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Types-of-Studies-Experimental-Epidemiology

The document discusses various types of epidemiological studies, focusing on experimental epidemiology and the levels of prevention, which include primary, secondary, and tertiary prevention strategies. It highlights the importance of informed consent in experimental studies, outlines the phases of biomedical clinical trials, and differentiates between clinical and field trials. Additionally, it mentions significant studies like the Turku Sugar Studies and the Salk Vaccine trial, emphasizing their roles in disease prevention and intervention effectiveness.

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abataysophiad
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10 views44 pages

Types-of-Studies-Experimental-Epidemiology

The document discusses various types of epidemiological studies, focusing on experimental epidemiology and the levels of prevention, which include primary, secondary, and tertiary prevention strategies. It highlights the importance of informed consent in experimental studies, outlines the phases of biomedical clinical trials, and differentiates between clinical and field trials. Additionally, it mentions significant studies like the Turku Sugar Studies and the Salk Vaccine trial, emphasizing their roles in disease prevention and intervention effectiveness.

Uploaded by

abataysophiad
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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WEEK 5

BIOSTATISTICS AND EPIDEMIOLOGY


Novie G. Salvador, DMD
TYPES OF STUDIES:
EXPERIMENTAL EPIDEMIOLOGY
PREVENTION IS BETTER THAN CURE
LEVELS OF PREVENTION
Level Services and Activities

Vaccination and post-exposure prophylaxis, Provision of information on


Primary behavioral and medical health risk, Counseling, Nutritional and Food
Supplementation, Dental Hygiene Education and Oral Health Services

Population-based screening programs for early detection of


Secondary diseases, Provision of maternal and child health programmed,
Provision of chemo-prophylactic agents to control risk factors

Rehabilitations, Support Groups, Vocational Rehabilitation


Tertiary
Programs
FLUORIDE TREATMENT
PRIMARY
FLUORIDE TREATMENT
SECONDARY
REMOVABLE PARTIAL DENTURE
TERTIARY
LEVELS OF PREVENTION
Level Services and Activities

Vaccination and post-exposure prophylaxis, Provision of information on


Primary behavioral and medical health risk, Counseling, Nutritional and Food
Supplementation, Dental Hygiene Education and Oral Health Services

Population-based screening programs for early detection of


Secondary diseases, Provision of maternal and child health programmed,
Provision of chemo-prophylactic agents to control risk factors

Rehabilitations, Support Groups, Vocational Rehabilitation


Tertiary
Programs
TYPES OF STUDIES:
EXPERIMENTAL EPIDEMIOLOGY
EXPERIMENTAL EPIDEMIOLOGY
EXPERIMENTAL OR INTERVENTION STUDIES
- Involve an active attempt to change
a disease determinant or the
progress of a disease through
treatment
EXPERIMENTAL OR INTERVENTION STUDIES
- Turku, Finland
Turku Sugar Studies
- 1970
- Substitution of sucrose in a normal diet with either fructose
- or xylitol
- Sucrose - high caries rate
125 subjects into 3 groups in 2 years
- Fructose - 32% lower caries rate than sucrose
- Xylitol - 85% lower caries rate
-
IS IT ETHICAL TO PERFORM EXPERIMENTAL
STUDIES ON HUMANS?
NO
INFORMED CONSENT
EXPERIMENTAL OR INTERVENTION STUDIES
- Vipeholm Study
- Gusta son et al
- 1954
- Vipeholm Hospital in Sweden
- Mentally-disabled
- 436 subjects
- Relationship between diet, frequency of sugar intake, and
dental caries
ff
EXPERIMENTAL OR INTERVENTION STUDIES
- Vipeholm Study
- Sticky food >
- Between meals >
EXPERIMENTAL OR INTERVENTION STUDIES
- Major experimental studies:
-Randomized Controlled Trials
-Field trials
-Community trials
RANDOMIZED CONTROLLED TRIALS
- Clinical trials
- Designed to study the e ects of a particular intervention,
usually a treatment for a speci c disease
- Subjects
- Random allocated to intervention and control groups
- People with disease
- Results
- Assessed by comparing outcomes
ff
fi
ARE ALL PEOPLE, REGARDLESS OF AGE, CAN TAKE
PART IN CLINICAL TRIALS?
YES
4 PHASES OF BIOMEDICAL CLINICAL TRIALS
Phase Description

Test new drugs for the first time in a small group of people to
I
evaluate a safe dosage range and identify side e ects
Test treatments that have been found to be safe in phase I, but
II now need a larger group of human subjects to monitor for any
adverse e ects
Conducted on larger populations and in di erent regions and
III countries, and are often the step right before a new treatment is
approved
After country approval and there is need for further testing in a
IV
wide population over a longer timeframe
ff
ff
ff
AFTER PHASE 4, DOES THE NEW TREATMENT STILL
NECESSITATE MORE CLINICAL TRIALS?
YES
WHAT IS THE USE OF RANDOMIZED CLINICAL
TRIALS?
TEST MEDICAL INTERVENTIONS :
DRUGS
CELLS AND OTHER BIOLOGICAL PRODUCTS
SURGICAL PROCEDURES
RADIOLOGICAL PROCEDURES,
DEVICES
BEHAVIORAL TREATMENTS
PREVENTIVE CARE
FIELD TRIALS
- Includes people who are healthy but presumed to be at risk
- Data collection takes place “in the eld” usually among non-
institutionalized people in the general population
- Purpose: Prevent diseases

fi
FIELD TRIALS
- Limitation: Logistically complicated and expensive
- Salk Vaccine
- One of the largest eld trials (over 1M children)
- Prevention of poliomyelitis (caused by poliovirus)
- Inactivated poliovirus
fi
HOW IS CLINICAL TRIAL DIFFERENT FROM FIELD
TRIAL?
CLINICAL TRIALS: FIELD TRIALS:
- PATIENTS - HEALTHY
- OFTEN THERAPEUTIC - OFTEN PROPHYLACTIC
- SECONDARY AND - PRIMARY PREVENTION
TERTIARY PREVENTION
SUB-ACUTE BACTERIAL ENDOCARDITIS
COMMUNITY TRIALS
-Subjects:
-Communities rather than individuals
-Diseases in uenced by social conditions
-Targets group behavior
fl
COMMUNITY TRIALS
- Stanford Five-City Community Intervention Trial
- For lower population risk of cardiovascular disease

- They used mass media and community-wide programs

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