Term Lists

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)

• Outcome assessment

Morbidity, mortality, length of stay, readmission Physical, social and psychological well-being Patient satisfaction, patient preference, self-assessment of functional capacity, quality of life

• Disablement Model

Pathology=>impairment (organ system dysfunction)=>functional limitation (restrictions in ADL)=>disability (limitations in role performance as a member of society)

• Acute conditions and chronic conditions

• 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