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© Dr Azmi Mohd Tamil, 2012




              How To Calculate Your
             Own Sample Size – Part 2
                       Tools to Calculate Sample Size




                                                        1
© Dr Azmi Mohd Tamil, 2012




                   Calculating power &
                       sample size
              As you’ve just seen, power is determined by
                Effect Size
                Number of subjects
                Choice of alpha (usually 0.05)

              You can download a free program (PS2) to
              calculate sample size from
         http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/PowerSampleSize
              Or you can use Statcalc (part of EpiInfo6) from
         http://www.cdc.gov/epiinfo/Epi6/EI6dnjp.htm to calculate sample size



                                                                                2
© Dr Azmi Mohd Tamil, 2012




                             3
© Dr Azmi Mohd Tamil, 2012



PS for Power/Sample Size calculations




      Any blue label
      leads to help


 Delta means expected
  difference in scores
   Expected standard
    deviation of the
      differences
                                    4
PS for Power/Sample Size calculations
© Dr Azmi Mohd Tamil, 2012



             Alternatively you can ask the program to calculate the
             sample size you need to give the power that you’re
             looking for
             Also plots graphs for a range of powers etc…




                                                                      5
© Dr Azmi Mohd Tamil, 2012




          PS2 can calculate sample size for
              Independent Case-Control Studies:
              Chi-square test, Fisher's exact test.
              Matched Case-Control Studies:
              McNemar's Test.
              Cohort Studies With Dichotomous Outcomes:
              Chi-square test, McNemar's test
              Continuous Response Measures in Two
              Groups: Paired and independent t tests.
              Linear Regression
              Survival Studies

                                                          6
© Dr Azmi Mohd Tamil, 2012




                             STATCALC




                                        7
© Dr Azmi Mohd Tamil, 2012




         StatCalc can calculate sample size
              Cross-Sectional – Prevalence Studies
              Cross-Sectional – Categorical Risk
              Factor & Outcome
              Cohort Studies With Dichotomous
              Outcomes: Categorical Risk Factor &
              Outcome
              Unmatched Case-Control Studies:
              Categorical Risk Factor & Outcome


                                                     8
© Dr Azmi Mohd Tamil, 2012




                        Or refer to tables;
              Lwanga SK,
              Lemeshow S., 1991.
              Sample Size
              Determination in
              Health Studies: A
              Practical Manual.
              WHO.
              Useful for
              prevalence studies.

                                              9
© Dr Azmi Mohd Tamil, 2012




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




                                                           10
© Dr Azmi Mohd Tamil, 2012




                             Step One

                    Determine your research design
                   and the outcome being measured



                                                     11
© Dr Azmi Mohd Tamil, 2012


                             STUDY DESIGNS

            OBSERVATIONAL                  EXPERIMENTAL
                STUDY                          STUDY

                                                 CLINICAL
            DESCRIPTIVE
               STUDY                              TRIAL

                             ECOLOGICAL
                             CORRELATION          CROSS-SECTIONAL

                                                   CASE CONTROL

                                      ANALYTIC        COHORT
                                       STUDY
                                                                    12
© Dr Azmi Mohd Tamil, 2012


           Examples of Study Design
              Study the prevalence of obesity in PPUKM -
              cross-sectional (prevalence)
              Comparing the rate of diabetes mellitus between
              Malays and non-Malays – cross-sectional
              (comparative)
              Comparing the rate of diabetes mellitus between
              those with cataract and those without cataract -
              case-control
              Measure the incidence and relative risk of diabetes
              mellitus between normal and overweight - cohort
              Comparing Drug “F” against Drug “S” for treating
              depression – clinical trial
              Measuring the sensitivity and specificity of a new
              serological test against the gold standard –
              diagnostic study
                                                                    13
© Dr Azmi Mohd Tamil, 2012




           Step 2 – Go to the Respective
               Slides for that Design
           Cross Sectional Study (prevalence) – Part 3
           Cross Sectional Study (comparative - qualitative
           dichotomous outcome) – Part 4
           Case Control (qualitative dichotomous outcome) –
           Part 5
           Cohort (qualitative dichotomous outcome) – Part 6
           Clinical Trial (qualitative dichotomous outcome) –
           Part 7
           Clinical Trial (continuous outcome) – Part 8
           Diagnostic Study – Part 9
         Each design requires a different approach for sample
           size calculation

                                                                14
© 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.



                                                                 15
© 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.


                                                                             16
© 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.



                                                                                                 17
© Dr Azmi Mohd Tamil, 2012




                             THANK
                              YOU


                                     18

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2. Tools to calculate samplesize

  • 1. © Dr Azmi Mohd Tamil, 2012 How To Calculate Your Own Sample Size – Part 2 Tools to Calculate Sample Size 1
  • 2. © Dr Azmi Mohd Tamil, 2012 Calculating power & sample size As you’ve just seen, power is determined by  Effect Size  Number of subjects  Choice of alpha (usually 0.05) You can download a free program (PS2) to calculate sample size from http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/PowerSampleSize Or you can use Statcalc (part of EpiInfo6) from http://www.cdc.gov/epiinfo/Epi6/EI6dnjp.htm to calculate sample size 2
  • 3. © Dr Azmi Mohd Tamil, 2012 3
  • 4. © Dr Azmi Mohd Tamil, 2012 PS for Power/Sample Size calculations Any blue label leads to help Delta means expected difference in scores Expected standard deviation of the differences 4
  • 5. PS for Power/Sample Size calculations © Dr Azmi Mohd Tamil, 2012 Alternatively you can ask the program to calculate the sample size you need to give the power that you’re looking for Also plots graphs for a range of powers etc… 5
  • 6. © Dr Azmi Mohd Tamil, 2012 PS2 can calculate sample size for Independent Case-Control Studies: Chi-square test, Fisher's exact test. Matched Case-Control Studies: McNemar's Test. Cohort Studies With Dichotomous Outcomes: Chi-square test, McNemar's test Continuous Response Measures in Two Groups: Paired and independent t tests. Linear Regression Survival Studies 6
  • 7. © Dr Azmi Mohd Tamil, 2012 STATCALC 7
  • 8. © Dr Azmi Mohd Tamil, 2012 StatCalc can calculate sample size Cross-Sectional – Prevalence Studies Cross-Sectional – Categorical Risk Factor & Outcome Cohort Studies With Dichotomous Outcomes: Categorical Risk Factor & Outcome Unmatched Case-Control Studies: Categorical Risk Factor & Outcome 8
  • 9. © Dr Azmi Mohd Tamil, 2012 Or refer to tables; Lwanga SK, Lemeshow S., 1991. Sample Size Determination in Health Studies: A Practical Manual. WHO. Useful for prevalence studies. 9
  • 10. © Dr Azmi Mohd Tamil, 2012 Alternative to table http://www.palmx.org/samplesize/Calc_Samplesize.xls 10
  • 11. © Dr Azmi Mohd Tamil, 2012 Step One Determine your research design and the outcome being measured 11
  • 12. © Dr Azmi Mohd Tamil, 2012 STUDY DESIGNS OBSERVATIONAL EXPERIMENTAL STUDY STUDY CLINICAL DESCRIPTIVE STUDY TRIAL ECOLOGICAL CORRELATION CROSS-SECTIONAL CASE CONTROL ANALYTIC COHORT STUDY 12
  • 13. © Dr Azmi Mohd Tamil, 2012 Examples of Study Design Study the prevalence of obesity in PPUKM - cross-sectional (prevalence) Comparing the rate of diabetes mellitus between Malays and non-Malays – cross-sectional (comparative) Comparing the rate of diabetes mellitus between those with cataract and those without cataract - case-control Measure the incidence and relative risk of diabetes mellitus between normal and overweight - cohort Comparing Drug “F” against Drug “S” for treating depression – clinical trial Measuring the sensitivity and specificity of a new serological test against the gold standard – diagnostic study 13
  • 14. © Dr Azmi Mohd Tamil, 2012 Step 2 – Go to the Respective Slides for that Design Cross Sectional Study (prevalence) – Part 3 Cross Sectional Study (comparative - qualitative dichotomous outcome) – Part 4 Case Control (qualitative dichotomous outcome) – Part 5 Cohort (qualitative dichotomous outcome) – Part 6 Clinical Trial (qualitative dichotomous outcome) – Part 7 Clinical Trial (continuous outcome) – Part 8 Diagnostic Study – Part 9 Each design requires a different approach for sample size calculation 14
  • 15. © 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. 15
  • 16. © 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. 16
  • 17. © 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. 17
  • 18. © Dr Azmi Mohd Tamil, 2012 THANK YOU 18