Download Reporting Clinical Adverse Events and Concomitant Medications - How to Compress Several Days Work into a few Minutes

Reporting clinical adverse events
and
concomitant medications . .
~
How to compress several
:days work into a fewm]ilutes.
,',
'
,
Christophe VIDY
ABSTRACT
Reporting clinical adverse events requires complex programming due to the many ,specific requirements
of clinical data. This is often time oonsumingand therefore we have developed a Frame application which
allows the end user to build reports with a point and click'system requiring little khowledge of SAS. The
application consists of three screens.
The first screen allows specific variables such as header, row and group to be defined. The second
requires the user to enter the layout characteristics such as title, footnote, page-size, linesize, sort ciiteria or
first page number. Once this information has been entered, the user can decide to view the report format in
an out-put window or store it in a file. In addition, the macro call used to generate the report can be stored.
The third screen allows the user to view the data to be reported using graphical drill down techniques.
INTRODUCTION
With the large amount of data recorded in today's clinical trials, there is a need to organise and summarise the information in an efficient manner which facilitates its retrieval from a database. Data is usually
summarised using quantitative statistical indicators (e.g. Mean, Standard deviation, Min, Max). However
qualitative measures such as counts and frequencies are used to summarise clinical safety information such
as adverse events. When summarising qualitative information there are two levels of presentation which can
be utilised. The first is a straight forward simple count of a number of events in the data. This can be
handled by SAS using procedures such as freq or tabulate.
The second level introduces constraints into the counting process. The question "How many patients
have at least one adverse event? " implies that a constraint must be applied to the searching algorithm used
to count the adverse events. If constraint were not applied, a simple count of adverse events would result.
Although simple counts are valid, there usefulness within the context of clinical safety is limited.
Within the pharmaceutical industry, counting with constraints is often used to present clinical safety and
patient medical histories. This requirement has led to the development of an application using the SAS
macro language and frame technology.
REQUIREMENT
The challenge was to build a software system which enabled users with a basic knowledge of SAS to report their clinical safety and patient medications data. We wanted the tool to be as simple as possible to use.
Because of the number of parameters needed to build a table and the number of controls on, the dataset, it
was necessary to provide a user friendly interface. After much discussion with end users, it was decided that
the software had to deal with the following:
... Splitting the header
... The page skip
... Splitting labels
... Sorting results
RHONE-POULENC RORER
11 May 1995
- Storage of the macro code generated
- Storage of results in an external file
In addition, it had of course to provide a way to enter table layout features such as title, footnote, header
note etc.
DESCRIPTION OF THE APPLICATION
The requirements led us to design an application consisting of three screens. The first screen was
designed to record the minimum information needed to build a table(Figure 1). The second collected layout
features of the table (Figure 3) an the third was built to provide a graphical overview of the data.
SCREENl
o
•
•
e
•
o
•
o
.0
10
11
12
13
Name of the SAS Dataset which contains the data
Variable list for which the unique combination gives the denominator for percentages
Variable to put in the vertical dimension
Variable to use as the horizontal dimension
Variable to cross with the line one in the vertical dimension:
Variable to cross with the Header one in the horizontal dimension.
The by variable
Name of the file to store the results .
Total required on the horizontal dimension
Onlinehelp
Exit button
Graphics button ( Figure 3)
Run button to visualise the result
.*.
RHONE-POULENC RORER
11 May 1995
1243
14 Name of the file to store the SAS code
15 Button to call the additional features screen
As shown in Figure I, the first screen is divided into three blocks:
... Required information
... Optional information
... Action
Clicking on one of the buttons prompts the user with a list box containing the different choices possible
for each item. The "Dataset" button 0 allows the user to choose the data upon which the report will be
based and the "Table keys" 8 button allows the users to select several variables in the dataset.
Code for the "Table keys" button.
ct2:
link ctfic ;
if fic= _blank_ then return ;
dsid=open(fic) ;
keypv=varlist(dsid,'A',attrn(dsid,'nvars'),'SELECT YOUR KEY VARIALES',
'N',",bodysull' 'libodyll"lIseverll"lIfiltre) ;
keypid=setnitemc(keypid,keypv,'_INIT_',1) ;
call nOtify('keypat','_sectexC ,keypv) ;
rc=close(dsid) ;
call notify('scrkey','_is_hidden_',ishidden) ;
if keypv ne _blank_ then if trt ne _blank_ then do ;
call method('notblank.scl' ,'keys',fic,getnitemc(keypid,'_iniC,1)
if result= 1 then do ;
keypid=setnitemc(keypid," ,'_INIT_',I) ;
keypat=_blank_ ;
return ;
end;
end ;
,t:rt;r~lt,messid)
;
iflength(keypv) > 19 then do ;
if ishidden= 1 then call notify ('scrkey' ,'_unhide_') ;
call notify ('scrkey','_secmax_' ,length(keypv)-18) ;
end;
else if ishidden=O then call notify('scrkey' ,'_hide_') ;
return ;
If a variable name doesn't fit in the entry field, a scrollbar appears beneath. Buttons. to 6 allow only a
single choice.
Once a variable is selected, it is removed from the selection list SO that duplication is prevented. When
the user chooses a dataset, if formats are linked to some of its variables,. a check is performed to ensure they
are accessible. Checks of consistency between the other variables are also performed.
RHONE-POULENC RORER
11 May 1995
1244
The final table obtained running the application with the parameters shown in Figure 1 is shown in
Figure 2. By default, if there is no label for a variable, the name is used. As for "Tabulate" or "Freq"
procedures, the "Fonnchar" used is the one set with the SAS "Fonnchar" option.
Incldon..
.v..... by ooot.-t body oyo"'"
with r.-dod max h""'olly
and eorted on the more frequent adYW'" event. In tr....,.'" A
DaI. : l1APRI4
Line variable label
Pag.:
PLACEBO
Telal pall.,1a
TREAT A
34
43
Pallante with
:
Pallante without ad_o••_ I :
32 (14.12)
2( 6.11)
40 (13.021
3( ...1
2 10 13
2
1
1 1
1
1
Bronohltlo
Dyopn ..
Eplatexle
Loryngilio
31.2
5.1
2.1
2.1
2.1
2.1
Bronohopulmon..y Inteellen
Hypov.,tllatlcn
SUparlmpo_lnlooIlon
Abdominal pain
Backpah
Int.ellen
PoIvlcpaln
Flu oyndrern.
2
1
Apnea
•• a Mlol.
A ....,I.
1
2 4.7
2 4.7
1 2.3
1 2.3
1 2.3
- - - - - - - 17 50.0 - - - - - - - 10 23.3
I 26.6
1 3 1
6 11.6
4 5
2
2 4 11.8
1
1 2.3
2
2 6.1
1
2 U
U
1 2.'
2.3
2.3
1 2.1
1 2.1
- - - - - - - 40 51.1
1
5 25 -31 40.3
2
2 2.6
1 2
3 3.1
3 3 3.1
1 1.3
1 1.3
1 1 1.3
1 1.3
1 1.3
------1 7 6
3
2
2
1
1
27 36.1
14 11.2
5 6.5
2 2.6
3 3.'
2 2.6
2 2.6
1 1.3
III
III
•
II
m
INTENSITY:
:;;11
11
Group variable
Footnote (Center)
1fI.~mluF!l1ll
SCREEN 2
The title, footnote, header note and sort criteria are entered via the second screen as shown in Figure 3.
Also shown are line size, pagesize and first page number fields. The user may modify any of these fields.
The default first page number is 1 and SAS default values for pagesize and linesize are used. The footnote
square is made from four "Radio box entry field" objects with an additional attribute for the entry field.
Clicking on these fields using the popmenu button of the mouse allows the user to select the type of
justification (left, center or right) for each line of footnote in the list box. As in the first screen, a scrollbar
appears under the "Column header value for sort" combo box (Figure 3) if the value or fonnatted value
doesn't fit in the entry field. The help icon calls the help frame which contains a context sensitive hypertext
image similar to that shown in Figure 2.
RHONE-POUf..ENC RORER
11 May 1995
1245
r
FIRST PAGE NUMBER
TREAT A
1..... 1
LINE SIZE:
180
PAGE SIZE
60
Titl,, _ _ _ _ _ _ ___
Incidence of adverse events by costart body system
with recorded max intensity
and sorted on the more frequent adverse events in treatment A
Footnote _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _......
INTENSITY: Mis=Missing Mil=Mild Mod=Moderate Sev=Severe
Lif=Life threatening
Ht,;"dr"."'It,; _ _ __
Project: RPXXXX
Study: ZZ~~__________________
SCREEN 3
The "graphics" button calls the screen shown in Figure 4. This screen allows users to move through the
data using a drill-down technique. The graph is ·updated each time the user changes the level of data being
looked at and is presented by either vertical or -hOrizontal bars, frequencies and percentages. Its layout
characteristics can be accessed using the "Appearance" button which leads to the Frame provided by SAS to
enter the characteristics for Graphic objects. When the number of "drill-down" levels exceeds three which is
the limit for title in a graphic object, the first "drill-down" level(s) are recalled in a list box which appears
under the "drill-down" arrows.
\
\
\. \,:.
-
RHONE-POULENC RORER
11 May 1995
1246
,,
i
L
PA'III!NI' 'MTN: AD\II!RSI! I!\II!NT
ax: 1.181.
Freq
40
.-------------------------~------~
30
20
10
0""---______
TREAT til
PLACEBO
TREftTI'IENT GROUP
CONCLUSION
The program demonstrates the power of SAS in providing a specialised application using frame and
macro technology at complex levels transparent to the user. We have used the application on many clinical
projects within the company and despite the speciality, it has proved to be flexible and has been applied to
many clinical reporting requirements not related to clinical safety.
\.
\;
'j
RHONE-POU~C
RORER.
11 May 1995:
,
1247
I
~ "
:~~
Lf'..:,
"~
__ .____ •___ '______ .____ ,____ .__ ._. __
,"_~_~.
__ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ,__________
.~
~
__
~
__ "
,~_,~
"_
,~
__ ___
~
~
__
~
__________________________________________ --------------------
L