Retrospective Databases

Question 1

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

Answer 1

Treatment related problem

Question 2

What is the difference between RCT and observational?

Answer 2

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

Question 3

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

Answer 3

Question 4

What is the difference between efficacy and effectiveness?

Answer 4

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

Question 5

Why do we use RCT?

Answer 5

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

Question 6

Advantages of RCT?

Answer 6

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

Question 8

Disadvantages of RCT?

Answer 8

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

Question 9

Advantages of retrospective databases?

Answer 9

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

Question 10

Disadvantages of retrospective databases?

Answer 10

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

Question 11

What are the retrospective databases?

Answer 11

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

Question 12

What is electronic medical rocords?

Answer 12

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

Question 13

What is the function of electronic medical records?

Answer 13

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

Question 14

What are the advantages of electronic medical records?

Answer 14

More complete resource for healthcare information than other methods

Question 15

What are the disadvantages of electronic med recs?

Answer 15

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

Question 16

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

Answer 16

Provide information on medical utilization patterns

Question 17

What is Medical Expenditure Panel Survey (MEPS)?

Answer 17

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

Question 18

What is the advantages of national health survey data?

Answer 18

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

Question 19

What are the disadvantages of national health survey data?

Answer 19

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

Question 19

What is Health Insurance Claims Records?

Answer 19

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

Question 20

What is the function of health insurance claims records?

Answer 20

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

Question 21

What is an advantages of health insurance claims record?

Answer 21

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

Question 22

What is an disadvantages of health insurance claims record?

Answer 22

Missing clinical information necessary to answer questions

Question 23

How do you critique retrospective database studies?

Answer 23

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

Question 24

What is Clear explanation of the database?

Answer 24

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.

Question 25

What is Clear explanation of patient-selection criteria?

Answer 25

Explain the criteria for selecting patients in the study Inclusion and exclusion

Question 26

What is eligibility of patients?

Answer 26

Explain procedures regarding patient eligibility issues Most common steps -> patient ineligibility at any time during study = exclusion criterion

Question 27

What are outcome measures

Answer 27

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

Question 28

What is Sensitivity analyses?

Answer 28

Should be conducted in retrospective database studies

Question 29

Benefits of retrospective databases?

Answer 29

Less time-consuming & less expensive than RCTs