Ph.D. Comprehensive Examination

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1 DEPARTMENT OF EPIDEMIOLOGY, BIOSTATISTICS, AND OCCUPATIONAL HEALTH Ph.D. Comprehensive Examination Epidemiology Stream Thursday, 6 December :00 4:00 PM 1. This is a closed book exam. Bilingual dictionaries are allowed but cannot be shared. You may also bring with you a one-page (two-sided) set of notes. 2. This exam includes 6 questions. The number of points allocated to each question is indicated. You must answer all questions. 3. The exam lasts three hours. No extra time will be granted. 4. Desk calculators are allowed but cannot be shared. The use of any other electronic device such as computers, phones, or BlackBerry-like devices is strictly forbidden. 5. You may answer in English or in French. 6. Please use a pen with black ink and write clearly. 7. All of your answers should fit within approximately one examination book (a maximum of two books is allowed). Version: Wednesday, February 06, 2008 Z:\PhD Exam 2007\Epidemiology Stream PM.doc

2 Study problem (Maté consumption and oral cancer risk): One of the most difficult tasks in cancer epidemiology is to measure associations that have a biological basis but are likely to be confounded by an overwhelmingly important risk factor. Tobacco smoking, the most important single risk factor for many types of cancer, plays just such a confounding role. Smoking is associated with lifestyle, diet, and behavioural characteristics that may themselves play a causal role for some cancers. However, it is sometimes very difficult to disentangle the confounding effect of smoking from the association between cancer risk and the putative smoking-associated risk factor. Case-control and cohort studies form the mainstay of the epidemiologic evidence base for what we know about cancer risk factors. It is customary to collect detailed information via questionnaires on smoking habits and other risk factors, established or not, and then adjust the analysis for the confounding effect of smoking. Incomplete control of confounding may represent a particularly difficult situation because the smoking-adjusted odds ratio for a candidate risk factor may suggest an association, which will then be interpreted with confidence by the reader because the investigator took the precaution of stating that adjustment had been done. The classical mistake of this kind was in a paper published in the New England Journal of Medicine in the 70 s, which showed that coffee drinking was possibly causally linked to pancreatic cancer (which is causally linked to smoking). The key analysis included adjustment for smoking, as it should have (smokers like to drink coffee more often than non-smokers) and the adjusted effect estimate for coffee drinking revealed an association that seemed credible. However, the authors later admitted (in a well known commentary by Gary Taubes in Science, 1995) that they used an inappropriate summary variable for smoking as a covariate, which left residual confounding to bias the relative risk estimate, even after adjustment. Less obvious examples of the above situation are found in the literature about cancers of the upper aero-digestive tract (UADT) (mouth, pharynx, larynx, and upper esophagus). Although strongly linked causally to tobacco smoking and alcohol consumption, these cancers have wide international variation in rates, which has been ascribed to the additional influence of some regionally-specific risk factors. Maté consumption seems to be one such factor. Maté is a type of tea extracted from the herb Ilex paraguariensis which is cultivated on a commercial scale throughout Southern South America. Maté is normally drunk very hot through a metal straw with a filtering tip. It is a common beverage in many regions of Argentina, Uruguay, and Southern Brazil. The incidence rates of UADT cancers in these areas are among the highest in the world. Biological plausibility for a causal effect exists. The putative carcinogenic mechanisms that have been hypothesized are: (i) the direct and repeated thermal injury of the exposed UADT epithelium over a lifetime (thermal injury leads to increased reparative cellular proliferation that may eventually become cancerous) and (ii) a direct and repeated exposure of the UADT to some unknown carcinogenic compound(s) present in the infusion. 2

3 Drinking maté is a social activity that is associated with smoking. Consumption prevalence among adults is as high as 80% in these regions. Dietary practices are also associated with oral cancer (low consumption of vitamins A and C) and so is alcohol consumption, both of which are associated with smoking. Although there have been a few epidemiologic studies, most of which point to elevations in risk of UADT cancers of 1.5 to 2-fold, a review conducted by the International Agency of Research on Cancer (IARC) in the early 90 s and a recent one by the World Cancer Research Fund and the American Institute for Cancer Research (WCRF/AICR, 2007) concluded that there is limited evidence for the carcinogenicity of hot maté drinking, because of insufficient proof that these studies convincingly dealt with the key issue of confounding by smoking and alcohol, and the also relevant problem of confounding by dietary practices. The IARC review also identified potential selection biases in some of the hospital-based casecontrol studies of this association. Study design and data analysis questions: Given the above risk assessment problem, the following questions relate to your choice of an epidemiologic study that could advance our knowledge on this topic and hope to disentangle the association between maté drinking and UADT cancers from the confounding issues described above. You were chosen by Health Canada to design such an investigation to fulfill an international agreement between the latter agency and the ministries of health of the above three countries, i.e., Argentina, Brazil, and Uruguay. Before you provide your answers to the questions below please read the background information provided at the end. 3

4 Question 1 (25 points) What type of epidemiologic study (cohort, case-control, or ecologic) would you choose? Please justify your decision. Be sure to address the study s potential statistical power in light of the above relative risks found in the literature. Question 2 (25 points) What steps would you take to avoid selection biases? Please discuss in light of your study design. Also keep in mind that you are facing the financial limitations described in item D below. Question 3 (10 points) How would you collect information on the relevant exposures and confounders? What precautions would you take to minimize measurement error? Question 4 (15 points) Propose a data analysis plan to address the difficult confounding issue mentioned above. Your key a priori confounders are in themselves multi-dimensional variables (age at start, frequency of consumption, etc.). What precautions would you take to be as conservative as possible to control for the confounding effect of smoking, alcohol, and diet? Keep in mind the residual confounding problem in the coffee and pancreatic cancer study described above. Question 5 (15 points) There are many different covariates that you want to adjust for (e.g., consider the myriad dietary items that subsume the protective role of diet and the different dimensions of smoking, e.g. intensity, duration, time since quitting for ex-smokers etc, as well as for alcohol drinking). What strategy for determining which potential confounding variables will be included in the final regression model would you use and why? Can you think of an alternative strategy to achieve the same objective? 4

5 Question 6 (10 points) Smoking and alcohol have been shown to interact synergistically as oral cancer risk factors. Keeping in mind that your study has a single hypothesis, i.e., that maté drinking is a risk factor for oral cancer, how would you treat in the data analysis the interaction between these two variables? Is it necessary to contemplate interaction between these two variables if your goal is only to control their confounding effects on the role of maté? 5

6 Background information (read before you proceed with answering the questions) The following are important points for consideration when providing your answers: a) Incidence rates of cancer of the mouth (an anatomical site with direct relevance to maté exposure that you chose to study) vary from 5 to 10 per 100,000 per year in these regions. b) There are tumour registries that enumerate all new cases of cancer in the main urban areas of the above regions. Diagnostic ascertainment is adequate by international standards. You would have ready access to any information that these services (e.g., registries, pathology labs, and hospital records) provide to assist you in your research. c) You would be able to have at your disposal a well trained local team of research assistants and clinical collaborators. Producing questionnaires and conducting interviews in Spanish or Portuguese is not a problem. d) Although you received a substantial research grant to conduct this international research study, you eventually found that you were not able to implement your preferred strategy of subject selection in all collaborating centres. In some, subjects could only be selected from hospitals and clinics. 6

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