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PTP 560. Research Methods Week 2. Thomas Ruediger, PT. 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

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PTP 560


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ptp 560
PTP 560
  • Research Methods
  • Week 2

Thomas Ruediger, PT

the research question
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
the variables
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
the hypotheses
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)
the literature
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
theory and clinical research
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
theory
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
theory1
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
theory2
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?
theory application
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
ethics in research
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
protect human rights
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!
integrity in research
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!
regulations
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

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

  • 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

http://privacyruleandresearch.nih.gov/pr_06.asp

institutional review board
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
informed consent
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
informed consent1
Informed Consent
  • Purpose of Research
  • Procedures
  • Risks and Discomforts
  • Benefits
  • Alternatives
  • Confidentiality
  • Request for more information
  • Refusal or withdrawal
  • Injury statement
  • Consent statement
  • Signatures
unethical research
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?
emg article
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?