Table 4

Outcome measures

Outcome measure (n)Baseline mean (SD)Month 12 mean (SD)Mean change (95% CI)p Value
MRSS (24)29.4 (8.6)22.8 (10.2)−6.6 (−4.5 to −8.7)<0.001
PFT All (22)
 FVC % predicted82.9 (21.1)89.3 (25.2)6.4 (1.9 to 10.9)0.008
 DLCO Hb adj % predicted78.0 (22.9)83.5 (29.2)5.5 (−1.5 to 12.4)0.12
PFT ILD (11)
 FVC % predicted73.3 (18.3)75.4 (20.7)2.1 (−2.8 to 7)0.36
 DLCO Hb adj % predicted64.7 (14.0)65.7 (15.6)1.0 (−8.1 to 10.1)0.81
PFT not ILD (11)
 FVC % predicted92.6 (19.8)103.2 (21.8)10.7 (3.3 to 18.2)0.01
 DLCO Hb adj % predicted91.3 (22.8)101.2 (29.2)9.9 (−1.7 to 21.5)0.09
HRQoL (24)
 VAS global46.7 (22.4)37.1 (28.2)−9.6 (0.2 to 19.0)0.046
 VAS SOB19.6 (24.2)12.8 (24.6)−6.7 (2.0 to 11.5)0.008
 VAS pain49.5 (27.4)30.8 (29.7)−18.7 (9.7 to 27.8)<0.001
 VAS RP37.3 (28.7)30.0 (28.9)−9.3 (−1.9 to 20.5)0.098
 VAS digital ulcers33.6 (37.8)21.1 (28.5)−12.5 (−0.9 to 25.9)0.066
 SHAQ-DI1.1 (0.6)1.1 (0.7)0.02 (−0.15 to 0.18)0.85
 SF-36 PC46.8 (17.3)53.5 (25.6)6.8 (1.7 to 15.3)0.11
 SF-36 MC61.5 (15.8)68.1 (18.6)−6.6 (−12.5 to −0.7)0.03
Other
 PGA6.3 (1.6)4.1 (2.3)−2.2 (−2.9 to −1.4)<0.001
 ESR25.6 (18.8)22.1 (15.5)−3.5 (−4.0 to 11.0)0.35
  • DLCO, diffusion capacity of carbon monoxide; ESR, erythrocyte sedimentation rate; FVC, forced vital capacity; Hb, haemoglobin; HRQoL, health-related quality of life; MC, mental component; MRSS, modified Rodnan skin score; PC, physical component; PFT, pulmonary function test; PGA, physician global assessment; RP, Raynaud's phenomenon; SF-36, short form 36; SHAQ-DI, scleroderma health assessment questionnaire disability index; SOB, shortness of breath; VAS, visual analogue scale.