Morton J. Kern MD Associate Chief Cardiology Clinical Professor of Medicine

1. Critical Thinking for the Interventionist: Analysis of the Medical Literature How to get your paper in the (and a few words on what I learned about going into Practice after 20 years in the University) IC Fellows Review Course Dec 11-14, 2007 Las Vegas, Nevada Morton J. Kern MD Associate Chief Cardiology Clinical Professor of Medicine University California Irvine

2. Disclosure: Morton J. Kern, MD Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below. Company NameRelationship Radi Medical Inc. Speakers Bureau Merrit Medical Inc. Consultant Therox Inc. Consultant Bracco Inc. Consultant

3. Steps in Manuscript Preparation and submission 1. Mentor 2. Project Idea 3. Data organization 4. Abstract 5. 1st Draft 6. 2nd Draft 7. 2nd Draft 8. 2nd Draft 9. Final Draft 10. Submission New Journal? 11. Resubmission Final Acceptance Cath and CV Interventions, 58:391-396, 2003

4. The Six Phases of A Project 1.        Enthusiasm 2.        Disillusionment 3.        Panic 4.        Search for the Guilty 5.        Punishment for the Innocent 6. Praises and Honors for the Non-Participants

5. The first step: Find a mentor. mentor

6. Data Driven Studies: INITIAL ORGANIZATION • Formulate a hypothesis • Organize the data. Note all studies will have missing points. Make tables • Review data tables with mentor and fill in new or mark missing data. • Learn to perform preliminary statistical analysis (correlation, regression, chi-square, and t-test). • Discuss best format for display of data and types of figures. • Sketch proposed figures to make major points.

7. You are here WRITING THE FIRST DRAFT can be a daunting task

8. WRITING THE FIRST DRAFT Helpful Steps to begin :Write the abstract from results. Answer the 5 fundamental questions. What question was asked (background); What was supposed to happen (tested hypothesis); How and in whom the study was the done (methods); What did you find (results); What does it mean to others (conclusion) Brevity and clarity are essential

9. WRITING THE FIRST DRAFT Write the methods State what was done. Presume the reader is not familiar with the study. Start with the IRB protocol Write the results. What were the most important differences or findings? Present the tables and graphs for secondary findings Write the discussion without references. The first draft should be brief with emphasis on the major points. The IRB protocol often has already stated a background and some discussion.

10. Writing the second Draft

11. WRITING THE SECOND DRAFT Re-write the abstract with no more than 250 words. a.       Include headings: background (1-2 sentences) b.       hypothesis (1 to 2 sentences) c.       Methods (1 to 2 sentences) d.       results (1 paragraph) e. conclusion (1 to 2 sentences).

12. Re-write the Methods. • Use Section headings: • Patientpopulations; study inclusion and exclusion criteria, and whether there was an IRB approved protocol. • Answer the commonly asked questions of how and why. For example, how long between steps? What were the controls? What was the drug dosing? The why of the methods will be explained later in the limitations section. • Consult methods from similar previously published studies. Extra detail can be put in an appendix.

13. Re-write the statistical methods • State how a sample size was obtained. • State what significant P values are and that mean and standard deviation will be used unless otherwise indicated. • A statistician may be needed for help.

14. A Brief Journey into Medical Statistics for Interventionalists • What’s the question and what data are used? • New data • Prospective, controlled, blinded, randomized trial • Registry of data • Single or Multicenter Data bases • Focused lab reserch data • Old data • After-the-fact (post hoc) analysis of data previously collected • Examination of collected registry data • Retrospective review • Meta-Analysis Courtesy of Greg Dehmer,MD

15. Learn from Others Circulation 2000;102:2024-27 • Stent Implant • Technique • Medical Rx • QCA Analysis- How done • Definitions • Success • MI NO STATISTICS • Patient Population • age, gender • risk factors • lesion treated • Questions: • Anything unusual? • Typical of my patients?

16. The Most Commonly Used Statistical Tests Statistical Tests in the NEJM – (760 Research and review articles Courtesy of Greg Dehmer,MD Emerson JD, et al. NEJM 1983;309:709-13.

17. Organize the Results section • Begin with the subject groups. Present comparisons within and between the subgroups. • Present results by measurement type such as hemodynamics, echo, etc. • Describe important changes from baseline then correlative data. Refer reader to figures. • For clinical studies, emphasize clinical outcome whenever possible. • For graphs, avoid duplication of data from the text.

18. Writing the Discussion • 5 major sections to a discussion • Present major findings first, "These data show that …“ • Present the significance of the data, "These data imply …“ • Compare data in a scholarly fashion, "These data are similar to … and different from …“ • Present weaknesses of the current study, "There are limitations to this work …“ • Conclude with clinical or scientific significance, "These data mean that … and future studies may include …"

19. Wrapping up the Drafts • Circulate draft to coauthors. Indicate return of comments by a specific date. If no comments are returned by the deadline, review criteria of authorship • Proceed to next draft. • NOTE: The "second draft" may require 5 to 10 drafts as the mentor and coauthors suggest new revisions.

20. SUBMITTING THE PAPER TO A JOURNAL • Follow the instructions to authors • Write a cover letter to the editor. Tell the editor what is especially new or unusual in the work. • Be honest and modest. • Make extra copies and keep in a file for future correspondences. • Obtain written permission for submission from each co-author • Cross fingers and continue working on other projects.

21. WORKING ON A SECOND SUBMISSION • The reasons for rejection are generally because of one or more “fatal” flaws. • invalid statistics, • using a method which cannot answer the question asked, • an error in methods, • too small a sample size, • the wrong conclusion from the data • poor scholarship (wrong references, errors in citation, errors in grammar, spelling and sentence structure). • Bad luck and Chance (viz Reviewer’s bias)

22. Resubmission • Overcome rejection. Every article has a home. • Read the reviews objectively. • Ask mentor what they mean. • Revise the manuscript --What comments can and cannot be addressed and state the reasons • Ignore any mean spirited language. • Write the response in a respectful, clear, and identifiable format keyed to the changes. • Prepare new submission as with prior drafts. • Discuss with the mentor about same journal or a new one.

23. FINAL ACCEPTANCE Read the acceptance letter fully. Feel good. Tell friends Send copies to co-authors. Call Mentor. Start next paper.

24. Case Reports • Valuable observations. May lead to new thinking • May identify you as new thinker • Helpful to others to avoid problems • May lead to more case reports or full data driven study • Helpful to your practice identity

25. Case Reports • Focused thought and single problem • Brief • Concise methods • Good Graphics • Unique events • Brief literature summary/table • Limitations or controversial issues • Summary and recommendation from what you learned

26. What I learned going into Private Practice after 20 years in the University Life Style Changes From to Professor Private Citizen Member of Univ. Member of Group Big Bureaucracy Small Hierarchy Less on-call More On-call Decent $ More Decent $ Lots of interaction Lone practioner Lots of conferences Few conferences Time to travel Lots of patients Good vacation Some vacation My own Office No office Short Daily Drive Long Commute

27. What I learned going into Private Practice after 20 years in the University Things you need to do in advance Get medical license…..1 yr (Calif) Get State BNDD……..4 mo Get Hospital Privledges Get New Driver’s License Get Fluoroscopy Permit

28. What I learned going into Private Practice after 20 years in the University Things you need to do on arrival at New Place Retain documents from training Retain malpractice claims Maintain friendship with prior secretary Establish new contacts in all hospital departments especially Medical Records, Staff Office, Cafeteria, Library Make Friends with all nurses, especially supervisors Make friends with primary care referral MDs. Have lunch with them, not cardiologists (They’re really nice but not your referral source). Become a leader in the service departments like Echo, ETT, Cath lab

29. What I learned going into Private Practice after 20 years in the University Things you need to do to Keep Sane The Library Books on Tape Out to Lunch with the Lab Turning off the Beeper Family Time Vacations Don’t sweat small stuff Enjoy the moments

30. What if I make a mistake picking a job? With your career path, considering your training and background, There are no real mistakes, only more experience to be gained before your best choice.