Session 2: Exercise sheet
Download the PDF · Download the Word file (to fill in) · Back to Session 2
Foundations of Clinical Research · Level 1 · Neudata · #ClearDataClearImpact · Week 2 · Saturday 7 November 2026 · online, 19:30–22:30
Name: ______________________________ Department: ______________________________
How to use this sheet. This sheet is sent by email before the session, as a Word file and as a PDF. Keep it open on your computer during the session and type your answers into the Word file (or print the PDF at home). - Recap quiz on Session 1: on your own, in the online form linked in the chat (8 minutes, start of the session). - Exercise 1 (Boolean search builder): on your own, for your own question, segment 2.1 (5 minutes). - Exercise 2 (paraphrasing): at home. - Exercise 3 (reading Paper 1’s abstract): on your own, segment 2.3 (12 minutes). The clean abstract is linked in the chat. - Exercise 4: your own Proposal builder 2 (35 minutes).
The answers are discussed in class, in the chat. There is no mark.
Recap quiz: Session 1 (individual, 8 minutes, in the online form)
- Which course paper is a trial and which is a cohort: Paper 1 (Boulet 2024) or Paper 2 (Hyun 2023)? ____________
- “In adults with sepsis, is a positive fluid balance by day 3, vs not, linked to death by day 28?” P ______ E ______ C ______ O ______ T ______
- Which FINER letter did our running example fail? ____________
- Which is an objective: “to understand fluid balance” or “to estimate the proportion fluid-positive on day 3”? ____________
- Write H0 for: “Does a restrictive protocol reduce fluid balance at day 5?” ________________________________________
The running example (for reference)
| P: Population | Adults (18+) with septic shock in the ICU |
| I: Intervention | Restrictive fluid strategy |
| C: Comparison | Usual care (standard fluids) |
| O: Outcome | Death from any cause |
| T: Time | Within 28 days |
Question: In adults with septic shock in the ICU, does a restrictive fluid strategy, compared with usual care, reduce 28-day mortality?
Exercise 1: Boolean search builder (individual, 5 minutes, segment 2.1)
Rules: join synonyms inside a block with OR. Join blocks with AND. Put each block in brackets. Write operators in CAPITALS. Use English search words.
Warm-up: which gives MORE hits? (circle) - septic shock AND fluids or septic shock OR fluids - sepsis or sepsis NOT neonatal
Build your search from your own PICO question (Session 1) and your synonym list. The comparison (C) is usually not searched.
| Block | Concept | Synonyms (2–4). Mark possible MeSH terms with (M) |
|---|---|---|
| P | ||
| I / E | ||
| O |
My search string:
( ______ OR ______ OR ______ ) AND ( ______ OR ______ OR ______ ) AND ( ______ OR ______ )
One filter I would add, and why: __________________________________________
Share your search. The trainer calls on two or three of you to read out one block; the class suggests a synonym to add. One synonym suggested for my search: ______________________
The search string from the live demo (copy it here to run at home):
("Shock, Septic"[Mesh] OR "septic shock"[tiab] OR sepsis[tiab])
AND ("Fluid Therapy"[Mesh] OR "fluid restrict*"[tiab] OR "restrictive fluid*"[tiab] OR "conservative fluid*"[tiab])
AND ("Mortality"[Mesh] OR mortality[tiab] OR death[tiab])| Field tag / symbol | Meaning |
|---|---|
[Mesh] or [mh] |
MeSH term (includes narrower terms automatically) |
[tiab] |
word in the title or abstract |
[pt] |
publication type, e.g. randomized controlled trial[pt] |
"..." |
exact phrase |
* |
any ending (truncation): restrict* = restrict, restricted, restriction, restrictive |
Exercise 2: Citing vs copying (paraphrase safely) (individual, at home, 10 minutes)
Method: read, close the paper, write from memory, check the facts, then cite. Patchwriting (copying the sentence and swapping a few words) is plagiarism even with a reference.
Part A: Spot the problem. The source is the Results section of Paper 2’s abstract (Hyun 2023):
“The positive fluid groups in both the D2 (HR, 2.13; 95% CI 1.48–3.06; P < 0.001) and D3 (HR, 1.56; 95% CI 1.10–2.22; P = 0.012) cohorts had significantly higher mortality rates than the negative fluid groups.”
For each version, tick OK or Problem, and say why.
| Version | OK | Problem | Why? |
|---|---|---|---|
| a) “The positive fluid groups in the D2 and D3 cohorts had significantly higher death rates than the negative fluid groups [2].” | ☐ | ☐ | |
| b) “In a matched registry cohort, a positive cumulative fluid balance on ICU days 2 and 3 was associated with higher 28-day mortality (hazard ratios 2.13 and 1.56) [2].” | ☐ | ☐ | |
| c) “Giving more fluid on days 2 and 3 doubles the risk of death [2].” | ☐ | ☐ | |
| d) “In a matched registry cohort, a positive cumulative fluid balance on ICU days 2 and 3 was associated with higher 28-day mortality.” (no citation) | ☐ | ☐ |
Part B: Your turn. Paraphrase this sentence from Paper 1’s abstract in your own words, with a citation:
“After 28 days, mortality and the numbers of days alive without life support were similar between groups.”
My paraphrase: ______________________________________________________________
Check: different structure? ☐ facts still correct? ☐ no stronger claim than the source? ☐ citation? ☐
Exercise 3: Read Paper 1’s abstract (individual, 12 minutes, segment 2.3)
Use the abstract only of Paper 1: Boulet N, et al. Crit Care 2024;28:429 (in Papers/). 8 minutes reading alone, then 4 minutes typing your primary outcome and main result in the chat.
The 15-minute reading order (for later): title (30 s), abstract (3 min), figures and tables (4 min), methods (5 min), then discussion and limitations (2–3 min). Stop early if the paper does not answer your question.
| Item | What the abstract says |
|---|---|
| Design (and blinding) | |
| P: who was included? | |
| I vs C: what was compared? | |
| Primary outcome (and when) | |
| Numbers: screened / randomised / analysed | |
| Main result: estimate with 95% CI and p | |
| Conclusion: one line | |
| Does the conclusion match the main result? | ☐ yes ☐ no. Why? |
| Any spin (words stronger than the numbers)? | ☐ yes ☐ no. Where? |
| Registration number | |
| Does this paper answer our running-example question (28-day mortality)? | ☐ yes ☐ no. Why? |
Fast finishers: read the title and abstract of Paper 2 (Hyun 2023). Which word in the title is stronger than the design allows? Which word does the abstract conclusion use instead?
Spin checklist: words to look for
| Data say | Spin says |
|---|---|
| p = 0.42 for the primary outcome | “a non-significant trend” |
| primary outcome: no difference | headline = a positive secondary outcome |
| observational association | “impact”, “effect”, “reduces” |
| change within one group only | “patients improved” |
Exercise 4: Proposal builder 2 (on your own, 35 minutes)
First the trainer searches live for the running example and you suggest terms and papers in the chat (10 minutes). Then you continue Part 1 of your own proposal in the Research Proposal template (Templates/Research_Proposal_Template.docx) and the literature review worksheet, building on last week’s question, aim and objectives. This sheet is your checklist. Anything unfinished is homework.
| Time | Task | Done |
|---|---|---|
| 0–10 min | Watch the trainer search and screen for the running example; suggest terms and papers in the chat | ☐ |
| 10–30 min | 1. Run your search string (Exercise 1) in PubMed; write the date, the filters and the number of hits | ☐ |
| 2. Screen titles and abstracts; pick 5 key papers; save them to Zotero (Send to → Citation manager, then import) | ☐ | |
| 3. Literature review worksheet: one row per paper | ☐ | |
| 4. Problem statement: three short paragraphs (about 300 words): (a) what is known, (b) what is not known (the gap), (c) why it matters here (local data, if you have them) | ☐ | |
| 5. Working title and keywords (see below) | ☐ | |
| 30–35 min | Two volunteers read their title and gap sentence aloud; everyone suggests one improvement in the chat | ☐ |
Working title and keywords
| Working title (10–16 words; population, comparison or exposure, and design visible; no abbreviations; no “impact” or “effect” for observational designs) | |
| Number of words | |
| Keywords (3–6; MeSH terms not already in the title) | 1. ____________ 2. ____________ 3. ____________ 4. ____________ |
Example (feasible rewrite of the running example): “Restrictive versus usual fluids in adults with septic shock: a pilot randomised trial” (13 words). Keywords: Fluid Therapy; Water-Electrolyte Balance; Critical Care; Vasoconstrictor Agents.
Literature review worksheet: one row per paper
| # | Study (first author, year, journal) | Design, size | Compared | Primary outcome: result | Key limitation | Why it matters for our question |
|---|---|---|---|---|---|---|
| 1 | ||||||
| 2 | ||||||
| 3 | ||||||
| 4 | ||||||
| 5 |
Search used for the references (paste the string, the database and the date):
Quality checks before you stop - [ ] The problem statement ends with your question; the title names the same population and outcome as the question. - [ ] At least one reference is a randomised trial or a systematic review, if one exists; you checked a trial registry for ongoing trials. - [ ] References are saved in Zotero. No sentence is copied from a source.
Exit question (in the chat, or the 1-question form linked there; 2 minutes, before you leave)
- Which gives MORE hits:
septic shock AND fluidsorseptic shock OR fluids? - What was the primary outcome of Paper 1?
Why we ask: it is not homework and not marked. It shows us what is still unclear. The trainers read every answer before Session 3.
Homework before Session 3 (next Saturday)
- Finish your five key references, worksheet rows and problem statement, so that your own Proposal Part 1 is complete with a working title and keywords.
- Read one of your papers with the 15-minute routine.
- Read the abstract of Paper 2 (Hyun 2023, Ann Intensive Care, in
Course/Papers) with the Exercise 3 grid. - Exercise 2 (paraphrasing) if not done in class.
- Optional: look up Paper 1’s registration (NCT04947904) on ClinicalTrials.gov.