Exclusion of older adults from randomized controlled trials in rheumatoid arthritis
Authors' conclusion
Older adults are commonly excluded from RCTs in RA based on both age limits and other eligibility criteria.
Study context
- Population
- Randomized controlled trials (RCTs) of pharmacological interventions in RA registered with ClinicalTrials.gov and started between 2013 and 2022RCTs
- Participants
- 290 rcts
- Outcome
- Co-primary: proportions of trials with an upper age limit and with eligibility criteria indirectly increasing risk of exclusion of older adults
Methodological detailsreview of RCTs registered with ClinicalTrials.gov, multivariable analysis
- Review of RCTs registered with ClinicalTrials.gov
- Multivariable analysis
Main finding
As reported in the abstract
Co-primary outcomes (single-group proportions of trials)
- Trials with an upper age limit of 85 years or less
- 143/290 (49%)
- Trials with ≥1 eligibility criterion implicitly excluding older adults
- 154/290 (53%)
- Implicit exclusion: specific comorbidities
- n = 114; 39%
- Implicit exclusion: compliance concerns
- n = 67; 23%
- Implicit exclusion: broad and vague exclusion criteria
- n = 57; 20%
Observational data: associations, not effects.
Further findings
Odds of an upper age limit by trial characteristics (multivariable analysis)
| aOR (CI) | P value | ||
|---|---|---|---|
| Trials performed in the USA | 0.34 (0.12–0.99) | P = 0.04 | |
| Intercontinental trials | 0.4 (0.18–0.87) | P = 0.02 | |
| 0.10.31310Adjusted odds ratio (log scale) |
Implicit exclusion criteria and trial characteristics
- No significant associations between these criteria and trial characteristics
Trials explicitly or implicitly excluding older patients
- Trials either explicitly or implicitly excluding older patients
- 217 (75%)
- Trials enrolling solely patients aged 65 and older
- one trial (0.3%)
- Trend towards increasing proportion of these trials over time
Original publication
Exclusion of older adults from randomized controlled trials in rheumatoid arthritis. Rheumatology (Oxford). Published 27 May 2023. doi:10.
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