Research and Development Flashcards

The CONSORT statement is a reporting guideline primarily used for which type of study?

Answer: Randomised controlled trials

CONSORT (Consolidated Standards of Reporting Trials) provides a checklist and flow diagram to improve the transparency and completeness of RCT reporting.

In a study evaluating a new biomarker for early AKI detection in ICU patients, the AUC-ROC is 0.85. How should this be interpreted?

Answer: There is an 85% probability that the biomarker ranks a randomly selected AKI patient higher than a non-AKI patient

The AUC-ROC represents the probability that the model ranks a randomly chosen positive case higher than a randomly chosen negative case, quantifying overall discriminative ability.

A Phase II ICU trial tests three doses of a novel sedative. The primary purpose of this trial phase is to:

Answer: Assess safety and determine appropriate dosing

Phase II trials evaluate preliminary efficacy, safety, and dose-finding in a moderate-sized population before proceeding to a definitive Phase III trial.

Which method is used to adjust for multiple confounders simultaneously in an observational ICU study to estimate the effect of an intervention?

Answer: Multivariable logistic or Cox regression

Multivariable regression allows simultaneous adjustment for several confounders to obtain a more unbiased estimate of the exposure-outcome association.

A propensity score analysis is conducted in an ICU study. The propensity score represents:

Answer: The probability of receiving the treatment given observed baseline characteristics

The propensity score is the conditional probability of treatment assignment given observed covariates, used to balance groups in observational studies.

In a stepped-wedge cluster randomised trial of an ICU bundle, clusters cross from control to intervention sequentially. What is the main advantage of this design over a parallel cluster RCT?

Answer: All clusters eventually receive the intervention, making it ethically and logistically attractive

Stepped-wedge designs are advantageous when withholding a potentially beneficial intervention from any cluster indefinitely is unethical, as all clusters eventually cross over to the intervention.

When interpreting a forest plot from a meta-analysis of ICU trials, a diamond that does not cross the line of no effect indicates:

Answer: A statistically significant pooled effect estimate

In a forest plot, the pooled effect estimate is represented by a diamond; if the diamond does not cross the null line (OR=1 or MD=0), the overall result is statistically significant.