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Giuseppe Biondi-Zoccai, MD Sapienza University of Rome, Latina, Italy Writing a scholarly paper.

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Presentation on theme: "Giuseppe Biondi-Zoccai, MD Sapienza University of Rome, Latina, Italy Writing a scholarly paper."— Presentation transcript:

1 Giuseppe Biondi-Zoccai, MD Sapienza University of Rome, Latina, Italy Writing a scholarly paper

2 Learning milestones Introduction Introduction Writing the Title and the Abstract Writing the Title and the Abstract Bibliographic search and writing the Introduction Bibliographic search and writing the Introduction Writing the Methods Writing the Methods Writing the Results Writing the Results Writing the Discussion Writing the Discussion Writing Tables and preparing Figures Writing Tables and preparing Figures Principles of peer-review 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 STUDIES/ EXPERIMENTS WRITE AND SUBMIT REWRITE AND RESUBMIT WAIT PUBLISHED! 4-24 months 2-4 months 14-44 Months! PROTOCOL/IRB 2-4 months BEST GUESS

9 Time to publication More realistic time from submission to publication projections in the WWW era: Letters to the Editor4-12 weeks Editorials3-6 months Reviews6-12 months Case reports6-12 months Non-RCT clinical studies6-18 months RCTs6-18 months Ground-breaking RCTs<6 months

10 Choosing a manuscript type Manuscript type EffortReward 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 1.Title 2.Abstract 3.Introduction 4.Methods 5.Results 6.Conclusion 7.Discussion Flowchart for paper drafting

12 Read a lot… First tip to effective writing

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

14 Who is the audience? Third tip to effective writing

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

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

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

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

19 CONSORT guidelines for RCT Moher et al, JAMA 2001

20 Never throw away a good sentence, but never keep 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 Abstract The more structured, the better SORT OUT II, JAMA 2008

24 Abstract The less structured, the worse ENDEAVOR II, Circulation 2006

25 Known Unknown Question Experimental approach Remember the KUQE approach!

26 What to choose for a bibliographic search? Simple and easy-going or … fast but tough?

27 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? 1st step: framing the question

28 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 2nd step: determining question type

29 Google Scholar Google Scholar is provided for free by Google It contains citations and direct links to abstracts or full text articles In addition, it enables citation analysis, thus forward and backward snowballing It’s not yet very structered, and highly relevant citations might not be included or missed because buried among thousands of non-relevant ones

30 PubMed is the web (and free) version of MEDLINE (provided by the US National Library of Medicine) It contains data on articles printed every day in several thousands medical journals around the world, even if there is some bias toward US and English-language publications It is reasonably comprehensive and sophisticated, especially for the expert user Nonetheless, many papers can still be missed by the MEDLINE indexers, and using PubMed requires some expertise PubMed

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

32 1.Keep problems open and undecided 2.Use the present tense for what is currently true 3.Use the past tense for previous findings 4.Use past tense to state the question 5.Avoid using names of other investigators (unless you really want to review your paper) 6.Repeat key terms from the title Introduction

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

34 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 …” Materials and methods

35 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 Materials and methods

36 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 Materials and methods

37 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 Statistics subsection

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

39 1.Logically answer the research question 2.Focus on primary endpoint and on additional data correlated to it 3.Correlate with the methods 4.Use data from this study only 5.Present all the representative data (with exact P values and confidence intervals) 6.Use tables, graphs, photographs, and drawings Results

40 What do these findings mean? The answer is in the Discussion. 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: 1.Brief summary of the study findings (no need for heading) 2.Current research context (use as heading) 3.Implications of the present study (use as heading) 4.Avenues for further research (use as heading) 5.Limitations of the present study (use as heading) 6.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: T he paper needs extensive revisions The 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 reviewers These issues may affect the overall structure of the paper, potentially changing some of the messages presented The paper can still be rejected at second revision… Minor revisions: T he paper can be published after minor corrections, usually and mainly related to English spelling or minor editing issues present along the text

48 Principles of peer-review –Confidential The 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 comments The aim of the peer review is to improve the manuscript –Can be challenged Peer-reviewers are not always right… Peer-review process

49 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?

51 Peer-review process For research papers: –Scientific reliability Research question (clearly defined and answered?) Overall design of the study (adequate?) Participants studied (adequately described?) Methods (adequately described? ethical?) Results (answer to the research question? credible?) Interpretation and conclusions (warranted by the data?) References (up to date and relevant?) Abstract (reflects accurately what the paper says?)

52 Rebuttal letter Reply point-by-point (help the reviewer, rewriting his/her comments first) Always consider that the reviewers are experts in the field, consider seriously their comments If their comment is adequate, modify your paper accordingly If you think you are right and the point of the reviewer incorrect, state politely, but firmly your reasons Quote references if needed

53 Rebuttal letter You can use figures, graphs, tables (that will not be published afterwards) to reinforce your thesis Highlight in the modified manuscript all the changes you made (and repeat them also in the rebuttal letter) While there is a word limit for a paper to be published (usually around 5000 words), there is no limit for the rebuttal letter… use this space to support your theories!

54 Don’t ever despair, but learn to enjoy the road… Abbate et al, Circ 2004;110:46-50 Number of citations 81 Abbate et al, Am J Cardiol 2010;105:1371-7 Number of citations 100

55 Take home messages

56 Medical writing requires focus on the message you want to deliver, the audience and the venue or instrument. There is no good writing but only rewriting. Only by always (but constructively) criticizing yourself you can navigate successfully the process of medical writing, peer-reviewing, and scholarly publication.

57 Many thanks for your attention! For any query: For these and other slides:

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