The Optimizing Medical Writing for the Regulatory Reader Workshop will now be held 29-31 October in Copenhagen. More information on this three-day workshop can be found at the Atrium website: https://www.atriumcph.com/course/Optimizing-Medical-Writing-for-the-Regulatory-Reader/56871

Watch for the full program announcement from Atrium. In interim, here’s the “thumbnail” overview of our course:
Day 1

• Explore how technology is impacting document design in 2019 and beyond
• Describe the reading persona for the decision-making regulatory reader
• Characterize and consider meaningful document quality standards that impact communication performance
• Recognize and analyze organization patterns and strategies to use in regulatory documents at the report and summary level

Day 2

• Characterize writing strategies for information design in reports, briefing books, and summary documents
• Consider best practice strategic review and how to get it from your teams
• Apply review techniques to be a surrogate for the end-user

Day 3

• Consider the medical writer in managing statistical outputs
• Discuss how tools and resources can help economize writing and optimize communication quality
• Examine and discuss text examples at the report and summary level of writing
• Consider the medical writer in project management

I will be co-facilitating Optimizing Medical Writing for the Regulatory Reader in Copenhagen in August. This will be a three-day public workshop that will allow attendees time to dive deep into the topic with expanded discussions and group exercises using case study documents. More details can be found on my LinkedIn page or on Atrium's registration page.

It has been some time since I last posted here on the McCulley/Cuppan blog. Just like some other things in my life, I simply got out of the habit. So, like my physical workouts, I am looking to make blog posts a more regular part of my life.

With that said, onto the question I want to consider in this post--why are most research documents that cross my computer screen written in the passive voice? Literally,  many, if not all of the clinical research reports, much of the regulatory documentation, and painfully all of the clinical research protocols are written in the passive voice.

Why do I even bring this topic up? Well, some researchers in the academic community feel that the use of the passive voice (verbs that do not indicate who or what is doing the action) can lead to writing where the sources or agents of action are not clear. This is my big criticism of protocols, a class of documents centered on characterizing events and agents. 

These writing researchers also comment that repeated use of the passive voice results in texts, which are “flat and tedious” to read. From my very subjective perspective, I have to agree with that last comment as I have certainly seen my share of documents that fit this description. 

It is worth noting here too that reading research shows most readers prefer active voice, especially readers for whom English is not their mother tongue.

The point of this blog is not a grammar lesson (trust me I’d never do that as I almost fall asleep from boredom when someone mentions the word grammar.) But just to be sure we are all on the same page by what I mean with ‘passive voice’ versus ‘active voice’; here is my explanation in a nutshell:

• In the active voice, the agent performing the action is the grammatical subject of the sentence and the recipient of the action is the grammatical object.
• The passive voice switches this around, making the recipient of the action the grammatical subject and the agent the object if the agent is even included.

Passive sentences that I read by the truck load contain phrases such as these:

• The three arms in the study will be…..
• Training on diary completion will be provided to patients…..

The worst abuse of passive voice is the heavy use of state-of-being verbs combined with past tense: (is, was, be) + (past tense) like the following examples:

• PDGF and its receptor (PDGFR) have been implicated in the pathobiology of pulmonary hypertension in animal studies……….
• Wonderdrug has been shown to be an effective treatment in XX disease.
• The molecular constructs most effective for PI3K/AKT/MTOR pathway inhibition were shown to be.......
• Mortality at 24 weeks after first dose was to be ascertained for………

Unfortunately, it is way too common in protocol writing for the author to utilize passive voice and fail to explicitly mention who will perform the act. Often the all-important agent is missing from the discussion and the reader must interpret who is the agent of a specified task. In numerous instances this will not be problematic, but in other cases it can cause confusion that leads to inquiries or missed tasks.

So back to the point of this discussion. I ask this question about the habitual use of the passive voice because many science journals, like Nature, and most of the leading style guides recommend the active voice over the passive voice. So if the top-flight journals like Nature and the leading style guides like the Chicago Manual of Style recommend writing in the active voice, then why do people working in pharmaceutical and medical device companies still demand passive voice as the default style pathway?

When I ask people in the workshops I teach at various pharmaceutical and medical device companies why they slavishly write in passive voice, the answers range from: “I did not know that is the style I was using.” to “This is the way science must be written.” Ignorance is never an acceptable excuse, but to invoke the need to meet some mythical style-standard is absurd. The slavish use of the passive voice in science writing is a self-maintained and mutually-committed act drawn from a fairy tale. I use the term fairy tale here with careful consideration. Fairy tales are about imaginary worlds. Hereto we have a situation where people imagine what readers want and prefer and routinely invoke the imaginary in defense of their personal or organizational belief system about high quality scientific writing.

From my perspective, the two leading reasons that the passive writing style is so broadly applied are:

1. Many writers have only read documents written in this style and are formally and informally conditioned to replicate the style. A prevalent form of conditioning is teachers in the sciences, at levels of the academic system, who demand their students write applying the passive voice style.
2. The power of precedence—what we did previously was accepted or published; therefore it had to be good. So make this document look, taste and smell like the previous ones.

The bottom line is writing in this style is a habit and a bad habit at that.

I am working my way through some papers addressing the psychological mechanisms that form and maintain habits in work groups and organizations. Now I am looking for references related to the meaningful steps necessary to mitigate or eliminate these habits. When and if I find an effective elixir for this bad writing habit, I will let you know.