Research and Development Flashcards

Under the UK Health Research Authority framework, which committee has primary responsibility for granting ethical approval for a clinical trial involving ICU patients?

Answer: An NHS Research Ethics Committee (REC)

NHS RECs are the bodies authorised to give ethical approval for research involving NHS patients, staff, or data, as overseen by the Health Research Authority.

In a critically ill patient who lacks capacity, which legal framework in England and Wales governs research participation without prior consent?

Answer: The Mental Capacity Act 2005

The Mental Capacity Act 2005 sets out conditions under which adults lacking capacity can be enrolled in research, requiring consultee agreement and ethical approval.

A researcher uses instrumental variable analysis in an ICU study. What is the primary purpose of this approach?

Answer: To estimate causal effects in observational data when randomisation is not feasible

Instrumental variable analysis exploits a variable associated with treatment but not directly with the outcome (except through treatment) to estimate causal effects and reduce confounding.

Which Grading of Recommendations Assessment, Development and Evaluation (GRADE) rating would be assigned to evidence from a well-conducted RCT with no serious risk of bias or imprecision?

Answer: High

Under GRADE, RCTs begin as high-quality evidence; rating is downgraded for risk of bias, inconsistency, indirectness, imprecision, or publication bias.

In an ICU trial with 10% loss to follow-up, which analytical approach best preserves the intention-to-treat principle?

Answer: Multiple imputation for missing outcome data

Multiple imputation uses observed data to generate plausible values for missing outcomes, preserving sample size and supporting a valid intention-to-treat analysis.

A critical care researcher uses the Delphi technique to develop a core outcome set. What is the defining feature of this method?

Answer: Iterative rounds of structured expert opinion with controlled feedback until consensus is reached

The Delphi technique involves multiple rounds of anonymous questionnaires with iterative feedback to converge on group consensus among experts.

When calculating sample size for a superiority trial, which change has the greatest effect on reducing the required sample size?

Answer: Increasing the expected effect size

Sample size is inversely proportional to the square of the effect size; doubling the expected effect size reduces the required sample size by approximately four-fold.