Chapter·Behavioral ScienceStudy designs

Meta-analyses and systematic reviewsDownloads

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1

A surgeon is interested in studying how different surgical techniques impact the healing of tendon injuries. In particular, he will compare 3 different types of suture repairs biomechanically in order to determine the maximum load before failure of the tendon 2 weeks after repair. He collects data on maximum load for 90 different repaired tendons from an animal model. Thirty tendons were repaired using each of the different suture techniques. Which of the following statistical measures is most appropriate for analyzing the results of this study?

AChi-squared

BWilcoxon rank sum

CPearson r coefficient

DStudent t-test

EANOVA

2

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

3

A research group wants to assess the safety and toxicity profile of a new drug. A clinical trial is conducted with 20 volunteers to estimate the maximum tolerated dose and monitor the apparent toxicity of the drug. The study design is best described as which of the following phases of a clinical trial?

APhase 0

BPhase III

CPhase V

DPhase II

EPhase I

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