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/*------------------<--- 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;