COHORT STUDIES

and
RANDOMIZED CLINICAL TRIAL

Presented by:

Senja Kemala
Dewi Sartika

( 081501010 )
(081501016)

Samira Khoiriah

( 081501011 )

Sri Wahyuni Tumangger (081501005)

COHORT STUDIES
or INCIDENCE

Of the various types of observational epidemiologic studies, cohort, or incidence, studies are generally thought to provide the most definitive information about disease etiology. They do provide the most direct measurement of the risk of disease development .

However , if carried out prospectively, they can be expensive and time-consuming, requiring a long-term commitment of funds and dedicated personnel.
Furthermore, as will be discussed, they are not free of potensial biases and other scientific problems.

How Cohort studies are carried out ?

1.

Defining the study population Initially, a study population or cohort is identified This cohort is to be followed up for the development of the diseases under investigation The cohort study focuses on disease to development

In order for a disease to develop, it must, of course, be absent initially and this must be established; the study population must be at risk for disease development.

For a rare rapidly fatal disease such as acute leukemia, a few cases initially present in the population will probably be self - evident.

For a more common disease such as coronary heart disease in middle-aged men, an initial examination of the potential study population may be required to find and exclude existing cases of disease.

2. Follow up

Once the population is initially defined and its members characteristics have been assessed, it is followed up for the development of the disease Follow-up procedures vary from study study both in intensity and completenes, depending on the disease manifestations to be measured

The duration of follow up required is determined primarily by the number of disease cases needed to assure statistical reliability of the findings.

This can usually be determined in advance, based on the size of the study population and the expected disease incidence.

For example: A study population numbering 1000 and expected incidence of 1% per year will yield about 10 new cases during each year of follow up. If 100 cases are needed to provide reliable answers, the study may be expected to the last about 10 years.

3. Data Analysis

As in a cross sectional study, the population is subdivided or classified according to the variables that are to be related to the disease. The disease incidence is determined for each subgroup and compared to see whether the presence or absence of the variable is related to subsequent disease development

If the study population is a special cohort exposed to a suspected etiologic factor, then its disease incidence is compared with that in a similar nonexposed cohort or in the general population

4. Interpretation and Evaluation of Cohort Studies

The emphasis in cohort studies is on the prediction of disease development They clearly demonstrate the time sequence between exposure and disease Furthermore, as has been pointed out , time sequence can sometimes be made clear in cross-sectional and case control studies as well

Cohort studies may also be biased due to loss of study subjects. This may occur initially if a portion of the target study population does not participate, or later as subjects of the study are lost to follow-up.

Marked losses of either type do not necessarily invalidate the study.

However, the investigatiors should consider whether the reason for loss of subjects, might have affected the study out come. Sometimes it is possible to gather outside information concerning lost subjects, particularly whether they left because of illness or death or for any reason that might be related to the exposures or disease under investigation.

RANDOMIZED CLINICAL
TRIAL

Randomized Clinical Trial

A study in which the participant are assigned by chance to separate groups that compare different treatments neither the researchers nor the participants can choose which group.

Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patients choice to be in a randomized trial.

CONTOH

Penelitian Framingham

Penelitian ini dimulai tahun 1950 dikota framingham Penduduknya mempunyai kisaran umur sesuai tujuan penelitian dengan jumlah subyek yang cukup memadai dari penelitian tuberkulosis sebelumnya yang berhasil dilakukan

Continue

Tindakan follow up dengan rawat inap relatif mudah dilaksanakan karena dikota tersebut terdapat rumah sakitpusat. Sehingga rujukan medis dan rujukan ilmiah diperoleh dengan mudah

Sources: Friedman,Gary D., (2004), Primer of Epidemiology, fifth edition, International Edition, Singapore., Page.134-138 anonim_ http://www.pharmacoepidemio Logy and randomized clinical trial.com

THANK YOU

SO MUCH