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The Treatment of Lead-Exposed Children (TLC) Trial example is described in Chapter 1 of your text.

In short,
children who had high blood lead levels were randomized to receive a placebo (control group) or a new
chelating agent, succimer (treatment/intervention group). Children were followed over time, and blood lead
levels (outcome, or dependent variable) were recorded at baseline, week 1, week 4, and week 6. The overall
goal is to determine if succimer is effective at decreasing blood lead levels. We also expect placebo to have
negligible impact on blood lead levels. Therefore, we want to compare treatment and control subjects over
time. Due to the randomization of a relatively large number of subjects, there should be no difference between
the groups at baseline.
We have a dataset of 100 subjects. Here is what the top part (first 10 subjects) of it looks like. Note that this is
not the proper setup for the dataset when we actually analyze the data. You will learn how to set up the dataset
later. Here, we have one observation per subject. Subject id is denoted by id. Treatment type, P-placebo or Asuccimer (note that ids do not match up with the ids in Table 1.1 of your book, and your book has S for
succimer, not A), denoted by trt. Blood lead level values (outcomes / dependent variable) are given by y0, y1,
y4, and y6 for baseline, week 1, week 4, and week 6, respectively.
proc print data=long.tlc; run;
Obs
id trt

y0

y1

y4

y6

1 P

30.8

26.9

25.8

23.8

2 A

26.5

14.8

19.5

21.0

3 A

25.8

23.0

19.1

23.2

4 P

24.7

24.5

22.0

22.5

5 A

20.4

2.8

3.2

9.4

6 A

20.4

5.4

4.5

11.9

7 P

28.6

20.8

19.2

18.4

8 P

33.7

31.6

28.5

25.1

9 P

19.7

14.9

15.3

14.7

10

10 P

31.1

31.2

29.2

30.1

/*Descriptive statistics. First need to sort by treatment type.*/


proc sort data=long.tlc; by trt; run;
proc means data=long.tlc;
var y0 y1 y4 y6;
by trt;
run;

Variable

Mean

trt=A
Std Dev

Minimum

Maximum

y0

50

26.5400000

5.0209358

19.7000000

41.1000000

y1

50

13.5220000

7.6724870

2.8000000

39.0000000

y4

50

15.5140000

7.8522065

3.0000000

40.4000000

y6

50

20.7620000

9.2463316

4.1000000

63.9000000

trt=P
Std Dev

Minimum

Maximum

Variable

Mean

y0

50

26.2720000

5.0241068

19.7000000

38.1000000

y1

50

24.6600000

5.4611803

14.9000000

40.8000000

y4

50

24.0700000

5.7531269

15.3000000

38.6000000

y6

50

23.6460000

5.6398079

13.5000000

43.3000000

/*Creating a dataset with the means*/


data means_data;
input Treatment Time Mean;
cards;
0 0 26.3
0 1 24.7
0 4 24.1
0 6 23.6
1 0 26.5
1 1 13.1
1 4 15.5
1 6 20.8
;
run;

/*Plotting the sample means by group across time. Same type of plot as Figure 1.1 in your text.*/
goptions reset=all gunit=pct cback=white colors=(black) border ftext=zapf htext=4;
title 'Estimated Mean Time Trend for Blood Lead Levels by Trial Arm';
symbol1 color=red interpol=join width=1 line=1 value=dot;
symbol2 color=blue interpol=join width=1 line=2 value=dot;
legend1 label=('Legend') frame position=(top right inside) /*value=(font=swiss)*/
mode=protect value=('Placebo' 'Succimer') across=1;
axis1 value=(font=swiss) major=(height=2 width=2) minor=(height=1)
label= (height=2 font=swiss 'Time (Weeks)') width=2;
axis2 value=(font=swiss) major=(height=2 width=2) minor=(height=1)
label= (height=2 font=swiss 'Estimated Mean Blood Lead Levels') width=2;
proc gplot data=means_data;
plot Mean*Time=Treatment/legend=legend1 haxis=axis1 vaxis=axis2;
run;
quit;

Sample means are approximately the same at baseline due to randomization working well. There is little
change over time in the placebo group. There is a large change from baseline to week 1 in the treatment group,
but then the mean increases over time. Your book explains that this rebound in blood lead levels is due to the
mobilization of lead that has been stored in tissues and bones.
Now lets look at a plot of the trajectories of several subjects over time. This is called a spaghetti plot. First, we
need to set up the data in a manner that we can make this plot.

/*Suppose we want to produce a spaghetti plot. We first need to setup the data so we can make this plot. Note
that the data needs to be setup in a manner that we can also analyze the data. To do this, we need one new
column that denotes time, and a single column with corresponding outcome values. This SAS code is based on
the code in Table 5.10 (page 137) of your text.*/
data tlc; set long.tlc;
y=y0; time=0; output; /*Observation for baseline*/
y=y1; time=1; output; /*Observation for Week 1*/
y=y4; time=4; output; /*Observation for Week 4*/
y=y6; time=6; output; /*Observation for Week 6*/
drop y0 y1 y4 y6;
run;
proc print data=tlc; run;

Obs

id trt

time

2 A

26.5

2 A

14.8

2 A

19.5

2 A

21.0

3 A

25.8

3 A

23.0

3 A

19.1

3 A

23.2

/*Plotting the trajectories for the first four treatment subjects (2, 3, 5, and 6)*/
goptions reset=all gunit=pct cback=white colors=(black) border ftext=zapf htext=2.5;
title 'Time Trends for Blood Lead Levels for Select Subjects';
symbol1 color=red interpol=join width=1 line=1 value=dot;
symbol2 color=blue interpol=join width=1 line=2 value=dot;
symbol3 color=black interpol=join width=1 line=1 value=dot;
symbol4 color=purple interpol=join width=1 line=2 value=dot;
legend1 label=('Legend') frame position=(top right inside)
mode=protect value=('ID 2' 'ID 3' 'ID 5' 'ID 6') across=1;
axis1 value=(font=swiss) major=(height=2 width=2) minor=(height=1)
label= (height=2 font=swiss 'Time (Weeks)') width=2;
axis2 value=(font=swiss) major=(height=2 width=2) minor=(height=1)
label= (height=2 font=swiss 'Blood Lead Levels') width=2;
proc gplot data=tlc;
plot y*time=id/legend=legend1 haxis=axis1 vaxis=axis2;
where id<7 and trt="A";
run;
quit;

This spaghetti plot is also called a time plot (page 34 of your text). Notice the between and within subject
variability. Different subjects clearly have different trajectories over time. Between-subject variability can be
seen by the fact that individuals tend to consistently have lower or larger blood lead levels over time. This is
one major source for the correlation among outcomes from the same subject is induced.

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