Reporting of Trial Results Flashcards

1
Q

What is the CONSORT statement?

A

A statement to improve the quality of reporting of RCTs

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2
Q

List the stages of the CONSORT diagram

A

Enrolment
Allocation
Follow-up
Analysis

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3
Q

What is entailed in the enrolment stage of CONSORT diagram?

A

External validity

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4
Q

What is entailed in the allocation stage of CONSORT diagram?

A

Internal validity - the extent to which a trial goes to eliminate

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5
Q

What is a p-value?

A

p-value is the probability (ranging from 0 to 1) that the results observed in a trial (or results more extreme) could have occurred by chance if the null hypothesis is true. Therefore, the smaller the p-value, the less likely the null hypothesis is to be true. For example, a p-value=0.0001 indicates the null hypothesis is very unlikely to be true whereas a p-value=0.53 indicates the observed results could easily have arisen by chance.

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6
Q

What is a confidence interval?

A

A confidence interval is an interval, constructed around an estimate from a sample (e.g. the estimate of the size of effect of an intervention), that indicates the uncertainty in the estimate because it was obtained from a sample.

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7
Q

Why is it important to consider both the p-value and confidence interval in the assessment of data?

A

A CI that is inclusive of 0 makes the assertion of the analysis invalid

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8
Q

What is a Kaplan-Meier Plot?

A

Key components for reporting results when the outcome for comparing treatment is the time for some disease/event to occur.

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9
Q

What additional information can be supplied alongside the KM plot to add to the information being given?

A

Median follow-up times
CIs or standard error
Add p-values to show statistical significance

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10
Q

How can we display potential publication bias graphically?

A

Funnel plots.

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11
Q

What is a funnel plot?

A

A graph that plots estimated treatment effect of a trial against its sample size /standard error.

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12
Q

How do funnel plots show potential publication bias?

A

Absence of smaller trials favouring against the intervention arm (negative trials) and an abundance of positive trials

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