RCT Schema Terms
- Excluded population
- Analyzed population
- Crossover population
- Study-arm population
- Follow-up activity
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