1. Introduction to Research

2. Purpose of Research Evidence-based practice Validate clinical practice through scientific inquiry Scientific rational must exist for clinical practice

3. Clinical Research Method of answering questions in systematic and objective way Examines clinical conditions and outcomes Establishes relationships among clinical phenomena Provides impetus for improving practice

4. Clinical Research Dynamic and creative Using a variety of qualitative and quantitative measurement tools Performed in a variety of settings Justify treatment

5. Sources of Knowledge WORSE BETTER Tradition - something is true because people have always known it to be true Authority - if they say it is true, it must be Trial and Error - haphazard and unsystematic Logical Reasoning - Deductive Inductive

6. Scientific Method Most rigorous process for acquiring new knowledge Incorporates elements of deduction and induction Systematic and controlled Empirical

7. Scientific Method Critical examination of hypothetical propositions (hypotheses) about the associations among natural phenomena

8. The Research Process Phase I Formulate a specific research question Phase II (Research Proposal) Describe the study Methods: Subject selection Testing Measurement

9. The Research Process Phase III Data collection Phase IV Analyze Interpret Draw valid conclusions Phase V Research report

10. Research Process Identify Problem Review Literature Identify Variables State Hypotheses Phase I – Identify Research Question Design Protocol Choose Sample Phase II – Design Study Collect Data Reduce Data Phase III - Methods Report Findings Suggestions Phase V Communication Analyze Data Interpret Findings Phase IV – Data Analysis

11. Basic vs. Applied Experimental vs. Non-Experimental Types of Research

12. True experimental Quasi-experimental Sequential clinical trials Single-case experimental designs Experimental Research

13. Descriptive Correlational Secondary Analysis Qualitative Epidemiological Non-experimental Research

14. Historical Evaluation Methodological Non-experimental Research

15. Role of Theory What is theory? Set of inter-related concepts, definitions or propositions Specifies relationships among variables Represents a systematic view of specific phenomena

16. Role of Theory Clinical research Systematic method for evaluating effectiveness of treatment Establishes basis for inductive generalizations about intervention Research validates theory

17. Purpose of Theories  Summarize existing knowledge  Explain observable events by showing how variables are related  Predict what should occur  Stimulate the development of new knowledge

18. Scientific Thought Laws THEORY Explanation of relationships Research Hypotheses Predicted relationships Conceptual Framework Empirical generalizations FACTS Empirical Obseravations DEDUCTION Theory testing INDUCTION Theory development

19. Characteristics of Theories  Rational explanation of observed facts  Economical - efficient  Important  Consistent with observed facts

20. Theory Development Not discovered but created Basic process is one of induction Multiple observations  collection of facts

21. Theory Testing In itself is not testable Test hypotheses deduced from the theory Validity of a theory is derived from: empirical testing of hypotheses observation of phenomena that theory describes

22. Hypothesis Educated guess about outcome of study Established after research questions are formulated and variables defined Results of research will support or not support the hypothesis

23. Hypothesis Hypothesis supported  theory supported Law theory reaches level of absolute consistency in outcomes

24. Ethical Issues in Research Relates to: conduct of clinical research in planning, implementation and to the valuing of human dignity and the protection of human rights.

25. Ethical Issues in Research Integrity of the Researcher Responsible for honesty and integrity Pursue questions in those areas of greater importance to society Research must be meaningful Research must be reliable and valid Minimize bias Publish honest results Researchers should be aware of conflict of interest True credit for authorship

26. Protection of Human Rights in Clinical Research Clinical research - document the efficacy and efficiency of treatment interventions Principles Respect for the individual Concern for each person’s well being Justice

27. Protection of Human Rights in Clinical Research Establishment of Human Rights: Syphilis Study Nurenberg code of 1947 Declaration of Helsenki 1974 National Research Act

28. Ensures the protection of human subjects in research: Research proposal Informed consent IRB approval of proposal and consent

29. Elements of Informed Consent Subjects must be fully informed Purpose Procedures Risks and discomforts Benefits Alternative to participation

30. Elements of Informed Consent Confidentiality Request for more information Refusal or withdrawal Injury statement Consent statement Signature

31. IRB Federal regulations (NIH) states: Must be 5 members Not all male or females, or member of one professional group One member must be concerned with non-scientific issues One member must not be affiliated with the institution