Control Of Allergic Rhinitis And Asthma Test Research Articles

Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study

Validated questionnaires are used to assess asthma control over the past 1-4 weeks from reporting. However, they do not adequately capture asthma control in patients with fluctuating symptoms. Using the Mobile Airways Sentinel Network for airway diseases (MASK-air) app, we developed and validated an electronic daily asthma control score (e-DASTHMA). We used MASK-air data (freely available to users in 27 countries) to develop and assess different daily control scores for asthma. Data-driven control scores were developed based on asthma symptoms reported by a visual analogue scale (VAS) and self-reported asthma medication use. We included the daily monitoring data from all MASK-air users aged 16-90 years (or older than 13 years to 90 years in countries with a lower age of digital consent) who had used the app in at least 3 different calendar months and had reported at least 1 day of asthma medication use. For each score, we assessed construct validity, test-retest reliability, responsiveness, and accuracy. We used VASs on dyspnoea and work disturbance, EQ-5D-VAS, Control of Allergic Rhinitis and Asthma Test (CARAT), CARAT asthma, and Work Productivity and Activity Impairment: Allergy Specific (WPAI:AS) questionnaires as comparators. We performed an internal validation using MASK-air data from Jan 1 to Oct 12, 2022, and an external validation using a cohort of patients with physician-diagnosed asthma (the INSPIRERS cohort) who had had their diagnosis and control (Global Initiative for Asthma [GINA] classification) of asthma ascertained by a physician. We studied 135 635 days of MASK-air data from 1662 users from May 21, 2015, to Dec 31, 2021. The scores were strongly correlated with VAS dyspnoea (Spearman correlation coefficient range 0·68-0·82) and moderately correlated with work comparators and quality-of-life-related comparators (for WPAI:AS work, we observed Spearman correlation coefficients of 0·59-0·68). They also displayed high test-retest reliability (intraclass correlation coefficients range 0·79-0·95) and moderate-to-high responsiveness (correlation coefficient range 0·69-0·79; effect size measures range 0·57-0·99 in the comparison with VAS dyspnoea). The best-performing score displayed a strong correlation with the effect of asthma on work and school activities in the INSPIRERS cohort (Spearman correlation coefficients 0·70; 95% CI 0·61-0·78) and good accuracy for the identification of patients with uncontrolled or partly controlled asthma according to GINA (area under the receiver operating curve 0·73; 95% CI 0·68-0·78). e-DASTHMA is a good tool for the daily assessment of asthma control. This tool can be used as an endpoint in clinical trials as well as in clinical practice to assess fluctuations in asthma control and guide treatment optimisation. None.

Home administration of biological treatment in severe asthma in real-life experience: impact on asthma control and quality of life.

Introduction. Several biological agents for the treatment of severe asthma have been approved for self-administration on an outpatient basis in the last years. However, data on the impact of home administration in outcomes such as asthma control and quality of life in real-life settings are sparse. Being this knowledge crucial for clinical practice, this study aimed to assess asthma control and quality of life in patients who transitioned from day hospital administration of biological therapy to home administration. Methods. A single-center prospective analysis of 33 patients treated with biologics for severe asthma, who switched from hospital to home treatment was performed. Asthma Control Test (ACT), Control of Allergic Rhinitis and Asthma Test (CARAT), Asthma Life Quality (ALQ) and the number of exacerbations were assessed 3 months before and 3 and 6 months after of home-use. Results. ACT and CARAT did not show statistical differences comparing to the baseline values (21.8 ± 2.7 and 23.8 ± 5.5) within 3 months (22.1 ± 2.4, p = 0.609; 23.2 ± 5.3, p = 0.572) or 6 months (23.4 ± 0.9, p = 0.553; 23.7 ± 6.2, p = 0.149) of home administration. Also, ALQ score did not show meaningful variations between baseline (9.5 ± 3.2) and after 3 months (11.2 ± 4.4, p = 0.275) and 6 months (10.3 ± 3.8, p = 0.209) of home-use. Regarding asthma exacerbations, we did not record a significant difference comparing to the baseline values of 3 months/patient exacerbations (0.2 ± 0.4) and after 3 months (0.2 ± 0.5, p = 0.786) or 6 months (0.2 ± 0.4, p = 1.000) of change in modality treatment. There was no cases of anaphylaxis or other serious adverse effects in those patients treated at home. Conclusions. Transition of day hospital administration of biologic treatment for severe asthma to home administration did not lead to any deterioration of asthma control or quality of life. Our results emphasized the efficacy and safety of home administration of biologic treatment and provide support on changing the paradigm of the administration of biological treatment in severe asthma.

Effect of ayurvedic interventions in the management of allergic rhinitis - An open label multi-centre single arm clinical study

Abstract BACKGROUND: The symptoms of Allergic Rhinitis,resemble the clinical presentation of Vataja Pratishyaya, a type of Pratishyaya, narrated in the Ayurveda classical texts. An exploratory clinical study was planned to assess the the safety and potential effect of a combination therapy of Ayurveda interventions, viz., Ayush VPR (a coded Ayurvedic formulation), Shirishadi Kwath (Anubhoota Yoga), and Nasya (intranasal drug administration) with Anutaila. MATERIALS AND METHODS: The study was an open-label, multicenter, prospective clinical study with pre-test and post-test design. Sixty participants aged between 18 and 65 years with the symptoms of AR were enrolled in the study as per the inclusion and exclusion criteria. The interventions given to the participants were Ayush VPR (3.5 g) powder, twice a day with honey and ghee after food, Shirishadi Kwath (20 ml) twice a day, orally on an empty stomach, and Anutaila Nasya (intranasal drug administration) for 7 days for two consecutive cycles with an interval of 7 days. The participants were assessed weekly for a total duration of 28 days. This was followed by a 28-day follow-up period, with assessments conducted at intervals of 14 days. The primary outcome was change in the CARAT (Control of Allergic Rhinitis and Asthma Test) score. RESULTS: Data of 60 participants were used for analysis. The mean age of participants was 35.8 ± 12.12., and the proportion of males and females were comparable with 51.7% females among the total participants. The mean CARAT score improved from baseline to the subsequent follow-ups at 7th, 14th, 21st, and 28th days. A significant improvement in the mean total CARAT score (P < 0.001) was observed after the 28th day of treatment and also at the end of the 56th day in comparison to baseline. CONCLUSION: The Ayurvedic formulations, Shirishadi Kwath, Ayush VPR, and Anutaila, are safe and significantly reduce rhinorrhea, nasal itching, sneezing fits, nasal congestion, and nasal obstruction. The present study reveals that the Ayurvedic treatment provided highly significant relief from AR.

Control of Allergic Rhinitis and Asthma Test: A systematic review of measurement properties and COSMIN analysis.

The Control of Allergic Rhinitis and Asthma Test (CARAT) is a patient‐reported outcome measurement (PROM) assessing the control of asthma and allergic rhinitis (AR) at a 4 week interval. This systematic review aimed to evaluate the measurement properties of CARAT. Following PRISMA and COSMIN guidelines, we searched five bibliographic databases and retrieved studies concerning the development, assessment of properties, validation, and/or cultural adaption of CARAT. The studies' methodological quality, the quality of measurement properties, and the overall quality of evidence were assessed. We performed meta‐analysis of CARAT measurement properties. We included 16 studies. Control of Allergic Rhinitis and Asthma Test displayed sufficient content validity and very good consistency (meta‐analytical Cronbach alpha = 0.83; 95% CI = 0.80–0.86;I 2 = 62.6%). Control of allergic rhinitis and Asthma Test meta‐analytical intraclass correlation coefficient was 0.91 (95% CI = 0.64–0.98;I 2 = 93.7%). It presented good construct validity, especially for correlations with Patient‐reported outcome measures assessing asthma (absolute Spearman correlation coefficients range = 0.67–0.73; moderate quality of evidence), and good responsiveness. Its minimal important difference is 3.5. Overall, CARAT has good internal consistency, reliability, construct validity and responsiveness, despite the heterogeneous quality of evidence. Control of Allergic Rhinitis and Asthma Test can be used to assess the control of asthma and AR. As first of its kind, this meta‐analysis of CARAT measurement properties sets a stronger level of evidence for asthma and/or AR control questionnaires.

Assessment of the Control of Allergic Rhinitis and Asthma Test (CARAT) using MASK-air

Several tools can assess the control of allergic rhinitis (AR), including symptom scores, control scores (e.g., Control of Allergic Rhinitis and Asthma Test [CARAT]1 and Allergic Rhinitis Control Test2), patients' self-administered visual analog scales (VASs), and patients' reported outcomes for quality of life and work.

Validity, reliability, and responsiveness of daily monitoring visual analog scales in MASK-air®.

BackgroundMASK‐air® is an app that supports allergic rhinitis patients in disease control. Users register daily allergy symptoms and their impact on activities using visual analog scales (VASs). We aimed to assess the concurrent validity, reliability, and responsiveness of these daily VASs.MethodsDaily monitoring VAS data were assessed in MASK‐air® users with allergic rhinitis. Concurrent validity was assessed by correlating daily VAS values with those of the EuroQol‐5 Dimensions (EQ‐5D) VAS, the Control of Allergic Rhinitis and Asthma Test (CARAT) score, and the Work Productivity and Activity Impairment Allergic Specific (WPAI‐AS) Questionnaire (work and activity impairment scores). Intra‐rater reliability was assessed in users providing multiple daily VASs within the same day. Test–retest reliability was tested in clinically stable users, as defined by the EQ‐5D VAS, CARAT, or “VAS Work” (i.e., VAS assessing the impact of allergy on work). Responsiveness was determined in users with two consecutive measurements of EQ‐5D‐VAS or “VAS Work” indicating clinical change.ResultsA total of 17,780 MASK‐air® users, with 317,176 VAS days, were assessed. Concurrent validity was moderate–high (Spearman correlation coefficient range: 0.437–0.716). Intra‐rater reliability intraclass correlation coefficients (ICCs) ranged between 0.870 (VAS assessing global allergy symptoms) and 0.937 (VAS assessing allergy symptoms on sleep). Test–retest reliability ICCs ranged between 0.604 and 0.878—“VAS Work” and “VAS asthma” presented the highest ICCs. Moderate/large responsiveness effect sizes were observed—the sleep VAS was associated with lower responsiveness, while the global allergy symptoms VAS demonstrated higher responsiveness.ConclusionIn MASK‐air®, daily monitoring VASs have high intra‐rater reliability and moderate–high validity, reliability, and responsiveness, pointing to a reliable measure of symptom loads.

Turkish language validity and reliability of the Control of Allergic Rhinitis and Asthma Test and its comparison with other scales

Patients with asthma often suffer from concomitant allergic rhinitis (AR). The Control of Allergic Rhinitis and Asthma Test (CARAT) is a validated tool to assess asthma and rhinitis multimorbidity. Turkish language validity and reliability of CARAT and its compatibility with other scales were evaluated in the study. Patients with asthma and concomitant AR were tested with CARAT. Pulmonary function tests, Asthma Control Test (ACT), Assessment Tool for Asthma (ATA) questionnaire and visual analogue scale (VAS) were also used at the same day. With the VAS, patients determined their rhinitis symptom levels, and asthma specialist determined the rhinitis and asthma control levels separately. These questionnaires were repeated in 14 ± 2 days. Three quarters (77%) of the 100 patients were female (mean age 46.5years). The mean CARAT score was 19.6 ± 7.2. The Cronbach's alpha coefficient of the Turkish version of the CARAT scale was 0.83, showing a high level of internal consistency. Test-retest reliability coefficient was determined as r = 0.98 (p < 0.001). The Kaiser-Meyer-Olkin coefficient of the CARAT scale was 0.79. The p value of the Bartlett test was <0.001. ACT, ATA and VAS expert scales were correlated with CARAT total score (0.577 ≤ r ≤ 0.871). The CARAT scale did not show statistically significant difference according to gender, education, working status, smoking status, presence of polyps and multiple allergen sensitivity (p > 0.05). The Turkish version of the CARAT is a reliable alternative tool for physicians in determining disease control in adult patients with asthma and AR.

Monitoring Adherence to Asthma Inhalers Using the InspirerMundi App: Analysis of Real-World, Medium-Term Feasibility Studies.

Background: Poor medication adherence is a major challenge in asthma and objective assessment of inhaler adherence is needed. InspirerMundi app aims to monitor inhaler adherence while turning it into a positive experience through gamification and social support.Objective: We assessed the medium-term feasibility of the InspirerMundi app to monitor inhaler adherence in real-world patients with persistent asthma (treated with daily inhaled medication). In addition, we attempted to identify the characteristics of the patients related to higher app use.Methods: Two real-world multicenter observational studies, with one initial face-to-face visit and a 4-month telephone interview, were conducted in 29 secondary care centers from Portugal. During an initial face-to-face visit, patients were invited to use the app daily to register their asthma medication intakes. A scheduled intake was considered taken when patients took a photo of the medication (inhaler, blister, or others) using the image-based medication detection tool. Medication adherence was calculated as the number of doses taken as a percentage of the number scheduled. Interacting with the app ≥30 days was used as the cut-off for higher app use.Results: A total of 114 patients {median 20 [percentile 25 to percentile 75 (P25–P75) 16–36] years, 62% adults} were invited, 107 (94%) installed the app and 83 (73%) completed the 4-month interview. Patients interacted with the app for a median of 18 [3–45] days, translated on a median use rate of 15 [3–38]%. Median inhaler adherence assessed through the app was 34 [4–73]% when considering all scheduled inhalations for the study period. Inhaler adherence assessed was not significantly correlated with self-reported estimates. Median adherence for oral and other medication was 41 [6–83]% and 43 [3–73]%, respectively. Patients with higher app use were slightly older (p = 0.012), more frequently taking medication for other health conditions (p = 0.040), and more frequently prescribed long-acting muscarinic antagonists (LAMA, p = 0.024). After 4 months, Control of Allergic Rhinitis and Asthma Test (CARAT) scores improved (p < 0.001), but no differences between patients interacting with the app for 30 days or less were seen.Conclusions: The InspirerMundi app was feasible to monitor inhaler adherence in patients with persistent asthma. The persistent use of this mHealth technology varies widely. A better understanding of characteristics related to higher app use is still needed before effectiveness studies are undertaken.

Validation of App and Phone Versions of the Control of Allergic Rhinitis and Asthma Test (CARAT).

Validation of App and Phone Versions of the Control of Allergic Rhinitis and Asthma Test (CARAT).

Identification of clusters of asthma control: A preliminary analysis of the Inspirers studies

Aims: To identify distinct asthma control clusters based on Control of Allergic Rhinitis and Asthma Test (CARAT) and to compare patients’ characteristics among these clusters. Methods: Adults and adolescents (≥13 years) with persistent asthma were recruited at 29 Portuguese hospital outpatient clinics, in the context of two observational studies of the INSPIRERS project. Demographic and clinical characteristics, adherence to inhaled medication, beliefs about inhaled medication, anxiety and depression, quality of life, and asthma control (CARAT, &gt;24 good control) were collected. Hierarchical cluster analysis was performed using CARAT total score (CARAT -T). Results: 410 patients (68% adults), with a median (percentile 25–percentile 75) age of 28 (16­‑46) years, were analysed. Three clusters were identified [mean CARAT -T (min -max)]: cluster 1 [27(24 -30)], cluster 2 [19(14 -23)] and cluster 3 [10(2 -13)]. Patients in cluster 1 (34%) were characterised by better asthma control, better quality of life, higher inhaler adherence and use of a single inhaler. Patients in clusters 2 (50%) and 3 (16%) had uncontrolled asthma, lower inhaler adherence, more symptoms of anxiety and depression and more than half had at least one exacerbation in the previous year. Furthermore, patients in cluster 3 were predominantly female, had more unscheduled medical visits and more anxiety symptoms, perceived a higher necessity of their prescribed inhalers but also higher levels of concern about taking these inhalers. There were no differences in age, body mass index, lung function, smoking status, hospital admissions or specialist physician follow -up time among the three clusters. Conclusion: An unsupervised method based on CARAT- -T, identified 3 clusters of patients with distinct, clinically meaningful characteristics. The cluster with better asthma control had a cut -off similar to the established in the validation study of CARAT and an additional cut -off seems to distinguish more severe disease. Further research is necessary to validate the asthma control clusters identified.

The Measurement of Asthma and Allergic Rhinitis Control in Children and Adolescents.

Asthma and allergic rhinitis (AR) are frequently associated. The objective of the treatment of asthma and AR should be the control of symptoms and disease progression. Therefore, the combined measurement of disease control is desirable. In this regard, a questionnaire able to together assess asthma and AR control has been validated: the CARAT (Control of Allergic Rhinitis and Asthma Test). A further pediatric version (CARATkids) has been generated. The current real-world study used different disease control measures in children and adolescents with asthma and rhinitis. A total of 138 children and adolescents were recruited at three allergy centers. CARAT, CARATkids, ACT (Asthma Control Test), cACT (children ACT), GINA (Global Initiative for Asthma) disease control classification, VAS (Visual Analog Scale) for asthma and nasal symptoms, and lung function were used in all subjects. There was a predominance of males (67.4%) and asthma was well-controlled (according to GINA classification) in about half the subjects. In children, the median CARAT and cACT values were 5 and 22 respectively. In adolescents, the median CARAT and ACT values were 23 for both tests. There were significant differences between CARAT and ACT (p = 0.035) as well as between CARATkids and cACT (p = 0.0001). However, the tests’ outcomes were different as assessed in different domains. CARAT and CARATkids are disease-control measurements that give additional information to other tests, therefore, these different questionnaires to measure disease control complement each other.

Effect of nasal irrigation on allergic rhinitis control in children; complementarity between CARAT and MASK outcomes

BackgroundNasal irrigations (NI) are increasingly used as an over-the-counter adjunctive treatment for allergic rhinitis (AR), but clinical studies on their effectiveness are limited.MethodsAn open-label, controlled, non-randomized, real-life study was conducted to evaluate the effectiveness of NI with a new hypertonic solution as add-on treatment for AR. Children and adolescents with AR were prescribed symptomatic treatment. The active group also received an additional sea-water NI solution supplemented with algae extracts. The primary endpoint was symptom control, assessed by the control of allergic rhinitis and asthma test (CARAT) questionnaires. Moreover, the MASK/Allergy Diary was used to track symptoms and daily medication use that were combined in a novel total symptom/medication score (TSMS).ResultsWe assessed 76 patients. Overall, there was a significant improvement of CARAT results (median Z-score change of 1.1 in the active/NI group vs. 0.4 in the control group; p = 0.035). Among patients > 12 years old (n = 51), there was a significant improvement in CARAT10 results among participants receiving NI (21.0 to 25.5; p < 0.001), but not in the regular treatment group (21.5 to 24.0; p = 0.100). For children < 12 years old (n = 25), the ΝΙ group had significantly improved symptom control (CARATKids results: 5.0 to 2.0; p = 0.002), in contrast to the control group (4.0 to 2.5; p = 0.057). MASK data on allergic symptoms were comparable between groups. However, the NI group had lower TSMS, more days with < 20% symptoms and fewer days using symptomatic treatment (26.9% vs. 43.5%; p = 0.005).ConclusionAddition of NI with a sea-water solution to regular treatment improved AR symptom control. CARAT questionnaires and MASK application can be useful outcome tools in real-life studies.

The effectiveness and safety of subcutaneous immunotherapy for inhalable allergens in patients with respiratory allergies

Specific immunotherapy is a treatment aimed at modifying the course of the allergic disease, with which important immunological and clinical changes are achieved. To assess the effectiveness and safety of subcutaneous immunotherapy in patients diagnosed with respiratory allergies in the University Hospital of Puebla, Mexico. A longitudinal, analytic, quasi-experimental study. The study was carried out with patients aged four to sixty-five years, diagnosed with allergic rhinitis or asthma, with sensitization to aeroallergens, in whom immunotherapy was started. For the effectiveness assessment, the Control of Allergic Rhinitis and Asthma Test (CARAT) was used. Safety was assessed through Portnoy's Questionnaire Survey of Adverse Reactions. 59 patients were included: 72.9% were female; 23.7% of them were diagnosed with allergic rhinitis and asthma, and 76.3% were diagnosed with allergic rhinitis. The comparison of averages of the CARAT questionnaire at the beginning of the treatment and after four months of follow up showed a statistically significant positive development. An incidence of adverse local reactions of 9.03% was found; no adverse systemic reactions were reported. The assessed scheme of subcutaneous immunotherapy got to significantly decrease the asthma symptoms and AR symptoms, with a desirable safety profile.

Add-on probiotics in patients with persistent allergic rhinitis: A randomized crossover clinical trial.

Current medications for allergic rhinitis (AR) may have undesirable side effects that could affect quality of life (QoL). Probiotics could be an alternative in these patients. The aim of this study was to assess the impact of add-on probiotics on symptoms and QoL of patients. In this randomized crossover clinical trial, patients with persistent AR were included. Each subject received budesonide with probiotic supplements (BP) or budesonide with placebo for 8 weeks (B), then vice versa for a further 8 weeks. There was an 8-week washout. The primary outcome was the change of the Short Form 36-Item Health Survey (SF-36) score. The secondary outcomes were assessed by the Sinonasal Outcome Test-22 (SNOT-22) and the Control of Allergic Rhinitis and Asthma Test (CARAT) questionnaires. A total of 152 subjects (30.1 ± 7.6 years) completed the study. The SF-36 score in both groups showed improvement compared with baseline values. Treatment BP was more effective than that of B. The Cohen's d and the number needed to treat for Physical Component Scales of SF-36 were 0.40 and 10.77, respectively. These values for Mental Component Scales were 0.33 and 12.61, respectively. Also, treatment BP showed more reduction in the score of SNOT-22 and CARAT. This study showed that the addition of probiotics to budesonide significantly improved QoL in persistent AR patients. However, the clinical situation of these patients may be not very representative of AR patients in general population. Further studies are recommended. 1b Laryngoscope, 129:1744-1750, 2019.

The control of allergic rhinitis in real life: a multicenter cross-sectional Italian study

BackgroundAllergic Rhinitis (AR) is a high-prevalence disease. In Europe about 25% of the general population is affected, and in Italy the prevalence is estimated to be 19.8%. The Allergic Rhinitis and its Impact on Asthma (ARIA) international document underlined that the prevalence of severe or refractory or overlapping rhinitis is increasing and represents a non-negligible socio-economic burden. In general, despite the social healthcare costs, allergic rhinitis remains underestimated, not sufficiently controlled and often undertreated.Aim of the studyIn this multi-center Italian observational and prospective study we assessed the control of AR in patients (> 16 years) without previous asthma diagnosis, referred to Allergy Centers.MethodsPatients of both sexes and older than 16 with rhinitis symptoms and without asthma were studied. A Visual Analogue Scale (VAS) and the CARAT (Control of Allergic Rhinitis and Asthma Test) were used as patient reported outcome. The possible causes of poor control of AR, as per protocol, were assessed accordingly.ResultsWe observed 250 patients in a real-life setting: more than 60% of them had an uncontrolled AR, only about 50% used multiple medications, and only a minority were receiving allergen immunotherapy.ConclusionThis survey, conducted in a real-life setting, confirmed that AR is overall poorly controlled. The VAS assessment well correlates with the structured CARAT questionnaire and with the relevant symptoms of AR.

Use of the Control of Allergic Rhinitis and Asthma Test and pulmonary function tests to assess asthma control in pregnancy.

Asthma is one of the most prevalent chronic medical conditions to complicate pregnancy. Similarly, active management strategies that prioritise asthma control in this vulnerable population can have a far-reaching impact. To describe lung function parameters and results of the Control of Allergic Rhinitis and Asthma Test (CARAT) questionnaire in pregnant asthmatics and to analyse correlations between lung function tests and CARAT results. All pregnant asthmatics who performed spirometry and CARAT between September 2014 and August 2015 were included. A medical records review was performed and data regarding demographics, sensitisation and medical prescriptions were recorded. Control of asthma and rhinitis was defined by CARAT total score (CARAT (T))≥24; upper airways (U) control if CARAT (U)>8; lower airways (L) control if CARAT (L)>15. Forty-two pregnant asthmatics were included, with a median age (interquartile range)of 32 (27-34) years; all had a previous medical diagnosis of asthma and rhinitis, 76% were atopic, 94% sensitised to dust mites and 43% were polissensitised. More than 80% presented poor control (CARAT (T)<24) in the first assessment and 15% had a percentage forced expiratory volume in the first second <80%. There were significant negative correlations between CARAT (L) and CARAT (T) scores and step-up of controller medication, (correlation coefficients =-0.453 and -0.392, respectively). The use of tools such as spirometry and validated questionnaires to objectively assess asthma control during pregnancy should be routinely applied to assist in the management of these patients. These data reinforce the importance of close monitoring of pregnant asthmatics to achieve and maintain better disease control.

Self-management research of asthma and good drug use (SMARAGD study): a pilot trial

Background Community pharmacists play an important role in supporting patients for optimal drug use. Objective To assess the effectiveness of monitoring in asthma patients with inhaled corticosteroids (ICS) on disease control. Setting Asthma patients using ICS were invited from two intervention (IG) and two control pharmacies (CG). Method Participating patients completed questionnaires at the study start and at 6-month follow-up, including the Control of Allergic Rhinitis and Asthma Test (CARAT) questionnaire. IG patients completed the CARAT questionnaire every 2 weeks and received counselling on disease management, ICS adherence, and inhalation technique when scores were suboptimal, deteriorating, or absent. For Turbuhaler users, additional electronic monitoring (EMI) was available, with daily alerts for ICS intake. Main outcome measure As the primary outcome, CARAT scores at follow-up were compared between IG and CG using linear regression. As secondary outcome, refill adherence was compared using logistic regression. Results From March to July 2015, we enrolled 39 IG and 41 CG patients. At follow-up, CARAT scores did not differ between IG and CG (−0.19; 95% confidence interval [CI], −2.57 to 2.20), neither did patient numbers with ICS adherence >80% (0.82; 95% CI, 0.28–2.37). Among EMI users, CARAT scores did not differ, but ICS adherence >80% showed a 4.52-fold increase (95% CI, 1.56–13.1) compared with EMI nonusers. Conclusion Among community-dwelling asthma patients, pharmacist monitoring did not affect CARAT scores, but EMI use showed improved ICS refill adherence.

Assessment of asthma control using CARAT in patients with and without Allergic Rhinitis: A pilot study in primary care

BackgroundAsthma and Allergic Rhinitis (AR) are two chronic inflammatory diseases that are often concomitant. The Control of Allergic Rhinitis and Asthma Test (CARAT) was developed to evaluate the control of these diseases from the patients’ perspective. Its performance in asthma patients without AR has not been previously studied. AimTo test the hypothesis that CARAT can be used to assess asthma control in patients with asthma and without AR. MethodsA cross-sectional study was conducted in 3 primary healthcare centres in Northern Portugal. Adult patients identified in the Electronic Patient Record with a diagnosis of asthma were invited to participate. CARAT was used to assess asthma control and Asthma Control Test (ACT) as a comparator. The associations between asthma patients without AR (AsAR) and with AR (AwAR) were analyzed with Spearman correlation. Additionally, Receiver Operating Characteristic (ROC) curve analysis, summarized by Area Under the Curve (AUC), was used to assess performance of CARAT for screening asthma that was not well-controlled. ResultsA total of 103 asthma patients completed the study, 64 (62%) had AwAR and in 87 (85%) asthma was not well-controlled. We observed a strong correlation between CARAT and ACT scores (r=0.734) in all asthma patients and in both groups: AsAR (r=0.737) and AwAR (r=0.843). ROC curve demonstrated CARAT as having a good discriminative power for both AsAR and AwAR groups (AUC=0.894 and 0.946, respectively). ConclusionThese initial results suggest that CARAT has a good discriminative performance, similar to other asthma control assessment tools, for asthma patients with and without AR.

MACVIA-ARIA Sentinel NetworK for allergic rhinitis (MASK-rhinitis): the new generation guideline implementation.

Several unmet needs have been identified in allergic rhinitis: identification of the time of onset of the pollen season, optimal control of rhinitis and comorbidities, patient stratification, multidisciplinary team for integrated care pathways, innovation in clinical trials and, above all, patient empowerment. MASK-rhinitis (MACVIA-ARIA Sentinel NetworK for allergic rhinitis) is a simple system centred around the patient which was devised to fill many of these gaps using Information and Communications Technology (ICT) tools and a clinical decision support system (CDSS) based on the most widely used guideline in allergic rhinitis and its asthma comorbidity (ARIA 2015 revision). It is one of the implementation systems of Action Plan B3 of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA). Three tools are used for the electronic monitoring of allergic diseases: a cell phone-based daily visual analogue scale (VAS) assessment of disease control, CARAT (Control of Allergic Rhinitis and Asthma Test) and e-Allergy screening (premedical system of early diagnosis of allergy and asthma based on online tools). These tools are combined with a clinical decision support system (CDSS) and are available in many languages. An e-CRF and an e-learning tool complete MASK. MASK is flexible and other tools can be added. It appears to be an advanced, global and integrated ICT answer for many unmet needs in allergic diseases which will improve policies and standards.

Asthma control and exacerbations in patients with severe asthma treated with omalizumab in Portugal

The analysis of outcomes from patients with severe asthma treated with omalizumab, using real-life prospective data, should contribute to future informed decisions about this treatment in Portugal.The aim of this study was to assess the clinical effect of omalizumab in Portuguese patients with severe persistent allergic asthma, considering specifically asthma control and exacerbations.This was an observational, prospective, multicentre study. Data were collected at routine care over a 12-month period. Disease control was defined by Control of Allergic Rhinitis and Asthma Test (CARAT) global score >24.All asthma patients already under treatment with omalizumab in 7 departments from 6 Portuguese hospitals were included (n=48). Most (77%) patients were female and the mean (SD) age was 51.9 (10.2) years old. During the study period, asthma was controlled in 34% of the visits and the 12-month exacerbation rate was 1.7 per patient (0.6 with unscheduled medical care). One-third of the patients needed unscheduled medical care because of asthma and 29% had to start or increase oral corticosteroid. There was still a 41% reduction in the total sum of oral corticosteroids usage from the first to the last trimester of the study.During routine treatment with omalizumab, Portuguese patients with severe asthma achieved asthma control in 1/3 of the visits and only 1/3 needed unscheduled or Emergency Room care because of asthma exacerbations. These outcomes support the maintenance of the clinical effect during treatment with omalizumab in routine care in Portugal.