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Sample Size Calculation

 Dr P Raghavendra
         2nd Year Post-Graduate
      Dept of Community Medicine,
  Siddhartha Medical College, Vijayawada
What is Sampling?
• A sample is a part of the population under
  study.
• In most situations, it might not be possible to
  study an entire population.
• We typically draw a subset of people drawn
  from a larger population and then use
  inferential statistics to make an inference from
  the sample and apply it to the whole
  population.
What is sampling?
• We try to study the characters of the
  population by measuring them from a smaller
  number of subjects.
• Sample is expected to be the MIRROR of the
  population.
• Cook sees only a handful of rice to check if it is
  cooked or not.
Attributes of a good sample
To extrapolate the inference of the sample to
  the population, the sample should be:
• A representative of the population.
• Should be large enough.
If sample is too large…
Good precision
Less errors
Less bias
But,
  Wastage of time, money and resources
  Resources could be as well be deviated to
  other projects.
  Not cost-effective
If sample is too small…
 Inaccurate results.
 More source of bias.
 Power of the study comes down.
 Study fails to give meaningful information.
 Waste of resources on a inaccurate study.
 Ethical issues about recruiting patients into a
 meaningless study.
The usual Question


How big a
sample is a
  good
How big should a sample be?
• Formulae are present.
• The forthcoming formulae are tailor-made for
  a power of 80% and a Confidence Interval of
  95%. (Acceptable levels)
• Power of the study is the ability to detect the
  true significance.
• 95% CI means 5% of erroneous significance.
Types of studies
• Based on what we are measuring, there are 4
  types of studies:
                       1. Calculating the proportion

  Qualitative
                      2. Calculating the difference of
                                proportions



                          3. Calculating the mean

  Quantitative

                    4.Calculating the difference in means
Qualitative v/s Quantitative
• Qualitative are those which can be answered
  as YES or NO, Male or Female, etc.
• We can only measure their numbers,
  eg: Number of males, Number of MDR-TB
  cases among TB patients, etc.
• A set of qualitative data can be expressed as
  proportions. Eg: Prevalence, success rate.
Qualitative v/s Quantitative
• Quantitative are those which can be measured
  in numbers, like Blood pressure, Age, etc.
• A set of quantitative date can be expressed in
  mean and its standard deviation.
• Mean is the average of all variables in the
  data.
• Standard deviation is a measure of the
  distribution of variables around the mean.
1. Calculating Proportion
• This is used in cases where we are trying to
  find proportions.
• Eg: for studies like:-
  – Estimation of prevalence of tuberculosis in
    Vijayawada city in 2012.
  – Prevalence of malignant hyperthermia as a
    complication of enflurane administration.
1. Calculating Proportion

            N=      4PQ/d 2
Where,
• P = Prevalence (from previous studies)
• Q = 100 – P
• d = allowable error (5-20% of P)
Exercise - 1
• Calculate the sample size required to find out
  the proportion of children receiving BCG
  vaccination if the BCG coverage of that area in
  previous studies was 80%.

• Sol: P = 80; Q = 100-P = 20; d= 20% 0f P = 16.
     N= 4PQ/d2
      = 4x80x20
         16x16
      = 25
2. Calculating Difference in proportion
• This is used when we measure the significance
  of difference between two proportions.
• Eg: For studies like:-
  – Diagnostic supremacy of CT Chest v/s X-ray chest
    in pulmonary tuberculosis.
  – Success rate of Streptomycin v/s Kanamycin in
    cure of MDR-TB
2. Calculating Difference in proportion

            N= 15.7 x x Q
                 (P1-P2 )2
Where,
• P1 and P2 are the proportions of the 2 groups
• is the average of P1 and P2
• Q is 100 -
Exercise - 2
• A new treatment regimen for Tuberculosis was
  planned. The success rates of DOTS was 75%.
  The success rate of the new treatment in a
  pilot study was 85%. Calculate the sample size
  for a study to compare the success rates of the
  two regimen.

              Hint: N= 15.7 x x Q
                          (P1-P2 )2
Solution to exercise - 2
Here, P1 = 75;           P2 = 85%;          = 80
     Q = 100 -   = 20;               P1-P2 = 10

Hence N    = (15.7 x 80 x 20) / (10 x 10)
           = 251
3. Calculating the mean
• This formula is used in quantitative studies
  where we are estimating the mean of the
  study group.
• Eg: For studies like:-
  – Estimation of mean age at diagnosis of
    tuberculosis in Vijayawada city
  – Bacteriological index at the initiation of DOTS in
    TB patients attending DOTS centre of
    GGH, Vijayawada
  – Mean time of onset of action of Sevoflurane
3. Calculating the mean

             N= 4        2/d2
Where,
• (Sigma) is the Standard deviation as in
  similar studies done previously
• d = allowable error (5-20% of )
Exercise - 3
• We are planning to do a study regarding Age
  of onset of smoking practice among youth in
  rural Vijayawada. A previous such study done
  in Andhra Pradesh gave a mean age at onset
  as 25 years with a standard deviation of 10
  years. Calculate the sample size required to do
  the planned study.
                 Hint: N= 4 2/d2
Solution to exercise - 3
Here,        = 10.
So,        d = 20% of   = 2.

Hence, N = (4 x 10x10) / (2 x 2)

           = 100
4. Calculating Difference in Means
• This is used in studies where we are
  calculating the difference achieved
  quantitatively during the study.
• Eg: For studies like:-
  – Average weight gain in patients of tuberculosis
    before and after DOTS.
  – Mean fall in Blood pressure due to propofol
    infusion.
4. Calculating Difference in Means

       N = 15.7 (           x       2
                        1       2)/d
 Where,
• 1 and 2 are the standard deviations of the 2
  study groups,
• d is the smallest meaningful difference that
  can be measured.
In before-after type of studies, 1 = 2 =
Exercise - 4
• Determine the sample size required to detect
  an increase of 10 cells/cu.mm in CD4 counts of
  HIV patients those receiving HAART, assuming
  the standard deviation of CD4 counts to be 70
  cells/cu.mm.

           Hint: N = 15.7 (   1x   2)/d2
Solution to exercise - 4
Here,     1   =   2   = 70,    d = 10

N       = (15.7 x 70 x 70) / (10 x 10)
        = 769
Frequently asked questions
• Where can we get the values of   or P?
Frequently asked questions
• When already we know the P, why should we
  do the study again?
Frequently asked questions
• How big should be the sample of a pilot
  study?
Frequently asked questions
• What should we do if we are not getting
  enough cases or if the sample size is bigger
  than the total number of cases?
Any Questions or
    Doubts??
Sample size calculation

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Sample size calculation

  • 1. Sample Size Calculation Dr P Raghavendra 2nd Year Post-Graduate Dept of Community Medicine, Siddhartha Medical College, Vijayawada
  • 2. What is Sampling? • A sample is a part of the population under study. • In most situations, it might not be possible to study an entire population. • We typically draw a subset of people drawn from a larger population and then use inferential statistics to make an inference from the sample and apply it to the whole population.
  • 3. What is sampling? • We try to study the characters of the population by measuring them from a smaller number of subjects. • Sample is expected to be the MIRROR of the population. • Cook sees only a handful of rice to check if it is cooked or not.
  • 4. Attributes of a good sample To extrapolate the inference of the sample to the population, the sample should be: • A representative of the population. • Should be large enough.
  • 5. If sample is too large… Good precision Less errors Less bias But, Wastage of time, money and resources Resources could be as well be deviated to other projects. Not cost-effective
  • 6. If sample is too small… Inaccurate results. More source of bias. Power of the study comes down. Study fails to give meaningful information. Waste of resources on a inaccurate study. Ethical issues about recruiting patients into a meaningless study.
  • 7. The usual Question How big a sample is a good
  • 8. How big should a sample be? • Formulae are present. • The forthcoming formulae are tailor-made for a power of 80% and a Confidence Interval of 95%. (Acceptable levels) • Power of the study is the ability to detect the true significance. • 95% CI means 5% of erroneous significance.
  • 9. Types of studies • Based on what we are measuring, there are 4 types of studies: 1. Calculating the proportion Qualitative 2. Calculating the difference of proportions 3. Calculating the mean Quantitative 4.Calculating the difference in means
  • 10. Qualitative v/s Quantitative • Qualitative are those which can be answered as YES or NO, Male or Female, etc. • We can only measure their numbers, eg: Number of males, Number of MDR-TB cases among TB patients, etc. • A set of qualitative data can be expressed as proportions. Eg: Prevalence, success rate.
  • 11. Qualitative v/s Quantitative • Quantitative are those which can be measured in numbers, like Blood pressure, Age, etc. • A set of quantitative date can be expressed in mean and its standard deviation. • Mean is the average of all variables in the data. • Standard deviation is a measure of the distribution of variables around the mean.
  • 12. 1. Calculating Proportion • This is used in cases where we are trying to find proportions. • Eg: for studies like:- – Estimation of prevalence of tuberculosis in Vijayawada city in 2012. – Prevalence of malignant hyperthermia as a complication of enflurane administration.
  • 13. 1. Calculating Proportion N= 4PQ/d 2 Where, • P = Prevalence (from previous studies) • Q = 100 – P • d = allowable error (5-20% of P)
  • 14. Exercise - 1 • Calculate the sample size required to find out the proportion of children receiving BCG vaccination if the BCG coverage of that area in previous studies was 80%. • Sol: P = 80; Q = 100-P = 20; d= 20% 0f P = 16. N= 4PQ/d2 = 4x80x20 16x16 = 25
  • 15. 2. Calculating Difference in proportion • This is used when we measure the significance of difference between two proportions. • Eg: For studies like:- – Diagnostic supremacy of CT Chest v/s X-ray chest in pulmonary tuberculosis. – Success rate of Streptomycin v/s Kanamycin in cure of MDR-TB
  • 16. 2. Calculating Difference in proportion N= 15.7 x x Q (P1-P2 )2 Where, • P1 and P2 are the proportions of the 2 groups • is the average of P1 and P2 • Q is 100 -
  • 17. Exercise - 2 • A new treatment regimen for Tuberculosis was planned. The success rates of DOTS was 75%. The success rate of the new treatment in a pilot study was 85%. Calculate the sample size for a study to compare the success rates of the two regimen. Hint: N= 15.7 x x Q (P1-P2 )2
  • 18. Solution to exercise - 2 Here, P1 = 75; P2 = 85%; = 80 Q = 100 - = 20; P1-P2 = 10 Hence N = (15.7 x 80 x 20) / (10 x 10) = 251
  • 19. 3. Calculating the mean • This formula is used in quantitative studies where we are estimating the mean of the study group. • Eg: For studies like:- – Estimation of mean age at diagnosis of tuberculosis in Vijayawada city – Bacteriological index at the initiation of DOTS in TB patients attending DOTS centre of GGH, Vijayawada – Mean time of onset of action of Sevoflurane
  • 20. 3. Calculating the mean N= 4 2/d2 Where, • (Sigma) is the Standard deviation as in similar studies done previously • d = allowable error (5-20% of )
  • 21. Exercise - 3 • We are planning to do a study regarding Age of onset of smoking practice among youth in rural Vijayawada. A previous such study done in Andhra Pradesh gave a mean age at onset as 25 years with a standard deviation of 10 years. Calculate the sample size required to do the planned study. Hint: N= 4 2/d2
  • 22. Solution to exercise - 3 Here, = 10. So, d = 20% of = 2. Hence, N = (4 x 10x10) / (2 x 2) = 100
  • 23. 4. Calculating Difference in Means • This is used in studies where we are calculating the difference achieved quantitatively during the study. • Eg: For studies like:- – Average weight gain in patients of tuberculosis before and after DOTS. – Mean fall in Blood pressure due to propofol infusion.
  • 24. 4. Calculating Difference in Means N = 15.7 ( x 2 1 2)/d Where, • 1 and 2 are the standard deviations of the 2 study groups, • d is the smallest meaningful difference that can be measured. In before-after type of studies, 1 = 2 =
  • 25. Exercise - 4 • Determine the sample size required to detect an increase of 10 cells/cu.mm in CD4 counts of HIV patients those receiving HAART, assuming the standard deviation of CD4 counts to be 70 cells/cu.mm. Hint: N = 15.7 ( 1x 2)/d2
  • 26. Solution to exercise - 4 Here, 1 = 2 = 70, d = 10 N = (15.7 x 70 x 70) / (10 x 10) = 769
  • 27. Frequently asked questions • Where can we get the values of or P?
  • 28. Frequently asked questions • When already we know the P, why should we do the study again?
  • 29. Frequently asked questions • How big should be the sample of a pilot study?
  • 30. Frequently asked questions • What should we do if we are not getting enough cases or if the sample size is bigger than the total number of cases?
  • 31. Any Questions or Doubts??