Relationship Between Clinical Control, Respiratory Symptoms and Quality of Life for Patients with COPD

Figures & data

Table 1 Criteria for Clinical Control Based on Clinical Criteria or CAT Criteria

Clinical Criteria for Control				CAT Criteria for Control
Concept	Item	FEV1≥50%	FEV1<50%	Concept	Item	FEV1≥50%	FEv1<50%
Low Impact (at least 3 of the 4)	Dyspnea	0–1	0–2	Low impact	CAT	0–10	0–16
	Rescue med	≤3 times/week		Stability (3 mo follow up)	Changes in CAT	≤2 points
	Sputum	White		Control		Low impact+ Stability
	Physical Activity	≥30 minutes/d
Stability (Both needed at 3 mo)	Exacerbations	None
	Subjective perception	Same/Better
Clinical Control		Low impact + Stability

Figure 1 STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) diagram of study participants.²⁴

Table 2 Baseline Clinical Characteristics of Participants at V1

	Total (n=93)	Clinical Criteria		p-value	CAT Criteria		p-value
		Controlled	Not controlled		Controlled	Not controlled
Age	65.9± 8.4	64.9±8.1	66.3±8.5	0.410	64.2±6.7	67.0±9.5	0.111
Sex (M), n (%)	79 (84.9%)	46 (88.0%)	33 (75.9%)	0.274	38 (86.4%)	39 (83.0%)	0.655
Smoking history
Current smokers, n (%)	22 (23.7%)	14 (28.0%)	8 (20.5%)	0.417	13 (25.9%)	9 (19.1%)	0.247
Tobacco consumption, pack-years	52.8±31.2	45.9±21.3	59.9±41.1	0.054	55.4±34.7	50.4± 28.4	0.451
FEV1, % predicted	49.8±16.5	51.6±16.5	48.8±16.5	0.426	49.5±16.7	50.5± 16.7	0.774
Mod and Severe exacerbations, prev year	0.9± 1.1	0.6± 1.1	1.0±0.9	0.120	0.5± 0.8	1.1± 1.2	0.005
Dyspnea, mMRC≥ 2	49 (52.8%)	19 (34%)	30 (74.4%)	0.001	17 (37.6%)	30 (63.8%)	0.037
6MWT	427.6±108.4	444.5±94.2	415.8±122.3	0.233	453.0±105.8	405.2± 107.7	0.043
GOLD grade, n (%)
GOLD A	37(39.8%)	28 (58%)	9 (22%)	0.008	29 (65%)	8 (17%)	<0.001
GOLD B	24 (25.8%)	12 (24%)	12 (30%)		6 (13%)	18 (38%)
GOLD C	11 (11.8%)	4 (6%)	7 (17%)		8 (18%)	3 (6%)
GOLD D	21 (22.6%)	8 (12%)	13 (32%)		2 (4%)	19 (39%)
COPD phenotype, n (%)
Non exacerbator	49 (52.7%)	32 (64%)	17 (43%)	0.047	29 (66%)	20 (42%)	0.025
ACO	13 (14.0%)	8 (16%)	5 (11%)		7 (16%	6 (14%)
Frequent exacerbator with CB	20 (21.5%)	2 (4%)	7 (18%)		1 (2%)	9 (19%)
Frequent exacerbator with emphysema	11 (11.8%)	8 (16%)	11 (28%)		7 (16%)	12 (25%)
COTE index	0.9±1.6	0.8±1.6	1.1±1.7	0.374	0.7±1.1	1.1±1.9	0.256
COTE index >4 points, n (%)	7 (7.6%)	3 (6.0%)	4(10.3%)	0.223	3 (6.8%)	4 (8.5%)	0.306
Symptom burden
CAT score	11.0±6.7	9.1±6.7	13.0±6.7	0.007	6.7±3.4	14.8±6.4	<0.001

Abbreviations: FEV1, forced expiratory volume at 1st second; mMRC, modified Medical Research Council; 6MWT, 6 minutes walking test; ACO, asthma; COPD, overlap; COTE, comorbidities index; CAT, COPD assessment test; CCQ, Clinical COPD questionnaire.

Table 3 Impact, Stability and Control During Study Visits (V1 and V2) Among Study Participants According to Clinical or CAT Criteria

CAT Evaluation	V1	V2	Clinical Evaluation	V1	V2
Impact (CAT)			Clinical Impact
Low	60 (64.4%)	57 (61.3%)	Low	62 (66.7%)	68 (73.1%)
High	33 (35.5%)	36 (38.8%)	High	31 (33.4%)	25 (26.9%)
Stability (CAT)			Stability (Exacerbations)
Stable	73 (78.5%)	68 (73.1%)	Stable	68 (73.1%)	66(70.9%)
No	20 (21.6%)	25 (26.9%)	No	25 (26.9%)	27 (29.1%)
Control (CAT)			Control
Controlled	45 (48.4%)	50 (53.8%)	Controlled	52 (55.1%)	55 (59.2%)
Not controlled	48 (51.6%)	43 (46.2%)	Not controlled	41 (44.1%)	38 (40.8%)

Table 4 Changes in Control Status Among Study Participants Between V1 and V2, Either by CAT Criteria or Clinical Criteria

	CAT Criteria	Clinical Criteria
Persistent controlled	34 (38.6%)	41 (44.8%)
Persistent non- controlled	29 (31.3%)	29 (31.3%)
Achieving control from V1 to V2	21 (21.7%%)	14 (15.4%)
Losing control from V1 to V2	9 (8.4%)	9 (8.5%)

Figure 2 Mean (SE) values of E-RS scores among patients controlled and not controlled (by CAT criteria-left- or by clinical criteria-right) at study visits. *p<0.05.

Figure 3 Mean (SE) weekly values of E-RS sub-scales scores (E-RS breath, E-RS cough and E-RS chest) at Visit 2 among controlled and not controlled patients (either by CAT criteria- left- or by clinical criteria-right). *p<0.05.

Table 5 Mean Weekly E-RS Scores at V0, V1 and V2 Among Controlled and Not Controlled Patients at V1 by CAT Criteria

		V0	P value	V1	P value	V2	P value
E-RS total score	Controlled	9.5±4.3	<0.001	11.2±6.2	<0.001	11.6±6.2	<0.001
	Not controlled	14.1±4.6		16.8±5.2		17.8±6.2
E-RS Breath	Controlled	3.0±3.3	<0.001	4.4±3.5	<0.001	4.7±2.9	<0.001
	Not controlled	5.8±3.2		8.2±3.7		8.6±4.5
E-RS Cough	Controlled	2.0±2.0	<0.001	2.0±1.8	0.001	2.1±1.5	<0.001
	Not controlled	3.8±2.2		3.6±2.3		3.7±2.1
E-RS Chest	Controlled	0.9±1.5	0.001	1.7±2.1	0.001	1.7±2.0	<0.001
	Not controlled	2.2±2.1		3.3±2.3		3.9±2.5

Notes: P values are referred to T test between controlled and not controlled patients at each visit.

Table 6 Mean Weekly E-RS Scores at V0, V1 and V2 Among Controlled and Not Controlled Patients at V1 by Clinical Criteria

		V0	P value	V1	P value	V2	P value
E-RS total score	Controlled	10.2±4.5	0.001	11.3±5.5	<0.001	12.5±5.5	<0.001
	Not controlled	13.6±4.8		16.9±5.2		17.5±7.0
E-RS Breath	Controlled	3.6±3.1	0.015	4.8±3.7	<0.001	5.3±3.1	<0.001
	Not controlled	5.4±3.8		8.4±3.6		8.7±4.8
E-RS Cough	Controlled	2.4±2.1	0.041	2.1±1.8	0.001	2.6±1.5	0.069
	Not controlled	3.4±2.4		3.6±2.2		3.4±2.4
E-RS Chest	Controlled	1.2±1.7	0.205	2.0±2.3	0.024	2.3±2.3	0.16
	Not controlled	1.7±2.1		3.1±2.2		3.7±2.8

Notes: P values are referred to T test between controlled and not controlled patients at each visit.

Figure 4 Mean EQ5D values at V2 between controlled and not controlled patients at V2 according to CAT criteria (left) and clinical criteria (right). *p<0.05.

von ElmE, AltmanDG, EggerM, PocockSJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for reporting observational studies. Lancet 2007 Oct 20;370(9596):1453–7. PMID: 18064739

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