Journal article review and critical appraisal – Colette Smith Welcome to your Journal article review and critical appraisal - Colette Smith What is the main reason for randomly allocating participants to treatment groups in a Randomised Controlled Trial (RCT)?It ensures treatment groups are similar in terms of their characteristics at the start of the trial; any differences are dut to chance onlyIt gives you a representative sample and ensures your results are generalizable to the wider population that you are interested inIt makes the group sizes roughly equal, which is useful as this means we are more likely to find a statistically significant result Researchers conduct a randomised controlled trial investigating the impact of an adherence intervention on achievement of virological suppression. They recruit 9750 participants from 27 HIV clinics across the UK. Participants from 14 of the clinics (a total of 4838 participants) are randomised to receive the new adherence intervention Participants from the other 13 clinics (a total of 4912 participants) are randomised to receive the standard of careParallel groups study designCrossover study designCluster study design Researchers conduct a randomised controlled trial (RCT) among antiretroviral-naïve individuals. Participants are randomised to receive either (I) a novel treatment regimen, Regimen A or (ii) the current gold standard regimen, Regimen B. The primary outcome is viral load <50 copies/ml at 48 weeks, using an Intent-to-treat (ITT) approach. Which of the following statements describes an ITT analysis?a. Individuals randomised to receive Regimen A, but who dropped out of the study before 48 weeks, should be excluded from the primary analysisb. All individuals randomised to receive Regimen A should be included in the Regimen A group for primary analysis, regardless of loss-to-follow-up or treatment switchc. Individuals randomised to receive Regimen A, but who switched to Regimen B before 48 weeks, should be included in the Regimen B group for primary analysis Researchers conduct a non-inferiority randomised controlled trial (RCT) among antiretroviral-naïve individuals. Participants are randomised to receive either Ii) a novel treatment regimen, Regimen A or (ii) the current gold standard regimen, Regimen B. Which of the following apply to non-inferiority studies?a. The non-inferiority margin should be chosen at the end of the study, once the results are knownb. The non-inferiority margin should be defined in advance, preferably using an established cut-offc. We should only consider a non inferiority margin once we are sure we have a non-significant p-value Researchers conduct a randomised controlled trial (RCT) among antiretroviral-naïve individuals. Participants are randomised to receive either Ii) a novel treatment regimen, Regimen A or (ii) the current gold standard regimen, Regimen B. The study will be double-blinded. What does double-blinded mean?a. Statisticians are not told which treatment group participants were allocated to when performing the primary analysisb. Participants and the clinical team are not aware which treatment group participants are allocated to during the trialc. Participants are told which treatment group they are allocated to, so they can modify their adherence if necessary Time is Up! Time's up
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