A research team develops a new monoclonal antibody checkpoint inhibitor for advanced melanoma that has shown promise in animal studies as well as high efficacy and low toxicity in early phase human clinical trials. The research team would now like to compare this drug to existing standard of care immunotherapy for advanced melanoma. The research team decides to conduct a non-randomized study where the novel drug will be offered to patients who are deemed to be at risk for toxicity with the current standard of care immunotherapy, while patients without such risk factors will receive the standard treatment. Which of the following best describes the level of evidence that this study can offer?
ALevel 1
BLevel 3
CLevel 5
DLevel 4
ELevel 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
A study is performed to determine whether cognitive behavioral therapy (CBT) increases compliance to dietary regimens. In order to test this hypothesis, a random group of volunteers who want to lose weight are selected from the community and subsequently randomized to no intervention and CBT groups. They are asked to record what they ate every day in a food journal and these recordings are correlated with objective serum and urine biomarkers for food intake. Surprisingly, it was found that even the group with no intervention had much higher rates of compliance to dietary regimens than the general population. Multivariate analysis showed no significant demographic or medical differences between the two groups. Which of the following most likely explains this finding from the study?
AConfounding effect
BHawthorne effect
CRecall bias
DPygmalion effect
EProcedure bias
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