ep test 2b
Terms
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- Ethics and Professional Stds
- Particularly important in epidemiologic research for several reasons: findings often have direct and immediate societal impact involve human subjects who derive no direct benefit from their participation often conducted with public funds
- Obligations to Study Subj's
- Privacy and confidentiality (one of prime reqs: ID and other data kept confid) Voluntary participation (must give subj’s choice to participate or not/how are they recruited) Informed consent must be obtained (clear/understandable/must notify them of their option to leave the study) Informing subjects of results of study (what findings were)
- Other Obligations (specifically for clinical trials)
- Balance of doubt and belief regarding product or procedure to be evaluated Cannot knowingly instigate harm, only modify its removal Anticipate unintended effects Stopping rules
- Stopping Rules
- Stopping a study before its scheduled endpoint: criteria established prior to initiation of the study interim measures of outcome monitored by an external body or group of researchers allows very good outcome to be shared or very poor outcome to be avoided
- Ethical Oversight
- Peer review in the funding process Institutional Review Boards (IRBs) approve studies: sometimes known as Protection of Human Subjects Committees
- Additional Issues
- Access to data Measurement and use of race and ethnicity Conflict of interest Communication of epidemiologic findings
- Study Design Parameters
- Descriptive versus analytic Retrospective versus prospective Observational versus intervention
- Descriptive Studies
- provide basic information for allocation of health resources for prevention and care provide the initial information base for hypothesis generation and analytic study design parameters
- Descriptive Study Design options
- Ecologic or correlational case reports or series, cross-sectional
- Ecologic or Correlational Studies
- examines information at the aggregated population level only the differences between populations can be described but the etiology of disease cannot be established
- Ecologic or Correlational Studies 2
- Disease data disease incidence rates, disease prevalence or cause-specific mortality rates Exposure data economic, environmental or lifestyle measures
- Data is collected in the 1970s from 39 countries on per capita dietary fat and population rates of breast cancer mortality. Finding: countries with increased fat consumption also have increased breast cancer mortality
- Ecologic (ex)
- Ecologic- advantages
- analysis is based on extant data from secondary sources, e.g. national or international agencies generally fast and easy to do relatively inexpensive can use a variety of different data types
- Ecologic- disadvantages
- unable to link disease and exposure factors at the individual level, which can lead to an ecologic fallacy no way to control for confounding factors measurement of exposure and disease may be imprecise or inaccurate
- Case reports or series
- Information on one person or a small number of persons: -often first notice of a new disease -derived most often from clinical practice
- PHC physician in the Southwest reported on a young Native man and his girlfriend who both had an unusual and ultimately fatal respiratory disease atypical pneumonia first recognition of what we now know as Hantavirus Pulmonary Syndrome
- Case report (ex)
- Physicians in New York and San Francisco report on a group of young men who have presented with atypical pneumonia and skin cancers, and concurrent immunodeficiency first recognition of what we now know AIDS
- Case series (ex)
- Case reports & series advtg's
- recognition of new diseases recognition of changes in old disease entities
- Case reports & series disadvtg's
- potentially very biased, given that they are most often generated solely from clinical settings non-representative of population as a whole may reflect associations that exist solely by chance
- Cross-sectional studies
- Also known as Population surveys Polls Use information from a sample of the population, not the entire population (NOT a census)
- Cross-sectional studies description
- Single point/period of examination Collects data from respondents at the individual level Gathers information on the distribution of prevalent disease and/or potential determinants, through a standardized survey instrument
- National household survey in the US gathers data on many diseases and risk factors from a sample of the entire population (NHANES, BRFSS). Distribution of risk factors and disease by demographic factors are used to guide health policy and point to areas
- Cross-sectional (ex)
- Cross-sectional advtg's
- provide information on the distribution of disease and/or risk factors provides these data at the individual level for analysis relatively inexpensive and time-efficient can be conducted on representative samples of the population
- Cross-sectional disadvtg's
- not usually possible to determine whether potential risk factor predated the disease reflect survivorship and thus may be biased with respect to disease etiology not particularly useful for diseases (or risks) of low frequency often rely on self-reported data, which may or may not be a reliable measure of disease or risk factor
- Graphs
- Look at 4 Graphs