Secondary outcomes

Outcome#Disease managementUsual managementDifference in adjusted means (95% CI)p-value
Subjects n157162
Moderate-severe exacerbations/patient2.0±2.02.0±1.90.815+
 Patients with at least 1 moderate-severe exacerbation112 (71.3)124 (76.5)
 Days to first exacerbation142.8±120.7141.9±121.20.556§
 Severe exacerbations/patient1.0±1.70.9±1.3
BODE index at 1 year4.7±2.15.3±2.0−0.5 (−0.9; −0.1)0.010
BODE index response rate at 1 year0.186ƒ,##
 Patients unchanged28 (26.4)28 (28.6)
 Patients who improved (decrease ≥1)45 (42.4)30 (30.6)
 Patients who worsened (increase ≥1)33 (31.1)40 (40.8)
6MWD m at 1 year300.5±96.6280.0±120.418.7 (−2.5; 39.8)0.084
6MWD response rate at 1 yearƒ0.126ƒ,##
 Patients unchanged35 (34.6)28 (28.3)
 Patients who improved (increase ≥26 m)38 (37.6)30 (30.3)
 Patients who worsened (decrease ≥26 m)28 (27.7)41 (41.4)
SGRQ-C total score at 1 year55.9±20.256.5±19.90.2 (−2.5; 3.0)0.862
 Patients with significant improvement (total score decrease ≥4)29 (29.6)31 (33.0)
HADS total score at 1 year20.9±3.220.8±3.10.2 (−0.3; 0.7)0.450
Smoking habits
 Patients who quit/baseline smokers9/342/340.021##
 Patients who restarted smoking/baseline ex-smokers3/1235/1280.501¶¶
Daily use of LTOT during study h per day13.7±6.314.3±6.60.2 (−1.3; 1.7)0.766++

Data are presented as n, n (%) or mean±sd, unless otherwise stated. Results shown are for the intention-to-treat population. p-values in bold type indicate statistically significant differences. #: at completion of 1-year follow-up period; : difference in means adjusted for baseline after ANCOVA and calculated as disease management group−usual management group; +: Wilcoxon rank-sum test; §: log-rank test; ƒ: patients with available data at baseline and 1 year; ##: Chi-squared test; ¶¶: Fisher's exact test; ++: difference in means adjusted for 3-month evaluation period after ANOVA and calculated as disease management group−usual management group. BODE index: body mass index, airflow obstruction, dyspnoea and exercise index; 6MWD: 6-min walking distance; SGRQ-C: chronic obstructive pulmonary disease-specific version of the Saint George's Respiratory Questionnaire; HADS: Hospital Anxiety and Depression Scale; LTOT: long-term oxygen therapy.