1. Introduction to Research

2. Wilson-1982
“Research is still not accepted by students as a respectable function for clinical practitioners.’To do’ not ‘to study’ sums up an attitude that clinical problems are far removed from research which has no value to student (clinical practitioners) immediate career goals and little clinical applicability.”

3. Purpose of Research Evidence-based practice
Validate clinical practice through scientific inquiry
Scientific rational must exist for clinical practice
Economic Challenges
- Healthcare reform / Insurance Companies
- Litigious Society

4. Evidence Based Practice
Is the integration of best research evidence with clinical experience and patient values
Sackett et al 2000

5. Inter-relationship Between
Best Evidence
Clinical Expertise
Patient Preferences
Clinical Context

6. 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

7. Clinical Research Dynamic and creative
Using a variety of qualitative and quantitative measurement tools
Performed in a variety of settings
Justify treatment
Ideal - “Scientist Practitioner”
Reality -
- usually not cost effective
- clinicians lack the skills

8. Sources of Knowledge
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
WORSE
BETTER
Rehab is rich in tradition
- offers a foundation
Authority - experts (Galen - father of preventative medicine
A.D.)
Deductive - major premise - minor premise - conclusion
Inductive - experience from observations - generalizations/
conclusions

9. Scientific Method Most rigorous process for acquiring new knowledge
Incorporates elements of deduction and induction
Systematic and controlled
Empirical
1st Deductive - Hypothesis
Later inductive - conclusions / generalizations
Factor

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

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

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

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

14. Research Questions? Examination Evaluation Diagnosis
Prognosis(plan of care)
Intervention
Outcomes

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

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

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

18. Non-experimental Research
Historical
Evaluation
Methodological

19. 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

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

21. 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

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

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

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

25. 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

26. 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

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

28. 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.

29. 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

30. 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

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

32. 1974 National Research Act
Ensures the protection of human subjects in research:
Research proposal
Informed consent
IRB approval of proposal and consent

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

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

35. 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