Term Lists

RCT Schema Terms

The following is the initial list selected by Barry. RCT Schema definitions for these terms are available on this document: File:ForCTO 031207.doc

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