Term Lists

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RCT Schema Terms

  • 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
  1. Acute conditions and chronic conditions
  1. Sources of knowledge

Tradition (precedent) Authority (trusted expert) Trial and error Logical reasoning - Deductive reasoning, Inductive reasoning Scientific method (establishing cause and effect relationships) – a systematic, empirical, controlled and critical examination of hypothetical propositions about the associations among natural phenomena.

Types of research Basic vs applied Observational [descriptive (describe populations) vs exploratory (find relationships)] vs experimental (test cause-and-effect relationships through the manipulation of variable) 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

Cohort or case-control studies – establish associations Methodological studies – establish reliability and validity of a new method Secondary analysis – exploring new relationships in old data Historical 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

Qualitative vs quantitative research

Research process Phase I: Identify the research question Identify the research problem Review of literature to provide a theoretical framework Identify variables State hypothesis Phase II: Design the study Design the protocol Choose a sample Phase III: Methods Collect data Reduce data Phase IV: Data analysis Analyze data Interpret findings Phase V: Communication Report findings Suggest future studies

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.

Hypothesis - specific predictions based on a theory.

Concepts – abstraction that allow us to classify natural phenomena and empirical observations

Constructs – concepts that represent non-observable behaviors or events

Variables – concepts that can be assigned values and thus must be defined operationally by the methods for measuring or evaluating them

Propositions – state the relationships between variables Hierarchical – show vertical relationships Temporal – order concepts in time and states a sequence of events Quantitative – frequency or duration of a specific behavior

Model – symbolic representation of the elements of a system Physical Schematic Process Statistical

Inductive theory – theory based on empirically verifiable observations

Hypothetical-deductive theory – theory developed on the basis of great insight and intuitive understanding with few or no prior observations

Law – a theory that has reached a level of absolute consistency in outcome, thus allowing precise prediction.

Empirical observations => Facts => Conceptual Framework => Theory => Research hypothesis => Facts

Deduction – theory testing

Induction – theory development