Principles Of Epidemiology

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These consist of clinical trials and community trials

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Experimental designs

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In this type of trial the unit of analysis is the individual and it is a controlled experiment

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clinical trials

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This is the most rigorous method of hypothesis testing (most feasible)
-exposed subjects and exposure levels controlled
- Not always appopriate for all conceivable hypothesis testing
Ex. Smoking and radon exposure to lung CA among uranium miners
-would involve deliberate exposure of subjects to potentially harmful agents.

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Randomized clinical trials

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In this type of trial..
-unit of analysis is the group or community outcomes
-Quai-experimental; no randomization of subjects to conditions

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Community trials

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What is the purpose of intervention studies?

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Test efficacy of preventive or therapeutic measures

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These types of trials
-Tightly controlled for: eligibility, intervention delivery, outcomes monitoring
-duration is days to years
-Subjects often volunteers diagnosed with disease or those interested
-Most appropriate for testing narrow hypotheses are vaccines, treatments, or individuals' behavior change; elimination of tabacco use among smokers

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Clinical trials

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-Subjects- all members of group or community
-Longer duration than Randomized clinical trials
-Usually involve primary prevention.

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Community trials

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These at the community level require:
-Simple intervention (response to vaccine)
-Sufficient number of communities involved

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Random clinical trials

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This happened in 1537:
- Experimental treatment: turpentine, rose oil, egg yolks
-Standard treatment of day: boiling oil

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Ambroise Pare' and battlefield woulds

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This happened in 1600:
-Experimental treatment: lemon juice or citrus
-standard: no special diet

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East India Shipping company and scurvy in sailors

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This happened in 1796:
-Experimental treatment: Inoculation with cowpox
-standard treatment: nothing or variolation with smallpox material

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Edward Jenner and smallpox

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This types of trials have no comparisons or randomization.

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Early clinical trials

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These types of trials:
-Infectious disease-polio
-Chronic diseases of noninfectious origin-diabetes
-Outcomes from several researchers pooled

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multicenter trials

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A ________ _______ is a planned experiment designed to assess the efficacy of treatment in many by comparing the outcomes in a group of patients treated with the test treatment with those observed in a comparable group of patients receiving a control treatment, where patients in both groups are enrolled, treated, and followed over the same time period

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Clinical trials

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This type of trial evaluates the effectiveness of:
-substance (vaccine against polio) or
-prevention program (vitamin supplementation)

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Prophylactic trial

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This type of trial evaluates the effectiveness of:
-Curative drugs or
-New surgical procedure

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Therapeutic trial

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These types of trials involve groups in which
-one designated control arm (current standard of care) placebo, or not intervention
-and one given new treatment or procedure

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Prophylactic and therapeutic trials

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-Evaluation of results showes reates of disease, death, recovery, and other
-Outcome of interest measured in intervention and control arms to evaluate efficacy

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Clinical endpoints

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-Measures of subclinical disease or physical measures

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Surrogate endpoints

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-Neural tube defects (anencephaly, spina bifida, or encephalocele)
-Randomized trial -33 centers in seven countries
-Vitamin supplementation near time of conception and prevention of NTDs; folic acid or mixture of A,D, B1, B2, B6, C and nicotinamide
-1,817 eligible subjects indluded women who were planning pregnancy, had a previous child with an NTD, and were not already taking vitamin supplements

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1991 medical research council vitamin study

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This type of study design the subject does not know to which group he is assigned, which prevents overstatement of responses and benefits and reduces the number leaving study

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Single-blind design

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in this type of study design the subject and investigator do not know to which group the subject is assigned, which reduces the likelihood of biased assessment by investigators

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Double-blind design

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How many phase trials are involved with pre-licensing evaluation of vaccine

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3

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What does phase I trials in pre-licensing evaluation of vaccine require?

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Safety in adult volunteers

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What does phase 2 trials in pre-licensing evaluation of vaccine require?

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Immunogenicity and reactivity in the target population

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What does phase 3 trials in pre-licensing evaluation of vaccine require?

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Protective efficacy

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__________ evaluation
-Safety and efficacy of vaccine
-disease surveillance
-serologic surveillance
-measurement of vaccine coverage

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Post-licensing evaluation

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In this phase
-number of subjects is less than 100
-Response: antibody formation in response to vaccine

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Phase 1

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In this phase
-number of subjects: 100-200
-Response: antibodies and clinical reactions to vaccine

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phase 2

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In this phase..
- Used to assess protective efficacy in target population
-main test of vaccine

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Phase 3

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A phase for anticancer drug testing, this involves in vitro and in vivo animal testing

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Pre-Phase I

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A phase for anticancer drug testing, this involves testing agent among human subjects and identifying the limiting toxicities, establish maximally tolerated dose, optimal dosage range, and describe the pharmacology of agent (metabolism, distribution, excretion of agent)

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Phase 1

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A phase for anticancer drug testing, this phase test the activity and efficacy with various tumor types and validates the toxicity and dosage data

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Phase 2

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A phase for anticancer drug testing, this phase determines value of new therapy vs. existing therapies and generate and publish recommendations for the medical community

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Phase 3

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What are the two general methods of randomization?

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Fixed or Adaptive

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Of the two types of methods of randomization:
-Easier
-Once subject is selected, passes eligibility, agrees to participate, then has equal chance of being assigned to either intervention or control arm

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Fixed

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What are the randomization techniques and which is the simplest?

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Simplest: flip a coin
Random number tables
computer algorithms

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Any planned or unplanned change of treatment for patient in clinical trial involving a switch of study treatments

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Crossover designs

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Protocol may specify in advance that switch from one treatment to another treatment occur during trial and after a predetermined period of follow-up. The patient serves as his or her own control.

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planned change of treatment

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This type of change of treatment is due to change in patient condition

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Unplanned

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These are
-Adverse effects caused by the medications
-Circumvented by animal studies (may not apply directly)

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Iatrogenic reactions

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When are trials interrupted?

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as soon as results are statistically significant

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NIH policy has provided DSMB which stands for?

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Data and Safety monitoring board

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this is an independent group of experts and are advise investors and funding agencies and phase III, sometimes 1 and 2 require this board for informed consent

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Data and safety monitoring board

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-describes risks and benefits of participating
-discloses purpose of trial, duration, procedures involved

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Informed consent

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CONSORT stands for?

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Consolidating standards of reporting trials

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These are the strengths of what?
-greatest control over study situation
-investigators controls exposure, amount, timing, and frequency and period of observation for endpoints
-Ability to randomize subjects to assignments which reduces the likelihood that groups differ significantly with respect to risk factor distribution.

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Clinical trials

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These are the limitations of what?
-Delivery and evaluation of treatment artificial
-Adherence to protocols may be difficult to enforce especially if treatment produces undesirable side effects or presents significant burden to subjects
-withholding beneficial treatment from controls presents ethical dilemma

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Clinical trials

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this is the definition of...
-any program or other planned effort designed to produce changes in a target population

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intervention

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-Allow determination of potential benefit of new policies and programs

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Intervention trials at level of entire communities

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-1972, Finland, cardiovascular disease

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North Karelia Project

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-13 yers, coronary heart disease

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Minnesota heart health program

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-Lower risk of cardiovascular disease
-2 treatment cities, 2 controls, 1 for morbidity/morality only
-6 years

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Stanford Five-city project

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-2 cities, 7 yrs
-Cross sectional surveys in both intervention and controls at baseline
-cross-sectional surveys 4 times during intervention
-cross sectional surveys at intervention end

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Pawtucket heart health program

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The only way to estimate directly realistic impact of behavior change or other modifiable exposure on disease incidence is through

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Community trials

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______ ____ inferior to clinical trials because
-lower ability to control entry, deliver intervention, monitor outcomes
-Likelihood that intervention and control units may differ with respect to racial composition, education level, age distribution, or other unmeasured variable
-shifting in study population composition

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Community trials

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How many stages of evaluation of community interventions are there?

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4

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Way of making sure program will work as planned; begin with idea for program

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formative evaluation

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Learn if program is serving target population as planned and if numbers are as expected; begin as soon as program begins

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process evaluation

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Measures changes in target population; informs planners whether making progress toward goals

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impact evaluation

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Conduct outcome evaluations at specified intervals; learn how well program has accomplished its ultimate goal

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Outcome evaluation

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-Study subjects felt they had been singled out and felt company was interested in their personal welfare.. this describes the..
-productivity increased in study group
-solomon four-group assignment allows determination of intervention effect and observation effect
-Epidemiologist seldom use expensive to add two additional study arms and reanalysis cast much doubt on existance of an actual effect

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hawthorne effect

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Ability to generalize results to target population associated with study subject selection protocol. Should increase diversity of human subjects who participate

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external validity

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Ability of study to detect the hypothesized outcomes
-linked to sample size; Larger: greater statistical power, reduced measurement error but cost increases with size

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Statistical power

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Can potentially vitiate or nullify intervention effects and does not take medicines, read brocheures, or other

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noncompliance