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Smoking & Lung Cancer Study - Mr. Shiv Shankar
Park's Textbook of Preventive and Social Medicine, Chapter on Epidemiology, pp. 89-91
1. STUDY DESIGN - IDENTIFICATION & JUSTIFICATION (3 marks)
The study is a PROSPECTIVE COHORT STUDY (also called Longitudinal / Incidence / Forward-looking study)
Justification:
| Feature of Cohort Study (Park) | Present in this Scenario? |
|---|
| Cohorts identified before the disease appears | Yes - grouped as smokers/non-smokers before lung cancer appears |
| Groups observed over a period of time | Yes - followed for 10 years |
| Study proceeds from cause to effect (exposure β disease) | Yes - Smoking (cause) β Lung cancer (effect) |
| Exposure already present, disease has not yet occurred | Yes - lung cancer is being observed over time |
DIRECTION OF STUDY:
PAST ββββββββββββββ PRESENT βββββββββββββββ FUTURE
|
Identify 2 groups: Observe for 10 years
β’ Smokers (exposed) β Lung cancer develops?
β’ Non-smokers (unexposed) β Lung cancer develops?
ββββββββββββ CAUSE TO EFFECT ββββββββββββΊ
Park: "Cohort study is known by a variety of names: prospective study, longitudinal study, incidence study, and forward-looking study."
This is specifically a prospective cohort study because:
- The outcome (lung cancer) had not yet occurred when investigation began
- The study begins in the present and continues into the future
2. ELEMENTS/STEPS TO CONDUCT THIS STUDY (7 marks)
Park lists 5 elements of a cohort study:
ELEMENTS OF A COHORT STUDY
β
βββ 1. Selection of Study Subjects
βββ 2. Obtaining Data on Exposure
βββ 3. Selection of Comparison Groups
βββ 4. Follow-up
βββ 5. Analysis
STEP 1: Selection of Study Subjects
Subjects are assembled in two ways:
(a) General Population:
- When exposure is fairly frequent in the population
- Cohorts drawn from well-defined geographical/political areas (e.g., Framingham Heart Study)
- In Mr. Shiv Shankar's study: select smokers and non-smokers from general population
(b) Special Groups:
- Professional groups (doctors, nurses, teachers)
- Classic example: Doll's prospective study - used British doctors listed in the Medical Register of the UK in 1951 to study smoking and lung cancer
- These groups are homogeneous and easy to follow-up
Key requirement: All subjects must be free of lung cancer at the start of the study
STEP 2: Obtaining Data on Exposure
Classify subjects according to:
- Whether they have been exposed (smoker) or not (non-smoker)
- Level or degree of exposure (e.g., number of cigarettes/day)
Sources of exposure data:
| Source | Example in this study |
|---|
| Personal interviews / mailed questionnaires | Smoking history (as done by Doll & Hill) |
| Review of records | Medical records, prescriptions |
| Medical examination | Lung function tests |
| Environmental surveys | Workplace exposure, passive smoking |
Also collect: demographic variables (age, sex, occupation) that might affect lung cancer frequency
STEP 3: Selection of Comparison Groups
(a) Internal comparisons: Single cohort classified by degree of exposure (e.g., light, moderate, heavy smokers vs non-smokers)
Park's Table shows:
| Cigarettes smoked | Death rate/100,000/year |
|---|
| 1/2 pack | 95.2 |
| 1/2 - 1 pack | 107.8 |
| 1 - 2 packs | 229.2 |
| 2 packs+ | 264.2 |
(b) External comparison: Smokers vs Non-smokers as separate cohorts β This is what Mr. Shiv Shankar is doing
(c) General population rates: If no control group available, compare with general population mortality data
STEP 4: Follow-up
- Duration: 10 years (as in the scenario)
- The aim is at least 95% follow-up of all participants
Methods of follow-up:
- Periodic medical examination of each cohort member
- Reviewing physician and hospital records
- Routine surveillance of death records
- Mailed questionnaires, telephone calls, periodic home visits - preferably all three on an annual basis
Losses to follow-up are inevitable due to death, change of residence, migration, or withdrawal - these may bias the results
STEP 5: Analysis
Data analyzed in terms of:
- (a) Incidence rates among exposed and non-exposed
- (b) Estimation of risk - Relative Risk and Attributable Risk
3. BIASES IN COHORT STUDY (5 marks)
BIASES IN COHORT STUDY
β
βββ 1. Selection Bias
βββ 2. Information / Observer Bias
βββ 3. Confounding Bias
βββ 4. Attrition / Loss to Follow-up Bias
βββ 5. Behavioural Change Bias
(a) Selection Bias
- Subjects who volunteer for the study may not represent all smokers/non-smokers in the population
- Smokers who agree to participate may be healthier than average ("Healthy worker effect")
- The comparison groups may not be truly comparable in demographic characteristics
(b) Information / Observer Bias
- Interviewer's bias: If the investigator knows who is in the exposed group (smokers), they may examine them more thoroughly for lung cancer signs
- Can be controlled by blinding the examiner to exposure status
(c) Confounding Bias
- Confounders like age, occupation, alcohol use, air pollution, socioeconomic status may independently affect lung cancer risk
- They are associated with both the exposure (smoking) and the outcome (lung cancer)
- Control: matching, stratification, or multivariate analysis
(d) Attrition / Loss to Follow-up Bias
- Over 10 years, participants may migrate, die, change behaviour, or drop out
- If smokers who develop early symptoms drop out more than non-smokers, the incidence of lung cancer among smokers will be underestimated
- Park: "losses may bias the results" - target β₯ 95% follow-up
(e) Behavioural Change Bias ("Hawthorne Effect")
- Park specifically mentions: "the study itself may alter people's behaviour"
- Being observed may cause smokers to quit or reduce smoking, leading to underestimation of the true risk
- This makes the relative risk appear smaller than it actually is
4. OUTCOME INDICATORS (5 marks)
The data in a cohort study are analyzed using the following outcome indicators:
(a) Incidence Rate
- Calculated directly in exposed and unexposed groups
- Using the 2Γ2 contingency table:
| Lung Cancer | No Lung Cancer | Total |
|---|
| Smokers (exposed) | a | b | a+b |
| Non-smokers (unexposed) | c | d | c+d |
- Incidence among smokers = a / (a+b)
- Incidence among non-smokers = c / (c+d)
Park's hypothetical example: Incidence = 10/1000 in smokers vs 1/1000 in non-smokers
(b) Relative Risk (RR)
"Relative risk is the ratio of the incidence of the disease among exposed and the incidence among non-exposed"
$$RR = \frac{\text{Incidence among exposed}}{\text{Incidence among non-exposed}} = \frac{a/(a+b)}{c/(c+d)}$$
Interpretation:
| RR Value | Meaning |
|---|
| RR = 1 | No association |
| RR > 1 | Positive association (exposure increases risk) |
| RR < 1 | Negative association (protective effect) |
Park's example: RR = 10/1 = 10 β smokers are 10 times more likely to develop lung cancer than non-smokers
(c) Attributable Risk (AR)
"Attributable risk is the difference in incidence rates of disease between an exposed group and a non-exposed group"
$$AR% = \frac{\text{Incidence(exposed)} - \text{Incidence(unexposed)}}{\text{Incidence(exposed)}} \times 100$$
Park's example: AR = (10-1)/10 Γ 100 = 90% β 90% of lung cancer in smokers is due to smoking
- AR tells us how much disease can be prevented if the risk factor is eliminated
(d) Population Attributable Risk (PAR)
$$PAR = \text{Incidence in total population} - \text{Incidence in non-exposed}$$
- Estimates how much lung cancer in the entire population could be reduced if smoking is eliminated
- Park's example from UK Physicians: 86% of lung cancer deaths could be avoided if cigarettes were eliminated
(e) Statistical Significance (P-value)
- Park's example: P < 0.001 (highly significant)
- Confirms the association between smoking and lung cancer is not due to chance
Summary Table of Outcome Indicators
| Indicator | Formula | What it tells us |
|---|
| Incidence Rate | Cases / Population at risk | Frequency of lung cancer in each group |
| Relative Risk | IR(exposed) / IR(unexposed) | Strength of association; aetiological role |
| Attributable Risk | IR(exposed) - IR(unexposed) | Disease prevented by removing exposure |
| Population AR | IR(total pop) - IR(unexposed) | Public health impact of eliminating smoking |
| P-value | Statistical test | Whether association is due to chance |
Source: Park's Textbook of Preventive and Social Medicine, pp. 88-91