Risk Communication Talk at AMWA Conference

I had a little over 20 people listen to me talking about risk communication during an AMWA open session last Friday. We had a nice discussion of the challenges we face as risk communicators, especially with the public's mistrust of the medical community.

Anyway, I want to share the slides of my presentation with you also. Click here to view the PDF.

Thanks for reading!

Consumer Health Writing in the NYT

The most e-mailed article at the nytimes.com as of Wednesday morning is a consumer health piece titled, "A Rise in Kidney Stones Is Seen in U.S. Children."

Of course this is a topic of great concern to parents and kidney stones in children should be discussed in the media, to increase awareness. What troubles me about the article (especially the headline) is the lack of data. The author herself acknowledges this in the second paragraph:

While there are no reliable data on the number of cases, pediatric urologists and nephrologists across the country say they are seeing a steep rise in young patients. Some hospitals have opened pediatric kidney stone clinics.

“The older doctors would say in the ’70s and ’80s, they’d see a kid with a stone once every few months,” said Dr. Caleb P. Nelson, a urology instructor at Harvard Medical School who is co-director of the new kidney stone center at Children’s Hospital Boston. “Now we see kids once a week or less.”

But is this anecdote from the Harvard doctor enough to claim a rise in kidney stones in US children? No. I'm not saying that the increase is not real, it may as well be real. But responsible medical writing should be evidence-based, and the matter-of-factly tone of the article has probably caused a lot of concern among NYT readers.

BTW, a quick search in PubMed for "kidney stones AND children" and "renal calculi AND children" brings up thousands of articles. From the abstracts I read, it seems that kidney stones are still considered rare in children. Interesting...

New Medical Writing Openings

• Senior Medical Writer, Global Medical Communications Agency -- ENGLAND, Middlesex
• Medical Writing Specialist -- MedFocus LLC, Montville, NJ
• Medical Writer
• Senior Medical Writing Project Specialist - Part Time -- UnitedHealth Group, North Carolina-Raleigh/Durham/RTP
  

Blog Recommendation and See-You-Later Note

You know my rambling about the importance of epidemiology and biostatistics in medical writing. Well, there's a great epidemiology blog you might want to check out at epiwonk.com.

I'm leaving tomorrow morning for the AMWA conference. So, if you're going too, I'll see you there. If not, I'll be back posting to the blog next week.

Thanks for reading!

Regulatory Writing: NDAs & INDs

Some new medical writers interested in regulatory writing ask about the difference between NDAs and INDs. In simple terms, when a drug is determined to be safe and effective, the manufacturer files a New Drug Application (NDA) with the FDA at completion of the clinical trials.

However, before the drug is approved, it has to be tested and shipped to other investigators. But how can the researchers use a drug not yet approved by the FDA? The answer is the Investigational Drug Application (IND), which allows an unapproved drug to be used in certain circumstances (there are different types of INDs, depending on the need).

Job Post and AMWA Announcement

First, the job post:

• Medical Writer / Document Editor -- MedFocus LLC, Bridgewater, NJ

Now, this is something that just came out in AMWA's e-newsletter that you may be able to contribute to, if you like:

In conjunction with our Creative Readings session at the 2008 Annual Conference, we’re hoping to gather and publish “101 Ways to Know You’re a Medical Writer.” We’re inviting all members to contribute to this effort, whether they are attending the conference or not. If you plan to participate in our Creative Readings session, either by reading a creative work or by being in the audience, you can bring your ideas with you—Wednesday evening, October 22. Or, you can e-mail them to Donna Miceli (dmiceli@comcast.net) before the conference. We will share some of them during the creative readings session and, hopefully, publish them in some form afterwards. To get your creative juices flowing, here are some contributions that we’ve already received:

“You know you’re a medical writer when…

…your friends and family members start calling you for medical advice.”

…you sneeze into the crook of your elbow.”

…a medical abbreviations Web site is first on your favorites list.”

How to Write an Abstract

By Marco Bomfoco (Guest blogger)

An academic abstract is a short restatement of all essential points of a research paper. The abstract is one single paragraph and is subject to specific word limits, typically under 300 words. It stands alone bellow the title or at the end of the paper. Note that an abstract is NOT an introduction or a plan to the paper. In the words of Craig W. Allin, "abstracts are an exercise in writing with precision and efficiency."

In fact, the abstract is written after the investigation and the whole article is completed. It should be written in the same language as the paper and should be translated into one of the world languages. We can say that the primary purpose of an abstract is to permit a quick appraise of the applicability, importance and validity of a research paper. But always recall that the reader KNOW the subject but HAS NOT READ the paper.

The abstract presents the information in four general sections: INTRODUCTION, METHODS, RESULTS and CONCLUSIONS. It is worth noting that an abstract is only text and follows strictly the logical order of the paper. That is, the abstract ought to parallel the structure of the original paper. At the same time, it adds NO new information, i. e. that is not stated in the paper. Now notice that the abstract can be viewed as an independent document. It is because of this that it should be unified, coherent (i.e. providing appropriate transitions or logical linkage between the information included), concise, and able to stand alone. In other words, the abstract should be complete in itself.

Surely, it is sometimes the case that an abstract will be read along with the title and in general it will likely be read without the rest of the document. In fact, we might consider that the abstract is the most important part of a scientific paper. It follows, then, that it is an absolute must to include all the keywords related to the study. Notice that keywords (also called search terms) represent the most important terms or concepts (words or phrases) relevant to your topic.

There are two types of abstracts: descriptive and informative. The descriptive or indicative abstract, identifies the contents of the research or the basic subject of the article, demonstrating the paper’s organization without providing results or conclusions. Thus, it is not very informative. This type of abstract is always very short, usually under 100 words; and it is useful for a long report. On the other hand, the informative abstract, which is also known simply as a summary, gives the principal argument and summarizes the principal data, providing the reader with an overview of the objectives, methods, results and conclusions of the study. So, be specific. You may also have heard of a "structured abstract" -- this is a subtype of the informative abstract which has more than one paragraph.

What to include?

The content of the abstract includes:

• Motivation and purpose: main subject or research question and review of the relevant literature.
• Specifics: problem statement, approach, objectives, hypothesis, research methodology (method(s) adopted or search strategies).
• Results: main findings (proposed solutions to the problem) and discussion.
• Conclusions and implications/outcomes: what the results mean and further points

As we can see, the abstract must state:

• The problem addressed and some background information.
• The solution or insight proposed (newly observed facts).
• An example that shows how it works.
• An evaluation: a comparison with existing answers/techniques.

Then, an abstract should provide answers for the following questions:

• What and why.
  
• What you found.
  
• How you did it.

But how do we begin?

What would be an effective way to begin an abstract? To help you on your way let us consider some introductory sentences.

First, let us see some opening sentences that DO NOT offer real information:

1. This paper reports on a method for...


2. The paper explores the notions of...


3. The purpose of our research is to consider how...


4. The objective of this study is to determine...

Thus, it is clear that you should avoid writing a statement of scope.

On the other hand, the sentences bellow represent good examples of introductory statements, for they go directly into the subject. They give something to the reader. Let us see how it works:

1. The development process of hypermedia and web systems poses very specific problems that do not appear in other software applications, such as…


2. Given a large set of data, a common data mining problem is to extract the frequent patterns occurring in this set.


3. According to many recent studies the effect of learning style on academic performance has been found to be significant and mismatch between teaching and learning styles causes learning failure and frustration.

Do’s and don’ts of abstract writing

• Do write a single paragraph.


• Do meet the specific word length.


• Do answer the questions: what, why, and how.


• Do use familiar language to the reader.


• Do use a few keywords.


• Do write short sentences.


• Do improve transitions between the sentences.


• Do use active voice.


• Do use third person singular.


• Do begin with a clear introductory statement written in the present tense.


• Do use past tense in the main body.


• Do write a concluding statement in the present tense: just tells what the results mean (e.g. "These results suggest...").


• Do fix grammar.


• Do use headings, subheadings and tables as a guide for writing.


• Do print and reread the abstract.


• Don't cite the sections of the paper.


• Don’t include references to the literature and to figures and tables.


• Don’t use abbreviations.


• Don’t add new information.


• Don't add superfluous information.


• Don’t add opinions.


• Don’t repeat information.


• Don’t repeat the article title.

Marco Antônio Bomfoco is a professor at the Faculty of Technology SENAC in South Brazil. A Ph.D. from Pontifical Catholic University of Rio Grande do Sul, and an M.A. from the same university, Marco is a long-time language enthusiast. His many interests include writing, general linguistics, anthropological linguistics, case theory and grammatical relations, history of linguistics, artificial languages, phenomenology, story telling, and myth. Article source here.

Medical Writing Jobs

• Scientific Reviewers -- Vishal Thali,Smart Solutions, Mumbai, India
• Clinical Project Manager/Senior Project Manager -- LHB Consultants, Inc. Austin, TX
  

How to Find Regulatory Writing Jobs

As I expected when I released the online course Introduction to Regulatory Writing in the US last month, interest is high for this type of course. As the government tightens its regulations on the pharmaceutical and biotechnology industries, the need for medical writers in the regulatory environment is growing.

So, if you want to find a regulatory writing job, you must first get prepared. You must know how the drug approval process works and how to prepare regulatory documents. You may learn about this at an AMWA workshop, enrolling at one of USP programs, or at MedicalWritingTraining.com.

Then, you need to create a strong resume and a relevant portfolio for your job hunting. I regularly post medical writing job openings in this blog, but there is a Web site I just visited that posts regulatory writing jobs. The visual presentation is very nice and they have a long list of openings. Check it out here. Even if you're not ready yet to apply for one of those jobs, read through the job descriptions and see what skills and experience are required. That will give you an idea of what to work on so you can get the best job possible.

Thanks for reading!

Medical Writing Position

• Medical Writing Sr Mgr - Amgen, Thousand Oaks, CA

About the AMWA Conference

The 2008 AMWA Conference is just two weeks away. Because of all the issues with the hurricane in the past few weeks, my attendance was at risk but it seems that I'll be able to go to Louisville after all.

However, because I could only decide to attend until this week, the organizers canceled my roundtable on self-publishing and gave the klatch on blogging to another leader. But I'll still be presenting an open session on Friday morning titled, "Communicating Health Risks." The session will review the role of medical writers as risk communicators, discussing how to best mediate between the scientific assessment of risk and the public's perception of risk.

Please come by and say hello if you get a chance. Thanks for reading!

Graduate and Certificate Programs in Biomedical Writing

Tomorrow, Tuesday, October 7 USPS will host a live chat session to answer questions about the programs they offer:

• Master of Science in Biomedical Writing
• Certificate in Regulatory Writing
• Certificate in Medical Marketing Writing

Click here to register.

Getting Back to Normal (and Jobs)

After a few hectic weeks on the road thanks to the hurricane, things are getting back to (a different) normal. Galveston is not the same. Anyway, just to get started again, here are some job postings.

• Medical Writer -- Arbor Scientia, Carlsbad, CA
  
• Clinical Medical Writer -- CRO, Uxbridge, England