1. No criminal on the run The concept of test of significance FETP India

2. Competency to be gained from this lecture Formulate and test null hypotheses

3. Key issues Null and alternate hypotheses Type I and Type II errors Statistical testing

4. What is the question at hand? Estimating a quantity? Test a hypothesis? Hypotheses

5. Taking into account the sampling variation in decision-making Studies are on sample of subjects and not on an entire population There is sampling variation Allowance should be given for sampling variation while a decision taking Hypotheses

6. Rationalizing decision-making Research studies test hypotheses  Experiment and data collection Hypotheses are tested on the basis of inference from available data Considering a difference as significant may be subjective The concept of statistical significance is a decision-making tool to make a subjective decision objective Hypotheses

7. A man is brought to court accused of a crime The judge needs to start from the hypothesis that the person is innocent The evidence is brought in:  Fingerprints  Pictures Hypotheses

8. Assessing whether the evidence is caused by chance or not The judge assesses whether the evidence could be due to chance If the probability that the evidence is caused by chance is high:  The judge accepts the hypothesis of innocence If the probability that the evidence is caused by chance is low:  The judge rejects the hypothesis of innocence Hypotheses

9. Hypotheses formulated by epidemiologists Ho: Null hypothesis (=“innocence”)  The difference observed is caused by chance, or sampling variation H1: Alternate hypothesis  The probability that the difference observed is caused by chance alone is low Hypotheses

10. From sampling distribution to hypothesis testing Epidemiologists decide a critical / rejection region  That decision is arbitrary If the value falls under an extreme, rejection region, the null hypothesis is rejected Hypotheses

11. Type I and type II errors Type I  Rejection error, also called alpha error  Rejecting the null hypothesis when it is true  Punishing an innocent  Particularly unacceptable to society  Must be minimized Type II  Acceptance error, also called beta error  Accepting the null hypothesis when it is false  Releasing a guilty person charged Errors

12. Balancing the risk of errors If the judge wants to always avoid type I error, he can release everyone  He will always commit the type II error If the judge wants to always avoid type II error, he can charge everyone  He will always commit the type I error To balance the risk of errors, we will fix one error and try to minimize the other Errors

13. Which error is more important? HypertensionHIV Effective drugs already available? ManyFew Concluding that new treatment is better when it is not Unfortunate Not so unfortunate Concluding that new treatment is no better when it is better Not so unfortunate Very unfortunate Which error is more important? Type IType II Errors

14. Examples of errors An example where type I error is important  If a new drug becomes available for HIV, we must minimize the risk to reject a drug that would work An example where type II error is important  If a new drug becomes available for hypertension, since lots of anti-hypertensive are already available, we cannot take a risk and can only accept a drug that is completely safe Errors

15. Behind errors are the right decisions 1-alpha  Probability of accepting the null hypothesis when it is the right decision 1-beta  Probability of rejecting the null hypothesis when it is the right decision  Also called statistical power Errors

16. Alpha and beta error Decision Accept HoReject Ho Truth Ho is true Good decision 1-alpha Alpha error Ho is falseBeta error Good decision 1 - beta Errors

17. Population of 10,000 Mean height = 65” S.d. = 10” 66” 63” 65” 64” 67” = 1 Sampling fluctuation in samples of 100 subjects for height measurement Even when statistically sound sampling techniques are employed  The mean in samples of 100 will not necessarily be 65”  Variation from sample to sample This must be taken into account when interpreting differences This method is called a significance test Sampling error of mean Testing

18. Magnitude of allowance Consider an expected difference of 0%  1%, 2%, 3% Not large  20%, 30% Large, not willing to consider the difference as 0% WHY?  If the true difference is 0%, the chance (probability) of getting a difference exceeding 20% is very small Testing

19. Decision rule Formulate a decision rule based on the probability of getting the observed difference  Null hypothesis (Ho) Assuming Ho is true, compute the probability of obtaining the observed difference If the probability is low:  Reject Ho Else, accept Ho Testing

20. Choosing a rejection level The definition of low probability is subjective Conventionally:  Low probability = 5% (P=0.05)  If P < 0.05, the observed difference is ‘significant (Statistically)  P< 0.01, sometimes termed as ‘Highly significant’ Computation of P-values:  Statistical exercise  Depends on the nature of data and design of the study Necessary condition: Probability sample  No test of significance on convenience or quota samples Testing

21. Population of 10, 000 A random sample of size 100 is drawn Mean height = 68” Concept of test of significance Question:  Could the population mean be 65” ? Hypothesis:  Population mean = 65” Question:  What is the probability of obtaining a sample mean of 68” from this population when sample size = 100 ? If this probability is small (e.g. < 5%)  Reject the Hypothesis If not, accept the Hypothesis Testing

22. Test of significance: Computation of probability Observed mean = 68”Postulated mean = 65” Standard deviation = 10”Sample size = 100 Sampling error (s.e.) of mean = 10 /  100 = 1 Compute: Observed mean - Postulated mean 68-65 ----------------------------------------- = -------- = 3 s.e. of mean 1 Critical value for significance at 5% level = 1.96 Since 3 > 1.96, the difference is statistically significant Exact probability = 0.0027, i.e., 0.27%

23. What if the distribution is not normal? Transform the data (e.g., drug concentration, cell counts) to some other scale to obtain a normal distribution  e.g., logarithm, square root If not feasible, and provided sample size exceeds 30, make use of the result that mean is approximately normally distributed Testing

24. Estimating the sample size The epidemiologist examines the willingness to commit:  Alpha error  Beta error Sample size calculation is the step at which decisions will be made in this respect Testing

25. Interpretation of significance “Significant” does not necessarily mean that the observed difference is REAL or IMPORTANT “Significant” only means that it is unlikely (<5%) that the difference is due to chance Trivial differences can be statistically significant if they are based on large numbers Testing

26. Interpretation of non-significance “Non - significant” does not necessarily mean that there is no real difference “Non - significant” means only that the observed difference could easily be due to chance  Probability of at least 5% There could be a real or important difference but due to inadequate sample size we might have obtained a non-significant result Testing

27. Significance does not systematically mean causation: Potential explanations for a significant association xChance: Addressed by the significance test ?Bias ?Confounding factor ?Causation  Consider after the first three have been ruled out  Test for causality criteria Testing

28. The choice of a one-sided test depends upon the alternate hypothesis One-sided test When the alternate hypothesis is in one direction The actual P-values need to be quoted instead of stating just p < 0.05 or p < 0.01 Testing

29. Quick checklist for statistical testing A statistical test is indeed needed The test used is adapted The test is calculated correctly The interpretation of the test is appropriate

30. Key messages Under the null hypotheses, differences observed are caused by chance alone Type I error consists in rejecting the null hypothesis when it is true while type II error consists in accepting the null hypothesis when it is false Statistical tests estimate the probability that a difference observed may be caused by chance alone