Exam 1

• Academic and clinical programs should be characterized by

  a culture that continuously pursues improvement where current practices are questioned, innovation is valued, and risk taking is embraced to achieve excellence.
• patient-oriented research

  research conducted with human subjects (or on material of human origin) for which an investigator (or colleague) directly interacts with human subjects; mechanisms of: Human disease, clinical trials, therapeutic interventions, development of new technologies, epidemiologic and behavioral studies, outcomes and health services research
• steps of the research process

  1. identify research problem 2. design the study 3. methods/procedures/collect data 4. analyze data and interpret results 5. report findings, suggest further studies
• basic research

  –Develop, refine or test theory–Acquisition of new knowledge, no reference to practical use of results–Often referred to as “Bench Research”- lab based
• applied research

  –Solving immediate practical problems with functional applications–Testing theories that direct practice–Conducted on participants-in the field
• translational research

  –Application of scientific findings to clinical relevance or generates scientific questions based on clinical scenarios–Often referred to as “Bedside to Bench and back to Bedside”–Often appears as a supplement to some NIH research grants
• quantitative research

  Measures outcomes with numerical data, Emphasizes specific controls and experimentation, Utilizes deductive and inductive reasoning
• qualitative research

  Central Phenomenon, Emphasizes understanding participants point of view, Utilizes open-ended questions and interviews, Includes recording observations made by researcher
• experimental research

  Manipulation of a variable and observe results, Suggests cause-and-effect relationships, Incorporates randomized controlled trials; effect of A on B
• exploratory/observational research


  No manipulation of variables, Explores relationships between variables, Correlation, predictions etc.; relationship between A and B
• descriptive research


  Characterizes data to understand phenomenon, Description of a specific case or a group of individual characteristics, Documents responses from interviews, questionnaires; describe subject characteristics
• Sources of knowledge


  • Tradition
  • Authority
  • Trial and Error
  • Deductive Reasoning
  • Inductive Reasoning
  • Scientific Method
• Tradition


  • Can create challenges for clinical science
  • Clinical decision making may stifle search for new information
  • May perpetuate an idea when contrary evidence may currently exist
• Authority


  • Trust placed in expertise or specialist
  • May be necessary when scientific evidence is not available
  • When a discrepancy is detected, relative to an authority, findings may not be readily accepted
• Trial and Error


  1. Clinical problem

  2. Attempt solution

  3. Assess results

  4. If positive, solution accepted

  5. If negative, solution rejected
• Deductive Reasoning


  Generalization to specific (Syllogism)
• Inductive Reasoning


  • Reverse type of logic
  • Develop Generalizations based on Specific Observations
  • Facilitated genesis of scientific approach
  • Could act as basis for intuitive process
• Scientific Method


  Rigorous process for acquiring new knowledge
• The process of EBP – 5As

  1) Ask a clinical question,

  2) Acquire relevant literature,

  3) Appraise the literature,

  4) Apply findings to clinical decision-making, 5) Assess success of the process.
• Outcomes of pt. care

  health(subjective; objective: vital signs), ROM (objective), pain (subjective), strength (subjective); provides the validation regarding the effectiveness of provider care
• outcomes research


  study of success of interventions in clinical practice and/or developing instruments to measure function and health status. Pt. care defined in disability and survival.
• PICO/PEO


  Patient, Intervention, Comparison, Outcome / Patient, Exposure(uncontrollable), Outcome
• biomedical model


  pathology<-> impairments; not as common; based on survival; Attention is on the physical aspects of health, with no consideration to how the pt. is affected by illness.
• disablement model


  pathology-impairment-functional limitation-disability; does not show capability; Assess acute and chronic conditions via functional consequences and social role
• ICF Model


  classification of functioning, disability and health; How people live with their current or fluctuating health conditions
• researcher integrity


  prioritize and pursue questions that are relevant to important healthcare issues; meaningful approach; minimize personal bias; statistical rigor vs data manipulation; honest reporting of results; recognize conflicts of interest; authorship
• guiding principles


  autonomy: did the individuals get to choose to participate (voluntary consent); beneficence: what are the risks and benefits; justice: fairness
• Control/Placebo groups


  • Randomized control designs>> observational designs • The “clinical dilemma” – The researcher is also the clinician, control assignment despite evidence of effective therapeutic intervention. – Declaration of Helsinski • Researcher obligations: – Inform participants of assignment possibilities (justice) – Offer experimental intervention after the study (Declaration of Helsinski)
• Nuremberg Code 1949


  WWII; German Physicians performed various research experiments on concentration camp detainees; Researchers did not have consent from detainees • Results: Individuals were either severely crippled or experienced death
• Tuskegee Syphilis Study


  • U.S. Public Health Service (1932-1972) • 600 Low Income Participants (African American Males) • Subjects injected with syphilis, disease monitored 40 years • Participants informed they were being treated for bad blood • Participants received free medical exams, free meals, and burial insurance • Promised treatment, but were not treated for disease
• Declaration of Helsinki


  established ethical principles; Research protocols should be reviewed by an independent committee before initiation; informed consent
• the Belmont report


  Establish guiding principles when using human subjects (Respect for Person (Autonomy), Do no harm, maximize benefits, minimize risks (Beneficence), Fair distribution of costs and benefits to participants (Justice)
• Institutional Review Board


  Federal Regulations (Consist of at least 5 members • One member must be concerned with nonscientific details • One member must not be affiliated with the institution) Review of Research Proposals: Scientific merit of the project, Competence of the investigators, Risk & Benefits to the subjects: Minimized and sufficiently outweighed by the benefits, Ability/Feasibility relative to identified resources, Subject selection and consent, privacy rule)
• IRB expedited vs. exempt review

  expedited: IRB chair and 1 other conduct the review vs. exempt: Surveys, interviews, or study of existing data, Non-sensitive issues, When actual patient records are used IRB approval is required
• protocol components


  • Background & Introduction • Objectives (Specific Aims) • Participant selection criteria • Study Design • Study Procedures & Measurements • Data Safety and Monitoring • Statistical Methods, Data Analysis, Interpretation • Study Resources • Recruitment • References
• informed consent 


  • Subject must be fully informed (Procedures clearly explained, Risks and benefits) • Confidentiality • Written in Lay language • Consent must be voluntary, may withdraw from study at any time • Researcher and participant have signed copies of consent form • Special consideration to “vulnerable” populations
• measurement allows us to

  Describe phenomenon (Quantity or quality, ‘standard’), Demonstrate change or relationship (Over time or between groups), Communicate the information to others (Objectivity to a variable, ‘common terms’), Decision-making or drawing conclusions, assign numerals to variables, represent quantities of characteristics
• terminology


  NUMERAL – Symbol or label, number VARIABLE – A ‘property or attribute’ that differentiates individuals or objects – Could have more than one value VALUE – Quantitative or Qualitative PRECISION – Exactness of a measure, depends on the sensitivity of the measuring system and variable itself ACCURACY – Degree of difference between measured score and a known standard
• continuous variable


  Anywhere along a Continuum, Has a defined range, Limitations: precision of apparatus or tool as well as the individual measuring
• discrete variable


  whole units ONLY, quantitative (HR, number of falls, MMT strength), qualitative (gender, closed-ended questions, limited to two values=dichotomous)