Exam 1

Question 1

High quality research is essential for? What 3 things?

What is the pharmacists role?

Answer 1

• Drug discovery and development
• Defining the role of drug practice
• Evaluating the impact of clinical services for paitent outcomes

Role in both creating and applying scientific evidence

Question 2

Biomedical Research Defined

Answer 2

• Research involves systematic study directed toward fuller scientific knowledge or understanding of a subject.
• Research is expensive and must be done right

Question 3

Biomed research

Basic Research

• Typically based on what type of research?
• What is the research about?

Applied 1

• What does this research seek to do?

Clinical research 2

• This research directly involves what?
• What does it define?

Answer 3

• Research about the fundamental aspects of phenomena without specific applications about processes or products
• Typically lab-based research in the core sciences (chemistry, etc)

Applied

• Research that seeks solutions to a specific need (disease, population, etc)

Clinical Research

• Research that directly involves a particular group or person, or samples of their tissues
• Defines the application of processes or products in prevention, diagnosis, prognosis, treatment, or cure of human disease

Question 4

Clinical Research

Pt oriented

• Mechanisms and effects of what?

Epidemiologic behavior

• What does it evaluate?

Health services

• What does it evaluate? What type of setting?
• Pharmaceutical practice/ policy research
  
  • Involves the research of what?
  • What perspectives? 5 of them

Answer 4

• Patient-oriented
  
  • Mechanisms of disease, effects of drug therapy or other interventions
    ​

Epidemiologic and behavioral

• Evaluates the distribution of and factors associated with diseases, health behaviors, and health in general

Health-services

• Evaluates the effectiveness and efficiency of treatment, interventions, and services in real-world practice
• Pharmaceutical practice/policy research
  
  • Involves research about the cost of, access to, and quality of care
  • Clinical, sociobehavioral, economic, organizational, or technological perspectives

Question 5

Evolving Research Paradigms

Translational Research

• Where does the knowledge go?
• What are the 2 type?

Comparative Effectiveness Research

• Head to head

Pt centered outcome research

• What is incorporated into the research process?
• What relevant information is provided?

Answer 5

Question 6

Scientific Research

• Information collection is based on?
• What should you do with data?
• How can you avoid subjective data?
• Natural Phenom?
• What does it provide for a research question and hypothesis?
• Moral?

Answer 6

Question 7

Steps in the research process

1-4

Quirky Patrick Ate Rubarb

Answer 7

Question 8

Step 1) Pose A research question

• Desirable characteristics of research question? Youre looking good!!
• Framework used to develop a question? Protest!
• Example question

Answer 8

Question 9

Number 2

Step 1) Pose a research question

• Rx questions can be thought of in 2 ways
• How do each of these work?
• Defines an expected relationship between?
• Typically based on?

Answer 9

Question 10

Step 2 Develop and Implement a research plan

What do research plans include?

Design is the overall plan to answer and test what 2 things? And then can be categorized into what two things?

Provide details regarding data collection, _____, _____?

Answer 10

Question 11

Step 3) Preform data collection and analysis

1. May be subject to errors/omissions since researchers cannot control data collection
2. Outlines how data will be collected and statistically analyzed
3. Preferred, since researchers control data collection
4. Typically, prospectively collected
5. Involves data collected during patient care but is subsequently analyzed for research
6. Involves data that was collected as part of a research study
7. Typically, retrospectively collected

Primary, Secondary, Data management and statistically analysis plan

Answer 11

Question 12

Step 4)

Abstract, Poster, Platform presentation, Journal Article, Structured format often used

Answer 12

Question 13

Step 4)

Intro, Methods, Results, Discussion

Answer 13

Question 14

EBM

Goal of clinical research?

Essential for?

Quality healthcare needs 6 things

Some Elephants Poop Toenails Every Eclipse

EBM integrates what?

Answer 14

Question 15

Steps to deliver EBM

4

1. Ask
2. Find
3. Appraise
4. Apply

Answer 15

Question 16

Validity

Extent the study results can be applied or generalized to other setting/populations

Extent the clinical outcome of interest (dependent variable) is caused by the intervention/tx

Good studies control for extraneous factors that influence the outcome (Coffee/lung cancer)

Answer 16

Question 17

Causality

____ is associated with the ____

8 Criterion for Causation

Answer 17

Question 18

Research design classifications

Answer 18

Question 19

Study purpose

What of them asks the who what when where why

The other one tests hypothesis and understanding the relationship and/or causal mechanism that exist b/w 2 or more variables

Answer 19

Question 20

Time Orientation

Think about the study design flow chart

Answer 20

Question 21

Investigator Orientation

Flow chart

Answer 21

Question 22

Experimental Settings in clinical research

Answer 22

Question 23

RCTs

• How is the intervention assign to subjects?
• How good is it at establishing Safety and Efficacy?
• Who gets the tx?
• Who gets the placebo or standard of care?
• What allows for baseline factors to be similar in the intervention and control groups?
• If theres differences in the results between groups whats causing it?
• What increases internal validity?
• What influences generalizability? 2 things

Answer 23

Question 24

Observational Designs

• Oberserves the relationship between?
• What doesnt happen in this?
• Single pt and unique experience?
• Group of pts and their experience?
• These two things above bring attention what?

Answer 24

Question 25

Cross Sectional Studies * What is the populations examined? * Used to assess? * YOu cant make implications of what in this?

Answer 25

Question 26

Case-Control Studies * What does the investigator identify? * After this identification. What does the investigator do and what does he determine? * What is determined and compared between the groups? * What can be present if you dont do a good job?

Answer 26

Question 27

Prospective Cohort Studies

Answer 27

Question 28

Retrospective Cohort Studies

Answer 28

Question 29

Research Methodologies Focuses on ____ and ____ \_\_\_\_\_ Primary vs. secondary medthods Consistency and reprooducability of the study results Inter-rater- reliabilty What extent does an instrument measure what it is intended to measure

Answer 29

Question 30

Research Methodologies Appearance of an instrument used to evaluate validity Does the instrument measure what it needs to? Does it measure what its reported to measure?

Answer 30

Question 31

Self Reported Research Methods * Unstructured interviews * Face-to-face interviews * In, person, mail, or online survey * Structured or standardized * Semi-structured * More difficult to conduct correctly than most believe * Open-ended/closed ended questions * S Survey insturments, Interviews

Answer 31

Question 32

Observational Research Methods Pts know their being watched Less likely to alter behavior Pts dont know their being watched More likely to alter behavior

Answer 32

Question 33

Biological Measures Research Methods 3 types

Answer 33

Question 34

RCTs

Answer 34

Question 35

Seven factors that influence internal validity

Answer 35

Question 36

Seve factors that influence internal validity

Answer 36

Question 37

Maximizing External Validity All about interactions

Answer 37

Question 38

Maximizing External Validity

Answer 38

Question 39

Bias

Answer 39

Question 40

Minimizing 5 common biases

Answer 40

Question 41

Minimizing 5 common biases

Answer 41

Question 42

Randomization Effective for reducing what? 4 types of randomization

Answer 42

Question 43

Randomization

Answer 43

Question 44

Blinding

Answer 44

Question 45

Sample Size Effect Size? Power?

Answer 45

Question 46

Research Protocol

Answer 46

Question 47

Selecting Participants

Answer 47

Question 48

Selection of the control group What are the 3 controls what are the 3 trials?

Answer 48

Question 49

Study Design Descriptions Parallel, Crossover, Factorial, Adaptive Evaluate multiple interventions in a single experiment Intervention or sample size changed after interim analysis Subjects recieve all interventions based on specified sequence 2x2 factorial design Each subject is their own control Susceptible to carry over Lingering outcomes

Answer 49

Question 50

Designing the Intervention Efficacy vs. Effectiveness

Answer 50

Question 51

Study Measurements

Answer 51

Question 52

Analyzing the results IOIS IM ANALYZING ISIS!!

Answer 52

Question 53

Analytical Approach Relative risk? Why? Risk difference? Number needed to treat

Answer 53

Question 54

Strengths and Weaknesses of RCTs

Answer 54