Writing High-Quality Publications; a textbook from 30 years of medical writing experience 

By: Vijay Soni, Ph.D. | Founder Scipreneur

Did you know that nearly 3 million scientific papers are written each year? Yet studies suggest that most trials registered on Clinicaltrials.gov are not published in peer-reviewed journals within 2.5 years after completion.

“Costs of manuscript rejections are staggering to institutions and incalculable to many researchers seeking grants and other forms of financial support,” said author Stephen W. Gutkin. “To address this challenge, my textbook leverages my 23 years of experience in getting more than 200 papers published in impactful peer-reviewed journals, most publications of authors’ first choice.”

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While operating Rete Biomedical Communications Corp. (Ridgewood and Wyckoff, NJ) from 1992 through 2015, Mr. Gutkin supported launch and commercialization of clinically diverse, billion-dollar molecules for 5 of the top 15 life sciences companies (by 2015 revenues). A number of papers were accepted “as is” (with no suggested peer revisions, a very infrequent event in medical publishing).
For the first time in one volume, “The Gutkin Manual” includes the following:

• Delineates principles of quality, including fair balance and connecting with one’s readers.

• Teaches you how to plan, manage, and drive a publication project, from “kickoff meeting” to page proofs.
• Offers interactive exercises in prose style.
• Walks you step by step in writing and editing manuscripts that report:
  • Randomized controlled trials.
  • Observational (“real-world”) studies.
  • Systematic literature reviews.
  • Meta-analyses.
  • Health economics and outcomes research.
• Covers study design, hypothesis testing, and data interpretation, including:
  • What a P value can and can’t tell you.
  • How to detect and control for >70 biases as well as confounding and residual confounding.
  • “Pencil and paper” exercises to complete most standard tests, including parametric and nonparametric statistics.
  • “DIY” exercises in how to do your own stats (or fact-check them) using widely available software, including Microsoft Excel and other, free, online platforms.
• Compiles >55 quality control (QC) checklists, forms, and templates to ease manuscript preparation and submission.
• Provides >70 minimum clinically important difference (MCID) thresholds for all-important patient-reported outcome measures (PROMs).

In an engaging and often light-hearted way, “The Gutkin Manual” includes pertinent references to the Beatles, political pundit Chris Matthews, Watson & Crick, Charles Darwin, and many others, including:

• Why there are fewer than 100 American men taller than basketball great Shaquille O’Neal and fewer than 200,000 shorter than actor Danny DeVito.
• “Raising a nice pint of Guinness” to a key statistical test.
• A certain afternoon beverage, randomization, and why Fisher’s Exact Test could also be called Fisher’s ‘Tea’ Test.
• How a jewelry heist can be used to explain the null hypothesis.
• Why the US incidence of lung cancer rose as a linear function of car sales in the 1950s.

“The Gutkin Manual” is receiving rave reviews from key opinion leaders; publication managers and medical directors in life sciences companies; as well as medical writers and editors, including the following from a noted epidemiologist:

“I thoroughly enjoyed reviewing Stephen Gutkin’s user manual Writing High-Quality Medical Publications. It is well written, very comprehensive, and ’user-friendly.’ All aspects of the process of preparing and writing a manuscript are well covered. As a biostatistician, I found his section on biostatistical methods to be thorough and written in an easily understood manner. I believe his manual would be an excellent reference for anyone preparing research for publication, whether it was their first or their twenty-first paper.” Ann Zauber, Ph.D. (Memorial Sloan Kettering Cancer Center, New York)

To discuss his book, Mr. Gutkin has delivered talks to the American Medical Writers Association (AMWA) and Weill Cornell Medicine (each in New York). He will also be delivering the keynote address (about fair balance in medical communications) to the Mid-Atlantic Chapter of AMWA on March 8, 2019. 

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