Exam 11 Flashcards
Define informed consent.
Duty to disclose risks, benefits, and alternatives to treatment
Patient must have capacity, cannot be coerced
Reasonable physician standard, reasonable patient standard
An adult with capacity has the right to make health care decisions for him or herself. What about a minor? An adult that lacks capacity?
Minor - typically require a parent or legal guardian to make healthcare decisions
Adult that lacks capacity - surrogate decision maker
What are some limits to parental authority?
Generally cannot refuse a lifesaving medical treatment
5 exceptions to confidentiality
- Continued treatment
- Consent
- Communication of a threat
- Compliance with the law
- Court order
Measures the total number of people with a condition of interest at a given point in time
Prevalence
Measures the number of new cases that arise in a population without the condition of interest over a given period of time
Incidence
What does a standardized mortality ratio of 1.2 mean?
There are 20% more deaths in this population than would be expected relative to other populations
What are the 2 types of epidemiological studies?
- Descriptive
2. Analytic
What are the 2 types of descriptive epidemiological studies?
- Case report
2. Case series
What are the two categories of analytical epidemiological studies?
- Observational
2. Interventional
What are the 5 types of observational studies?
- Community surveys
- Ecological
- Cross-sectional
- Case-control
- Cohort
What are the 2 types of interventional studies?
- Clinical trial (randomized control, non-inferiority, equivalence)
- Community intervention
Studies done looking at variables at the group or population level
Ecological
Advantages - can use when measurement of individual level variables is not possible or ethical, quick, cheap, quick assessment of a health status in a community
Disadvatnages - bias, ecological fallacy
Type of clinical trial exploring if a new treatment is “no worse” than a current treatment
Non-inferiority
One sided trial vs. two sided trial
1 - non-inferiority
2 - equivalence
Type of clinical trial that shows a new treatment should not be inferior to NOR superior to current treatment (not different - good for generic medications)
Equivalence trials
Study that randomizes communities instead of individuals
Community interventions
Comprehensive review of many studies to summarize findings on a particular health topic
Systematic review
Advantages - more studies/sources provide more information, cheaper than repeating studies, results more generalizable than individual studies, strong evidence-based resource
Disadvantages - can be difficult to combine studies, summary only as good as the individual source
Statistical analysis of multiple studies to develop a single conclusion
Meta-analysis
Advantages - more studies = greater statistical power, more complex analysis, can do subgroup analysis
Disadvantages - advanced statistical techniques needed, heterogeneity of study population/study can make extraction difficult, possible publication bias, only as good as source
Quantitative measure of difference between groups
Effect size
Assumption - if all studies included were very large, they would all yield the same results; studies results can only vary by chance
Fixed-effect model
very restrictive, over-estimates precision, does not allow for study heterogeneity
Assumption - studies included are a random sample from all studies that addressed the question; study questions might be different but are related enough to be combined
Random-effect model
more conservative, will slow less statistical significance, more realistic, allows for study heterogeneity
Describe features of a forest plot - square, horizontal line, diamond
Each study is a square, size proportional to weight of study
Confidence interval is the horizontal line
Summary effect is diamond
Variability in study outcomes between studies
Heterogeneity
How can heterogeneity be assessed?
Forest plots Statistical tests (Cochran Q test, I^2 statistic)
Features of a Cochran Q test
Statistical significance - yes/no
Assumption - underlying effect in each study is the same
Low p value indicates significant heterogeneity
Recognized as a poor test
Measures the magnitude of variability between studies
I^2 statistic
How can you assess the cause of heterogeneity?
- Subgroup analyses - assess separate criterion in each study to see if at a subgroup level there is still significant heterogeneity (categorical variables)
- Meta-regression - assess separate criterion in each study to see if at a subgroup level there is still significant heterogeneity (continuous variables)
Studies with significant results published earlier than those with non-significant findings indicate ___ bias.
Time-lag
Define publication bias
Only positives studies published
How can bias be assessed?
Kappa statistic (interrater reliability, >0.75 excellent, <0.40 poor)
Bias risk scale
Funnel plots
Maternal mortality rate = ?
Number of deaths/100,000 live births
Neonatal mortality rate = ?
Number of deaths in first 28 days/1,000 live births
Infant mortality rate = ?
Number of deaths in children <1 y/o divided by 1,000 live births
Mortality rate = ?
Total deaths in a time interval or cause-specific deaths/1,000 or 100,000
Standardized mortality rate = ?
Observed deaths in a population/expected deaths in a standard population
Case fatality rate = ?
of deaths in a population of people who have a disease/total number of people who have a disease (in a given period of time)
Morbidity rate = ?
of non-fatal cases of a disease in a population
Attack rate = ?
of cases of disease ina population during a specific time period
Secondary attack rate = ?
new cases of a specified disease among contacts of known cases/size of contact population at risk