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Uworld Biostatistics

The document discusses key concepts in clinical trials and statistical analysis: 1. Randomization and blinding are used in clinical trials to minimize bias and confounding. Intention-to-treat analysis maintains the randomization. 2. Statistical distributions can be used to standardize data using z-scores. 3. Groups can be compared using t-tests, ANOVA, chi-square or Fisher's exact test depending on the type and size of the samples. 4. Statistical power depends on the alpha level, magnitude of difference between groups, and sample size. Larger samples and differences increase power while stricter criteria decrease power.

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311 views

Uworld Biostatistics

The document discusses key concepts in clinical trials and statistical analysis: 1. Randomization and blinding are used in clinical trials to minimize bias and confounding. Intention-to-treat analysis maintains the randomization. 2. Statistical distributions can be used to standardize data using z-scores. 3. Groups can be compared using t-tests, ANOVA, chi-square or Fisher's exact test depending on the type and size of the samples. 4. Statistical power depends on the alpha level, magnitude of difference between groups, and sample size. Larger samples and differences increase power while stricter criteria decrease power.

Uploaded by

Костянтин Романів
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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p.

42 = LENGTH-TIME bias = when screening test preferentially detect less agressive


form of disease and therefore increases survival time.

p59 = Clinical trials

Randomization minimizes the effect of confounding.

Single blinded study patients dont know if they take drug or placebo = minimize
placebo effect.

Blinding caregiver = less observer bias.

Intention-to-treat = principle usd in analysis. If a patient who is assigned to placebo


group begins to take drugs, or patient from study group stop taking their medicine
we still analyze them as they are still in their groups. (increase randomization, less
false positives but more false negatives)

as treated rule opposite, we analyze patients with that group they are similar to
(from placebo started to take drugs now analyze with treated population)

P.63 = Statistical distribution

Take value -> substract from it mean -> divide by SD = Z score ()indicate how many
SDs a given value is from the mean.

p.66 = Comparing Groups

Variables to be compared:

1. Means:
1.1. Independent samples = Two-sample T test (2 groups) or ANOVA (more
than 2 groups)
1.2. Same individuals followed over time = Paired T test.
2. Proportions:
1.1. Big sample size = Chi-square test
1.2. Small sample size = Fisher`s exact test!!! (if expected value in either of
the cell is less than 10)

Two-sample T test = Student test.

P.74 = Statistical power

Power of the study depends on:

-alpha level = lowering the alpha level (strenghtening the significance criterion, eg
not 0,05 but 0,01 we change criteria to more strict = if we have we surely know that
it works and not to chance alone) = but this decreases the power of the study (we
have less chances to see results, even though they are and increase risk of beta-
error (FN))

-the magnitude of difference in outcome between the study groups (subte


difference is more difficult to detect than a big difference)

-increasing the sample size increases the probability of detecting the difference in
outcome between the study groups

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