Chapter 9: Cohort Studies Cohort - investigator selects a group of exposed individuals and a group of nonexposed individuals and follows

up both groups to compare the incidence of disease (or rate of death from disease) - disease free persons classified on exposure at the beginning of the follow-up period and followed to ascertain the occurrence of disease in each group, so classification of disease status occurs at the end of the period. 2 Types: 1) Retrospective:

2) Prospective: calculations: incidence of those exposed

incidence of the non-exposed because we are identifying new cases of disease (incidence) as they occur, we can determine whether a temporal relationship exists between the exposure and the disease 1) Research Question: -do persons with the factor (or exposure) of interest develop (or avoid) the out come more frequently than those without the factor (or unexposed)

2) Hypothesis: - may determine what outcomes are to be expected, how these outcomes are expected to manifest themselves, how to ascertain, sample size, analytic approach 3) Definition of Exposure: -determines measurement and analysis -identify exposure via questionnaires, existing records, lab tests, physical exam important to get info on exposure history (age of exposure/last exposure, duration, intensity) Definition of Non-Exposed:

4)

- comparable to exposed with the exception of exposure (sometimes difficult to find completely unexposed) - imp to recognize healthy worker effect 5) Definition of Diseased: - case definition should be precise, specific, and clearly established prior to first case - use well established criteria so results are comparable - how to identify? self-report, physical exam, interview, surveillance

6) Confounders: - control for in analysis phase using statistical techniques or stratification - control in design phase, including matching 7) Exclusion/Inclusion Criteria: - usually focus on specific disease as defined 8) Follow-up - attrition potential major source of bias - differential loses, especially if related factors associated with disease could bias results 9) Analysis: - Relative risk measure of association)

- Attributable risk (measure of impact) Measures of Impact: 1) 2) Attributable Risk: Rate of disease in exposed group attributable to exposure Attributable Risk Percent: Proportion of incidence in exposed group attributable to exposure Population Attributable Risk: proportion of disease in total population attributable to exposure - function of both the strength of the association (magnitude of relative risk) and the prevalence of the exposure

3)

Disadvantages:

Advantages:

Chapter 10: Cross-Sectional Studies: - examines the relationship between diseases/outcomes and other variables of interest as they exist; in a defined population, at one particular time - both exposure and disease outcome are determined at the same time for each subject Research Question: - Do certain characteristics of the exposure factor coexist with the health problem of interest? - Generation of Null Hypothesis there is no difference in the prevalence of disease among those with and without the exposure Useful for: - providing info on disease prevalence - public health planning / resource allocation - investigation of disease - generating hypotheses about exposure-disease relationships Advantages: Disadvantages:

Measure of Association: - Prevalence Ratio

interpretation: the disease is x times as prevalent in the exposed compared to the unexposed

- Prevalence Odds Ratio:

Interpretation: the odds of exposure/disease among those with the disease/exposure are X times the odds among those without disease/exposure Chapter 10: Case-Control Studies: - collects data after onset of disease in cases, selects disease free controls, and looks back to determine past exposure - compares ratio of exposed to unexposed among those with the disease to ratio among controls (Odds Ratio) incidence or prevalence not determined cases have outcome of interest controls do not have outcome of interest

Advantages:

Disadvantages:

Measurement of Association: Odds Ratio - proportion of cases with exposure is compared to proportion of controls with exposure Selection of Cases: - ask about exposure prior to symptoms - est diagnostic criteria - most desirable case selection is the inclusion of all incident cases in a defined population (population - based registries) - for diseases which do not routinely result in hospitalization, patients seeking care from office-based physicians or clinic can be source of cases Selection of Controls:

- very difficult within case control design - should be representative of the population from which the cases arose 3 most common: - probability sample of pop from which cases came - person seeking medical attention at same institution as cases for conditions believed to be unrelated to case diagnosis - neighbors/friends of cases

Controls (cont) - if cases are all individuals developing disease in a defined population, best control group would be a probability sample of population - if cases are from a population specified by other than geographic location (pre-paid health care, clinics, workers), appropriate control group would be individuals from similar settings - if cases are individuals whose illnesses were diagnosed at a few selected medical facilities may be difficult to identify the population sampling frame from which cases arose (catchment of hospital) Hospital Based Case-Control Studies: seek controls with other diseases not related to outcome of interest and their disease does not increase or decrease their risk of exposure (may bias OR)

Potential Biases: - Selection Bas

- Recall Bias

- Temporal sequencing of exposure and disease

Measuring Confounders: - obtain information on potential confounders from same sources as for exposures - accurate measure of confounder is important Matching as a control for Confounders:

Advantages:

Disadvantages:

Chapter 11: Measures of Association Absolute Risk - the incidence of a disease in a population - can indicate the magnitude of the risk in a group of people with certain exposure, but because it does not take into consideration the risk of disease in non-exposed individuals, it does not indicate whether the exposure is associated with an increased risk of the disease Relative Risk: (Cohort) What is the ratio of the risk of disease in exposed individuals to the risk of disease in non-exposed individuals? - can be calculated directly

Interpretation: 1) RR = 1: no evidence exists for any association of the disease with the exposure in question 2) RR > 1: the risk in exposed persons is greater than the risk in non-exposed persons, evidence for a positive association - may be causal 3) RR < 1: the risk in exposed persons is less than the risks in non-exposed persons, evidence of a negative association - ma be indicative of protective effect Odds Ratio: (Cohort) - the ratio of the odds of development of disease in exposed persons to the odds of development of disease in non exposed persons

(Case-Control) - do not have information about incidence (Thus cant calculate relative risk), this is because you start with cases and controls rather than exposed and non-exposed persons. - the ratio of the odds that the cases were exposed to the odds that the controls were exposed What are the odds that a case was exposed? What are the odds that a control was exposed?

~ in both types of studies the odds ratio is an excellent measure of whether a certain exposure is associated with a specific disease Interpretation of Odds Ratio: - if the exposure is not related to the disease, OR = 1 - if the exposure is positively related to the disease, OR >1 - if the exposure is negatively related to the disease, OR < 1 When is the odds ratio a good estimate of Relative Risk in a Case-Control (p 208) 1) When cases studied are representative, with regard to history of exposure, of all people with the disease in the population from which the cases were drawn 2) When the controls studied are representative, with regard to history of exposure, of all people without the disease in the population from which the cases were drawn 3) When the disease being studied does not occur frequently (rare)

Chapter 12: Measures of Impact Attributable Risk: - the amount or proportion of disease incidence (or disease risk) that can be attributed to a specific exposure - important for clinical practice and public health, because it addresses a different question; - how much of the risk (incidence) of disease can we hope to prevent if we are able to eliminate exposure to the agent in question?

Population Attributable Risk: - What proportion of the disease incidence in a total population (both exposed and non exposed) can be attributed to a specific exposure? - What would be the total impact of a prevention program on the community