Figures
- Figure 1–
a) Capacity of Daily Living during the Morning (CDLM) and b) Global Chest Symptoms Questionnaire (GCSQ) scores of patients classified by health status according to the St George’s Respiratory Questionnaire for COPD patients (SGRQ-C). Data are mean±sd (minimum and maximum), with the central line within the box representing the mean, the outer edges of the box representing the sd, and the whiskers representing the minimum and the maximum. □: Study 1; ▓: Study 2. For Study 1, SGRQ-C grouping, by quartile values, were: group (G)I <51, GII ≥51 to <63, GIII ≥63 to <75 and GIV ≥75; corresponding figures for Study 2 were GI <53; GII ≥53 to <67; GIII ≥67 to <80 and GIV ≥80.
- Figure 2–
a) Capacity of Daily Living during the Morning (CDLM) questionnaire and b) Global Chest Symptoms Questionnaire (GCSQ) scores of patients classified according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity stage. Data are mean±sd (minimum and maximum), with the central line within the box representing the mean, the outer edges of the box representing the sd, and the whiskers representing the minimum and the maximum. □: Study 1; ▓: Study 2. Group (G)II, GIII and GIV refer to GOLD severity stages II–IV and were based on forced expiratory volume in 1 s % predicted of normal post-dose GII ≥50 to <80, GIII ≥30 to <50 and GIV <30, e.g. GIV <30 is GOLD severity stage IV with FEV1 <30% predicted normal post-dose.
Tables
- Table 1– Items included in the Capacity of Daily Living during the Morning (CDLM) questionnaire and the Global Chest Symptoms Questionnaire (GCSQ)
Items Response options CDLM questionnaire 1) Did you wash yourself this morning other than your face i.e. body wash, shower or bathe? a, c 2) Did you dry yourself with a towel after washing this morning? a, c 3) Did you get dressed this morning? b, c 4) Did you eat breakfast this morning? b, c 5) Did you walk around your home early this morning after taking your medicine? b, c 6) Did you walk around your home later this morning? b, c GCSQ 1) How short of breath are you feeling right now? d 2) How tight does your chest feel right now? d Response options were as follows. a: “Yes, I did it by myself”; “Yes, but I needed help”; “No, I was unable to”; “No, I did not for other reasons”. b: “Yes, I did”; “No, I was unable to”; “No, I did not for other reasons”. c: If answering “yes”, subjects were asked to answer the follow-up question “How difficult was it for you to perform the task?” by selecting from the following response options “Not at all”, “A little”, “Moderately”, “Very” or “Extremely”. d: “Not at all”, “A little”, “Moderately”, “Very”, “Extremely”.
- Table 2– Patient demographics of Studies 1# and 2¶
Characteristic Study 1 Study 2 PBO + TIO BUD/FORM + TIO All Subjects n 331 329 442 Males 245 (74) 251 (76) 316 (71) Mean age yrs (range) 62.5 (41–82) 62.4 (40–85) 63.0 (40–86) Median time since diagnosis yrs (range) 5.7 (0.2–52.6) 5.7 (0.3–43.4) 6.3 (0–52) Previous smokers % 54 58 66 Median smoking history pack-yrs (IQR) 38 (11) 36 (12) 40 (30) Mean FEV1 % pred normal (range) 37.7 (16–51) 38.1 (10–58) 36.1 (13−51) GOLD severity stage+ II ≥50–<80% 70 (21) 90 (27) 98 (22) III ≥30–<50% 217 (66) 203 (62) 261 (59) IV <30% 42 (13) 33 (10) 82 (19) Data are presented as n (%), unless otherwise stated. PBO: placebo; TIO: tiotropium; BUD: budesonide; FORM: formoterol; IQR: interquartile range; FEV1: forced expiratory volume in 1 s; % pred: % predicted; GOLD: Global Initiative for Chronic Obstructive Lung Disease. #: Welte et al. 12; ¶: Partridge et al. 14; +: defined by measuring post-bronchodilator FEV1 as % pred normal. Data from 12, 14.
- Table 3– Reliability estimates of the Capacity of Daily Living during the Morning (CDLM) questionnaire and the Global Chest Symptoms Questionnaire (GCSQ)
Internal consistency# ICC Study 1 Study 2 Study 1 Study 2 Subjects n 660 441 578 376 CDLM 0.93 0.93 0.89 0.90 GCSQ 0.82 0.88 0.82 0.75 ICC: intraclass correlation coefficient. #: Cronbach’s α.
- Table 4– Pearson product–moment correlations between Capacity of Daily Living during the Morning (CDLM) or the Global Chest Symptoms Questionnaire (GCSQ) score and measures of lung function, symptoms and health status
CDLM GCSQ Study 1 Study 2 Study 1 Study 2 Subjects n 547 361 646 437 PEF morning 0.10* 0.11* -0.12* -0.16* FEV1 morning 0.01 0.03 -0.08 0.00 Total rescue -0.37*** -0.17*** 0.40*** 0.20*** Breathlessness -0.65*** 0.73*** Cough -0.43*** 0.51 Chest tightness -0.58*** 0.81*** Sleep -0.56*** 0.58*** CCQ Total -0.61*** 0.70*** Symptoms -0.49*** 0.65*** Function -0.63*** 0.65*** Mental -0.53*** 0.59*** SGRQ-C Total -0.55*** -0.49*** 0.52*** 0.35*** Symptoms -0.32*** -0.16*** 0.42*** 0.27*** Activity -0.57*** -0.43*** 0.44*** 0.26*** Impact -0.47*** -0.48*** 0.46*** 0.33*** PEF: peak expiratory flow; FEV1: forced expiratory volume in 1 s; CCQ: Clinical COPD Questionnaire; SGRQ-C: St George’s Respiratory Questionnaire for COPD patients. *: p<0.05; ***: p<0.001.
- Table 5– Assessment of morning responsiveness to change according to Capacity of Daily Living during the Morning (CDLM) questionnaire and Global Chest Symptoms Questionnaire (GCSQ) scores from run-in to the end of treatment
Subjects n Mean ES SRM t-statistic Run-in End Change CDLM Study 1 230 4.13 4.33 0.16 0.24 0.44 6.73*** Study 2 316 3.61 3.86 0.22 0.23 0.36 6.36*** GCSQ Study 1 287 1.41 1.26 -0.15 0.24 0.34 5.77*** Study 2 418 1.61 1.41 -0.20 0.32 0.42 8.74*** ES: effect size; SRM: standardised response mean. ***: p<0.001. Analyses of responsiveness were made for patients who received a change in treatment compared to the run-in period, i.e. not including the placebo group in Study 1, but including both active treatment groups in Study 2.
- Table 6– Assessment of morning responsiveness to change according to Global Chest Symptoms Questionnaire (GCSQ) and peak expiratory flow (PEF) scores from pre- to post-dose
Subjects n Mean change ES SRM t-statistic Correlation r-value Study 1 ΔGCSQ5 296 -0.18 -0.27 -0.69 -11.67*** -0.22 ΔPEF5 294 12.44 0.19 0.63 10.86*** ΔGCSQ15 293 -0.26 -0.40 -0.89 -15.24*** -0.28 ΔPEF15 293 16.11 0.24 0.81 13.86*** Study 2 ΔGCSQ5 380 -0.20 -0.30 -0.68 -13.40*** -0.12 ΔPEF5 379 8.68 0.15 0.47 9.16*** ΔGCSQ15 380 -0.32 -0.48 -0.79 -15.29*** -0.19 ΔPEF15 380 11.95 0.21 0.55 10.68*** ΔGCSQ5 and δGCSQ15: change in GCSQ score from pre-dose to 5- and 15-min post-dose, respectively. δPEF5 and δPEF15: change in PEF from pre-dose to 5- and 15 min post-dose, respectively. ES: effect size; SRM: standardised response mean. ***: p<0.001.
- Table 7– Estimates of minimally important differences (MIDs) for Capacity of Daily Living during the Morning (CDLM) and Global Chest Symptoms Questionnaire (GCSQ) scores using anchor- and distribution-based approaches
Subjects n Anchor-based approach Distribution-based approaches SGRQ-C (sem)# SEM¶ 0.5 sd+ CDLM questonnaire Study 1 469 0.15 (0.01) 0.19 0.40 Study 2 316 0.22 (0.02) 0.28 0.42 GCSQ Study 1 578 0.13 (0.01) 0.27 0.32 Study 2 418 0.12 (0.02) 0.22 0.44 SGRQ-C: St George's Respiratory Questionnaire for chronic obstructive pulmonary disease patients; SEM: standard error of measurement. #: MID = 4; ¶: MID = sd×square root (1–α); +: MID = 0.5×sd.
