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PTP 560 Research Methods Week 2 Thomas Ruediger, PT.

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1 PTP 560 Research Methods Week 2 Thomas Ruediger, PT

2 The Research Question More important than ability as statistician Requires refinement to answerable question – Topic – Research Problem – Research Question Research Question shaped by: – Clinical experience/interest – Feasibility and importance – Population to be sampled – Rationale – Variables to consider

3 The Variables Independent (IV in this course) – The predictor – Can have more than one IV – Always at least two levels for each independent variable Dependent (DV in this course) – The outcome – Can have more than one – No levels

4 The Hypotheses Research – True expectation Statistical (null) – There is no difference/no relationship between IV and DV Directional (difference will be in a specific direction) Non-directional (only that there will be a difference) Simple (One IV and One DV) Complex (more than one IV and or DV)

5 The Literature Review it every step of the way (Fig 7.1 P & W) Differentiate your sources – Primary sources Peer reviewed journal articles Oral presentations from the researcher Interviews Personal experience – Secondary sources Textbooks (good source of citations of primary sources) Review articles

6 Theory and Clinical Research Clinical Research – Systematic method – Effectiveness of treatment – Establishing generalizations Theory – Ultimate goal of research – Contributes to practice – Organizes complex evidence – Scientific theory Empirical Verification required

7 Theory Summarize knowledge Frame future observations Predict future events Stimulate research/thinking Background for a clinical question This is what you’ll get most credit for in your CR Components – Concepts=chair(chrome, plastic, screws together make our concept of a chair) – Constructs=IQ, Pain (can not see, but rather a theory or application that we understand) Theory may rise to level of being a law – gravity Propositions (Maslow example)= – 1) Biological Needs 2) Safety 3) Love 4) Self-esteem 5) Self-actulalization

8 Theory Models – Simplifications/analogies (disk=like jelly dounut_ – Possible explanations for complex processes Inductive theories (Development) specific to general, generalize to the major population. Deductive Theories (Testing) General to specific – Intuitive – Hypothetical Characteristics – Thorough and rational – Verifiable (Reproducible***) – Economical – Important

9 Theory Testing – Not the theory – Hypothesis/hypotheses that can be observed Two possible outcomes of testing – Reject The underlying theory isn’t supported in this situation – Fail to reject In this situation, the underlying theory is supported Clinical application (Effectiveness) – As opposed to laboratory (Efficacious) – Every time you treat a patient – Keep track of what you do! – What if the outcome doesn’t support your prediction?

10 Theory Application Continue to observe Change in the face of irreconcilable evidence Derive a meta-theory – Explain complex phenomena Multi-factorial nature of disability Regulation of insulin Continual effort to refine/improve

11 Ethics in Research Be Honest – Report what you find – Report what you don’t find Have Integrity – Conduct meaningful research – Use sound principles Appropriate sample Appropriate analysis Minimize personal bias

12 Protect Human Rights Guiding Principles *testable – *Autonomy of the individual – *Beneficence Do no harm Protect from harm by maximizing possible benefits and minimizing possible risks of harm. – *Justice Fairness in distribution of burdens and benefits. Use Control/Comparison Groups – Control If no intervention shown to be effective If establishing ineffectiveness is important – Comparison If there is a current effective treatment Doesn’t establish that the new is better than none!

13 Integrity in Research Use Control/Comparison Groups – Control If no intervention shown to be effective If establishing ineffectiveness is important – Comparison If there is a current effective treatment Doesn’t establish that the new is better than none!

14 Regulations Nuremburg Code - 1947 Declaration of Helsinki -1964 Belmont Report - 1974 Common Rule (45 CFR 46) TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46 PROTECTION OF HUMAN SUBJECTS Privacy Rule (HIPAA component) – Does not apply to research – May affect researchers access to information, but it does not regulate them or research, per se

15 Institutional Review Board At least five members At least one man, one woman Must be able to competently review science – But not all members in one professional group One must be concerned with non-scientific – Clergy – Ethicist – Lawyer One must be unaffiliated “Public” Member

16 Informed Consent Must be voluntary Special consideration to the vulnerable – Mental illness – Developmental disability – Diminished mental capacity – Prisoners – Children – Student/soldiers/subordinates Free to withdraw consent at any time – Without losing quality of care – May withdraw even after data collection is complete

17 Informed Consent Purpose of Research Procedures Risks and Discomforts Benefits Alternatives Confidentiality Request for more information Refusal or withdrawal Injury statement Consent statement Signatures

18 Unethical research Nazi physicians Tuskegee Study – Study for county wide epidemic of “Bad Blood “ Multi-organ impact Mental illness, blindness, severe damage to the heart and aorta, and death. – 1932-1972 – 399 men followed to assess course of the disease – Why was this unethical? – By the mid 1940s, how was this treated?

19 EMG Article What was the Research Question? Why is the Research Question important? Who were the subjects? – Number/Age/Gender/etc – Inclusion/Exclusion Criteria What was/were the IV(s)? What was/were the DV(s) What were the results? How were they reported? – Mean, SD, range, others? What kind of study is this? Could you reproduce the study?

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