The two papers
The two published papers answer the course’s running-example question in two different ways:
In adults with septic shock in the ICU, does a restrictive fluid strategy, compared with usual care, reduce mortality?
Paper 1 is a randomised trial and Paper 2 is an observational cohort. Reading them side by side shows how the study design limits what a paper is allowed to claim. Both are open access: read them on the publisher’s website with the DOI links below, or download the original PDF here.
Paper 1: randomised controlled trial
| Citation | Boulet N, Quenot J-P, Serrand C, et al. Impact on fluid balance of an optimized restrictive strategy targeting non-resuscitative fluids in intensive care patients with septic shock: a single-blind, multicenter, randomized, controlled, pilot study. Crit Care. 2024;28:429. |
| DOI | 10.1186/s13054-024-05155-z |
| Original article (PDF, from the publisher) | |
| Design | Single-blind, multicentre, parallel-group pilot RCT; 48 patients analysed. Primary outcome: cumulative fluid balance at day 5. Registered as NCT04947904. |
| Reporting guideline | CONSORT |
| Licence | CC BY-NC-ND 4.0 |
Paper 2: observational cohort
| Citation | Hyun D-G, Ahn JH, Huh JW, et al., on behalf of the Korean Sepsis Alliance (KSA) Investigators. Impact of a cumulative positive fluid balance during the first three ICU days in patients with sepsis: a propensity score-matched cohort study. Ann Intensive Care. 2023;13:105. |
| DOI | 10.1186/s13613-023-01178-x |
| Original article (PDF, from the publisher) | |
| Design | Propensity score-matched cohort from a prospective multicentre sepsis registry (20 hospitals). Primary outcome: 28-day mortality. |
| Reporting guideline | STROBE |
| Licence | CC BY 4.0 |
How the papers are used in the course
| Session | Use |
|---|---|
| 2 | Example records for the PubMed search demo; reading Paper 1’s abstract against the abstract checklist and looking for spin |
| 3–4 | One question answered by two designs; confounding by indication; which risk-of-bias tool fits each paper |
| 5–6 | Fluid balance as a CRF variable; reading hazard ratios, CIs, p-values and Kaplan–Meier curves; Paper 2 is the published model for the FLUID-ICU analysis |
| 7–8 | Worked examples of titles, abstracts, introductions, results and discussions; reporting guidelines; Be the reviewer: the whole class appraises Paper 1 and Paper 2 together with the critical appraisal checklist |
Note
Both articles are open access. The PDFs offered here are the publishers’ original versions, unchanged, shared under their licences (Paper 1: CC BY-NC-ND 4.0; Paper 2: CC BY 4.0). Please cite the papers as given above.