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Sample size Power Random allocation R.Raveendran Why is sample size important? Validity Accuracy Finance Resources Ethics What factors will affect the size of the sample? Degree of difference Type I error Type II error Variation of data Drop out Non-compliance What methods can be used to determine the sample size? × From previous studies ? Nomograms & tables ! Arbitrary numbers Formulas Computer programs How to calculate the sample size? Assess the difference expected (0.5 kg) Find out the SD of groups (0.4) Set the level of significance (alpha - 0.05) Set the beta level (0.02) Select the appropriate formula (unpaired t) Calculate the sample size u-v (diff/sd)/ Give allowances for drop-outs & noncompliance Power Probability that a study can detect a difference Priori power determination : Power = 1 – beta Beta or type 2 error is the chances of missing a difference (false negative rate) Posteriori power calculation : Why? How? What is the implication? Random Allocation Each unit in a sample has equal chance to be assigned a treatment Treatment 1 Treatment 2 Simple Block Stratified Cluster 3 4 5 7 8 1 2 6 9 10 Thank you Degree of difference The minimum difference that is clinically or practically important e.g. A drug reduces BP by 2 mm of Hg (120 to 118). Is it clinically important? What about 4 mm of Hg? What about 6? 20? 10? 30? 40? Implication – Large difference needs small sample size Small difference needs large sample size Type I and II errors Question : Is the rice cooked? Possible Results : + (Yes) True False - (No) True False Type I and II errors Groups : Group A Vs B Question : Is there a difference between groups? Possible Results : + (Yes) - (No) True False True False Type I error = False + Type II error = False - P Limit - 5% P Limit - 20% Power Calculation Why? To find out whether a negative result is TRUE or FALSE How? Using the formula or computer programs What information is needed? The difference (0.5) Alpha (0.05) Sample size and SD both groups (5, 5 & 0.29, 0.33) Statistical test used (Unpaired t) Implication? No power; redo the experiment / no diff.