Accepted Manuscript Inhaler devices in asthma and copd – an assessment of inhaler technique and patient preferences Pedro Chorão , Ana Pereira , João Fonseca PII:
S0954-6111(14)00166-8
DOI:
10.1016/j.rmed.2014.04.019
Reference:
YRMED 4502
To appear in:
Respiratory Medicine
Received Date: 23 February 2014 Revised Date:
7 April 2014
Accepted Date: 23 April 2014
Please cite this article as: Chorão P, Pereira A, Fonseca J, Inhaler devices in asthma and copd – an assessment of inhaler technique and patient preferences, Respiratory Medicine (2014), doi: 10.1016/ j.rmed.2014.04.019. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Background: Incorrect use of inhaler devices remains an obstacle for respiratory diseases management. We aimed to evaluate the frequency of inhaler technique errors; to determine the devices perceived as the easiest and favourite to use; to study the association of device type, demographics and patient preferences with inhaler technique (IT).
RI PT
Methods: Cross-sectional assessment of 301 adults, with asthma (194) or chronic pulmonary obstructive disease, undergoing treatment with Aerolizer®, Autohaler®, Breezehaler®, Diskus®, Handihaler®, MDI without spacer, Miat-haler®, Novolizer®, Respimat® and/or Turbohaler®. Patients completed self-assessment questionnaires and face-to-face interview, with demonstration of inhaler technique. The rate of wrong steps (number of wrong steps ÷ number of total steps; RWS) was the primary outcome. Adjusted odds ratio (aOR) (95% confidence intervals [CI]) for presenting ≥1 IT errors were computed.
M AN U
SC
Results: From the 464 inhaler technique performances, the median RWS was 18%. Turbohaler® (21%) and Diskus® (19%) were chosen as easiest and Novolizer® (18%), Diskus® (18%), Turbohaler® (17%) as favourite for daily use. Females (aOR 2.68 [95% CI 1.55-4.65]; vs. males], patients with >64 yr. (aOR 2.73 [95% CI 1.15-6.48]; vs 12 years of school education). Continuous variables were described using mean with standard deviation (SD) or median with interquartile range (IQR), as appropriate to the data distribution; comparisons were performed using non-parametric Mann-Whitney U and KruskallWallis tests, as adequate. The inhalers used by less than 5% of total patients were not analysed individually except in what refers to the patient’s preferences. The associations between the RWS and both VAS score and duration of inhaler use were studied with Spearman correlation coefficients (r2). The level of significance was set at p64 79 26 School years 1-4 138 46 5-9 67 22 10-12 62 21 > 12 34 11 Number of current different inhalers 1 166 55 2 108 36 ≥3 27 9
ACCEPTED MANUSCRIPT
Turbohaler Diskus Handihaler Aerolizer MDI Respimat Novolizer Breezehaler Miat-haler Autohaler
Frequency Self-evaluation of of use correct technique* n % P50 (P25-P75) 128 27 86 (74-97) 90 19 95 (74-97) 77 17 96 (75-97) 64 14 96 (75-97) 54 12 92 (74-97) 18 4 97 (76-97) 12 3 78 (74-97) 11 2 96 (85-98) 8 2 59 (12-97) 2 12 0.58 (0.28-1.21) Number of diferent devices 1 Reference >1 1.80 (1.10-2.94) Inhaler device Aerolizer 3.46 (1.27-9.42) Diskus 1.36 (0.69-2.68) Handihaler 3.47 (1.37-8.79) MDI 1.47 (0.64-3.35) Other 0.86 (0.40-1.82) Turbohaler Reference Time of inhaler use (years) 5 1.28 (0.65-2.53) Already using the easiest device Yes Reference No 1.26 (0.77-2.08) Already using the favourite device Yes Reference No 1.43 (0.84-2.42)
Adjusted OR (95% CI)
M AN U
Crude OR (95% CI)
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
MANUSCRIPT Supplementary Table 1 – EvaluationACCEPTED of technique errors in Aerolizer®, Breezehaler® and Handihaler®. Aerolizer 64 n %
30
4
31 11 21
48 17 33
2 3 2 1
7 23 20
11 36 31
3 2 3
2 NA
3 NA
NA
11
17
M AN U
RI PT
19
SC
1. Remove the protective cover 2.0 Prepare the dose 2.1 Open the inhaler 2.2 Insert the capsule and close 2.3 Perfurate the capsule once and release the lateral trigger(s) 2.4 Mouthpiece oriented upwards 3.0 Exhale as much as confortably possible 3.1 Do not exhale into the mouthpiece 4.0 Inhale rapid and forcefully 4.1 Inhale only through the mouth 4.2 Close the lips around the mouthpiece 4.3 Do not cover the air entrance holes 5. Apnoea after inhalation Hold breath at least 10 seconds 6. Exhale naturally 6.1 Do not exhale into the mouthpiece 7. Repeat steps 3 through 6 8. Open the inhaler, check if there is any medication left in the capsule and repeat if necessary
Breezehaler 11 n
AC C
EP
TE D
NA – Not applicable. Blank spaces represent steps with no errors observed. Error in step 2.3 was considered when patient primed the lateral trigger more than once. Only 2 patients using Handihale to perform step 2.3. For step 5. the apnoea period was evaluated and two types of error were considered (holding breath less than 10 seconds and expelling air immediately).
ACCEPTED MANUSCRIPT
Handihaler®.
36
2 27
3 35
18 27 18 9
32 12 20 1
42 16 26 1
27 18 27
NA 11 39 1 6 31
NA 14 51 1 8 40
21
27
NA
SC
3
AC C
EP
nly 2 patients using Handihaler failed ere considered (holding breath for
M AN U
2
RI PT
Handihaler 77 n %
TE D
Breezehaler 11 %
ACCEPTED MANUSCRIPT
Supplementary Table 2 – Evaluation of technique errors in Diskus®, Miat-haler®, Novolizer® and Turbohaler®. Novolizer (n=12) n %
30 27 29
5 3 1 5
63 38 13 63
1 2 2
8 17 17
1 14 37
1 16 41
1 3 3
13 38 38
1 2 5
8 17 42
9
10
SC
27 24 26
M AN U
1. Open the inhaler 2. Prepare the dose 3.0 Exhale as much as confortably possible 3.1 Do not exhale into the mouthpiece 4.0 Inhale rapid and forcefully 4.1 Inhale only through the mouth 4.2 Close the lips around the mouthpiece 5. Apnoea after inhalation Hold breath at least 10 seconds 6. Exhale naturally 6.1 Do not exhale into the mouthpiece
Miat-haler (n=8) n %
Turbohaler (n=128) n %
RI PT
Diskus (n=90) n %
13 36 28 24 3 1 19 46 3 10
19 28 22 19 2 1 15 36 2 8
AC C
EP
TE D
NA – Not applicable. Blank spaces represent steps with no errors observed. In Diskus dose preparation was evaluated by pulling down the trigger, in Novolizer by the colour change in the indicator, in Miat-haler by pressing the lid fully down and then upwards and in Turbohaler by full rotation and counter-rotation. In Novolizer, rapid and forcefully inhalation was evaluated by the colour change in the indicator. For step 5. the apnoea period was evaluated and two types of error were considered (holding breath for less than 10 seconds and expelling air immediately).
MANUSCRIPT Supplementary Table 3 - Evaluation ACCEPTED of technique errors in MDI without spacer, Autohaler® and Respimat®.
20 19 2 5 13 3 1 1 NA 6 34
M AN U
SC
RI PT
1. Prepare the dose (Autohaler: Step 2) 2. Remove the protective cover 3. Shake the inhaler 4. Exhale as much as confortably possible 5.0 Inhale slow and deeply 5.1 Coordinate the beggining of the inhalation with the firing of the inhaler 5.2 Continue to inhale after firing the inhaler 5.3 Inhale only through the mouth 5.4 Close the lips around the mouthpiece 5.5 Hold the inhaler upright (MDI/Autohaler) or horizontally (Respimat) 5.6 Do not cover the air entrance holes 6. Apnoea after inhalation Hold breath at least 10 seconds
MDI 54 n % NA NA 37 35 4 9 24 6 2 2 NA 11 63
AC C
EP
TE D
NA – Not applicable. Blank spaces represent steps with no errors observed. In Autohaler preparing the dose consisted in placing the valve upwards with the inhaler held upright and in Respimat rota degrees. For step 5. the apnoea period was evaluated and two types of error were considered (holding breath for less tha expelling air immediately).
NA
NA
NA 8
NA 44
NA
NA
4 5
22 28
NA
NA
1
50
5 5 7
28 28 39
SC
Respimat 18 n %
M AN U
Autohaler 2 n %
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
ght and in Respimat rotating the base 180º olding breath for less than 10 seconds and
S0954-6111(14)00166-8
DOI:
10.1016/j.rmed.2014.04.019
Reference:
YRMED 4502
To appear in:
Respiratory Medicine
Received Date: 23 February 2014 Revised Date:
7 April 2014
Accepted Date: 23 April 2014
Please cite this article as: Chorão P, Pereira A, Fonseca J, Inhaler devices in asthma and copd – an assessment of inhaler technique and patient preferences, Respiratory Medicine (2014), doi: 10.1016/ j.rmed.2014.04.019. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Background: Incorrect use of inhaler devices remains an obstacle for respiratory diseases management. We aimed to evaluate the frequency of inhaler technique errors; to determine the devices perceived as the easiest and favourite to use; to study the association of device type, demographics and patient preferences with inhaler technique (IT).
RI PT
Methods: Cross-sectional assessment of 301 adults, with asthma (194) or chronic pulmonary obstructive disease, undergoing treatment with Aerolizer®, Autohaler®, Breezehaler®, Diskus®, Handihaler®, MDI without spacer, Miat-haler®, Novolizer®, Respimat® and/or Turbohaler®. Patients completed self-assessment questionnaires and face-to-face interview, with demonstration of inhaler technique. The rate of wrong steps (number of wrong steps ÷ number of total steps; RWS) was the primary outcome. Adjusted odds ratio (aOR) (95% confidence intervals [CI]) for presenting ≥1 IT errors were computed.
M AN U
SC
Results: From the 464 inhaler technique performances, the median RWS was 18%. Turbohaler® (21%) and Diskus® (19%) were chosen as easiest and Novolizer® (18%), Diskus® (18%), Turbohaler® (17%) as favourite for daily use. Females (aOR 2.68 [95% CI 1.55-4.65]; vs. males], patients with >64 yr. (aOR 2.73 [95% CI 1.15-6.48]; vs 12 years of school education). Continuous variables were described using mean with standard deviation (SD) or median with interquartile range (IQR), as appropriate to the data distribution; comparisons were performed using non-parametric Mann-Whitney U and KruskallWallis tests, as adequate. The inhalers used by less than 5% of total patients were not analysed individually except in what refers to the patient’s preferences. The associations between the RWS and both VAS score and duration of inhaler use were studied with Spearman correlation coefficients (r2). The level of significance was set at p64 79 26 School years 1-4 138 46 5-9 67 22 10-12 62 21 > 12 34 11 Number of current different inhalers 1 166 55 2 108 36 ≥3 27 9
ACCEPTED MANUSCRIPT
Turbohaler Diskus Handihaler Aerolizer MDI Respimat Novolizer Breezehaler Miat-haler Autohaler
Frequency Self-evaluation of of use correct technique* n % P50 (P25-P75) 128 27 86 (74-97) 90 19 95 (74-97) 77 17 96 (75-97) 64 14 96 (75-97) 54 12 92 (74-97) 18 4 97 (76-97) 12 3 78 (74-97) 11 2 96 (85-98) 8 2 59 (12-97) 2 12 0.58 (0.28-1.21) Number of diferent devices 1 Reference >1 1.80 (1.10-2.94) Inhaler device Aerolizer 3.46 (1.27-9.42) Diskus 1.36 (0.69-2.68) Handihaler 3.47 (1.37-8.79) MDI 1.47 (0.64-3.35) Other 0.86 (0.40-1.82) Turbohaler Reference Time of inhaler use (years) 5 1.28 (0.65-2.53) Already using the easiest device Yes Reference No 1.26 (0.77-2.08) Already using the favourite device Yes Reference No 1.43 (0.84-2.42)
Adjusted OR (95% CI)
M AN U
Crude OR (95% CI)
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT
MANUSCRIPT Supplementary Table 1 – EvaluationACCEPTED of technique errors in Aerolizer®, Breezehaler® and Handihaler®. Aerolizer 64 n %
30
4
31 11 21
48 17 33
2 3 2 1
7 23 20
11 36 31
3 2 3
2 NA
3 NA
NA
11
17
M AN U
RI PT
19
SC
1. Remove the protective cover 2.0 Prepare the dose 2.1 Open the inhaler 2.2 Insert the capsule and close 2.3 Perfurate the capsule once and release the lateral trigger(s) 2.4 Mouthpiece oriented upwards 3.0 Exhale as much as confortably possible 3.1 Do not exhale into the mouthpiece 4.0 Inhale rapid and forcefully 4.1 Inhale only through the mouth 4.2 Close the lips around the mouthpiece 4.3 Do not cover the air entrance holes 5. Apnoea after inhalation Hold breath at least 10 seconds 6. Exhale naturally 6.1 Do not exhale into the mouthpiece 7. Repeat steps 3 through 6 8. Open the inhaler, check if there is any medication left in the capsule and repeat if necessary
Breezehaler 11 n
AC C
EP
TE D
NA – Not applicable. Blank spaces represent steps with no errors observed. Error in step 2.3 was considered when patient primed the lateral trigger more than once. Only 2 patients using Handihale to perform step 2.3. For step 5. the apnoea period was evaluated and two types of error were considered (holding breath less than 10 seconds and expelling air immediately).
ACCEPTED MANUSCRIPT
Handihaler®.
36
2 27
3 35
18 27 18 9
32 12 20 1
42 16 26 1
27 18 27
NA 11 39 1 6 31
NA 14 51 1 8 40
21
27
NA
SC
3
AC C
EP
nly 2 patients using Handihaler failed ere considered (holding breath for
M AN U
2
RI PT
Handihaler 77 n %
TE D
Breezehaler 11 %
ACCEPTED MANUSCRIPT
Supplementary Table 2 – Evaluation of technique errors in Diskus®, Miat-haler®, Novolizer® and Turbohaler®. Novolizer (n=12) n %
30 27 29
5 3 1 5
63 38 13 63
1 2 2
8 17 17
1 14 37
1 16 41
1 3 3
13 38 38
1 2 5
8 17 42
9
10
SC
27 24 26
M AN U
1. Open the inhaler 2. Prepare the dose 3.0 Exhale as much as confortably possible 3.1 Do not exhale into the mouthpiece 4.0 Inhale rapid and forcefully 4.1 Inhale only through the mouth 4.2 Close the lips around the mouthpiece 5. Apnoea after inhalation Hold breath at least 10 seconds 6. Exhale naturally 6.1 Do not exhale into the mouthpiece
Miat-haler (n=8) n %
Turbohaler (n=128) n %
RI PT
Diskus (n=90) n %
13 36 28 24 3 1 19 46 3 10
19 28 22 19 2 1 15 36 2 8
AC C
EP
TE D
NA – Not applicable. Blank spaces represent steps with no errors observed. In Diskus dose preparation was evaluated by pulling down the trigger, in Novolizer by the colour change in the indicator, in Miat-haler by pressing the lid fully down and then upwards and in Turbohaler by full rotation and counter-rotation. In Novolizer, rapid and forcefully inhalation was evaluated by the colour change in the indicator. For step 5. the apnoea period was evaluated and two types of error were considered (holding breath for less than 10 seconds and expelling air immediately).
MANUSCRIPT Supplementary Table 3 - Evaluation ACCEPTED of technique errors in MDI without spacer, Autohaler® and Respimat®.
20 19 2 5 13 3 1 1 NA 6 34
M AN U
SC
RI PT
1. Prepare the dose (Autohaler: Step 2) 2. Remove the protective cover 3. Shake the inhaler 4. Exhale as much as confortably possible 5.0 Inhale slow and deeply 5.1 Coordinate the beggining of the inhalation with the firing of the inhaler 5.2 Continue to inhale after firing the inhaler 5.3 Inhale only through the mouth 5.4 Close the lips around the mouthpiece 5.5 Hold the inhaler upright (MDI/Autohaler) or horizontally (Respimat) 5.6 Do not cover the air entrance holes 6. Apnoea after inhalation Hold breath at least 10 seconds
MDI 54 n % NA NA 37 35 4 9 24 6 2 2 NA 11 63
AC C
EP
TE D
NA – Not applicable. Blank spaces represent steps with no errors observed. In Autohaler preparing the dose consisted in placing the valve upwards with the inhaler held upright and in Respimat rota degrees. For step 5. the apnoea period was evaluated and two types of error were considered (holding breath for less tha expelling air immediately).
NA
NA
NA 8
NA 44
NA
NA
4 5
22 28
NA
NA
1
50
5 5 7
28 28 39
SC
Respimat 18 n %
M AN U
Autohaler 2 n %
RI PT
ACCEPTED MANUSCRIPT
AC C
EP
TE D
ght and in Respimat rotating the base 180º olding breath for less than 10 seconds and
