Mini Data Analysis 9

Increasing blood pressure in academics!

The blood pressure data are given in long form where the predictor variables are subject id
(subj), blood pressure (bp), group (0=placebo or 1=medication), time (baseline or after 3
months of treatment) and a group by time interaction (groupbytime) with one row for each
time point. I have also included four extra variables, bp0p, bp3p,bp0m, and bp3m which
give the blood pressure values at times 0 and 3 months separately for the placebo (p) and
medication (m) groups. This will be useful for parts (a) - (c).

(a) Obtain means and standard deviations for each of the two treatment groups at each of the
two time points. What do these values suggest intuitively about the results of the trial?

Baseline measures for both treatment groups (placebo and medication) appear to have the same
mean blood pressure at baseline (about 160). At follow-up, the mean in the control group appear
to be under 160, however, at follow-up the mean of the treatment group appears to have
decreased to 145. This data tells us that the medication that the treatment group is receiving
 appears to be working, as no change was visible in the placebo group, indicating that there was
no placebo effect.

Report
bp0p bp3p bp0m bp3m
Mean 159.697138914 159.581158120 159.977154622 144.990088704
N 50 50 50 50
Std. Deviation 1.0753425222 1.5063827347 1.4057152071 1.4001113216

Report
bp
time group Mean N Std. Deviation
0 0 159.697138914 50 1.0753425222
1 159.977154622 50 1.4057152071
Total 159.837146768 100 1.2530675988
3 0 159.581158120 50 1.5063827347
1 144.990088704 50 1.4001113216
Total 152.285623412 100 7.4736764983
Total 0 159.639148517 100 1.3034075864
1 152.483621663 100 7.6595385978
Total 156.061385090 200 6.5495602337

(b) Is there a difference in blood pressure between the two groups at baseline? What about at
the end of treatment? Evaluate this formally by performing a simple test at each time
point. What do your results suggest about treatment? Why might you not simply report the
end of treatment analysis as your final result and not worry about the repeated measures?

Our data shows that there is no difference in blood pressure levels for both groups at baseline
(two-sided p-value of 0.266), however we see a highly significant difference between both
groups at the follow-up (two-sided p-value=0.0001). Therefore, the results suggest that the
medication the treatment group is receiving is having an effect on lowering blood pressure.

Group Statistics
group N Mean Std. Deviation Std. Error Mean
bp 1 50 159.977154622 1.4057152071 .1987981511
 0 50 159.697138914 1.0753425222 .1520763979

Independent Samples Test

Levene's Test
for Equality of
Variances t-test for Equality of Means

95% Confidence Interval of the

Sig. (2- Mean Std. Error Difference

F Sig. t df tailed) Difference Difference Lower Upper

bp Equal 1.699 .195 1.119 98 .266 .2800157080 .2502956965 -.2166879556 .7767193716
variances
assumed

Equal 1.119 91.720 .266 .2800157080 .2502956965 -.2171134028 .7771448188

variances not
assumed

Group Statistics
group N Mean Std. Deviation Std. Error Mean
bp 1 50 144.990088704 1.4001113216 .1980056420
0 50 159.581158120 1.5063827347 .2130346894

Independent Samples Test

Levene's
Test for
Equality of
Variances t-test for Equality of Means
95% Confidence Interval of the
Sig. (2- Std. Error Difference
F Sig. t df tailed) Mean Difference Difference Lower Upper
bp Equal .207 .650 -50.168 98 .000 -14.5910694160 .2908436231 -15.1682391205 -14.0138997115
variances
assumed
Equal -50.168 97.480 .000 -14.5910694160 .2908436231 -15.1682775959 -14.0138612361
variances
not
assumed

(c) Is there evidence of change over time within either the placebo group or the treatment
group? Carry out an appropriate simple test within each group to answer this question.
Why is it not sufficient to simply note that there is a significant improvement in the
treatment group over time?

Our data indicated that there is no change between the placebo group (p-value=0.605), however
we do see a significant change in the treatment group (p-value=0.0001). The medication has
resulted in a decreased blood pressure levels in the treatment group. Since the placebo group did
not have an effect such as the treatment group, our data suggests that the medication given to the
treatment group is in fact working in lowering blood pressure.

Paired Samples Statistics

Mean N Std. Deviation Std. Error Mean
Pair 1 bp0p 159.697138914 50 1.0753425222 .1520763979
bp3p 159.581158120 50 1.5063827347 .2130346894
Pair 2 bp0m 159.977154622 50 1.4057152071 .1987981511
bp3m 144.990088704 50 1.4001113216 .1980056420

Paired Samples Correlations

N Correlation Sig.
Pair 1 bp0p & bp3p 50 .290 .041
Pair 2 bp0m & bp3m 50 .399 .004

Paired Samples Test

Paired Differences Sig.
Std. Error 95% Confidence Interval of the (2-
Mean Std. Deviation Mean Difference t df tailed)
 Lower Upper
Pair bp0p .1159807940 1.5771566598 .2230436338 -.3322421693 .5642037573 .520 49 .605
1 -
bp3p
Pair bp0m 14.9870659180 1.5382144319 .2175363711 14.5499102134 15.4242216226 68.895 49 .000
2 -
bp3m

(d) Now use SPSS or SAS to fit a model with data from both groups at both timepoints, using
the repeated measures formulation of the model and assuming a compound symmetric
covariance structure. Use blood pressure as your outcome and group, time and a group by
time interaction as predictors. Use the model to answer the following question:

Is there evidence of a significant group by time interaction? Explain as carefully as you can
what this tells you about the effect of the treatment. Incorporate the direction and
magnitude of the various regression coefficients into your explanation. Does it matter
whether the coefficients of the individual group and time variables are significant? What
are they telling you?

The group by time interaction has a corresponding p-value=0.001 indicating that we have a
significant interaction. The intercept for B0=159.697 corresponds to the average blood pressure
of those in the placebo group at baseline. The regression coefficient for group, B1=0.280 which
indicates the baseline (time=0) difference between the placebo and treatment group. This data
indicates that at baseline (time=0), blood pressure is a little higher in the treatment group
compared to the placebo group. The data indicates that there is no change from baseline to
follow-up in the placebo group, however, there is a change from baseline to follow-up in the
treatment group than the placebo group, although not significantly different (p-value=0.258)
from the placebo group. If we look at the time regression coefficient, B2= -0.116, this indicates
that the change in blood pressure associated with a one-unit change (in the 3 month duration) in
time for the placebo group. Therefore, there is a decrease in blood pressure in the placebo group
over the 3 month period, but the change in blood pressure is not significant (p-value=0.599). The
regression coefficient for the group by time interaction, B3= -14.871, indicates that the rate of
change in blood pressure over the 3 month duration is different between both placebo and
treatment group. Therefore, this tells us that blood pressure decreases by 15 units for a 3 month
duration in the treatment group compared to that of the placebo group, and this is significantly
different (p-value=0.0001).
 Tests of Model Effects
Type III
Source Wald Chi-Square df Sig.
(Intercept) 2014307.991 1 .000
group 1058.664 1 .000
time 2397.815 1 .000
group * time 2324.726 1 .000
Dependent Variable: bp
Model: (Intercept), group, time, group * time

Parameter Estimates
95% Wald Confidence
Interval Hypothesis Test
Wald Chi-
Parameter B Std. Error Lower Upper Square df Sig.
(Intercept) 159.697 .1505 159.402 159.992 1125238.442 1 .000
[group=1] .280 .2478 -.206 .766 1.277 1 .258
[group=0] 0a . . . . . .
[time=3] -.116 .2208 -.549 .317 .276 1 .599
[time=0] 0a . . . . . .
[group=1] * [time=3] -14.871 .3084 -15.476 -14.267 2324.726 1 .000
[group=1] * [time=0] 0a . . . . . .
[group=0] * [time=3] 0a . . . . . .
[group=0] * [time=0] 0a . . . . . .
(Scale) 1.840
Dependent Variable: bp
Model: (Intercept), group, time, group * time
a. Set to zero because this parameter is redundant.
SPSS Output

* Chart Builder.
GGRAPH
/GRAPHDATASET NAME="graphdataset" VARIABLES=time bp subject
MISSING=LISTWISE REPORTMISSING=NO
/GRAPHSPEC SOURCE=INLINE.
BEGIN GPL
SOURCE: s=userSource(id("graphdataset"))
DATA: time=col(source(s), name("time"))
DATA: bp=col(source(s), name("bp"))
DATA: subject=col(source(s), name("subject"), unit.category())
GUIDE: axis(dim(1), label("time"))
GUIDE: axis(dim(2), label("bp"))
GUIDE: legend(aesthetic(aesthetic.color.interior), label("subject"))
GUIDE: text.title(label("Multiple Line of bp by time by subject"))
ELEMENT: line(position(time*bp), color.interior(subject), missing.wings())
END GPL.

MEANS TABLES=bp BY time BY group

/CELLS=MEAN COUNT STDDEV.

USE ALL.
COMPUTE filter_$=(time = 0).
VARIABLE LABELS filter_$ 'time = 0 (FILTER)'.
VALUE LABELS filter_$ 0 'Not Selected' 1 'Selected'.
FORMATS filter_$ (f1.0).
FILTER BY filter_$.
EXECUTE.
T-TEST GROUPS=group(1 0)
/MISSING=ANALYSIS
/VARIABLES=bp
/CRITERIA=CI(.95).

USE ALL.
COMPUTE filter_$=(time = 3).
VARIABLE LABELS filter_$ 'time = 3 (FILTER)'.
VALUE LABELS filter_$ 0 'Not Selected' 1 'Selected'.
FORMATS filter_$ (f1.0).
FILTER BY filter_$.
EXECUTE.
T-TEST GROUPS=group(1 0)
/MISSING=ANALYSIS
/VARIABLES=bp
/CRITERIA=CI(.95).

FILTER OFF.
USE ALL.
EXECUTE.
T-TEST PAIRS=bp0p bp0m WITH bp3p bp3m (PAIRED)
 /CRITERIA=CI(.9500)
/MISSING=ANALYSIS.

* Generalized Estimating Equations.

GENLIN bp BY group time (ORDER=DESCENDING)
/MODEL group time group*time INTERCEPT=YES
DISTRIBUTION=NORMAL LINK=IDENTITY
/CRITERIA SCALE=MLE PCONVERGE=1E-006(ABSOLUTE) SINGULAR=1E-012
ANALYSISTYPE=3(WALD) CILEVEL=95
LIKELIHOOD=FULL
/REPEATED SUBJECT=subject WITHINSUBJECT=time SORT=YES CORRTYPE=INDEPENDENT
ADJUSTCORR=YES
COVB=ROBUST
/MISSING CLASSMISSING=EXCLUDE
/PRINT CPS DESCRIPTIVES MODELINFO FIT SUMMARY SOLUTION.