University of North Carolina at Chapel Hill School of Public Health Department of Epidemiology Fundamentals of Epidemiology (EPID 168) Midterm Exam, Fall 1996 EPID 168 Most of the questions in this examination are based on the article: Garry VM, Schreinemachers D, Harkins ME, Griffith J. Pesticide appliers, biocides, and birth defects in rural Minnesota. Environ Health Perspect 1996;104:394-399. A copy of this article was provided to you before this examination and can be used in answering the following questions. 1. Briefly state the primary study question of this report. Identify the main exposure and outcome of interest. (3 pts) 2. Briefly explain the difference between disease classification based on manifestational criteria and disease classification based on causal criteria. What is the logic for analyzing the data in relation to categories of anomalies grouped by organ system? (4 pts) ___________________________________________________________ 3. As discussed in class, epidemiologic studies often have both descriptive and analytic characteristics. State one way in which this study is descriptive and one way in which it is analytic? (4 pts) 4. The reporting of birth defects was provided in accord with state statutes, and grouping of birth defects categories followed the National Centers for Health Statistics guidelines (page 394 second paragraph - methods). This reporting of birth defects is an example of which of the following types of data collection methods. Choose one best answer. (4 pts) A. Active surveillance B. Ongoing crossectional survey C. Passive surveillance D. Follow up study of dynamic population 5. This study determined exposure and outcomes using data from "a list of all members of the agricultural community who were certified to apply restricted-use pesticides in 1991" (p. 394-methods) and from "all in- wedlock live births recorded in the state for the years 1989 through 1992" (p. 394-methods). Briefly assess the strength of these data sources in establishing the temporal sequence of pesticide exposure and birth defects and provide support for your assessment. (4 pts) 6. For each of the following epidemiologic measures, indicate whether it is a rate, a proportion, or a ratio that is neither a rate nor a proportion, or none of these. Circle the best answer (4 pts) A. Population attributable risk (PAR) rate proportion ratio neither B. Incidence density (ID) rate proportion ratio neither C. Prevalence rate proportion ratio neither D. Relative risk rate proportion ratio neither 7. The use of the term "rate" is not an infallible guide to the specific epidemiologic measure being presented. Which one of the following epidemiologic measures best characterizes the measure that the authors refer to as the "rate of anomalies per 1000 live births" (Table 2 - footnote)? Choose one best answer. (4 pts) A. cumulative incidence (CI) B. incidence density (ID) C. prevalence D. attributable risk proportion 8. The authors indicate that table 1 supports their statement... "pesticide appliers had significantly more children with an anomaly than did nonappliers" (p.395 results first paragraph). This statement is readily understood but not literally correct. Which one of the following state the finding more precisely? Choose one best answer. (4 pts) A. pesticide appliers had 1.37 times more births with anomalies than did the general population. B. pesticide appliers had more children with birth anomalies than did the general population. C. pesticide appliers had a greater proportion of births with anomalies as compared to the general population. D. Pesticide appliers accounted for more births with anomalies than did the general population. 9. Table 1 presents both crude and age-adjusted odds ratios. In the table, the age adjusted odds ratio for gastrointestinal anomalies is slightly larger than the crude estimate, as is the case for most of the odds ratios presented. If the difference between the crude and age-adjusted odds ratios had been large, explain in general terms what this would mean regarding the respective ages of the pesticide appliers and the general population. Assume the maternal age structure of the combined population was used as the standard. (3 pts) ___________________________________________________________________ 10. Using data in Table 1: a. Compute an estimate of the potential impact of pesticides on birth anomalies (in wedlock, all types together) to fathers who are certified pesticide appliers. State the assumption required to interpret this estimate. (4 pts) b. Compute an estimate of the potential impact of pesticides on birth anomalies (in wedlock, all types together) in the Minnesota population as a whole. (3 pts). 11. Using the data presented in Table 1, recalculate the crude odds ratio for all births with anomalies assuming that all musculoskeletal birth anomalies occurring among those with maternal age greater than 30 and the "other" anomalies among maternal age > 35 were later found to actually have occurred among persons incorrectly classified as appliers. Explain what implications this new calculation would have on the conclusions of the study. (3 pts) ___________________________________________________________________ 12. It is possible that the pesticides examined in this study might have reduced fecundity or increased the proportion of conceptions not resulting in live births. Assume that both of these effects (lower fecundity, more spontaneous abortions, and more still births) have in fact occurred in the pesticide applier population studied here, so that the number of live births to pesticide applier fathers is smaller than it would have been in the absence of pesticide exposure. Which of the following statements is (are) TRUE and which is (are) FALSE? (2 pts each) TRUE FALSE ____ ____ A. Since all births would be affected equally, effects on fecundity and spontaneous abortion WOULD NOT have influenced the size of the odds ratio presented in this study. [This question is problematic.] ____ ____ B. If pesticides were equally likely to cause fetal loss and birth anomalies, then the odds ratios would strongly understate the harmful effects of pesticides. 13. Table 4 shows the frequency per 1000 births of major anomalies for the general population by region. Which of the following best describes the study design from which these data were obtained. (4 pts) A. ecologic study B. prospective cohort study C. retrospective cohort study D. region-specific case control study 14. The authors begin their discussion section by stating that this report "is an initial step in the evaluation of the possible relationships between the frequency of birth anomalies and pesticide use". They conclude, however by saying that these data "signify a clear-cut need for comprehensive examination of the health issues involved". This latter statement seems to indicate that the authors suspect a causal relationship. Identify and describe three criteria for causal inference for which at least some information is present in the article. Give specific examples from the article to support your selection. (9 pts) ___________________________________________________________________ 15. Suppose that after this publication came out, another study was conducted in Illinois to investigate the hypothesis that birth defects occurred more often in Illinois as compared to Minnesota. However, in this new study the authors thought that the type of water consumed could be related to birth defects. They wanted to adjust (standardize) the rates of defects in the two states for water type. Data from the two studies are compared as below. Births by state and water type Minnesota Pesticide Appliers Illinois Pesticide Appliers Normal With anomalies Normal With anomalies Water Type (#) (#) rate* (#) (#) rate* Well water only 3379 93 26.8 100 2 ____ City water only 874 27 30.0 200 6 ____ Bottled water only 206 5 23.7 7293 145 ____ Total 4456 125 28.0 7593 153 ____ * per 1000 live births a. calculate the crude rate and the water-type specific rates for Illinois. Briefly describe how these two states compare in crude rates of birth anomalies. (4 pts) b. Using the combined number of live births as a standard, calculate a standardized rate (standardized for water type) for each of the states. Briefly describe how these standardized rates compare with each other and reasons why they may or may not agree with the crude rates. (6 pts) 16. Would an inference of causality based on the data in Table 4 be subject to criticism based on the ecologic fallacy concept. Briefly explain your answer. (2 pts) 17. Which of the following statements about the present study are (is) TRUE and which are (is) FALSE. Indicate TRUE or FALSE for each statement. (2 pts each) TRUE FALSE ____ ____ A. Subjects used in the analyses for Table 1 of this study were selected on the basis of their exposure status. ____ ____ B. Table 4 in this study supplied dose response evidence to support an inference of a causal relationship between pesticides and birth defects. ____ ____ C. The age-adjusted odds ratio for all birth anomalies of 1.41 is considered a modest association. ____ ____ D. Since birth defects of these types are rare in the general population, a cohort study could be designed to efficiently examine further the relationship of pesticides and birth anomalies. ____ ____ E. Exposure status in this study was randomized resulting in an equal distribution of known and unknown confounding variables between pesticide appliers and the general population. ____ ____ F. a correlation coefficient is a measure of association but is not useful in assessing the dichotomous outcomes measured in this study. ____ ____ G. Table 1 used stratified analyses to adjust for a confounding effect of maternal age on the association between musculoskeletal/integumental anomalies and pesticide exposure. [question #18 has been removed, 10/7/97] 19. Succinctly evaluate whether or not, on the basis of the information in the article (including information that the authors cite to other work), further measures are warranted now to prevent birth defects caused by chlorophenoxy herbicides. (5 pts) 1/22/97, 10/7/97 - wr:vs \ mepid168 \ exams 1996 Midterm exam