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Clinic trials: prospective cohort study. Good design is sufficient number of subjects. Field and community intervention trails: vaccines, dietary intervention. Need large number participants. Test Significance Degree of conflict Confidence interval Bias Confounding Biologic credibility Risk: probability of an individual of experiencing a specific event, in a specific time, under specific conditions. We estimate individual risks from populations. Risk can be negative (ie protects) or positive (ie causal). ‘Risk’ and ‘Odds’ The risk of an event happening is simply the number of those who experience the event divided by the total number of people at risk of having that event. It is usually expressed as a proportion or as a percentage. a/a+b The odds of an event is the number of those who experience the event divided by the number of those who do not. It is expressed as a number from zero (event will never happen) to infinity (event is certain to happen). a:b Measures of effect We compare outcomes in two groups – those who are exposed and those who are not exposed (controls) Odds ratio = a:b/c:d Risk ratio = a/(a+b)/c(c+d) OR and RR are different – but approximate each other in rare events. RR is a better indication of risk, but requires prospective studies. See BMJ 1998;316:989-991 TIME Not Exposed Exposed Outcomes Cohort Study, recruit at exposure, measure Outcome Advantage - Measures risk ratio (RR). Disadvantages - Time, n, cost. Cohort Study T1 T2 Cohort Study Risk ratio (RR) = Rate exposed Rate unexposed A direct measure of risk Make sure 95% CI is given (Cases included in denominator) (relative risk) Case-Control Study, recruit on outcome, measure exposure (odds ratio OR). Advantages – time, n, cost. Disadvantage – no direct risk measurement. TIME No or Less Exposure Exposed Outcomes Cases Controls Case-Control Study T1 Odds ratio (OR) = Odds in exposed Odds in unexposed Case-Control Study (Cases not included in denominator) Sensitivit
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