--- %%NOBANNER%% -->
/*------------------<--- Start of Description -->--------------------\
| Sample size for comparison of two median survival curves; |
| Provides approximate sample size for logrank test. |
| Assumptions are uniform accrual and exponential survival |
|--------------------<--- End of Description -->---------------------|
|--------------------------------------------------------------------|
|--------------<--- Start of Files or Arguments Needed -->-----------|
| Arguments: |
| - Required: |
| T0 = length of accrual period(uniform accrual assumed) |
| T = total length of study(=T0+follow-up after last patient) |
| y1 = true group 1 median survival |
| min_y2 = smallest possible true group 2 median survival |
| - Optional: |
| max_y2 = largest possible true median survival for group 2 |
| inc_y2 = increment value for range of y2 |
| r = ratio of group 2/group 1 sample size(n2/n1),default=1 |
| alpha = type 1 error, e.g. .01 or .05, default=.05 |
| sides = 1 or 2 for 1 or 2 sided test, default=2 |
| power = desired power, e.g. .80, .90, default=.80 |
| plot = 'P' for line printer plot of group 2 sample size vs y2 |
| 'G' for SAS/GRAPH plot of group 2 sample size vs y2 |
| unit = units for time, e.g. years, months, days, hours |
| Output: Sample size per group for true group 1 mean of y1 vs true |
| group 2 means ranging from min_y2 to max_y2 |
|---------------<--- End of Files or Arguments Needed -->------------|
|--------------------------------------------------------------------|
|----------------<--- Start of Example and Usage -->-----------------|
| Example: %sv2md_ss(sides=1,power=.9,y1=3.466,min_y2=0.31, |
| max_y2=2.31,inc_y2=.2, t0=3,t=5,unit=yrs,plot=p);|
| Usage: %sv2md_ss (ALPHA=.05,SIDES=2,POWER=.80,Y1=.,MIN_Y2=., |
| MAX_Y2=.,INC_Y2=.,R=1,T0=.,T=.,PLOT= , UNIT=); |
| Reference: Bergstralh, EJ. SAS macros for sample size and power |
| calculations. Proceedings of the 9th annual SAS Users |
| Group International Conference. |
| Equation #17. |
\-------------------<--- End of Example and Usage -->---------------*/
%MACRO sv2md_ss (ALPHA=.05,SIDES=2,POWER=.80,Y1=.,MIN_Y2=.,
MAX_Y2=.,INC_Y2=.,R=1,T0=.,T=.,PLOT= , UNIT=);
/*--------------------------------------------\
| Author: Michael Riggs and Eric Bergstralh; |
| Purpose: Sample size for comparison of two |
| median survival curves; |
\--------------------------------------------*/
OPTIONS MISSING=' ' NOCENTER;
%LET PLOT=%UPCASE(&PLOT);
DATA T1;
ALPHA=&ALPHA;
SIDES=&SIDES;
Y1=&Y1;
MIN_Y2=&MIN_Y2;
MAX_Y2=&MAX_Y2;
INC_Y2=&INC_Y2;
POWER=&POWER;
R=&R;
T0=&T0;
T=&T;
ZALPHA=(PROBIT(1-ALPHA))*(SIDES=1) + (PROBIT(1-ALPHA/2))*(SIDES=2);
ZBETA=PROBIT(POWER);
IF MAX_Y2=. THEN DO;
MAX_Y2=MIN_Y2+1; INC_Y2=MIN_Y2+2; *NEED 1 EXEC OF DO;
END;
TY1=Y1;
TT=T;
TT0=T0;
TR=R;
CALL SYMPUT ('TOTFOL', PUT((T-T0),4.1));
DO Y2=MIN_Y2 TO MAX_Y2 BY INC_Y2;
LAMBDA1=LOG(2)/TY1;
LAMBDA2=LOG(2)/Y2;
LAMBD_BR=(LAMBDA1+TR*LAMBDA2)/(1+TR);
IF TT0 GT 0 THEN DO;
PHILBDA1=LAMBDA1**2 *
1/ (1-(EXP(-LAMBDA1*(TT-TT0))-EXP(-LAMBDA1*TT)) /
(LAMBDA1*TT0) );
PHILBDA2=LAMBDA2**2 *
1/ (1-(EXP(-LAMBDA2*(TT-TT0))-EXP(-LAMBDA2*TT)) /
(LAMBDA2*TT0) );
PHILBDBR=LAMBD_BR**2 *
1/ (1-(EXP(-LAMBD_BR*(TT-TT0))-EXP(-LAMBD_BR*TT)) /
(LAMBD_BR*TT0) );
END;
IF TT0=0 THEN DO; *ALL PTS ENTER STUDY AT SAME TIME;
PHILBDA1=LAMBDA1**2/(1-EXP(-LAMBDA1*TT));
PHILBDA2=LAMBDA2**2/(1-EXP(-LAMBDA2*TT));
PHILBDBR=LAMBD_BR**2/(1-EXP(-LAMBD_BR*TT));
END;
N1=((ZALPHA*SQRT(PHILBDBR*(1+1/TR)) +
ZBETA*SQRT(PHILBDA1+PHILBDA2/TR)) /
(LAMBDA1-LAMBDA2) ) **2;
N1=CEIL(N1);
N2=N1*TR;
OUTPUT;
END;
LABEL Y1="Group 1*Median (&UNIT)*Survival"
Y2="Group 2*Median (&UNIT)*Survival"
T0="Recruitment*Period*(&unit)"
n1="Group 1*Sample Size"
n2="Group 2*Sample Size"
T="Time*(&UNIT) of*Analysis";
PROC PRINT SPLIT='*';
ID Y1; var Y2 N1 N2;
TITLE3
"SAMPLE SIZE REQUIREMENTS FOR COMPARISON OF TWO MEDIAN SURVIVALS";
TITLE4"Uniform accrual for &t0 &unit(T0) is assumed with analysis at &t &unit
(T)";
title5
"Alpha=&alpha, Sides=&sides, Power=&power, Ratio N2/N1=&r, True Group 1
Median Survival=&y1 &unit";
%IF &MAX_Y2 NE . %THEN %DO;
%IF &PLOT= P %THEN %DO;
PROC PLOT NOLEGEND;
PLOT N2*Y2/ HAXIS=&MIN_Y2 TO &MAX_Y2 BY &INC_Y2;
LABEL N2='Group 2 sample size'
Y2="Group2 median survival(&unit)";
%END;
%ELSE %IF &PLOT= G %THEN %DO;
PROC GPLOT ;
PLOT N2*Y2;
SYMBOL1 F=SPECIAL V=J H=1 I=j L=1;
SYMBOL2 F=SPECIAL V=M H=1 I=j L=2;
LABEL N2='N2'
Y2="Group 2 median survival(&unit)";
run; quit;
%END;
RUN;
%END;
%MEND sv2md_ss;