Reduced reactogenicity of primary vaccination with DT3aP-HBV-IPV/Hib compared with DT2aP-HBV-IPV-Hib among infants: Mathematical projections in six countries.

The hexavalent vaccines DT3aP-HBV-IPV/Hib and DT2aP-HBV-IPV-Hib are routinely used for primary immunization of infants against diphtheria, tetanus, pertussis, hepatitis B virus, poliomyelitis, and Haemophilus influenzae type b. A recent publication showed that after primary immunization with these vaccines, the odds ratios of adverse reactions (ARs) were significantly lower for DT3aP-HBV-IPV/Hib than for DT2aP-HBV-IPV-Hib. Our aim is to understand the impact of the various reactogenicity profiles at country level by comparing the ARs induced by one dose of DT3aP-HBV-IPV/Hib versus DT2aP-HBV-IPV-Hib in the primary infant immunization course. A mathematical projection tool was developed to simulate vaccination of infants with both vaccines in six countries: Austria, the Czech Republic, France, Jordan, Spain, and the Netherlands. Proportions of three local and five systemic ARs of interest for both vaccines were based on findings from a previous meta-analysis of ARs in infants. The absolute risk reductions calculated ranged from 3.0% (95% confidence interval [CI]: 2.8%-3.2%) for "Swelling at the injection site, any grade" to 10.0% (95% CI: 9.5%-10.5%) for "Fever, any grade." The difference in occurrence of the AR "Fever, any grade" between vaccines in 2020 ranged from over 7,000 in Austria to over 62,000 in France. Over 5 years, this would amount to a reduction of over 150,000 ARs in Austria and over 1.4 million ARs in France when using DT3aP-HBV-IPV/Hib instead of DT2aP-HBV-IPV-Hib. In conclusion, the estimated numbers of ARs following hexavalent vaccination in six countries showed that vaccination of infants with DT3aP-HBV-IPV/Hib could lead to fewer ARs than vaccination with DT2aP-HBV-IPV-Hib.

Vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b is often performed with combined vaccines against these six diseases. In many countries, these are the first vaccinations received by infants, and potential adverse reactions could affect compliance with future vaccinations. A previous study examined two of the combined vaccines, DT3aP-HBV-IPV/Hib and DT2aP-HBV-IPV-Hib, and showed that local adverse reactions at the injection site (pain, redness, and swelling) and general adverse reactions (fever, drowsiness, irritability, persistent crying, and lack of appetite) were less common after vaccination with DT3aP-HBV-IPV/Hib than with DT2aP-HBV-IPV-Hib.To understand the impact of this finding at a population level, we compared the adverse reactions caused by the hypothetical administration of the two vaccines under similar conditions. We simulated the vaccination of infants with both vaccines in six countries: Austria, the Czech Republic, France, Jordan, Spain, and the Netherlands.The simulation showed that the DT3aP-HBV-IPV/Hib vaccine could reduce cases of swelling at the injection site by 3% and fever by 10%. For the year 2020, the resulting reduction in the estimated number of fever occurrences would have ranged from over 7,000 in Austria to over 62,000 in France. In total, adverse reactions avoided could hypothetically have ranged from 30,781 in Austria to 269,025 in France. Over 5 years, this could have avoided an estimated number of adverse reactions of over 150,000 in Austria to over 1.4 million in France. In conclusion, such a switch of vaccine could substantially reduce adverse reactions.

Potential normalization of an asthma mHealth intervention in community pharmacies: Applying a theory-based framework.

BACKGROUND: Effective mobile health (mHealth) interventions have been developed to support patients with their medication use, however to date few are widely used in pharmacy practice. Normalization of an intervention is essential to have a population impact, which is defined as 'the process of getting a new intervention into routine practice'. OBJECTIVE: The aim of this study was to assess the normalization potential of a complex mHealth intervention for adolescents with asthma (ADolescent Adherence Patient Tool; ADAPT) in community pharmacy practice. METHODS: The Normalization Process Theory (NPT), a sociological action theory, was retrospectively applied to study the normalization potential of ADAPT. NPT explains factors that promote or hinder implementation, embedding, and integration of new interventions in clinical practice. Evaluation data (structured interviews and questionnaires) of 23 pharmacists who used the ADAPT intervention were used for this study. RESULTS: Pharmacists understood the purpose of the ADAPT intervention and were prepared to undertake the necessary work of implementation. However changes at different levels are needed to support full normalization, such as changes in the intervention itself and changes in the pharmacist's work flow. The potential for normalization could also be enhanced by the use of product champions and appropriate reimbursement guidelines, to ensure uptake of the intervention by other pharmacists. Support from professional bodies for the use of mHealth could also promote normalization. CONCLUSIONS: Normalization of mHealth is a complex continuous process. The ADAPT intervention has the potential to be normalized in community pharmacy practice, but full normalization would require changes in both daily pharmacy practice and reimbursement models.

Asthma control and quality of life in adolescents: The role of illness perceptions, medication beliefs, and adherence.

Objective: Asthma control and quality of life (QoL) are important disease outcomes for asthma patients. Illness perceptions (cognitive and emotional representations of the illness) and medication beliefs have been found to be important determinants of medication adherence, and subsequently disease control and QoL in adults with asthma. In adolescents, this issue needs further elucidation. Therefore, the aim of this study was to explore the relationship between illness perceptions, medication beliefs, medication adherence, disease control, and QoL in adolescents with asthma.Methods: In this cross-sectional study, we used baseline data of adolescents with asthma (age 12-18 years) who participated in the ADolescent Adherence Patient Tool (ADAPT) study. Questionnaires were administrated online, and included sociodemographic variables and validated questionnaires measuring self-reported illness perceptions, medication beliefs, medication adherence, disease control, and QoL.Results: Data of 243 adolescents with asthma were available; age 15.1 ± 2.0 years and 53% females. More than half of these adolescents (62%; n = 151) reported to be non-adherent (Medication Adherence Report Scale ≤23) and 77% (n = 188) had uncontrolled asthma. There was a strong positive correlation between disease control and QoL (r = 0.74). All illness perceptions items were correlated with disease control and QoL, with the strongest correlation between 'identity' (symptom perception) and QoL (r=-0.66). Medication adherence was correlated to medication beliefs (r = 0.38), disease control (r = 0.23), and QoL (r = 0.14), whereas medication beliefs were only associated with adherence.Conclusions: Stimulating positive illness perceptions and medication beliefs might improve adherence, which in turn might lead to improved disease control and better QoL.

Evaluation of a mobile health intervention to support asthma self-management and adherence in the pharmacy.

Background Several effective mobile health (mHealth) interventions have been developed to support patients with their medication use, however hardly any is implemented in clinical practice. Process evaluations and user experiences are therefore important for further implementation. Objective To explore experiences, barriers, and facilitators of pharmacists and patients towards the use of the interactive ADolescent Adherence Patient Tool (ADAPT). In addition, the perceptions of pharmacists towards mHealth interventions in general were explored. Setting Dutch community pharmacies. Methods Pharmacists (N = 24) and adolescent asthma patients (N = 87; age 12-18) completed a questionnaire about the ADAPT intervention. Pharmacists who did not have access to the ADAPT intervention (N = 26) completed a questionnaire on their perceptions towards mHealth. Main outcome measure Experiences, barriers, and facilitators of pharmacists and patients. Results Most patients (78%) would recommend the ADAPT intervention to others, and thought that the pharmacy was the right place for mHealth aiming to support adherence (63%). The possibility to monitor asthma symptoms was highly appreciated by patients and pharmacists. Pharmacists were satisfied with ADAPT intervention (96%), and using the intervention was not time consuming (91%). The ADAPT intervention promoted contact with patients (74%) and facilitated the healthcare providing role of pharmacists (83%). Pharmacists who did not have access to the ADAPT intervention mentioned time constraints and funding as main barriers for using mHealth. Conclusion Pharmacists and patients perceived many beneficial effects and were positive about the the use of the interactive ADolescent Adherence Patient Tool (ADAPT) intervention. This study emphasizes opportunities for mHealth in improving the quality of care, which supports the need for further implementation in clinical practice.

Effective Engagement of Adolescent Asthma Patients With Mobile Health-Supporting Medication Adherence.

BACKGROUND: Mobile health (mHealth) apps have the potential to support patients' medication use and are therefore increasingly used. Apps with broad functionality are suggested to be more effective; however, not much is known about the actual use of different functionalities and the effective engagement. OBJECTIVE: The aim of this study was to explore the use and the effective engagement of adolescents (aged 12 to 18 years) with the Adolescent Adherence Patient Tool (ADAPT). METHODS: The ADAPT intervention consisted of an app for patients, which was connected to a management system for their pharmacist. The aim of the ADAPT intervention was to improve medication adherence and, therefore, the app contained multiple functionalities: questionnaires to monitor symptoms and adherence, medication reminders, short movies, pharmacist chat, and peer chat. For this study, data of the ADAPT study and a cluster randomized controlled trial were used. Adolescents with asthma had 6 months' access to the ADAPT intervention, and all app usage was securely registered in a log file. RESULTS: In total, 86 adolescents (mean age 15.0, SD 2.0 years) used the ADAPT app 17 times (range 1-113) per person. Females used the app more often than males (P=.01) and for a longer period of time (P=.03). On average, 3 different functionalities were used, and 13% of the adolescents used all functionalities of the app. The questionnaires to monitor symptoms and adherence were used by most adolescents. The total app use did not affect adherence; however, activity in the pharmacist chat positively affected medication adherence (P=.03), in particular, if patients sent messages to their pharmacist (P=.01). CONCLUSIONS: mHealth apps for adolescents with asthma should contain different functionalities to serve the diverging needs and preferences of individual patients. Suggested key functionalities to promote use and effectiveness in adolescents with asthma are questionnaires to monitor symptoms and a health care provider chat.

Effect of a mHealth intervention on adherence in adolescents with asthma: A randomized controlled trial.

BACKGROUND: Adherence rates among asthma patients are generally low and decrease during adolescence, resulting in poorly controlled asthma. The aim of our study was to evaluate the effectiveness of the ADolescent Adherence Patient Tool (ADAPT), an interactive mobile health (mHealth) intervention, in supporting self-management and improving inhaled corticosteroid adherence in adolescents with asthma. METHODS: We conducted a cluster randomized controlled trial in 66 Dutch community pharmacies. Asthma patients aged 12-18 years were invited to participate, based on pharmacy medication refill records. The main study outcome was self-reported medication adherence, measured with the Medication Adherence Report Scale (MARS). Secondary outcomes were asthma control and quality of life. Outcomes were measured at start (t = 0 months) and at the end of follow-up (t = 6 months). Mixed-effects models were used to analyze the effect. RESULTS: In total, 234 adolescents (147 in the control group and 87 in the intervention group) completed the study; mean age 15.1 ± 1.9 years and 52.6% females. Adherence rates of patients with low baseline adherence (MARS scores ≤19; n = 76) increased with 1.42 points in the intervention group (n = 26). Adherence rates of patients in the control group (n = 50) decreased with 0.70 points. Thus there was a positive effect of the intervention on medication adherence (MARS +2.12, p = 0.04). This effect was stronger (MARS +2.52, p = 0.02) in poor adherent adolescents with uncontrolled asthma (n = 74). No effect of the intervention was observed on asthma control or quality of life. CONCLUSIONS: The ADAPT intervention increases medication adherence in adolescents with asthma having poor adherence rates at baseline. Healthcare providers should consider a tailored mHealth approach to improve the asthma treatment.

Drug utilisation among Dutch adolescents: a pharmacy prescription records study.

BACKGROUND: Studies on adolescent drug use are scarce as most studies do not distinguish between children and adolescents. Therefore, we assessed overall drug use in adolescents. METHODS: A retrospective cohort study was conducted using pharmacy dispensing records from 62 community pharmacies in the Netherlands. Dispensing records of the previous 5 years were extracted for adolescents (12-18 years). RESULTS: The study population consisted of 47 421 adolescents who collected at least one medication prescription during adolescence (mean age 15.5±1.8 years; 48.9% males). Half of them collected dermatologicals (46.2% males; 52.3% females), followed by drugs for the respiratory system (43.4% males; 40.3% females) and anti-infectives for systemic use (31.3% males; 39.1% females). The percentage of males using dermatologicals slightly increased, while the percentage of female users decreased with age. The most prescribed active ingredient was methylphenidate. CONCLUSIONS: These insights into adolescent drug use help us to better understand adolescent healthcare use. TRIAL REGISTRATION NUMBER: Dutch trial register NTR5061.

Adolescents' Perspectives on Atopic Dermatitis Treatment-Experiences, Preferences, and Beliefs.

Importance: For a considerable proportion of pediatric patients, atopic dermatitis symptoms persist into adolescence. Previous studies have focused mainly on (parents of) children, whereas little is known about adolescents with atopic dermatitis. Objective: To explore the beliefs, experiences, and preferences of adolescents with atopic dermatitis toward their treatment. Design, Setting, and Participants: We conducted a qualitative study employing focus group interviews of 15 adolescents (aged 12-18 years) who collected at least 1 prescription for topical corticosteroids in class 2 (moderately potent) or 3 (potent) in the preceding year. The study included 9 community pharmacies in 3 different regions in the Netherlands. Data were collected from November to December 2016, until data saturation was reached. Focus groups were recorded, transcribed verbatim, and data were analyzed by 2 researchers. Main Outcomes and Measures: Adolescents' beliefs, experiences, and preferences toward their atopic dermatitis treatment were explored during focus groups. We used a thick analysis approach to analyze the transcripts; both deductive and inductive coding were used to analyze the transcripts. Results: Three focus groups including 15 adolescents (8 male) with a mean age of 15.3 (range, 12-18) years were conducted. Adolescents were in general satisfied with the efficacy of the treatment; however, they prefer a faster and more persistent effect. Most adolescents had little contact with their physicians and did not completely adhere to the prescribed medication regimen; they developed their own routine of using topical corticosteroids in combination with emollients and moisturizers. They also seemed to have incorrect beliefs about the mechanism of action. Conclusions and Relevance: Adolescents developed their own way of using topical treatment for atopic dermatitis. Some practical suggestions were mentioned to improve medication use. Health care providers should devote special attention to adolescents with atopic dermatitis to make them more aware of the principles of topical treatment and ensure proper use.

Attention-Deficit/Hyperactivity Disorder Medication Use in Adolescents: The Patient's Perspective.

PURPOSE: The purpose of the study was to gain more insight into the attitudes of adolescents using medication for attention-deficit/hyperactivity disorder (ADHD). METHODS: A cross-sectional study among adolescents (aged 12-18 years) who filled at least two prescriptions for ADHD medication in the preceding year was conducted. Adolescents were invited to fill in an online questionnaire containing questions on sociodemographics, health status, illness perceptions, medication adherence, and medication beliefs. RESULTS: We invited 1,200 adolescents of whom 181 adolescents (122 males, mean age 14.2 ± 1.7 years) completed the online questionnaire. They mostly used methylphenidate (n = 167; 92%) as a pharmacological treatment for ADHD. Half of the study population (n = 93; 51%) experienced side effects, such as decreased appetite and sleep problems. Most participants (n = 150; 83%) had an indifferent attitude (perceived low necessity and low concerns) toward their ADHD medication. More than half of the study population (n = 111; 61%) reported to be nonadherent based on the Medication Adherence Report Scale. The highest score of the Brief Illness Perception Questionnaire was on "treatment control," suggesting that adolescents do think their medication is effective, despite their indifferent drug attitude. CONCLUSIONS: Most adolescents using ADHD medication had an indifferent attitude toward their medication and reported low adherence rates. These findings should be taken into account when treating adolescents with ADHD; regular counseling and monitoring of the pharmacological treatment might be useful to optimize treatment.

mHealth intervention to support asthma self-management in adolescents: the ADAPT study.

PURPOSE: Poor medication adherence in adolescents with asthma results in poorly controlled disease and increased morbidity. The aim of the ADolescent Adherence Patient Tool (ADAPT) study is to develop an mHealth intervention to support self-management and to evaluate the effectiveness in improving medication adherence and asthma control. INTERVENTION: The ADAPT intervention consists of an interactive smartphone application (app) connected to a desktop application for health care providers, in this study, the community pharmacist. The app contains several functions to improve adherence as follows: 1) a questionnaire function to rate asthma symptoms and monitor these over time; 2) short movie clips with medication and disease information; 3) a medication reminder; 4) a chat function with peers; and 5) a chat function with the pharmacist. The pharmacist receives data from the patient's app through the desktop application, which enables the pharmacist to send information and feedback to the patient. STUDY DESIGN: The ADAPT intervention is tested in a community pharmacy-based cluster randomized controlled trial in the Netherlands, aiming to include 352 adolescents with asthma. The main outcome is adherence, measured by patient's self-report and refill adherence calculated from pharmacy dispensing records. In addition, asthma control, illness perceptions, medication beliefs, and asthma-related quality of life are measured. CONCLUSION: This study will provide in-depth knowledge on the effectiveness of an mHealth intervention to support asthma self-management in adolescents. These insights will also be useful for adolescents with other chronic diseases.