Shared Decision-Making Facilitates Inhaler Choice in Patients with Newly-Diagnosed Chronic Obstructive Pulmonary Disease: A Multicenter Prospective Study

Figures & data

Figure 1 (A) Flowchart showing the enrollment of patients. (B) Bullseye plot showing the numbers of patients choosing different inhalers on the visit 1 (inner circle) and the decision of keeping or changing inhalers on the visit 2 (outer circle).

Table 1 Baseline Characteristics of Patients Completed Two Visits

Variables	Respimat^®	Ellipta^®	Breezhaler^®	P value
Number	36	41	19
Age (years old)	66 (61–72)	69 (63–72)	66 (61–74)	0.7336
Male	33 (92%)	39 (95%)	18 (95%)	0.8624
Education
Junior high school or lower	17 (47%)	23 (56%)	11 (58%)	0.4699
Senior high school or higher	19 (53%)	18 (44%)	8 (42%)
Smoking history
Current smoker	23 (64%)	18 (44%)	8 (42%)	0.1532
Ex-smoker	10 (28%)	20 (49%)	11 (58%)
Comorbidity (any)	32 (89%)	38 (93%)	16 (84%)	0.5127
Hand Tremor	0 (0%)	1 (2%)	0 (0%)	>0.999
Old cerebral vascular accident	3 (8%)	2 (5%)	0 (0%)	0.6103
Depression	1 (3%)	1 (2%)	1 (5%)	0.7934
Insomnia	4 (11%)	6 (15%)	4 (21%)	0.6050
Obstructive sleep apnea	1 (3%)	0 (0%)	0 (0%)	0.5729
Cataract	8 (22%)	6 (15%)	2 (11%)	0.5943
Other eye diseases	2 (6%)	1 (2%)	0 (0%)	0.5971
Coronary artery disease/MI	4 (11%)	8 (20%)	4 (21%)	0.4919
Heart failure	0 (0%)	0 (0%)	1 (5%)	0.1979
Hypertension	15 (42%)	24 (59%)	10 (53%)	0.3449
Arrhythmia	5 (14%)	2 (5%)	2 (11%)	0.3888
Diabetes mellitus	7 (19%)	10 (24%)	4 (21%)	0.9475
Dyslipidemia	9 (25%)	7 (17%)	2 (11%)	0.4053
Pulmonary fibrosis	1 (3%)	1 (2%)	0 (0%)	>0.999
Bronchiectasis	1 (3%)	3 (7%)	0 (0%)	0.5279
Chronic kidney disease	0 (0%)	2 (5%)	1 (5%)	0.4163
Cirrhosis	0 (0%)	1 (2%)	0 (0%)	>0.999
Dental problems	5 (14%)	1 (2%)	1 (5%)	0.1376
Malignancy	5 (14%)	5 (12%)	1 (5%)	0.7126
Others	10 (28%)	13 (32%)	5 (26%)	0.9164
Airflow limitation (GOLD grade)
1 (FEV1 ≥ 80%pred)	9 (25%)	14 (34%)	6 (32%)	0.3116
2 (80%pred > FEV1 ≥ 50%pred)	24 (67%)	21 (51%)	8 (42%)
3 (50%pred > FEV1 ≥ 30%pred)	3 (8%)	6 (15%)	4 (21%)
4 (FEV1 < 30%pred)	0 (0%)	0 (0%)	1 (5%)
Baseline CAT score	7.5 (5–12)	7 (3–11)	6 (4–10)	0.2933
<10	21 (58%)	27 (66%)	14 (74%)	0.5719
≥10	15 (42%)	14 (34%)	5 (26%)
Baseline mMRC grade	2 (1–2)	2 (1–2)	2 (1–2)	0.7685
<2	14 (39%)	14 (34%)	7 (37%)	0.9609
≥2	22 (61%)	27 (66%)	12 (63%)
Acute exacerbation (AE) in the past year
No	32 (89%)	38 (93%)	17 (89%)	0.7396
Mild AE (≥1 time)	1 (3%)	2 (5%)	1 (5%)
Moderate AE (once)	2 (6%)	0 (0%)	0 (0%)
≥2 moderate AE or ≥1 severe AE	1 (3%)	1 (2%)	1 (5%)
GOLD group
A	10 (28%)	13 (32%)	7 (37%)	0.6862
B	25 (69%)	27 (66%)	11 (58%)
C	0 (0%)	1 (2%)	0 (0%)
D	1 (3%)	0 (0%)	1 (5%)

Notes: Data are presented in n (%) or median (interquartile range). P values were assessed with Fisher’s exact test or Kruskal–Wallis test. Acute exacerbation (AE), according to the GOLD guideline, are classified as mild (treated with short-acting bronchodilators only, SABDs), moderate (treated with SABDs plus antibiotics and/or oral corticosteroids) or severe (patient requires hospitalization or visits the emergency room). Severe exacerbations may also be associated with acute respiratory failure.

Abbreviations: MI, myocardial infarction; pred, predicted; GOLD, Global Initiative for Chronic Obstructive Lung Disease; CAT, COPD Assessment Test; mMRC, Modified British Medical Research Council.

Table 2 Number of Patients with Error(s) and Times of Error(s) That Required Re-Education in Patients Completed Two Visits

Variables	Respimat^®	Ellipta^®	Breezhaler^®	P value
Correctness (visit 1)
Any error	30 (83%)	31 (76%)	12 (63%)	0.2451
Totally correct	6 (17%)	10 (24%)	7 (37%)
Error times per step (visit 1)	0.5 (0.2–1.1)	0.2 (0.2–0.4)	0.1 (0–0.5)	0.0265
Correctness (visit 2)
Any error	18 (50%)	9 (22%)	9 (47%)	0.0253
Totally correct	18 (50%)	32 (78%)	10 (53%)
Error times per step (visit 2)	0.1 (0–0.4)	0 (0–0)	0 (0–0.2)	0.0379
Improvement in error times per step (visit 2 - visit 1)	0.3 (0–0.9)	0.2 (0–0.4)	0.1 (0–0.4)	0.1194
Critical error (visit 1)	26 (72%)	31 (76%)	12 (63%)	0.5832
Critical preparation error (visit 1)	18 (50%)	11 (27%)	9 (47%)	0.0897
Did not twist the base one half-turn	16 (44%)	N/A	N/A
Did not open the device correctly	7 (19%)	11 (27%)	4 (21%)
Did not place capsule in the chamber	N/A	N/A	3 (16%)
Did not close the mouthpiece	N/A	N/A	3 (16%)
Did not press button to pierce the capsule	N/A	N/A	6 (32%)
Critical delivery error (visit 1)	24 (67%)	28 (68%)	8 (42%)	0.1298
Did not seal lips around mouthpiece during inhalation, synchronize actuation and inhalation (Respimat only), inhale slowly (Respimat)/forcefully (Ellipta)/quickly (Breezhaler) and deeply, or hold breath after inhalation	24 (67%)	28 (68%)	8 (42%)
Did not remove capsule and check for powder residue	N/A	N/A	4 (21%)
Critical error (visit 2)	10 (28%)	9 (22%)	9 (47%)	0.1401
Critical preparation error (visit 2)	3 (8%)	2 (5%)	3 (16%)	0.3577
Did not twist the base one half-turn	2 (6%)	N/A	N/A
Did not open the device correctly	3 (8%)	2 (5%)	2 (11%)
Did not place capsule in the chamber	N/A	N/A	2 (11%)
Did not close the mouthpiece	N/A	N/A	2 (11%)
Did not press button to pierce the capsule	N/A	N/A	3 (16%)
Critical delivery error (visit 2)	8 (22%)	9 (22%)	8 (42%)	0.2532
Did not seal lips around mouthpiece during inhalation, synchronize actuation and inhalation (Respimat only), inhale slowly (Respimat)/forcefully (Ellipta)/quickly (Breezhaler) and deeply, or hold breath after inhalation	8 (22%)	9 (22%)	8 (42%)
Did not remove capsule and check for powder residue	N/A	N/A	3 (16%)

Notes: Data are presented in n (%) or median (interquartile range). P values were assessed with Fisher’s exact test or Kruskal–Wallis test.

Table 3 Adherence, Satisfaction Score, and Willingness to Keep the Inhaler

Variables	Respimat^®	Ellipta^®	Breezhaler^®	P value
Adherence
Use as the prescription daily	28 (80%)	36 (88%)	15 (79%)	0.6135
Use in 5–6 days per week	6 (17%)	5 (12%)	3 (16%)
Use ≤4 days per week	1 (3%)	0 (0%)	1 (5%)
Satisfaction score
1	1 (3%)	1 (2%)	0 (0%)	0.6791
2	2 (6%)	0 (0%)	1 (5%)
3	9 (25%)	10 (24%)	2 (11%)
4	18 (50%)	21 (51%)	13 (68%)
5	6 (17%)	9 (22%)	3 (16%)
Satisfied
No (satisfaction score ≤3)	12 (33%)	11 (27%)	3 (16%)	0.3969
Yes (satisfaction score ≥4)	24 (67%)	30 (73%)	16 (84%)
Willingness to keep the inhaler
No	2 (6%)	3 (7%)	2 (11%)	0.7770
Yes	34 (94%)	38 (93%)	17 (89%)

Notes: Data are presented in n (%). Adherence was evaluated by a patient-reported questionnaire from good (use as the prescription daily), fair (use in 5–6 days per week), to poor (use ≤4 days per week) at visit 2. The patients were also asked to answer a five-point scale satisfaction score which ranged from (1) very unsatisfied, (2) unsatisfied, (3) fair, (4) satisfied, to (5) very satisfied at visit 2. A satisfaction score ≥4 was considered that the patient had good satisfaction to the device from the SDM process. P values were assessed with Fisher’s exact test.

Table 4 Factors Associated with Satisfaction, Willingness to Continue Use, and Symptom Improvement in Patients Completed Two Visits

Variable	Satisfied (Satisfaction Score ≥4)		Willing to Continue Use		Improvement of CAT ≥2
	Univariate	Multivariable	Univariate	Multivariable	Univariate	Multivariable
Inhaler chosen initially
Respimat^®	0.4 [0.1–1.5]	0.2 [0.0–1.2]	2.0 [0.3–15.5]	2.3 [0.2–21.9]	1.0 [0.3–3.1]	0.9 [0.3–3.3]
Ellipta^®	0.5 [0.1–2.1]	0.4 [0.1–1.7]	1.5 [0.2–9.8]	1.5 [0.2–11.3]	0.9 [0.3–2.8]	0.9 [0.3–3.0]
Breezhaler^®	Ref	Ref	Ref	Ref	Ref	Ref
Age
<65	Ref	Ref	Ref	Ref	Ref	Ref
≥65	1.3 [0.5–3.3]	1.1 [0.4–3.1]	1.5 [0.3–7.0]	1.6 [0.3–8.0]	1.2 [0.5–2.9]	1.1 [0.4–2.9]
Sex
Female	Ref	Ref	Ref	Ref	Ref	Ref
Male	^†		^†		2.3 [0.4–13.1]	1.3 [0.1–24.2]
Education
Junior high school or lower	Ref	Ref	Ref	Ref	Ref	Ref
Senior high school or higher	0.8 [0.3–2.1]	0.6 [0.2–1.7]	0.6 [0.1–3.0]	0.5 [0.1–2.8]	0.8 [0.4–1.8]	1.0 [0.4–2.5]
Smoking history
Never smoker	Ref	Ref	Ref	Ref	Ref	Ref
Ever smoker	0.5 [0.1–4.7]	0.3 [0.0–4.1]	2.8 [0.3–28.0]	3.4 [0.3–39.6]	6 [0.7–53.2]	8.1 [0.3–219.6]
Comorbidity
No	Ref	Ref	Ref	Ref	Ref	Ref
Yes	1.9 [0.5–7.5]	6.2 [1.1–33.7]*	^†		2.8 [0.7–11.6]	1.8 [0.4–8.8]
Airflow limitation (GOLD grade)
1 or 2 (FEV1 ≥ 50%pred)	Ref	Ref	Ref	Ref	Ref	Ref
3 or 4 (FEV1 < 50%pred)	0.6 [0.2–2.1]	0.2 [0.0–0.8]*	0.4 [0.1–2.2]	0.4 [0.1–2.7]	1.8 [0.6–5.8]	1.6 [0.4–6.5]
Acute exacerbation within a year
No	Ref	Ref	Ref	Ref	Ref	Ref
Yes	3.2 [0.4–27.1]	16.5 [1.4–200.1]*	^†		1.2 [0.3–4.6]	0.6 [0.1–3.5]
CAT score (visit 1)
<10	Ref	Ref	Ref	Ref	Ref	Ref
≥10	0.4 [0.2–1.1]	0.3 [0.1–0.8]*	0.7 [0.1–3.4]	0.6 [0.1–3.3]	6.5 [2.5–17.4]	7.0 [2.4–20.6]*

Notes: Data are analysed by logistic regression and presented in odds ratio (95% confidence interval). All variables in the univariate analyses were included in the multivariable logistic regression models. *P value <0.05. ^†Odds ratio cannot be assessed due to very low number in a group.

Abbreviations: pred, predicted; GOLD, Global Initiative for Chronic Obstructive Lung Disease; CAT, COPD Assessment Test.