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Introduction to Research

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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

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