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History of Epidemiology HIPPOCRATES (400 BC): “On Airs, Waters, and Places” –Hypothesized that disease might be associated with the physical environment, including seasonal variation in illness. JOHN GRAUNT (1662): “Nature and Political Observations Made Upon the Bills of Mortality” – First to employ quantitative methods in describing population vital statistics. JOHN SNOW (1850): Formulated natural epidemiological experiment to test the hypothesis that cholera was transmitted by contaminated water. History of Epidemiology (cont.) DOLL & HILL (1950): Used a case-control design to describe and test the association between smoking and lung cancer. FRANCES at al. (1950): Huge formal field trial of the Poliomyelitis vaccine in school children. DAWBER et al. (1955): Used the cohort design to study risk factors for cardiovascular disease in the Framingham Heart Study. ROOTS OF MODERN EPIDEMIOLOGY 1. ACUTE DISEASE INVESTIGATION ----- Emphasis on empirical systematic investigation, biology, and environment/host manipulation 2. MEDICINE ----- All early epidemiologists were physicians. ROOTS OF MODERN EPIDEMIOLOGY 3. STATISTICS ----- Emphasis on the scientific method, quantification and measurement, and hypothesis testing. In 1960s, many epidemiologists were statisticians. 4. SOCIAL SCIENCES ----- Investigation of human behavior in relation to disease, and methods of data collection (surveys, etc.) ROOTS OF MODERN EPIDEMIOLOGY 5. COMPUTER SCIENCES ----- Emergence of “chronic” disease epidemiology required the ability to handle large amounts of data and to perform complex analyses. 6. MANAGERIAL SCIENCES ----- Management principles for acquisition of grants, research collaboration, and management of clinical trials. ROOTS OF MODERN EPIDEMIOLOGY 7. GENOMICS ----- 2001 marked first publication of draft sequences of the human genome. Intensive investigations being conducted to identify “disease susceptibility genes” “geneenvironment” interactions, and “gene-gene” interactions. Levels of Inference from Epidemiologic Evidence, and Attendant Concerns Epidemiology provides varying levels of information: INFERENCE Relations between operational measurements among study measurements Association between measured exposure and disease among study participants Causal effect of exposure on disease in the study population REQUIREMENTS None Accurate measurement of both exposure and disease Freedom from “confounding” Levels of Inference from Epidemiologic Evidence, and Attendant Concerns Epidemiology provides varying levels of information: INFERENCE REQUIREMENTS Causal effect of exposure on disease in external populations Generalizability (external validity) Prevention of disease through elimination or reduction of exposure Amenability of exposure to modification Substantial public health impact from elimination or reduction of exposure Large “attributable fraction” EVOLVING FIELD OF EPIDEMIOLOGY Chief Causes of Death in the U.S. -- 1900 Pneumonia/Influenza Tuberculosis Gastritis, enteritis, colitis Heart disease Senility, ill-defined conditions Vascular lesions affecting CNS Nephritis and renal sclerosis 11.8% 11.3% 8.3% 8.0% 6.8% 6.2% 4.7% Chief Causes of Death in the U.S. -- 2001* Disease of heart Malignant neoplasms Cerebrovascular diseases Chronic lower respiratory diseases Unintentional injuries Diabetes mellitus Pneumonia & influenza *Age-adjusted per 100,000 248 196 58 44 36 25 22 Leading Causes of Death in Children In Developing Countries -- 2002 Cause of Death % of all Deaths Perinatal conditions 23.1 Lower respiratory infections 18.1 Diarrhoeal diseases 15.2 Malaria 10.7 Measles 5.4 Congenital anomalies 3.8 HIV/AIDS 3.6 Pertussis 2.9 Other 17.2 Causes of Mortality Worldwide: 2002: Ages 15 - 59 Cause Deaths (000) HIV/AIDS 2279 Ischemic heart disease 1332 Tuberculosis 1036 Road traffic injuries 814 Cerebrovascular disease 783 Self-inflicted injuries 672 Violence 473 Causes of Mortality Worldwide: 2002: Ages 60 and Older Cause Deaths (000) Ischemic heart disease 5825 Cerebrovascular disease 4689 COPD 2399 Lower respiratory infections 1396 Trachea, bronchus, lung cancers 928 Diabetes mellitus 754 Hypertensive heart disease 735 Stomach cancer 605 Causes of Disease Burden (DALYs) Worldwide: 2002: Ages 15 - 59 Cause DALYs (000) HIV/AIDS 68661 Unipolar depressive disorders 57843 Tuberculosis 28380 Road traffic injuries 27264 Ischemic heart disease 26155 Alcohol use disorders 19567 Hearing loss, adult onset 19486 Violence 18962 Causes of Disease Burden (DALYs) Worldwide: 2002: Ages 60 and Older Cause DALYs (000) Ischemic heart disease 31481 Cerebrovascular disease 29595 COPD 14380 Alzheimers and other dementias 8569 Cataracts 7384 Lower respiratory infections 6597 Hearing loss, adult onset 6548 Trachea, bronchus, lung cancers 5952 EVOLVING FIELD OF EPIDEMIOLOGY Historically, in developed countries, there has been a marked shift in the leading causes of mortality from “infectious” to “chronic” diseases. In the U.S. today, the fastest growing segment of the population is aged 85 and older. Virtually all “chronic” diseases have multi-factorial etiologies. Discussion Question 3 If a “cure” was found for heart disease, how might this likely affect mortality rates from: (1) AIDS; and (2) Cancer in the United States? Discussion Question 3 Most likely: 1. AIDS-related mortality would be largely unaffected since most deaths from AIDS occur in persons not at high risk (age) for heart disease mortality. 2. Cancer mortality would increase since persons who would have died from heart disease would now be at risk of dying from cancer. This concept of one cause of mortality affecting another is know as “competing risks.” PRACTICAL AND ETHICAL ISSUES Measures of disease and exposure occurrence are often not easy to obtain. Many diseases occur infrequently in human populations. PRACTICAL AND ETHICAL ISSUES Unlike experimental science, the investigator cannot manipulate study variables (i.e those hypothesized to be causes of disease). Investigator must deal with budgetary and subject privacy concerns. EXAMPLES OF UNETHICAL “RESEARCH” Criminal and unscientific behavior of physicians in concentration camps in Nazi Germany – led to adoption of Nuremberg Code (1947). 1936 – U.S. Public Health Service started study of effects of untreated syphilis in Tuskegee, AL long after effective treatment for the disease was known. 1963- Jewish Chronic Diseases Hospital – 22 elderly patients injected with cancer cells without their knowledge to test immunological response. Willowbrook State Hospital, NY: retarded children deliberately infected with viral hepatitis to study natural history. ETHICS 1974: Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Requires the establishment of Institutional Review Boards (IRBs) for all research funded in whole or in part by the federal government. 1996: Health Insurance Portability and Accountability Act (HIPAA): Privacy Rule issued to assure that individual’s health information is properly protected, while allowing the flow of health information needed to promote high-quality health care and to protect the public’s health and well-being. HIPAA The HIPAA Privacy Rule protects individual “identifiable” health information known as “protected health information” transmitted or maintained in any form or medium. Includes: --Demographic or other information relating to past, current, or future physical or mental health or condition of an individual --Provision or payment of health care to an individual that is created or received by a health care provider, health plan, employer, or health care clearinghouse --- Individual genetic information SOME PROFESSIONAL AND ETHICAL ISSUES Should informed consent be required for routine review of medical records? Who should have access to the study data, and when? How should study findings be disseminated to the public? Should epidemiologists be advocates for specific public health policies? Discussion Question 4 What are the important criteria that IRBs consider in approving human research studies? Discussion Question 4 Criteria include: 1. Risks to study participants are minimized. 2. Risks are reasonable in relation to anticipated benefits. 3. Selection of study participants is equitable. 4. Informed consent is obtained and documented for each participant. 5. Adequate monitoring of data collection to ensure the safety of study participants. 6. Privacy of participants and confidentiality of data are protected. THE HOST - ENVIRONMENT INTERACTION ANKYLOSING SPONDYLITIS Persons with HLA-B27 approximately 90 times more likely to develop the disease (Genetic Susceptibility) However, only 10% of the individuals with HLA-B27 will develop the disease (Environmental Exposure) THE HOST - ENVIRONMENT INTERACTION “Virtually all chronic diseases have multi-factorial etiologies” -- many may have infectious components. Enteroviruses Epstein Barr virus Chlamydia pneumoniae Helicobacter pylori Hepatitis B and C Borna disease virus Type I diabetes B-cell lymphomas Heart disease Peptic ulcers Liver cancer Schizophrenia Natural history of disease Exposure Onset of symptoms Usual time of diagnosis Pathologic changes Stage of susceptibility PRIMARY PREVENTION Stage of subclinical disease SECONDARY PREVENTION Stage of clinical disease Stage of recovery, disability or death TERTIARY PREVENTION The natural history of disease STAGE 1: Susceptibility DESCRIPTION: Risk factors which assist the development of disease exist, but disease has not developed EXAMPLE: Smoking The natural history of disease (cont’d) STAGE 2: Presymptomatic disease DESCRIPTION: Changes have occurred to lead toward illness but disease is not yet clinically detectable EXAMPLE: Alveoli deteriorate The natural history of disease (cont’d) STAGE 3: Clinical Disease DESCRIPTION: Detectable signs and/or symptoms of disease exist EXAMPLE: Emphysema detected by pulmonary function test The natural history of disease (cont’d) STAGE 4: Disability DESCRIPTION: Disease has progressed to the point of causing a residual effect EXAMPLE: Person has difficulty breathing LEVELS OF PREVENTION LEVEL: Primary DESCRIPTION: Promote general health and avoid risk factors for disease --- Utilize protective measures to prevent susceptibility and presymptomatic disease EXAMPLE: Stop smoking or choose not to start; avoid areas where people are smoking LEVELS OF PREVENTION (cont’d) LEVEL: DESCRIPTION: Secondary EXAMPLE: Routine pulmonary function tests for those at risk; medicine to help patients breath more easily; smoking cessation programs if patient smokes Early detection and timely treatment LEVELS OF PREVENTION (cont’d) LEVEL: Tertiary DESCRIPTION: Rehabilitation and prevention of further disease or disability EXAMPLE: Oxygen therapy; facilitating ambulation with technical devices PREVENTION APPROACHES Population-Based Approach: • Preventive measure widely applied to an entire population (public health approach) • Strive for small absolute change among many persons • Must be relatively inexpensive and non-invasive PREVENTION APPROACHES High-Risk Approach: • Target group of individual at high risk • Strive for strong risk factor control • Often times requires clinical action to identify the high risk group and to motivate risk factor control. LEVELS OF PREVENTION (Review) PRIMARY PREVENTION Prevention of disease by controlling risk factors (e.g., non-smoking promotion) LEVELS OF PREVENTION (Review) SECONDARY PREVENTION Reduction in consequences of disease by early diagnosis and treatment (e.g., cervical cancer screening) LEVELS OF PREVENTION (Review) TERTIARY PREVENTION Reduction in complications of disease (e.g., MV crashes and ICU)