Giuseppe Biondi-Zoccai, MDSapienza University of Rome, Latina, Italy

giuseppe.biondizoccai@uniroma1.itgbiondizoccai@gmail.com

Writing a scholarly paper

Learning milestones• 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

Why should you write a scholarly paper?

CLINICIAN

RESEARCHER

Introductory remarks

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

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)

Paraphrasing Groucho…

The more you write, the better writer

you will become…

…and if I can write in ENGLISH,

most of you can!

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

Gestational period for a clinical trial paper

START

STUDIES/EXPERIMENTS

WRITE ANDSUBMIT

REWRITE ANDRESUBMIT

WAIT

PUBLISHED!

4-24 months

2-4 months

2-4 months

2-4 months

2-4 months

14-44 Months!

PROTOCOL/IRB 2-4 months

BEST GUESS

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

Choosing a manuscript type

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 +++ +++

1. Title

2. Abstract

3. Introduction

4. Methods

5. Results

6. Conclusion

7. Discussion

Flowchart for paper drafting

Read a lot…

First tip to effective writing

What is the message

you want to sell?

Second tip to effective writing

Who is the audience?

Third tip to effective writing

No matter what, keep

clear writing!

Fourth tip to effective writing

Do not mistake the tree

for the forest!!!

Fifth tip to effective writing

Introduction (± Aim)

Methods

Results

And

Discussion

IMRAD algorithm

Expanded IMRAD algorithmIntroduction Background

Limitations of current evidenceStudy hypothesis

Methods DesignPatientsProceduresFollow-upEnd-pointsAdditional analysesStatistical analysis

Results Baseline and procedural dataEarly outcomesMid-to-long term outcomesAdditional analyses

Discussion Summary of study findingsCurrent research contextImplications of the present studyAvenues for further researchLimitations of the present studyConclusions

CONSORT guidelines for RCT

Moher et al, JAMA 2001

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

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

Abstract

Introduction (± Aim) 2-3 phrases

Methods 2-3 phrases

Results 3-5 phrases

(And)

Conclusions 1-3 phrases

Abstract The more structured, the better

SORT OUT II, JAMA 2008

Abstract The less structured, the worse

ENDEAVOR II, Circulation 2006

• Known

• Unknown

• Question

• Experimental approach

Remember the KUQE approach!

What to choose for a bibliographic search?

Simple and easy-going

or …

fast but tough?

• 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

• 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

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

• 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

What question (problem) was studied and

what is your underlying hypothesis?

The answer is in the Introduction.

Introduction

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

Materials and methods

How was the problem studied?

The answer is in the 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 …”

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

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

Materials and methods

• 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

What were the findings?

The answer is in the Results.

Results

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

What do these findings mean?

The answer is in the Discussion.

Discussion

Discussion vs Results

Remember:

Results and Discussion sections

should appear as written by

two different people!

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)

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

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!

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

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 paperUsually 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)

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

• 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 commentsThe aim of the peer review is to improve the manuscript

– Can be challengedPeer-reviewers are not always right…

Peer-review process

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

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?

Peer-review process

• For research papers:

– Scientific reliabilityResearch 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?)

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

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!

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

Take home messages

Take home messages• 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.

Many thanks for your attention!

For any query:giuseppe.biondizoccai@uniroma1.it

gbiondizoccai@gmail.com

For these and other slides:http://www.metcardio.org/slides.html