Difference between revisions of "High-level Concepts v0.2"

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(High-Level Concepts version 0.2)
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Additions from Richard in <font style=color:green>green</font> font
 
Additions from Richard in <font style=color:green>green</font> font
 +
 +
Additions from Wenle and Jim in <font style=color:orange>orange</font> font
 
*Events
 
*Events
 
*Periods
 
*Periods
 
**Study phases
 
**Study phases
 +
***<font style="color:orange">patient screening phase - reach out patients for potential study subjects
 +
***subject enrollment phase - obtain informed consent for eligible subejcts
 +
***baseline phase - perform assessment before study treatment
 +
***treatment phase - treat study subjects
 +
***follow-up phase - obtain assessments after study treatment</font>
 
**Protocol phases  
 
**Protocol phases  
 
*Sequence of events
 
*Sequence of events
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</font>
 
</font>
 
*Research types
 
*Research types
**<font style="color:blue">Randomized Clinical Trial</font>
+
**<font style="color:blue">Randomized Clinical Trial</font><font style="color:orange"> - can we change this term to "Clinical Trial"?
 +
***phase I - dose finding, safety
 +
***phase II - dose finding - efficacy
 +
****phase II a - small scale feasibility
 +
****phase II b - randomized comparative using intermediate endpoints
 +
***phase III trial - Randomized comparative with definitive clinical endpoints
 +
***phase IV trial - post marketing safety and efficacy
 +
</font>
 
*Methods
 
*Methods
 
*Stakeholders
 
*Stakeholders
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***Enrolled population
 
***Enrolled population
 
***Eligible population
 
***Eligible population
***Screened population
+
***Screened population</font>
</font>
+
***<font style="color:orange">Completer population
 +
***Premature termination population</font>
 
**<font style="color:blue">Excluded population
 
**<font style="color:blue">Excluded population
 
***Excluded postrandomization population
 
***Excluded postrandomization population
 
***Not-randomized-population
 
***Not-randomized-population
 
***Not-enrolled-population
 
***Not-enrolled-population
***Not-eligible-population
+
***Not-eligible-population</font>
</font>
 
 
**<font style="color:blue">Analyzed-population
 
**<font style="color:blue">Analyzed-population
 
***All subjects
 
***All subjects
 
***Study arm population
 
***Study arm population
 
***Crossover population
 
***Crossover population
***Subgroup population
+
***Subgroup population</font>
</font>
+
***<font style="color:orange">Intent-to-treat population  - based on randomization
 +
***per-protocol population - exclude those with servious protocol violations</font>
 
*Variables
 
*Variables
 
**Independent variable
 
**Independent variable
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****Usual care
 
****Usual care
 
****Counseling
 
****Counseling
***Cointervention
+
***Cointervention</font>
</font>
 
 
**Dependent variable (responding variable)
 
**Dependent variable (responding variable)
 
***Outcome
 
***Outcome
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****Secondary outcome
 
****Secondary outcome
 
****Adverse event/Side effect
 
****Adverse event/Side effect
****Ancillary outcome
+
****Ancillary outcome</font>
</font>
+
****<font style="color:orange">efficacy assessment
 +
****safety assessment
 +
*****adverse events
 +
******severity
 +
******relationship to study treatment
 +
******serious</font>
 
*Digital and paper artifacts
 
*Digital and paper artifacts
 
*Protocol
 
*Protocol
 
**<font style="color:blue">Intended protocol
 
**<font style="color:blue">Intended protocol
 
**Executed protocol
 
**Executed protocol
**Protocol change
+
**Protocol change</font>
</font>
 
 
*Protocol application
 
*Protocol application
 
**Assessments
 
**Assessments
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**<font style="color:blue">Treatment assignment
 
**<font style="color:blue">Treatment assignment
 
**Blinding  
 
**Blinding  
**Follow-up
+
**Follow-up</font>
</font>
 
 
*Measurement scale
 
*Measurement scale
 
**Nominal
 
**Nominal

Revision as of 08:37, 10 May 2007

Go back to CTO:Main Page

High-Level Concepts version 0.2

Initial High-level Concepts in black font

Additions from Simona in blue font

Additions from Richard in green font

Additions from Wenle and Jim in orange font

  • Events
  • Periods
    • Study phases
      • patient screening phase - reach out patients for potential study subjects
      • subject enrollment phase - obtain informed consent for eligible subejcts
      • baseline phase - perform assessment before study treatment
      • treatment phase - treat study subjects
      • follow-up phase - obtain assessments after study treatment
    • Protocol phases
  • Sequence of events
  • Study designs
    • Descriptive research – research in which the investigator attempts to describe a group of individuals based on a set of variable in order to document their characteristics
      • Case study – description of one or more patients
      • Developmental research – description of pattern of change over time
      • Normative research – establishing normal values
      • Qualitative research – gathering data through interview or observation
      • Evaluation research – objectively assess a program or policy by describing the needs for the services or policy, often using surveys or questionaires
    • Exploratory research
      • Cohort or case-control studies – establish associations through epidemiological studies
      • Methodological studies – establish reliability and validity of a new method
      • Secondary analysis – exploring new relationships in old data
      • Historical research – reconstructing the past through an assessment of archives or other records
    • Experimental research
      • Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
        • Single-subject design
        • Sequential clinical trial
        • Evaluation research – assessment of the success of a program or policy
      • Quasi-experimental research
      • Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis

  • Research types
    • Randomized Clinical Trial - can we change this term to "Clinical Trial"?
      • phase I - dose finding, safety
      • phase II - dose finding - efficacy
        • phase II a - small scale feasibility
        • phase II b - randomized comparative using intermediate endpoints
      • phase III trial - Randomized comparative with definitive clinical endpoints
      • phase IV trial - post marketing safety and efficacy

  • Methods
  • Stakeholders
    • Participants
    • Investigators
    • Monitors
      • Study committee
    • Sponsors
  • Populations
    • Recruited population
      • Randomized population
      • Enrolled population
      • Eligible population
      • Screened population
      • Completer population
      • Premature termination population
    • Excluded population
      • Excluded postrandomization population
      • Not-randomized-population
      • Not-enrolled-population
      • Not-eligible-population
    • Analyzed-population
      • All subjects
      • Study arm population
      • Crossover population
      • Subgroup population
      • Intent-to-treat population - based on randomization
      • per-protocol population - exclude those with servious protocol violations
  • Variables
    • Independent variable
      • Intervention
        • Procedure
        • Device implantation
        • Drug treatment
        • Placebo treatment
        • Sham procedure
        • Usual care
        • Counseling
      • Cointervention
    • Dependent variable (responding variable)
      • Outcome
        • Primary outcome
        • Secondary outcome
        • Adverse event/Side effect
        • Ancillary outcome
        • efficacy assessment
        • safety assessment
          • adverse events
            • severity
            • relationship to study treatment
            • serious
  • Digital and paper artifacts
  • Protocol
    • Intended protocol
    • Executed protocol
    • Protocol change
  • Protocol application
    • Assessments
      • Experimental assays
      • Observations
        • Physical exam
      • Interview
      • Self-assessments
    • Data analysis
      • Data partitioning
      • Data transformation
      • Data pooling
      • Data summarization
      • Reliability
      • Correlation
    • Specimen processing
      • Procurement
      • Specimen partitioning/purification
      • Specimen storage
    • Treatment assignment
    • Blinding
    • Follow-up
  • Measurement scale
    • Nominal
    • Ordinal
    • Interval
    • Ratio
  • Participant characteristic (phenotype)
    • Baseline characteristic