Question B Developing a Case Control Study to assess relationship between coffee drinking and bladder cancer In case-control studies,

participants are selected based upon their outcome (disease) status, and exposure levels are compared between them. People with outcome are called cases, and people without outcome are controls. Cases should be collected from a variety of sources such as hospitals, clinics and other registries to ensure the true population is being sampled. The criteria for eligibility must be carefully tailored to fit the study being done and also to minimalize biases. Controls should ideally be collected from the same population as the cases. Multiple control for each case can be used i.e. for each 1 case, 3 controls are selected. Matching must be done to ensure the cases are and controls are similar in certain aspects such as age, gender, race, socioeconomic status and others. Matching is done to remove the influence of any variable on the causation of the disease. An example would be to exclude smokers in both cases and also controls. After the cases and controls have been selected, interviews can then be done to collect data. The collected data is then analyzed and odds ratio of exposure in the diseases patients can be calculated. Table: Contingency table analyzing the case control study Coffee drinkers Not coffee drinkers Total The odds ratio is calculated as; Odds of bladder cancer in the exposed group/ odds of disease in non exposed group Odds Ratio = ad bc Case control study is suitable in studying rare as well as common disease and it is also less expensive and can be performed in a relatively shorter time. Many different exposures can be studied at the same time and this can be used to study multiple hypotheses. The number of subjects is also fewer. The disadvantages would be incomplete information during interview, problems in defining and seeking control group and matching variable and the fact that it only yields odds ratio. Common biases encountered would be selection bias, information bias and confounding. The temporal relationship between exposure and disease is also unclear. Bladder cancer a c a+c No bladder cancer b d b+d Total a+b c+d a+b+c+d

Flow diagram of Case Control Study design to study the relationship between coffee drinking and bladder cancer Population to study is defined

Eligible population according to set criteria

Cases

Controls

Consent and complete interview

Consent and complete interview

Assess history of intake/exposure of coffee drinking

Analysis and interpretation

Have bladder cancer

Do not have bladder cancer

Drinks coffee

Does not drink coffee

Drinks coffee

Does not drink coffee

Developing a Cohort Study to assess relationship between coffee drinking and bladder cancer

A cohort is defined as a group of people with a common characteristic or experience. In a cohort study, a group of healthy subjects are defined according to exposure status and are followed over time to define incidence of symptoms, disease or death. Usually two groups are compared, an exposed and an unexposed group. The unexposed group should be drawn from the same population as those exposed. Cohort study maybe prospective (follow up into the future) or retrospective (start following by taking history from the past). Ideally, the unexposed comparison group should resemble the exposed members in the cohort in every way except exposure. Group matching of the controls in terms of age, gender and ethnicity distribution was also done to ensure comparability and eliminate confounding or biases Many sources can be relied for information on exposure such as interviews, medical and employment records, direct physical examinations, laboratory test and others. After defining the cases and controls to be monitored, we must then decide and a time for follow up. This would usually depend on the risk factor and also the disease being studied. The consent from each subject must be taken and follow up on this individuals were done to through correspondence, periodic examinations, screening and hospitalization records to determine the occurrence of bladder cancer. The data collected which is the incidence of bladder cancer in the individuals, is then analyzed and interpreted. The occurrence of the outcome is usually measured using incidence rates and relative risk. Table: Contingency table analyzing the cohort study Coffee drinkers Not coffee drinkers Bladder cancer a c No bladder cancer b d Total a+b c+d

The relative risk ratio is calculated as; Incidence rate in the exposed/ Incidence rate in the unexposed Relative Risk Ratio = a/ (a+b) c/ (c+d)