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Pharmacoeconomics > Retrospective Databases > Flashcards

Retrospective Databases Flashcards

1
Q

Investigators must seek relevant information available in literature to assist in making decisions for a ___

A

Treatment related problem

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2
Q

What is the difference between RCT and observational?

A

RCT: provide efficacy data and uses randomization
Observational: Provide effectiveness data and has a risk of selection bias

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3
Q

Describe the pyramaid of studies? Risk of bias? Quality of evidence?

A
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4
Q

What is the difference between efficacy and effectiveness?

A

Efficacy: focuses on if the drug can work uder ideal conditions
Effectiveness: focuses on if the drug does work in real-world clinical practice

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5
Q

Why do we use RCT?

A
  1. Will recruit specific patient groups for the studies with exclusion criteria
  2. More patient monitoring occurs in RCTs than in general practice
  3. Higher medication adherence rates occur in RCTs
  4. Gold standard for determining efficacy
  5. Required by FDA prior to drug approval in the USA
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6
Q

Advantages of RCT?

A
  1. More rigourous
  2. Requires FDA approval
  3. Randomization reduces chance of baseline differences
  4. Collection of clinical and PRO data
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7
Q
A
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8
Q

Disadvantages of RCT?

A
  1. Only select patients
  2. Short-term follow-up period
  3. High cost for patient recruitment & follow-up
  4. Unrealistic, protocol-driven costs
  5. Includes only highly adherent patients
  6. Includes a small sample size
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9
Q

Advantages of retrospective databases?

A
  1. Broad range of patients
  2. Lower costs to conduct study
  3. Includes a larger sample size
  4. Longer time period for follow up
  5. Easier to perform sensitivity analysis
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10
Q

Disadvantages of retrospective databases?

A
  1. Risk of selection bias
  2. May only include one population
  3. May be missing relevant data
  4. Potential for miscoded data
  5. Clinical and PRO data may be lacking
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11
Q

What are the retrospective databases?

A
  1. Electronic Medical records
  2. National health survey data
  3. health insurance claims rrecords
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12
Q

What is electronic medical rocords?

A
  1. An electronic format of patient medical records that can be accessed via technology by HCP throughout its system
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13
Q

What is the function of electronic medical records?

A
  1. Provides detailed information about patient encounters
  2. Great data resource for pharmacoeconomic studies
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14
Q

What are the advantages of electronic medical records?

A

More complete resource for healthcare information than other methods

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15
Q

What are the disadvantages of electronic med recs?

A
  1. Expensive for implementing an EMR system
  2. TIme-consuming to locate and collect relevant information needed for a given study
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16
Q

What is National Hospital Ambulatory Medical Care Survey (NHAMS)?

A

Provide information on medical utilization patterns

17
Q

What is Medical Expenditure Panel Survey (MEPS)?

A

Estimates healthcare use/expenditures for non-institutionalized civilians in US

18
Q

What is the advantages of national health survey data?

A
  1. Povides high-quality information on healthcare costs/utilization
  2. General representation of US population
19
Q

What are the disadvantages of national health survey data?

A
  1. Potential for missed data variables of interest (i.e., patient co-pays or deductibles)
  2. Data collected for certain services are more accurate than other services
  3. Difficult to analyze survey data due to statistical complexity
19
Q

What is Health Insurance Claims Records?

A

Insurance records (AKA “claims data”) are often used in PE studies, as they provide specific information on a large group of patients

  1. Public insurers
  2. Private insurers
20
Q

What is the function of health insurance claims records?

A

Provides a clearer picture of a patient’s overall medical utilization, as investigators can merge claims data from different services & settings

21
Q

What is an advantages of health insurance claims record?

A
  1. Large amounts of patient data available in easily retrievable format
  2. Data collection system costs already paid by insurer who needs data to pay claims
22
Q

What is an disadvantages of health insurance claims record?

A

Missing clinical information necessary to answer questions

23
Q

How do you critique retrospective database studies?

A
  1. Clear explanation of the database
  2. Clear explanation of patient-selection criteria
  3. Eligibility of patients
  4. Clinical or outcome measures
  5. Sensitivity analyses
24
Q

What is Clear explanation of the database?

A
  1. Discuss the specific databases used in a study.
  2. Outline the time period used for data collection.
  3. Describe the population covered in the database.
  4. Address the type of information available in the databases.
  5. Disclose any relevant formulary or payment restrictions specific to an insurance plan.
25
Q

What is Clear explanation of patient-selection criteria?

A

Explain the criteria for selecting patients in the study

Inclusion and exclusion

26
Q

What is eligibility of patients?

A

Explain procedures regarding patient eligibility issues

Most common steps -> patient ineligibility at any time during study = exclusion criterion

27
Q

What are outcome measures

A
  1. Medical claims databases may not likely contain patient outcome variables (i.e., BP or BG readings) or patient-reported outcomes (PROs).
  2. Clinical outcomes can be inferred from billed medical service data
  3. Double counting
28
Q

What is Sensitivity analyses?

A

Should be conducted in retrospective database studies

29
Q

Benefits of retrospective databases?

A

Less time-consuming & less expensive than RCTs

Pharmacoeconomics (9 decks)

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