Figure 3. Additional Patient-Reported Outcomes.

A, Mean change in profile of mood states (POMS) total mood disturbance (TMD) from baseline to 24 months was approximately double in the closed-loop compared with open-loop group, a significant difference (closed-loop group: 18.6; open-loop group: 9.4; difference, 9.2 [95% CI, 1.8-16.5]; P = .02; repeated-measures model: estimate of the difference, 10.7 [95% CI, 3.9-17.6]; P = .002). Additionally, 68.0% of closed-loop compared with 42.9% of open-loop patients had a minimum clinically important difference (MCID) of ≥10 points (difference, 25.1% [95% CI, 5.4%-44.9%]; P = .02). B, For study inclusion, patients were required to be classified as having a severe disability or as “crippled” on the Oswestry Disability Index (ODI) (score, 41-80). At 24 months, 78.0% closed-loop vs 59.5% open-loop patients improved to minimum or moderate disability (score, 0-40). C, The mean improvement in the European Quality of Life Five-Dimensional Five-Level (EQ-5D-5L) index score was greater than 3 times the MCID (MCID = 0.074) in the closed-loop group (mean [SD], 0.254 [0.157]) and greater than 2 times the MCID in the open-loop group (mean [SD], 0.208 [0.163]).

^aSignificant difference between treatment groups (P < .05).