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Introduction to Clinical Epidemiology

Spring 1999 Elective


UT-H HSC
Jan Risser, PhD and Will Risser, MD PhD
Epidemiology

Basic science concerned with the patterns of


disease frequency in human population
Distribution of disease by person, place, time
Assumption:
Disease does not occur randomly
Disease has identifiable causes
which can be altered and therefore
prevent disease from developing
Jan
Risser,
PhD
Spring, 1999
Will
Definition of Epidemiology

The study of the distribution and


determinants of health-related states or events
in specified population, and the application of
this study to control of health problems.
[source: Last (ed.) Dictionary of Epidemiology, 1995]

Jan
Risser,
PhD
Spring, 1999
Will
Definition of Epidemiology

Study: surveillance, observation, hypothesis testing,


analytic research, and experiments.
Distribution: analysis by time, place, and person.
Determinants: physical, biological, social, cultural, and
behavioral factors that influence health.
Health-related states or events: diseases, causes of
death, behavior, reactions to preventive regimens, and
provision and use of health services.

Jan
Risser,
PhD
Spring, 1999
Will
Definition of Epidemiology

Specified populations: those groups of people with


identifiable characteristics
Application to control: refers to the goal of
epidemiology, that is to assess the public health importance
of diseases, identify the population at risk, identify the causes
of disease,describe the natural history of disease, and
evaluate the prevention and control of disease

Jan
Risser,
PhD
Spring, 1999
Will
Aims of epidemiologic research

Describe the health status of a population


Explain the etiology of disease
Predict the disease occurrence
Control the disease distribution
Preventable Causes of Disease
BEINGS
Biological factors and Behavioral Factors
Environmental factors
Immunologic factors
Nutritional factors
Genetic factors
Services, Social factors, and Spiritual factors
[JF Jekel, Epidemiology, Biostatistics, and Preventive Medicine, 1996]
Jan
Risser,
PhD
Spring, 1999
Will
Causal model of risk factors for CVD

Morbidity and Mortality


(Stroke, MI)

Biological Risk Factors


(Hypertension, Blood Lipids, Homocysteine)

Genetic Risk Factors Behavioral Risk Factors


(Family History) (Cigarette, Diet, Exercise)

Environmental Factors
(Socioeconomic Status, Work Environment)
Epidemiology & Clinical Medicine
Epidemiology is used in clinical medicine to:
describe the natural history of diseases
discuss disease causality
- proximate: biological mechanisms of disease
- distal: social and environmental causes of disease
provide disease surveillance
- essential for evaluating community health problems -
- and setting disease control priorities
[Greenberg RS (ed.) Medical Epidemiology, 1993]
Jan
Risser,
PhD
Spring, 1999
Will
Epidemiology & Clinical Medicine

Epidemiology is used in clinical medicine to:


evaluate diagnostic testing
- evaluate usefulness, sensitivity, specificity
- to set cutoff points, and develop screening strategies
evaluate prognosis
- by identifying prognostic factors
- through cohort and case control studies
[Greenberg RS (ed.) Medical Epidemiology, 1993]

Jan
Risser,
PhD
Spring, 1999
Will
Epidemiologic Process

In the epidemiologic process, researchers:


Define the problem: ask a well focused
question
hypothesis statement

Identify the cause: test the hypothesis


is there an association between exposure and outcome

Interpret the results:


threats to validity (bias, confounding),
role of chance
Jan
Risser,
PhD
Spring, 1999
Will
Brief History of Epidemiology
Classical Infectious Diseases Epidemiology
Edward Jenner (1749-1823)
developed a vaccine against smallpox using cow pox
160 years before virus was identified
John Snow (1813-1858)
described the association between dirty water and cholera
44 years before vibrio was identified
Ignaz Semmelweis (1818-1865)
described the association between childbed fever and
physicians unclean hands
32 years before causal agent was discovered
Jan
Risser,
PhD
Spring, 1999
Will
Brief History of Epidemiology
Classical Nutritional Epidemiology
James Lind (1716-1794)
conducted an experiment which showed that scurvy could
be treated and prevented with limes, lemons, and oranges
ascorbic acid was discovered 175 years later
Joseph Goldberger (1874-1927)
identified that pellagra was not infectious but nutritional
in origin and could be prevented by increasing the amount
of animal products in the diet and substituting oatmeal for
corn grits
niacin was discovered 10 years later
Jan
Risser,
PhD
Spring, 1999
Will
Brief History of Epidemiology
Epidemiology of Chronic Diseases
Observational Studies:
R Doll & AB Hill. Early case-control study. Smoking and
carcinoma of the lung: Preliminary report. [Br. Med. J. 2:739, 1950]
Cohort Studies:
An approach to longitudinal studies in a community: the
Framingham study. 10,000 residents gave baseline
information. Follow-up is now 50 years. [Annals New York
Academy of Sciences 107:539;1963]

Jan
Risser,
PhD
Spring, 1999
Will
Brief History of Epidemiology
Epidemiology of Chronic Diseases

Experimental Studies:
Hypertension Detection and Follow-up Program Cooperative
Group. 10,500 subjects randomly assigned to two groups:
1. stepped care - antihypertensive therapy increased stepwise to achieve
and maintain blood pressure reduction to goal.
2. Referred care - subjects were referred to their primary care physician and
treated as usual.

mortality stepped care 9.0/100 referred care 9.7/100


final blood pressure 84.1 in stepped care 89.1 in referred care
Jan
Risser,
PhD
Spring, 1999
Will
Brief History of Epidemiology
Epidemiology of Chronic Diseases

Physician Health Study


randomized, placebo-controlled, double-blind clinical trial
conducted entirely through the mail
22,071 male physicians enrolled to study the effects of aspirin on
cardiovascular disease and the effects of beta-carotene on cancer
randomly assigned to one of four groups
aspirin beta carotene
active active
active placebo
placebo active
placebo placebo
Jan
Risser,
PhD
Spring, 1999
Will
Observational and Analytical Epidemiology

Descriptive epidemiology
the occurrence of disease (cross-sectional)
Etiologic epidemiology (quasi-experimental)
cause of disease (cohort, case-control)
Experimental epidemiology
assessment of therapy (cohort, randomized clinical
trial)

Jan
Risser,
PhD
Spring, 1999
Will
Research Design Used in Epidemiology

Case Reports / Case Series


Case control
Cohort: prospective or retrospective
Cross sectional
Qualitative (Randomized Clinical Trials)
Secondary data analysis
Definitions in Epidemiology
Bias
Confounding
Frequency Measures
Prevalence
Incidence
Measures of Association
Causal Inference

Jan
Risser,
PhD
Spring, 1999
Will
BIAS
systematic errors in collecting or interpreting data
such that there is deviation of results or inferences
from the truth.
selection bias: noncomparable criteria used to
enroll participants.
information bias: noncomparable information is
obtained due to interviewer bias or due to recall bias

Jan
Risser,
PhD
Spring, 1999
Will
BIAS
Bias results from systematic flaws in study design,
data collection, or the analysis or interpretation of
results.

Jan
Risser,
PhD
Spring, 1999
Will
Selection BIAS

Selection bias
Hospital Mean duration Labor
deliveries of labor complications
Season
Summer 180 8.0 hr 7.8% (14/180)
Winter 240 10.5 hr 11.7% (28/240)

Jan
Risser,
PhD
Spring, 1999
Will
Selection BIAS

DELIVERIES Mean duration Labor


Hospt. Home All of Labor Complications
Season
Summer 180 20 200 8.0 hr 8.0% (16/200)
Winter 240 160 400 8.0 hr 8.0% (32/400)

Home deliveries were more common in winter. Labor


complications among home deliveries were low. Women with
prolonged or complicated labor attempt to reach the hospital no
matter what season.
Jan
Risser,
PhD
Spring, 1999
Will
Information BIAS

Response bias - a systematic error that results when


subjects respond inaccurately to an investigators questions

Lushton County Medical Society commissioned a survey of


community perceptions regarding physician impairment by
alcohol or drugs. [Biomedical Bestiary. Michael, Boyce & Wilcox]
Persons were asked for anonymous impressions regarding their
personal physician.

Jan
Risser,
PhD
Spring, 1999
Will
Information BIAS

1000 persons were randomly chosen from the


community and sent a simple postcard
1. Is your physicians medical judgment
ever compromised by the use of alcohol or drugs? 0.4%
2. Does the physician drug or alcohol abuse threaten the
professional image of physicians in Lushton? 78%
3. Are physicians who use drugs or alcohol a threat
to their patients? 85%
98% response rate
Jan
Risser,
PhD
Spring, 1999
Will
Information BIAS

1000 original respondents re-interviewed after 12%


of the licensed physicians in the county were cited
for drug- or alcohol-related malpractice.
1. Is your physicians medical judgment ever compromised by the
use of alcohol or drugs? [0.4%] 8%
2. Does the physician drug or alcohol abuse threaten the
professional image of physicians in Lushton? [78%] 80%
3. Are physicians who use drugs or alcohol a threat
to their patients? [85%] 82%
Jan
Risser,
PhD
Spring, 1999
Will
Confounding
a mixing of effects
between the exposure, the disease, and other factors
associated with both the exposure and the disease
such that the effects the effects of the two processes
are not separated.

Jan
Risser,
PhD
Spring, 1999
Will
Confounding
Confounding results when the effect of an
exposure on the disease (or outcome) is distorted
because of the association of exposure with other
factor(s) that influence the outcome under study.

Jan
Risser,
PhD
Spring, 1999
Will
Confounding
[Biomedical Bestiary: Michael, Boyce & Wilcox, Little Brown. 1984]

Observed association, presumed causation

Gambling Cancer

Smoking,
Unobserved association
Alcohol, True association

other
Factors
Jan
Risser,
PhD
Spring, 1999
Will