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 Independent Predictor Exposure EFFECT dependent outcome disease 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. CASE CONTROL (Case-referent, case history, retrospective study) *but using the term retrospective study is being discouraged since theres a term as retrospectivecohort, to avoid confusion. 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 General features: Subjects are selected based on their disease status -Cases (have the disease) -Controls (dont have the disease) Comparison of the odds of exposure to a risk factor among the cases and controls Exposure (past) Disease (present) disease or dependent variable - YOU MUST CONFIRM IT FIRST! -Colonic cancer o Histologically confirmed colonic CA: then thats the only time youll label this as a case - Asthma o o PFT parameters Clinical wheezing * the study will be erroneous if you label a people as case if even they dont have the disease. symptoms: dyspnea,
D- with disease

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

- without exposure

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.

2. Sources of cases -Hospital-based Legend:

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

case-control

study:

most

commonly utilized source of cases -Population-based case-control study e.g. you can go to Area C and look for asthmatic patient 1

SY 2011-2012

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 Interpretation: OR OR = 1 () association 1 (+) association OR>1 (+)causative association OR<1 (+)preventive association Issues in the assessment of exposure status 1. Definition of exposure 2. Methods of ascertainment (determining Cross-sectional PR PR PR = > < 1 1 1 () association (+) association (+) association

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

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: 2050 year old females with

interviewing a case or a control.

histologically-confirmed breast CA admitted at Measure of association: ODDS RATIO/ CROSS PRODUCT RATIO/ RELATIVE ODDS the UMC from 2000- 2006 Ratio: 1 case : 1 control

S= Sample people E= Exposure to a factor = not expose to the a factor D= develop the disease =who dont develop the disease Two bars means that we need to determine first if the people have the disease or they dont have the disease yet and then include only who DONT have the disease. Check if those who dont 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.

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. 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

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

Issues in the definition and selection exposed 1. Sources of the exposed population From the general population Special exposure groups Unusual exposures - Environmental hazards Unusual work experience - Occupation Unusual lifestyle - Dietary practices, IDU

of the

Wherein: N= general population to whom we are generalizing

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. Interpretation: RR 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) Example: Research question: Is Hib vaccine associated with the development of leukemia among children in Dasmarinas, Cavite, 2006? RR = 1 () association 1 (+) association

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

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.

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

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 Appropriate use Rare disease Rare exposure

Cohort

Ability to assess E and Multiple D Bias exposures Ascertainment

etiologic Multiple effects of an exposure

of Ascertainment of disease- follow up bias (attrition problem) Requires follow-up

exposure recall bias Study time Less time-consuming

Sample size required

Smaller

large

Cost

Less expensive

More expensive

Temporal relationship Difficult to establish of E and D Measure of risk An approximate (odds)

More

readily

established

incidence More accurate

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