High-level Concepts v0.2

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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
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