Anticipated barriers and facilitators for implementing smart inhalers in asthma medication adherence management.

Smart inhalers are electronic monitoring devices which are promising in increasing medication adherence and maintaining asthma control. A multi-stakeholder capacity and needs assessment is recommended prior to implementation in healthcare systems. This study aimed to explore perceptions of stakeholders and to identify anticipated facilitators and barriers associated with the implementation of smart digital inhalers in the Dutch healthcare system. Data were collected through focus group discussions with female patients with asthma (n = 9) and healthcare professionals (n = 7) and through individual semi-structured interviews with policy makers (n = 4) and smart inhaler developers (n = 4). Data were analysed using the Framework method. Five themes were identified: (i) perceived benefits, (ii) usability, (iii) feasibility, (iv) payment and reimbursement, and (v) data safety and ownership. In total, 14 barriers and 32 facilitators were found among all stakeholders. The results of this study could contribute to the design of a tailored implementation strategy for smart inhalers in daily practice.

Development of a tool to detect small airways dysfunction in asthma clinical practice.

BACKGROUND: Small airways dysfunction (SAD) in asthma is difficult to measure and a gold standard is lacking. The aim of this study was to develop a simple tool including items of the Small Airways Dysfunction Tool (SADT) questionnaire, basic patient characteristics and respiratory tests available depending on the clinical setting to predict SAD in asthma. METHODS: This study was based on the data of the multinational ATLANTIS (Assessment of Small Airways Involvement in Asthma) study including the earlier developed SADT questionnaire. Key SADT items together with clinical information were now used to build logistic regression models to predict SAD group (less likely or more likely to have SAD). Diagnostic ability of the models was expressed as area under the receiver operating characteristic curve (AUC) and positive likelihood ratio (LR+). RESULTS: SADT item 8, "I sometimes wheeze when I am sitting or lying quietly", and the patient characteristics age, age at asthma diagnosis and body mass index could reasonably well detect SAD (AUC 0.74, LR+ 2.3). The diagnostic ability increased by adding spirometry (percentage predicted forced expiratory volume in 1 s: AUC 0.87, LR+ 5.0) and oscillometry (resistance difference between 5 and 20 Hz and reactance area: AUC 0.96, LR+ 12.8). CONCLUSIONS: If access to respiratory tests is limited (e.g. primary care in many countries), patients with SAD could reasonably well be identified by asking about wheezing at rest and a few patient characteristics. In (advanced) hospital settings patients with SAD could be identified with considerably higher accuracy using spirometry and oscillometry.

Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma: protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial.

INTRODUCTION: Suboptimal asthma control is associated with incorrect inhaler use and poor medication adherence, which could lead to unfavourable clinical and economic outcomes. Smart inhaler programmes using electronic monitoring devices (EMDs) could support self-management and increase medication adherence and asthma control. However, evidence on long-term benefits and acceptability is scarce. This study aims to investigate the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes in adults with uncontrolled asthma, to evaluate its acceptability and to identify subgroups who would benefit most based on patient characteristics. METHODS AND ANALYSIS: This open-label cluster randomised controlled trial of 12 months will be conducted in primary care in the Netherlands. General practices will be randomly assigned to either intervention or control group. We aim to include 242 patients. The intervention consists of (1) an EMD attached to the patient's inhaler that measures medication use; (2) a smartphone application to set medication reminders, receive motivational messages and track asthma symptoms; and (3) a portal for healthcare professionals to view data on medication use. The control group is passively monitored by the EMD but cannot view their inhaler data or receive feedback. Eligible patients are adults with suboptimal controlled asthma (Asthma Control Questionnaire score ≥0.75) with evidence of non-adherence established by the EMD during a 6-week run-in period. Primary outcome is the difference in mean medication adherence between intervention and control group. Secondary outcomes include asthma control, asthma-related quality of life, exacerbations, acceptance, cost-effectiveness and whether the effect of the intervention on medication adherence and asthma control is modified by patient characteristics (eg, self-efficacy, medication beliefs and eHealth literacy).Trial registration numberNL7854.

Validation of the food allergy quality of life questionnaire series in Chinese families with food-allergic children.

BACKGROUND: Anxiety from accidental exposure and vigilant dietary monitoring impair the quality of life (QoL) of food-allergic patients. A comprehensive food allergy-specific questionnaire allows patients to accurately report their QoL. This study validated the Food Allergy Quality of Life Questionnaire (FAQLQ) series and assessed the QoL of Chinese food-allergic patients and their caregivers. METHODS: FAQLQ series developed by EuroPrevall consists of four separate questionnaires for parents, children, adolescents and adults. All questionnaires were translated into traditional Chinese by standard forward and backward methods. A cross-sectional study was conducted on food-allergic patients and children's parents using an age-appropriate questionnaire. The performance indices of FAQLQ and their correlation with independent measures of food allergy were analyzed, and factor analysis was performed to confirm the factor structure of FAQLQ questionnaires. RESULTS: Cross-sectional validation was performed on 214 participants, with 40 reassessed for test-retest reliability. Overall scores for the FAQLQ series had good internal consistency with Cronbach's α ≥.90. Good construct validity was demonstrated by correlations between FAQLQ-Parent Form, FAQLQ-Child Form, FAQLQ-Teenager Form, FAQLQ-Adult Form and Food Allergy Independent Measure (FAIM) scores, except in 0- to 3-year-old children. Test-retest analyses revealed a significant correlation between total FAQLQ score, parent-reported FAIM and food anxiety domain in 4-6 years, and between total score and FAIM in 7-12 years. Exploratory factor analysis categorized items in the FAQLQ series into three to four domains. CONCLUSION: FAQLQ series provide a valid and reliable measure for QoL in Chinese food-allergic patients and caregivers, except for parents of children aged 0-3 years. Items for all FAQLQ questionnaires are categorized into different functional domains in our population.

Managing food allergy: GA2LEN guideline 2022.

Food allergy affects approximately 2-4% of children and adults. This guideline provides recommendations for managing food allergy from the Global Allergy and Asthma European Network (GA2LEN). A multidisciplinary international Task Force developed the guideline using the Appraisal of Guidelines for Research and Evaluation (AGREE) II framework and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. We reviewed the latest available evidence as of April 2021 (161 studies) and created recommendations by balancing benefits, harms, feasibility, and patient and clinician experiences. We suggest that people diagnosed with food allergy avoid triggering allergens (low certainty evidence). We suggest that infants with cow's milk allergy who need a breastmilk alternative use either hypoallergenic extensively hydrolyzed cow's milk formula or an amino acid-based formula (moderate certainty). For selected children with peanut allergy, we recommend oral immunotherapy (high certainty), though epicutaneous immunotherapy might be considered depending on individual preferences and availability (moderate certainty). We suggest considering oral immunotherapy for children with persistent severe hen's egg or cow's milk allergy (moderate certainty). There are significant gaps in evidence about safety and effectiveness of the various strategies. Research is needed to determine the best approaches to education, how to predict the risk of severe reactions, whether immunotherapy is cost-effective and whether biological therapies are effective alone or combined with allergen immunotherapy.

Perceptions on Home-Administration of Biologics in the Context of Severe Asthma: An International Qualitative Study.

BACKGROUND: Biologics are an effective therapy for severe asthma. Home administration of biologics by patients is likely to facilitate their accessibility. Yet little is known about patients' and health care providers' (HCPs) perceptions regarding home administration of biologics. OBJECTIVE: The aim of this study is to create more insight into the perceptions and experiences of patients and HCPs regarding home administration of biologics in the context of the treatment of severe asthma. METHODS: A qualitative international study was performed in the Netherlands, United States, Australia, and United Kingdom. In each country, 2 focus groups were held with potential/recent and long-term users of biologics at home. Prior to the focus groups, patients were prompted with themes on online forums. For triangulation purposes, interviews were held with HCPs to discuss salient findings from forums and focus groups. Data were analyzed with qualitative content analysis. RESULTS: In total, 75 patients participated in the forums, of which 40 participated in the focus groups. Furthermore, 12 HCPs were interviewed. The following overarching themes were identified: living with severe asthma; practical aspects of using biologics; the role of HCPs regarding biologics; social support from family, friends, and others; effectiveness of biologics and other treatments; side effects of biologics. CONCLUSIONS: This study showed that, for those using biologics for severe asthma, the benefits of home administration of biologics usually outweigh inconvenience and side effects. Guided practice, accessible support contact, and monitoring including social support should be central in the transition from hospital to home administration of asthma biologics.

Allergic and hypersensitivity conditions in non-specialist care: Flow diagrams to support clinical practice.

Most patients presenting with allergies are first seen by primary care health professionals. The perceived knowledge gaps and educational needs were recently assessed in response to which the LOGOGRAM Task Force was established with the remit of constructing pragmatic flow diagrams for common allergic conditions in line with an earlier EAACI proposal to develop simplified pathways for the diagnosis and management of allergic diseases in primary care. To address the lack of accessible and pragmatic guidance, we designed flow diagrams for five major clinical allergy conditions: asthma, anaphylaxis, food allergy, drug allergy, and urticaria. Existing established allergy guidelines were collected and iteratively distilled to produce five pragmatic and accessible tools to aid diagnosis and management of these common allergic problems. Ultimately, they should now be validated prospectively in primary care settings.

Health-related quality of life of food-allergic children compared with healthy controls and other diseases.

BACKGROUND: Food allergy is a potentially life-threatening disease, affecting up to 10% of the pediatric population. OBJECTIVE: The aim of our study was to assess the health-related quality of life (HRQL) of food-allergic patients compared with the general population and patients with other chronic diseases with dietary or allergic burden, in a cross-sectional study. METHODS: We recruited patients aged 8-17 years diagnosed with food allergy and matched healthy controls recruited in schools. We also included patients with asthma, inflammatory bowel disease, celiac disease, diabetes, obesity, and eating disorders. We used the CHQ-CF87 questionnaire for generic HRQL assessment. Food allergy HRQL was also assessed using specific questionnaires: Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM). RESULTS: One hundred and thirty-five food-allergic children, 255 children with chronic diseases, and 463 healthy controls were included in the analyses. Food-allergic patients had a better HRQL than healthy controls in the Behavior (BE), Bodily Pain (BP), Family Activities (FA), and Mental Health (MH) domains and a worse HRQL in the General Health Perception (GH) domain (p = .048). Food-allergic patients exhibited a better HRQL than patients affected by other chronic diseases, notably diabetes. Although an epinephrine autoinjector had been prescribed to 87.4% of the food-allergic children, only 54.2% of them carried it at all times. CONCLUSION: Food-allergic patients display overall good HRQL compared with the general population and those with other diseases with daily symptoms and treatments, in line with recent improvements in food allergy management.

Current allergy educational needs in primary care. Results of the EAACI working group on primary care survey exploring the confidence to manage and the opportunity to refer patients with allergy.

The aim of this survey was to explore the specific educational needs of a cohort of European GPs with regards to allergy training so that future educational initiatives may better support the delivery of allergy services in primary care. METHOD: This study took the form of a cross-sectional observational study in which a structured electronic questionnaire was distributed to primary care providers, in eight languages, across 8 European countries between September 2019 and November 2019. Data associated with demographic parameters, professional qualifications, type of employment, level of confidence regarding competencies for diagnosis and treatment of allergic diseases, referral of patients to allergist and preferred method of learning and assessment were collected. A 5-point Likert scale was used to assess level of confidence. Exploratory analysis was carried out. RESULTS: A total of 687 responses were available for analysis, with 99.3% of responders working within Europe. 70.1% of participants were female; and 48.0% and 48.0% of participants respectively had received some undergraduate and/or postgraduate allergy education. Confidence in dealing with different aspect of allergy management differed between countries. The main reason for specialist referral was a perceived need for tertiary assessment (54.3%), and the main barrier for referral was the consideration that the patient's condition could be appropriately diagnosed and treated in a primary care facility. Up to 44.7% and 55.3% of participants reported that they preferred e-Learning over traditional learning. CONCLUSIONS: This study identified the specific areas of skills training and educational needs of GPs in managing allergic conditions in primary care, and provided insights into possible strategies for more feasible and cost-effective approaches.

High Use of SABAs is Associated with Higher Exacerbation Rate in Dutch Patients with Asthma.

PURPOSE: Many patients with asthma still have insufficient disease control, despite the availability of effective treatment options. A substantial proportion of patients appear to rely more on short-acting beta2-agonist (SABA) rather than on anti-inflammatory maintenance treatment. The aim of this study was to describe differences in indicators of asthma symptoms and exacerbations among patients using more or less SABA than the guideline-recommended threshold of <3 times/week. PATIENTS AND METHODS: Data from Dutch respondents in the European REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey were used in this post hoc analysis. The survey included asthma patients aged 18-50 years with at least two prescriptions for their asthma in the past two years. SABA use was categorized into two groups: <3 (low-SABA users) or ≥3 (high-SABA users) times in the last week. RESULTS: Of the 736 asthma patients, 21% did not use SABA and 19% used SABA 1 to 2 times (all low SABA users) and 60% used SABA ≥3 times (high SABA users) in the last week. The majority of high and low SABA users also reported using an ICS-containing treatment. Significant differences were found for all indicators related to exacerbations (p<0.001): high SABA users more frequently used antibiotics and oral steroids, more frequently visited the emergency departments or needed an overnight hospital stay. Indicators of asthma symptoms were not significantly different between both groups. CONCLUSION: The majority of a Dutch asthmatic population reported high SABA use and had frequent moderate/severe exacerbations. More effective interventions are needed to change healthcare providers' and patients' behaviours to improve care and reduce SABA (over)use.

Work absence in patients with asthma and/or COPD: a population-based study.

Chronic obstructive pulmonary disease (COPD) and asthma impact on work productivity, but their population-based burden and clinical predictors are understudied. In this observational, real-life study, work absence of 14,383 asthma and/or COPD patients present in the MAJORICA cohort (Spain) was compared with the general population. Using multivariable regression, we studied the association of work absence with demographic and clinical characteristics. Patients with asthma and/or COPD had more work absence than the general population (15.2% vs 8.9%, p < 0.0001). Patients with asthma had more often periods of work absence compared to patients with COPD (16.0% vs 12.8%, p < 0.0001). The number of days absent were, however, less in asthma than in COPD (median: 15 days [IQR: 5-51] vs 39 days [IQR: 13-134], p < 0.001). Patients with asthma-COPD overlap were in between (14.5% with absence; median: 27 days [IQR: 10-82]). Comorbid anxiety, allergic rhinitis, and sleep apnoea were independently associated with more work absence.

Burden and socioeconomics of asthma, allergic rhinitis, atopic dermatitis and food allergy.

INTRODUCTION: Asthma, allergic rhinitis, atopic dermatitis, and food allergy affect approximately 20% of the global population. Few studies describe the burden of the totality of these diseases and only a handful studies provide a comprehensive overview of the socioeconomic impact of these diseases. AREAS COVERED: For this narrative review, we searched Pubmed using selected keywords and inspected relevant references using a snowballing process. We provide an overview of the socioeconomic burden of allergic diseases (in particular, asthma, allergic rhinitis, atopic dermatitis, and food allergy). The focus of this review is on their epidemiology (incidence, prevalence), burden (disability-adjusted life years, quality of life), and direct and indirect costs (absenteeism and presenteeism). We have put special emphasis on differences between countries. EXPERT COMMENTARY: Both the prevalence and the burden of allergic diseases are considerable with prevalence varying between 1% and 20%. We identified a plethora of studies on asthma, but studies were generally difficult to compare due to the heterogeneity in measures used. There were only few studies on the burden of food allergy; therefore, more studies on this allergy are required. For future studies, we recommend standardizing epidemiologic, socioeconomic impact, and quality of life measures of allergic diseases.

Prevalence of Asthma Characteristics in COPD Patients in a Dutch Well-Established Asthma/COPD Service for Primary Care.

Purpose: Primary care COPD guidelines indicate that COPD patients with asthma characteristics should be treated as having asthma. This study aims to describe the prevalence of asthma characteristics in patients with a pulmonologist-confirmed working diagnosis of COPD or ACO. Patients and Methods: This retrospective cross-sectional study used real-life data (collected between 2007 and 2017) from a Dutch asthma/COPD-service, a structured web-based system in which pulmonologists support general practitioners in their diagnosis of patients with suspicion of obstructive lung disease. The prevalence of asthma characteristics (history of asthma, atopy, symptoms, and reversibility) and blood eosinophil (Eos) counts were assessed in patients with a working diagnosis of COPD or ACO. Results: Of the 14,141 patients, ≥40 years in the dataset, 4475 (31.6%) were diagnosed with asthma, 3532 (25.0%) with COPD, and 1276 (9.0%) with ACO. Asthma characteristics were present in 65.6% (n=1956) of the COPD and 90.9% (n=1059) of the ACO patients. Eos counts of ≥ 300 cells per µL were found in 35.7% (n=924) of the COPD patients and 35.3% (n=341) of the ACO patients. Conclusion: In this group of COPD and ACO patients remotely diagnosed by pulmonologists, a substantial proportion would be considered to have asthma characteristics according to the guidelines. This may explain the high number of inhaled corticosteroid (ICS) prescriptions found in primary care COPD patients. Prospective studies are necessary to identify patients who may or may not benefit from ICS containing treatment. Hence, personalized care in primary care can be optimized.

Likely questionnaire-diagnosed food allergy in 78, 890 adults from the northern Netherlands.

BACKGROUND: It is challenging to define likely food allergy (FA) in large populations which limited the number of large studies regarding risk factors for FA. OBJECTIVE: We studied the prevalence and characteristics of self-reported FA (s-rFA) in the large, population-based Dutch Lifelines cohort and identified associated risk factors. METHODS: Likely food allergic cases (LikelyFA) were classified based on questionnaire reported characteristics consistent with FA. Subjects with atypical characteristics were classified as Indeterminate. We investigated 13 potential risk factors for LikelyFA such as birth mode and living on a farm and addressed health-related quality of life (H-RQOL). RESULTS: Of the 78, 890 subjects, 12.1% had s-rFA of which 4.0% and 8.1% were classified as LikelyFA and Indeterminate, respectively. Younger age, female sex, asthma, eczema and nasal allergy increased the risk of LikelyFA (p-value range <1.00*10-250-1.29*10-7). Living in a small city/large village or suburb during childhood was associated with a higher risk of LikelyFA than living on a farm (p-value = 7.81*10-4 and p = 4.84*10-4, respectively). Subjects classified as Indeterminate more often reported depression and burn-out compared to those without FA (p-value = 1.46*10-4 and p = 8.39*10-13, respectively). No association was found with ethnicity, (duration of) breastfeeding, birth mode and reported eating disorder. Mental and physical component scores measuring H-RQOL were lower in both those classified as LikelyFA and Indeterminate compared to those without FA. CONCLUSION: The prevalence of s-rFA among adults is considerable and one-third reports characteristics consistent with LikelyFA. Living on a farm decreased the risk of LikelyFA. The association of poorer H-RQOL as well as depression and burn-out with questionable self-perceived FA is striking and a priority for future study.

Development and construct validation of a parent-proxy quality of life instrument in children with bronchopulmonary dysplasia aged 4-8 years old.

PURPOSE: Children with bronchopulmonary dysplasia often develop complications that affect them well into adult life. Very little is known about how this affects their quality of life, since no sensitive instrument is available to measure health-related quality of life in this population. In this study, a Dutch parent-proxy instrument was developed for this purpose. METHODS: A list of items was generated after literature search and interviews with both parents of patients and clinical experts. Clinically relevant items were selected with the clinical impact method and item analysis. Results of clinical tests to measure complications in children with bronchopulmonary dysplasia were correlated with these items to select the items that show construct validity. Cronbach's alpha was calculated to estimate internal consistency of the items in the final questionnaire. RESULTS: In total, 92 children and their parents and 7 clinicians participated. Of 130 identified items, 47 showed clinical relevance. Spirometry, the Child Behavior Checklist, mean arterial pressure, and body mass index were used to determine construct validity of 33 items. These items were structured within five domains: pulmonary complaints, school functioning, growth and nutrition, exercise and locomotion, emotional functioning and health care concerns. The questionnaire showed excellent internal consistency with Cronbach's alpha of 0.919. CONCLUSION: This study developed a disease-specific parent-proxy instrument to measure health-related quality of life in children with bronchopulmonary dysplasia aged 4-8 years old, the BPD-QoL. All included items show construct validity and internal consistency reliability. Future research should focus on further validation and analysis of responsiveness and reliability.

The feasibility of an allergy management support system (AMSS) for IgE-mediated allergy in primary care.

BACKGROUND: The allergy management support system (AMSS) was developed to assist general practitioners (GPs) to handle the increasing burden of allergic diseases and facilitates the diagnosis and management of allergy. The aim of this cluster-randomized controlled pilot study was to test the feasibility of this AMSS for primary care. METHODS: GPs received diagnostic and management recommendations generated by the AMSS in addition to sIgE-test results (intervention) or GPs received sIgE-test results only (control). The AMSS recommendations are based on the previously developed patient-completed AMSS questionnaire and sIgE-test results. The AMSS was considered feasible when > 70% of the AMSS recommendations were sent to the GP within ten working days of sIgE-testing. GPs completed a questionnaire on their diagnosis and management before (T1) and after (T2) receiving sIgE test results. Agreement and disagreement concerning diagnosis, medication and referrals between GPs and AMSS was investigated at T1 and T2. A total agreement score between GPs and AMSS was calculated. GPs in the intervention group completed a questionnaire to evaluate the utility of the AMSS. Semi-structured interviews were used to explore the motivation of GPs who did not include patients in this pilot study. RESULTS: Twenty-seven GPs included 101 patients. Forty-two patients (72%) completed the AMSS questionnaire in the intervention group. The majority of the AMSS recommendations (93%) were returned to the GP within 10 working days after sIgE-test results were known [mean (SD) 4.7 (4.0) working days]. GPs in the intervention group reported largely following the AMSS recommendations in 71% of cases. The total agreement scores concerning diagnosis were significantly higher (p < 0.001) in the intervention group than the control group [mean (SD); 0.9 (1.8) vs - 0.8 (1.0)]. The agreement concerning medication or referral between GPs and AMSS did not differ between the intervention and the control group. GPs in the intervention group were reasonably positive about the AMSS. Not enrolling patients was not caused by anticipated ineffectiveness of the AMSS. CONCLUSION: The AMSS can be considered to be feasible for primary care. GPs tend to follow the AMSS recommendations. The AMSS may contribute to the empowerment of GPs to better manage allergy patients in primary care.Trial registration ISRCTN ISRCTN36780877. Registered 23 November 2017 (retrospectively registered).