Here's one of our most popular posts from the archives:
How important is language and writing style in a clinical study report? I
was recently asked this question by a medical writer working for one of
my McCulley/Cuppan clients. The writer is dealing with a team that
seems to obsess over every word in every draft and the writer is looking
for some help in how to address the situation.
Here is my response to the question:
You are asking about lexical and syntactical elements of writing (the third element of writing is grammatical.)
Lexical
pertains to the words (vocabulary) of a language. In the context of
clinical research we need to talk about several applied lexicons of
scientific phraseology that apply broadly to science and then narrowly
to a specific therapeutic area. The admittedly most distinctive feature
of any clinical study report is the application of specific scientific
and technical prose. So, language is very important in a CSR to avoid
lexical ambiguity (why I so love statisticians and their demands for
careful use of language when describing statistical observations) in
order to allow the reader to derive the intended meaning.
My
experience suggests that many people in Pharma think attention to
syntactical elements (style) means they are either eliminating ambiguity
or improving clarity of message. Rarely is this the case.
You have
heard me say before that style does not matter in the type of writing
represented in clinical study reports submitted to regulatory
authorities in the US and elsewhere.
My
position is supported by current discourse theory. Discourse theory
states that, as a rule in scientific writing, meaning is largely derived
from the precise use of key scientific words, not how these words are
strung together. It is the key words that create the meta-level
knowledge of the report. Varying style does little to aid or impede
comprehension.
What happens
is people often chase and play around with the style of document.
Largely they are looking to manipulate an advanced set of discourse markers specific
for clinical science writing or some subset specific to a therapeutic
discipline. Discourse markers are the word elements that string together
the key scientific words and help signal transitions within and across
sentences. These discourse markers are the elements that provide for
style. There are macro
markers (those indicating overall organization) and micro markers
(functioning as fillers, indicating links between sentences, etc.)
Comprehension studies show that manipulating discourse
markers--that is, messing with style--in most instances does not
influence reader comprehension. It is worth noting that manipulation of
macro markers appears to have some impact on comprehension for
non-native speakers of English (why it is worth using textual advanced
organizers to help with document readability.)
So the
net-net is: there is little fruit to be picked from messing with style
in a clinical study report. Put review focus on the use and placement of
key terms.
This is a
bit of a non-sequitur to the question, but a concept I’d like to share.
To derive meaning from scientific text, readers will rely on their prior
knowledge, and cues provided by the key terms and data they encounter
or fail to find in a sentence, paragraph, table, or section of a
clinical study report. So what I’d really prefer to get people thinking
about is the semantical elements of their documents. Semantics is
fundamentally about encoding knowledge and how you as an author enable
the reader to process your representation of knowledge in a meaningful
way. Semantics is about how much interpretive space you provide to the
reader in a document by what you say and equally important, by what you
do not say. Of course you cannot get to the point of thinking about
semantics unless you see clinical study reports as something more than
just a warehouse for data.