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OBSERVATIONAL STUDY DESIGN

Oleh : Dr. Nurjannah, MPH

Objectives
1. Describe each study design 2. State the advantages and disadvantages of each study design 3. Understand the difference between descriptive and analytic studies 4. To be able to aply different study design to the same research question 5. Recognize each study design in medical literature

Type of Study
Epidemiological Study Observational Study Interventional Study

Grup
Descriptive or Analitycal Ecological Study

Individual

Descriptive

Analytical

Cross Sectional study

Cohort Study

Case Control Study

Type of Studies
Observational Analytic Studies Cross Sectional studies Case Control studies Cohrt Studies

Cross Sectional
The simple form an observational Both exposures and outcome are measured at the same time A snapshot of the health (or other) experiences of the population at that particular point in time

Cross Sectional
Also called a survey (collection of opinions) or pool (a questionnaire administered to a sample of a people, often about a single issue) Designed to determine what is happening ? right now Examines a characteristic or set of characteristic in a set of subjects at one point in time ( prevalence)

Advantages
Quick and inexpensive First step for a cohort study Able to yield prevalence estimates Researcher has control over selection of subjects Researcher a control over the mesurments used Can study several factors or outcomes at the one time Often provides early clues for hypothesis generation & later more definitive study

Disadvantages
Do not establish the true temporal sequence of events They can only ascertain whether exposure is associated with a given outcome; they cannot determine whether the exposure caused the outcome Potenstial bias in measuring exposure Potential sampling bias and/or survivor bias They are not feasible for rare condition Does not yield incidence or true relative risk

Example Breast Feeding and Obesity cross sectional study


Abstract : Objective : to assess the impact of breast feeding on the risk of obesity and risk of being overweight in children attending school in Calima. In a sample of 80 childen, early feeding, diet and lifestylefactors were assessedusing response to a questionnaire completed by parents
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Sample : 80 children aged 9 & 10, all Filipinos Main Outcome Measure Height and weight measurement BMI calculation : kg / height (m)2 Being overweight was defined as having a body mass index above : male : 18.86 for 9 y/o 19.61 for 10 y/o

Female : 19.2 for 9 y/o 20.2 for 10 y/o (NCHS) BMI for age Questionnaire : Was your children breast fed?, How long was your child exclusively breast fed? Other question : number of sibling, parents ages and education, child health (LBW), early feeding, frequency of eating selected food

Statistical Analyses
The prevalence of overweight and obese children were calculated according to the duration of breast feeding X2 test (chi square) were used to compare breastfed and nonbreastfed children and their association to an obese / overweight child.

Result
The prevalences of obesity in children who had never been breastfed was 4.5 % as compared with 2.8% in breast fed children. A clear dose response effect was identified for the duration of breast feeding on the prevalence of obesity

The prevalence was 3,8 % for 2 month of exclusive breast feeding, 2.3 % for 3-5 month, 1.7 % for 6-12 month, and 0.8% for more than 12 month Breast feeding as a significant protective factor against obesity development Similar relations were found with the prevalence of being overweight The protective effect of breast feeding was not attributable to differences in social class or lifestyle

Conclusion
Prolonged breast feeding may help decrease the prevalence of obesity in childhood

Since obese children have a high risk of becoming obese adults, such preventive measures may eventually result in a reductin in the prevalence of cardiovascular diseases related to obesity

Case Control Study


A case-control study is distinguished by the fact that subject are selected on the basis of whether or not they have the disease (or other outcom) of interest Case (person/group with a given disease) are then compared to control (person/ group without the given disease) in terms of their history of exposure to a hypothesized causal factor

Case Control Study


Ascertain of exposure of background of the two group and compare the proportion Best suited for study of diseases where medical care usually sought (hip fracture, cancer) bacauses it make to easier to identify cases

Stucture
Exposure
Exposed a Not exposed b Exposed c Not exposed d Control (people without desease)
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Outcome
Case (people with desease)

Design

Population

Selection of cases
Ideally, investigator identifies & enrolls all incident cases in a defined population in a spcified time period Selected cases from registries or hospital, clinics Whenn all incident cases in population are included, the study is a representative; otherwise there is potential for bias (e.g. referal bias

Selection of Controls
Critical that exposure in the control is representative of the exposure in the population Ideal controls would have same/similar characteristics as the cases Matching case control

Population-Based Controls
The best control group is a random sample of individuals from same source population (as the cases) who have not the developed the disease Population-based controls are the best way ensure that the distribution of exposure among the controls is representative

Hospitals Control
Hospital control are the most frequently used source Hospital control may not be representative of exposure rates in the target population The use of other ill as person control will provide a valid result only if their illness is unralated the exposure in question

Benefit of Using Hospital Controls


Convenient Cheap Numerus Avoids non-response When a population-based case registry is not available, hospital control better represent the subpopulation from wich the cases arose

Other Controls
Neighborhood controls are somewhat matched on SES & environmental exposure but may overmatch & be expensive Friends & relatives also cause problems with overmatching with habits, environment and ccupation & are generally a poor choice for controls

Use of Multiple Controls


Case to control ratio used is usually 1:1; if large number and cost is the same for both group If a study has a small number of cases, increasing the number of controls increass power of study

Advantages
Relatively shorter time and inexpensive Good for desease with long latency Valuable for studying rare or uncommon conditions Multiple etiologic factors evaluated for single deseases Well suited for studying disease with long induction period A relatively small number of subjects are required

Disadvantages
Inefficient if the exposure is very rare They are limited to one outcome variable Incidence rates or absolute risk estimates cannot be directly derived from them Do not establish the temporal sequence of event; in some situations the temporal relationship between exposure and desease may thus be difficult to establish
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Disadvantages
Prone to bias (selection of cases and controls recall, misclassification) Difficult to determine representativeness of case and controls Unless study is population based cant measure incidence of desease Bad for rare exposure (despite a large number of case, may still end up with few expossed cases)

Cohort Studies
An observational research design which begin when a groupof people (a cohort) initially free of desease, are classified according to a given exposure, and then followed up over time

Cohort Stucture
Exposure
Disease a

Outcome

Design

Exposed
No disease b Disease c Not disease d Not exposed Population (People without disease)

Type of Cohort
1. Prospective Fixed Open or Dynamic 2. Retrospective

Prospective Cohort
Fixed Cohort Study When the exposure groups in a cohort study are defined at the onset of the study without movement of individuals between exposure groups, the exposure group are reffered to as fixed cohorts (occupational. War)

Structure
Prospective fixed cohort study
Exposure Disease

? ?

Prospective Cohort
Open or Dynamic Cohort Study The other type of prospective cohort study is the open or dynamic cohort study where in individuals can be unexpose at one time and unexposed at another time. The person time analysis can take this into account in calculating incidence densities

Structure
Prospective dynamic (open) cohort study
Exposure Disease

? ?

Retrospective Cohort
The point of initial exposure occurred some time in the past and the experience of the population is followed up to the present time

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Retrospective Cohort Structure


Prospective fixed cohort study
Exposure Disease

? ?
= Present
= Absent ? = To detemined

Basic on which group are selected at


beginning of study

Advantages
Provide strong information about the causation of disease Provide the measurement of the risk of developing disease Exposure can be measured without bias, because at the same time the outcomes sre known; known confounder can be measured (especially in a prospective study)

Advantages
Can be used to examine multiple outcomes A range of factor that may influence the outcome (e.g. smoking) can be measured Suitable for examining the effect of rare exposures because this group can be preferentially recruited at the baseline Allows the incidence of the disease to be established

Disadvantages
Costly and time consuming May be difficult to accurately define and measure exposure in some circumstances Losses the follow up are not uncommon and may introduce serious bias Information bias may very in its effect over the course of data collection due to sometime subtle drifting of the quality of data collection Use of the retrospective design is only possible if historical data of adequate quality are available

Rancangan Penelitian Retrospective


F. Resiko (+)
Retrospektif
Efek (+) p o p u l a s i

F. Resiko (-)
F. Resiko (+) Retrospektif F. Resiko (-) Efek (-)

Rancangan Penelitian Cross Sectional


Populasi / Sampel

Faktor Resiko (+)

Faktor Resiko (-)

Efek (+)

Efek (-)

Efek (+)

Efek (-)

TERIMA KASIH

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