Is detection of disease-modifying osteoarthritis drug treatment more effective when performing cartilage morphometry without blinding to MR image acquisition order?
Primary result · TFTJ_ThC change, unblinded vs blinded (all groups)Result — go to the resultDifference −35 µmAuthors' conclusion
These results do not reveal that detection of proposed DMOAD treatment is enhanced with MRIs read unblinded to order; rather, the sensitivity is similar to blinded analysis.
Study context
- Population
- Knee OA patients in the FORWARD RCT randomised 1:1:1:1:1 to intra-articular placebo, sprifermin 30 µg or 100 µg every 6 or 12 M549 randomised
- Participants
- 352 patients
- Comparison
- Cartilage morphometry read unblinded vs blinded to magnetic resonance imaging (MRI) acquisition order
- Primary endpoint
- Total femorotibial joint cartilage thickness (TFTJ_ThC) change, unblinded vs blinded analysis
- Follow-up
- 24 months
Methodological detailsmethodological comparison of blinded vs unblinded MRI reading
- Methodological comparison of blinded vs unblinded MRI reading
Primary result
As reported in the abstract
TFTJ_ThC change, unblinded vs blinded (all groups)
Difference
−35 µm
Further findings
| Outcome | Placebo | 100 µg/every 6 M | Difference (µm) (95% CI) | |
|---|---|---|---|---|
| TFTJ_ThC change, unblinded analysis: placebovs 100 µg every 6 M · 24 monthsCohen D = −0.66 | −46 ± 57 µm | −2.2 ± 73 µm | 44 (22–66) | |
| TFTJ_ThC change, blinded analysis: placebovs 100 µg every 6 M · 24 monthsCohen D = −0.69 | −11 ± 53 µm | 30 ± 62 µm | 40 (21–60) | |
| −50050100Difference, µm (linear scale) |
Treatment effect of 100 µg sprifermin every 6 M on TFTJ_ThC (both analyses) · 24 months
- Statistically significant treatment effects
- P < 0.001
Original publication
Is detection of disease-modifying osteoarthritis drug treatment more effective when performing cartilage morphometry without blinding to MR image acquisition order? Osteoarthritis Cartilage. Published 4 June 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →