Key concepts in clinical epidemiology: addressing and reporting sources of bias in randomised controlled trials

Randomised controlled trials are widely considered the most robust design for evaluating the effects of clinical interventions. While generalisability is often limited, randomisation aims to ensure that effects observed are genuine. However, there are common sources of bias, even in well-conducted trials, that pose a threat to this interpretation. The revised Cochrane risk-of-bias tool for trials (RoB 2) distinguishes five domains of bias that can affect the results of trials stemming from (1) the randomisation process, (2) deviations from intended interventions, (3) missing outcome data, (4) outcome measurement, and (5) reporting of findings.

Source: Journal of Clinical Epidemiology - September 24, 2021 Category: Epidemiology Authors: Daniel Kotz, Robert West Source Type: research