Types of Reporting of ADRs
•Case Reporting of ADRs
•Analysis of secular trend of ADRs
•Cohort studies for ADRs
A)prospective cohort studies
B)retrospective cohort studies
•Case controlled studies for ADRs
•Cross sectional studies for ADRs
•spontaneous Reporting of ADRs
Case reporting of ADRs:
When the report of a single person is
published in a medical journal is called case reporting.
Most ADRs are reported in a medical
journal through case reporting. For
publishing a case report conformation is necessary.
E.g. dechallenge and rechallenge , lab
investigations, dose reduction etc is
necessary for conformation.
It is a long process because a case report
is build when there is large number of reports of ADRs are available. It can’t be formed on a single report. It is
formed on the similar reports of multiple cases.
Analysis of secular trends / ecological correlated studies:
It is evaluated to that whether the
trend between the suspected cause concide with the suspected event or not.
For example:
In 1981, by the introduction of oral
contraceptives, the cases of pulmonary
thromboembolism increased as their consumption increased.
Cohort studies:
Compare the group of individuals
having the same characteristics or experience.
Cohort study is research comparative
study. Cohort studies used for testing the hypothesis.
For example:
Two patients one is taking diclofenac and
another is taking ibuprofen both are taking NSAIDs but different. All the characteristics of patients must be
similar the only difference is the use of drugs they are using.
For example:
200 patients suffers from joint pain the
patients are of similar characteristics.
100 are taking Rofecoxib and 100 are taking celecoxib.
Out of 100 who are taking rofecoxib 15
deaths occur due to CVS toxicity.
Out of 100 who are taking celecoxib 5
deaths occur due to CVS toxicity.
The study shows that the incidence of
CVS toxicity is higher with the use of rofecoxib .
For example:
group of hypertension patients, pharmaceutical industry patients/people.
There are 2 types of cohort studies
1)prospective cohort studies
2)retrospective cohort studies
1)prospective cohort studies:
In prospective cohort studies we look
for development of disease in future.
Group of individuals showing the same
characteristics. Prospective cohort studies are observational studies.
Prospective cohort studies is a longitudinal
cohort studies that follow over a group of similar individuals (cohort) who
differs with the respect to certain factors .Under study to determine how these
factors affect rate of certain outcomes.
For example:
One might follow a cohort of middle aged
truck drivers who vary in terms of smoking habits, to test the hypothesis that
20 years incidence rate of lung cancer will be highest among heavy smokers
followed by moderate smokers and then non smokers.
2)Retrospective cohort studies:
In retrospective cohort studies we
check the previous records. We look back in time, thus using existing data such
as medical records or claim database.
Advantages of cohort studies:
•cohort studies are authentic
•in cohort studies multiple outcomes
can be evaluated for single exposure/risk factor.
Disadvantages of cohort studies:
•cohort studies is time consuming
•cohort studies is expensive
•chance of follow up
•quitting the studies
Case controlled studies:
Case controlled studies is used for
establishing case and effect relationship. Individuals are categorized on the
basis of outcomes. Those patients who developed the ADRs or the outcomes of
interest are known as case. Those patients who do not developed the ADRs
are called controlled.
Cross sectional studies:
In cross sectional studies outcomes and
cases are evaluated at the same time .
E.g. it is just like taking a picture you
can’t established the time effect / temporal relationship. We can’t establish cause and effect
relationship.
They are good for generating
hypothesis but are not good for testing hypothesis. The hypothesis are usually
tested from cohort studies.
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