1. Study type & design
a. What question does it answer? (Descriptive, analytical, interventional?)
b. Is the design matched to the question?
c. Randomisation & blinding reported? (Ch 3)
2. Population & external validity
a. Who was included? (Inclusion/exclusion criteria)
b. Where? (Setting, country, volume)
c. Does it match your ICU?
3. Intervention & comparison
a. What was the intervention? (dose, timing, duration)
b. Was it delivered as described?
c. Standard care vs placebo?
4. Outcomes & measurement
a. Primary outcome? (clinically meaningful?)
b. How measured? (blinded?)
c. Outcome definition clear?
5. Statistical analysis
a. Primary analysis: ITT vs PP? (Ch 4)
b. Appropriate for data type? (Ch 5–13)
c. Confounders adjusted? (Ch 13)
d. Sample size/power reported? (Ch 7)
e. Interaction/sensitivity analyses? (Ch 13)
5. Results
a. Effect measures with 95% CIs? (Ch 7, 9)
b. CI clinically meaningful? (not just p < 0.05)
c. Results consistent with design?
6. Limitations & generalisability
a. Author‑acknowledged limitations
b. Sensitivity analyses?
c. Applicable to your ICU?
7. Decision
a. Should you change practice?
b. What further evidence is needed?
Open-access source library (verified free)
Resource | What you get |
StatPearls (NCBI Bookshelf) | Peer-reviewed chapters on biostatistics, study design, regression, Bayesian stats, survival analysis. |
BMJ Statistics Notes (Altman & Bland) | Short, practical pieces on CI interpretation, t‑tests, diagnostic metrics, odds ratios, and more. |
OpenIntro Statistics (openintro.org) | Free textbook with chapters on descriptive stats, probability, inference, regression, and meta‑analysis — includes R code. |
EQUATOR Network (equator-network.org) | PRISMA, CONSORT, STROBE, AMSTAR‑2 checklists — the gold standard for reporting and appraising studies. |
Cochrane RoR (riskofbias.org) | Tool for assessing risk of bias in randomized trials (for systematic reviewers). |
PMC full‑text articles | Freely available peer‑reviewed papers on ICU biostatistics, adaptive designs, Bayesian methods, and pragmatic trials. |