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SY 2011-2012

SY 2011-2012 Subject: COMMED Topic: Research Design 2 Lecturer: Dr. Carnate Date of Lecture:  
SY 2011-2012 Subject: COMMED Topic: Research Design 2 Lecturer: Dr. Carnate Date of Lecture:  

Subject: COMMED Topic: Research Design 2 Lecturer: Dr. Carnate Date of Lecture:   Transcriptionist: Angry Birds! Pages: 6

ANALYTIC RESEARCH DESIGN

Is there an association/relationship between:

CAUSE EFFECT

Independent dependent

Predictor

outcome

Exposure

disease

Key strategy is the use of comparison groups

*for analytical research design we would like to look

if there is cause and effect relationship between

two variable, by making use of the COMPARISON

GROUP. This makes Analytic research design

different from descriptive design.

CASE CONTROL (Case-referent, case history,

retrospective study)

*but using the term retrospective study is being

discouraged since there’s a term as retrospective-

cohort, to avoid confusion.

General features:

Subjects are selected based on their disease

status

-Cases (have the disease)

-Controls (don’t have the disease)

Comparison of the odds of exposure to a

risk factor among the cases and controls

 Exposure (past)  Disease (present) Legend:
 Exposure (past)  Disease (present)
Legend:

N- general population to whom we are generalizing S- Sample people

D- with disease Ď - without disease

E- if there is exposure in the past Ē - without exposure

Steps:

1. Define and select the cases

2. Define and select the controls

3. Determine/Assess exposure status

4. Compute for measure of association

5. Interpret the measure of association

*and in every step there is an issue. The following

are the issues.

Issues in the definition and selection of cases

-selecting people who have the disease or positive

dependent variable.

1. Definite/strict diagnostic criteria

- who would we be calling as having the

disease or dependent variable

- YOU MUST CONFIRM IT FIRST!

-Colonic cancer

o Histologically confirmed colonic CA:

then that’s the only time you’ll label

this as a case

- Asthma

o

PFT parameters

o

Clinical symptoms: dyspnea,

wheezing

* the study will be erroneous if you label a people

as case if even they don’t have the disease.

2. Sources of cases

-Hospital-based case-control study: most

commonly utilized source of cases

-Population-based case-control study

for

asthmatic patient

e.g.

you

can

go

to

Area

C

and look

Issues in the definition and selection of controls -cases and controls have to be similar in every way possible except for disease status.

1. Comparable to the source population of the

cases -if the cases came from the hospital, controls should come from there too

Hospital patients

General population

-Special control series/ Neighborhood controls

If you have a case you can get the twin of the case as the control.

Neighbor of the case

They

are

more

likely

to

have

similar

 

exposure

 

2.

Matching of controls to cases

 

-Matching

characteristics:

age,

gender,

social

class,

etc.

(this

are

variables

that

are

usual

confounders) -Optimum ratio:

1 case : 1 control

1 case : 4 controls

Issues in the assessment of exposure status

1. Definition of exposure

2. Methods of ascertainment (determining exposure status)

-Personal interview -Medical records

-Physical measurement

3. Use the same methods of ascertainment for

cases and controls (RECALL BIAS) Recall Bias- there is a tendency for a case to have some memory of an exposure even if it is not true. **interviewer should not know if he is interviewing a case or a control.

Measure of association: ODDS RATIO/ CROSS PRODUCT RATIO/ RELATIVE ODDS

association: ODDS RATIO/ CROSS PRODUCT RATIO/ RELATIVE ODDS Interpretation: OR = 1 ( – ) association
association: ODDS RATIO/ CROSS PRODUCT RATIO/ RELATIVE ODDS Interpretation: OR = 1 ( – ) association
association: ODDS RATIO/ CROSS PRODUCT RATIO/ RELATIVE ODDS Interpretation: OR = 1 ( – ) association

Interpretation:

OR

= 1

() association

OR

≠ 1

(+) association

OR>1 (+)causative association OR<1 (+)preventive association Cross-sectional

PR

=

1

() association

PR

>

1

(+) association

PR

<

1

(+) association

Example:

Research question: Is there an association between receiving HRT and development of breast cancer among women in Dasmarinas, Cavite, 2006? Cases: 20- 50 year old females with histologically-confirmed breast CA admitted at the UMC from 2000- 2006. Controls: 20- 50 year old females with histologically-confirmed breast CA admitted at the UMC from 2000- 2006 Ratio: 1 case : 1 control

Interpretation: There is an association between HRT and breast CA; the association is causative. Women

Interpretation: There is an association between HRT and breast CA; the association is causative. Women with breast CA are 21X more likely to have a history of exposure to HRT than women without breast CA. The odds of HRT exposure is 21X greater among women with breast CA than among women without breast CA.

COHORT (Follow-up, Incidence, Longitudinal, Prospective) **avoid using prospective study General features:

Subjects are selected based on their exposure status - Exposed - Unexposed

Comparison of incidence of disease among the exposed and unexposed

of incidence of disease among the exposed and unexposed Wherein: N = general population to whom

Wherein:

N= general population to whom we are generalizing

S= Sample people E= Exposure to a factor Ē = not expose to the a factor D= develop the disease

Ď=who don’t develop the disease

Two bars means that we need to determine first if the people have the disease or they don’t have the disease yet and then include only who DON’T have the disease. Check if those who don’t have the disease are exposed to a factor or not. Then follow up in the future if they will develop the disease or not. This will help in establishing that the exposure came ahead of the disease.

establishing that the exposure came ahead of the disease. Steps: 1. Define and select the exposed

Steps:

1. Define and select the exposed

2. Define and select the unexposed

3. Determine/Assess disease status

4. Compute for measure of association

5. Interpret the measure of association

Issues in the definition and selection exposed 1. Sources of the exposed population

From the general population

Special exposure groups

Unusual exposures

- Environmental hazards

of the

Unusual work experience

- Occupation

Unusual lifestyle - Dietary practices, IDU

Issues

in

the

definition

and

selection

of

the

unexposed 1. Comparable to the exposed group

in

all

aspects except for the exposure status

Internal comparison group e.g. if exposed group is from Area C, unexposed group should be from there too.

External comparison group e.g. if exposed group is from Calaca, unexposed group should be outside of Calaca.

Issues in the assessment of disease status

1. Definite diagnostic criteria

2. Methods of ascertainment

-Personal interview -Medical records -Physical measurement 3. Use the same methods of ascertainment for exposed and unexposed (Follow up Bias)

Follow up Bias- if you fail to determine if the unexposed group develop the disease or not, follow up bias may occur. Study will be erroenous.

or not, follow up bias may occur. Study will be erroenous. Interpretation: RR = 1 (
or not, follow up bias may occur. Study will be erroenous. Interpretation: RR = 1 (
or not, follow up bias may occur. Study will be erroenous. Interpretation: RR = 1 (

Interpretation:

RR

= 1

() association

RR

≠ 1

(+) association

RR>1 (+)causative association RR<1 (+)preventive association

Example:

Research question: Is Hib vaccine associated with the development of leukemia among children in Dasmarinas, Cavite, 2006?

Exposed Population: 500 children who received 3 doses of Hib vaccine Unexposed Population: 500 children who did not receive any Hib dose 5 year follow up

received 3 doses of Hib vaccine Unexposed Population: 500 children who did not receive any Hib
received 3 doses of Hib vaccine Unexposed Population: 500 children who did not receive any Hib

RELATIVE RISK: .375 Interpretation: There is an association between receiving Hib vaccine and development of leukemia; the association is protective. Children who received 3 doses of Hib vaccine are 0.375X less likely to develop leukemia than those who did not. The risk of developing leukemia among children who received 3 doses of Hib vaccine is 0.375X less than the risk among children who did not receive the vaccine.

 

Case-control

 

Cohort

 

Appropriate use

Rare disease

Rare exposure

 

Ability to assess E and

Multiple

etiologic

Multiple effects of an exposure

 

D

exposures

 

Bias

Ascertainment of exposure recall bias

Ascertainment of disease- follow up bias (attrition problem)

Study time

Less time-consuming

Requires follow-up

 

Sample size required

Smaller

large

Cost

Less expensive

More expensive

 

Temporal relationship of E and D

Difficult to establish

More

readily

established

incidence

Measure of risk

An approximate (odds)

More accurate

 
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