A systematic assessment of the characteristics of randomized controlled trials cited by acute coronary syndrome clinical practice guidelines
Authors' conclusion
This analysis demonstrates that RCTs cited by CPGs can still have significant methodological issues and limitations
Study context
- Population
- RCTs cited in ACC/AHA (2013, 2014) and ESC (2017, 2020) clinical practice guidelines for ST elevation myocardial infarction (STEMI) and non-ST elevation acute coronary syndrome (NSTE-ACS)RCTs
- Participants
- 407 rcts
- Outcome
- Methodological features of cited RCTs
Main finding
As reported in the abstract
- RCTs among non-duplicated references (2128)
- 19.1%
- Multicentre
- 81.8%
- Pharmacological interventions
- 63.1%
- 2-arm design
- 82.6%
- Superiority design
- 90.4%
- Active comparator
- 60.2%
- Funded by industry
- 46.2%
- Median observed sample size (patients)
- 1001
- Achieved ≥80% of intended sample size
- 84.2%
- Single primary outcome
- 90.9%
- Composite primary outcome
- 51.9%
- Superiority RCTs with P≥0.05 for primary outcome
- 44.0%
- Superiority RCTs with observed risk reduction >15%
- 61.9%
- Lower-than-expected treatment effect
- 67.6%
- ≥20% lower-than-expected treatment effect
- 34.4%
- Post hoc statistical power ≥80%
- 33.9%
Observational data: associations, not effects.
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
A systematic assessment of the characteristics of randomized controlled trials cited by acute coronary syndrome clinical practice guidelines. Eur Heart J Qual Care Clin Outcomes. Published 9 June 2023. doi:10.
Summarised from the published abstract; every number is checked against it