Sample size calculator as per NABH Standard




 What is sample size?

The sample size is define as the number of observations used for determining the estimation of a given population.

Sample size means the number of observation or participants included in the data collection/study. The sample should be of appropriate size and representative of population being studied.

An adequate and appropriate sample size will ensure that study/data collection will yield reliable information suggest the clinical and non-clinical significance of the study.

For Calculating the sample size four basic component are required

1.       P Value (or Alpha) : level of significance we assume P<0.05 is significant. This type of error in clinical research is also known as type 1 error or alpha. Type 1 error is inversely proportional to sample size.

2.       Power : Sometimes we may commit another type of error where we may fail to detect the difference when actually there is the difference. This is known as Type II error that detects false negative results, exactly opposite to mentioned above where we find false positive results when actually there was no difference. Type II error is the probability of failing to find the difference between two study groups when actually a difference exist and it is termed as beta (β). The “power” of the study then is equal to (1-β) and for a β of 0.2, the power is 0.8, which is the minimum power required to accept the null hypothesis.

3.       The effect size: Effect size (ES) is the minimal difference that need to detect between study groups. The difference between the value of the variable in the control group and that in the test drug group is known as ES.

4.       The variability: The sample size calculation also depend on population variance of given outcome variable, which is estimated by the standard deviation. Sample size is directly proportional to SD, for e.g. in homogeneous population SD will be low so as sample size require is low.

 Sample size will be denoted by “n”.

 Sample size calculation

n=N/(1+Ne2)

(where n = number of sample, N= Total population and e = Error tolerance)

By using 95% confidence level ( margin of error of 0.05)

Screening population

Sample size

50

44

100

80

150

109

200

133

500

222

1000

286

2000

333

 For values beyond the preview of the table use “Sample size calculator” in excel sheet: Download


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