Daly Section Flashcards

(49 cards)

1
Q

What is the main aim of clinical research?

A

To determine efficacy

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2
Q

What is the main aim of outcomes research?

A

To determine effectiveness

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3
Q

What is the main aim of pharmacoeconomics?

A

To determine efficiency

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4
Q

What study design is typically used in clinical research?

A

Randomized Clinical Trials

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5
Q

What study design is typically used in outcomes research?

A

Observational studies and RCTs

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6
Q

What type of study design is typically used in pharmacoeconomics?

A

Economic analyses based on outcomes and clinical trials.

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7
Q

What is the main measure used in clinical research?

A

Efficacy and safety intermediate end points

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8
Q

What is the main measure used in outcomes research?

A

Patient-related outcomes

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9
Q

What is the main measure used in pharmacoeconomics?

A

Costs and Outcomes

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10
Q

What strategies are typically used in pharmacoeconomics research?

A
  1. Use of Published Studies
  2. Build an Economic Model
  3. Conduct a pharmacoeconomic study
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11
Q

What are the advantages of published literature in pharmacoeconomics?

A
  1. Quick
  2. Inexpensive
  3. Subject peer reviews
  4. Results from RCT often
  5. Variety of results can be examined.
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12
Q

What are the disadvantages of published literature in pharmacoeconomics?

A
  1. Results from RCTs
  2. Difficult to generalize results
  3. May not be comparative
  4. Misuse of pharmacoeconomic terms
  5. Variations in rigor/quality
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13
Q

What are the advantages of building an economic model in pharmacoeconomics?

A
  1. Quick
  2. Relatively Inexpensive
  3. Yields organization-specific results
  4. Bridges efficacy and effectiveness
  5. Data collection is unobtrusive
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14
Q

What are the disadvantages of buidling an economic model in pharmacoeconomics?

A
  1. Results dependent on assumptions
  2. Potential for researcher bias
  3. Controversial
  4. Reluctance of decision makers to accept results.
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15
Q

What are the advantages of conducting a pharmacoeconomic study?

A
  1. Flexible
  2. Usually Comparative
  3. Yields Organization-Specific data
  4. Reflects usual care or effectiveness
  5. Data from multiple sources may be used.
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16
Q

What are the disadvantages of conducting a pharmacoeconomic study?

A
  1. Expensive
  2. Time Consuming
  3. Difficult to control and randomize
  4. Potential for patient selection bias
  5. Potential for small sample size.
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17
Q

What are some tips for identifying pharmacoeconomic resources?

A
  1. Do not immediately go to database and look up costs
  2. Identify what variables are needed before collecting anything.
  3. Identify resources in terms of what is actually being used.
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18
Q

When measuring pharmacoeconomic resources, how should resources be counted?

A

Count resources in the units of service required to produced the intended benefit.

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19
Q

How should resources be valued in pharmacoeconomics?

A

Market value is used to value resources

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20
Q

What is theoretically the best value measure but not often used?

A

Opportunity costs
–> often not used because market value is acceptable and easier to understand.

21
Q

Are charges and costs the same thing?

22
Q

What are the three types of outcomes?

A
  1. Humanistic
  2. Clinical
  3. Economic
23
Q

_______ outcomes are outcomes which the pharmacist actually controls.

A

Pharmacotherapeutic

24
Q

______ outcomes are outcomes which represent the contribution of drug therapy in addressing overall clinical outcomes.

A

Pharmaceutical Outcomes

25
Are clinical indicators and intermediate outcomes acceptable to use as outcomes?
No --> These should only be used when the final outcomes are not readily identified or the time required for the outcome to occur are quite lengthy --> In some cases, intermediate outcomes represent the outcomes which the pharmacist should be held accountable. --> It is important to determine the confidence one has in linking intermediate and final outcomes.
26
What are economic outcomes?
1. Direct medical resources used to provide a service or achieve an outcome, including healthcare provider time and services. 2. Health-related quality of life 3. Patient Satisfaction 4. Reduced activity days
27
What are the types of study designs?
1. Experimental designs (RCT, economic clinical trials) 2. Observational Designs 3. Simulation Designs 4. Combination Designs
28
Biases to ______ ______ affect the accuracy of the results of the study as they apply to those who participated in the study?
Internal Validity ---> Patient Selection Bias ---> Cross over bias ----> Errors in measurement of outcomes ----> Errors in ascertainment of exposure to technology.
29
Biases to ______ ______ affect the gneralizability of the results to other settings.
External Validity ---> Differences among people studied versus people with whom the results will be applied.
30
True or False: All designs are affected by biases, but the patterns are different for different study designs.
True
31
______ may be the only ones able to provide certain information
Patients
32
Should the data analysis plan be developed before or after a study starts?
Before
33
True or False: A data analysis plan should not clearly state what data is to be collected to allow for more opportunity to formulate conclusions?
False: The study should: --> Limit data to be collected ---> If uncertain how to use data, do not include it.
34
In an economic analysis _____ is likely to be skewed
Healthcare resource use.
35
What type of costs should be used in an economic analysis?
Incremental costs ---> depending on whether comparing within or among interventions.
36
When should the IRB board be involved in a prospective study?
--> Before the study starts ---> This ensures patients are not put at an undue risk ---> Ensures consent form fully discusses risks and benefits
37
When should the IRB board be involved in a retrospective study?
Sometimes --> Institutions should review the protocol --> Different institutions have different policies regarding the notification of patients. ---> Contact an IRB member for clarification regarding institutional policies.
38
When analyzing claims data, is there any government oversight?
Yes, all data must be de-identified before the analysis.
39
Do patient questionaires require IRB review?
Some do ---> Questionaires count as informed consent!!
40
_______ database studies have become an increasingly important source of outcomes data, especially among MCOs.
Retrospective database studies.
41
What are the advantages of a prospective observational analysis?
1. Flexible 2. Yields provider specific data 3. Reflects usual care or effectiveness 4. Usually offers comparative data 5. Data from multiple sources may be used. 6. Less expensive than randomized controlled trials. 7. Prospective
42
What are the disadvantages of a prospective observational analysis?
1. Prospective 2. Expensive (time and money) 3. Difficult to control and randomize 4. Potential for patient selection bias 5. Small sample size 6. Difficulty generalizing results to other providers 7. Longer timeframe
43
What are the advantages of retrospective database analysis?
1. Has potential for large sample size 2. Can provide data quickly 3. Is customer specific 4. Reflects usual care or effectiveness 5. Relatively inexpensive 6. Shorter timeframe 7. Data collection is unobtrusive
44
What are the disadvantages of retrospective database analysis?
1. Retrospective 2. Inconsistent coding 3. Variations in database quality among managed care plans 4. Inconsistent access to pharmacy versus medical claims 5. Inability to randomize patients to treatment.
45
What are the steps to a pharmacoeconomic analysis?
1. Define the problem 2. Define Objectives 3. Identify alternatives 4. Formulate Research hypothesis 5. Establish a frame work 6. conduct pharmacoeconomic research
46
How is pharmacoeconomics used today?
1. Evaluate the value of pharmacy services 2. Contract with payers 3. Determine cost-effective therapy recommendations for patients/partners 4. New opportunities/jobs
47
_______ is putting pharmacoeconomic principles, methods, and theories into practice to assess the value of pharmaceutical products and services in "real word" practice settings.
Applied Pharmacoeconomics ---> Primary application is to inform local decision making
48
In applied pharmacoeconomics what are some common applications of economic assessments?
1. Formulary management 2. Clinical guidelines 3. Drug Use Policies 4. Service or Program Evaluation 5. Individual Patient Treatment decisions.
49
_______ is a cost-containment tool used by hospitals/managed care that does not always represent a list of the lest expensive alternatives. --> The function of this is to optimize therapeutic outcomes while controlling costs.
Formulary Management