Publishing and Presenting Clinical Research 2010

Week One

Amy J. Markowitz, JDamyjmarkowitz@alum.wellesley.edu

415-307-0391

A Writer’s Algorithm or

Papers Without (too much) Pain

A Rubric to Efficiently Organize and Write a Manuscript

Today's agenda

• Course overview

• A framework for presenting research

• The Writer’s Algorithm– The basics of good writing habits– The sections of a paper– The basics of effective self-editing

My expectations of you

• Show up prepared

• Interrupt frequently, but avoid tangents unless they are really interesting

• Share your “stuff” with others - research and writing are not solitary pursuits - at least not mostly

• You’ll have a useful deliverable when the torture is through

Course structure and function

• Anatomy– Overview, introductions– Abstracts– Results; tables and figures and Discussion– Anger Management or Responding to Reviews

• Bonus = Warren Browner– Delivering the Piece de Resistance: The talk or paper

Course structure and function

• Physiology– Brief “lecture”– Your work

• Can be anonymous

• Essential if we are to succeed

– Q and A

Most research involves a simple findingA > B

Weight of experimental mice > Weight of control miceBone density with TT genotype > Bone density with tt genotype

Survival after surgery > Survival with medical therapy Health care in UK > Health care in US

Keep this top o’ mind, especially when delivering your Nobel Speech

Title

• Based on the research question

• Try to make it interesting (catchy), declarative, maybe even provocative

• Remember the magic words– Randomized, blinded, prospective, etc.

The 4 basic parts of an abstract, paper,

or presentation• Introduction: Why would it matter if you could

show that A > B?

• Methods: How you will show that A > B.– (Effect size: Comparing A with B)

• Results: Show that A > B.

• Discussion: What is the implication, now that we know that A >B?

Begin Before the Beginning

• Scribble or type a list of topics, themes, ideas, conclusions, in any order

• Work for about 15 minutes and then reward yourself with a latte or a quick peek at the Tivo’d Daily Show

Create a Scaffold

• Using the Instructions for Authors contained on the Web site of every journal, set up the major headings/sections of the paper

• You are now not looking at a blank screen and can treat yourself to a snack or a latte

Put on the Sorting Hat

• Insert fragments from the scribbled list into the scaffolding sections, eg, background? result? discussion?

• Pen a meaningful topic sentence for the fragments. Note: meaningful means an original idea that sets up the issue to be discussed in that section or paragraph

• Continue to fill in the space under the topic sentences by moving entries around, and by adding entries from the scribbled list

• Pull out your Endnote Library and troll around

Put on the Sorting Hat(continued)

• Note ideas for tables, boxes, figures• Re-check rules for authors as to formatting

requirements• Note areas that require further thought or

discussion• Go for a run or a ride

Write an Introduction

• Do not reinvent the wheel - go back to the grant, proposal, RFP

• Content: The introduction is your promise to the reader

• Style: Write the way that you speak, but not conversationally

Content of Introduction

• The introduction is your promise to the reader (in 3 paragraphs or less)

• Describe the background, raison d’etre of the study, the reason your findings are relevant, and (if you’re feeling gutsy) the contribution you have made

• Close the intro with a road map of what the reviewer/reader will find in the paper

Style of Introduction• Write the way that you speak, but not

conversationally• Be economical in your articulation: Avoid

connectors, descriptors, or transitions that you would not feel comfortable saying aloud, or presenting orally (eg, hence, thusly)

Dictionary of Useful Research Phrases

• "It has long been known..." <-> I didn't look up the original reference.

• "A definite trend is evident..." <-> These data are practically meaningless.

• "Of great theoretical and practical importance..." <-> Interesting to me.

http://writedit.wordpress.com/category/biomedical-writingediting/

Finishing the Introduction

• Read your introduction aloud to yourself to see if it rings true and sounds sensible

• Call it a day

Write the Easy Parts First

• Good bets for knocking off sections are the Methodology and Results sections

• Methods: Carefully track the research protocol, and if you repeat or reproduce a part of the protocol as stated in your original proposal, do not paraphrase or change verbiage

Methods: How will you show that A > B?

• Who (what) did you study?

• What, if anything, did you do to them?

• How did you make your measurements?

• How did you compare A with B?

• Statistical tests to “show” that A ≠ B

Effect size: Comparing A with B

• Magnitude: A – B, A ÷ B, etc.

• Precision: 95% confidence interval – If A – B > 0, how much “> 0”?

• Easy to forget about the effect size – Esp. if someone else analyzes data for you!

Results: Showing that A > B

• Make sure the main result is obvious – Don’t bury it in the middle of a long paragraph, an

8 x 6 table, or a complex figure

• Use alternative “definitions” of A and B– Different measurement techniques or times– “Multivariate” adjustment– In various subgroups

Results: Showing that A > B

• Different ways of presenting the effect size

• A – B (2 kg, 15% more)

• A ¸ B (1.5 x, 50% greater)

• NNT

• K-M curves

• etc.

Results/Discussion(Pull out the scribbled list again)

Framing the Content• What grabbed you about your results?• Was there an expected or unexpected finding? If you are

presenting something new, build the case in a logical order – eg, is this study the result of a long line of similar research that is “confirmatory, but”?

• Is it presenting a new theory to explain an old phenomenon? Is it rebutting a long-held belief in the field?

• Does it have implications for research policy or social policy?

• Will it be a useful “tear-out” with pragmatic clinical utility?

Discussion

• Actually speak to the reader • Argue your case with the facts that you’ve

set forth formulaically in the Results sections

• Use I.A.C. (Idea - Analysis - Conclusion)• Check each paragraph against the next: be

certain that you are connecting the dots for the readers, not bludgeoning them

Styling Your Discussion

Using the topic sentences you’ve already drafted, write stand-alone paragraphs following the “I.A.C.” rubric:

• Idea (the topic sentence)• Analysis (the clinical, microbiologic, biochemical,

social, economic, explanation of the result)• Concluding sentence which sums up the analysis,

and often will serve as a transition to the next paragraph

Styling Your Discussion(continued)

• If you find that you are stuck, and cannot create an I.A.C. paragraph for a particular result, go back to the topic sentence, and make sure that it is worthy of a whole finding/result

• Consider whether you have enough (interesting) results to merit another paper (after this one is completed)

Anticipate Possible Criticism

• Careful, not defensive, explanation• Anticipate critique of your methodology or

study design and present the reasoning behind your choices

• Your design and study criteria were well thought out in the beginning – now is not the time to have a crisis of confidence

Conclude With a Send-off

• A conclusion is not a repetition

• Take the bully pulpit, and set a course

• Set a research agenda; get others interested in your field

• Create some controversy that is well-founded on the basis of your findings

Some Practical Advice

• Return to the Instructions for Authors and re-check formatting requirements, word length, formatting of references, suggested number of references, advice about graphics, the works

• Print hard copy of the manuscript, and proof it for substance by reading it aloud once, making hard copy corrections (you will be amazed at what you will find to self-edit)

• Then, and only then, run spell check • Wait a day, re-read, and with a sigh of relief, hit the

send key to your co-authors, or friendly readers

Credit Where It I$ Due

"This project was supported by Grant Number KL2 RR024130 from the National Center for Research Resources (NCRR).”

Access Where It Is Due

The NIH Public Access PolicyThe Policy implements Division G, Title II, Section 218 of PL 110-161(Consolidated Appropriations Act, 2008) which states:

SEC. 218. The Director of the National Institutes of Health shall require that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

Well-organized information about the NIH Public Access policyhttp://publicaccess.nih.gov/.http://publicaccess.nih.gov/FAQ.htm#b1

Compliance: a three-step processI) Address Copyright. Before you sign a publication orcopyright transfer agreement, make sure that the agreement allows the paperto be submitted to NIH in accordance with the Public Access Policy.

II) Submit the paper to NIH. a. Some publishers make the final published version of every NIH-fundedarticle publicly available in PubMed Central within 12 months of publicationwithout author involvement. See http://publicaccess.nih.gov/submit_process_journals.htm for a list of these journals. b. Deposit a copy of the final peer-reviewed manuscript in the NIHManuscript Submission (NIHMS) system (http://www.nihms.nih.gov/).c. Someone else (e.g., a research assistant or librarian), orpublisher, may deposit the final peer-reviewed manuscript files in theNIH Manuscript Submission system for you.

III) Cite. As of May 25, 2008, when citing a paper in NIH applications, proposals, and progress reports that falls under the Policy, authored or co-authored by you or arose from your NIH award, you must include the PubMed Central reference number. This policy includes applications submitted to the NIH for the May 25, 2008 due date and subsequent due dates.