University of North Carolina at Chapel Hill School of Public Health Department of Epidemiology Fundamentals of Epidemiology (EPID 168) Final Examination, Fall 1997 Answer Guide 1. C. Analytic study of data collected to investigate the hypothesized relationship 2. a. A finding from a migrant study or studies: "Studies of migrants provide some evidence; for example, migrants to the United States from Japan experienced a rate of breast cancer intermediate between the lower rate in Japan and the higher rate in the U.S." b. A finding from descriptive epidemiology: *Many possibilities, including either of these sentences: "This finding implies a possible connection between the trend toward increasing bottlefeeding in the postwar period and current trends toward increasing incidence of breast cancer. Furthermore, it offers a partial explanation of the international variation in breast cancer rates, with rates considerably lower in less developed than in developed nations." c. An association from an ecologic study: *"Micozzi found mean adult height and breast cancer incidence in 30 countries to be highly correlated (r=0.8)." 3. B. Age is causally related to breast cancer risk and infant feeding practices have changed over time. 4. D. Common exposure, rare endemic disease. 5. B. Secular changes in infant feeding practices result in an association between age and exposure to breastmilk. 6. A. selecting from a pool of prevalent cases would make separation of factors associated with risk and those with survival more difficult. 7. a. Primary -- Primary breast cancer is a tumor that originates in the breast, rather than a tumor in the breast that is the result of metastasis from a tumor that originated in another location or tissue. In general, tumors originating in the same organ and tissue are more likely to have similar etiologies than are tumors that originate in different organs. b. Histologically-confirmed -- histological confirmation refers to the verification of the diagnosis (of breast cancer) through laboratory examination of tumor tissue. Microscopic examination of tumor cells establishes the existence and type of tumor with a greater degree of certainty than does a clinical diagnosis alone. Counting only histological-confirmed cases reduces the potential for false positive breast cancer diagnoses and the misclassification bias will cause. 8. B. The random selection of controls from the community provides a better estimate of breastmilk exposure among the source population. 9. A. Kappa coefficient 10. Table: Biomarker validation of women's self-report of having been breastfed Breastfeeding biomarker found Yes No Total S r -------------------------------------------- e e Breastfed 70 26 96 l p f o Not breastfed 80 28 108 r -------------------------------------------- t Total 150 54 204 Derivation: 204 cases tested (overall total), 73.5% (=150) have the marker (so 54=204-150 do not), 80 are false negatives by self-report (so 80 = "yes" biomarker, "no" self-report), and the remaining cells and marginals are obtained from these numbers. a. Sensitivity = 70 / 150 = 47% (Answers the question, "Of women who truly were breastfred, as demonstrated by the presence of the biomarker for having been breastfed, what % were correctly classified by self-report?")) b. Specificity = 28 / 54 = 52% (Answers the question, "Of women who were not breastfed, as demonstrated by the absence of the biomarker, what % were correctly classified by self-report?") c. Positive predictive value (PPV) = 70 / 96 = 73% (Answers the question, "Of women classified, on the basis of their self-report, as 'having been breastfed', what % were correctly classified?") d. Negative predictive value (NPV) = 28 / 108 = 26% (Answers the question, "Of women classified, on the basis of their self-report, as 'not having been breastfed', what % were correctly classified?") 11. a. Table: Adult breast cancer by having been breastfed as an infant, among premenopausal women with education beyond high school Case Control Total ------------------------ Breastfed 61 93 154 Not breastfed 69 61 130 ------------------------- Total 130 154 284 OR = (61 x 61) / (93 x 69) = 0.58. Interpretation: having been breastfed appears to be protective against female adult breast cancer, with a reduction in risk of approximately 40%. b. Table: Adult breast cancer by having been breastfed as an infant, among premenopausal women with education beyond high school, assuming that 20% of controls who reported having been breastfed had in fact not been Cases Controls Total ------------------------- Breastfed 61 74 135 Not breastfed 69 80 149 ------------------------- Total 130 154 284 Derivation: 20% of the 93 controls who reported having been breastfed had not been, so 20% of 93 (=18.6->19) are switched from "Breastfed" to "Not breastfed", being added to the 61 who reported not having been breastfed. The remaining 80% of 93 (=74.4->74) remain in the upper row. OR = (61 x 80) / (74 x 69) = 1.0, i.e. no association. c. B. differential misclassification of exposure 12. TRUE or FALSE a. False - matching controls to cases does not prevent the matching variable (age) from being associated with the exposure (having been breastfed), so the matching cannot prevent confounding. (See also d. and e.) b. True - The nurse telephoned hospitals on a frequent, regular basis, to identify all breast cancer cases. c. False - The difference in the proportions interviewed among cases and among controls provides a great deal of potential for selection bias, but if nonparticipation was not related to having been breastfed then selection bias will not occur. d. False - The matching caused cases and controls to have the same age distribution, so it did "work"; matching would not be expected to eliminate an association between age and the exposure, since exposure status was not known when controls were being selected and in any case would not have been used in the matching procedure. e. False - The matching procedure prevented an association. f. False - The association between body mass index and breast cancer can be assessed by estimating odds ratios from Table 2. To avoid confounding infant feeding history we should preferably assess the association separately in breastfed women and in women who have not been breastfed (omitting the complexities from considering body mass to be an intervening variable in the effect of infant feeding history). To avoid being misled by a possible "synergism" involving infant feeding and body mass, ideally we would look in the "unexposed" group. However, although this study focuses on breastfeeding, one can also consider "formula feeding" as an exposure that might be "synergistic" with body mass. So we can choose either exposure group (or both). Here are the computations: From Table 2: Cases Controls ------------------------- ------------------------- Breastfed Not breastfed Breastfed Not breastfed Body mass ---------- -------------- --------- ------------- index (kg/mz) 16-22 48 15 89 19 23-27 103 26 125 16 >27 90 17 91 16 To show the details, here is a table for estimating OR's for body mass index and breast cancer: Breastfed Not breastfed Total Body mass --------------- --------------- --------------- index (kg/m sq) Cases Controls Cases Controls Cases Controls 16-22 48 89 15 19 63 108 23-27 103 125 26 16 129 141 >27 90 91 17 16 107 107 and the resulting OR's are [e.g., (90 * 89) / (48 * 91) = 1.83]: Breastfed Not breastfed Total Body mass --------- ------------- --------- index (kg/m sq) 16-22 (ref. level) 1.0 1.0 1.0 23-27 1.83 2.06 1.57 >27 1.83 1.34 1.71 The OR's in the total column are shown to illustrate that in this case there is some confounding by breastfeeding history, at body mass index level 23-27 kg/m sq. Within either breastfed or not breastfed group there is no "dose-response" relationship. g. True - Generally, generally an outbreak investigation begins after the outbreak has begun and the investigation seeks to determine what characteristics of cases might have been responsible for their disease. If the cases happened to be part of an existing cohort for which the requisite exposure information was already available in some form, then a retrospective cohort study would be another possibility. If cases are still occurring a prospective cohort study might be initiated, but the better an idea the investigators have about which exposures to assess, the more they should intervene to minimize the occurrence of additional cases. h. False - for a factor to be considered a confounder, it must be an independent risk factor for the outcome, but this requirement does not pertain to effect modification. For example, genital ulcers cannot cause HIV by themselves, but in conjunction with a sex partner who is HIV infected, genital ulcers can increase (modify) the risk of HIV infection. 13. Potential confounders are factors that are known or suspected risk factors for breast cancer or its detection, or at least proxies for such factors. 14. a. Breast cancer risk and no previous pregnancies Cases Controls Total ------------------------------- No pregnancies 50 38 88 >= 3 pregnancies 167 216 383 ------------------------------- Total 217 254 471 OR = (50 x 216) / (38 x 167) = 1.7 (for zero vs. >= 3 pregnancies) Interpretation: having never been pregnant was associated with an increased breast cancer rate, with an apparent 70% greater rate among nulligravidae (women who have never been pregnant). Other choices of a reference level produce the same result, e.g., 1-2 pregnancies as the reference level: OR = (50 x 102) / (38 x 82) = 1.6. If both groups, 1-2 pregnancies and 3+ pregnancies are combined and used as the reference group, then: OR = (50 x 318) / (38 x 249) = 1.7 b. Height above 165 centimeters and having been breastfed Height > 165 cm < 160 cm Total ----------------------------------- Breastfed 148 183 331 Not breastfed 41 25 66 ---------------------------------- Total 189 208 397 OR = (148 x 25) / (183 x 41) = 0.49. Interpretation: Women who were breastfed were less likely to be over 165 cm. tall. Other possible OR's -- > 165 vs. 160-165: OR = (148 x 43) / (213 x 41) = 0.73 > 165 vs. all others: OR = (148 x 68) / (396 x 41) = 0.62 c. Breast cancer and having been breastfed (crude) Cases Controls Total ---------------------------------- Breastfed 241 305 546 Not breastfed 58 51 109 ---------------------------------- Total 299 356 655 OR = (241 x 51) / (305 x 58) = 0.69 Interpretation: having been breastfed was associated with lower risk of breast cancer 15. D. The statement refers to the (relative) risk of breast cancer between women who were and were not breastfed, estimated using the odds ratio. 16. a. Estimate RR for Not breastfed as 1/OR for Breastfed: 1 / 0.69 = 1.45 ARP = (RR - 1) / RR = (1.45 - 1) / 1.45 = 0.45/1.45 = 0.31 Interpretation: Some 31% of breast cancer in women who were not breastfed was attributable to their having not been breastfed. b. If know the formula (or can derive it from the diagram and the "grand synthesis"): P(E|D) (RR-1) PARP = --------------- and since breast cancer is rare, use OR. RR (117) ----------- (1.47-1) (117+112) (0.51) (0.47) Premenopausal: ----------------------- = --------------- = 0.16 1.47 1.47 AND (58) -------------- (1.45-1) (58+241) (0.19) (0.45) Postmenopausal: ------------------------- = --------------- = 0.06 1.45 1.45 Meaning: In women who wre not breastfed, some 16% of premenopausal breast cancer and some 6% of postmenopausal breast cancer were attributable to their having not been breastfed. OR, reason as follows: Proportion of exposed (Not breastfed) cases that are atttributable to not having been breastfed is: ARP = (RR-1)/RR Since breast cancer is rare, we can estimate with (OR-1)/OR = (1.47-1) / 1.47 = 0.3197 for postmenopausal. However, this proportion applies only to cases who are exposed (because ARP is "proportion of exposed cases . . ."). So estimate proportion of all cases who are exposed: = Pr(Exposed|Case) = 117 / (117+112) = 0.51 for postmenopausal Muliplying 1. by 2., 0.51 x 0.3197 = 16% for postmenopausal c. The PARP for premenopausal breast cancer is expected to be greater due to the secular decrease in breastfeeding during the decades when these women were infants. Thus, the proportion exposed to not having been breastfed is substantially greater for the premenopausal breast cancer cases. Hence, their PARP is greater. 17. Logistic model coefficients for risk factor variables are natural logarithms of odds ratios per one unit change in the variable. So the coefficient was ln(0.70) = -0.3567 Assumptions: a. True - The odds of breast cancer vary as the product of the odds for age and the odds for education. b. False - Only in a few special cases will the product of two odds equal their sum (e.g., both odds equal zero or both odds equal two). The logistic model is additive in the logit (logarithm of odds), multiplicative in the odds. c. False - One of the reasons for using mathematical modeling is that the risk factors (exposures and potential confounders) ARE associated (i.e., not independently distributed) d. True - Breast cancer is a rare disease. 18. C. The observed relative risk would be biased toward the null. 19. Smaller sample sizes produce wider confidence intervals, so if the point estimates for the crude and stratum-specific measures are about the same, then the confidence intervals for the latter will be wider. 20. AGE < 60 AGE > 60 TOTAL ---------------------------------------------------- Breast Bottle Breast Bottle Breast Bottle ------ ------ ------ ------ ------ ------ Cases 24 40 256 100 280 140 Controls 79 86 204 54 280 140 ---------------------------------------------------- OR 0.653 0.678 1.0 a. Control women in older stratum are more likely to have been breastfed than control women in the younger stratum, e.g., odds of having been breastfed are 0.9 (79/86) among younger women and 3.8 for AGE > 60. b. Age is a strong risk factor for breast cancer, so if breastfed women were older than bottle-fed women, than a possible protective effect of breastfeeding could have been offset by the greater risk associated with older age. 21. An epidemiology graduate student finds evidence in the literature that childhood sunlight exposure may affect adult breast cancer risk. To explore this hypothesis, she obtains from the authors the place of birth for all of the subjects in the present study and constructs a sunlight exposure variable ("high" or "low") based on geologic and meteorologic data for the years of the subject=B9s childhood. Her data show that 56.2% of the 219 premenopausal women who were NOT breastfed as infants grew up with "high" sunlight exposure. Based on this fact and the partially-completed tables below, (a) calculate the odds ratio of breast cancer with respect to breastmilk exposure within each of the two sunlight exposure strata, and (b) briefly describe the relationship of the sunlight exposure variable to the association between breast cancer and breastmilk exposure (i.e. in relation to confounding and effect modification. (4 pts) High Sunlight Cases Controls Total Breastfed Yes 44 24 68 Breastfed No 81 *42 123 Total 125 66 191 Low Sunlight Cases Controls Total Breastfed Yes 67 *120 187 Breastfed No 36 *61 97 Total 103 181 284 * crude from Table 1 or Table 3 = 0.68 High sunlight OR = (44x42)/(24x81) = 0.95 Low sunlight OR = (67x61)/(120x36) = 0.95. Sunlight is a confounder of the protective effect of breastfeeding as an infant. It is not an effect modifier. 22. Use the data from Table 2 (Distribution of Characteristics of Postmenopausal Cases and Controls) to draw separate 2 x 2 tables for women who have had: a. 0 pregnancies, b. 1-2 pregnancies, c. >=3 pregnancies. Be sure to include appropriate labels. (5 pts) 0 pregnancies 1-2 pregnancies 3 pregnancies Cases Controls Cases Controls Cases Controls Breast 34 35 71 90 136 180 Bottle 16 3 11 12 31 36 Total 50 38 82 102 167 216 a) Calculate odds ratios for each of these three categories. 0 pregnancies: OR = (34 x 3) / (16 x 35) = 0.18 1-2 pregnancies: OR = (71 x 12) / (11 x 90) = 0.86 >=3 pregnancies: OR = (136 x 36) / (31 x 180) = 0.88 b) Assuming no effects of confounding, interpret your findings in part (a). There is effect modification. The magnitude of the protective effect of having been breast-fed on development of breast cancer is dependent on pregnancy history. Having been breast-fed is a stronger protective factor for those women who never had a pregnancy. 23. A hypothetical cross-sectional ancillary study to this report was conducted. In that study a survey of breast cancer annual incidence rates in geographically distinct areas was completed, Region A in the upper midwest where breast cancer mortality is high, and Region B the Southeast where mortality from breast cancer is low. The following data were obtained. Region A Region B Cases Population Rate/1000 Cases Population Rate/1000 < High School Education Age 40-50 10 7,000 1.4 10 15,000 0.7 51-60 15 10,000 1.5 20 5,000 4.0 61-65 30 3,000 10 600 55,000 10.9 Total 55 20,000 630 75,000 High School Education Age 40-50 5 1,000 5.0 6 2,000 3.0 51-60 5 2,000 2.5 10 15,000 0.7 61-65 4 500 8.0 4 1,000 4.0 Total 14 3,500 20 18,000 Grand Total 69 23,500 650 93,000 Crude 2.9 a. Compute the overall Region B crude event rate: (1 pt) = 7.0/1000 Using the total population as a standard compute the following by the direct method of adjustment: b. Age and educational achievement adjusted rate for Region A (2 pts) = 6.0/1000 c. Age and educational achievement adjusted rate for Region B (2 pts) = 6.3/1000 d. Comparison of the overall crude rates with the age and educational achievement adjusted rates. Briefly explain your findings. (2 pts): Much of the difference between the crude rates of the two regions is due to the different distributions of age and educational achievement. 24. Causal relationship - Comment specifically on at least two of Bradford Hill's criteria for causal inference. Include in your comments data or statements from the article. (5 pts) 25. Assuming that this relationship is causal, why might a similar study, 50 years from now, fail to find as strong a relationship? (2 pts) Formula changes (less fat), overfeeding reduced reflecting recent trends. _____________________________________________ Schoenbach, \ epid168 \ exams 1997 Final exam - answer guide; 12/10/1998, 12/12/1998