Chapter·BiostatisticsRCTs

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1

A 38-year-old project manager is told by her boss that her team will need to work on an additional project in the coming week for a very important client. This frustrates the woman, who already feels that she works too many hours. Instead of discussing her feelings directly with her boss, the woman leaves a voice message for her boss the next day and deceitfully says she cannot come to work for the next week because of a family emergency. Which of the following psychological defense mechanisms is this individual demonstrating?

ADisplacement

BActing out

CMalingering

DPassive aggression

EBlocking

2

A researcher is conducting a study to compare fracture risk in male patients above the age of 65 who received annual DEXA screening to peers who did not receive screening. He conducts a randomized controlled trial in 900 patients, with half of participants assigned to each experimental group. The researcher ultimately finds similar rates of fractures in the two groups. He then notices that he had forgotten to include 400 patients in his analysis. Including the additional participants in his analysis would most likely affect the study's results in which of the following ways?

AWider confidence intervals of results

BIncreased probability of committing a type II error

CDecreased significance level of results

DIncreased external validity of results

EIncreased probability of rejecting the null hypothesis when it is truly false

3

A pharmaceutical company conducts a randomized clinical trial to demonstrate that their new anticoagulant drug, Aclotsaban, prevents more thrombotic events following total knee arthroplasty than the current standard of care. A significant number of patients are lost to follow-up, and many fail to complete treatment according to the study arm to which they were assigned. Despite these protocol deviations, the results for the patients who completed the course of Aclotsaban are encouraging. Which of the following analytical approaches is most appropriate for the primary analysis to establish the efficacy of Aclotsaban?

AIntention-to-treat analysis

BSub-group analysis

CPer-protocol analysis

DAs-treated analysis

ENon-inferiority analysis

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