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Evidence Based Pharmacotherapy > Decision analysis > Flashcards

Decision analysis Flashcards

1
Q

Decision Analysis

A

An analytical method for systematically comparing different decision options.
Provides an orderly, analytical approach to assist decision maker in identifying the preferred course of action from among competing alternatives.

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2
Q

When to use decision analysis?

A

When uncertainty about clinical strategy is evident,
When differences in benefits and risk are evident
No head to head trials

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3
Q

Decision analysis characteristics

A

Explicit- forces you to structure the decision you face as well as identify the consequences of the possible outcomes.
Quantitative- Forces you to assign number to probability estimates and outcome valuations.

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4
Q

Applications of decision analysis

A

Choosing among treatments
Choosing between treatment and no treatment
Preventing diseases (vaccinations)
Preventing complications

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5
Q

Decision tree

A

Built to be reflective of clinical reality.

Focuses on most important components, not “real world”

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6
Q

Steps in decision analysis

A
  1. ) Identify decision
  2. ) Specify alternatives
  3. ) Draw tree
  4. ) specify branch, outcomes, probabilities
  5. ) Calculations
  6. ) Conduct a sensitivity analysis
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7
Q

Identifying specifc decision

A

Time period of analysis?
Objective of study?
Perspective?
Example- Decision on whether to add new abx A to an institutional formulary

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8
Q

Specify alternatives

A 
Ideally, compare the most effective treatments
Comparison: 
standard treatment vs. new treatment
Intervention vs. no intervention
More than two competing options.

Example- what should abx A compare to?

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9
Q

What is a choice represented by?

A

Square

Represents conscious decision

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10
Q

What is a chance represented by?

A

Circle
Represents probabilities
It is a chance node

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11
Q

What is terminal (final outcome) represented by?

A

Triangle.

Represents dollars, quality adjusted life years, survival

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12
Q

For each option of decision analysis, what do you need?

A

Probability of occurrence and consequences of occurrence.

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13
Q

Interpretation of a probability of outcome D of 0.126.

A

If 100 people went through the model, about 13 people (12.6) would go down pathway D.

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14
Q

Average cost

A

The cost multiplied by the probability for each terminal node and then added for each option provides the average cost.

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15
Q

Incremental Cost Effectiveness Ratio (ICER)

A

Change in costs/change in outcomes

Example- if 500: 500 more dollars for each additional success with abx a.

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16
Q

Incremental net benefit

A

Alternative to ICER
An estimate for health benefits (outcomes) is added into the incremental analysis (lambda, max willingness to pay, estimated value)
If INB >0, then the intervention is considered cost-effective.

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17
Q

What does it mean if the ICER is positive?

A

One medication is more effective and more costly.

Using a lambda value makes it easier to choose. If the INB value is negative, you lose value.

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18
Q

Sensitivity Analysis

A

Measures the uncertainty in a model
Does not compensate for poor assumptions
The larger the variability, induced by changing a parameter, the more sensitive the outcome is

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19
Q

Overview of Markov modeling

A

Some diseases have complex outcomes that require longer f/u periods (>1 year)
Patients my transition between health states
Each f/u interval is called a cycle

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20
Q

Health states in Markov

A

Must be mutually exclusive. Cannot have the 2 states at the same time. Typically one occurs from complications of another.

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21
Q

Steps in markov modeling

A
  1. ) Choose health states
  2. ) Determine transition states
  3. ) Choose how long and how many cycles
  4. ) Estimate probabilities associated with moving in and out of health states
  5. ) Estimate costs and outcomes.
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22
Q

Absorbing state in markov model

A

Once a pt is in an absorbing state, he/she cannot transition out of it.
Death
Diabetes

You need an absorbing state to finish the model.

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23
Q

Disadvantages of Markov Modeling

A

Complexity and transparency
The Markovian assumption- knowing only the present state of health is sufficient to project the trajectory of future states.

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24
Q

Drug policy is maintained through

A

Formulary system

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25
Q

Formulary

A

Preferred list of pharmaceuticals to be used in a health system that reflects current clinical judgement.

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26
Q

Open formulary

A

Can bring in products not on list.

PBM: Payer will provide coverage for formulary and non-formulary drugs

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27
Q

Closed formulary

A

Health system: Limited/no capability to bring in non-approved products
PBM: Non-formulary drugs not reimbursed by the payer.

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28
Q

Formulary maintenance

A

P and T committee
Voting members- physicians, pharmacists, nurses, health system administrators, respiratory therapists, social workers.
Subcommittees may report through P&T

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29
Q

P&T Activities

A 
Formulary drug review
FDA drug safety alerts
Shortage formulary review
Medication use evaluations
Drug cost savings initiatives
Monitor drug use reports
Pharm rep code of conduct enforcement
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30
Q

Formulary categories

A

Formulary
Restricted formulary
Non-formulary
Non-formulary non-stock

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31
Q

Formulary category: Formulary

A

Readily available for use

Provider should order and expect for patient to receive in 1-2 hours

32
Q

Formulary category: Restricted formulary

A

Readily available if certain criteria are met

Drugs may be restricted to disease states, lab values, hospital floors, providers, etc.

33
Q

Formulary category: Non-formulary

A

Not readily available

May be able to order for individual patients if clinical need is demonstrated

34
Q

Formulary category: Non-formulary non-stock

A

Will not be available for use under any circumstances.

35
Q

Formulary maintenance decision

A

Safety data, efficacy data, cost data

36
Q

Formulary system support tools

A

Policy
Guidelines
restrictions
Therapeutic interchanges

37
Q

Policies

A

Dictate how drugs will be ordered, dispensed, administered, monitored, and assessed
Should not deviate from policy
Can help TJH medication management standards
Examples: look-alike sound-alike, vaccine storage, handling, dofetilide use

38
Q

Guidelines

A

Support evidence-based use of drugs or for disease states
May support restrictions
May guide administration practices
Providers can deviate

39
Q

Restrictions

A

Criteria that must be met in order to use drug- clinical, provider-based, location-based, financial
If outside that criteria is considered non-formulary and may require approval

40
Q

Therapeutic Interchanges

A

Replace a prescribed drug to another chemically different, clinically similar drug
Evidence-based interchange to equivalent doses of preferred agent
Streamline inventory
Example- PPI

41
Q

Formulary assessment process

A

Request- from providers or pharmacists. Want to know about drug name, clinical reasoning, evidence, estimated volume of use, and conflicts of interest

Analysis- Performed by non-biased third party (Drug policy specialist). Assess efficacy, safety, cost data. Recommendation

P&T decision- presentation of data, questions from committee members, vote.

42
Q

Formulary analysis

A

Safety data, cost data, efficacy data, other

43
Q

Safety, what are we looking at?

A 
Contraindications
Warnings/precautions
AE
Post-marketing data
Look-alike sound-alike
Packaging issues
44
Q

Efficacy, what are we looking at?

A

Published information
Reviews/expert opinions
Guidelines

45
Q

Cost, what are we looking at?

A

Pharmacoeconomic studies if available
Cost per unit, per dose, relative to alternatives
Volume- based analysis to estimate annual impact
Medication access: third party coverage/assistance programs

46
Q

Presentation of drug

A

Pharmacist and other non-biased third party presents drug assessment to P&T or subcommittee

47
Q

Implementation of formulary

A 
Electronic medical record changes
Dose limitations, order sets, product selection
Educate
Procurement
Storage
48
Q

Order sets/protocols

A

Help drive how drugs are used in formulary system

Example: Order set for amphotericin B liposomal that includes pre-hydration and medication

49
Q

Procurement

A

Traditional wholesale
Direct purchase
Limited distribution

50
Q

White bagging

A

Can only get through outside specialty pharmacy, sent to hospital

51
Q

Brown bagging

A

Specialty drug dispensed by outside pharmacy and sent to patients home

52
Q

Clear bagging

A

Specialty drug acquired/dispensed by institutions own specialty pharmacy and stored prior to use

53
Q

Quality of life in clinical medicine

A

Represents the functional effect of an illness and its consequent therapy upon a patient, as perceived by the patient

54
Q

Measuring HRQoL

A

Utility measures

Health status measures

55
Q

Utility measures

A

Also referred to as “preference-based measures” or QALY measures
Estimates the utility or “value” that individuals assign to different health states
Number between 0-1 X length of time in each health state to represent the combined impact on morbidity and mortality in linear fashion
Also used to calculate cost-utility
Standard gamble and time trade off

56
Q

Health status measures

A

A patients estimation of their own health at a point in time
Measured based off of patients viewpoint
Measured in multiple domains; often many scores

57
Q

HRQoL Domains

A

Physical functioning
Social and Role Functioning
Mental Health
General Health perceptions

58
Q

Physical functioning

A

Limitations or disability
Physical abilities
Days in bed
Bodily pain

59
Q

Social and Role functioning

A

Interpersonal contacts- frequency of contacts with family/friends
Social resources- social media
Are you able to continue doing the things you want to do in life?

60
Q

Mental health

A

Anxiety/depression
Psychological well-being
Behavioral/emotional control
Cognitive function

61
Q

General health perceptions

A

Current self-rating of health

Outlook for future

62
Q

General health status instruments

A

General health

Disease specific

63
Q

Generic HRQoL instruments

A

Relative to any type of situation
Advantages- readily available, reliability and validity known, comparable across studies
Disadvantages- questions may not be applicable, may not focus on area of interest, may not be sensitive to change

64
Q

Disease specific QOL measures

A

Advantages- tailor made, focuses on question of interest, more likely to detect change
Disadvantages- time and effort to design, reliability and validity testing necessary, may not be comprehensive , may not be acceptable to others, cannot cross studies

65
Q

QOL tools

A

Karnofsky functional performance scale
EuroQol Instrument
Medical Outcomes Study 36-item Short-form health survey

66
Q

Karnovsky

A

Objective measure of functional performance.
Completed by healthcare professional with input by patient.
Each category is subdivided into 3 descriptors, each associated with a score. The higher the score, the better overall functioning.
Categorizes on ability to perform daily activities.

67
Q

EQ-5D

A

Non-disease specific instrument for measuring of health and health-related qol in patients
Self completion by pt
Comprises 5 dimensions of health- mobility, self-care, usual activities, pain/discomfort, anxiety and depression
Scale is 0-1

68
Q

MOS SF-36

A

36 questions measuring 8 health attributes
Subjective health-realted QOL
Self administered
Great insight into health of patient

69
Q

SF-36 measurement model

A

Physical health and mental health broken into 8 total domains

70
Q

Psychometrics

A

The science of using standardized tests or scales to evaluate attributes of an individual
Used to translate peoples behavior, feelings, and personal evaluations into quantifiable data
Reliability and validity

71
Q

Key factors in selecting HRQOL tool

A 
Reliability and validity
Responsiveness
Acceptability for use
Frequency of use
Culturally valid
72
Q

Reliability

A

Measure is consistent and reproducible
Test-retest reliability
Internal consistency
Intra and inter observer reliability

73
Q

Validity

A

Does the questionnaire really measure QOL?

74
Q

Responsiveness

A

Do scores accurately reflect over time?

75
Q

What is most widely used QOL tool?

A

SF-36

In many languages, culturally tested

76
Q

What is the use of QOL in clinical trials and practice?

A

Very important to look at whole patient.

Evidence Based Pharmacotherapy (3 decks)

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