Sullivan LM Essentials of Biostatistics

Chapter 7 Problems Need help on 2, 8, 19

1. The following data was collected in a clinical trial evaluating a new compound designed
to improve wound healing in trauma patients. The new compound was compared against
a placebo. After treatment for 5 das with the new compound or placebo the e!tent of
wound healing was measured and the data are shown below.
"ercent #ound $ealing
Treatment %&'5( ')&5%( 51&*5( *)&1%%(
+ew ,ompound -n.1'5/ 15 0* 0' 11 1'5
"lacebo -n.1'5/ 0) 15 01 1% 1'5
51 2' )) 51 '5%
3s there a difference in the e!tent of wound healing b treatment4 -$int5 Are treatment
and the percent wound healing independent4/ 6un the appropriate test at a 5( level of
significance.
Step 1. Set up hpotheses and determine level of significance.
$%5
$15 .%.%5
Step '. Select the appropriate test statistic.
Step 0. Set up decision rule.
Step 1. ,ompute the test statistic.
Step 5. ,onclusion.
E!pected '5.5 11 00 '5.5
'5.5 11 00 '5.5
-o&e/7'8e 1.0'1 %.09% %.%0% 9.1'' 11.1))...
1.0'1 %.09% %.%0% 9.1'' 11.1))
'2.001
:;. 0
,hi&val 0.%9E&%)
$o5 +o influence
$15 +ew compound influence percent heals
,ompute 5 <' .'2.0= df.0.
"&value.%.%%%
,onclusion5 6e>ect $%
+ew compound influence percent heals
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Sullivan LM Essentials of Biostatistics
'. ?se the data in "roblem @1 and pool the data across the treatments into one sample of
siAe n.'5%. ?se the pooled data to test whether the distribution of the percent wound
healing is appro!imatel normal. Specificall= use the following distribution5 0%(= 1%(=
'%( and 1%( and .%.%5 to run the appropriate test.
Step15 $pothesis
+ull $pothesis5 The proportion of the percent wound healing is appro!imatel normal.
Alternate
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Sullivan LM Essentials of Biostatistics
0. The following table displas descriptive statistics on the sub>ects involved in the stud
described in "roblem @1.
,haracteristic +ew ,ompound "lacebo p&value
Mean Age= ears 1*.' 1).1 %.*5)1
( Males 11( 59( %.%'15
Mean Educational Level= ears 10.1 11.' %.)292
Mean Annual 3ncome= B%%%s B0)=5)% B0*=1*% %.051)
Mean Bod Mass 3nde! '1.* '5.1 %.%251
Are an of the characteristics significantl different between groups4 Custif
briefl. -$int5 +o calculations= >ust interpret above./
#hich gender has a significant correlation to the higher income level noted4
1. An investigator hpothesiAes that cholesterol levels in children might be affected b
educating their parents on proper nutrition and e!ercise. A sample of 1% families with a
child between the ages of 1%&15 who has been diagnosed with high cholesterol agree to
participate in the stud. All parents are provided educational information on nutrition and
e!ercise. After following the prescribed program= their childDs total cholesterol level is
measured. The childrenDs mean cholesterol level is 1*5 with a standard deviation of 19.5.
3s there significant evidence of a reduction in total cholesterol in the children4 6un the
appropriate test at the 5( level of significance and assume that the null value for total
cholesterol is 191.
Step 1. Set up hpotheses and determine level of significance
Step '. Select the appropriate test statistic.
Step 0. Set up decision rule. .
Step 1. ,ompute the test statistic.
Step 5. ,onclusion.
E . -1*5&191/ sFrt-1%/819.5 . &5.129
The two&tailed " value is less than %.%%%1.
p&value GG alpha-%.%5/= null hpothesis can be re>ected to claim that the reduction is significant
enough.
0
Sullivan LM Essentials of Biostatistics
5. The following data were collected in an e!periment designed to investigate the impact of
different positions of the mother on fetal heart rate. ;etal heart rate is measured b
ultrasound in beats per minute. The stud included '% women who were assigned to one
position and had the fetal heart rate measured in that position. Each woman was between
'2&0' weeHs gestation. The data are shown below.
BacH Side Sitting Standing
'% '1 '1 ')
'1 '0 '5 '5
') '5 '* '2
'1 '1 '2 '9
19 1) '1 '5
Mean . ''.% Mean . '1.2 Mean . '5.) Mean .').)
3s there a significant difference in mean fetal heart rates b position4 6un the test
at a 5( level of significance.
6e>ect $% if calculated ; I 1.%*)2
At %.%5 the data gives significant evidence to support the claim
). A clinical trial is conducted comparing a new pain reliever for arthritis to a placebo.
"articipants are randoml assigned to receive the new treatment or a placebo and the
outcome is pain relief within 0% minutes. The data are shown below.
"ain 6elief +o "ain 6elief
+ew Medication 11 *)
"lacebo '1 99
3s there a significant difference in the proportions of patients reporting pain relief4 6un
the test at a 5( level of significance.
p1.118-11J*)/ . %.0)* = n1.11J*).1'%
p'.'18-'1J99/ . %.1*5 = n'.'1J99.1'%
$%5 p1.p'
$15 p1 is not eFual to p'
standard error= SE . sFrt--p1-1&p1/8n1/ J -p'-1&p'/8n'//
. %.%5)%0
test statistic= A . -p1&p'/8SE
A . 0.1'*
alpha= a.%.%5
critical value . Ea8' . E%.%'5 . 1.9)
re>ect $% is A G &1.9) or AI1.9)
since AI1.9) hence re>ect $%
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Sullivan LM Essentials of Biostatistics
*. A clinical trial is planned to compare an e!perimental medication designed to lower
blood pressure to a placebo. Before starting the trial= a pilot stud is conducted involving
* participants. The ob>ective of the stud is to assess how sstolic blood pressure
changes over time untreated. Sstolic blood pressures are measured at baseline and again
1 weeHs later. 3s there a statisticall significant difference in blood pressures over time4
6un the test at a 5( level of significance.
Baseline 1'% 115 10% 1)% 15' 110 1')
1 #eeHs 1'' 11' 105 152 155 11% 10%
Baseline mean5 101.*
1 weeHs mean5 105.)
Sample mean difference5 101.*&105.) . &%.9
ME . ).105* &&& 95(
,35 -&*.%0)= 5.'05*/
2. The main trial in problem @* is conducted and involves a total of '%% patients. "atients
are enrolled and randomiAed to receive either the e!perimental medication or the placebo.
The data shown below are data collected at the end of the stud after ) weeHs on the
assigned treatment.
E!perimental -n.1%%/ "lacebo -n.1%%/
Mean -S:/ Sstolic Blood "ressure 1'%.' -15.1/ 101.1 -12.9/
( $pertensive 11( ''(
( #ith Side Effects )( 2(
a. Test if there is a significant difference in mean sstolic blood pressures between groups
using .%.%5.
Answer5
b. Test if there is a significant difference in the proportions of hpertensive patients between
groups using .%.%5.
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Sullivan LM Essentials of Biostatistics
9. Suppose in the trial described in problem @2 that patients were recruited from 0 different
clinical sites. ?se the following data to test if there is a difference in the proportions of
hpertensive patients across clinical sites.
Site 1 Site ' Site 0
$pertensive 1% 11 1'
+ot $pertensive )2 5) 1%
1%. A clinical trial is conducted to compare an e!perimental medication to placebo to reduce
the smptoms of asthma. Two hundred participants are enrolled in the stud and
randomiAed to receive either the e!perimental medication or placebo. The primar
outcome is self&reported reduction of smptoms. Among 1%% participants who received
the e!perimental medication= 02 reported a reduction of smptoms as compared to '1
participants of 1%% assigned to placebo. Test if there is a significant difference in the
proportions of participants reporting a reduction of smptoms between the e!perimental
and placebo groups. ?se .%.%5.
11. Suppose more detail was actuall recorded in the primar outcome in the clinical trial
described in problem @1%. The data were recorded as follows.
,hange in Smptoms
Treatment Much
#orse
#orse +o change Better Much
Better
E!perimental 1% 1* 05 '2 1%
"lacebo 1' '5 1' 1' 9
3s there a difference in change in smptoms b treatment group4 6un the appropriate test
at a 5( level of significance.
1'. Suppose a secondar outcome was recorded in the trial described in problem @1%
reflecting asthma smptom severit measured on a scale of %&1%% with higher scores
indicating more severe smptoms. 3n the participants who received the e!perimental
medication the mean smptom score was *1 with a standard deviation of 5.) and in the
placebo group the mean smptom score was 25 with a standard deviation of ).%. 3s there
a significant difference in mean smptom scores between groups4 6un the appropriate
test at a 5( level of significance.
10. 6ecent recommendations suggest )% minutes of phsical activit per da. A sample of 5%
adults in a stud of cardiovascular risH factors report e!ercising a mean of 02 minutes per
da with a standard deviation of 19 minutes. Based on the sample data= is the phsical
activit significantl less than recommended4 6un the appropriate test at a 5( level of
significance.
)
Sullivan LM Essentials of Biostatistics
11. Suppose a hpertension trial is mounted and 12 participants are randoml assigned to one
of the comparison treatments. Each participant taHes the assigned medication and their
sstolic blood pressure -SB"/ is recorded after ) months on the assigned treatment. The
data are as follows.
Standard Treatment "lacebo +ew Treatment
1'1 101 111
111 110 11*
100 112 1'1
1'5 11' 1'1
1'2 15% 1''
115 1)% 1'2
3s there a difference in mean SB" among treatments4 6un the appropriate test at
.%.%5.
?1. 1'0.20 ?'.1'2.20 ?0.100.20 M.1'2.20
$%5 u1.u'.u0
$15 not all population means are eFual
S.01*2.5%
ST . )K5%.0%%
SE .S&ST .01'2.5
; . -0%%8'/8-01'2.5815/
; . %.)5)
critical value .;-a=-H&1/=-+&H// . ;-%.%5='=15/ . 0.)2
since ;G0.)2 hence $% can not be re>ected
Therefore no difference in mean SB" and treatments
15. A stud is conducted to compare mean cholesterol levels for individuals following a low
carbohdrate diet for at least ) months to individuals following a conventional -low&fat=
low calorie/ diet for at least ) months. The data are summariAed below5
:iet "rogram Sample SiAe Mean ,holesterol Std :ev ,holesterol
Low ,arbohdrate 5% ''5.1 '1.5
,onventional *5 '%0.2 '1.)
Test if there is a significant difference in mean cholesterol levels between the diet
programs using a 5( level of significance.
1). Another outcome variable in the stud described in problem @15 was hper&
cholesterolemia= defined as total cholesterol over ''%. Among the individuals who
followed the low carbohdrate diet= 5)( were hpercholesterolemic and among the
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Sullivan LM Essentials of Biostatistics
individuals who followed the conventional diet= 1%( were hpercholesterolemic. Test if
there is a significant difference in the proportions using a 5( level of significance.
1*. The following table compares bacHground characteristics of the participants involved in
the stud described in problem @15.
,haracteristics of "articipants Low ,arbohdrate
-n.5%/
,onventional
-n.*5/
p&value
Mean Age= ears 5'.1 50.1 %.*5)1
( Males 1'( 01( %.%115
Mean Educational Level= rs 15.0 1'.9 %.%'0*
Mean ;amil 3ncome= B B09=51% B1*=92% %.%5*)
Are there an statisticall significant differences in patient characteristics between the
different diet programs4 Custif briefl.
12. Suppose the results of the analsis in problems @15 & @1* are reported and criticiAed
because the participants were not randomiAed to different diets and that there ma be
other factors associated with changes in cholesterol. A third stud is run to attempt to
estimate the effect of the low carbohdrate diet on cholesterol levels. 3n the third stud=
participantDs cholesterol levels are measured before starting the program and then again
after ) months on the program. The data are shown below.
Before "rogram '1% '0% 19% '15 ')% '%%
After ) Months '15 '1% 19% '%% '2% '1%
3s there a significant increase in cholesterol after ) months on the low carbohdrate
program4 6un the appropriate test at a 5( level of significance.
19. Suppose a new stud is conducted to compare 0 new appetite suppressants -A= B= ,/ to a
placebo in terms of their effects on weight reduction. A total of 2% participants are
involved and the are randoml assigned to the comparison groups -in eFual numbers/.
The outcome of interest is weight reduction= measured in pounds. The following data are
observed after 0 months on treatment.
A B , "lacebo
Mean -S:/
#eight 6eduction
).1 -1.1/ 2.9 -1.%/ '.' -0.9/ '.5 -1.0/

3s there a significant difference in mean weight reduction among the 1 treatments4 ?se a
5( level of significance. $int5 SST.1=5'%.
2
Sullivan LM Essentials of Biostatistics
'%. The mean lifetime for cardiac stents is 2.9 ears. A medical device compan has
implemented some improvements in the manufacturing process and hpothesiAes that the
lifetime is now longer. A stud of 1% new devices reveals a mean lifetime of 9.* ears
with a standard deviation of 0.1 ears. 3s there statistical evidence of a prolonged
lifetime of the stents4 6un the test at a 5( level of significance.
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