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RCT Schema Terms

The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: ForCTO_031207.doc

We also created an additional list: proposed RCT Schema definitions for the terms in the list are available on this document: ForCTO_041807.doc

• Secondary-study
• Trial
• Anchored-time
• Interval
• Double-anchored-interval
• Single-anchored-interval
• Timepoint
• Time-range
• Duration
• Date
• Exclusion-rule
• Inclusion-rule
• Recruitment-flowchart
• Primary-recruitment-flowchart
• Recruited-population
• Randomized-population
• Enrolled-population
• Eligible-population
• Screened-population
• Excluded population
• Analyzed population
• Crossover population
• Study-arm population
• Site-enrollment
• Protocol-concept
• Follow-up activity
• Protocol-change
• Treatment-assignment
• Protocol
• Executed-protocol
• Intended-protocol
• Reason
• Withdrawal-reason
• Outcomes-followup
• Secondary-study-protocol
• Intended-secondary-study-protocol
• Executed-secondary-study-protocol
• Stopping-rule
• Cost
• Outcome
• Baseline
• Study-outcome
• Primary-outcome
• Secondary-outcome
• Ancillary-outcome
• Side-effect
• Study-site
• Trial-participant
• Investigator
• Study-committee
• Funder
• Institution
• Blinding
• Blinding-method
• Intervention-step
• Drug-step
• Non-drug-intervention-step
• Intervention-arm
• Comparison-arm
• Experimental-arm
• Cointervention*
• Intervention*
• Procedure
• Device
• Drug
• No-treatment
• Placebo

Foundations of Clinical Research (Scheuermann list)

1. Outcome assessment
   1. Morbidity
   2. mortality
   3. length of stay
   4. readmission
   5. Physical
   6. social
   7. psychological well-being
   8. Patient satisfaction
   9. patient preference
   10. self-assessment of functional capacity
   11. quality of life
2. Acute conditions and chronic conditions
3. Sources of knowledge
   1. Tradition (precedent)
   2. Authority (trusted expert)
   3. Trial and error
   4. Logical reasoning - Deductive reasoning, Inductive reasoning
   5. Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.
4. Types of research
   1. Basic vs applied
   2. Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable)
   3. Case study – description of one or more patients
   4. Developmental research – description of pattern of change over time
   5. Normative research – establishing normal values
   6. Qualitative research – gathering data through interview or observation
   7. Cohort or case-control studies – establish associations
   8. Methodological studies – establish reliability and validity of a new method
   9. Secondary analysis – exploring new relationships in old data
   10. Historical research
   11. Randomized clinical trial – controlled comparison of an experimental intervention allowing the assessment of the causes of outcomes
   12. Single-subject design
   13. Sequential clinical trial
   14. Evaluation research – assessment of the success of a program or policy
   15. Quasi-experimental research
   16. Meta-analysis – statistically combining findings from several different studies to obtain a summary analysis
   17. Qualitative vs quantitative research
5. Research process
   1. Phase I: Identify the research question
      1. Identify the research problem
      2. Review of literature to provide a theoretical framework
      3. Identify variables
      4. State hypothesis
   2. Phase II: Design the study
      1. Design the protocol
      2. Choose a sample
   3. Phase III: Methods
      1. Collect data
      2. Reduce data
   4. Phase IV: Data analysis
      1. Analyze data
      2. Interpret findings
   5. Phase V: Communication
      1. Report findings
      2. Suggest future studies
6. Theory – a set of interrelated concepts, definitions or propositions that specifies relationships among variables a represents a systematic view of specific phenomena. A good theory should provide a thorough and rationale explanation of observed facts, and should be economical, important and fluid.
7. Hypothesis - specific predictions based on a theory.
8. Concepts – abstraction that allow us to classify natural phenomena and empirical observations
9. Constructs – concepts that represent non-observable behaviors or events
10. Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them
11. Propositions – state the relationships between variables
    1. Hierarchical – show vertical relationships
    2. Temporal – order concepts in time and states a sequence of events
    3. Quantitative – frequency or duration of a specific behavior
12. Model – symbolic representation of the elements of a system
    1. Physical
    2. Schematic
    3. Process
    4. Statistical
13. Inductive theory – theory based on empirically verifiable observations
14. Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations
15. Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.
16. Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts
17. Deduction – theory testing
18. Induction – theory development

Terms collected by Wenle Zhao from MUSC

• adherence
• accrual rate
• active control
• adjustment
• type I error
• type II error
• balanced design
• baseline
• bias
• prognostic factor
• confounding factor
• block
• permuted block randomization
• minimization randomization
• biased coin randomizaiton
• urn randomization
• response adaptive randomization
• play the winner
• random play the winner
• case report
• case report form
• data clarification request
• data clarification query
• censoring
• efficacy
• safety
• treatment
• intervention
• crossover
• comparative treatment efficacy
• interim analysis
• deterministic
• stop rule
• phase I trial
• phase II trial
• phase III trial
• phase IV trial
• dichotomous
• dose finding
• dropouts
• eligibility
• experiment
• estimate
• follow-up
• sequential design
• group sequential
• endpoint
• intention to treat
• data-dependent stopping
• lost to follow-up
• meta-analysis
• monitoring
• data and safety monitoring board
• institutional review board
• null hypothesis
• alternative hypothesis
• nesting design
• observation
• odds
• odds ratio
• parallel design
• plecabo
• power
• sample size
• primary outcome
• surrogate outcome
• protocol
• per-protocol population
• intention to treat population
• pseudorandom
• p-value
• treatment allocation
• imbalance
• selection bias
• expectation bias
• statistical significant
• stratification
• univariable
• multivariable
• adverse event
• serious adverse event
• cluster randomization
• community intervention trial
• coding
• complaince
• protocal complaince
• protocol violation
• protocol exception
• auditing
• allocation ratio
• assessment
• assessment bias
• early termination
• informed consent
• withdrawal consent
• source document
• principal investigator
• study coordinator
• data management
• project management
• regulatory management
• case-control design
• blinding
• double blinding
• tocxicity
• cohort
• evaluation
• confidence interval
• confirmatory trial
• confounder
• CONSORT statement
• constrain
• context
• diagnostic trial
• controls
• concurrent controls
• historic controls
• crossover trial
• carryover effect
• recruitment
• washout period
• equivalence trials
• statistical analysis plan
• data management plan
• project management plan
• sponsor
• inclusion criteria
• equipoise
• exclusion criteria
• factorial design
• interaction
• main effect
• one-sided test
• two-sided test
• missing data
• imputation of missing data
• investigator competence
• local control
• masking
• double masking
• triple masking
• trilple blinding
• data safety monitoring committee
• minority representation
• negative findings
• positive findings
• noninferiority
• nonadherence
• sample size inflation
• noncomplaince
• repeat measurement
• time to event
• medical safety monitor
• pivotal trials
• prevention trials
• assessment schedule
• data collection schedule
• quality assurance
• electronic data capture
• clinical trial management system
• database
• analysis datasets
• retrospective design
• screening
• sham treatment
• steering committee
• excecutive committee
• baseline comparability
• optimal allocation
• Neyman allocation
• response
• intersubject
• subject
• intrasubject
• population
• varibility
• binormial
• continous
• derived data
• discret
• primary efficacy
• primary response
• placebo controlled
• single-site
• single-center
• multi-site
• multi-center
• superiority
• bioequivalence
• treatment group
• titration
• tolerability
• phase IIA
• phase IIB
• phase IIB
• investigational new drug (IND) application
• new drug application (NDA)
• over-the -count (OTC)
• drug lot
• treatment-emergenet adverse event (TEAE)
• as-treated
• cross-sectional analysis