Cross sectional, Case Control and Cohort study

Dr. Shahistha Parveen

Assistant Professor
RAKCODS
 Learning Outcome

Collect and analyze relevant knowledge from various resources in order

to make appropriate clinical decisions for patient’s oral health care
Research design
 Contents
• Epidemiology • Cohort Study
• Case control study • Steps
• Steps • Bias in study
• Bias in study • Advantages
• Advantages • Disadvantages
• Disadvantages

• Case control study

• Steps
• Bias in study
• Advantages
• Disadvantages
 Introduction

• EPIDEMIOLOGY

• Epidemiology - Greek terms- “epi” - upon,

• “Demos” - people, “logos” –study.

• EPIDEMIOLOGY - the study of the distribution and determinants of health-related

states or events in specified populations and the application of this study to control of
health problems.
 Epidemiology Classification

Case report
Case series
Descriptive
Cross sectional
Observational
Case Control
Analytical
Epidemiology Cohort Study
Randomized Controlled
Trials

Experimental Field Trials

Community Trials
 Cross-Sectional Study
A study that examines the relationship between diseases and other variables of

interest as they exist in a defined population at one particular time

Best for quantifying the prevalence of a disease or risk factor, and for quantifying

the accuracy of a diagnostic test

The participants in a Cross-sectional Study are just selected based on the inclusion

and exclusion criteria set for the study unlike Case–control Studies or Cohort studies

Case–control Studies: (Participants selected based on the outcome status)

Cohort studies: (Participants selected based on the exposure status)
 Advantages:

1. Cross-sectional studies can usually be conducted relatively faster and are

inexpensive – particularly when compared with Cohort studies (prospective)

2. It will give us information about the prevalence of outcomes or exposures; this

information will be useful for designing the cohort study

3. These study designs may be useful for public health planning, monitoring, and
evaluation
 Limitations

• Since this is a one time measurement of exposure and outcome, it is difficult to

derive causal relationships from cross-sectional analysis

• These studies are also prone to certain biases

• The prevalence of an outcome depends on the incidence of the disease as well as

the length of survival following the outcome
 ****Key points- Cross sectional studies

1. Cross sectional studies are the best way to determine prevalence

2. They are relatively quick

3. It can study multiple outcomes

4. Do not themselves differentiate between cause and effect or the sequence of events
 Case-Control Studies

Patients with a certain outcome or disease and an appropriate group of controls

without the outcome or disease are selected and then information is obtained on
whether the subjects have been exposed to the factor under investigation

1. Both exposure and outcome have occurred before the start of study

2. Study proceed backward from effect to cause

3. Uses a control or comparison group to support or refute an inference

 Case-Control Studies

• In a Case-Control study there are two groups of people:

• one has a health issue (Case group), and this group is “matched” to a Control group
without the health issue based on characteristics like age, gender, occupation

• In this study type, we can look back in the patient’s histories to look for exposure to risk
factors that are common to the Case group, but not the Control group

• These studies estimate the odds between the exposure and the health outcome,
however they cannot prove causality

• Case-Control studies might also be referred to as retrospective or case-referent studies

 Advantages:
1. Quick and cheap

2. Only feasible method for very rare disorders

3. Fewer subjects needed than cross-sectional studies

 Cases (People with disease)

Population

Controls (People without disease)

Direction of inquiry
Basic steps in Case-control Study

1. Selection of cases

2. Selection of cases controls

3. Matching

4. Measurement of exposure

5. Analysis and interpretation

 1. Selection of Cases

• Case is a crucial to case control study

• Diagnostic criteria – Disease and stage of the disease -must be specified

Eligibility criteria

• Sources
 2. Selection of Control

• Must be free from the diseases under study and similar to the cases as possible.
• Comparison group is identified before a study is done
Sources

**Failure to select comparable controls can introduce “bias” in case control studies.
 3. Matching

Defined as
process by which we select controls in such a way that they are similar to the cases
with regard to certain pertinent variables which known to influence the outcome of the
diseases and which, if not adequately matched for comparability, could distort or
confound the results

Should be done to ensure comparability between cases and controls

 Several kinds of matching procedures

1. Group Matching

2. Pair Matching:
E.g. 50 year old mason with a particular disease as case 50 year old mason without disease as a control
 Confounding Factors

• Defined as “one which is associated with the exposure and the disease and is
distributed unequally in the study and control group”

• Eg: Smoking and alcohol in throat cancer, Age in oral cancer

 4. Measurement of exposure

Information obtained should be same for both the cases and controls
 5. Analysis and Interpretation
• Exposure rates: Direct estimation of exposure rates to a suspected factor in disease and
non disease groups.

• Estimation of risk
Cases with lung cancer Controls without lung cancer

Smokers 33 (a ) 55 (b)

Non smokers 02 (c ) 27 (d)

a /a+c = 94.2%
b/b+d = 67%
 Estimation of the Disease Risk

Relative risk or risk ratio – Ratio between the incidence of disease among Exposed
persons and incidence among non-exposed:
Incidence among exposed
Incidence among non-exposed
Odds ratio/ Cross product ratio- is strength of association between risk factor and
outcome

Odds ratio =a X d / c X b
33 X 27 = 8
55 X 2 OR =1 indicates that the rate of disease is unaffected by exposure of workers to the agent of interest.
OR >1 indicates an increase in the rate of disease in exposed workers.

** Smokers have showed a risk of having lung cancer 8 times that of nonsmokers
 Dental amalgam and multiple sclerosis: a case-control study

• Dental amalgams containing mercury have recently been suggested as a possible risk factor
for Multiple Sclerosis.

Duration: 1991- 1994

Cases: 143 MS patients

Control: 128 controls

To obtain information on socio-demographic characteristics and the number of dental amalgams

and the time since restoration based on dentists' records.

• Who had >15 fillings had an odds ratio (OR) of 2.57 compared to those who had none

A suggestive elevated risk was found for those individuals with a large number of dental
amalgams, and for a long period of time
 Dental erosion in asthma: a case-control study

• Asthma medication places patients at risk of dental erosion by reducing salivary

protection against extrinsic or intrinsic acids

• But patterns of lesions in asthmatics may differ from patterns in non-asthmatics,

because gastro- oesophageal reflux (GOR) is found in 60 per cent of asthmatics

Cases: The lesions in 44 asthma cases

Controls: 423 patients referred concerning excessive tooth wear

Higher incidence of erosion was found in asthmatics. The clinical significance is that
asthmatics are at risk of dental erosion from extrinsic acid,
 BIAS in Case Control Studies

• Bias “ is any systemic error in the determination of the association between the
exposure and the disease”.

• Bias due to confounding Information bias

• Memory or recall bias

• Telescopic bias

• Interviewer’s bias
 Disadvantages of Case Control Studies

1. Patient recall about their history can be inaccurate (recall bias)

2. Patients aware of certain risk factors may focus on those and ignore other exposures

3. No randomization is possible, lowering internal validity of the study.

4. Finding a Control group that matches the Case group appropriately can be difficult

5. This study type does not prove a clear causal relationship between risk factors and
illness, only calculates the odds ratio
 *** Key points

• Case-control studies are simple to organize

• Retrospectively compare two groups

• Aim to identify predictors of an outcome

• Permit assessment of the influence of predictors on outcome via calculation of an

odds ratio

• Useful for hypothesis generation

• Can only look at one outcome

• Bias is an major problem

 3. Cohort Study
• Cohort studies are longitudinal, observational studies, which investigate predictive risk
factors

• Cohorts identified prior to appearance of disease

• Proceeds forward – Cause to Effect

• Study participants are observed over a period of time

• The incidence of disease in the exposed group is compared with unexposed group

• They differ from clinical trials, in that no intervention, treatment

• Because of the observational nature, they can only find correlation between a Risk
factor and disease rather than the cause
 Cohort Study

• Data are obtained from groups who have been exposed, or not exposed, to the new
technology or factor of interest (eg from databases). No allocation of exposure is made
by the researcher. Best for study the effect of predictive risk factors on an outcome

Advantages:

1. Ethically safe

2. Subjects can be matched

3. It can establish timing and directionality of events

4. Eligibility criteria and outcome assessments can be standardized

5. Administratively easier and cheaper than RCT

 Two types : Prospective and Retrospective Cohort studies

Prospective  The two groups of cohorts (exposed and un-exposed) are followed prospectively
over time to track the development of new disease.

 Example: Researchers compared four different groups of women (two at-risk groups,
two low-risk groups) to investigate which groups were more likely to develop Post-
traumatic stress disorder PTSD symptoms after a birthing event

Retrospective  Cohorts are defined from a previous point in time, and are not followed up
 Information or data is collected from past clinical records and the outcome of
interest is investigated.
 Example: In a retrospective cohort study researchers used previously collected
data to investigate whether there was an association between birth experience
and subsequent maternal care-giving attitudes and behaviour over a 12-month
period
 Cohort Studies- Prospective
Time

Direction of inquiry
Disease
Exposed
No Disease
People
Population without
disease Disease
Not Exposed
No Disease
 Cohort Studies - Retrospective

• Mortality and cancer incidence studies are unique among retrospective cohort studies
in that they can be conducted using national cancer and mortality registers even if there
has been no medical surveillance of the work force
Basic steps in Case-control Study

1. Selection of Study Subjects

2. Selection of controls

3. Measurement of exposure

4. Follow up

5. Analysis and interpretation

 1. Selection of Study Subjects

1. General population
• If cause of death fairly frequent in population
• If population very large - Appropriate sample taken

2. SPECIAL GROUP:
• Group that can be readily studied
Select groups
• Professional group
• Government employees
• Volunteers

Exposure group: exposure rare

• E.g.: radiologists, workers in industries
 2. Selection of Comparison Groups

INTERNAL COMPARISON: in-built study group

• From cohorts selected – one member enters study and rest are comparative group

EXTERNAL COMPARISON:
• When information on degree of exposure not available

COMPARISON WITH GENERAL POPULATION RATES:

• When no information available
E.g.: Frequency of cancer amongst Asbestos workers general population in same
geographic area
 3. Obtaining Data on Exposure

COHORT MEMBERS
Interviews/ questionnaires

REVIEW OF RECORDS
Medical records – H/O surgery etc

MEDICAL EXAMINATION/ SPECIAL TESTS

E. g: blood pressure, ECG etc
 3. Obtaining Data on Exposure

• Informationabout exposure should be collected that will allow classification of

cohort members

• Whether or not they have been exposed to suspected factor

• According to level or degree of exposure

• Demographic variables that may affect frequency of disease under investigation

 4. Follow- Up

Regular follow up required

It includes:
1. Periodic medical examination of each member of cohort

2. Reviewing physician and hospital records

3. Routine surveillance of death records

4. Mailed questionnaires, telephone calls, periodic home visits

5. Certain percentage of losses inevitable

 5. Analysis
• Data analyzed in terms of:
• Incidence rate of outcome among exposed and non- exposed group

Estimation of risk
• Relative risk
• Attributable risk

RELATIVE RISK (RR)

• Measures strength of association between suspected cause and association
• Incidence of the disease among exposed Incidence of the disease among non-exposed.

RR = Rate of disease (exposed group)

Rate of disease(unexposed group)
 Attributable Risk (AR)

It indicates to what extent the disease under study can be attributed to the exposure
Rates of disease among exposed group –non-exposed group X 100
Rates of disease among exposed group

Suggests the amount of disease that might be eliminated if the factor under study could
be controlled or eliminated.
 Disadvantages

1. Controls may be difficult to identify

2. Exposure may be linked to a hidden confounder

3. Blinding is difficult

4. Randomization not present

5. For rare disease, large sample sizes or long follow-up necessary

 **** Key points- Cohort studies

• It describe incidence or natural history

• They analyze predictors (risk factors) thereby enabling calculation of relative risk

• Cohort studies measure causes from effects

• Retrospective cohorts where available are cheaper and quicker

• Confounding variables are the major problem in analyzing cohort studies

• Subject selection and loss to follow up is a major potential cause of bias

CASE CONTROL STUDY COHORT STUDY

Retrospective “Effect To Cause” Prospective “Cause To Effect”

Disease has already occurred Disease is expected to occur in future

Presence of exposure in cases and controls Development of disease in exposed and non–exposed
compared compared

Relatively easy to carry out Time consuming and difficult to carry out
Useful for rare cases with smaller number Suitable for common diseases with common exposure
Can only have one outcome, but can have multiple Can have multiple outcomes
exposure
Only derives odds ratio Derives relative risk, attributable risk
Substantial biases can occur Biases are generally lower
Relatively less costly and dropouts Expensive and dropout rate higher
 The Strengthening of Reporting of Observational Studies in
Epidemiology Statement (STROBE)

STROBE provides a checklist of important steps for conducting these types of studies, as
well as acting as best-practice reporting guidelines

The STROBE Statement consists of a checklist of 22 items, which relate to the title,
abstract, introduction, methods, results, and discussion sections of articles.
Eighteen items are common to cohort studies, case- control studies and cross-
sectional studies and four are specific to each of the three study designs

The STROBE Statement provides guidance to authors about how to improve the reporting
of observational studies and facilitates critical appraisal and interpretation of studies
Contnd
References

1. Hackshaw A, Paul E, Davenport E. Evidence-Based Dentistry: An

Introduction. 2007 [2. ed.] Blackwell Munksgaard, Oxford OX4 2DQ, UK

2. Forrest J L. Evidence-Based decision making : a translational guide for

dental professionals. 2009 [1. ed.] Wolters Kluwer Health/Lippincott
Williams & Wilkins, Philadelphia (Pa.)
Thank you