Writing a scholarly paper

1. Writing a scholarly paper Giuseppe Biondi-Zoccai, MD Sapienza University of Rome, Latina, Italy giuseppe.biondizoccai@uniroma1.it gbiondizoccai@gmail.com

2. Learningmilestones • Introduction • Writing the Title and the Abstract • Bibliographic search and writing the Introduction • Writing the Methods • Writing the Results • Writing the Discussion • Writing Tables and preparing Figures • Principles of peer-review

3. Why should you write a scholarly paper? CLINICIAN RESEARCHER

4. Introductory remarks • Clinical writing is just like PCI: nobody is accomplished at the beginning, but all remarkably improve with practice

5. Remember Grossman’s words I have not found…writing one bit easier today than it was 30 years ago. I still have to work at it very hard and make many revisions, with a rare exception… because the saying of Francis Bacon has always been deeply impressed in my mind..”Writing [maketh an] exact man.”Morton Grossman (>400 scientific papers, 134 editorials, and 71 books or book chapters)

6. Paraphrasing Groucho… The more you write, the better writer you will become… …and if I can write in ENGLISH, most of you can!

7. Who gets the credit? In science, the credit goes to the man who convinces the world, not to the man to whom the idea first occurs. ─ Sir Francis Darwin

8. Gestational period for a clinical trial paper START PROTOCOL/IRB2-4 months STUDIES/ EXPERIMENTS 4-24 months 14-44 Months! WRITE AND SUBMIT 2-4 months REWRITE AND RESUBMIT 2-4 months 2-4 months WAIT 2-4 months PUBLISHED! BEST GUESS

9. Time to publication • More realistic time from submission to publication projections in the WWW era: • Letters to the Editor 4-12 weeks • Editorials 3-6 months • Reviews 6-12 months • Case reports 6-12 months • Non-RCT clinical studies 6-18 months • RCTs 6-18 months • Ground-breaking RCTs <6 months

10. Choosing a manuscripttype Manuscript type Effort Reward Abstract for scientific meeting ± ± Letter to the Editor ± ± Editorial + + Book chapter + + Qualitative review + + Systematic review ++ ++ Case reports or Images ±± Case series + + Non-RCT study ++ ++ RCT +++ +++

11. Flowchartforpaperdrafting • Title • Abstract • Introduction • Methods • Results • Conclusion • Discussion

12. First tiptoeffectivewriting Read a lot…

13. Second tip to effective writing What is the message you want to sell?

14. Third tip to effective writing Who is the audience?

15. Fourth tip to effective writing No matter what, keep clear writing!

16. Fifth tip to effective writing Do not mistake the tree for the forest!!!

17. IMRAD algorithm Introduction (± Aim) Methods Results And Discussion

18. Expanded IMRAD algorithm IntroductionBackground Limitations of current evidence Study hypothesis MethodsDesign Patients Procedures Follow-up End-points Additional analyses Statistical analysis Results Baseline and procedural data Early outcomes Mid-to-long term outcomes Additional analyses DiscussionSummary of study findings Current research context Implications of the present study Avenues for further research Limitations of the present study Conclusions

19. CONSORT guidelinesfor RCT Moher et al, JAMA 2001

20. Neverthrowaway a goodsentence, butneverkeep a bad one! • “There is no good writing… only good re-writing” • Rationale: We are better at editing than writing • Methods of conserving sentences: • Write about the same thing • Use similar methods • Dictation

21. Title The title is like the eyes They may mislead, but they are decisive in making the choice for having a glance at the article

22. Abstract Introduction (± Aim) 2-3 phrases Methods 2-3 phrases Results 3-5 phrases (And) Conclusions 1-3 phrases

23. AbstractThe more structured, the better SORT OUT II, JAMA 2008

24. AbstractThe less structured, the worse ENDEAVOR II, Circulation 2006

25. Remember the KUQE approach! • Known • Unknown • Question • Experimental approach

26. What to choose for a bibliographic search? or … fast buttough? Simpleand easy-going

27. 1st step: framing the question • Population:who are the relevant patients? • Intervention or exposure:what are the management strategies we want to appraise or the relevant harmful exposure we want to study? • Outcome:what are the patient-relevant consequences of the exposure in which we are interested?

28. 2nd step: determiningquestiontype • Therapy:determining the effect of different treatments on improving patient function and avoiding adverse events • Harm:ascertaining the effects of potentially harmful agents on patient function, morbidity, and mortality • Diagnosis:establishing the power of an intervention to differentiate between those with and those without a target condition or disease • Prognosis:estimating the future course of a patient’s disease

29. Google Scholar • Google Scholarisprovidedfor free by Google • Itcontainscitations and directlinkstoabstracts or full text articles • In addition, itenablescitationanalysis, thusforward and backwardsnowballing • It’s notyetverystructered, and highlyrelevantcitationsmightnotbeincluded or missedbecauseburiedamongthousandsofnon-relevantones

30. PubMed • PubMed is the web (and free) versionof MEDLINE (providedby the US National Libraryof Medicine) • Itcontains data on articlesprintedeveryday in severalthousandsmedicaljournalsaround the world, evenifthereis some biastoward US and English-languagepublications • Itisreasonablycomprehensive and sophisticated, especiallyfor the expert user • Nonetheless, manypapers can stillbemissedby the MEDLINE indexers, and using PubMed requires some expertise

31. Introduction What question (problem) was studied and what is your underlying hypothesis? The answer is in the Introduction.

32. Introduction • Keep problems open and undecided • Use the present tense for what is currently true • Use the past tense for previous findings • Use past tense to state the question • Avoid using names of other investigators (unless you really want to review your paper) • Repeat key terms from the title

33. Materials and methods How was the problem studied? The answer is in the Methods

34. Materials and methods • Describe with full details what was done to answer the research question • In the beginning include a clear statement of study design: • “The study was a double-blind, randomized, parallel design … designed to compare the efficacy and safety of …” • Include also a sentence about IRB approval, informed consent, or compliance with animal welfare regulations: • “The protocol was approved by the institutional review board, and all patients gave informed consent …”

35. Materials and methods • State the protocol/procedures. Repeat the question and the aims: • “We tested the efficacy of drug XX administered orally in a dose of XX mg, given XX times daily for up to XX months.” • “There were 2 primary endpoints. The first was event-free survival at XX days, with an event defined as…” • Describe materials/methods or subjects adequately • Write in a logical order (usually chronological) • Describe analytical methods

36. Materials and methods • Use subheadings (design, patients, procedures, follow-up, endpoints….) • Do not include results in Methods • Include appropriate figures and tables if useful to graphically explain concepts • Write in past tense • Use active voice whenever possible • Cite references for published methods • Describe new methods fully

37. Statisticssubsection • Explain how you handled and reported categorical and continuous variables • Explain how you tested for significance at both univariate and multivariate analysis • Define tails and threshold p value • State width of confidence intervals • Provide sample size computation • Spell out which software package was used • Quote extensively and be ready to defend • yourself if you use sophisticated analytic tools

38. Results What were the findings? The answer is in the Results.

39. Results • Logically answer the research question • Focus on primary endpoint and on additional data correlated to it • Correlate with the methods • Use data from this study only • Present all the representative data (with exact P values and confidence intervals) • Use tables, graphs, photographs, and drawings

40. Discussion What do these findings mean? The answer is in the Discussion.

41. Discussion vs Results Remember: Results and Discussion sections should appear as written by two different people!

42. Structuring the Discussion • The usual structure of the Discussion is: • Brief summary of the study findings (no need for heading) • Current research context (use as heading) • Implications of the present study (use as heading) • Avenues for further research (use as heading) • Limitations of the present study (use as heading) • Conclusions (may use as heading)

43. Tables • Tables are useful, especially to clarify important points for the busy reader • Try to lump similar data together • Do not replicate in the text but a few numbers that you have reported in the Tables • May be subdivided in: • Baseline (or Patient) characteristics • Lesion and procedural characteristics • Outcomes • Additional (eg multivariable) analyses

44. Figures • Figures are also useful, especially to clarify important points for the busy reader • In many cases the figures help you document that what you say you did is true (eg angiograms, microscopy, etc.) • Remember that they should be professionally prepared • Bear in mind that color figures may be expensive!

45. Once the paper is submitted… • Editorial process: • the paper is registered • The paper is read by an editor who decides if it deserves peer-review • If yes, it is sent to referees (peer-reviewers) • Decision-making (the editor decides, not the referees) • Decision: acceptance, rejection, de novo submission, major revisions, minor revisions

46. Once the paper is submitted… Acceptance:PARTY!! Rejection:We need to send our paper to another journal… De novo submission: The paper needs extensive revisionsThe editor thinks it can be published but usually at least 1 reviewer has been very negative over the paper Usually at the second submission the reviewers are different from the first submission (in particular the negative reviewers are excluded from a second review by the editor)

47. Once the paper is submitted… Major revisions:The consensus of the editor and the reviewers is that the paper can be published pending modifications and changes in the paper according to the points and issues raised by the reviewersThese issues may affect the overall structure of the paper, potentially changing some of the messages presentedThe paper can still be rejected at second revision… Minor revisions: The paper can be published after minor corrections, usually and mainly related to English spelling or minor editing issues present along the text

48. Peer-reviewprocess • Principles of peer-review • ConfidentialThe author does not know who the reviewers are but the reviewers know who the author is…Double blind (or fully open) peer review implemented in some journals… • Providing guidance to editors The peer-reviewers do not reject, they only advice…The editor rejects • Constructive commentsThe aim of the peer review is to improve the manuscript • Can be challengedPeer-reviewers are not always right…

49. Peer-review process • General guidance for reviewers: • Is the subject of the paper important? • Does the paper add enough to existing knowledge? • Does the paper read well and make sense? The goal of peer-review is to give comments and references to help: - editors taking a right decision - authors improving their paper

50. Peer-review process • For research papers: • Originality:Does this work add enough to what is already published?If so, what is it? • Importance to readers:Does the paper matter to clinicians, patients, teachers, policymakers? Is this journal the right place?