The results of this real-world evidence study showed a positive impact of a Diagnostic Therapeutic Educational Pathway (DTEP) in preschool children on both control of wheezing symptoms as well as on the incidence of health outcomes, particularly hospitalization and emergency room visits. Several previous randomized clinical trials have shown not only that asthma control can be substantially improved by self-management training, a core component of which is patient education, but also that educational and behavioral interventions can achieve positive results in asthma control in children and adults (10, 11). We have previously documented a favorable impact of our DTEP on asthma control and asthma-related outcomes among children and adolescents aged 6-17 years (12-16). Since no previous study had evaluated the impact of a Diagnostic Therapeutic Educational Pathway (DTEP) on asthma control among children of less than 6 years so far, the present study, to our knowledge, is the first to do so.
The before-DTEP IRs were particularly elevated especially among the youngest children with IRs for emergency room visit higher than 500/1000 person-years in children aged 0-2 years. This means that about one of two patients had required emergency room visits each year prior to the DTEP intervention. Moreover, the before-DTEP IRs for the other outcomes were higher among children aged 0-2 years than those aged 3-5 years, and much higher than those aged more than 6 years, as reported in another study (15). These findings agree with previous observations which showed a more frequent use of health services and consumption of health-care resources in preschool than in older children and adults (6-8).
The comparison of the before- and after-DTEP frequencies of health outcomes showed that the proportion of children with well-controlled wheezing symptoms approximately doubled from the 1st to 3rd visit, from 39.5% to 60.9% and from 25.5% to 75.5% in children aged 0-2 and 3-5 years, respectively. Accordingly, the IRs of hospitalization and emergency room visits were halved from before- to after-DTEP, especially in the youngest population, and the use of drugs, not proper to treat wheezing, as LABA plus corticosteroids and antibiotics, declined, especially among 3-5 years old children.
The optimal pharmacologic treatment regimen for preschool children with wheezing continues to remain unclear. The GINA guidelines for asthma management devote a specific chapter to diagnosis and treatment of asthma in children aged 5 years and younger (1). A recent multicenter, randomized, clinical trial on children aged 12 to 59 months with clinically diagnosed asthma, due to their caregivers’ reporting of daytime symptoms, nighttime awakening or wheezing episodes, necessitating treatment with daily controller therapy, showed that individualized therapy based on determination of aeroallergen sensitization and blood eosinophil may be more beneficial than uniform treatment (17).
In our Center, young children with wheezing are prescribed pharmacologic treatment according to the GINA recommendations and symptom control levels; drug prescription changed from before, during and after DTEP accordingly, though some differences were noted between 0-2 and 3-5 years old ones. A statistically significant reduction of drug prescriptions, e.g. LABA plus corticosteroids, antibiotics and systemic steroids, that are often over-prescribed, emerged in both age groups.
Important differences were observed according to category of drugs. The prescription of drugs for management of wheezing attack, such as inhaled short-acting beta-2 agonist (SABA), increased in 0-2 years old children, from before to after-DTEP, suggesting a more frequent recognition of symptoms in them, whereas it did not vary in those aged 3-5 years, probably because the wheezing symptoms had been already recognized by their primary care physicians in the period before DTEP. The rate of systemic corticosteroid usage, commonly prescribed for management of the wheezing attack, decreased in both groups, especially in 3-5 years old children, probably due to a clearer clinical pattern and the choice of SABA as the first line treatment.
Prescription of inhaled corticosteroids increased in the 0-2 age group, from before to after DTEP, possibly for control of wheezing, whereas it did not vary in the 3-5 age group most likely because the symptoms remained well controlled without daily therapy due to an appropriate wheezing management, and with the interaction between specialists and primary care physicians (14, 1, 3, 18). The increase of daily therapy with leukotriene receptor antagonists in 0-2 years old subjects is consistent with GINA recommendations, since these medications are considered as other controller options for obtaining and maintaining wheezing control associated with upper respiratory tract infections (i.e. laryngitis or rhinitis). The rate did not vary significantly in the 3-5 age group possibly due to a better control of symptoms without daily drug therapy.
The control of wheezing symptoms achieved and maintained with first-line therapy, specifically inhaled corticosteroid at lower dosage or leukotriene receptor antagonist, was followed by a decrease in the prescriptions of daily therapy with LABA plus corticosteroids, in both groups. This finding is consistent with GINA recommendations that there are insufficient data about the efficacy and safety of combination ICS/long- acting beta2-agonist (LABA) in this age group to recommend their use. Antibiotic prescriptions, which were largely inconsistent with GINA guidelines, were reduced following improved symptom control.
Although the results of this clinical and implementation research study showed some positive impact of the DTEP, it had some limitations. The retrospective design and the absence of a control group limit generalizations that can be drawn from these results. At the same time, the current and complete documentation of clinical data at each visit, using a dedicated software and the record linkage with the LHA database for computing the rates of wheezing-related health outcomes, reduced risk of information bias. Future randomized controlled studies will be required to more definitively delineate the effectiveness of a DPTE pathway intervention in the management of wheezing in children aged less than 6 years.