throbber
Allergy
`
`B R I E F C O M M U N I C A T I O N
`
`A majority of parents of children with peanut allergy fear
`using the epinephrine auto-injector
`L. Chad1, M. Ben-Shoshan2, Y. Asai3, S. Cherkaoui4, R. Alizadehfar2, Y. St-Pierre5, L. Harada6,
`M. Allen7 & A. Clarke5,8
`
`1Department of Paediatrics, University of Toronto, Toronto, ON; 2Division of Pediatric Allergy and Clinical Immunology, Department of
`Pediatrics, McGill University Health Centre, Montreal; 3Division of Dermatology, Department of Medicine, McGill University Health Centre,
`Montreal; 4Department of Medicine, University of Montreal, Montreal; 5Division of Clinical Epidemiology, Department of Medicine, McGill
`University Health Center, Montreal, QC; 6Anaphylaxis Canada, Toronto; 7Allergy Asthma Information Association, Toronto, ON; 8Division of
`Clinical Immunology and Allergy, Department of Medicine, McGill University Health Center, Montreal, QC, Canada
`
`To cite this article: Chad L, Ben-Shoshan M, Asai Y, Cherkaoui S, Alizadehfar R, St-Pierre Y, Harada L, Allen M, Clarke A. A majority of parents of children with
`
`peanut allergy fear using the epinephrine auto-injector. Allergy 2013; 68: 1605–1609.
`
`Keywords
`epidemiology; epinephrine auto-injectors;
`food allergy; peanut allergy.
`
`Correspondence
`Dr. Ann Clarke, McGill University Health
`Centre (MUHC), 687 Pine Avenue West,
`V Building, Montreal, Quebec,
`Canada H3A 1A1.
`Tel.: (514) 934-1934 ext. 44716
`Fax: (514) 934-8293
`E-mail: ann.clarke@mcgill.ca
`
`Accepted for publication 7 August 2013
`
`DOI:10.1111/all.12262
`
`Edited by: Hans-Uwe Simon
`
`Abstract
`
`Prompt epinephrine administration is crucial in managing anaphylaxis, but epi-
`nephrine auto-injectors (EAIs) are underutilized by patients and their families.
`Children with peanut allergy were recruited from the Allergy Clinics at the Mon-
`treal Children’s Hospital, food allergy advocacy organizations and organizations
`providing products to allergic individuals. Parents of children who had been pre-
`scribed an EAI were queried on whether they were fearful of using it and on fac-
`tors that may contribute to fear. A majority of parents (672/1209 = 56%)
`expressed fear regarding the use of the EAI. Parents attributed the fear to hurting
`the child, using the EAI incorrectly or a bad outcome. Parents whose child had
`longer disease duration or a severe reaction and parents who were satisfied with
`the EAI training or found it easy to use were less likely to be afraid. Families
`may benefit from simulation training and more education on the recognition and
`management of anaphylaxis.
`
`in managing
`Prompt epinephrine administration is crucial
`(EAI)
`are
`anaphylaxis, but
`epinephrine
`auto-injectors
`underutilized by physicians and patients and their families
`(1–6). Although others have described deficiencies in paren-
`tal knowledge regarding indications and technical aspects
`(7–10)
`of EAI administration,
`few have examined the
`parental anxiety associated with its use (11, 12). We identi-
`fied factors that might contribute to parental fear of using
`an EAI.
`
`Abbreviations
`CI, confidence interval; EAI, epinephrine auto-injector; MCH,
`Montreal Children’s Hospital; SD, standard deviation; SPT, skin
`prick test.
`
`Methods
`
`Study design
`
`Children with peanut allergy (eligibility criteria below) were
`recruited from the Allergy Clinics at the Montreal Children’s
`Hospital
`(MCH)
`and
`allergy
`advocacy
`organizations
`(Table 1). Details on the
`cohort have been published
`elsewhere (3).
`the MCH with peanut allergy
`Children diagnosed at
`between 2000 and 2004 were
`retrospectively identified
`through chart review, and those diagnosed at the MCH
`between 2004 and December 2011 were identified prospec-
`tively at their visit. Recruitment from other sources began in
`2006, and children were only included once an allergist
`
`Allergy 68 (2013) 1605–1609 © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
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`Parents fear using the epinephrine auto-injector
`
`Chad et al.
`
`Table 1 Characteristics of respondents and nonrespondents
`
`Respondents
`(n = 1229)
`
`Nonrespondents
`(n = 410)
`
`Difference
`(95% CI)
`
`Age at recruitment, years
`Mean (SD)
`Range
`Age at diagnosis†, years, mean (SD)
`Disease duration at recruitment, years, mean (SD)
`Sex, % boys
`Ethnic background of child, % Caucasian
`Personal atopic history, %
`Atopic dermatitis
`Asthma
`Allergic rhinitis
`Other food allergies
`At least 1 atopic comorbidity
`Severity of most severe reaction, %
`No reaction
`Mild (1 or 2 mild symptoms‡)
`Moderate‡
`Severe‡
`Source of recruitment§%, Montreal Children’s Hospital
`Age of parents
`Mother, years, mean (SD)
`Father, years, mean (SD)
`Mother’s education and work status, %
`Completed high school
`Completed college education
`Completed university education
`Currently employed
`Father’s education and work status, %
`Completed high school
`Completed college education
`Completed university education
`Currently employed
`
`6.9 (3.9)
`0–17
`2.2 (1.8)
`4.7 (3.9)
`62.2
`91.9
`
`53.4
`49.5
`37.6
`50.7
`88.1
`
`9.2
`21.3
`49.8
`19.8
`54.4
`
`7.6 (4.0)
`0–17
`2.4 (2.1)
`5.3 (4.1)
`60.5
`86.6
`
`45.6
`56.6
`37.6
`54.4
`85.6
`
`13.9
`25.3
`47.4
`13.4
`76.1
`
`37.9 (5.7)
`40.0 (6.2)
`
`38.3 (6.0)
`40.8 (6.3)
`
`8.6
`27.3
`62.9
`70.6
`
`14.7
`26.8
`54.4
`89.5
`
`16.6
`28.9
`52.0
`64.1
`
`21.9
`21.4
`51.0
`87.1
`
`0.7 (1.2, 0.3)
`0.2 (0.4, 0.1)
`0.6 (1.0, 0.1)
`1.7 (3.8, 7.1)
`
`5.4 (1.7, 9.0)
`
`7.8 (2.2, 13.3)
`
`7.1 (12.7, 1.6)
`0.0 (5.4, 5.4)
`3.7 (9.3, 1.9)
`2.5 (1.3, 6.4)
`4.7 (8.6, 0.9)
`4.0 (8.9, 0.9)
`2.4 (3.3, 8.1)
`21.7 (26.6, 16.7)
`0.4 (1.0, 0.3)
`0.8 (1.5, 0.1)
`8.0 (11.9, 4.0)
`1.6 (6.7, 3.5)
`
`6.4 (2.3, 10.4)
`
`10.8 (5.2, 16.5)
`6.5 (1.2, 11.8)
`
`5.4 (0.6, 10.2)
`
`7.2 (11.8, 2.6)
`3.3 (2.4, 9.0)
`2.4 (1.2, 6.1)
`
`†Age of first reaction to peanut or age at diagnosis after confirmatory testing.
`‡Mild signs/symptoms: pruritus, urticaria, flushing, rhinoconjunctivitis; moderate: angioedema, throat tightness, gastrointestinal complaints,
`breathing difficulties other than wheeze; severe: wheeze, cyanosis, circulatory collapse.
`§Other sources included Anaphylaxis Canada, Association Quebecoise des Allergies Alimentaires, the Allergy/Asthma Information Associa-
`tion, MedicAlert Foundation, Paladin, Allergic Living magazine and Dejouer les Allergies Alimentaires.
`
`confirmed their diagnosis. Parents provided information on
`personal and family demographics, atopic history and their
`child’s most severe reaction to peanut.
`Parents of children who were prescribed an EAI completed
`a questionnaire (mailed between January 2008 and December
`2011) on whether and why they were afraid to use the EAI,
`whether their child had ever been treated with an EAI, the
`type of prescribing physician, whether they had received
`training and from whom, their level of satisfaction with the
`training, whether the EAI was easy to use,
`the interval
`between the first reaction and the EAI prescription, the initial
`type of EAI prescribed, whether they had changed devices,
`and the number of EAIs purchased.
`The study was approved by the McGill University Health
`Centre Research Ethics Board.
`
`Criteria for diagnosis of peanut allergy
`
`Children were considered allergic to peanut if they had:
` A convincing history (13) of an allergic reaction and a
`positive skin prick test (SPT) to peanut or peanut-specific
`IgE ≥ 0.35 kU/l (14) or
` An uncertain or no history of an allergic reaction and
`either a positive SPT and peanut-specific IgE ≥ 15 kU/l
`(15) or a positive challenge to peanut.
`
`Statistical analysis
`
`Descriptive statistics were compiled for all variables. Univari-
`ate and multivariate logistic regression analyses were used to
`examine potential predictors (Table 2) of parental fear (i.e.
`
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`Chad et al.
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`Parents fear using the epinephrine auto-injector
`
`Table 2 Characteristics of participants† stratified by degree of parental fear
`
`Afraid/somewhat
`afraid (n = 672)
`
`Not afraid
`(n = 537)
`
`Difference
`(95% CI)
`
`Child factors‡
`Age at EAI questionnaire§, years
`Mean (SD)
`Age at diagnosis, years, mean (SD)
`Disease duration at EAI questionnaire, years, mean (SD)
`Sex, % boys
`Ethnic background of child, % Caucasian
`Personal atopic history, %
`Atopic dermatitis
`Asthma
`Allergic rhinitis
`Other food allergies
`At least 1 atopic comorbidity
`Severity of most severe reaction, %
`No reaction
`Mild (1 or 2 mild symptoms)
`Moderate
`Severe
`Has required EAI, %
`Source of recruitment%, Mtl Children’s Hospital
`Parental factors
`Age of parents
`Mother, years, mean (SD)
`Father, years, mean (SD)
`Mother’s education and work status, %
`High education (college and above)
`Currently employed, %
`Father’s education and work status, %
`High education (college and above)
`Currently employed, %
`Satisfaction with EAI training, %
`Satisfied
`Somewhat satisfied
`Not satisfied
`No training received
`EAI easy to use, %
`EAI factors
`Initial prescriber, %
`Paediatrician
`Allergist
`Family physician
`Emergency doctor
`Other doctor
`Initial Instructor (may be more than 1), %
`Paediatrician
`Allergist
`Family Physician
`Emergency Doctor
`Other Doctor
`Pharmacist
`Nurse
`Other or unknown
`Time of prescription, %
`Immediately after reaction
`<1 month
`
`7.5 (4.1)
`2.2 (1.6)
`5.4 (4.0)
`63.7
`92.7
`
`55.1
`48.7
`36.3
`50.4
`89.4
`
`9.2
`21.0
`52.5
`17.3
`15.8
`56.8
`
`9.0 (4.3)
`2.2 (1.9)
`6.8 (4.4)
`60.5
`91.4
`
`51.4
`50.3
`39.1
`51.2
`86.4
`
`7.8
`22.0
`46.7
`23.5
`21.8
`50.8
`
`37.2 (5.6)
`39.3 (6.2)
`
`38.9 (5.7)
`40.9 (6.2)
`
`90.5
`71.3
`
`81.2
`90.8
`
`63.0
`14.4
`3.4
`19.2
`68.0
`
`10.9
`48.5
`19.2
`20.2
`1.2
`
`8.0
`35.1
`7.1
`3.3
`0.5
`27.2
`11.0
`4.7
`
`33.3
`16.5
`
`89.7
`69.5
`
`80.8
`87.7
`
`72.6
`9.6
`1.0
`16.9
`81.9
`
`10.4
`50.4
`21.6
`16.1
`1.5
`
`6.3
`37.7
`7.3
`2.4
`0.6
`22.2
`12.7
`4.7
`
`33.7
`14.3
`
`1.5 (2.0, 1.0)
`0.1 (0.3, 0.1)
`1.4 (1.9, 1.0)
`3.2 (2.3, 8.7)
`1.3 (1.8, 4.4)
`3.7 (2.0, 9.3)
`1.6 (7.3, 4.1)
`2.8 (8.3, 2.7)
`0.8 (6.4, 4.9)
`3.0 (0.7, 6.7)
`1.4 (1.8, 4.6)
`1.0 (5.8, 3.7)
`6.2 (10.9, 1.6)
`6.0 (10.5, 1.5)
`
`5.8 (0.1, 11.6)
`
`6.0 (0.4, 11.7)
`
`1.6 (2.3, 1.0)
`1.6 (2.3, 0.9)
`0.8 (2.6, 4.2)
`1.8 (3.4, 7.0)
`0.4 (4.1, 4.9)
`3.1 (0.5, 6.6)
`9.5 (14.9, 4.2)
`
`4.8 (1.0, 8.5)
`2.5 (0.8, 4.1)
`
`2.3 (2.1, 6.7)
`13.9 (18.7, 9.1)
`
`0.5 (3.0, 4.0)
`1.9 (7.6, 3.8)
`2.3 (7.0, 2.3)
`4.1 (0.3, 8.4)
`0.3 (1.6, 1.0)
`1.6 (1.3, 4.5)
`2.6 (8.0, 2.9)
`0.2 (3.2, 2.7)
`0.9 (1.0, 2.8)
`0.1 (0.9, 0.7)
`1.7 (5.4, 2.0)
`0.0 (2.4, 2.4)
`0.4 (5.7, 5.0)
`2.2 (1.9, 6.3)
`
`5.0 (0.1, 9.9)
`
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`Parents fear using the epinephrine auto-injector
`
`Chad et al.
`
`Table 2 (Continued)
`
`1–6 months
`6–12 months
`More than 1 year
`Before reaction
`At time of diagnosis
`Unknown
`Kind of EAI initially prescribed (may be >1), %
`EpiPen
`TwinJect
`Other
`Unknown
`Type of device changed, %
`Number of EAIs purchased (SD)
`
`Afraid/somewhat
`afraid (n = 672)
`
`Not afraid
`(n = 537)
`
`Difference
`(95% CI)
`
`18.0
`4.5
`3.9
`12.9
`2.8
`8.0
`
`91.5
`9.1
`0.3
`0.7
`22.3
`2.7 (1.3)
`
`20.3
`4.5
`5.0
`10.8
`5.0
`6.3
`
`94.6
`7.1
`0.2
`0
`23.3
`2.7 (1.5)
`
`2.3 (6.8, 2.2)
`0.0 (2.3, 2.3)
`1.2 (3.5, 1.2)
`2.1 (1.5, 5.8)
`2.2 (4.4, 0.0)
`1.7 (1.2, 4.6)
`3.1 (5.9, 0.2)
`2.0 (1.1, 5.1)
`0.1 (0.4, 0.7)
`0.9 (5.7, 3.8)
`0.1 (0.2, 0.1)
`
`0.7 (0.1, 1.4)
`
`EAI, epinephrine auto-injectors.
`†1209 of 1229 total respondents responded to the questionnaire on parental fear.
`‡Potential predictors for the multivariate regression included the child factors listed above – age at completion of EAI questionnaire, disease
`duration, sex, ethnicity, other atopic conditions, severity of most severe reaction to peanut, whether the child was ever treated with an EAI
`and the source of recruitment. Parental factors included age, education, employment, satisfaction with EAI training and ease of use of EAI.
`Epinephrine auto-injectors factors included who prescribed the initial EAI, who provided the initial EAI training, interval between first reaction
`and EAI prescription, the type and number of EAIs purchased, and whether the parent had changed the type of device. Model selection to
`predict the outcome of interest (i.e. afraid or somewhat afraid) was based on the Bayesian information criteria.
`§Refers to the EAI questionnaire that parents completed; for some, this was at the time of recruitment, and for others, it was after recruit-
`ment into the peanut allergy database.
`
`parents responded either ‘afraid’, ‘somewhat afraid’ or not
`afraid).
`
`training at the time of the initial prescription (19.2% and
`16.9%).
`
`Results
`
`Patient and parental characteristics
`
`Of 1639 parents surveyed, 1229 (75%) responded with 54.4%
`recruited from the MCH (Table 1). The mean age at diagno-
`sis was 2.2 years, and participants were recruited a mean of
`4.7 years after diagnosis. Participants were predominantly
`male (62.2%) and Caucasian (91.9%).
`Respondents were similar to nonrespondents with respect
`to age at diagnosis, sex, percentage with at least one atopic
`comorbidity and maternal age. Respondents were slightly
`younger with shorter disease duration, more likely to be Cau-
`casian, more likely to have experienced a severe reaction and
`mothers were more likely to have completed university and
`be employed.
`Almost 56% of parents reported being afraid or somewhat
`afraid to use the EAI (Table 2). Of the 65.4% of parents cit-
`ing a reason, the most frequently cited fears included hurting
`the child (34.6%), using the EAI incorrectly (32.5%) or fear
`of a bad outcome or death (24.5%).
`Both groups of parents reported that they most often
`received the initial EAI prescription from an allergist
`(48.5% and 50.4%) (Table 2). Similarly, they reported that
`they most often received instruction at
`the time of
`the
`initial prescription from an allergist
`(35.1% and 37.7%).
`Comparable proportions
`in each group received no
`
`Predictors of fear
`
`The parents who were afraid or somewhat afraid had a child
`(7.5 vs
`with peanut allergy who was
`slightly younger
`9.0 years) with shorter disease duration (5.4 vs 6.8 years)
`(Table 2). Further, these parents were less likely to have a
`child who had experienced a severe reaction (17.3% vs
`23.5%) or who had required the EAI (15.8% vs 21.8%).
`Parents expressing fear were also slightly younger, were less
`satisfied with the EAI training (63.0% vs 72.6%) and were
`less likely to find the EAI easy to use (68.0% vs 81.9%).
`In the multivariate analysis, parents of children who
`never had a severe reaction (odds ratio [OR] 1.54, 95% CI,
`1.13, 2.10), had either no EAI training or were only some-
`what satisfied (OR 1.42, 95% CI, 1.08, 1.90) or were not
`satisfied with their training (OR 4.00, 95% CI, 1.47, 10.90),
`or did not find the EAI easy to use (OR 1.89, 95% CI,
`1.42, 2.50) were more likely to express fear. However, par-
`ents of children with a longer disease duration (OR per
`year 0.95, 95% CI, 0.92, 0.99) or whose mother was older
`(OR per year 0.97, 95% CI 0.95, 1.00) were less likely to
`express fear.
`
`Discussion
`
`Our study, with 1209 participants, is the largest on parental
`attitudes towards the EAI and factors associated with fear of
`
`1608
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`Chad et al.
`
`Parents fear using the epinephrine auto-injector
`
`use. The only other study (11) to examine parental comfort
`with EAI use involved 165 parents; a study (12) evaluating
`patient attitudes towards the EAI surveyed only 70 respon-
`dents. Our response rate was high (75%), and respondents
`and nonrespondents were reasonably similar. A majority
`reported being afraid/somewhat afraid to use the EAI, high-
`lighting an important barrier to the management of anaphy-
`laxis. It is understandable that parents who were not satisfied
`with their training or did not find the EAI to use were more
`likely to be afraid. Families may benefit from simulation
`training that would not only focus on developing technical
`competence in EAI administration, but would also provide
`education on the recognition and broader management of
`anaphylaxis.
`Parents whose children had had a severe reaction were less
`likely to be afraid, possibly because they were more aware of
`the gravity of anaphylaxis and confident that the benefits of
`the EAI outweighed its risks. Further, parents of children
`with more remote diagnoses of peanut allergy were also less
`fearful, likely because they had become more accustomed to
`its management.
`Our study is limited in that there was little ethnic diversity,
`and the majority of parents were highly educated and employed.
`Further, those who participated may have been motivated by
`greater disease severity. Had a more varied sample participated,
`an even greater proportion may have expressed fear.
`
`Funding
`
`This study received funding from the Foundation of the
`Montreal Children’s Hospital, The Foundation of the McGill
`University Health Center and the Allergy, Genes and Envi-
`ronment Network of Centres of Excellence (AllerGEN
`NCE).
`
`Author contributions
`
`Conception and design: LC, MB-S, YA, SC, RA, YS-P, AC.
`Acquisition of data: MB-S, YA, RA, LH, MA, AC.
`Interpretation of data: SC.
`Analysis and interpretation of data: LC, MB-S, YA, RA,
`YS-P, AC.
`Drafting of article: LC, AC.
`intellectual
`important
`Revision of article
`critically for
`content: LC, MB-S, YA, SC, RA, YS-P, LH, MA, AC.
`Approval of the version to be published: LC, MB-S, YA,
`SC, RA, YS-P, LH, MA, AC.
`
`Conflict of interest
`
`None.
`
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`Allergy 68 (2013) 1605–1609 © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
`
`1609
`
`Opiant Exhibit 2184
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685
`Page 5
`
`

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