24 September 2010

6 Questions Regarding Medical Writing as a Profession

A follow-up to some earlier posts regarding medical writing as a profession. I have six questions I am pondering about the notion that medical writing is a profession. I welcome your thoughts on these questions.
  1. Why should medical writers attend to professionalization issues? Why not?
  2. Why is professional status necessary or desirable? Why not?
  3. If you want to use the term professional, then who should set the standards and minimum qualifications for use of the term "professional"? How should the standards be established? Does an AMWA or EMWA certification make you a professional?
  4. What can be learned from other professions that have achieved a professional identity?
  5. Some observers will suggest that seeking professional status is merely a form of elitism where desire is to control knowledge and restrict access?
  6. What theories/practices inform medical writers as authorities and thus warrant professional status?

Originally published on our Knowledge Management blog

    16 September 2010

    Proving Document Quality

    You say you produce high-quality document products? Great, now prove it! Although many can recognize quality when they read it, the prospect of measuring documentation quality seems dubious to many.

    I work with a great many clients where authors say they generate high quality documents, but they can only show that their documents are accurate. That is, accurate in terms of template, source data, and grammar conformance. Beyond these three inspection parameters, many regard documentation quality as inherently immeasurable. I argue that these three parameters by themselves are wholly insufficient measures of document quality and that important aspects of how documents convey meaning can be measured.

    Surely they must see other metrics of value, especially when considering factors like the number of regulatory questions elicited by errors of omission and commission in their very accurate submission documents or the number of protocol amendments generated over the life of their very accurate research protocol.

    Some see additional metrics as meaningful, but not for their type of documentation. In the realm of clinical development documentation, many consider their output unique and beyond measurement. I hear more than a few medical writers say, “We know our own field intimately, and everywhere we look we see shades of gray and unique situations, so measuring is not useful.” and others in clinical development say “We are unique, and your notions of quality do not apply to us.”

    Still others find the prospect of measuring output impractical or suggest that even if they had data, “Against what standards could we make comparisons?”

    Even easily measured attributes like accuracy are not effectively tracked. Documents are routinely verified/corrected by quality control operators, yet the output is rarely tabulated and statistically analyzed to provide a measure of writer performance. The intention is merely to ensure the document is archived as accurate in terms of template, source data, and grammar conformance.

    I do not know of any pharmaceutical or medical device company that makes use of any statistical quality control techniques to track their document quality. It would be easy to apply similar principles as used in the auto industry or pharmaceutical manufacturing. The auto manufacturers turn out millions of units every year, and each company tracks manufacturing defects, but not by examining every car. Instead, they pull a few cars off the assembly line and tear them apart. Pharmaceutical manufacturers test an appropriate sample from each manufacturing lot. In both cases the products are measured against a set of well-defined acceptance criteria.

    Such acceptance criteria exist for technical and scientific documents (in our work at McCulley/Cuppan we have developed such a set of criteria that we use during our training and consulting work for clients) so such quality control methods could easily be deployed.


    Originally published on our Knowledge Management blog

    01 September 2010

    More Regarding Merit of Peer Review

    Last week the New York Times had a major article devoted to web alternatives to peer review. Actually it does not describe an alternative to peer review but rather an alternative way of doing peer review via the web. The concept is not new, but by getting major coverage by the NYT, perhaps web-mediated review is starting to get some real traction.

    Way back in 2004, Gerry McKiernan, Science and Technology Librarian at Iowa State University, posted a great paper suggesting internet-based peer review alternatives: "Peer Review in the Internet Age: Five Easy Pieces."

    Last point for this post, here is an interesting editorial paper: "Is Peer Review Censorship?"  written by Arturo Casadevall and Ferric C. Fang that appeared in the American Society for Microbiology. As a point of emphasis to echo comments we have made previously in this blog, I note their comment that:
    The current system persists despite abundant evidence of imperfections in the peer review process. Most scientists would agree that peer review improves manuscripts and prevents some errors in publication. However, although there is widespread consensus among scientists that peer review is a good thing, there are remarkably little data that the system works as intended.
    Once again, why is a community so driven by evidence, so willing to cast a closed eye to the paucity of support for the practice of peer review?


    Originally published on our Knowledge Management blog

    05 June 2010

    What's wrong with Peer Review? Quite a bit, actually.

    I continue to follow conversations on other blogs and web sites where people are talking about peer review.  Here's the link to a very interesting paper by Michael Nielsen: “Three myths about scientific peer review” that is definitely worth the read. Another article I suggest you check out is by Alison McCook and published in The Scientist: Is Peer Review Broken? In particular, please read the section titled The Religion of Peer Review where McCook expands on our argument that an abundance of data from a range of journals suggests peer review does little to improve papers.

    So the question I have to pose then is "given the lack of evidence that peer review works, then why do so many scientists in the life sciences remained joined at the hip to the notion that review really makes for high quality publications?".


    Originally published on our Knowledge Management blog

    23 May 2010

    More on Topic: Is Medical Writing Really a Profession?

    I posed this question on a medical writing affinity group I belong to on Linked In (Professional Medical / Scientific Writers). The shared commentary, all from medical writers, has been quite interesting. In this post I want to share a few of the commentaries and my responses.

    It was stated by one commentator: “I do feel, because of the way this question is worded, there is a need to defend my profession.” Another said: “It seems to me that whether or not one describes medical writing as a profession is partly down to semantics, and what any individual person understands by the term profession.”  In response, I am not asking you to defend your work, but I am asking you to defend that the work of medical writers as a class is indeed a profession. I shared some thoughts regarding how the scholars characterize the concept of a profession, as I think much more than semantics is involved here.

    Another commented “Is medical writing a profession? Well, some parts of it are more professionalized than others, but I think.... as a whole? No, currently it's a job description.” I wholly concur with this position for reasons I have already expressed and additional reasons I will add in this discussion entry. I modified slightly another comment made in the Linked In discussion to help shape a sense of the needed attributes for applying the moniker of professional to medical writing: “That practitioners are expected to understand the complexities of language and communication we've seen in this discussion so far and medical writers use workplace research and academic theory to push the practice of medical writing forward.”

    Another interesting comment posed as a question is the following: “On another level, the question is: are you hiring a profession or an individual?” My observations find writing approaches within organizations and across the industry are idiosyncratic and outcomes unpredictable, so therefore the answer is clearly you are hiring individuals. By the way—this variability contributes to why so many enterprises struggle to identify “markers” to use to judge capabilities of medical writing candidates.
    This same person said: “which part do we emphasize: the medical or the writer?” The answer I suggest is neither—the emphasis is on reporting first and foremost (and reporting in a manner that is accurate and compliant), then medical insight, and a distant third is writing (in terms of sharing information and shaping knowledge).

    Lastly, I want to highlight the following comments: “Currently, I don't know that medical writers are seen as the experts on Medical Writing -- most of the public discourse seems to think we are unreflective cheerleaders for whoever pays our salaries....” and “ We do a lot of the applied science stuff already. But we have not come together to share that as professionals, and I think that's the biggest barrier to professionalism .”  Harsh commentaries both, but I suggest each is valid based on my observations of the ways of working in this industry. Unfortunately, I will suggest medical writers who do “applied science stuff” in terms of writing practice and document products are far and few between.

    Yes, I want medical writing to be considered a profession. I did not start this post to raise a beef with the notion of medical writing. I opened in the discussion in the hopes of fomenting a thought-filled argument about what it takes to call oneself a professional medical writer. An aspect of professionalism is intelligent practice as defined by scholars like Schon. Intelligent practice is the application of knowledge to the body of work at hand. In this case, documents. I am suggesting that such intelligent practice is not a common attribute within or across communities of medical writing. I say this because of a significant amount of data that suggests the vast majority of documents produced by medical writers fail. These documents fail in terms of purpose, conveyance of logic, and meeting reader’s needs.

    In defense of my claim I submit to you that there is considerable data in the public record regarding target-audience usability for the output of medical writing. A survey of keen interest to me shows that FDA reviewers cite poor document quality as a significant impediment to effective, efficient reviews; a comprehension study of clinical study protocols found that over 50% of test subjects (clinical investigators and study sight managers) failed to achieve a passing score in identifying roles and decision making responsibilities in the conduct of a clinical trial. I also suggest that much has been and continues to be written about the poor quality of manuscripts submitted to journals for publications. Additionally, analyses of the writing output in various clinical research genre suggests the documents are written for a persona that has a high command of the English language, enjoys reading long, dense narrative passages, and has an exquisite memory (I am pretty sure this persona does not match the broad audience these document products are intended to serve.)

    When I raise these above points with medical writers, which I do all the time, I can say nearly all are unaware of any elements of the work I generalized above. Further, the vast majority of medical writers I encounter are unaware of any aspects of reading theory. Also I suggest to you that few medical writers can distinguish the differences between the concepts of data, versus information, versus knowledge; few of the hundreds of medical writers I have spoken to in the past 10 years have heard of the concept of plain language; most have not heard of the concept of document usability; and even fewer attempt to apply such concepts to their work (why would you when you see your work is to report versus transfer knowledge.) There are certainly individuals and even groups of medical writers who operate in a manner that warrant use of the term professional, but I am unable to find as appropriate, the broad application of the term to the various communities within medical writing.

    I am suggesting that the intelligent practice of seeing clinical research documents as tools to be used by others outside of an enterprise is largely absent from the “ways of working” mindset of most medical writers. I am also suggesting that the task of document production—at all levels and for all forms of documentation in the clinical research community—is largely inefficient. Few know what it really costs the organization per page to produce a final version document (many are afraid to know that number); few consider techniques and tools to really transform the document production process (much of what I see done to improve work streams is at best incremental, but is largely “feel good” activity that has no impact whatsoever); few engage in meaningful post work reflection where performance is analyzed consistently across document projects by well-described standards. I could go on, but I think this is enough detail to support my position.

    A hallmark of professionals as defined by Donald Schon and others is a continual reflection on practice, both during work and post-mortem and then application of what is learned to transform ways of working and product. If reflection is occurring, then I suggest little fruit is born by the activity for I hear all of the same criticisms of medical writers and clinical documents today as I did in 1994.


    Originally published on our Knowledge Management blog

    09 May 2010

    Is Medical Writing Really a Profession in Practice?

    I’ve been reading a book by Donald Schön, The Reflective Practitioner: How Professionals Think in Action, that has got me thinking about the working definition of the term “profession” and whether this term is appropriately applied to the field of medical writing. I am not sure it is for the following reasons.

    When considering medical writing as a profession then one must ask whether the knowledge base of medical writing has the requisite properties and whether it is regularly applied to everyday problems of practice. Many who work to define professions state that the systematic knowledge base of any profession is thought to have 4 essential properties:
    1. Specialized
    2. Firmly bounded
    3. Scientific
    4. Standardized
    Some would suggest the above parameters make Medical Writing a good fit under the moniker of profession. However, I call into question how many medical writers really look closely at the disciplines of writing or knowledge management. Much output I see and many conversations I have with medical writers suggest many write to standards bounded by myths and personal preference and not driven by the evidence of science.
    Edgar Schein suggests there are three well-defined components to professional knowledge:
    1. Underlying discipline or basic science
    2. Skills and attitudinal component
    3. Applied science component (yields diagnostic problem-solving techniques to the actual delivery of the services)
    I would find that Medical Writing fails to be a true profession as suggested by Schein’s criteria. I see the central gap being the failure to develop a general body of scientific knowledge bearing precisely on the problem of effective and efficient medical writing practices. I say this because of my McCulley/Cuppan work where I have many observations of how medical writing is considered and applied in the pharmaceutical and medical device industries.

    For Schein, basic and applied sciences are convergent whereas practice is divergent. This suggests that the hallmark of the true practitioner is the ability to take the convergent knowledge base and convert it into skills and services that are tailored to the unique requirements of the client system—a process that demands divergent thinking skills. My observations suggest that many who operate under the aegis of medical writing are poorly placed to engage in effective, meaningful divergent thinking. The preferred thought pattern is at best the convergent model of “what did I/we do last time?” and at worst “just let me populate the tables and make sure this document is compliant with the template and ICH E3 guidance."

    I think I am largely in the camp of those who would call Medical Writing something besides a profession. But I am certainly not with those who would suggest it is but an avocation. Frankly, such a description is quite derisive.

    I find myself considering applicable to medical writing the Grady McGonagill position that those who rely on intuition and reflect on their work only episodically risk accumulating unintegrated clusters of habitual practice. They may develop to a level of competence but not beyond. I’d say this is a reasonable description that fits the largest cohort of those who work under the mantel of medical writing.

    So what do you think—is Medical Writing truly a profession in practice?


    Originally published on our Knowledge Management blog

    07 May 2010

    7 Rules for Great PPT Presentations

    Having an understanding of what makes for an awful PowerPoint presentation can make it intimidating to create your own. Who wants to be the creator of one of those presentations?
    In our consulting work at McCulley/Cuppan, we've sat through, created, and helped others create many presentations (including ones to FDA and other regulatory agencies), so we have some experience with good and bad PPT. Here's a list of rules we've developed over the years for designing effective presentations:
    1. Adopt your audience's mind--it's always about them, not you
    2. When you are the subject matter expert and have done lots of research, you may feel compelled to share it all in the PPT slides. Avoid this. Instead, focus on what your audience is most interested in. (Your knowledge will come through in the way you discuss the topic and answer questions.)
    3. Clarify your intentions
    4. How will you proceed with the presentation? Will there be a Q&A session? If so, when? Let your audience know upfront how much time you will take and the basic outline of how the time will be spent.
    5. Simplify, simplify, simplify
    6. Simpler is always better. Simple design, simple text. As Hans Hofmann said nearly 100 yers ago: "To simplify, eliminate the unnecessary so the necessary can speak."
    7. Embrace limitations and practice restraint--know when to stop
    8. Once again, all of your knowledge does not need to be demonstrated in this one presentation. Respect the time and concentration limits of your audience.
    9. Do like the pros do--script, storyboard, create
    10. Planning is the key to effective presentations. Work with the end in mind even before you build the first slide and the content of your presentation will be more compelling.
    11. Think communication not decoration
    12. PowerPoint is a tool to help you convey knowledge; keep the slide design simple so the focus stays on the content.
    13. All presentations are storytelling, so become a master storyteller
    14. Learn from the master storytellers around you, people whose presentations you've enjoyed attending. If you don't have any nearby, learn from well-respected presenters such as Garr Reynolds, Steve Jobs and Guy Kawasaki. Tell a tale that engages the audience and makes them want to listen and learn from you.  
       
      Originally published on our Knowledge Management blog