2. Session V Analyzing Data

3. Session Overview Analysis planning Descriptive epidemiology –Attack rates Analytic epidemiology –Measures of association –Tests of significance

4. Learning Objectives Understand what an analytic study contributes to an epidemiological outbreak investigation Know why and how to generate measures of association for cohort and case-control studies Understand how to interpret measures of association (risk ratios, odds ratios) and corresponding confidence intervals Understand how to interpret tests of significance

5. Basic Steps of an Outbreak Investigation 1.Verify the diagnosis and confirm the outbreak 2.Define a case and conduct case finding 3.Tabulate and orient data: time, place, person 4.Take immediate control measures 5.Formulate and test hypotheses 6.Plan and execute additional studies 7.Implement and evaluate control measures 8.Communicate findings

6. Analysis Planning

7. –An invaluable investment of time –Helps you select the most appropriate epidemiologic methods –Helps assure that the work leading up to analysis yields a database structure and content that your preferred analysis software needs to successfully run analysis programs

8. Analysis Planning Several factors influence—and sometimes limit—your approach to data analysis: –Research question –Exposure and outcome variables –Study design –Sample population selection

9. Analysis Planning Three key considerations as you plan your analysis: 1.Work backwards from the research question(s) to design the most efficient data collection instrument 2.Study design will determine which statistical tests and measures of association you evaluate in the analysis output 3.Consider the need to present, graph, or map data

10. Analysis Planning 1.Work backwards from the research question(s) to design the most efficient data collection instrument Develop a sound data collection instrument Collect pieces of information that can be counted, sorted, and recoded or stratified Analysis phase is not the time to realize that you should have asked questions differently!

11. Analysis Planning 2.Study design will determine which statistical tools you will use Use risk ratio (RR) with cohort studies and odds ratio (OR) with case-control studies Some sampling methods (e.g., matching in case-controls studies) require special types of analysis

12. Analysis Planning 3.Consider the need to present, graph, or map data Even if you collect continuous data, you may later categorize it so you can generate a bar graph and assess frequency distributions If you plan to map data, you may need X and Y coordinate or denominator data

13. Data Cleaning Check for accuracy –Outliers Check for completeness –Missing values Determine whether or not to create or collapse data categories Get to know the basic descriptive findings

14. Data Cleaning: Outliers Outliers can be cases at the very beginning and end that may not appear to be related –First check to make certain they are not due to a collection, coding or data entry error If they are not an error, they may represent –Baseline level of illness –Outbreak source –A case exposed earlier than the others –An unrelated case –A case exposed later than the others –A case with a long incubation period

15. Data Cleaning: Distribution of Variables “Outlier”

16. Data Cleaning: Missing Values The investigator can check into missing values that are expected versus those that are due to problems in data collection or entry The number of missing values for each variable can also be learned from frequency distributions

17. Data Cleaning: Data Categories Which variables are continuous versus categorical? Collapse existing categories into fewer? Create categories from continuous? (e.g., age)

18. Attack Rates

19. Attack Rates (AR) AR # of cases of a disease # of people at risk (for a limited period of time) Food-specific AR # people who ate a food and became ill # of people who ate that food

20. Food-Specific Attack Rates CDC. Outbreak of foodborne streptococcal disease. MMWR 23:365, 1974. Consumed Item Did Not Consume Item ItemIllTotalAR(%)IllTotalAR(%) Chicken124626172959 Cake264361203263 Water102442335165 Green Salad42547832114 Asparagus4667426961 This food is probably not the source of infection

21. Hypothesis Generation vs. Hypothesis Testing

22. Formulate hypotheses –Occurs after having spoken with some case – patients and public health officials –Based on information from literature review –Based on descriptive epidemiology (step #3) Test hypotheses –Occurs after hypotheses have been generated –Based on analytic epidemiology

23. Descriptive Epidemiology Analytic Epidemiology Search for cluesClues available Formulate hypothesesTest hypotheses No comparison groupComparison group Answers: How much, who, what, when, where Answers: How, why

24. Measures of Association Assess the strength of an association between an exposure and the outcome of interest Two widely used measures: –Risk ratio (a.k.a. relative risk, RR) Used with cohort studies –Odds ratio (a.k.a. OR) Used with case-control studies

25. 2 x 2 Tables Used to summarize counts of disease and exposure in order to do calculations of association Outcome ExposureYesNoTotal Yesaba + b Nocdc + d Totala + cb + da + b + c + d

26. 2 x 2 Tables a = number who are exposed and have the outcome b = number who are exposed and do not have the outcome c = number who are not exposed and have the outcome d = number who are not exposed and do not have the outcome Outcome ExposureYesNoTotal Yesaba + b Nocdc + d Totala + cb + da + b + c + d

27. 2 x 2 Tables a + b = total number who are exposed c + d = total number who are not exposed a + c = total number who have the outcome b + d = total number who do not have the outcome a + b + c + d = total study population Outcome ExposureYesNoTotal Yesaba + b Nocdc + d Totala + cb + da + b + c + d

28. Risk Ratio IllNot IllTotal ExposedABA+B UnexposedCDC+D Risk Ratio[A/(A+B)] [C/(C+D)]

29. Interpreting a Risk Ratio RR=1.0 = no association between exposure and disease RR>1.0 = positive association RR<1.0 = negative association / protective effect

30. Risk Ratio Example IllWellTotal Ate alfalfa sprouts 431154 Did not eat alfalfa sprouts 31821 Total462975 RR = (43 / 54) / (3 / 21) = 5.6

31. Odds Ratio CasesControls ExposedAB UnexposedCD Odds Ratio(A/C)/(B/D)=(A*D)/(B*C)

32. Interpreting an Odds Ratio The odds ratio is interpreted in the same way as a risk ratio: OR=1.0 = no association between exposure and disease OR>1.0 = positive association OR<1.0 = negative association

33. Odds Ratio Example CaseControlTotal Ate at restaurant X 602585 Did not eat at restaurant X 185573 Total 7880158 OR = (60 / 18) / (25 / 55) = 7.3

34. What to do with a Zero Cell CaseControlTotal Ate at restaurant X600 Did not eat at restaurant X 185573 Total7855133 Try to recruit more study participants Add 1 to each cell* *Remember to document / report this!

35. Tests of Significance Indication of reliability of the association that was observed Answers the question “How likely is it that the observed association may be due to chance?” Two main tests: 1.95% Confidence Intervals (CI) 2.p-values

36. Confidence Intervals Allow the investigator to: –Evaluate statistical significance –Assess the precision of the estimate (the odds ratio or risk ratio) Consist of a lower bound and an upper bound –Example: RR=1.9, 95% CI: 1.1-3.1

37. Confidence Intervals Provide information on precision of estimate –Narrow confidence intervals =more precise Example: OR=10, 95% CI: 9.0 - 11.0 –Wide confidence intervals =less precise Example: OR=10, 95% CI: 0.9 - 44.0

38. p-values The p-value is a measure of how likely the observed association would be to occur by chance alone, in the absence of a true association A very small p-value means that you are very unlikely to observe such a RR or OR if there was no true association A p-value of 0.05 indicates only a 5% chance that the RR or OR was observed by chance alone

39. Plan and Execute Additional Studies To gather more specific info –Example: Salmonella muenchen Intervention study –Example: Implement intensive hand-washing

40. Session V Summary Analysis planning will ensure that you get the most valuable / useful data out of your investigation. Attack rates are descriptive statistics used in cohort studies that are useful for comparing the risk of disease in groups with different exposures (such as consumption of individual food items).

41. Session V Summary Analytic epidemiology allows you to test the hypotheses generated via review of descriptive statistics and the medical literature. The measures of association for case-control and cohort analytic studies, respectively, are odds ratios and risk ratios. Confidence intervals and p-values that accompany measures of association evaluate the statistical significance of the measures.

42. References and Resources Centers for Disease Control and Prevention (1992). Principles of Epidemiology, 2 nd ed. Atlanta, GA: Public Health Practice Program Office. Gordis L. (1996). Epidemiology. Philadelphia, WB Saunders. Rothman KJ. Epidemiology: An Introduction. New York, Oxford University Press, 2002. Stehr-Green, J. and Stehr-Green, P. (2004). Hypothesis Generating Interviews. Module 3 of a Field Epidemiology Methods course being developed in the NC Center for Public Health Preparedness, UNC Chapel Hill.