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