(Author: Roland Rashleigh-Berry
Date: 21 Mar 2007)
Introduction
There are a number of standards used in creating clinical reports that
are not specified anywhere and yet they are commonly used. They are mainly
standards of the nature "making sure it is all there". An awareness of
these standards is useful for when you come to create your own reporting
macros. I will list the standards I know below along with an explanation,
as well as mention how they are handled by Spectre.
Page x of Y labels
Instead of labelling pages "Page 1", "Page 2" etc., it is standard to have
pages labelled in the way "Page 1 of N", "Page 2 of N" etc. where "N" is
the total number of pages. I have never seen any table or listing created
for submission purposes that is not labelled in this way. The reason the
total number of pages is shown on every page is to make sure all pages
are present in the report. I guess this comes from the days of paper submissions
where there was a possibility that the report file was only partially printed
so you had to make sure that all the pages were there. Having the total
number of pages displayed enabled you to check this. This standard is still
used because even with electronic submission I suppose it is remotely possible
that a report file could be truncated but in any case, printouts are sometimes
made from electronically submitted PDFs and it is important to know that
all the pages have been printed. This "Page x of Y" labelling is for "making
sure it is all there". Spectre adds these labels where it finds the target
character "FF"x on a page using either the "pagexofy" script or using the
%pagexofy macro where the reporting macros are being used outside of the
full Spectre system. It has macros that can help you put this "FF"x character
in your title line but you would normally use the client titles macro to
do this.
"No data" reports
If you have to report on something but you have no data to match then instead
of not creating the report at all, it is standard to produce a "No Data"
report. To give an example, this could be "study deaths" and yet none occurred
during the study so instead of producing no report for this it is better
to produce a report that has all the normal titles (but usually no footnotes)
with a message like "NO DATA" clearly shown on the single page. This shows
that you have not forgotten to produce the report, or that some error resulted
in no report, but instead you have produced the report letting people know
that there was no matching data. Spectre comes with a macro %nodata to
help you create this type of report. The macro has processing to suppress
footnotes and any "by" title lines which will not be needed for this report.
Show all treatment arms
Sometimes, certain types of Adverse Event will not occur in a treatment
arm. When producing a table where this is the case, it is better to show
this treatment arm plugged with zero counts and zero percentages rather
than not show the treatment arm at all. This lets people know that you
haven't somehow excluded the treatment arm from the analysis. The two main
reporting macros %unistats and %npcttab work in this way by creating this
treatment arm as a variable and plugging it with zeroes.
Show zero population treatment arms
Not only might there be no Adverse Events for a treatment arm, it might
not even be possible for this to occur because the subset of patients you
are analysing might not be represented in a treatment arm. Suppose you
were reporting on paedeatric Adverse Events then none of them might be
in the highest dosage treatment arm. Instead of leaving out this treatment
arm then it is better if this arm is shown but with a zero population.
And since it is not possible for Adverse Events to be in this treatment
arm and it is also meaningless to calculate percentages of this zero population
then instead of plugging this arm with zero counts and zero percentages,
it is better to leave it plugged with spaces. The two main reporting macros
%unistats and %npcttab work in this way but you must be sure to use the
third positional parameter of %popfmt so that it can find all the treatment
arm values you want to show.
Single line footnotes
Less common than it used to be, it was standard to show a single solid
footnote line even if there were no footnote lines containing information
that needed to be displayed. This comes from the days of impact printers
where the ribbon might have run out of ink over a segment or for laser
printers that might be running low on toner such that the end of a page
gets missed off. If you see at least one footnote on a page then you know
that the printing got to the end of the page so it is highly likely that
all the data has been displayed. Spectre does not enforce this standard
and you will have to do it in your code if you need it. You can do this
in the client titles macro if you wish if this is a standard the client
uses. The %titles macro will put in a blank line as a footnote if none
were put out by the client titles macro but this is only to ensure the
page has the full number of lines on it. This is done to help the pages
print with the correct layout if a non-Spectre printing method is used.
Alignment of footnotes and titles
This standard is nothing to do with "making sure it is all there". Instead
it lists the most common alignment used for titles and footnotes in clinical
reports.
Footnotes are always left-aligned although some footnotes might be deliberately
indented from the left. Report header lines that may contain the study
identifier, date of program run, name of program and name of output file
are usually at the top of the page, are left-aligned and may have text
placed at the right so that the contents span the full width of the line.
The "Page x of Y" label is usually in the right-most position of the top
header line. Title lines that state the title of the report are normally
centred. "By" title lines are normally left-aligned. The client titles
macro will automatically left-align footnotes defined in the .titles member
(but allows you to put in spaces for indentation purposes) through a call
to the %titlegen macro. Header lines are put out by the client titles macro
and it is up to the programmer to make sure everything is in the right
place. If a space is used in front of a title in the .titles member then
it will be left-aligned by the %titlegen macro that gets called by the
client titles macro. This can be used for "by" titles lines. For "by" title
lines that are created in a reporting macro, left-alignment can be achieved
using the %latitle macro. Similarly, footnotes can be left-aligned using
the %lafootnote macro.
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