Table 3.
RLC | NLC | Difference† | |||
---|---|---|---|---|---|
Mean (SD) | Mean (SD) | Mean (95% CI) | p Value* | ||
Costs | |||||
Clinic consultations (only) | PP (69; 79)‡ | 198 (57.9) | 158 (76.7) | 34.2 (14.9 to 53.5) | 0.0008 |
ITT | 184 (79.5) | 148 (81.2) | 35.9 (15.6 to 56.1) | 0.0006 | |
NHS | |||||
(Clinic plus additional NHS resources) | PP (42; 50)‡ | 2171 (2822) | 1239 (2063) | 663 (−403 to 1730) | 0.2194 |
ITT | 2191 (3814) | 2282 (4277) | −150 (−1240 to 939) | 0.7858 | |
Healthcare | |||||
(NHS resources plus out-of-pocket expenditure) | PP (42; 50)‡ | 2286 (2793) | 1276 (2091) | 710 (−352 to 1773) | 0.1872 |
ITT | 2304 (3773) | 2386 (4565) | −128 (−1263 to 1006) | 0.8245 | |
Societal | |||||
(Healthcare plus productivity loss through time off work) | PP (42; 50)‡ | 2485 (2844) | 1357 (2107) | 863 (−219 to 1944) | 0.1161 |
ITT | 2415 (3785) | 2550 (4727) | −195 (−1354 to 963) | 0.7406 | |
Effects | |||||
QALY | PP (39; 48)‡ | 0.561 (0.228) | 0.552 (0.244) | 0.016 (−0.049 to 0.082) | 0.0002 |
ITT | 0.575 (0.234) | 0.554 (0.259) | 0.020 (−0.030 to 0.071) | <0.0001 | |
Average DAS28 change§ | PP (64; 69) ‡ | 0.02 (1.32) | 0.11 (1.05) | −0.31 (−0.63 to 0.02) | <0.0001 |
ITT | 0.06 (1.32) | 0.10 (1.10) | −0.15 (−0.45 to 0.14) | <0.0001 | |
Results of sensitivity test—after additional adjustment for baseline biological agents | |||||
Costs | |||||
NHS | |||||
PP (42; 50)‡ | 2171 (2822) | 1239 (2063) | 806.05 (–111.62 to 1723.72) | ||
ITT | 2191 (3814) | 2282 (4277) | 447.67 (−526.16 to 1421.50) | ||
Healthcare | |||||
PP (42; 50)‡ | 2286 (2793) | 1276 (2091) | 852.15 (−63.37 to 1767.67) | ||
ITT | 2304 (3773) | 2386 (4565) | 494.53 (−516.34 to 15015.41) | ||
Effects | |||||
QALY | PP (39; 48)‡ | 0.561 (0.228) | 0.552 (0.244) | 0.017 (−0.049 to 0.083) | |
ITT | 0.575 (0.234) | 0.554 (0.259) | 0.018 (−0.034 to 0.070) | ||
Average DAS28 change§ | PP (64; 69)‡ | 0.02 (1.32) | 0.11 (1.05) | −0.308 (−0.640 to 0.025) | |
ITT | 0.06 (1.32) | 0.10 (1.10) | −0.220 (−0.5458 to 0.105) |
*p Values based on superiority testing (ie, null hypothesis: standardised mean difference = 0.0) in relation to comparison of costs, and non-inferiority testing (ie, null hypothesis: standardised mean difference = 0.4) in relation to comparison of effects.
†Difference in mean DAS28 change scores for the RLC group minus NLC group (adjusted for age, gender, centre, baseline DAS28 score and baseline EQ5D) with CI.
‡Analysis of complete cases (number of responders to resource/time-off work questions—RLC group; NLC group).
§As presented in table 2.
DAS28, disease activity score in 28 joints; ITT, intention-to-treat; NLC, nurse-led clinic; PP, per protocol; QALY; quality-adjusted life-year; RLC, rheumatologist-led clinic.