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Research Note

Achieving good adherence to inhaled corticosteroids after weighing canisters of asthmatic children

[version 1; peer review: 2 approved, 1 approved with reservations]
PUBLISHED 14 Mar 2017
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Abstract

Background: The metered-dose inhalers (MDIs) currently available for inhaled corticosteroid delivery do not offer an integrated dose counter; therefore, it is difficult to evaluate adherence of patients. The present authors developed a linear regression equation using canister weight to calculate the number of doses actuated from the MDIs. This study aimed to assess medical adherence after the integration of regular weighing of the canisters into the routine service. Methods: A cohort study was carried out between May 2013 and April 2014. Children aged less than 8 years with a diagnosis of asthma were recruited. The duration of adherence assessment was 24 weeks. Participants had a regular schedule every 8 weeks to obtain a new FLIXOTIDE® 125 inhaler. Parents were asked to collect the discarded MDI canisters, which were then weighed by a laboratory scale. The weight of each canister was replaced in the regression equation to calculate the number of doses actuated from the MDIs. Results: A total of 52 asthmatic children participated in the study. The median age was 52.7 months. At the end of 24 weeks, 44, 33, and 23 discarded MDI canisters were collected from visits 1, 2, and 3, respectively. The median percentages of adherence were 96.8%, 96.3%, and 96.3%, respectively. In 11 discarded canisters (11%), the remaining medication was more than 30% of the labeled doses. Approximately 90% of the participants had no asthma exacerbation during 24-week study period. Conclusion: High adherence rates were achieved after integration of canister weighing into the asthma care service.

Keywords

canister weight, adherence, compliance, inhaled corticosteroids, asthma, wheezing, children, cohort study

Introduction

Inhaled corticosteroids (ICSs) are the standard treatment for asthmatic children. Non-adherence with prescribed ICS treatment clearly causes uncontrolled asthma1. Feedback from parents is the traditional approach to assess the adherence to the treatment regimen; however, there is an overestimation by the patients of the remaining amount of medication2. Even though integration of a dose counter into the inhaler device improves the tracking adherence to prescribed medication3, the metered-dose inhalers (MDIs) currently available for ICS delivery do not offer integrated dose counters.

Weighing of the MDI canisters may be an alternative method to assess a patient's medication adherence. The present authors previously developed a linear regression equation using canister weight to calculate the number of doses actuated from the MDIs4. Weighing of the canisters was implemented into our asthma care system in March 2013. This study was designed to assess a patient's medication adherence after the integration of regular weighing of the canisters into the routine service.

Methods

Study design and subjects

A cohort study was carried out between May 2013 and April 2014. The inclusion criteria were children aged less than 8 years with a diagnosis of asthma who attended the Pediatric Allergy Clinic at Songklanagarind Hospital (Hat Yai, Songkhla, Thailand) and had exacerbation of asthma requiring hospitalization or an emergency department visit within the previous year. Patients who had a previous history of intubation or other chronic conditions were excluded.

The research protocol (REC 55-021-01-1-2) was approved by the Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University. Informed consent was obtained from the parents/guardians.

Asthma management

Fluticasone propionate was selected as the ICS therapy for the study. A FLIXOTIDE® 125 Inhaler (GlaxoSmithKline) is a pressurized metered-dose inhaler, which delivers 125 microgram of fluticasone propionate per actuation. Each canister supplies 120 actuations. FLIXOTIDE® 125 Inhaler and BabyHALER® (GlaxoSmithKline), a device to help patients taking inhaled medicine, were prescribed to all participants. The dosage of fluticasone propionate was one actuation twice a day. The add-on asthma therapies were provided according to the GINA guideline5. Participants needed to participate in a regular schedule every 8 weeks to obtain a new FLIXOTIDE® 125 inhaler. For patients who did not achieve adequate control or maintain the adherence rate, the inhalation technique and medication doses were revised at the time they visited the clinic. Exacerbation was defined as asthma deterioration that required treatment with systemic corticosteroids or emergency department utilization or hospitalization.

Adherence assessment

The duration of adherence assessment was 24 weeks. Each participant received three canisters of FLIXOTIDE® 125 Inhaler. Parents were asked to collect the discarded inhalers at the 8-week (visit 1), 16-week (visit 2), and 24-week (visit 3) after recruitment. The discarded MDI canisters were weighed by a laboratory scale (Sartorius Basic®). The weight of each canister was replaced in the regression equation to calculate the number of doses actuated from the MDIs. A regression equation for a fluticasone propionate MDI canister gives the number (n) of doses actuated from the MDIs:

              n = 276.16 – (14.62 × canister weight).4

Statistical analysis

All of the statistical analyses were conducted with R software (version 3.3.2) by the R Foundation for Statistical Computing. Adherence in each 8-week interval was calculated as the amount of medication actuated divided by the amount prescribed. Percentage of adherence was reported as median and range.

Results

A total of 52 asthmatic children participated in the study. The characteristics of the participants are shown in Table 1. Half of the participants were male. The median age was 52.7 months (range, 18.3–91.7) and the age at the onset of asthma was 12 months (range, 1.0–48.0). Parents were the major caregivers. In total, 32% of the participants had other allergic co-morbidities. Most of participants had received ICS therapy for longer than 3 months. At the end of 24 weeks, 44, 33, and 23 (total 100) discarded MDI canisters were collected from visits 1, 2, and 3, respectively. The remaining median weights of the discarded canisters from visits 1, 2, and 3 were 11.172g, 11.229g, and 11.113 g, respectively, and the median percentages of adherence were 96.8%, 96.3%, and 96.3%, respectively. In 11 discarded canisters (11%), the remaining medication was more than 30% of the labeled doses. Approximately 90% of the participants had no asthma exacerbation during 24-week study period (Table 2).

Table 1. Demographic data of asthmatic children.

VariableResults (N=52)
Male, n (%)29 (55.8)
Weight, kg, median (range)18.2 (10.9–30.0)
Height, cm, median (range)107.4 (84.6–127.5)
Age, months, median (range)52.7 (18.3–91.7)
Age onset, months, median (range)12 (1.0–48.0)
Allergic disease, n (%)
      •    Atopic dermatitis
      •    Allergic rhinitis
      •    Food allergy
17 (32.7)
3 (5.8)
12 (23.1)
5 (9.6)
Caregiver, n (%)
      •    Parents
      •    Grandparents

44 (84.6)
7 (13.5)
Number of hospitalizations, times/
person, median (range)
1 (1–5)
Number of exacerbations within previous
year, times/person, median (range)
3 (1–9)
Duration from last exacerbation, months,
median (range)
4 (3–11)
Duration of ICS therapy, n (%)
      •    0–3 months
      •    More than 3 months

15 (28.9)
37 (71.1)
Number of studied canisters, n (%)
      •    Visit 1
      •    Visit 2
      •    Visit 3

44 (84.6)
33 (63.4)
23 (44.2)

Table 2. Canister weight and percentage of adherence.

VariablesVisit 1Visit 2Visit 3
Number of canisters443323
New canister weight, g,
median (range)
18.838
(18.663–18.929)
18.819
(18.607–18.907)
18.812
(18.470–18.913)
Discard canister weight, g,
median (range)
11.172
(7.889–16.042)
11.229
(7.825–17.146)
11.113
(9.400–16.020)
Actuated doses calculated from
canister weight, median (range)
112.8
(41.6–160.8)
112.0
(25.5–161.8)
113.7
(42.0–138.7)
Percentage of adherence,
median (range)
96.8%
(33.0–143.6)
96.3%
(20.2–126.4)
96.3%
(36.8–118.7)
Number of participants with
exacerbation
121
date_originaloriginal weightdate_discarddiscard weightresults of the actuated dose equationday of canister use prescribed dosepercent of adherencevisit
4/4/201318.89530/5/201311.46210956112971
22/5/201318.81124/7/201310.74811963126941
2/7/201318.8921/9/201310.258126611221031
1/8/201318.8812/10/201314.1416962124561
20/8/201318.83922/10/201310.133128631261021
1/9/201318.92929/10/201311.02711558116991
15/9/201318.86412/11/201310.454123581161061
8/10/201318.7793/12/201312.02710056112901
8/10/201318.8113/12/201314.7616056112541
8/10/201318.8493/12/201310.63121561121081
9/10/201318.8593/12/201311.54410755110981
9/10/201318.7874/12/201312.3549656112851
8/10/201318.85211/12/201310.46512364128961
22/10/201318.79117/12/201315.9214356112391
22/10/201318.80817/12/201311.31711156112991
22/10/201318.83717/12/20137.889161561121441
22/10/201318.85517/12/201312.6339156112821
25/10/201318.8920/12/201312.659156112811
22/10/201318.66324/12/201316.0424263126331
25/10/201318.82124/12/201315.3235260120431
30/10/201318.82924/12/201311.88110255110931
30/10/201318.84324/12/201310.731119551101081
1/11/201318.87424/12/201312.2749753106911
30/10/201318.81825/12/201310.776119561121061
8/11/201318.823/1/201410.691120561121071
8/11/201318.8643/1/201412.06110056112891
8/11/201318.8543/1/201410.831118561121051
5/11/201318.8097/1/201410.56812263126971
6/11/201318.8568/1/201410.5612263126971
6/11/201318.8198/1/201413.8037463126591
13/11/201318.8628/1/201411.90810256112911
8/11/201318.899/1/20149.833132621241071
8/11/201318.8769/1/201410.03130621241041
20/11/201318.84515/1/20149.358139561121241
22/11/201318.81417/1/201411.43410956112971
29/11/201318.83824/1/201410.847118561121051
4/12/201318.8275/2/20147.934160631261271
18/12/201318.79419/2/201414.9785763126451
8/1/201418.7967/3/20149.994130581161121
8/1/201418.82612/3/201410.07129631261021
10/1/201418.84312/3/201410.48123611221011
10/1/201418.80314/3/201412.3529663126761
7/2/201418.884/4/201411.98410156112901
12/2/201418.77511/4/201411.9810158116871
30/5/201318.87430/7/201314.3296761122552
1/9/201318.81929/10/201310.52122581161052
2/10/201318.8726/12/201313.9037365130562
22/10/201318.88817/12/201311.229112561121002
29/10/201318.76724/12/201310.607121561121082
12/11/201318.8677/1/201410.742119561121062
3/12/201318.8755/2/20148.614150641281172
3/12/201318.8235/2/20149.494137641281072
3/12/201318.8565/2/20148.988145641281132
4/12/201318.8155/2/201410.58912163126962
3/12/201318.7375/2/20147.825162641281262
11/12/201318.73911/2/20149.16142621241152
17/12/201318.84818/2/201415.5724863126382
17/12/201318.6918/2/201417.1462563126202
25/12/201318.81519/2/201412.5089356112832
20/12/201318.8221/2/201412.02410063126802
17/12/201318.86525/2/201410.94211670140832
24/12/201318.82525/2/201413.9487263126572
24/12/201318.78825/2/201411.55510763126852
24/12/201318.78825/2/20149.962131631261042
24/12/201318.84525/2/201414.1227063126552
3/1/201418.80925/2/201411.503108531061022
3/1/201418.8354/3/201410.86211760120982
8/1/201418.8014/3/201411.71510555110952
7/1/201418.8157/3/201412.289759118822
8/1/201418.7787/3/201411.32111158116952
8/1/201418.9077/3/201414.4416558116562
8/1/201418.6077/3/201410.359125581161082
9/1/201418.7237/3/201410.557122571141072
3/1/201418.8837/3/201410.064129631261022
17/1/201418.80314/3/201414.2326856112612
24/1/201418.85221/3/201410.796118561121062
5/2/201418.8062/4/201412.3849556112852
30/7/201318.8569/10/20139.413971142983
29/10/201318.80424/12/201310.813118561121053
6/12/201318.8225/2/201410.213127611221043
17/12/201318.81918/2/201410.90611763126933
24/12/201318.80925/2/201410.63212163126963
7/1/201418.8357/3/201410.081129591181093
5/2/201418.8482/4/20149.797133561121193
5/2/201418.872/4/201411.55610756112963
11/2/201418.474/4/201413.0968552104813
5/2/201418.744/4/201411.37611058116953
5/2/201418.8154/4/201411.24411258116963
5/2/201418.844/4/201410.253126581161093
21/2/201418.77118/4/201410.905117561121043
18/2/201418.78923/4/201411.83110364128813
25/2/201418.76123/4/201416.024257114373
25/2/201418.75523/4/201410.832118571141033
25/2/201418.81223/4/201411.019115571141013
25/2/201418.79223/4/201415.8044557114403
25/2/201418.87623/4/201411.113114571141003
7/3/201418.71430/4/201413.8067454108693
7/3/201418.84630/4/201413.4637954108733
7/3/201418.91330/4/201414.1776954108643
Dataset 1.Canister weight and percent of adherence.
Raw data of canister weight (original and discarded weight), results of the actuated dose equation and percent of adherence.

Discussion

The present study demonstrated high adherence rates with low variations between the three visits. The percentage of discarded canisters, which had more than 30% of the labeled dosage of medication remaining, reduced from 22% in our previous cross-sectional study6 to 11% in this study. Achieving good adherence in this cohort could be explained by the Hawthorn effect: the parents and participants knew that their adherence would be measured by weighing the canisters; therefore, the individuals modified or improved their adherence in response to the awareness of being observed.

Approximately 90% of the participants had no asthma exacerbation throughout the study period. In our previous study, only 59% of the patients had adequate control6. Patients had access to the same educational and medication intervention, but the adherence rates were significantly different. Previous studies verified that the adherence rates had an association between lower adherence rates and poor asthma control7,8.

Although weighing of canisters was less accurate than a dose counter for measuring adherence9, the present study demonstrated that a weight-remaining dose correlation could be used to determine the inhaler medication adherence in real life, and intensive monitoring of adherence was successful in achieving control.

In conclusion, our results demonstrated that high adherence rates were achieved after integration of canister weighing into the asthma care service. The present study highlighted the need to incorporate a method to monitor medical adherence in clinical practice, which may contribute to adequate asthma control.

Data availability

Dataset 1: Canister weight and percent of adherence. Raw data of canister weight (original and discarded weight), results of the actuated dose equation and percent of adherence. doi, 10.5256/f1000research.10710.d15097010

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Chuenjit W, Engchuan V, Yuenyongviwat A and Sangsupawanich P. Achieving good adherence to inhaled corticosteroids after weighing canisters of asthmatic children [version 1; peer review: 2 approved, 1 approved with reservations]. F1000Research 2017, 6:266 (https://doi.org/10.12688/f1000research.10710.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 14 Mar 2017
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Reviewer Report 09 Aug 2017
Orathai Piboonpocanun,  Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand 
Approved
VIEWS 5
The authors tried to use canister weight to calculate the number of doses actuated from the MDIs and to assess medical adherence to MDIs.
There are some issues which need clarification
  1. Please clarify why the
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Piboonpocanun O. Reviewer Report For: Achieving good adherence to inhaled corticosteroids after weighing canisters of asthmatic children [version 1; peer review: 2 approved, 1 approved with reservations]. F1000Research 2017, 6:266 (https://doi.org/10.5256/f1000research.11547.r24513)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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11
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Reviewer Report 24 Apr 2017
Bee Wah Lee, Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore 
Approved with Reservations
VIEWS 11
This study evaluated adherence to ICS prophylaxis in asthmatic children by using weight of canister as a means to determine inhaler compliance, by calculating doses used by using a regression equation based on canister weight. The authors conclude that in ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Lee BW. Reviewer Report For: Achieving good adherence to inhaled corticosteroids after weighing canisters of asthmatic children [version 1; peer review: 2 approved, 1 approved with reservations]. F1000Research 2017, 6:266 (https://doi.org/10.5256/f1000research.11547.r22150)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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8
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Reviewer Report 21 Apr 2017
Wiparat Manuyakorn, Division of Allergy, Immunology, and Rheumatology, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand 
Approved
VIEWS 8
The article is well written. However, there is some minor comment.
1. The authors mentioned that "The metered-dose inhalers (MDIs) currently available for inhaled
corticosteroid delivery do not offer an integrated dose counter". This statement was true at ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Manuyakorn W. Reviewer Report For: Achieving good adherence to inhaled corticosteroids after weighing canisters of asthmatic children [version 1; peer review: 2 approved, 1 approved with reservations]. F1000Research 2017, 6:266 (https://doi.org/10.5256/f1000research.11547.r21967)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

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Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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