Exam 1 Flashcards
High quality research is essential for? What 3 things?
What is the pharmacists role?
- 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
Biomedical Research Defined
- Research involves systematic study directed toward fuller scientific knowledge or understanding of a subject.
- Research is expensive and must be done right
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?
- 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
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
- Patient-oriented
- Mechanisms of disease, effects of drug therapy or other interventions
- 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
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?
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?
Steps in the research process
1-4
Quirky Patrick Ate Rubarb
Step 1) Pose A research question
- Desirable characteristics of research question? Youre looking good!!
- Framework used to develop a question? Protest!
- Example question
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?
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, _____, _____?
Step 3) Preform data collection and analysis
- May be subject to errors/omissions since researchers cannot control data collection
- Outlines how data will be collected and statistically analyzed
- Preferred, since researchers control data collection
- Typically, prospectively collected
- Involves data collected during patient care but is subsequently analyzed for research
- Involves data that was collected as part of a research study
- Typically, retrospectively collected
Primary, Secondary, Data management and statistically analysis plan
Step 4)
Abstract, Poster, Platform presentation, Journal Article, Structured format often used
Step 4)
Intro, Methods, Results, Discussion
EBM
Goal of clinical research?
Essential for?
Quality healthcare needs 6 things
Some Elephants Poop Toenails Every Eclipse
EBM integrates what?
Steps to deliver EBM
4
- Ask
- Find
- Appraise
- Apply
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)
Causality
____ is associated with the ____
8 Criterion for Causation
Research design classifications
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
Time Orientation
Think about the study design flow chart
Investigator Orientation
Flow chart
Experimental Settings in clinical research
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
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?
Cross Sectional Studies
- What is the populations examined?
- Used to assess?
- YOu cant make implications of what in this?
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?
Prospective Cohort Studies
Retrospective Cohort Studies
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
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?
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
Observational Research Methods
Pts know their being watched
Less likely to alter behavior
Pts dont know their being watched
More likely to alter behavior
Biological Measures Research Methods
3 types
RCTs
Seven factors that influence internal validity
Seve factors that influence internal validity
Maximizing External Validity
All about interactions
Maximizing External Validity
Bias
Minimizing 5 common biases
Minimizing 5 common biases
Randomization
Effective for reducing what?
4 types of randomization
Randomization
Blinding
Sample Size
Effect Size?
Power?
Research Protocol
Selecting Participants
Selection of the control group
What are the 3 controls
what are the 3 trials?
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
Designing the Intervention
Efficacy vs. Effectiveness
Study Measurements
Analyzing the results
IOIS IM ANALYZING ISIS!!
Analytical Approach
Relative risk? Why?
Risk difference?
Number needed to treat
Strengths and Weaknesses of RCTs
