feature describing the intended relative proportion of assignment across groups.
This is a set of terms for study design characteristics.
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).
An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups.
interventional research with randomized assignment
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.
A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups
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.
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.
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.
interventional research with non-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.
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.
A clinical trial conducted under conditions of routine clinical practice.
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.
A clinical trial to gather initial evidence in humans to support further investigation of an intervention.
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).
A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of 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.
A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of 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.
A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use.
A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.
An observational study to identify adverse events related to the use of an approved clinical intervention.
A study design in which two or more groups are compared.
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.
A comparative study design in which participants receive two or more alternative exposures during separate periods of time.
A crossover cohort design in which two or more cohorts have different orders of exposures.
A crossover cohort design in which all participants are in a single cohort with the same order of exposures.
A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).
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.
A matched study design in which related or non-related family members are compared.
A family study design in which twin siblings are compared.
A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.
A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.
A non-comparative study design in which two or more participants are evaluated in a single group (or cohort).
A non-comparative study design in which a single participant is evaluated.
A study design in which the unit of observation is a population or community.
A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings.
A study design process in which data is collected at a single point in time.
A study design process in which data is collected at two or more points in time.
A longitudinal data collection which includes a set of time-ordered observations.
A time series design which includes comparisons of observations before and after an event or exposure.
A study design process in which the data are recorded and collected during the study for the purpose of the same study.
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.
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.
RWD collection from clinical care records
real world data collection from medical records
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.
real world data collection from personal care records
RWD collection from personal medical records
real world data collection from healthcare financing records
Real world data collection from data obtained routinely for a purpose of recording healthcare financing.
RWD collection from healthcare financing records
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.
real world data collection from monitoring procedures
Real world data collection from data obtained routinely for a purpose of repeated testing.
RWD collection from monitoring procedures
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.
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.
A study design process in which data are collected from two or more geographic locations.
A study design process in which data are analyzed with mathematical or statistical methods and formulas.
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.
A study design process in which study participants are not informed of their intervention assignment.
A study design process in which the people administering the intervention are not informed of the intervention assignment.
A study design process in which the people determining the outcome are not informed of the intervention assignment.
A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment.
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.
A study design feature in which two or more institutions are responsible for the conduct of the study.
A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.
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.
includes patient-centered outcome measure
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.
includes disease-oriented outcome measure
A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.
A study design feature specifying the intent of the study.
A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.
A study goal with the intent to generate a predictive algorithm.
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.
A study design feature in which the study intent is to compare two or more interventions or exposures.
A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms.
A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.
A study design feature in which the study intent is to compare two or more interventions with respect to harms.
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.
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.
A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects.
A study design feature describing the intended relative proportion of assignment across groups.