Session 8 · Publish: finish the paper, get it out, present

Foundations of Clinical Research: From Clinical Question to Publication

Vương Mỹ Lượng & Bernard Osang’ir

Neudata Consulting Ltd

Session 8 · Publish: finish the paper, get it out, present

Part 1

Week 8 · Saturday, 19:30-22:30 (online)

  • 19:30 Recap: Session 7
  • 19:35 8.1 Writing the paper (II): Introduction, Discussion, Abstract, Title
  • 20:00 Manuscript workshop 2: Q1 together, then your own
  • 20:30 8.2 Getting published: from checklist to reviewers
  • 21:05 8.3 Be the reviewer: Papers 1 and 2, as a whole class
  • 21:30 Proposal presentations (about 5 volunteers), 22:15 closing

Recap: three questions from Session 7

QUICK QUIZ · 5 min

  • Who consents for a sedated patient in septic shock?
  • Which STROBE item asks for crude and adjusted estimates?
  • Where does ‘this may be because sicker patients got more fluid’ belong?

Answers

  • The legal representative (or deferred consent, if the committee approved it)
  • Item 16 (main results)
  • Discussion, not Results

OUTPUT Everyone back in writing mode

8.1 | 25 minutes

Writing the paper (II)

Introduction, Discussion, Abstract and Title, in that order

Introduction: a funnel in three paragraphs

KEY MESSAGE Known, unknown, aim. The aim matches the primary outcome.

Worked example: the Introduction funnel for FLUID-ICU (Q1)

1 Known

  • Fluids save lives early in sepsis
  • A positive balance is linked to death (Paper 2 and other cohorts)

2 Not known

  • Sicker patients get more fluid
  • Unclear whether the link remains after adjusting for severity

3 Aim

  • We examined whether a positive balance by day 3 is associated with 28-day mortality, after adjustment

KEY MESSAGE Three paragraphs, about 350 words. The aim uses ‘associated’.

Discussion: six moves

1 Answer

  • First sentence answers the question
  • Paper 1, p.8

2 Compare

  • With other studies, and why they differ
  • Paper 1: vs CLASSIC, POINCARE-2

3 Explain

  • Mechanism, briefly
  • Paper 2: four-phase fluid model

4 Limits

  • Specific: mechanism, direction, fix
  • Paper 1: control-group contamination

5 Implications

  • For practice and research, labelled
  • Paper 1: ‘would probably be advantageous’ is speculation

6 Conclusion

  • Same message as abstract and title

KEY MESSAGE Answer first. Limitations with their direction. Conclusion = abstract = title.

Worked example: the Discussion for FLUID-ICU question 1

Six moves, one sentence each (simulated data).

  • 1 Answer: A positive balance by day 3 was associated with higher 28-day mortality (adjusted OR 1.62, 95% CI 1.02 to 2.59).
  • 2 Compare: This agrees with Paper 2 (day-2 HR 2.13), although our adjusted estimate is smaller.
  • 3 Explain: Most of the crude association (OR 2.49) reflected confounding by indication: sicker patients received more fluid.
  • 4 Limitations: Residual confounding and reverse causation may exaggerate the association. The CI of the adjusted Cox HR reached 1.00.
  • 5 Implications: These data do not justify restricting fluid. A randomised trial (like Paper 1) is needed.
  • 6 Conclusion: ‘associated with’, the same verb as the aim, abstract and title.

Why the odds ratio shrank: explain it in the Discussion

FLUID-ICU Q1 (simulated)

  • Crude OR 2.49 (1.70 to 3.70)
  • Adjusted OR 1.62 (1.02 to 2.59)
  • Imputed OR 1.70 (1.09 to 2.64)
  • Gap = confounding by indication

KEY MESSAGE Report both, explain the gap. Keep the verb at ‘associated’.

Calibrated language: match the verb to the design

Stronger claim = needs a stronger design

Verb (strongest at the top) Needs at least
‘causes’, ‘prevents’, ‘proves’ Several large RCTs agree
‘reduced’, ‘increased’, ‘did not reduce’ A randomised trial (Paper 1)
‘may contribute to’, ‘is consistent with’ Observational + causal reasoning
‘is associated with’, ‘predicts’ Cohort, case-control (Paper 2)
‘was observed in’, ‘was common’ Descriptive, case series

Never: ‘trend’ for p = 0.42. ‘No difference’ (say ‘no evidence of a difference’). ‘First’, ‘ever’, ‘novel’ unchecked. ‘Impact’ in an observational study.

KEY MESSAGE Climb the ladder only as far as your design allows.

Check: fix the verb (FLUID-ICU, simulated)

QUICK QUIZ · 2 min

  • ‘A positive balance caused higher mortality (OR 1.62).’
  • ‘Fluid overload increases AKI (acute kidney injury) (OR 1.27 per 10 ml/kg).’
  • ‘There was a trend towards death (Cox HR 1.46, 95% CI 1.00 to 2.13).’
  • ‘Lactate predicts death (OR 1.39 per mmol/L).’

Better

  • ‘… was associated with …’
  • ‘… was associated with higher odds of AKI’
  • ‘HR 1.46 (1.00 to 2.13): the CI reaches 1’
  • Fine for prediction. For cause, ‘associated with’

The structured abstract: the shop window

Section What it must say Good example
Background Problem, gap and aim in 1-2 sentences
Methods Design, setting, participants, exposure, primary outcome, analysis Paper 2: population, setting and size
Results Numbers analysed. Main effect with 95% CI. Key secondary results Paper 2: every result as HR (95% CI)
Conclusion Answer the aim in words the design allows Paper 1: negative result stated plainly

250-300 words, plus the registration number for trials. Fix in Paper 1: medians reported, but the estimate called a ‘mean difference’.

Worked example: the abstract and title for FLUID-ICU question 1

Copy the numbers from your Results (simulated data, about 120 words shown).

  • Title: Positive fluid balance by day 3 and 28-day mortality in sepsis: a multicentre cohort study
  • Background: A positive fluid balance is linked to death in sepsis, but sicker patients receive more fluid. We examined the association after adjustment for severity.
  • Methods: Prospective cohort (simulated teaching data), 620 adults, 4 ICUs, 2023-2024. Exposure: positive balance by day 3. Outcome: 28-day death. Logistic and Cox regression adjusted for severity.
  • Results: Of 618 patients, 373 (60.4%) had a positive balance, 35.9% vs 18.4% died. Crude OR 2.49 (1.70 to 3.70), adjusted OR 1.62 (95% CI 1.02 to 2.59).
  • Conclusions: A positive balance was modestly associated with 28-day mortality. Most of the crude association reflected severity. A randomised trial is needed.

Title and keywords: your PICO in one line

Formula from your PICO: design, I vs C, in P, on O. 10-16 words. No ‘impact’, ‘novel’, ‘first’.

Paper 1 (trial)

  • Published: ‘Impact on fluid balance of an optimized restrictive strategy targeting non-resuscitative fluids in … septic shock: a single-blind, … pilot study’
  • Problem: over 25 words, value words
  • Better: Restricting non-resuscitative fluids in septic shock: a multicentre pilot randomised trial

Paper 2 (cohort)

  • Published: ‘Impact of a cumulative positive fluid balance during the first three ICU days in patients with sepsis: a propensity score-matched cohort study’
  • Problem: ‘impact’ is a causal word for a cohort
  • Better: Positive fluid balance in the first three ICU days and 28-day mortality in sepsis: a propensity-matched cohort

KEY MESSAGE Keywords: 3-6 MeSH terms (PubMed subject headings) not already in the title.

Before you submit: references, checklist, final read

References

  • Use a reference manager
  • Check every citation
  • Paper 2 cites the wrong reference for its covariates

Reporting checklist

  • Fill it in while writing
  • Add page numbers
  • Neither paper names CONSORT or STROBE

Final read

  • Text = table, for every number
  • Call-outs point to the right figure
  • A colleague reads the tables

KEY MESSAGE Most errors in these two papers needed no new data, only a careful co-author.

Manuscript workshop 2 | 30 minutes

Complete the draft: together, then on your own

22 minutes drafting Q1 live with the whole class, then 8 minutes on your own aim and title

Manuscript workshop 2, part 1: we complete Q1 together

WHOLE-CLASS TASK · 22 min

  • Introduction (6 min): three paragraphs. You suggest sentences aloud when called on
  • Discussion (9 min): six moves, one or two sentences each
  • Abstract (5 min): numbers copied from the class Results
  • Title and verb check (2 min): every ‘cause’ or ‘impact’ becomes ‘associated with’

Use

  • Class Q1 draft from Session 7 (PDF)
  • Results pack Q1
  • The worked examples (slides)

OUTPUT A complete class draft for Q1, shared as a PDF after the session

Manuscript workshop 2, part 2: your own aim and title

INDIVIDUAL TASK · 8 min

  • Write the aim sentence for your question (Q1 to Q5)
  • Write your title: design stated, 10-16 words, ‘associated’
  • Two volunteers read their title aloud. The instructor comments
  • Tonight: add the Introduction, Discussion and Abstract. Submit by 23:59

Submit

  • Complete draft, about 2,000 words
  • By 23:59 tonight
  • Course folder or email to the course lead
  • Then the peer review (closing slides)

OUTPUT Your aim sentence and working title. The complete draft submitted by 23:59 tonight

8.2 | 20 minutes

Getting published

From checklist to reviewers, and the traps on the way

Reporting guidelines: choose by design

Study design Reporting guideline Our example
Randomised trial CONSORT Paper 1
Cohort, case-control, cross-sectional STROBE Paper 2, FLUID-ICU
Diagnostic accuracy study STARD
Systematic review or meta-analysis PRISMA
Trial protocol SPIRIT
Case report CARE

All checklists are free at the EQUATOR Network (equator-network.org). Name your guideline in Proposal Part 4 and use it as a writing checklist.

Choosing a journal: four checks

Decide the target journal before you write: it sets the rules.

Fit

  • Who needs your result?
  • Read 3 recent issues
  • Similar designs published?

Trust

  • Indexed in MEDLINE, DOAJ, Scopus or Web of Science
  • Clear peer-review policy

Rules

  • Guide for Authors
  • Word limit, checklist
  • Registration required?

Cost and speed

  • Article fee (APC) and waivers
  • Licence: who may re-use the paper
  • Paper 1: 7 weeks. Paper 2: 7 months

KEY MESSAGE A good journal is one your readers read, and one that is honestly run.

Spot the predatory journal

KEY MESSAGE If a journal finds you by flattering e-mail, check it twice.

Live demo: find a checklist and check a journal

LIVE DEMO · 3 min

  • Open the EQUATOR Network website and search ‘CONSORT’
  • Show the checklist and the flow diagram (Paper 1 has one)
  • Find STROBE the same way (Paper 2 and FLUID-ICU)
  • Check a journal in DOAJ and in the NLM Catalog
  • Open the Think.Check.Submit checklist

Watch for

  • Where the checklist PDF is
  • How to see if a journal is in MEDLINE
  • Three questions to ask any journal

OUTPUT Everyone checks the journal and guideline in their own publication plan at home

The submission package

Item What it contains
Cover letter Why this journal, what is new. Not under review elsewhere
Title page Authors, affiliations, ORCID iDs (free researcher identifiers), corresponding author, word count
Manuscript IMRaD, formatted as the Guide for Authors says (blinded if asked)
Tables and figures Separate files, right format and resolution
Reporting checklist CONSORT, STROBE …, with page numbers
Declarations Ethics number, consent, conflicts of interest, funding, data sharing, author roles, AI use
Registration number Trials and systematic reviews
Suggested reviewers Experts with no conflict, not recent co-authors
Supplementary files Protocol, extra tables, long flow charts

The peer-review journey

Rejected? Improve the paper, then submit to another journal. Never to two at once.

Submit

  • Manuscript, cover letter, checklist

Editor

  • Screens the paper
  • Desk rejection is common

Reviewers

  • 2 or 3 peer reviewers comment

Decision

  • Accept, minor or major revision, or reject

Revise

  • Change the paper
  • Reply point by point

Accepted

  • Proofs, then publication

KEY MESSAGE Most papers are revised before acceptance. Reply to every point politely.

Responding to reviewers: the point-by-point table

Comment, response, and exactly where the paper changed. Illustrative rows built on the annotated Paper 1.

R1.1

  • Comment: please do not call p = 0.42 a ‘non-significant trend’.
  • Accept: thank you, we agree. We report the estimate with its 95% CI and removed ‘trend’.
  • Change: Discussion, p.10, lines 4-6

R1.2

  • Comment: how was allocation concealed with blocks of 2?
  • Clarify: allocation was central and computer-generated. Block size added as a limitation.
  • Change: Methods p.3, limitations p.10

R2.1

  • Comment: please add 90-day mortality.
  • Rebut, politely: 90-day status was not a pre-specified outcome and was not collected.
  • Change: noted as a limitation, p.10

KEY MESSAGE Thank, answer every point, show what changed, and disagree politely with evidence.

Check: true or false?

QUICK QUIZ · 2 min

  • ‘A journal that e-mails me first is probably predatory’
  • ‘I can send my paper to two journals at once to save time’
  • ‘A preprint has been peer reviewed’
  • ‘I must answer every reviewer comment, even if I disagree’
  • ‘The FLUID-ICU paper should follow CONSORT’

Answers

  • Often: check it twice
  • False: duplicate submission
  • False: posted before peer review
  • True: politely, with evidence
  • False: STROBE (cohort)

Break

15 min

8.3 | 25 minutes

Be the reviewer

The whole class appraises Paper 1 and Paper 2 together

Two papers, one question

Same clinical question (fluids in septic shock), two designs. Both PDFs: Course/Papers.

Paper 1: randomised trial

  • Boulet 2024, Critical Care
  • Pilot trial, 48 patients analysed
  • Restrictive vs usual fluids in septic shock
  • Primary outcome: fluid balance on day 5

Paper 2: cohort study

  • Hyun 2023, Annals of Intensive Care
  • Propensity-matched cohort, 2516 patients
  • Positive fluid balance in sepsis
  • Outcome: 28-day mortality

KEY MESSAGE Same question, two designs: compare what each may claim.

The 10-question checklist (1-5)

1 Question

  • Can you write the study’s PICO in one line?

2 Design

  • What is the design, and is it the right one for the question?

3 Participants

  • Who was included, and who was left out?
  • Would your patients have been included?

4 Comparison groups

  • Were the groups similar at the start (Table 1)?
  • How was this achieved: randomisation, matching or adjustment?

5 Bias

  • Who knew which group patients were in (blinding)?
  • Could that change the outcome?

The 10-question checklist (6-10)

6 Outcome

  • Was there one pre-specified primary outcome, measured the same way in both groups?

7 Numbers

  • What is the main result as an effect size with 95% CI?
  • Is the CI narrow or wide?

8 Words vs design

  • Do the conclusions match the design (‘associated’ vs ‘caused’, no ‘trend’ for p = 0.42)?

9 Limitations

  • Are the main limitations stated honestly?
  • Name one the authors missed.

10 Use

  • Would this change practice in your unit?
  • Why, or why not?

Be the reviewer: the whole class appraises both papers

WHOLE-CLASS TASK · 15 min

  • The instructor shows the right page of each paper on the shared screen
  • Paper 1: questions 4, 5, 7, 8 and 9
  • Paper 2: questions 4, 5, 8 and 9
  • For each question, vote in the poll: Yes, No or Can’t tell
  • A volunteer gives the page and the sentence, microphone on

Where to look

  • Abstract: question and result
  • Methods: design, blinding, outcome
  • Table 1: groups similar?
  • Discussion: words and limitations

OUTPUT A class answer grid for both papers, shared as a PDF. The other questions as homework

What may each design claim?

Paper 1: randomised trial (n = 48)

  • Chance decided the groups: known and unknown factors balanced
  • Day-5 balance: difference 13.2 ml/kg (95% CI -15.2 to 41.6), p = 0.42
  • May say: ‘did not reduce’
  • But too small to be sure: no ‘trend’

Paper 2: matched cohort (n = 2516)

  • Doctors decided the fluid: only measured factors balanced
  • Day-2 positive balance and 28-day death: HR 2.13 (95% CI 1.48 to 3.06)
  • May say: ‘is associated with’
  • Not ‘impact’ or ‘show’: sicker patients get more fluid

KEY MESSAGE Randomisation earns the word ‘caused’. Observation earns ‘associated’.

The two papers side by side

Paper 1: RCT (Boulet 2024) Paper 2: cohort (Hyun 2023)
Groups made similar by Randomisation 1:1 (blocks of 2)
Who knew the group Clinicians knew, patients, statistician blinded
Main result 13.2 ml/kg (95% CI -15.2 to 41.6), p = 0.42
Missed limitation Blocks of 2 with unblinded clinicians
Wording problem ‘Non-significant trend’ (p = 0.42)
May claim Did not reduce day-5 balance (small pilot)

RCT = randomised controlled trial. Pages and details: Course/Resources/appraisal_instructor_guide.md

Proposal presentations | 45 minutes

Your proposals and publication plans

About 5 volunteers, 6 minutes each, then 2 minutes of feedback. Everyone submits slides.

How proposals and presentations are scored

Criterion What we look for Points
12 Structure and content All 6 slides. Question, design, outcome, sample size, ethics, journal and guideline visible 0-6
13 Clarity Every doctor and nurse in the class understands. One message per slide 0-6
14 Visual design Readable on a shared screen. Pictures, not text 0-6
15 Timekeeping Finished between 5:00 and 6:00 0-6
16 Questions and discussion Answers directly and honestly, names the limitations 0-6

Written proposal (criteria 1-11, /70): everyone. Criteria 12-16 (/30): presenters only. Rubric: Course/Assignment/proposal_rubric.md

Proposal presentations

PRESENTATIONS · 45 min

  • About 5 volunteers present their own proposal: 6 minutes, 6 slides
  • Slides: title, problem and PICO, design, data and analysis, ethics and feasibility, publication plan
  • Time signals in the chat: ‘2 min’ at 4:00, ‘1 min’ at 5:00, ‘Time’ at 6:00
  • Feedback, 2 minutes: two people give two stars and a wish (microphone on), then the instructor
  • Everyone submits slides and the written proposal

Running order

  • 21:30 Presenter 1
  • 21:38 Presenter 2
  • 21:46 Presenter 3
  • 21:54 Presenter 4
  • 22:02 Presenter 5
  • 22:10 Closing round (5 min)

OUTPUT About five proposals presented. Every proposal and slide set submitted

Extra slides | Session 8

Extra slides: Session 8

Use only if time allows, or for self-study

Key words of Session 8

Term In plain words
Introduction funnel Known, not known, aim: three paragraphs
Six moves Answer, compare, explain, limitations, implications, conclusion
Calibrated language Verbs as strong as the design allows (‘associated’, not ‘caused’)
Predatory journal Takes fees without real peer review or indexing
Point-by-point response A table answering every reviewer comment with the change made
Preprint Public manuscript posted before peer review

Full glossary (English-Vietnamese): Course/References/glossary_EN_VN (PDF in the course folder)

Write it right: fix the spin, then draft your title

INDIVIDUAL TASK · 6 min

  • Rewrite Paper 1’s ‘non-significant trend’ sentence honestly (2 min)
  • Rewrite Paper 2’s title with calibrated wording
  • Draft the working title of your own proposal from its PICO (4 min)
  • One line each for Background, Methods, expected Results, Conclusion

Publication plan (Part 4)

  • Working title
  • Abstract skeleton
  • Authors and their roles
  • Target journal and guideline (8.2)

OUTPUT Working title and abstract skeleton for your own presentation

Preprints, open access and licences

Preprint

  • Posted before peer review (e.g. medRxiv)
  • Fast, timestamped, open feedback
  • Not peer-reviewed: say so
  • Check the journal’s policy

Open access

  • Free for everyone to read
  • Gold: the journal charges a fee (APC)
  • Green: accepted version in a repository
  • Ask about fee waivers

Licence

  • CC BY: re-use with credit (Paper 2)
  • CC BY-NC-ND: share, no changes (Paper 1)
  • Read it before you sign

KEY MESSAGE Know who can read, re-use and pay before you submit.

After acceptance: proofs, sharing, corrections

Accepted

  • Congratulations

Proofs

  • Check every number, name and table

Published

  • Online, with a DOI

Share

  • Repository, plain-language summary, your unit

Correct

  • Openly, if errors appear

KEY MESSAGE Read the proofs as carefully as the data. Errors become permanent.

Rejected? Resubmit smarter

Rejection is normal: most papers are rejected at least once.

Desk rejection

  • Out of scope or poorly reported
  • Often within days
  • Re-target the journal

After review

  • Read the reviews, wait a day
  • Fix what they found
  • Never resubmit unchanged

Next journal

  • Reformat to its Guide for Authors
  • Use transfer offers if given
  • Appeal only for a clear error

KEY MESSAGE The next reviewer may be the same person. Fix the problems first.

Conference abstracts and posters

KEY MESSAGE A poster is a billboard: one message, one figure, readable from 2 metres.

From question to publication: what you can now do

Protect

  • Ethics, consent, registration
  • Honest data and authorship

Write

  • IMRaD in the right order
  • Numbers with CIs
  • Verbs that match the design

Publish

  • Reporting checklist
  • Trusted journal
  • Polite, complete responses

Review

  • 10 questions
  • What each design may claim

KEY MESSAGE Next: submit your proposal and your manuscript, then review one peer’s draft.

Closing: what you built and what happens next

Part 2

Session 8 · 22:15-22:30

  • Post-course quiz (the same 24 questions)
  • What you built in eight sessions
  • Course evaluation
  • After the course: submit, then review one peer’s manuscript
  • Next steps

Post-course quiz

QUICK QUIZ · 8 min

  • The same 24 questions as in Session 1, in an online form (link in the chat)
  • Individual, no discussion
  • Use the same participant code as in Session 1
  • The answer key is shared after the course

OUTPUT Quiz submitted (participant code only)

What you built in eight sessions

Ask & find

  • A PICO question
  • 5 key references
  • A working title

Design

  • A justified design
  • Outcomes
  • A bias plan

Analyse

  • A CRF and analysis plan
  • The course dataset read and interpreted

Write

  • Methods, Results
  • Introduction, Discussion, Abstract

Publish

  • Your own proposal
  • Your own draft manuscript

KEY MESSAGE Each of you leaves with a research proposal and a draft paper.

Course evaluation

INDIVIDUAL TASK · 2 min

  • Rate each session: content, pace, usefulness
  • One thing to keep, one thing to change
  • Interested in Level 2 (statistical modelling in R)?

OUTPUT Evaluation form submitted (anonymous)

After the course: peer review like real authors

Tonight

  • Submit your complete draft by 23:59
  • Course folder or email

2 days

  • The course lead sends you one peer’s draft to review

Week 1

  • Send your review report
  • Use the 10-question checklist

Week 2

  • Revised draft and response letter
  • Use the response-to-reviewers template

KEY MESSAGE Individual homework: everyone reviews one draft and receives one review (Course/Assignment/peer_review_instructions).

What comes next

Your toolkit

  • Slides, handouts, glossary
  • Templates: proposal, protocol, consent form, case report form (CRF), analysis plan
  • Templates: manuscript, response to reviewers

Keep going

  • Take your proposal to the ethics committee
  • Level 2: statistical modelling in R
  • Level 3: advanced methods

Thank you!

Good questions. Sound designs. Honest analysis. Clear writing.