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JR I

A cohort study or panel study is a form of Longitudinal & a type of observational study, It is one of the type of clinical study design.

longitudinal Prospective studies Forward looking study I Incidence study

It is an analysis of risk factors which follows a group of people who do not have the disease, and uses correlations to determine the absolute risk of subject contraction.

A cohort is a group of people who share a common characteristics & experiences within a defined period. In a cohort study the population under investigation consists of individuals who are at risk of developing a specific disease, effect or health outcome Ancient Roman military unit, A band of warriors. -Persons banded together. Group of persons with a common statistical characteristic. [Latin] E.g.

We compare with group who have exposed the cause(risk factors) but not with final outcome (disease). The comparison group may be the general population. From which the cohort is drawn, or it may be another cohort of persons thought to have had little or no exposure to the substance/ cause/ risk factors which is under investigation. Alternatively, subgroups within the cohort may be compared with each other.

A cohort study is often undertaken to obtain evidence. Which try to disprove the existence of a suspected association between cause and effect Failure to disprove a hypothesis often strengthens confidence in it. The cohort(group under study) is selected before the appearance of the outcome(disease) which is under investigation. The study groups follow a group of people who do not have the outcome parameters for a period of time and see who develops or acquire it at the end of specific period(new incidence).

In Short Cohort study assesses exposure at baseline(outcome/ disease/ event free) & also assesses effect(outcome/ disease/ event) status of exposed and non exposed at follow-up(end of set time).

When there is good evidence of exposure and disease. When exposure is rare but incidence of disease is higher among exposed When follow-up is easy, cohort is stable When ample funds are available.

FRAME WORK OF COHORT STUDIES Disease


FRAME WORKStatus OF COHORT STUDIES
Total
A+B A C A+C

Yes
B D B+D

No Study Comparision

Exposure Yes Status No

C+D

GENERAL CONSIDERATION WHILE SELECTION OF COHORTS 1. Both the cohorts are free of the effects(outcome/ disease/ event) . 2. Both the groups should equally susceptible to effect(outcome/ disease/ event) 3. Both the groups should be statistically comparable for many factors. 4. Diagnostic and eligibility criteria for the effect(outcome/ disease/ event) should be defined well in advance.

ELEMENTS OF COHORT STUDY Selection of study subjects Obtaining data on exposure/ cause factors. Selection of comparison groups. Follow ups Analysis

SELECTION OF STUDY SUBJECTS General population


Whole population in an area A representative sample

Special group of population

Select group

occupation group / professional group (Dolls study )

Exposure groups

Person having exposure to some physical, chemical or biological agent e.g. X-ray exposure to radiologists

OBTAINING DATA ON EXPOSURE Personal interviews / mailed questionnaire Reviews of records

Dose of drug, radiation, type of surgery etc

Medical examination or special test

Blood, B, P, M, X, R, Phys,

Environmental survey By obtaining the data of exposure we can classify cohorts as


Exposed and non exposed and By degree exposure we can sub classify cohorts

study

Follow up Follow up is the most critical part of the

To obtain data about outcome to be determined (morbidity or death)

Some loss to follow up is inevitable due to death, change of address, migration, change of occupation.

Mailed questionnaire, telephone calls, personal interviews Periodic medical examination Reviewing records Surveillance of death records

ANALYSIS
Calculation of incidence rates among exposed and non exposed groups Estimation of risk

Disease Status Exposure Yes No Total Yes A C A+C No B D B+D Total A+B C+D N

INCIDENCE RATE Incidence among exposed = a a+b Incidence among non-exposed = c c+d

ESTIMATION OF RISK Relative Risk=

incidence of disease among exposed RR = ______________________________ Incidence of disease among non-exposed a/a+b = _________ c/c+d

ATTRIBUTABLE RISK Incidence of disease among exposed incidence of disease among non exposed AR = _______________________________ Incidence of disease among exposed

a/a+b c/c+d AR = _______________ a/a+b

TYPES OF COHORT STUDY Prospective cohort study: Exposure factors are identified at the beginning of a study and a defined population is followed into the future. Retrospective (historical) cohort study: past medical records for the defined population are used to identify exposure factors Combination of Retrospective and Prospective cohort study.

Open Cohort Studies [dynamic populations, such as the population of Los Angeles] involve a population that is defined just by the state of being a part of the study in question (and being monitored for the outcome). Date of entry and exit from the study is individually defined, therefore, the size of the study population is not constant. In open cohort studies, researchers can only calculate rate based data, such as, incidence rates and variants thereof. Closed Cohort Studies [static populations, such as patients entered into a clinical trial] involve participants who enter into the study at one defining point in time and where it is presumed that no new participants can enter the cohort. Given this, the number of study participants remains constant (or can only decrease)

COHORT STUDY
Strengths We can find out incidence rate and risk More than one disease related to single exposure can establish cause effect avoiding the debate as to which is the cause and which is the effect. good when exposure is rare minimizes selection and information bias a randomized control study may be unethical. Either original data or secondary data can be used in this design

Weaknesses losses to follow-up the two groups may differ in ways other than the variable under study. often requires large sample ineffective for rare diseases long time to complete expensive Ethical issues lack of randomisation in the cohort design, its external validity is lower

Cohort studies can either be conducted prospectively, or retrospectively from archived records.

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