User Acceptability and Technical Robustness Evaluation of a Novel Smart Pill Bottle Prototype Designed to Support Medication Adherence

Purpose: Smart medication adherence monitoring devices can provide objective and granular drug utilization data and help patients engaging with their treatment. In this proof-of-concept study, the acceptability and technical robustness of a novel smart pill bottle prototype (SPBP) were assessed in order to allow further optimization. Methods: The SPBP is an app-controlled automatic dispense system, capturing real-time data on a web-based platform, which sends text reminders and measures storage conditions. A heterogeneous group of ten volunteers was asked to dispense placebo capsules with the SPBP and to follow a predefined dosing schedule for a trial period of 2 weeks. Afterwards, a questionnaire was filled out during a short interview. Primary outcome was dispense adherence as measured by the bottle. Other study outcomes included system acceptability (System Usability Scale [SUS]), self-reported adherence (MARS) and technical robustness of the bottle’s mechanics (electronic pill dispenser) and sensors (bottle temperature). Results: The overall dispense adherence rate as measured by the SPBP was 88%. All participants completed the study and four participants had an adherence rate of 100% during the study. The dispense adherence rates corresponded well with participants’ self-reported adherence with an average MARS total score of 23.6 (out of 25). Participants judged the system easy to use, with a mean SUS score of 79.3 (range: 57.5– 97.5). The overall mean temperature difference between the bottle sensor and calibrated external sensor was − 0.82°C (range: − 1.37°C to − 0.21°C). Conclusion: The SPBP was well accepted and this study provides data for further optimization and follow-up studies. Smart adherence technologies such as these may change the way healthcare professionals, trialists and patients manage medication adherence

GINA 2020: Potential impacts, opportunities and challenges for primary care

In 2019, it was reported that changes to asthma management reported in the Global Initiative for Asthma "…might be considered the most fundamental changes in asthma management in 30 years." These changes refer to the recommendation that the treatment of asthma in adolescents and adults would no longer include short acting ß2 agonist (SABA) only, but that people with asthma should receive either symptom-driven inhaled corticosteroids (ICS)-containing treatment (mild asthma) or daily ICS-containing treatment. The fundamental reason for this shift was driven by concerns about the risks and consequences associated with SABA only treatment, the need to improve the day-to-day management of asthma symptoms to prevent exacerbations and emergent evidence. These recommendations have subsequently been reinforced and characterized in GINA 2020 and it is reasonable to say that they are significant: not only in terms of an asthma management framework, but also as a management approach in practice. This opinion article specifically focuses on opportunities and challenges associated with the implementation of GINA 2020 in primary care practice which need to be recognised and addressed if the shift in asthma treatment paradigm is to be successfully implemented into day-to-day practice

Trajectory analyses of adherence patterns in a real-life moderate to severe asthma population

Background: Global Initiative for Asthma step 5 therapies (GINA-5), other than inhaled corticosteroids and long-acting β-agonists in fixed dose combinations (ICS/LABA FDC), often entail more expensive (eg, monoclonal biologics) or less safe (eg, maintenance oral corticosteroids [OCS]) treatments. It is therefore important to assess poor inhaler adherence as a possible cause of suboptimal response to ICS/LABA FDC before additional GINA-5. Objective: To determine rates of, and time to, additional GINA-5 after first-year ICS/LABA FDC use, and their association with inhaler adherence. Methods: Patients initiating ICS/LABA FDC between 2013 and 2017 were identified from Australian national dispensing data. Group-based trajectory modeling was used to estimate medication adherence patterns. Multivariable Cox proportional hazards models were used to examine the association between adherence trajectories and GINA-5 addition during 2-year follow-up. Results: In total, 3062 new ICS/LABA FDC users were identified, of whom 120 (3.9%) received additional GINA-5 (OCS: 89; long-acting muscarinic antagonists: 39; biologics: &lt;3). Mean time to commencing additional GINA-5 was 705.2 (standard deviation, 1.7) days. Adherence trajectories were nonpersistent use (20%), seasonal use (8%), poor adherence (58%), and good adherence (13%). Although poor adherence was associated with longer time to additional GINA-5 (adjusted hazard ratio: 0.58; 95% confidence interval: 0.35-0.95), over 80% of additional GINA-5 was commenced in poorly adherent patients. Use of ≥2 OCS/antibiotic courses also predicted additional GINA-5. Conclusions: Almost 1 in 20 people with asthma commenced additional GINA-5 after ICS/LABA initiation, most of whom (&gt;80%) were poorly adherent to inhaled preventers. There is a substantial unmet need for inhaler adherence to be addressed before prescribing additional GINA-5.</p

Prevalence of Seasonal Influenza Vaccination in Chronic Obstructive Pulmonary Disease (COPD) Patients in the Balearic Islands (Spain) and Its Effect on COPD Exacerbations: A Population-Based Retrospective Cohort Study

To determine the prevalence of influenza vaccination in chronic obstructive pulmonary disease (COPD) patients and its effect on COPD exacerbations, we conducted a retrospective population-based cohort study analyzing real-life data. We included all registered COPD patients ?40 years old using respiratory medication during the study period (2012?2013). Influenza vaccination during the 2012/2013 campaign was the parameter studied. Moderate and severe exacerbations during 2013 were the dependent outcome variables. Logistic regression adjusting for age, gender, concomitant asthma diagnosis, COPD severity, smoking status, number of moderate and severe exacerbations the previous year, and comorbidities was performed, and 59.6% of the patients received seasonal influenza vaccination. The percentage of patients with exacerbations was higher among those vaccinated. Influenza vaccination had a statistically significantly negative (non-protective) crude effect favoring the risk of severe exacerbations: OR: 1.20 (95% CI; 1.05?1.37). This association diminished and lost statistical significance after adjustment: aOR: 0.93 (95% CI; 0.74?1.18). The protective effect in the analysis restricted to the epidemic period was not significant: aOR: 0.82 (95% CI; 0.58?1.16). We concluded that prevalence of influenza vaccination was suboptimal. In contrast with most of the available evidence, our results did not support a protective effect of influenza vaccination on the risk of admission for COPD exacerbation

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

Patient-reported barriers to accepting a technological adherence package in the MAGNIFY trial.

Peer reviewedPostprin

Reimbursed medication adherence enhancing interventions in 12 european countries:Current state of the art and future challenges

Background: Medication non-adherence jeopardises the effectiveness of chronic therapies and negatively affects financial sustainability of healthcare systems. Available medication adherence-enhancing interventions (MAEIs) are utilised infrequently, and even more rarely reimbursed. The aim of this paper was to review reimbursed MAEIs across selected European countries. Methods: Data on reimbursed MAEIs were collected from European countries at the ENABLE Cost Action expert meeting in September 2021. The identified MAEIs were analysed and clustered according to their characteristics, direct vs. indirect relation to adherence, and the targeted adherence phase. Results: Out of 12 contributing countries, 10 reported reimbursed MAEIs, 28 in total, of which 20 were identified as MAEIs targeting adherence directly. Reimbursed MAEIs were most often performed by either doctors (n = 6), nurses (n = 6), or pharmacists (n = 3). The most common types of MAEIs were education (n = 6), medication regimen management (n = 5), and adherence monitoring feedback (n = 4). Only seven reimbursed MAEIs were technology-mediated, whereas 11 addressed two interlinked phases of medication adherence, i.e., implementation and persistence. Conclusion: Our review highlights the scarcity of reimbursed MAEIs across the selected European countries, and calls for their more frequent use and reimbursement

‘Frisse’ berglucht toch niet altijd gezond?

Eerdere onderzoeken naar de relatie tussen hoogte en COPD trokken tegenstrijdige conclusies. Een van de belangrijkste risicofactoren voor COPD wereldwijd namen ze daarbij echter vrijwel niet mee: fijnstof binnenshuis. Daarom vergeleken wij fijnstofconcentraties en COPD-prevalentie binnenshuis tussen hooglanden en laaglanden in Kirgistan. Zowel fijnstof als COPD kwam alarmerend veel voor in de hooglanden. Maar ook in onze lage landen kunnen de fijnstofconcentraties binnenshuis oplopen tot ver boven de aanbevolen waarden, bijvoorbeeld tijdens het koken en openhaardgebruik

Prevalence and Characteristics of Asthma-COPD Overlap in Routine Primary Care Practices

Rationale: Adults may exhibit characteristics of both asthma and chronic obstructive pulmonary disease (COPD), a situation recently described as asthma-COPD overlap (ACO). There is a paucity of information about ACO in primary care. Objectives: To estimate the prevalence and describe characteristics of individuals withACOin primary care practices among patients currently diagnosed with asthma, COPD, or both; and to compare the prevalence and characteristics of ACO among the three source populations. Methods: The Respiratory Effectiveness Group conducted a crosssectional study of individuals ≥40 years old and with ≥2 outpatient primary care visits over a 2-year period in theUKOptimum Patient Care Research Database. Patients were classified into one of three source populations based on diagnostic codes: 1) COPD only, 2) both asthma and COPD, or 3) asthma only.ACOwas defined as the presence of all of the following 1) age ≥40 years, 2) current or former smoking, 3) postbronchodilator airflow limitation (forced expiratory volume in 1 second/ forced vital capacity <0.7), and 4) ≥12% and ≥200 ml reversibility in post-bronchodilator forced expiratory volume in 1 second. Results: Among 2,165 individuals (1,015 COPD only, 395 with both asthma and COPD, and 755 asthma only), the overall prevalence of ACO was 20% (95% confidence interval, 18-23%). Patients with ACO had a mean age of 70 years (standard deviation, 11 yr), 60% were men, 73% were former smokers (the rest were current smokers), and 66% were overweight or obese. Comorbid conditions were common in patients with ACO, including diabetes (53%), cardiovascular disease (36%), hypertension (30%), eczema (23%), and rhinitis (21%). The prevalence of ACO was higher in patients with a diagnosis of both asthma and COPD (32%) compared with a diagnosis of COPD only (20%; P<0.001) or asthma only (14%; P<0.001). Demographic and clinical characteristics of ACO varied across these three source populations. Conclusions: One in five individuals with a diagnosis of COPD, asthma, or both asthma and COPD in primary care settings have ACO based on the Respiratory Effectiveness Group ACO Working group criteria. The prevalence and characteristics of patients with ACO varies across the three source populations