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7. Calculate samplesize for clinical trials
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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