Session 7: Exercise sheet
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Foundations of Clinical Research · Level 1 · Neudata · #ClearDataClearImpact · Week 7 · Saturday 12 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 | Integrity scenarios: green, amber or red? | 20:25 (5 min) | Whole class, polls: 3 scenarios in class, 3 at home |
| B | Proposal builder 7: ethics, registration, feasibility, publication plan | 20:30 (15 min) | The instructor models it on the running example; you write your own Part 4 at home |
| C | Manuscript workshop 1: Methods + Results of your FLUID-ICU paper | 21:35 (45 min) | 30 min whole class on Q1, then 15 min on your own question; finish at home |
Files you need (all in the course folder and sent before the session): the results pack for the question you chose (Course/Data/results_packs/Results_Pack_Q1 to Q5); the manuscript template (Course/Templates/Manuscript_Template_IMRaD); Paper 1 (Boulet 2024, a randomised pilot trial of restrictive fluids in septic shock) and Paper 2 (Hyun 2023, a propensity-matched cohort of fluid balance and death in sepsis), both in Course/Papers.
Part A: Integrity scenarios: green, amber or red? (5 minutes, 20:25)
In class we vote on scenarios 1, 3 and 4 in a poll; scenarios 2, 5 and 6 are homework. For each scenario choose:
- GREEN: acceptable as described.
- AMBER: acceptable only if something is fixed or disclosed (say what).
- RED: research misconduct or a serious breach. Do not do it.
Write one sentence explaining your colour.
| # | Scenario | Colour | Why? |
|---|---|---|---|
| 1 | Three patients’ day-3 fluid charts are lost. A resident “remembers roughly” what their balances were and enters values so the dataset is complete. | ||
| 2 | After seeing the results, the team removes two patients with “strange” fluid values because they weaken the association. The paper does not mention it. | ||
| 3 | The head of department did not take part in the study but asks to be last author “because it is my department”. | ||
| 4 | (a) A nurse uses an AI chatbot to improve the English of the Discussion she wrote, checks every sentence, and states this in the Acknowledgements. (b) A colleague uploads the study spreadsheet (names and hospital numbers included) to a free public chatbot and asks it to “run the statistics”. | (a) | |
| (b) | |||
| 5 | A cohort of patients with sepsis like FLUID-ICU is published as three papers (mortality, acute kidney injury and ICU stay) in three journals, none mentioning the others. | ||
| 6 | Two paragraphs of a published review are copied word for word into your Introduction. The review is cited at the end of the paragraph, but there are no quotation marks. |
Part B: Proposal builder 7: ethics, registration, feasibility and publication plan
In class (20:30, 15 minutes): the instructor fills in this worksheet live on the shared screen for the running example (a retrospective cohort of fluid balance and 28-day mortality in adults with septic shock in our ICU). You suggest answers in the chat.
At home this week: fill it in for your own proposal. It becomes Part 4 of your written proposal and slides 5 (ethics and feasibility) and 6 (publication plan) of your presentation. Everyone submits the written proposal and the 6 slides before 19:30 on the day of Session 8 (Course/Assignment/proposal_brief.md).
B1. Ethics and consent
| Question | Your answer |
|---|---|
| Which ethics committee will review the study? What type of review do you expect (exempt / expedited / full)? The committee decides. | |
| Who are the participants, and can they decide for themselves when they become eligible? | |
| Who gives consent (patient / legal representative / deferred consent / waiver requested)? Use the ICU consent flowchart (Session 7 slides). | |
| Who takes consent, when and where? | |
| What are the risks and burdens for participants, and how are they minimised? | |
| Does the study need registration (trials: yes, before the first patient, in ClinicalTrials.gov or another WHO registry; systematic reviews: PROSPERO; observational: recommended)? |
B2. Confidentiality
| Question | Your answer |
|---|---|
| Which direct identifiers will you collect (if any), and why? | |
| How will each patient get a study code? | |
| Where is the key file (code to identity) kept, and who can open it? | |
| Where will the de-identified data be stored (institution-approved, password-protected)? |
B3. Feasibility check (tick and comment)
| ✓ | Question | Comment |
|---|---|---|
| ☐ | Time: realistic timeline (ethics 1–3 months, recruitment, analysis, writing)? | |
| ☐ | Money: budget headings named (staff time, materials/tests, publication fee)? | |
| ☐ | People: who collects data (nights, weekends), who analyses, protected time? | |
| ☐ | Patients: how many eligible patients did your unit see last year? How many can you realistically enrol? | |
| ☐ | Data: are the key variables recorded routinely? How much is likely missing? |
Biggest feasibility risk: ______________________ One fix: ______________________
B4. Publication plan (slide 6 of your presentation)
| Item | Your answer |
|---|---|
| Working title (from your PICO: design, I vs C, P, O; 10–16 words) | |
| Target journal (and a back-up), checked in DOAJ / NLM Catalog, with fees and licence known | |
| Reporting guideline (CONSORT / STROBE / STARD / PRISMA / SPIRIT / CARE) | |
| Registration needed? Where? (from B1) | |
| Authors (all four ICMJE criteria) and their roles (CRediT) | |
| Conflicts of interest and funding to declare | |
| Data-sharing statement (what, where, under which conditions) | |
| Conference where you would present an abstract first |
Structured-abstract skeleton. One line each. Results are the results you expect to report (format, not numbers).
| Section | One line |
|---|---|
| Background | |
| Methods | |
| Results (expected) | e.g. “28-day mortality: n/N per group, RR (95% CI)” |
| Conclusion | Write the sentence you would use if the result is positive, and the one you would use if it is not. |
Part C: Manuscript workshop 1: Methods and Results (45 minutes, 21:35)
What you are doing
Each participant writes the Methods and Results of their own short STROBE-guided paper on one FLUID-ICU question, using only the results pack for that question. We give you the results; you write the paper. Nobody calculates anything.
| Question | Topic | Results pack |
|---|---|---|
| Q1 | Positive fluid balance by day 3 and 28-day mortality | Course/Data/results_packs/Results_Pack_Q1 |
| Q2 | Cumulative fluid balance and acute kidney injury (AKI) | Results_Pack_Q2 |
| Q3 | Cumulative fluid balance and ventilator-free days | Results_Pack_Q3 |
| Q4 | Initial lactate and 28-day mortality; complete-case vs multiple imputation | Results_Pack_Q4 |
| Q5 | Fluid balance and ICU length of stay among survivors | Results_Pack_Q5 |
FLUID-ICU is a simulated teaching dataset. In your ethics sentence write: “This analysis used a simulated teaching dataset; no ethics approval or consent was required.”
How the 45 minutes are used
| Clock | Who | Task |
|---|---|---|
| 21:35–21:50 | Whole class, on Q1 | The instructor shares the template and results pack Q1. You suggest each Methods sentence in the chat; the instructor types the best one. |
| 21:50–22:02 | Whole class, on Q1 | Results: participants first, the Table 1 sentence, outcome numbers, crude and adjusted estimates. |
| 22:02–22:05 | Whole class | A volunteer reads every number in the class draft against the pack. |
| 22:05–22:20 | You, alone | Open the results pack for YOUR question. Follow the structure of the class draft and start your Methods. Ask questions in the chat. |
| At home | You | Finish the Methods and Results (~600 words), Table 1 and one figure or table. If you chose Q1, write it in your own words; do not copy the class draft. |
The class draft is shared as a PDF after the session.
Methods: headings and checklist (STROBE items in brackets)
- Study design and setting (4, 5): prospective multicentre cohort; 4 ICUs; dates as given in the pack.
- Participants (6): who was included and excluded; how many.
- Variables (7): exposure (how fluid balance was calculated and over which days), outcome (definition and time point), confounders adjusted for.
- Data sources (8): routine ICU charts / study case report form.
- Bias (9): how confounding by indication was addressed (adjustment for severity).
- Study size (10): “all eligible patients in the cohort were included” (no new sample size for a fixed dataset).
- Statistical analysis (12): summary statistics; the test for each comparison; the regression model(s) and which variables; how missing data were handled; software (R, version from the pack); reporting of 95% CIs.
Results checklist
Question-specific reminders
- Q3: ventilator-free days are skewed and count death as zero; choose the summary accordingly.
- Q4: report BOTH the complete-case and the multiple-imputation estimates.
- Q5: survivors only; use medians and IQR.
Deliverable
Your own Methods + Results (~600 words) + Table 1 + one figure or table, saved as Surname_Manuscript_QN_draft1 in the course folder (or sent by email) before Session 8. In Session 8 you add the Introduction, Discussion, Abstract and Title, and submit the complete draft by 23:59 that day (Course/Assignment/manuscript_brief.md).