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© Dr Azmi Mohd Tamil, 2012




                   Calculate Your Own
                   Sample Size – Part 3
                             Cross-Sectional Study –
                              Measuring Prevalence



                                                       1
© Dr Azmi Mohd Tamil, 2012




                             Cross-Sectional
              What is the outcome being measured?
                Is it the prevalence of disease/risk
                 factor?
                In the specific objective, it is stated that the
                 study is conducted to determine the
                 prevalence of the disease/risk factor.




                                                                    2
© Dr Azmi Mohd Tamil, 2012




                              Prevalence in
                             Cross-Sectional
              Do a literature review to estimate the
              prevalence being studied.
              Determine the absolute precision required i.e.
              5 percentage points (usually between 3 to 5).
              Calculate using (Kish L. 1965)
                          n = (Z1-α)2(P(1-P)/D2)
              or refer to a table in S.K. Lwanga, S.
              Lemeshaw 1991, Sample Size Determination
              in Health Studies, pg 25
              Or use StatCalc from EpiInfo6.

                                                               3
© Dr Azmi Mohd Tamil, 2012




           Example – To determine
            Prevalence of Obesity
              Confidence interval = 1 - α = 95%;
               Z1-α = Z0.95 = 1.96
              (from normal distribution table).
              Prevalence = P = 20%
              Absolute precision required = 5 percentage
              points,
              (therefore if the calculated prevalence of the
              study is 20%, then the true value of the
              prevalence lies between 15-25%).

                                                               4
© Dr Azmi Mohd Tamil, 2012




                     Calculate Manually
              n = (Z1-α)2(P(1-P)/D2) where
              Z1-α = Z0.95 = 1.96 (from normal distribution
              table. This value of 1.96 is standard for
              CI of 95%).
              P = 20% = 0.2 in this example
              D = 5% = 0.05 in this example
              n = 1.962 x (0.2(1-0.2)/0.052) = 245.84

                                                              5
© Dr Azmi Mohd Tamil, 2012




                             Refer to Table
              Refer to the table in S.K. Lwanga, S.
              Lemeshaw 1991, Sample Size
              Determination in Health Studies pg 25.
              With a Prevalence (P) of 20%, precision
              of 0.05, the table indicates that the
              sample size required is 246.



                                                        6
© Dr Azmi Mohd Tamil, 2012


Prevalence = 20%
precision = 0.05




                             7
© Dr Azmi Mohd Tamil, 2012




                    Alternative to table
     http://www.palmx.org/samplesize/Calc_Samplesize.xls




                                                           8
Or use StatCalc (Step 1)
© Dr Azmi Mohd Tamil, 2012




    P = 20% = 0.2 in this example
    D = 5% = 0.05 therefore the true value of the prevalence lies between 15-
    25%. So worse acceptable result is either 15% or 25%
    Press F4 to calculate.




                                                                            9
StatCalc (Step 2)
© Dr Azmi Mohd Tamil, 2012




    Using 95% confidence level, the sample size required
    is 246, the same value as manual calculation & the
    table.




                                                      10
Formula for Sample Size of
© Dr Azmi Mohd Tamil, 2012



                      A Prevalence Study
    It is the same since all calculations uses the same formula.




                                                                   11
© Dr Azmi Mohd Tamil, 2012




              If Prevalence Below 10%
                    or Above 90%
              If the prevalence being studied is below 10%,
              therefore the level of precision should be half
              of the prevalence; i.e. prevalence of Diabetes
              Mellitus is 6% therefore d must be set at 3%.
              The same applies to prevalence of above
              90%. The level of precision should be half of
              the (1-prevalence); i.e. prevalence of BCG
              vaccination is 96% therefore d must be set at
              2%.

                                                                12
© Dr Azmi Mohd Tamil, 2012




                    SS Calculation for a
                     Known Population
              What if the required sample size is
              larger than the population being
              studied?
              i.e. study on stress among staff at
              Rembau Health Clinic. Expected rate of
              stress is 50% therefore at 5% precision,
              the required sample size is 384. But the
              number of staff is only 30!

                                                         13
© Dr Azmi Mohd Tamil, 2012




                    SS Calculation for a
                     Known Population
              Krejcie & Morgan
                  Krejcie, R.V. & Morgan, D.W. (1970). Determining sample size for
                   research activities. Educational & Psychological Measurement, 30,
                   607-610.




                  S = required sample size
                   N = the given population size
                   P = prevalence
                   d = the degree of accuracy
                   X2 = 3.841 for the .95 confidence level


                                                                                       14
© Dr Azmi Mohd Tamil, 2012




               Table - Krejcie, R.V. &
                Morgan, D.W. (1970).
                             Assumption of the table;
                             prevalence = 50%. So
                             need only 28 out of 30
                             for the study on stress,
                             not 384.
                             If population > 250,000,
                             sample size equal to
                             Kish’s formula.




                                                        15
© Dr Azmi Mohd Tamil, 2012



      Kish, L (1960) = Krejcie, R.V.
        & Morgan, D.W. (1970) ?
      Kish, L (1960)                                 Krejcie, R.V. & Morgan, D.W. (1970)
      n = (Z1-α)2(P(1-P)/D2)
      S = n/(1+(n/population)

      (Z1-α)2 = X2 = 3.841
      Population = N
                                                     So we can use STATCALC
      P= P
                                                     to calculate sample size for
      D2 = d2 = 0.0025 (for 5%)                      a known population!

      We usually use only 1st half of the formula!


                                                                                           16
StatCalc
© Dr Azmi Mohd Tamil, 2012




    Using 95% confidence level, the sample size required
    is 28, the same value as in the table.




                                                      17
© Dr Azmi Mohd Tamil, 2012




                  What If There Is
                No Prior Information?
              Instead of saying "Sample sizes are not
              provided because there is no prior
              information on which to base them“, do this
              instead;
                Find previously published information
                Conduct small pre-study
                If a very preliminary pilot study, sample size
                 calculations not usually necessary
                Assume that the prevalence is 50% since that will
                 give you the largest required sample size.


                                                                     18
© Dr Azmi Mohd Tamil, 2012




                             Conclusion
              You can calculate your own sample size.
              Tools are available and most of them are free.
              Decide what is your study design and choose
              the appropriate method to calculate the
              sample size.
              If despite following ALL these notes
              fastidiously, your proposal is still rejected by
              the committee due to sample size, kindly SEE
              THEM, not us.



                                                                 19
© Dr Azmi Mohd Tamil, 2012




               References (incl. for StatCalc)
             Fleiss JL. Statistical methods for rates and proportions. New
             York: John Wiley and Sons, 1981.
             Gehan EA. Clinical Trials in Cancer Research. Environmental
             Health Perspectives Vol. 32, pp. 3148, 1979.
             Jones SR, Carley S & Harrison M. An introduction to power and
             sample size estimation. Emergency Medical Journal
             2003;20;453-458. 2003
             Kish L. Survey sampling. John Wiley & Sons, N.Y., 1965.
             Krejcie, R.V. & Morgan, D.W. (1970). Determining sample size
             for research activities. Educational & Psychological
             Measurement, 30, 607-610.
             Snedecor GW, Cochran WG. 1989. Statistical Methods. 8th Ed.
             Ames: Iowa State Press.


                                                                             20
© Dr Azmi Mohd Tamil, 2012




                         References (PS2)
              Dupont WD, Plummer WD, Jr: Power and Sample Size Calculations: A Review
              and Computer Program. Controlled Clinical Trials 11:116-128, 1990
              Dupont WD, Plummer WD, Jr: Power and Sample Size Calculations for Studies
              Involving Linear Regression. Controlled Clinical Trials 19:589-601, 1998
              Schoenfeld DA, Richter JR: Nomograms for calculating the number of patients
              needed for a clinical trial with survival as an endpoint. Biometrics 38:163-170,
              1982
              Pearson ES, Hartley HO: Biometrika Tables for Statisticians Vol. I 3rd Ed.
              Cambridge: Cambridge University Press, 1970
              Schlesselman JJ: Case-Control Studies: Design, Conduct, Analysis. New York:
              Oxford University Press, 1982
              Casagrande JT, Pike MC, Smith PG: An improved approximate formula for
              calculating sample sizes for comparing two binomial distributions. Biometrics
              34:483-486, 1978
              Dupont WD: Power calculations for matched case-control studies. Biometrics
              44:1157-1168, 1988
              Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley
              and Sons, 1981.



                                                                                                 21
© Dr Azmi Mohd Tamil, 2012




                             THANK
                              YOU


                                     22

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3. Calculate samplesize for prevalence studies

  • 1. © Dr Azmi Mohd Tamil, 2012 Calculate Your Own Sample Size – Part 3 Cross-Sectional Study – Measuring Prevalence 1
  • 2. © Dr Azmi Mohd Tamil, 2012 Cross-Sectional What is the outcome being measured?  Is it the prevalence of disease/risk factor?  In the specific objective, it is stated that the study is conducted to determine the prevalence of the disease/risk factor. 2
  • 3. © Dr Azmi Mohd Tamil, 2012 Prevalence in Cross-Sectional Do a literature review to estimate the prevalence being studied. Determine the absolute precision required i.e. 5 percentage points (usually between 3 to 5). Calculate using (Kish L. 1965) n = (Z1-α)2(P(1-P)/D2) or refer to a table in S.K. Lwanga, S. Lemeshaw 1991, Sample Size Determination in Health Studies, pg 25 Or use StatCalc from EpiInfo6. 3
  • 4. © Dr Azmi Mohd Tamil, 2012 Example – To determine Prevalence of Obesity Confidence interval = 1 - α = 95%; Z1-α = Z0.95 = 1.96 (from normal distribution table). Prevalence = P = 20% Absolute precision required = 5 percentage points, (therefore if the calculated prevalence of the study is 20%, then the true value of the prevalence lies between 15-25%). 4
  • 5. © Dr Azmi Mohd Tamil, 2012 Calculate Manually n = (Z1-α)2(P(1-P)/D2) where Z1-α = Z0.95 = 1.96 (from normal distribution table. This value of 1.96 is standard for CI of 95%). P = 20% = 0.2 in this example D = 5% = 0.05 in this example n = 1.962 x (0.2(1-0.2)/0.052) = 245.84 5
  • 6. © Dr Azmi Mohd Tamil, 2012 Refer to Table Refer to the table in S.K. Lwanga, S. Lemeshaw 1991, Sample Size Determination in Health Studies pg 25. With a Prevalence (P) of 20%, precision of 0.05, the table indicates that the sample size required is 246. 6
  • 7. © Dr Azmi Mohd Tamil, 2012 Prevalence = 20% precision = 0.05 7
  • 8. © Dr Azmi Mohd Tamil, 2012 Alternative to table http://www.palmx.org/samplesize/Calc_Samplesize.xls 8
  • 9. Or use StatCalc (Step 1) © Dr Azmi Mohd Tamil, 2012 P = 20% = 0.2 in this example D = 5% = 0.05 therefore the true value of the prevalence lies between 15- 25%. So worse acceptable result is either 15% or 25% Press F4 to calculate. 9
  • 10. StatCalc (Step 2) © Dr Azmi Mohd Tamil, 2012 Using 95% confidence level, the sample size required is 246, the same value as manual calculation & the table. 10
  • 11. Formula for Sample Size of © Dr Azmi Mohd Tamil, 2012 A Prevalence Study It is the same since all calculations uses the same formula. 11
  • 12. © Dr Azmi Mohd Tamil, 2012 If Prevalence Below 10% or Above 90% If the prevalence being studied is below 10%, therefore the level of precision should be half of the prevalence; i.e. prevalence of Diabetes Mellitus is 6% therefore d must be set at 3%. The same applies to prevalence of above 90%. The level of precision should be half of the (1-prevalence); i.e. prevalence of BCG vaccination is 96% therefore d must be set at 2%. 12
  • 13. © Dr Azmi Mohd Tamil, 2012 SS Calculation for a Known Population What if the required sample size is larger than the population being studied? i.e. study on stress among staff at Rembau Health Clinic. Expected rate of stress is 50% therefore at 5% precision, the required sample size is 384. But the number of staff is only 30! 13
  • 14. © Dr Azmi Mohd Tamil, 2012 SS Calculation for a Known Population Krejcie & Morgan  Krejcie, R.V. & Morgan, D.W. (1970). Determining sample size for research activities. Educational & Psychological Measurement, 30, 607-610.  S = required sample size N = the given population size P = prevalence d = the degree of accuracy X2 = 3.841 for the .95 confidence level 14
  • 15. © Dr Azmi Mohd Tamil, 2012 Table - Krejcie, R.V. & Morgan, D.W. (1970). Assumption of the table; prevalence = 50%. So need only 28 out of 30 for the study on stress, not 384. If population > 250,000, sample size equal to Kish’s formula. 15
  • 16. © Dr Azmi Mohd Tamil, 2012 Kish, L (1960) = Krejcie, R.V. & Morgan, D.W. (1970) ? Kish, L (1960) Krejcie, R.V. & Morgan, D.W. (1970) n = (Z1-α)2(P(1-P)/D2) S = n/(1+(n/population) (Z1-α)2 = X2 = 3.841 Population = N So we can use STATCALC P= P to calculate sample size for D2 = d2 = 0.0025 (for 5%) a known population! We usually use only 1st half of the formula! 16
  • 17. StatCalc © Dr Azmi Mohd Tamil, 2012 Using 95% confidence level, the sample size required is 28, the same value as in the table. 17
  • 18. © Dr Azmi Mohd Tamil, 2012 What If There Is No Prior Information? Instead of saying "Sample sizes are not provided because there is no prior information on which to base them“, do this instead;  Find previously published information  Conduct small pre-study  If a very preliminary pilot study, sample size calculations not usually necessary  Assume that the prevalence is 50% since that will give you the largest required sample size. 18
  • 19. © Dr Azmi Mohd Tamil, 2012 Conclusion You can calculate your own sample size. Tools are available and most of them are free. Decide what is your study design and choose the appropriate method to calculate the sample size. If despite following ALL these notes fastidiously, your proposal is still rejected by the committee due to sample size, kindly SEE THEM, not us. 19
  • 20. © Dr Azmi Mohd Tamil, 2012 References (incl. for StatCalc) Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley and Sons, 1981. Gehan EA. Clinical Trials in Cancer Research. Environmental Health Perspectives Vol. 32, pp. 3148, 1979. Jones SR, Carley S & Harrison M. An introduction to power and sample size estimation. Emergency Medical Journal 2003;20;453-458. 2003 Kish L. Survey sampling. John Wiley & Sons, N.Y., 1965. Krejcie, R.V. & Morgan, D.W. (1970). Determining sample size for research activities. Educational & Psychological Measurement, 30, 607-610. Snedecor GW, Cochran WG. 1989. Statistical Methods. 8th Ed. Ames: Iowa State Press. 20
  • 21. © Dr Azmi Mohd Tamil, 2012 References (PS2) Dupont WD, Plummer WD, Jr: Power and Sample Size Calculations: A Review and Computer Program. Controlled Clinical Trials 11:116-128, 1990 Dupont WD, Plummer WD, Jr: Power and Sample Size Calculations for Studies Involving Linear Regression. Controlled Clinical Trials 19:589-601, 1998 Schoenfeld DA, Richter JR: Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint. Biometrics 38:163-170, 1982 Pearson ES, Hartley HO: Biometrika Tables for Statisticians Vol. I 3rd Ed. Cambridge: Cambridge University Press, 1970 Schlesselman JJ: Case-Control Studies: Design, Conduct, Analysis. New York: Oxford University Press, 1982 Casagrande JT, Pike MC, Smith PG: An improved approximate formula for calculating sample sizes for comparing two binomial distributions. Biometrics 34:483-486, 1978 Dupont WD: Power calculations for matched case-control studies. Biometrics 44:1157-1168, 1988 Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley and Sons, 1981. 21
  • 22. © Dr Azmi Mohd Tamil, 2012 THANK YOU 22