Session 8: Exercise sheet

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Foundations of Clinical Research · Level 1 · Neudata · #ClearDataClearImpact · Week 8 · Saturday 19 December 2026 · online, 19:30–22:30

Name: ______________________________ Department: ______________________________

This sheet is sent by email before the session, as a Word file and as a PDF. Keep it open on your screen and type your answers into the Word file (or print the PDF). In class the whole group works together: you answer in the chat or in polls, and the instructor writes the class answer on the shared screen. The writing you hand in is your own.

Part Exercise When How
A Writing exercises: fix the spin, verb ladder, results sentence, title from PICO homework Alone
B Manuscript workshop 2: Introduction, Discussion, Abstract, Title 20:00 (30 min) 22 min whole class on Q1, then 8 min on your own aim and title; finish tonight
C Getting published: spot the predatory journal; responding to reviewers homework Alone
D Answer grid: “Be the reviewer” 21:05 (25 min) Whole class with polls; you fill in your own grid

Files you need (sent before the session; all in the course folder): Paper 1 (Boulet 2024, Crit Care, a randomised pilot trial of restrictive fluids in septic shock) and Paper 2 (Hyun 2023, Ann Intensive Care, a propensity-matched cohort of fluid balance and death in sepsis), original PDFs in Course/Papers; the class Q1 draft from Session 7 (PDF); your own Methods and Results draft and the results pack for your question.

Part A: Writing exercises (homework)

Use these to practise after the session, before you finish your manuscript.

A1. Fix the spin

Rewrite each sentence so it says only what the data and the design allow.

# Original sentence (from the papers) Your rewrite
a Paper 1 (p.10), primary outcome p = 0.42, difference 13.2 ml/kg (95% CI −15.2 to 41.6): the authors base the case for a larger trial on “the non-significant trend in fluid balance reduction”.
b Paper 2 (p.4): “a positive fluid balance on the first ICU day did not impact the 28-day mortality”.
c Paper 2 (title): “Impact of a cumulative positive fluid balance during the first three ICU days in patients with sepsis …”
d Paper 1 (p.10): the protocol obtained “the lowest fluid balance on Day 5 ever published”.

A2. Climb the verb ladder

Choose the strongest verb each design allows: was observed in · is associated with · may contribute to · reduced / did not reduce · causes.

# Study Strongest honest verb
a A case series of 12 ICU patients with septic shock who developed pulmonary oedema after large fluid volumes
b A cohort of 3,000 septic patients: positive fluid balance and mortality, adjusted for severity
c A single randomised trial of 48 patients: restrictive protocol and day-5 fluid balance
d Five large randomised trials and a meta-analysis, all consistent
e A cross-sectional survey of how completely fluid-balance charts are filled in on two ICUs

A3. Write the results sentence (number + CI, no adjectives)

Write one sentence for each, in the style “In [whom], [outcome] was [effect] ([measure] [value], 95% CI [lower] to [upper])”.

  1. Paper 2, Day-3 cohort: 28-day mortality, positive vs negative fluid balance, HR 1.56, 95% CI 1.10 to 2.22, P = 0.012.
  2. Paper 1: death by day 28, 6/24 (restrictive) vs 6/24 (control), relative risk 1.0, 95% CI 0.38 to 2.66.
  3. Paper 2, Day-1 cohort: HR 1.17, 95% CI 0.85 to 1.60, P = 0.354.

A4. A title from your PICO

Formula: [Design] of [Intervention / exposure] vs [Comparator] in [Population]: effect on / association with [Outcome]. 10–16 words, design stated, no “impact”, “novel”, “first”.

My PICO: P ______________ I/E ______________ C ______________ O ______________

Working title: ________________________________________________________________

Word count: ____ Design named? ☐ Calibrated verb (association for observational designs)? ☐

Part B: Manuscript workshop 2: complete the draft (30 minutes, 20:00)

Today the Introduction, Discussion, Abstract and Title are added, and the draft is complete. We give you the results; you write the paper.

How the 30 minutes are used

Clock Who Task
20:00–20:06 Whole class, on Q1 Introduction: three paragraphs (known, not known, aim). You suggest sentences in the chat; the instructor types them into the class draft.
20:06–20:15 Whole class Discussion: six moves (answer, compare, explain, limitations with direction, implications, conclusion).
20:15–20:20 Whole class Abstract: Background / Methods / Results / Conclusions, numbers copied from the class Results.
20:20–20:22 Whole class Title and verb check: every “cause”, “impact”, “effect of” and “show” becomes “associated with”.
20:22–20:30 You, alone Write the aim sentence and the title for YOUR question. Paste your title in the chat.
Tonight, by 23:59 You Add your Introduction (~350 words), Discussion (~600 words), Abstract (≤ 250 words) and Title + 3–6 keywords, and submit the complete draft.

The completed class draft for Q1 is shared as a PDF after the session. If you chose Q1, write your paper in your own words; do not copy the class draft.

Discussion: six moves checklist

Question-specific reminders

  • Q1: crude and adjusted ORs differ. Explain confounding by indication in move 3 or 4.
  • Q2: acute kidney injury may also cause fluid accumulation (reverse causation). Say so.
  • Q3: ventilator-free days are skewed and count death as zero. Explain what the measure means.
  • Q4: compare complete-case and multiple-imputation estimates; say what the missing-data assumption (MAR, missing at random) means for your conclusion.
  • Q5: survivors only. Those who died are excluded, so say who the result applies to.

Deliverable

Your complete draft (~2,000 words, template Course/Templates/Manuscript_Template_IMRaD) saved as Surname_Manuscript_QN_draft.docx, submitted by 23:59 on the day of Session 8 (course folder or email to the course lead; see Course/Assignment/manuscript_brief.md). Then the individual peer review: within 2 days the course lead sends you one classmate’s draft; you review it with the 10 questions of Part D and send your review within 1 week; you send your revised draft and a response letter (Course/Templates/Response_to_Reviewers_Template) within 2 weeks (Course/Assignment/peer_review_instructions.md).

Part C: Getting published (homework)

C1. Spot the predatory journal

1. Find the red flags in this (invented) invitation. How many can you find?

From: editorial.board.gjcmr@freemail.com Subject: Invitation to publish in our esteemed journal!!

Dear Respected Professor/Doctor,

Greetings! We have gone through your excellent article and are delighted to invite you to submit to the Global Journal of Clinical Medicine, Nursing, Engineering and Management Research. We publish all areas of science.

Our journal has an Impact Factor of 9.2 (International Universal Index). We guarantee peer review within 48 hours and publication in 5 days. Processing charges will be communicated after acceptance. Special discount this week only!

Kindly submit your manuscript by replying to this e-mail.

2. Which journal would you trust? For each (invented) profile, write Trust / Check further / Avoid and one reason.

Journal profile Your verdict Reason
J1: Indexed in MEDLINE (confirmed in the NLM Catalog), editor names verifiable at universities, fee (APC) shown on the website, median 9 weeks to first decision, uses CONSORT/STROBE checklists.
J2: Says “indexed in Google Scholar and Index Copernicus”, promises acceptance in 72 hours, no fee information, editorial board photos without affiliations.
J3: Open access, listed in DOAJ, small society journal, no impact factor yet, clear peer-review and retraction policy.
J4: Its name differs by one word from a well-known journal; the website address is different from the real journal’s; it e-mailed you first.

3. Three checks you can always do: Think.Check.Submit checklist · DOAJ (Directory of Open Access Journals) · NLM Catalog (“currently indexed in MEDLINE”). You can also ask your librarian.

C2. Responding to reviewers

Imagine your own proposed study has been completed and submitted. Write a response row for each comment (thank, answer, say exactly what changed). One of them deserves a polite rebuttal.

# Reviewer comment Our response Change made (page, line)
R1.1 “The title says your intervention improves outcomes, but this is an observational study.”
R1.2 “Please report the main result with a confidence interval, not only the p-value.”
R1.3 “Text and Table 2 give different numbers of patients analysed (212 vs 208).”
R2.1 “Please add 1-year mortality.” (Your protocol followed patients to day 28 only.)

Tone checklist: ☐ thanked the reviewer ☐ answered every point ☐ said where the manuscript changed ☐ disagreed only with evidence, politely

Part D: Answer grid: “Be the reviewer” (25 minutes, 21:05)

What you are doing

Two published papers answer our running question (fluids in septic shock) with different designs:

Paper Design
Paper 1 Boulet N, et al. Crit Care 2024;28:429 (restrictive strategy targeting non-resuscitative fluids, OPTIFLUID) Randomised controlled pilot trial, 48 patients analysed
Paper 2 Hyun D-G, et al. Ann Intensive Care 2023;13:105 (cumulative positive fluid balance in the first three ICU days) Propensity-score-matched cohort from a sepsis registry, 2516 patients

The whole class appraises both papers together. The instructor shows the right page on the shared screen, you vote Yes / No / Can’t tell in a poll, and a volunteer gives the page and the sentence in the chat. Fill in your own grid as we go. “Can’t tell” is a good answer when the paper does not say.

Page numbers are the journal’s own page numbers printed at the top of each page (“Page X of 13” for Paper 1, “Page X of 9” for Paper 2). Use the original (unannotated) PDF.

How the 25 minutes are used

Clock What happens
21:05–21:08 The two papers and the 10 questions (slides).
21:08–21:23 Whole-class appraisal with polls. Paper 1: questions 4, 5, 7, 8 and 9. Paper 2: questions 4, 5, 8 and 9.
21:23–21:30 What may each design claim? The side-by-side summary.
At home Answer the remaining questions (1–3, 6 and 10) for both papers.

Why this matters: after the course you use the same 10 questions to review one classmate’s FLUID-ICU manuscript (individual peer review, 2 weeks).

Where to look

Question Paper 1 (RCT): pages Paper 2 (cohort): pages
1 Question Abstract (p.1); last paragraph of Background (p.3) Abstract (p.1); end of Background (p.2)
2 Design Title (p.1); “Trial design and oversight” (p.3) Title (p.1); Methods (pp.2–3)
3 Participants “Patients” (p.3); flow chart Fig. 1 (p.5); Discussion limitations (p.10) “Data source and patient selection” (p.2); Results first paragraph (p.3)
4 Comparison groups “Randomization and blinding” (p.3); Table 1 (p.6) “Propensity score matching” (pp.2–3); Table 1 (pp.5–6); text p.4
5 Bias “Randomization and blinding” (p.3); Discussion (p.8) Methods (pp.2–3); Discussion limitations (pp.7–8)
6 Outcome “Outcomes” (p.4) “Propensity score matching and outcomes” (p.3)
7 Numbers “Primary outcome” (p.6); Table 3 (p.10) Abstract (p.1); “Outcomes” (p.4)
8 Words vs design Abstract conclusion (p.1); Discussion (pp.8, 10); Conclusions (p.11) Title (p.1); Abstract conclusion (p.1); Discussion (pp.4, 7); Conclusions (p.8)
9 Limitations Discussion (pp.8–10) Discussion (pp.7–8)
10 Use Your judgement (whole paper) Your judgement (whole paper)

Answer grid (one copy per paper)

Paper: 1 / 2

# Question (simplified appraisal checklist) Yes No Can’t tell Page Notes (one line)
1 Question: Can you write the study’s PICO in one line? ☐ ☐ ☐ P: … I/E: … C: … O: …
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 / adjustment)? ☐ ☐ ☐
5 Bias: Who knew which group patients were in (blinding)? Could that change the outcome? ☐ ☐ ☐
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? ☐ ☐ ☐ Effect: ……… 95% CI: ………
8 Words vs design: Do the conclusions match the design (“associated” vs “caused”; no “trend” for p = 0.42)? ☐ ☐ ☐ Words found:
9 Limitations: Are the main limitations stated honestly? Name one the authors missed. ☐ ☐ ☐ Missed:
10 Use: Would this change practice in your unit? Why / why not? ☐ ☐ ☐

My verdict in one sentence: ______________________________________________

One thing I would copy into my own proposal: ______________________________

Hints if you are stuck

  • Q1: the PICO is usually in the last paragraph of the Introduction (“we aimed to …”). Is the paper’s outcome the same as in our running question (28-day mortality)?
  • Q4: a randomised trial makes groups similar by chance; a cohort can only match or adjust for what was measured. Find the sentence that says which.
  • Q5: who decided how much fluid each patient received, and did they know the group?
  • Q7: look for “difference” or “HR” followed by brackets. Does the interval include 0 (for a difference) or 1 (for a ratio)?
  • Q8: search for the words impact, show, trend, ever, regardless.