Study Design

{
  "description" : "This is a set of terms for study design characteristics.",
  "compose" : {
    "exclude" : [ ],
    "include" : [ {
      "system" : "https://fevir.net/sevco",
      "extension" : [ {
        "extension" : [ {
          "valueString" : "concept",
          "url" : "path"
        }, {
          "url" : "count",
          "valueInteger" : 73
        } ],
        "url" : "http://health-samurai.io/extensions/excised-data"
      } ],
      "version" : "2.0"
    } ]
  },
  "date" : "2022-08-24T12:40:00+00:00",
  "meta" : {
    "lastUpdated" : "2022-05-12T12:40:00+00:00",
    "profile" : [ "http://hl7.org/fhir/StructureDefinition/shareablevalueset" ]
  },
  "publisher" : "Health Level Seven International",
  "name" : "StudyDesign",
  "copyright" : "This material derives from the HL7 Terminology THO. THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html",
  "experimental" : false,
  "resourceType" : "ValueSet",
  "title" : "Study Design",
  "extension" : [ {
    "valueCode" : "cds",
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"
  }, {
    "valueCode" : "trial-use",
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"
  }, {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 2
  }, {
    "url" : "http://health-samurai.io/extensions/source",
    "valueCode" : "db"
  } ],
  "status" : "active",
  "language" : "en",
  "id" : "002396c3-32ad-4b93-b819-07d7cd64a986",
  "url" : "http://terminology.hl7.org/ValueSet/study-design",
  "version" : "1.0.0",
  "contact" : [ {
    "telecom" : [ {
      "system" : "url",
      "value" : "http://hl7.org"
    }, {
      "system" : "email",
      "value" : "hq@HL7.org"
    } ]
  } ],
  "text" : {
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet study-design</b></p><a name=\"study-design\"> </a><a name=\"hcstudy-design\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Last updated: 2022-05-12 12:40:00+0000; Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"http://hl7.org/fhir/R5/shareablevalueset.html\">Shareable ValueSet</a></p></div><ul><li>Include these codes as defined in <a href=\"http://tx.fhir.org/r5\"><code>https://fevir.net/sevco</code></a><span title=\"Version is explicitly stated to be 2.0\"> version &#x1F4CD;2.0</span><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td><td><b>Definition (core metadata concept)</b></td><td><b>Synonym (core metadata concept)</b></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801001\">SEVCO:01001</a></td><td>interventional research</td><td>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).</td><td>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).</td><td>experimental study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801003\">SEVCO:01003</a></td><td>randomized assignment</td><td>An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups.</td><td>An interventional study design in which an independent variable (an exposure or intervention) is prospectively assigned or modified by random chance to separate groups.</td><td>RCT</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801006\">SEVCO:01006</a></td><td>simple randomization</td><td>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.</td><td>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.</td><td>unrestricted randomization</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801007\">SEVCO:01007</a></td><td>stratified randomization</td><td>A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups</td><td>A randomized assignment in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801008\">SEVCO:01008</a></td><td>block randomization</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801009\">SEVCO:01009</a></td><td>adaptive randomization</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801005\">SEVCO:01005</a></td><td>non-randomized assignment</td><td>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.</td><td>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.</td><td>interventional research with non-randomized assignment</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801004\">SEVCO:01004</a></td><td>quasi-randomized assignment</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801029\">SEVCO:01029</a></td><td>clinical trial</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801041\">SEVCO:01041</a></td><td>pragmatic clinical trial</td><td>A clinical trial conducted under conditions of routine clinical practice.</td><td>A clinical trial conducted under conditions of routine clinical practice.</td><td>pragmatic trial</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801038\">SEVCO:01038</a></td><td>expanded access study</td><td>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.</td><td>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.</td><td>expanded access trial</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801030\">SEVCO:01030</a></td><td>phase 1 trial</td><td>A clinical trial to gather initial evidence in humans to support further investigation of an intervention.</td><td>A clinical trial to gather initial evidence in humans to support further investigation of an intervention.</td><td>phase I clinical trial</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801031\">SEVCO:01031</a></td><td>exploratory investigational new drug study</td><td>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).</td><td>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).</td><td>exploratory ind study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801032\">SEVCO:01032</a></td><td>phase 1/phase 2 trial</td><td>A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of phase 2 trial.</td><td>A clinical trial with a component meeting the definition of phase 1 trial and a component meeting the definition of phase 2 trial.</td><td>trial phase 1/2</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801033\">SEVCO:01033</a></td><td>phase 2 trial</td><td>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.</td><td>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.</td><td>phase II clinical trial</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801034\">SEVCO:01034</a></td><td>phase 2/phase 3 trial</td><td>A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of phase 3 trial.</td><td>A clinical trial with a component meeting the definition of phase 2 trial and a component meeting the definition of phase 3 trial.</td><td>trial phase 2/3</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801035\">SEVCO:01035</a></td><td>phase 3 trial</td><td>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.</td><td>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.</td><td>phase III clinical trial</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801036\">SEVCO:01036</a></td><td>post-marketing study</td><td>A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use.</td><td>A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an already approved clinical use.</td><td>post-approval study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801002\">SEVCO:01002</a></td><td>observational research</td><td>A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.</td><td>A study design in which the independent variables (exposures or interventions) are not prospectively assigned or modified by the investigator.</td><td>non-interventional research</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801037\">SEVCO:01037</a></td><td>post-marketing surveillance study</td><td>An observational study to identify adverse events related to the use of an approved clinical intervention.</td><td>An observational study to identify adverse events related to the use of an approved clinical intervention.</td><td>postmarketing evaluation study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801010\">SEVCO:01010</a></td><td>comparative study design</td><td>A study design in which two or more groups are compared.</td><td>A study design in which two or more groups are compared.</td><td>comparative research</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801011\">SEVCO:01011</a></td><td>parallel cohort design</td><td>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.</td><td>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.</td><td>concurrent cohort study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801012\">SEVCO:01012</a></td><td>crossover cohort design</td><td>A comparative study design in which participants receive two or more alternative exposures during separate periods of time.</td><td>A comparative study design in which participants receive two or more alternative exposures during separate periods of time.</td><td>crossover trial</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801024\">SEVCO:01024</a></td><td>controlled crossover cohort design</td><td>A crossover cohort design in which two or more cohorts have different orders of exposures.</td><td>A crossover cohort design in which two or more cohorts have different orders of exposures.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801025\">SEVCO:01025</a></td><td>single-arm crossover design</td><td>A crossover cohort design in which all participants are in a single cohort with the same order of exposures.</td><td>A crossover cohort design in which all participants are in a single cohort with the same order of exposures.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801013\">SEVCO:01013</a></td><td>case control design</td><td>A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).</td><td>A comparative study design in which the groups being compared are defined by outcome presence (case) or absence (control).</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801014\">SEVCO:01014</a></td><td>matching for comparison</td><td>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.</td><td>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.</td><td>matched study design</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801020\">SEVCO:01020</a></td><td>family study design</td><td>A matched study design in which related or non-related family members are compared.</td><td>A matched study design in which related or non-related family members are compared.</td><td>family based study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801021\">SEVCO:01021</a></td><td>twin study design</td><td>A family study design in which twin siblings are compared.</td><td>A family study design in which twin siblings are compared.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801015\">SEVCO:01015</a></td><td>cluster as unit of allocation</td><td>A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.</td><td>A comparative study design in which participants are allocated to exposures (interventions) by their membership in groups (called clusters) rather than by individualized assignments.</td><td>clustering for comparison</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801023\">SEVCO:01023</a></td><td>non-comparative study design</td><td>A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.</td><td>A study design with no comparisons between groups with different exposures and no comparisons between groups with different outcomes.</td><td>descriptive study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801016\">SEVCO:01016</a></td><td>uncontrolled cohort design</td><td>A non-comparative study design in which two or more participants are evaluated in a single group (or cohort).</td><td>A non-comparative study design in which two or more participants are evaluated in a single group (or cohort).</td><td>non-controlled cohort design</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801017\">SEVCO:01017</a></td><td>case report</td><td>A non-comparative study design in which a single participant is evaluated.</td><td>A non-comparative study design in which a single participant is evaluated.</td><td>case study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801022\">SEVCO:01022</a></td><td>population-based design</td><td>A study design in which the unit of observation is a population or community.</td><td>A study design in which the unit of observation is a population or community.</td><td>population study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801044\">SEVCO:01044</a></td><td>ecological design</td><td>A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings.</td><td>A study design in which the unit of observation is a population or community defined by social relationships or physical surroundings.</td><td>ecologic study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801027\">SEVCO:01027</a></td><td>cross sectional data collection</td><td>A study design process in which data is collected at a single point in time.</td><td>A study design process in which data is collected at a single point in time.</td><td>cross-sectional study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801028\">SEVCO:01028</a></td><td>longitudinal data collection</td><td>A study design process in which data is collected at two or more points in time.</td><td>A study design process in which data is collected at two or more points in time.</td><td>longitudinal study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801018\">SEVCO:01018</a></td><td>time series design</td><td>A longitudinal data collection which includes a set of time-ordered observations.</td><td>A longitudinal data collection which includes a set of time-ordered observations.</td><td>multiple time point comparison</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801019\">SEVCO:01019</a></td><td>before and after comparison</td><td>A time series design which includes comparisons of observations before and after an event or exposure.</td><td>A time series design which includes comparisons of observations before and after an event or exposure.</td><td>before-after comparison</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801045\">SEVCO:01045</a></td><td>primary data collection</td><td>A study design process in which the data are recorded and collected during the study for the purpose of the same study.</td><td>A study design process in which the data are recorded and collected during the study for the purpose of the same study.</td><td>study-generated data collection</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801026\">SEVCO:01026</a></td><td>real world data collection</td><td>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.</td><td>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.</td><td>RWD collection</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801039\">SEVCO:01039</a></td><td>real world data collection from healthcare records</td><td>Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional.</td><td>Real world data collection from data obtained routinely for a purpose of recording healthcare delivery in a record controlled by a healthcare professional.</td><td>real world data collection from medical records</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801050\">SEVCO:01050</a></td><td>real world data collection from personal health records</td><td>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.</td><td>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.</td><td>RWD collection from personal medical records</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801040\">SEVCO:01040</a></td><td>real world data collection from healthcare financing records</td><td>Real world data collection from data obtained routinely for a purpose of recording healthcare financing.</td><td>Real world data collection from data obtained routinely for a purpose of recording healthcare financing.</td><td>RWD collection from healthcare financing records</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801048\">SEVCO:01048</a></td><td>real world data collection from testing procedures</td><td>Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination.</td><td>Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic testing or screening examination.</td><td>RWD collection from testing procedures</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801046\">SEVCO:01046</a></td><td>real world data collection from monitoring procedures</td><td>Real world data collection from data obtained routinely for a purpose of repeated testing.</td><td>Real world data collection from data obtained routinely for a purpose of repeated testing.</td><td>RWD collection from monitoring procedures</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801049\">SEVCO:01049</a></td><td>secondary data collection from prior research</td><td>A study design process in which the data are collected from data obtained during a different study than the current study.</td><td>A study design process in which the data are collected from data obtained during a different study than the current study.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801042\">SEVCO:01042</a></td><td>secondary data collection from a registry</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801051\">SEVCO:01051</a></td><td>multisite data collection</td><td>A study design process in which data are collected from two or more geographic locations.</td><td>A study design process in which data are collected from two or more geographic locations.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801086\">SEVCO:01086</a></td><td>quantitative analysis</td><td>A study design process in which data are analyzed with mathematical or statistical methods and formulas.</td><td>A study design process in which data are analyzed with mathematical or statistical methods and formulas.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801087\">SEVCO:01087</a></td><td>qualitative analysis</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801060\">SEVCO:01060</a></td><td>blinding of study participants</td><td>A study design process in which study participants are not informed of their intervention assignment.</td><td>A study design process in which study participants are not informed of their intervention assignment.</td><td>masking of study participants</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801061\">SEVCO:01061</a></td><td>blinding of intervention providers</td><td>A study design process in which the people administering the intervention are not informed of the intervention assignment.</td><td>A study design process in which the people administering the intervention are not informed of the intervention assignment.</td><td>masking of intervention deliverers</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801062\">SEVCO:01062</a></td><td>blinding of outcome assessors</td><td>A study design process in which the people determining the outcome are not informed of the intervention assignment.</td><td>A study design process in which the people determining the outcome are not informed of the intervention assignment.</td><td>masking of outcome assessors</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801063\">SEVCO:01063</a></td><td>blinding of data analysts</td><td>A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment.</td><td>A study design process in which the people managing or processing the data and statistical analysis are not informed of the intervention assignment.</td><td>masking of data analysts</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801064\">SEVCO:01064</a></td><td>allocation concealment</td><td>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.</td><td>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.</td><td>masking of randomization assignment</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801043\">SEVCO:01043</a></td><td>multicentric</td><td>A study design feature in which two or more institutions are responsible for the conduct of the study.</td><td>A study design feature in which two or more institutions are responsible for the conduct of the study.</td><td>multicenter study</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801052\">SEVCO:01052</a></td><td>includes patient-reported outcome</td><td>A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.</td><td>A study design feature in which one or more outcomes are reported directly from the patient without interpretation by a clinician or researcher.</td><td>PRO</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801053\">SEVCO:01053</a></td><td>includes patient-centered outcome</td><td>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.</td><td>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.</td><td>includes clinical outcome measure</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801054\">SEVCO:01054</a></td><td>includes disease-oriented outcome</td><td>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.</td><td>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.</td><td>includes surrogate outcome measure</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801085\">SEVCO:01085</a></td><td>includes process measure</td><td>A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.</td><td>A study design feature in which one or more outcomes are actions or behaviors of a healthcare professional or care team.</td><td>includes process outcome measure</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801089\">SEVCO:01089</a></td><td>study goal</td><td>A study design feature specifying the intent of the study.</td><td>A study design feature specifying the intent of the study.</td><td>study aim</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801096\">SEVCO:01096</a></td><td>evaluation goal</td><td>A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.</td><td>A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person or piece of equipment.</td><td>evaluation aim</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801097\">SEVCO:01097</a></td><td>derivation goal</td><td>A study goal with the intent to generate a predictive algorithm.</td><td>A study goal with the intent to generate a predictive algorithm.</td><td>derivation study goal</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801098\">SEVCO:01098</a></td><td>validation goal</td><td>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.</td><td>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.</td><td>validation study goal</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801088\">SEVCO:01088</a></td><td>comparison goal</td><td>A study design feature in which the study intent is to compare two or more interventions or exposures.</td><td>A study design feature in which the study intent is to compare two or more interventions or exposures.</td><td>comparative analysis goal</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801091\">SEVCO:01091</a></td><td>comparative effectiveness goal</td><td>A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms.</td><td>A study design feature in which the study intent is to compare two or more interventions with respect to benefits and/or harms.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801090\">SEVCO:01090</a></td><td>comparative efficacy goal</td><td>A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.</td><td>A study design feature in which the study intent is to compare two or more interventions with respect to effectiveness in ideal conditions.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801092\">SEVCO:01092</a></td><td>comparative safety goal</td><td>A study design feature in which the study intent is to compare two or more interventions with respect to harms.</td><td>A study design feature in which the study intent is to compare two or more interventions with respect to harms.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801093\">SEVCO:01093</a></td><td>equivalence goal</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801094\">SEVCO:01094</a></td><td>non-inferiority goal</td><td>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.</td><td>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.</td><td></td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801095\">SEVCO:01095</a></td><td>superiority goal</td><td>A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects.</td><td>A study goal with the intent to compare two or more interventions or exposures and detect a difference in effects.</td><td>superiority study goal</td></tr><tr><td><a href=\"http://tx.fhir.org/r5/ValueSet/1848#1848-SEVCO.5801100\">SEVCO:01100</a></td><td>allocation ratio</td><td>A study design feature describing the intended relative proportion of assignment across groups.</td><td>A study design feature describing the intended relative proportion of assignment across groups.</td><td></td></tr></table></li></ul></div>",
    "status" : "extensions"
  }
}