Scientific project

Week 2
By Divyam Singh
48-1a

The epidemiologic approach to causation. Establishing the cause of a

disease.
Q1. Definitions of a cause.
A1- We know that in epidemiology, the “cause” is an agent (microbial germs,
polluted water, smoking, etc.) that modifies health, and the “effect” describes
the the way that the health is changed by the agent. The agent is often
potentially pathogenic (in which case it is known as a “risk factor”).
Q2- Characteristics of a cause.
A2- Any factor becomes a cause when it precede the effect. Can be either a host
or environmental factor (e.g., characteristics, conditions, actions of individuals,
events, natural, social or economic phenomena) May be positive (presence of a
causative exposure) or negative (lack of a preventive exposure).
Q3- Risk factors versus causes.
A3- Epidemiologists often use the term "risk factor" to indicate a factor that is
associated with a given outcome. However, a risk factor is not necessarily a
cause. The term risk factor includes surrogates for underlying causes.
Q4- Historical development of disease causation theories.
A4- Germ theory was proposed by Louis Pasteur (1822 –1895) and Robert Koch
(1843 –1910). Germ theory postulates that every human disease is caused by a
microbe or germ, which is specific for that disease and one must be able to
isolate the microbe from the diseased human being.
The Germ theory viewed diseases in terms of a causal network similar to that of
Fracastoro, but with much more detail about the nature of germs and possible
treatments.
Q5- Hill's guidelines for assessing causation.
A5- Bradford Hill's criteria have been summarized as including
 1) the demonstration of a strong association between the causative agent and
the outcome,
2) consistency of the findings across research sites and methodologies,
3) the demonstration of specificity of the causative agent in terms of the
outcomes it produces,
4) the demonstration of the appropriate temporal sequence, so that the
causative agent occurs prior to the outcome,
5) the demonstration of a biological gradient, in which more of the causative
agent leads to a poorer outcome,
6) the demonstration of a biologic rationale, such that it makes sense that the
causative agent causes the outcome,
7) coherence of the findings, such that the causation argument is in agreement
with what we already know,
8) experimental evidence, and
9) evidence from analogous conditions.
Q6- Use of Hill's guidelines by epidemiologists today.
A6- Bradford Hill's criteria are potentially helpful for neuropsychiatry because
they
1) are widely accepted and applied throughout medicine,
2) may increase rigor in establishing causation through the structure they
provide,
3) facilitate the teaching of important lessons about the role of the brain in
producing Behavioral change (e.g., if there is an absence of a biologic gradient,
this suggests hypotheses related to brain function that might explain this
finding), and
4) suggest research approaches (e.g., the need to establish a temporal sequence
speaks to the need for prospective studies). The criteria are reviewed below in
terms of their role in establishing an argument of causation in neuropsychiatry
and of the challenges and opportunities inherent in each of the criteria.
Q7- Sufficient-component cause model.  
A7- The sufficient cause model gives an account of the causes of a particular
effect, whereas the counterfactual (or potential outcome) model gives an
account of the various effects or outcomes of a particular cause or intervention.

Randomized controlled trials, design and application.

Q1- Overview of experimental studies.
A1- Experimental epidemiology tests a hypothesis about a disease or disease
treatment in a group of people. This strategy might be used to test whether or
not a particular antibiotic is effective against a particular disease-causing
organism.
Q2- Study population
A2- Population and epidemiology studies involve studying the health of
populations—both at specific time points and over longer periods of time—to
uncover patterns, trends, and outcomes that may be applicable to the general
population.
Q3- Sample size
A3- In the design of intervention and observational epidemiological studies
sample size calculations are used to provide estimates of the minimum number
of observations that need to be made to ensure that the stated objectives of a
study are met.
Q4- consent process
A4- Consent for participation in research requires an informed consent process.
This process involves an information exchange and on-going
communication that takes place between the investigator (researcher) and the
potential research participant (subject).
Q5- treatment assignment
A5- A Treatment Assignment Code (TAC) and a Treatment Assignment
Description (TAD) must accompany each clinical trial where a unique treatment
characteristic is utilized to uniformly group patients for separate analysis of
adverse events and response data.
Q6- use of placebo and masking
A6-The use of placebos and sham procedures facilitates masking and thereby
prevents bias in assessment of subjective outcomes, such as pain relief. At the
end of three weeks, they tested all the patients with questionnaires assessing
the level of their pain and other symptoms.
Q7- Maintenance and assessment of compliance
A7- A Compliance Assessment is used to to assess and document the current
state of compliance oversight, management and related risks in a given
compliance area. Consult with University Compliance and the lead Compliance
Partner to plan, conduct and finalize your assessment.
Compliance maintenance refers to the act of ensuring your facility is adhering to
all relevant statutory and regulatory laws and legislation. Health and Safety
regulations are par for the course when it comes to managing a facility, and it is
vital that your business adheres to all relevant legislation.
Q8- ascertaining the outcomes
A8-A key feature of epidemiology is the measurement of disease outcomes in
relation to a population at risk. The population at risk is the group of people,
healthy or sick, who would be counted as cases if they had the disease being
studied.
Outcome measures used in research are best able to answer research
questions. The methods for assessing physician and hospital performance
include process measures, patient-experience measures, structure measures,
and measures used to assess the outcomes of treatment.