Foundations of Clinical Research: From Clinical Question to Publication
Vương Mỹ Lượng & Bernard Osang’ir
Neudata Consulting Ltd

Part 1
QUICK QUIZ · 5 min
Answers
OUTPUT Everyone back in writing mode
Writing the paper (II)
Introduction, Discussion, Abstract and Title, in that order
KEY MESSAGE Known, unknown, aim. The aim matches the primary outcome.
1 Known
2 Not known
3 Aim
KEY MESSAGE Three paragraphs, about 350 words. The aim uses ‘associated’.
1 Answer
2 Compare
3 Explain
4 Limits
5 Implications
6 Conclusion
KEY MESSAGE Answer first. Limitations with their direction. Conclusion = abstract = title.
Six moves, one sentence each (simulated data).

KEY MESSAGE Report both, explain the gap. Keep the verb at ‘associated’.
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.
QUICK QUIZ · 2 min
Better
| 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’.
Copy the numbers from your Results (simulated data, about 120 words shown).
Formula from your PICO: design, I vs C, in P, on O. 10-16 words. No ‘impact’, ‘novel’, ‘first’.
Paper 1 (trial)
Paper 2 (cohort)
KEY MESSAGE Keywords: 3-6 MeSH terms (PubMed subject headings) not already in the title.
References
Reporting checklist
Final read
KEY MESSAGE Most errors in these two papers needed no new data, only a careful co-author.
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
WHOLE-CLASS TASK · 22 min
Use
OUTPUT A complete class draft for Q1, shared as a PDF after the session
INDIVIDUAL TASK · 8 min
Submit
OUTPUT Your aim sentence and working title. The complete draft submitted by 23:59 tonight
Getting published
From checklist to reviewers, and the traps on the way
| 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.
Decide the target journal before you write: it sets the rules.
Fit
Trust
Rules
Cost and speed
KEY MESSAGE A good journal is one your readers read, and one that is honestly run.
KEY MESSAGE If a journal finds you by flattering e-mail, check it twice.
LIVE DEMO · 3 min
Watch for
OUTPUT Everyone checks the journal and guideline in their own publication plan at home
| 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 |
Rejected? Improve the paper, then submit to another journal. Never to two at once.
Submit
Editor
Reviewers
Decision
Revise
Accepted
KEY MESSAGE Most papers are revised before acceptance. Reply to every point politely.
Comment, response, and exactly where the paper changed. Illustrative rows built on the annotated Paper 1.
R1.1
R1.2
R2.1
KEY MESSAGE Thank, answer every point, show what changed, and disagree politely with evidence.
QUICK QUIZ · 2 min
Answers

Break
15 min
Be the reviewer
The whole class appraises Paper 1 and Paper 2 together
Same clinical question (fluids in septic shock), two designs. Both PDFs: Course/Papers.
Paper 1: randomised trial
Paper 2: cohort study
KEY MESSAGE Same question, two designs: compare what each may claim.
1 Question
2 Design
3 Participants
4 Comparison groups
5 Bias
6 Outcome
7 Numbers
8 Words vs design
9 Limitations
10 Use
WHOLE-CLASS TASK · 15 min
Where to look
OUTPUT A class answer grid for both papers, shared as a PDF. The other questions as homework
Paper 1: randomised trial (n = 48)
Paper 2: matched cohort (n = 2516)
KEY MESSAGE Randomisation earns the word ‘caused’. Observation earns ‘associated’.
| 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
Your proposals and publication plans
About 5 volunteers, 6 minutes each, then 2 minutes of feedback. Everyone submits slides.
| 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
PRESENTATIONS · 45 min
Running order
OUTPUT About five proposals presented. Every proposal and slide set submitted
Extra slides: Session 8
Use only if time allows, or for self-study
| 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)
INDIVIDUAL TASK · 6 min
Publication plan (Part 4)
OUTPUT Working title and abstract skeleton for your own presentation
Preprint
Open access
Licence
KEY MESSAGE Know who can read, re-use and pay before you submit.
Accepted
Proofs
Published
Share
Correct
KEY MESSAGE Read the proofs as carefully as the data. Errors become permanent.
Rejection is normal: most papers are rejected at least once.
Desk rejection
After review
Next journal
KEY MESSAGE The next reviewer may be the same person. Fix the problems first.
KEY MESSAGE A poster is a billboard: one message, one figure, readable from 2 metres.
Protect
Write
Publish
Review
KEY MESSAGE Next: submit your proposal and your manuscript, then review one peer’s draft.

Part 2
QUICK QUIZ · 8 min
OUTPUT Quiz submitted (participant code only)
Ask & find
Design
Analyse
Write
Publish
KEY MESSAGE Each of you leaves with a research proposal and a draft paper.
INDIVIDUAL TASK · 2 min
OUTPUT Evaluation form submitted (anonymous)
Tonight
2 days
Week 1
Week 2
KEY MESSAGE Individual homework: everyone reviews one draft and receives one review (Course/Assignment/peer_review_instructions).
Your toolkit
Keep going
Thank you!
Good questions. Sound designs. Honest analysis. Clear writing.

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