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Designing a New Study: II.

Cross-sectional and Casecontrol Studies

• A cohort study: the sequence of making the measurements is the same as the chronology of cause and effect. • Cross-sectional (prevalence) study
º All measurements on a single occasion. º Determine predictor and and outcome after the data collection º Estimate prevalence

• Case-control study

º Begin with the outcome, then identify the predictor º Explore the potential association

age. • e..CROSS-SECTIONAL STUDIES Well suited to the goal of describing variables and their distribution patterns • Structure º Similar to cohort study (except that measurements are made at once) º Can examine associations based on the investigator’s hypothesis. race---usually predictors blood lead level and hyperactivity ---->misleading (historic information on the time course) .g. not based on the study design.

No Disease Sample Steps: 1. Select a sampling from the population 2. No disease No risk factor.Cross-sectional Study Risk factor. Disease Risk factor. Measure predictor and outcome variables . Disease Population No risk factor.

CROSS-SECTIONAL STUDIES • Designing º º º º º Settle on the research question Specify criteria for the target and accessible populations Establish the design for drawing the sample Decide the phenomena to study Define the approach to measuring appropriate variables. Example 8.1: Sexually transmitted disease and the use of oral contraceptives .

Statistics for expressing disease frequency in observational studies Type of Study Cross-sectional Statistics Prevalence Definition # of people who have the disease at one point in time # of people at risk at that point Cohort Incidence # of new cases of disease over a period of time # of people at risk during that period * Relative prevalence = Relative risk prevalence/incidence bias .

000 in a general population for a stomach cancer in 45-59 year old men º Susceptible to prevalence/incidence bias • e. 1 in 10...g.Cross-sectional Studies • strength º Relatively fast and inexpensive º No waiting time to see the outcome º No loss to follow-up º Provide the prevalence of a disease or a risk factor º Convenient for examining networks of causal links • alcohol intake and HDLcholesterol • weakness º Difficult to establish causal relationship º Impractical for the study of rare diseases or risk factors from a general population • e.g. Kids with HLA-A2 were at increased risk factor for the incidence of leukemia ??? [truth was that HLA-A2 kids live longer] º First step for investigations .

within a sample of patients with a disease there may be association of interest.. Furthermore. for example.V. the higher risk of Kaposi sarcoma among AIDS patients who are homosexual than among AIDS patients who are I. 727 were homosexual or bisexual males and 236 were I. Of the first 1000 patients with AIDS. drug abusers. drug abusers.V.Cross-sectional Studies • Case series =~ cross sectional studies for relatively rare diseases º the sample from a diseased population not from a general population º suitable to describe the characteristics of the disease than to analyzing differences between these patients and healthy people e.g. .

following a single group of people) . • e.Cross-sectional Studies • Serial Surveys º To draw inferences about changing patterns over time..e.g. census data º Not a cohort study (i..

Case-Control Studies • Structure º the prevalence of the risk factor in subjects with the disease (cases) can be compared with the prevalence in subjects without the disease (controls). º Retrospective º “house red” more modest and a little riskier than the other selections. but much less expensive and sometimes surprisingly good! .

Case-control design THE PAST OR PRESENT THE PRESENT Population with disease (cases) Risk factor present Risk factor absent Disease Sample of cases Risk factor present Risk factor absent No disease Sample of controls Much larger population without disease (controls) .

Select a sample from a population at risk that is free of the disease (controls) 3. Select a sample from a population of people with the disease (cases) 2.Case-Control Studies • Steps: 1. Measure predictor variables .

Designing a case-control study • Settle on the research question • Specify criteria for the target and accessible populations (the cases and the controls) • Establish the design for drawing the sample • Decide the phenomena to study • Define the variables and measurement approaches. and establishes the hypotheses to be tested. .

Designing a case-control study • Settle on the research question “Whether there is an association between use of aspirin and the development of Reye’s syndrome” .

Designing a case-control study • Specify criteria for the target and accessible populations (the cases and the controls) º The cases: Children with a viral infection followed by Reye’s syndrome º The controls: Children with a viral infection but no Reye’s syndrome .

Designing a case-control study • Establish the design for drawing the sample(cases) “all 30 patients with Reye’s syndrome who are accessible to him for study” • Establish the design for drawing the sample(controls) “60 patients drawn from the much larger population of accessible patients who have had minor viral illnesses without Reye’s syndrome” .

“ask the subjects in both groups about their use of aspirin.” “approximate relative risk can be computed” .Designing a case-control study • Decide the phenomena to study • Define the variables and measurement approaches. and establishes the hypotheses to be tested.

. • Can yield some descriptive information on the characteristics of the cases and an estimate of the strength of the association between each predictor variable and the presence or absence of the disease (odds ratio). rather than by their proportions in the population.Designing a case-control study • Cannot yield estimates of the incidence or prevalence of a disease. because the proportion of study subjects who have the disease is determined by how many cases and how many controls the investigator chooses to sample.

c/(c + d)] = a ( c + d) c (a + b) . [a/(a + b) .Odds ratio and relative risk Disease Risk factor present Risk factor absent a c No disease b d • Odds ratio in a cross sectional studies ad/cb ad/cd = a/b c/d .

Case-Control Studies • Strengths º Efficiency for rare outcomes • high yield of information from relatively few subjects • Weaknesses º no incidence º no prevalence º no attributable or excess risk º Sampling bias. and how to control it • randomization is near impossible (pts with a diagnosed) • misdiagnosed or misdiagnosed are omitted º Usefulness for generating hypotheses .

Case-Control Studies • Weaknesses º selection of cases ---relatively straightforward º selection of controls---?? º Sampling the cases and controls in the same way º Matching º Using two or more control groups º Using a population-based sample º Differential measurement bias. and how to control it • Use of data recorded before the outcome occurred • Blinding .