Sample size calculations.ppt

Sample size calculations Marie-Pierre Sylvestre mp.sylvestre@epimgh.mcgill.ca Material adapted from http://www.sgul.ac.uk/depts/phs/guide/size.htm June 2007 Why bother? Sample size calculations are important to ensure that estimates are obtained with required precision or confidence. E.g. a prevalence of 10% from a sample of size 20 ... 95%CI is 1% to 31%... ... a prevalence of 10% from a sample of size 400 ... 95%CI is 7% to 13% In studies concerned with detecting an effect if an effect deemed to be clinically or biologically important exists, then there is a high chance of it being detected, i.e. that the analysis will be statistically significant. If the sample is too small, then even if large differences are observed, it will be impossible to show that these are due to anything more than sampling variation. Some terminology Significance level Cut-off point for the p-value, below which the null hypothesis will be rejected and it will be concluded that there is evidence of an effect. Typically set at 5%. One-sided and two-sided tests of significance Two-sided tests should be used unless there is a very good reason for doing otherwise. Power Power is the probability that the null hypothesis will be correctly rejected i.e. rejected when there is indeed a real difference or association. It can also be thought of as 100 minus the percentage chance of missing a real effect - therefore the higher the power, the lower the chance of missing a real effect. Power is typically set at 80% or 90% but not below 80%. Effect size of clinical importance This is the smallest difference between the group means or proportions (or odds ratio/relative risk closest to unity) which would be considered to be clinically or biologically important. The sample size should be set so that if such a difference exists, then it is very likely that a statistically significant result would be obtained. Example (1) Estimating a single proportion Scenario: The prevalence of dysfunctional