FFICM Research and Development 3

Question 1

Which ethical principle underpins the requirement that ICU research participants (or their surrogates) must be told about risks, benefits, and alternatives before enrolling?

Accepted Answer

Autonomy

Answer

Autonomy requires that individuals have the right to make informed decisions about participation in research, forming the ethical basis for informed consent.

Question 2

A multicentre ICU trial reports an odds ratio of 0.72 (95% CI 0.55–0.94) for 30-day mortality with a new intervention. What is the correct interpretation?

Accepted Answer

The intervention is associated with a statistically significant reduction in the odds of mortality

Answer

An OR of 0.72 with a 95% CI that does not cross 1.0 (0.55–0.94) indicates a statistically significant 28% reduction in the odds of mortality.

Question 3

When designing a crossover trial in critically ill patients, which major limitation must be considered compared to a parallel-group design?

Accepted Answer

Carryover effects from the first treatment period

Answer

Carryover (residual) effects occur when the first treatment continues to influence outcomes during the second treatment period, potentially biasing results in crossover designs.

Question 4

In critical care, surrogate outcomes (e.g., PaO2/FiO2 ratio) are used in trials. What is the main risk of using surrogate rather than patient-centred outcomes?

Accepted Answer

Improvement in the surrogate may not translate to benefit in patient-important outcomes

Answer

Surrogates may not capture the full spectrum of patient benefit or harm; a drug improving oxygenation does not necessarily reduce mortality or improve quality of life.

Question 5

A researcher calculates the number needed to treat (NNT) from a trial where 30% of controls and 20% of treatment patients died. What is the NNT?

Accepted Answer

10

Answer

NNT = 1 / absolute risk reduction = 1 / (0.30 − 0.20) = 1 / 0.10 = 10.

(FFICM) Final Faculty of Intensive Care Medicine Practice Test

(FFICM) Final Faculty of Intensive Care Medicine Practice Test

FFICM Research and Development 3