Term
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Definition
| A study in which an intervention (medication) is introduced to observe effects compared to a placebo |
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Term
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Definition
| Subjects are randomly chosen to receive intervention |
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Term
| Quasi-experimental design |
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Definition
observational
NOT randomized |
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Term
| What kind of data source is i3 INNOVUS? aka: Inventiv |
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Definition
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Term
| What do dependent variables measure? Do they change in a study? |
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Definition
| Outcome; not really. They are the purpose of the study |
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Term
| Can there be more than one dependent variable? |
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Definition
Yes; example
1. Antidepressant use
2. # of psychotherapy visits |
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Term
| Describe independent variables |
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Definition
Variable used to examine the dependent variable; example
1. Time
2. Age
3. Insurer
4. Region
5. Gender |
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Term
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Definition
| study of determinants and distribution of disease/health in human populations |
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Term
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Definition
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Term
| When should the term efficacy be used to describe results? |
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Definition
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Term
| When should the term effectiveness be used to describe results |
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Definition
| Post-marketing, phase four, the period of PEPI |
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Term
| 2 measures of drug exposure |
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Definition
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Term
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Definition
1. Use trends
2. Determinants of use (does socioeconomic status effect use)
3. Effectiveness
4. Risk
5. Regulatory effects
6. REMs |
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Term
| What incentive did the "Best Pharm for Children" Act give |
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Definition
| 6mo patent extensions if kids use is studied |
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Term
| FDAAA Sentinel Initiative |
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Definition
| Safety data based on a numerator and a denominator |
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Term
| Is phase 4 research mandated? |
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Definition
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Term
| Who is treated in phases of drug development? |
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Definition
Preclinical = animals
Ph 1 = healthy
Ph 2 = patients; small scale
Ph 3 = patients; large scale
Ph 4 = patients; PEPI-style |
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Term
| Would a RCT be appropriate for PEPI? |
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Definition
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Term
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Definition
1. $
2. Hawthorne effect
3. Blinding problems
4. No long-term data
5. Ethical limitations |
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Term
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Definition
1. Experimental-RCT
2. Observational-Analytic-cohort
3. Observational-Analytic-case control
4. Observational-Descriptive-trend
5. Observational-Descriptive-Prevalence
6. Observational-Descriptive-case series
7. Observational-Descriptive-case report |
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Term
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Definition
1. Drug utilization
2. Drug safety
3. Advocacy for change |
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Term
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Definition
y is independent variables
x is dependent variable.
y is a function of x, but it can/will be endlessly modified |
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Term
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Definition
1. no value = no change
2. pos. value = improved health
3. neg. value = worsened |
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Term
| Is evidence of harm found in observational studies accepted as proof? |
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Definition
| NO! Association is not causal |
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Term
| Criteria for causal nature association |
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Definition
1. Bio plausible
2. strength of ass.
3. time sequence
4. specificity of ass.
5. consistency of ass. |
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Term
| What is considered a quantitative measure of strength? |
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Definition
Dose-response
Experimental study
NOT a p-value; relative risk |
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Term
| Scintific method must have _______ hypothesis to access _______ likeliness |
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Definition
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Term
| 8 Questions to ask when evaluating a study? |
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Definition
1. Did study test pre-specified hypothesis?
2. Ind. & Dep. vars. clearly defined?
3. Is control group similar?
4. Is ass. of ind. var sufficiently different btwn control and exp. group?
5. unbiased ass. of ind. dep var?
6. Observation equal/complete
7. Did analysis account for confounding
8. Generalizable? |
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Term
| The two measures of drug utilization |
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Definition
1. persons with dispensings
2. medical visits with rx |
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Term
| an example of extent v. variation of drug utilization |
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Definition
| prescribing diffs between regions |
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Term
| Two types of PEPI studies on Drug utilization |
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Definition
1. trend (time)
2. pattern of use |
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Term
| Sources of prescription drug data; |
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Definition
1. IMS Global (prescriber specialty, socioeco, sales info)
2. ARCOS database (C-II bulk drug sales)
3. NDTI (5yr of disease-specific-drug dist) |
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Term
| Federal treatment data surveys (population) |
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Definition
1. NAMCS/NHAMCS (region, physician specialty, practice) Drug prescribed.
2. MEPS patient self-report
3. Medicare Part D
4. Medicare Client Beneficiary survey
5. NHANES |
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Term
| Sources of population drug data? |
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Definition
1. Group Health/kiaser HMO
3. Medstat/marketscan = Medicaid data |
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Term
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Definition
1. limited socioeconomic pop
2. care varies between states |
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Term
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Definition
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Term
| Why is median better than mean |
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Definition
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Term
| Different types of prevalence |
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Definition
point = at one time
period = over a period of time |
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Term
| descriptive v. analytical |
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Definition
Descriptive answers what it is?
Analytical describes why it is? how it came to be? |
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Term
| Advantages of pop info on drug exposure? |
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Definition
1. $
2. Large sample
3. Effectiveness data
4. Policy impacts
5. Generalizable |
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Term
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Definition
compliance = taking according to the plan
adherence = Are you taking? Pattern you are taking? |
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Term
| Disadvantages of pop info on drug exposure? |
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Definition
1. No clinical details (dosing)
2. Consumption Assumption
3. OTC unaccounted for |
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Term
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Definition
| continuity of use from init-discon |
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Term
| 2 COMMON measures to estimate population level drug use from REFILL data |
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Definition
MPR - Med possession ratio
PDC - Portion of days covered |
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Term
| T/F MPR can be greater than 1 |
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Definition
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Term
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Definition
| # days of supply/# days in evaluation period |
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Term
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Definition
| total days of use/total days in eval period |
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Term
| LESS common measures to est. pop. drug use |
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Definition
Anniversary model
minimum refill model
refill sequence model
hybrid model |
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Term
| What is the criteria for adherence |
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Definition
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Term
| T/F Adherence is a simple construct and a summary measure accurately represents exposure |
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Definition
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Term
| T/F Persistence is a better metric in determining harm/benefit effect |
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Definition
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Term
| Public health issues related to drug exposure |
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Definition
1. optimize use/improve adherence
2. Evaluate effectiveness
3. Assess economics |
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Term
| The healthy adherer effect |
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Definition
| People with healthy lifestyle are more like to adhere |
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Term
| 4 steps of drug exposure; all have room for misclassification |
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Definition
1. Prescribe
2. Fill
3. Use start
4. Use stop. |
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Term
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Definition
1. induction- casual action to disease
2. latent - disease start to detection
3. active |
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Term
| T/F misclassifications of adverse events can occur based on when therapy was started in the disease process? |
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Definition
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Term
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Definition
| Specifically choosing people with outcome variable you want to study (cases), and a random sampling of people without (controls) |
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