Here are the answers for Assignment 6: Analytical Studies:
Q1) Relative risk of more than 1 indicates that the ___
c) Incidence among exposed is higher than among unexposed
Relative Risk (RR) = Incidence in exposed / Incidence in unexposed. RR > 1 means the numerator is larger, so the exposed group has higher incidence - indicating a positive association between exposure and disease.
Q2) All babies born in a particular year will form a birth cohort.
a) True
A birth cohort is defined as a group of people who share a common birth experience within a defined time period. All babies born in a given year sharing the same temporal starting point is the textbook definition of a birth cohort.
Q3) Exposure is assigned by the investigator in which of the following epidemiological studies?
The options are cut off, but the answer is Experimental study (Randomized Controlled Trial). In observational studies (cohort, case-control, cross-sectional), the investigator only observes exposure. Only in experimental studies does the investigator actively assign exposure/intervention.
Q6) All the following are elements of a cohort study, EXCEPT:
c) It involves randomization of participants
Cohort studies are observational - participants are followed based on their naturally occurring exposure status, not randomized. Randomization is a feature of experimental studies (RCTs). Calculating incidence, proceeding from exposure to outcome, and following up participants are all genuine cohort study features.
Q7) All the following are limitations of a case-control study, EXCEPT:
d) It can introduce attrition bias
Attrition bias occurs due to loss to follow-up over time - this is a limitation of cohort studies (which follow people forward), not case-control studies (which are retrospective and do not follow people forward). Recall bias, inability to determine incidence, and difficulty selecting controls are all genuine case-control limitations.
Q9) Multicentric study: 1000 diabetic and 2500 non-diabetic participants recruited, cataract-free at baseline, followed for 10 years to document new cataract cases. What is the study design?
c) Prospective cohort study
Key features pointing to a prospective cohort: participants grouped by exposure (diabetes vs no diabetes), free of outcome at baseline, followed forward in time, and incidence of the outcome (cataract) was measured. No randomization occurred, ruling out experimental study.
Q10) Odds ratio calculation - salt intake and hypertension:
Using the data provided:
- Cases (hypertension, n=600): 100 with high salt intake, 500 without
- Controls (no hypertension, n=600): 30 with high salt intake, 570 without
OR = (a × d) / (b × c) = (100 × 570) / (500 × 30) = 57,000 / 15,000 = 3.8
The odds ratio is 3.8, meaning people with high salt intake have 3.8 times higher odds of hypertension compared to those with low salt intake.Here are the answers for Assignment 7: Experimental Studies:
Q1) Which of the following constitutes the cornerstone of the design of randomized controlled trials?
b) Randomization
Randomization is the defining and most fundamental feature of an RCT. It ensures that both known and unknown confounders are equally distributed between groups by chance, making the comparison valid. Blinding, placebo, and recruitment are important elements but are not the cornerstone.
Q2) Which phase of a clinical trial is referred to as post-marketing surveillance?
d) Phase 4
Phase 4 occurs after a drug has been approved and is in regular use. It monitors long-term safety, rare adverse effects, and effectiveness in the general population under real-world conditions. This is post-marketing surveillance by definition.
Q3) Long-term adverse effects and efficacy of a new drug can be tested in which phase of a clinical trial?
d) Phase 4
Phase 4 (post-marketing surveillance) is the phase where the drug is used in large, diverse, real-world populations over extended periods. This allows detection of rare or delayed adverse effects that were not apparent in the earlier, smaller, shorter phases.
- Phase 1 = safety/dosage in healthy volunteers
- Phase 2 = efficacy and side effects in small patient groups
- Phase 3 = large-scale efficacy vs. standard treatment
Q4) Which of the following can reduce the chance of co-intervention in a clinical trial?
d) Blinding
Co-intervention occurs when participants or caregivers, knowing the treatment assignment, seek or provide additional treatments that can confound results. Blinding (masking the treatment allocation from participants and/or investigators) directly prevents this by keeping everyone unaware of who is receiving what, thus eliminating the motivation for co-intervention.Here are the answers for Assignment 8: Validity of Epidemiological Studies:
Q1) Obtaining an estimate that is generalizable to the study population is referred to as ___
b) Internal validity
Internal validity refers to how accurately a study's results reflect the true association within the study population itself (free from bias and confounding). External validity (generalizability) refers to applying results beyond the study population to other populations. The question asks about generalizability to the study population - which is internal validity.
Q2) Which constitutes any process that tends to produce results that depart systematically from true values?
b) Bias
Bias is defined as any systematic error in a study that causes a departure from the true value. "Systematic" is the key word - it distinguishes bias from chance/random error, which is non-systematic and unpredictable.
Q3) Effect of an exposure is distorted by extraneous factors related to both exposure and outcome. What is this called?
b) Confounding
This is the textbook definition of confounding. A confounder must: (1) be associated with the exposure, (2) be an independent risk factor for the outcome, and (3) not be on the causal pathway. It distorts the observed exposure-outcome relationship.
Q4) Biases can occur during which of the following stages of a research study?
d) Any of the above stages
Bias can enter at every stage - during study design (e.g., selecting a non-representative sample), during implementation (e.g., differential data collection), and during data analysis (e.g., selective reporting). No stage is immune.
Q7) Better recall of exposure only among cases in a case-control study will result in which of the following?
a) Information bias
When cases (who have the disease) remember or report past exposures more thoroughly than controls (who do not), this creates differential misclassification - a type of information bias, specifically recall bias. It is not selection bias because participants are already selected; the distortion arises from how information is reported.
Q8) Crude measure of association in the presence of a confounder is the actual causal association.
b) False
When a confounder is present, the crude (unadjusted) measure of association is distorted - it does not represent the true causal association. The adjusted measure (after controlling for the confounder) is the better estimate of the actual association.
Q9) Which measure(s) is related to ensuring internal validity of a study?
The options are cut off, but the answer relates to controlling for bias and confounding (e.g., randomization, blinding, restriction, matching, or statistical adjustment). These are the methods that protect internal validity by ensuring the results accurately reflect the true association within the study sample.