Identifying critical inhalation technique errors in Dry Powder Inhaler use in patients with COPD based on the association with health status and exacerbations: findings from the multi-country cross-sectional observational PIFotal study.

BACKGROUND: Correct inhaler use depends on a complex interplay of factors, including device preparation and generating sufficient inspiratory flow. It is currently unknown which inhalation technique errors can be considered critical in Chronic Obstructive Pulmonary Disease (COPD) patients on Dry Powder Inhaler (DPI) maintenance therapy. OBJECTIVE: To investigate the association between inhalation technique errors and health status or exacerbations in patients with COPD. Additionally, the association between the number of errors and COPD outcomes was determined. METHODS: The PIFotal study is a cross-sectional multi-country observational study in a primary care setting, including 1434 COPD patients aged ≥ 40 years (50.1% female; mean age 69.2 yrs) using a DPI for their maintenance therapy. Inhalation technique was video recorded and scored by two independent researchers using inhaler-specific checklists. Health status was assessed with two questionnaires; the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT). The number of moderate and severe exacerbations in the past 12 months was recorded. Critical errors were identified based on their association with health status or exacerbations through multi-level prediction models adjusted for identified confounding. RESULTS: Errors in inhalation technique steps 'Breathe in', 'Hold breath', and 'Breathe out calmly after inhalation' were significantly associated with poorer CCQ and CAT outcomes and thus deemed critical. None of the errors were significantly associated with moderate exacerbations. Patients with errors 'Preparation', 'Hold inhaler in correct position during inhalation', and 'Breathe in' had significantly more severe exacerbations, and therefore these errors were also deemed critical. 81.3% of patients with COPD made at least one critical error. Specific combinations of errors were associated with worse outcomes. The more inhalation technique errors identified, the poorer the health status and the higher the exacerbation rate. CONCLUSION: In this study, we identified multiple critical inhalation technique errors in COPD patients using DPIs each associated with poorer outcomes. Explorative analysis revealed that specific combinations of errors may be of clinical relevance, especially those related to the inhalation manoeuvre. COPD outcomes worsened with increasing error count. These results warrant further prospective longitudinal studies to establish the effect of correcting these errors on COPD control. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT04532853 (31/08/2020).

[What not to do in the therapeutic management of bronchial asthma. Delphi consensus recommendations for physicians who treat asthma]. / Qué no se debe hacer en el manejo terapéutico del asma bronquial. Recomendaciones por consenso Delphi para los médicos que tratan el asma.

Asthma is one of the most prevalent diseases in Spain, yet despite the great diagnostic and therapeutic advances made in this field, health outcomes suggest that up to 80% of patients do not have their asthma well controlled. Although the causes of this situation are diverse, there are some practices among the professionals who treat asthma that are not conducive to improving health outcomes in this disease. Our working group has prepared this document in order to remind clinicians of a series of basic guidelines, aligned with current guidelines and recent literature, and agreed by a multidisciplinary expert panel using Delphi methodology. These recommendations about what not to do in the management of asthma in the adult patient are structured into four areas: diagnosis, monitoring, treatment and prevention of exacerbations.

Correlation between disease severity factors and EQ-5D utilities in chronic obstructive pulmonary disease.

PURPOSE: Impaired health-related quality of life (HRQoL) is associated with poor health outcomes in chronic obstructive pulmonary disease (COPD). The aim of this study was to determine health utilities in patients with COPD and to identify the variables with the greatest impact. METHODS: This is a pooled analysis of data from 4 observational studies performed in stable COPD patients. Evaluation of patient HRQoL utilities was performed using the Spanish version of the self-administered EuroQoL 5 Dimensions (EQ-5D) questionnaire. EQ-5D utilities were described and compared according to several markers of disease severity. RESULTS: 6198 patients reported a mean (SD) EQ-5D index of 0.67 (0.26). A linear dose response relationship between EQ-5D utility and modified Medical Research Council (mMRC) score, forced expiratory volume in one 1 s (% predicted), COPD hospital admissions in the previous year, self-reported daily walking time, Charlson index, body mass index, obstruction, dyspnoea and exacerbation (BODEx) index, COPD assessment test (CAT), hospital anxiety and depression scale was observed (p for trend < 0.001). In multivariate analysis, patients reporting lower utility values were those with more dyspnoea, more comorbidities, using long-term oxygen therapy, with previous hospitalisations due to a COPD exacerbation and higher (worse) CAT score. CONCLUSION: HRQoL measures such as EQ-5D can assist clinicians to understand the impact of respiratory disease on COPD patients.

Predictive value of control of COPD for risk of exacerbations: An international, prospective study.

BACKGROUND AND OBJECTIVE: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHODS: This international, multicentre, prospective study aimed to validate the concept of control in COPD. Patients with COPD were classified as controlled/uncontrolled by clinical criteria or CAT scores at baseline and followed up for 18 months. The main outcome was the difference in rate of a composite endpoint of moderate and severe exacerbations or death over the 18-month follow-up period. RESULTS: A total of 307 patients were analysed (mean age = 68.6 years and mean FEV1 % = 52.5%). Up to 65% and 37.9% of patients were classified as controlled by clinical criteria or CAT, respectively. Controlled patients had significantly less exacerbations during follow-up (by clinical criteria: 1.1 vs 2.6, P < 0.001; by CAT: 1.1 vs 1.9, P = 0.014). Time to first exacerbation was significantly prolonged for patients controlled by clinical criteria only (median: 93 days, IQR: 63; 242 vs 274 days, IQR: 221; 497 days; P < 0.001). Control status by clinical criteria was a better predictor of exacerbations compared to CAT criteria (AUC: 0.67 vs 0.57). CONCLUSION: Control status, defined by easy-to-obtain clinical criteria, is predictive of future exacerbation risk and time to the next exacerbation. The concept of control can be used in clinical practice at each clinical visit as a complement to the current recommendations of initial treatment proposed by guidelines.

[Association between the use of short-acting bronchodilators and the risk of hospitalization for asthma in a real-life clinical practice population cohort]. / Asociación entre la utilización de broncodilatadores de corta duración y el riesgo de hospitalización por asma en condiciones de práctica clínica habitual en una cohorte poblacional.

OBJECTIVE: To determine the number of short-acting beta-agonists (SABA) canisters dispensed in a pharmacy during one year that is associated with higher asthma hospitalization risk in the same period in patients with active asthma. Multi-centre cross-sectional descriptive design. LOCATION: Primary care, MAJORICA cohort including sociodemographic, clinical and electronic prescription system data coded during clinical practice from 68,578 patients with COPD and asthma in the Balearic Islands. PARTICIPANTS: A total of 7,648 patients older than 18 years with active asthma, who got any SABA canister from the pharmacy during the 2014-2015 period were included. COPD patients were excluded. MAIN MEASUREMENTS: Asthma hospitalization, respiratory medication, tobacco, co-morbidities, age and gender. RESULTS: Mean age 47 years, 38% women, 23.2% active smokers. Seventy-seven patients (1%) were admitted for asthma exacerbation in the study period. Patients who received more than 8 SABA containers per year increased the risk of hospitalization (OR 2.81; 95% CI 1.27-6.24). Severity by therapeutic step and amount of inhaled corticosteroids, as well as heart failure and sleep apnea were also significantly associated with hospitalization. CONCLUSIONS: There is a significant association between the risk of hospitalization and the higher number of SABA canisters dispensed from the pharmacy. The number of canisters/year that best defines a higher risk of hospitalization is≥8 and could be used to identify asthma at risk.

Wrong inhalation technique is associated to poor asthma clinical outcomes. Is there room for improvement?

PURPOSE OF REVIEW: The long-term goals of asthma management are to control symptoms and to reduce the risk of exacerbations. Inhaled medication is the cornerstone of pharmacological treatment for asthma; therefore, good inhalation technique is the key for asthma management. However, up to 70% of asthma patients do not use their inhalers correctly. There is evidence on how poor inhalation technique is associated to poor asthma control. The purpose of this review is to present the most recent research in this field to help clinicians understand the importance of proper inhalers use and the possible interventions to optimize patients' inhalation technique. RECENT FINDINGS: New evidence on how poor inhaler technique and specific critical errors are significantly associated to poor asthma control and exacerbations and how this negative impact could be improved by optimizing device selection, enhancing shared decision-making and giving more importance to education, both for patients and healthcare professionals. New devices and additional tools might help patients to achieve the correct inhaler technique and could form the basis of simplified educational interventions. SUMMARY: There is an urgent need for specific interventions including new educational strategies to minimize the negative effects of wrong inhalation technique in asthma clinical outcomes.

Efficacy of high doses of penicillin versus amoxicillin in the treatment of uncomplicated community acquired pneumonia in adults. A non-inferiority controlled clinical trial.

INTRODUCTION: Community-acquired pneumonia (CAP) is treated with penicillin in some northern European countries. OBJECTIVES: To evaluate whether high-dose penicillin V is as effective as high-dose amoxicillin for the treatment of non-severe CAP. DESIGN: Multicentre, parallel, double-blind, controlled, randomized clinical trial. SETTING: 31 primary care centers in Spain. PARTICIPANTS: Patients from 18 to 75 years of age with no significant associated comorbidity and with symptoms of lower respiratory tract infection and radiological confirmation of CAP were randomized to receive either penicillin V 1.6 million units, or amoxicillin 1000mg three times per day for 10 days. MAIN MEASUREMENTS: The main outcome was clinical cure at 14 days, and the primary hypothesis was that penicillin V would be non-inferior to amoxicillin with regard to this outcome, with a margin of 15% for the difference in proportions. EudraCT register 2012-003511-63. RESULTS: A total of 43 subjects (amoxicillin: 28; penicillin: 15) were randomized. Clinical cure was observed in 10 (90.9%) patients assigned to penicillin and in 25 (100%) patients assigned to amoxicillin with a difference of -9.1% (95% CI, -41.3% to 6.4%; p=.951) for non-inferiority. In the intention-to-treat analysis, amoxicillin was found to be 28.6% superior to penicillin (95% CI, 7.3-58.1%; p=.009 for superiority). The number of adverse events was similar in both groups. CONCLUSIONS: There was a trend favoring high-dose amoxicillin versus high-dose penicillin in adults with uncomplicated CAP. The main limitation of this trial was the low statistical power due to the low number of patients included.

Characteristics of patients making serious inhaler errors with a dry powder inhaler and association with asthma-related events in a primary care setting.

OBJECTIVE: Correct inhaler technique is central to effective delivery of asthma therapy. The study aim was to identify factors associated with serious inhaler technique errors and their prevalence among primary care patients with asthma using the Diskus dry powder inhaler (DPI). METHODS: This was a historical, multinational, cross-sectional study (2011-2013) using the iHARP database, an international initiative that includes patient- and healthcare provider-reported questionnaires from eight countries. Patients with asthma were observed for serious inhaler errors by trained healthcare providers as predefined by the iHARP steering committee. Multivariable logistic regression, stepwise reduced, was used to identify clinical characteristics and asthma-related outcomes associated with ≥1 serious errors. RESULTS: Of 3681 patients with asthma, 623 (17%) were using a Diskus (mean [SD] age, 51 [14]; 61% women). A total of 341 (55%) patients made ≥1 serious errors. The most common errors were the failure to exhale before inhalation, insufficient breath-hold at the end of inhalation, and inhalation that was not forceful from the start. Factors significantly associated with ≥1 serious errors included asthma-related hospitalization the previous year (odds ratio [OR] 2.07; 95% confidence interval [CI], 1.26-3.40); obesity (OR 1.75; 1.17-2.63); poor asthma control the previous 4 weeks (OR 1.57; 1.04-2.36); female sex (OR 1.51; 1.08-2.10); and no inhaler technique review during the previous year (OR 1.45; 1.04-2.02). CONCLUSIONS: Patients with evidence of poor asthma control should be targeted for a review of their inhaler technique even when using a device thought to have a low error rate.

External validation of multidimensional prognostic indices (ADO, BODEx and DOSE) in a primary care international cohort (PROEPOC/COPD cohort).

BACKGROUND: Due to the heterogeneous and systemic nature of the chronic obstructive pulmonary disease (COPD), the new guidelines are oriented toward individualized attention. Multidimensional scales could facilitate its proper clinical and prognostic assessment, but not all of them were validated in an international primary care cohort, different from the original ones used for model development. Therefore, our main aim is to assess the prognostic capacity of the ADO, BODEx and DOSE indices in primary care for predicting mortality in COPD patients and to validate the models obtained in subgroups of patients, classified by revised Global Initiative for Chronic Obstructive Lung Disease (2011) and updated Spanish Guideline (2014). Besides, we want to confirm that the prognostic capacity of all indices increases if the number of exacerbations is substituted by the interval between them and to assess the impact on health of the patient's lifestyle, social network and adherence to treatment. METHODS: Design: External validation of scales, open and prospective cohort study in primary care. SETTING: 36 health centres in 6 European high, medium and low income countries. SUBJECTS: 477 patients diagnosed with COPD, captured in clinical visit by their General Practitioner/Nurse. PREDICTORS: Detailed patient history, exacerbations, lung function test and questionnaires at baseline. OUTCOMES: Exacerbations, all-cause mortality and specific mortality, within 5 years of recruitment. ANALYSIS: Multivariate logistic regression and Cox regression will be used. Possible non-linear effect of the indices will be studied by using Structured Additive Regression models with penalised splines. Subsequently, we will assess different aspects of the regression models: discrimination, calibration and diagnostic precision. Clinical variables modulated in primary care and the interval between exacerbations will be considered and incorporated into the analysis. DISCUSSION: The Research Agenda for General Practice/Family Medicine highlights that the evidence on predictive values of prognostic indices in primary care is scarce. A prospective cohort like that of PROEPOC/COPD provides good opportunities for research into COPD and make communication easier between family practitioners, nursing staff, pneumologists and other professionals, supporting a multi-disciplinary approach to the treatment of these patients. TRIAL REGISTRATION: ISRCTN52402811 . Date: 15/01/2015. Prospectively registered.

Triple Therapy and Clinical Control in B+ COPD Patients: A Pragmatic, Prospective, Randomized Trial.

INTRODUCTION: Treatment with LABA/LAMA is recommended in GOLD B patients. We hypothesized that triple therapy (LABA/LAMA/ICS) will be superior to LABA/LAMA in achieving and maintaining clinical control (CC), a composite outcome that considers both impact and disease stability in a subgroup of GOLD B patients (here termed GOLD B+ patients) characterized by: (1) remaining symptomatic (CAT≥10) despite regular LABA/LAMA therapy; (2) having suffered one moderate exacerbation in the previous year; and (3) having blood eosinophil counts (BEC) ≥150cells/µL. METHODS: The ANTES B+ study is a prospective, multicenter, open label, randomized, pragmatic, controlled trial designed to test this hypothesis. It will randomize 1028 B+ patients to continue with their usual LABA/LAMA combination prescribed by their attending physician or to begin fluticasone furoate (FF) 92µg/umeclidinium (UMEC) 55µg/vilanterol (VI) 22µg in a single inhaler q.d. for 12 months. The primary efficacy outcome will be the level of CC achieved. Secondary outcomes include the clinical important deterioration index (CID), annual rate of exacerbations, and FEV1. Exploratory objectives include the interaction of BEC and smoking status, all-cause mortality and proportion of patients on LABA/LAMA arm that switch therapy arms. Safety analysis include adverse events and incidence of pneumonia. RESULTS: The first patient was recruited on February 29, 2024; results are expected in the first quarter of 2026. CONCLUSIONS: The ANTES B+ study is the first to: (1) explore the efficacy and safety of triple therapy in a population of B+ COPD patients and (2) use a composite index (CC) as the primary result of a COPD trial.

Rational use of inhaled corticosteroids for the treatment of COPD: a plain language summary.

WHAT IS THIS SUMMARY ABOUT?: Inhaled corticosteroids (ICS) are a type of medication delivered via an inhaler device that are commonly used in the treatment of asthma. ICS can also be used to treat chronic obstructive pulmonary disease (COPD), a progressive respiratory condition in which the lungs become worse over time. However, unlike in asthma, ICS are only effective in a small proportion of people with COPD. ICS can cause significant side effects in people with COPD, including pneumonia. Because of this, guidelines written by COPD experts recommend that ICS should largely be prescribed to people with COPD whose symptoms flare up frequently and become difficult to manage (episodes known as exacerbations). Despite this guidance, records collected from routine clinical practice suggest that many healthcare professionals prescribe ICS to people with COPD who do not have frequent exacerbations, putting them at unnecessary risk of side effects. The over-prescription of ICS in COPD may partly be due to the recent introduction of single-inhaler combination therapies, which combine ICS with other medicines (bronchodilators). This 'one inhaler for all' approach is a concerning trend as it goes against global COPD treatment guidelines, which recommend ICS use in only a small proportion of people. This is a plain language summary of a review article originally published in the journal NPJ Primary Care Respiratory Medicine. In this review, we investigate the benefits and risks of ICS use in COPD. Using data from both randomized controlled trials (RCTs) and observational studies, we explain which people benefit from ICS use, and why health regulatory bodies have concluded that ICS do not help people with COPD to live longer. Lastly, we provide practical guidance for doctors and people with COPD regarding when ICS should be prescribed and when they should be withdrawn.

[Prevalence of cardiovascular risk factors in Balearic workers apparently healthy]. / Prevalencia de factores de riesgo cardiovascular en trabajadores aparentemente sanos.

BACKGROUND: the prevalence of cardiovascular risk factors is well known in the general population. The aim of our study is to determine the prevalence of unknown major cardiovascular risk factors, in an apparently healthy Balearic working population. METHOD: data were obtained to 3,035 people randomly selected and with unknown previous diagnosis of hypertension, diabetes or hypercholesterolemia. To compare proportions we used the χ2 test and the t-Student test for comparison of means. RESULTS: the prevalence of unknown hypertension in men was 20.6%, hypercholesterolemia 11.6%and 2.6% diabetes. The prevalence of unknown hypertension, hypercholesterolemia and diabetes in women were 8.3,5.4 and 0.8%, respectively. All cardiovascular risk factors except low HDL-cholesterol were more prevalent in men. 14.4%of men and 5.5% of women met metabolic syndrome. CONCLUSIONS: there is a very high prevalence of cardiovascular risk factors in the working population considered theoretically healthy. This highlights the important role in this field from the occupational health units to make them emerge.

Inhaled Corticosteroid Use Among COPD Patients in Primary Care in Spain.

PURPOSE: Inhaled corticosteroids (ICS) are frequently used to treat chronic obstructive pulmonary disease (COPD) outside the current recommendations. Our aim was to describe ICS use in COPD patients and to identify factors associated with ICS use among COPD patients treated within primary care in Spain. PATIENTS AND METHODS: This was a cross-sectional, non-interventional and multicenter study of patients with COPD treated in primary care. Patient characteristics and exacerbations were described in terms of ICS use among the overall cohort, and among those with spirometry confirmed COPD (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] ratio <70%). Multivariable logistic regression was used to identify factors associated with ICS use. RESULTS: A total of 901 patients were included, of which 47.9% (n = 432) were treated with ICS. A total of 240 patients (26.6%) experienced moderate/severe exacerbations in the prior year, while 309 (34.3%) during the previous two years. History of asthma totaled 11.6% (n = 105). The most frequent phenotype was non-exacerbator (51.6%), and the proportion of patient with moderate or severe exacerbations was significantly higher among ICS treated patients compared to non-treated: 37.5% versus 16.6% during the previous year (p < 0.001), and 46.8% versus 22.8% during the previous 2-years (p < 0.001), respectively. Patient characteristics were similar among spirometry confirmed patients and the overall population. Factors significantly associated with ICS use were a history of asthma (OR = 4.39, 95% CI: 2.67-7.26), the presence of moderate or severe exacerbations in the last year (OR = 2.52, 95% CI: 1.81-3.49), followed by higher mMRC and higher CAT score. CONCLUSION: Nearly half of patients in primary care in Spain are treated with ICS, despite most of them being non-exacerbators. History of asthma, exacerbations, and worse dyspnea and CAT scores are associated with ICS use.

Validation of the Spanish Activity Questionnaire in COPD (SAQ-COPD) in Patients with Chronic Obstructive Pulmonary Disease.

Purpose: The Spanish Activity Questionnaire in COPD (SAQ-COPD) is a short, simple physical activity (PA) measurement instrument for patients with chronic obstructive pulmonary disease (COPD). In this study, we analyzed its validity and sensitivity to change. Methods: Prospective scale validation study. An accelerometer (DynaPort MoveMonitor®) and the Yale Physical Activity Survey (YPAS) were used as reference standards. The analyses examined the criterion validity (Spearman correlations), internal consistency (Cronbach's alpha), factorial structure, test-retest reliability (intraclass correlation coefficient, ICC), sensitivity to change and receiver operating characteristic (ROC) curve to classify patients with low PA. Results: A total of 300 patients diagnosed with COPD were analyzed (73% males, mean age 66 ± 8 years, 40.3% with severe airflow limitation). Cronbach's alpha was 0.60 and Spearman's correlations with accelerometer measurements of PA [number of steps, metabolic equivalents (MET), physical activity level (PAL)] and YPAS ranged from 0.37 to 0.53 (all p < 0.001). ICC was 0.69 (95% CI 0.61-0.74) and the area under the ROC curve to identify low PA was 0.65 (95% confidence interval: 0.58-0.73). Significant variations in SAQ-COPD scores were found between groups defined by YPAS for change. Conclusion: The SAQ-COPD questionnaire is a valid instrument for classifying PA in patients with COPD. Correlations with other instruments provide criterion validity and also demonstrate good sensitivity to change.

Impact of Blood Eosinophil Variability in Asthma: A Real-Life Population Study.

Rationale: Blood eosinophil count predicts response to inhaled corticosteroids and specific biologic therapies in selected patients with asthma. Despite this important role, fundamental aspects of eosinophil behavior in asthma have not been studied. Objectives: To investigate the behavior of blood eosinophils in a population, comparing their distribution with the general population and studying their intraindividual variability over time in relation to hospital episodes (emergency department visits and hospitalizations) in clinical practice. Methods: The distribution and variability of 35,703 eosinophil determinations in 10,059 stable patients with asthma were investigated in the MAJORICA (Majorca Real-Life Investigation in COPD and Asthma) cohort. Eosinophil distribution in the asthma population was compared with a control sample from the general population of 8,557 individuals. Eosinophil variability and hospital episodes were analyzed using correlations, receiver operating characteristic (ROC) curves, and multiple regression analysis. We defined the Eosinophil Variability Index as (Eosmax - Eosmin / Eosmax) × 100%. The findings of the asthma population were retested in an external well-characterized asthma cohort. Results: The eosinophil count values and variability were higher in the asthma population than in the general population (P < 0.001). Variability data showed a better association with hospital episodes than the counting values. An Eosinophil Variability Index ⩾50% was a better predictor for any hospital episode than any of the absolute counting values. These results were validated in the external cohort. Conclusions: The eosinophil variability in patients with asthma better identifies the risk of any hospital episode than the absolute counting values currently used to target specific treatments.

Analysis of the impact of social determinants and primary care morbidity on population health outcomes by combining big data: A research protocol.

Background: In recent years, different tools have been developed to facilitate analysis of social determinants of health (SDH) and apply this to health policy. The possibility of generating predictive models of health outcomes which combine a wide range of socioeconomic indicators with health problems is an approach that is receiving increasing attention. Our objectives are twofold: (1) to predict population health outcomes measured as hospital morbidity, taking primary care (PC) morbidity adjusted for SDH as predictors; and (2) to analyze the geographic variability of the impact of SDH-adjusted PC morbidity on hospital morbidity, by combining data sourced from electronic health records and selected operations of the National Statistics Institute (Instituto Nacional de Estadística/INE). Methods: The following will be conducted: a qualitative study to select socio-health indicators using RAND methodology in accordance with SDH frameworks, based on indicators published by the INE in selected operations; and a quantitative study combining two large databases drawn from different Spain's Autonomous Regions (ARs) to enable hospital morbidity to be ascertained, i.e., PC electronic health records and the minimum basic data set (MBDS) for hospital discharges. These will be linked to socioeconomic indicators, previously selected by geographic unit. The outcome variable will be hospital morbidity, and the independent variables will be age, sex, PC morbidity, geographic unit, and socioeconomic indicators. Analysis: To achieve the first objective, predictive models will be used, with a test-and-training technique, fitting multiple logistic regression models. In the analysis of geographic variability, penalized mixed models will be used, with geographic units considered as random effects and independent predictors as fixed effects. Discussion: This study seeks to show the relationship between SDH and population health, and the geographic differences determined by such determinants. The main limitations are posed by the collection of data for healthcare as opposed to research purposes, and the time lag between collection and publication of data, sampling errors and missing data in registries and surveys. The main strength lies in the project's multidisciplinary nature (family medicine, pediatrics, public health, nursing, psychology, engineering, geography).

Clinical recommendations for dry powder inhaler use in the management of COPD in primary care.

Over 1400 patients using dry powder inhalers (DPIs) to deliver COPD maintenance therapies were recruited across Europe and Australia. Their peak inspiratory flow (PIF) was measured, inhaler technique was observed, and adherence to treatment assessed. From relating the findings with patient health status, and thereby identifying critical errors, key clinical recommendations for primary care clinicians were determined, namely - measure PIF before prescribing a DPI to ensure inhalation manoeuvre ability is well-matched with the device. Some patients could benefit from inhalation training whereas others should have their DPI changed for one better suited to their inspiratory ability or alternatively be prescribed an active device (such as a soft mist inhaler or pressurized metered dose inhaler). Observing the inhalation technique was valuable however this misses suboptimal PIF (approaching one fourth of patients with a satisfactory observed manoeuvre had a suboptimal PIF for their DPI). Assess adherence as deliberate non-adherence can point to a mismatch between a patient and their inhaler (deliberate non-adherence was significantly associated with PIFs below the minimum for the DPI). In-person observation of inhalation technique was found to be inferior to video rating based on device-specific checklists. Where video assessments are not possible, observation training for healthcare professionals would therefore be valuable particularly to improve the ability to identify the critical errors associated with health status namely 'teeth and lips sealed around mouthpiece', 'breathe in' and 'breathing out calmly after inhalation'. However, it is recommended that observation alone should not replace PIF measurement in the DPI selection process.Trial registration: https://clinicaltrials.gov/ct2/show/NCT04532853 .

Factors associated with health status and exacerbations in COPD maintenance therapy with dry powder inhalers.

The study aimed to determine the associations of Peak Inspiratory Flow (PIF), inhalation technique and adherence with health status and exacerbations in participants with COPD using DPI maintenance therapy. This cross-sectional multi-country observational real-world study included COPD participants aged ≥40 years using a DPI for maintenance therapy. PIF was measured three times with the In-Check DIAL G16: (1) typical PIF at resistance of participant's inhaler, (2) maximal PIF at resistance of participant's inhaler, (3) maximal PIF at low resistance. Suboptimal PIF (sPIF) was defined as PIF lower than required for the device. Participants completed questionnaires on health status (Clinical COPD Questionnaire (CCQ)), adherence (Test of Adherence to Inhalers (TAI)) and exacerbations. Inhalation technique was assessed by standardised evaluation of video recordings. Complete data were available from 1434 participants (50.1% female, mean age 69.2 years). GOLD stage was available for 801 participants: GOLD stage I (23.6%), II (54.9%), III (17.4%) and IV (4.1%)). Of all participants, 29% had a sPIF, and 16% were shown able to generate an optimal PIF but failed to do so. sPIF was significantly associated with worse health status (0.226 (95% CI 0.107-0.346), worse units on CCQ; p = 0.001). The errors 'teeth and lips sealed around mouthpiece', 'breathe in', and 'breathe out calmly after inhalation' were related to health status. Adherence was not associated with health status. After correcting for multiple testing, no significant association was found with moderate or severe exacerbations in the last 12 months. To conclude, sPIF is associated with poorer health status. This study demonstrates the importance of PIF assessment in DPI inhalation therapy. Healthcare professionals should consider selecting appropriate inhalers in cases of sPIF.

Suboptimal Peak Inspiratory Flow and Critical Inhalation Errors are Associated with Higher COPD-Related Healthcare Costs.

Purpose: To assess the relationship between suboptimal Peak Inspiratory Flow (sPIF), inhalation technique errors, and non-adherence, with Healthcare Resource Utilisation (HCRU) in Chronic Obstructive Pulmonary Disease (COPD) patients receiving maintenance therapy via a Dry Powder Inhaler (DPI). Patients and methods: The cross-sectional, multi-country PIFotal study included 1434 COPD patients (≥40 years) using a DPI for maintenance therapy. PIF was measured with the In-Check DIAL G16, and sPIF was defined as a typical PIF lower than required for the device. Inhalation technique was assessed by standardised evaluation of video recordings and grouped into 10 steps. Patients completed the "Test of Adherence to Inhalers" questionnaire. HCRU was operationalised as COPD-related costs for primary healthcare, secondary healthcare, medication, and total COPD-related costs in a 1-year period. Results: Participants with sPIF had higher medication costs compared with those with optimal PIF (cost ratio [CR]: 1.07, 95% CI [1.01, 1.14]). Multiple inhalation technique errors were associated with increased HCRU. Specifically, "insufficient inspiratory effort" with higher secondary healthcare costs (CR: 2.20, 95% CI [1.37, 3.54]) and higher total COPD-related costs (CR: 1.16, 95% CI 1.03-1.31). "no breath-hold following the inhalation manoeuvre (<6 s)" with higher medication costs (CR: 1.08, 95% CI [1.02, 1.15]) and total COPD-related costs (CR 1.17, 95% CI [1.07, 1.28]), and "not breathing out calmly after inhalation" with higher medication costs (CR: 1.19, 95% CI [1.04, 1.37]). Non-adherence was not significantly associated with HCRU. Conclusion: sPIF and inhalation technique errors were associated with higher COPD-related healthcare utilisation and costs in COPD patients on DPI maintenance therapy.