IDENTIFYING AND RECRUITING HEALTHY CONTROL SUBJECTS FROM A MANAGED CARE ORGANIZATION - A METHODOLOGY FOR MOLECULAR EPIDEMIOLOGIC CASE-CONTROL STUDIES OF CANCER

Case-control studies with stringent matching criteria require large po ols of healthy subjects from which to select matched controls. This pa per describes a successful method of identifying a large pool of poten tial control subjects to participate in two molecular epidemiological case-control studies of lung cancer, each enrolling 400 case subjects and 400 control subjects. These studies are not population based, and the study base is not well-defined. Therefore, potential control subje cts are being identified and recruited through 20 area clinic sites of a large multispecialty health maintenance organization. Because the r esearch focus is driven by genetic hypotheses and we are controlling f or multiple smoking-related variables, representativeness is of lesser concern. To identify potential control subjects, a one-page questionn aire is distributed to patients in the waiting room to assess contact information as well as data relevant to the case-control matching proc ess. An average of 2,228 questionnaires are returned monthly toward a target pool of 40,000; of these, 59% of the respondents fulfill eligib ility criteria as a control subject for one of the studies and are not averse to being contacted in the future for the purpose of research. When compared to former smokers and never smokers, current smokers in the control population were least likely to refuse further contact. A collaborative arrangement with a managed care organization offers a fe asible mechanism through which researchers can access a large, ethnica lly diverse population of potential control subjects.