Thalidomide and TB Status in Weight Gains in HIV+ Patients 2-Way ANOVA Using Regression with Dummy Variables All patients are HIV+ 16 also have Tuberculosis (TB+), 16 do not have Tuberculosis (TB-) Half of TB+ patients received Thalidomide, half received placebo Half of TB- patients received Thalidomide, half received placebo Y = weight gain (kg) in 21 day period Define dummy variables: TB=1 if patient is TB+, 0 if patient is TBThal=1 if patient was assigned Thalidomide, 0 if placebo TB_Thal=TB*Thal Model: E(Y) = TB + Thal + TB_Thal Group Means: Group TB + TB /Thal 1 TB Placebo 1 TB /Thal 0 TB-/Placebo 0 Thal 1 0 1 0 TB_Thal 1 0 0 0 E(Y) Conditional on TB+, Thalidomide (vs Placebo) Effect: ( Conditional on TB-, Thalidomide (vs Placebo) Effect: ( So, the thalidomide effect is the same in the two patient populations (TB+/TB-) if Results fitting model in SPSS, with wt_gain as dependent variable, tb and thal in block 1 for independent variables, and tb_thal in block 2. Note that with either variable having more than 2 levels, there would be more than 2 variables in block 1, and more than one variable in block 2. Variables Entered/Removedb Model 1 2 Variables Entered THAL, TBa TB_THALa Variables Removed Method Enter Enter . . a. All requested variables entered. b. Dependent Variable: WTGAIN Model Summary Model 1 2 R .649a .723b R Square .422 .522 Adjusted R Square .382 .471 Std. Error of the Estimate 2.0463 1.8928 a. Predictors: (Constant), THAL, TB b. Predictors: (Constant), THAL, TB, TB_THAL ANOVAc Model 1 2 Regres sion Residual Total Regres sion Residual Total Sum of Squares 88.563 121.438 210.000 109.687 100.313 210.000 df 2 29 31 3 28 31 Mean Square 44.281 4.188 F 10.575 Sig. .000a 36.562 3.583 10.206 .000b a. Predic tors: (Constant), THAL, TB b. Predic tors: (Constant), THAL, TB, TB_THAL c. Dependent Variable: W TGAIN Model 1 is Reduced Model Model 2 is Full (Complete) Model Coeffi cientsa Model 1 2 (Const ant) TB THAL (Const ant) TB THAL TB_THAL Unstandardized Coeffic ients B St d. Error -.125 .627 -.313 .723 3.313 .723 .687 .669 -1. 937 .946 1.688 .946 3.250 1.338 St andardiz ed Coeffic ients Beta -.061 .647 -.378 .329 .549 t -.200 -.432 4.579 1.027 -2. 047 1.783 2.428 Sig. .843 .669 .000 .313 .050 .085 .022 a. Dependent Variable: W TGAIN Test for interaction H0: No interaction between TB status and drug (thalidomide/placebo) on weight gains in HIV+ patients () HA: Interaction exists ( Not equal to 0) t-test (This can only be used because there is only one interaction term in model) TS: tobs = 3.250 / 1.338 = 2.428 p-value=.022 (see above table for variable TB_THAL) F-test (This can me used when there are any number of interaction terms being simultaneously tested equal to 0). SSE(REDUCED) = 121.438 (See ANOVA table above) SSE(FULL) = 100.313 (See ANOVA table above) MSE(FULL) = 3.583 (See ANOVA table above) # of Parameters being tested = 0 in H0 = 1 dfError(Full) = 28 TS: Fobs = [ (SSE(REDUCED) – SSE(FULL))/#Parms in H0 ] / MSE(FULL) = [ (121.438 – 100.313) /1 ] / 3.583 = 5.90 RR: Fobs > F.05,1,28 = 4.20 Reject H0, conclude there is a significant interaction. Estimated group means (Parameter values in previous tables replaced by estimates from full model): Group TB+/Thal TBPlacebo TB-/Thal TB-/Placebo TB 1 1 0 0 Thal 1 0 1 0 TB_Thal 1 0 0 0 Estimated mean 0.687-1.937+1.688+3.250 = 3.688 0.687-1.937 = -1.250 0.687 + 1.688 = 2.375 0.687 Plot these means with TB status (+/-) on the horizontal axis to observe the interaction (separate lines for each treatment group: thalidomide and placebo). 4 3 2 1 0 WTGAIN THA L -1 Thalidomide -2 Placebo -.2 0.0 .2 .4 .6 .8 1.0 1.2 TB Source: J.D. Klausner, S. Makonkawkeyoon, P. Akarrasewi, et al. (1996). “The Effect of Thalidomide on The Pathogenesis of HIV-1 in M. Tuberculosis Infection”, Journal of Acquired Immune Deficiency Syndromes and Hunan Retrovirology. Vol. 11, pp 247-257.