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).

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 .

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.

Real-World Impact of Nonclinical Inhaler Regimen Switches on Asthma or COPD: A Systematic Review.

BACKGROUND: Switching inhaler regimens can be driven by poor disease control but also by nonclinical factors, such as cost and environmental impact. The consequences of switching for nonclinical reasons are largely unclear. OBJECTIVE: To systematically review the real-world consequences of switching inhaler regimens for nonclinical reasons in asthma and/or chronic obstructive pulmonary disease patients. METHODS: Embase, MEDLINE, EBM Reviews, and EconLit were searched to November 21, 2020. Conference searches and reference checking were also performed. Real-world studies of asthma and/or chronic obstructive pulmonary disease patients undergoing a switch in inhaler regimen for any reason apart from clinical need were included. Two reviewers screened and extracted data. Key outcomes included symptom control, exacerbations, and patient-doctor relationships. RESULTS: A total of 8,958 records were screened and 21 studies included. Higher-quality (matched comparative) studies were prioritized. Five matched studies (6 datasets) reported on symptom control: 5 datasets (n = 7,530) with unclear patient consent reported improved disease control following switching, and 1 dataset (n = 1,648) with non-consented patients reported significantly worsened disease control. Three matched studies (5 datasets, n = 10,084) reported on exacerbation rate ratios; results were heterogeneous depending on the definition used. Two studies (n = 137) reported that switching inhaler regimens could have a negative impact on the doctor-patient relationship, especially when the switches were non-consented. Study quality was generally low. CONCLUSIONS: Switching inhaler regimens is a complex issue that can have variable clinical consequences and can harm the patient-doctor relationship. Limited high-quality evidence was identified, and study designs were heterogeneous. A robust framework is needed to guide the personalized switching of inhalers.

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.

Relationship between Peak Inspiratory Flow and Patient and Disease Characteristics in Individuals with COPD-A Systematic Scoping Review.

Optimal delivery of medication via dry powder inhalers, the most commonly prescribed inhaler type, is dependent on a patient achieving a minimum level of inspiratory flow during inhalation. However, measurement of peak inspiratory flow (PIF) against the simulated resistance of a dry powder inhaler is not frequently performed in clinical practice due to time or equipment limitations. Therefore, defining which patient characteristics are associated with lower PIF is critically important to help clinicians optimize their inhaler choice through a more personalized approach to prescribing. The objective of this scoping review was to systematically evaluate patient and disease characteristics determining PIF in patients with chronic obstructive pulmonary disease (COPD). Medline, Cochrane and Embase databases were systematically searched for relevant studies on PIF in patients with COPD published in English between January 2000 and May 2021. The quality of evidence was assessed using a modified Grading of Recommendations Assessment, Development and Evaluation checklist. Of 3382 citations retrieved, 35 publications were included in the review (nine scored as high quality, 13 as moderate, nine as low, and four as very low). Factors correlating with PIF in >70% of papers included both patient characteristics (lower PIF correlated with increased age, female gender, shorter height, decreased handgrip and inspiratory muscle strength, and certain comorbidities) and disease characteristics (lower PIF correlated with markers of lung hyperinflation, lower peak expiratory flow [PEF] and increased disease severity). Other factors correlating with adequate/optimal or improved PIF included education/counseling and exercise/inspiratory muscle training; impaired physical function and errors in inhalation technique/non-adherence were associated with low/suboptimal PIF. In conclusion, clinicians should measure PIF against the simulated resistance of a particular device wherever possible. However, as this often cannot be done due to lack of resources or time, the patient and disease characteristics that influence PIF, as identified in this review, can help clinicians to choose the most appropriate inhaler type for their patients.

Impact of PIF, Inhalation Technique and Medication Adherence on Health Status and Exacerbations in COPD: Protocol of a Real-World Observational Study (PIFotal COPD Study).

INTRODUCTION: Dry powder inhalers (DPIs), a commonly prescribed inhaler type for respiratory diseases, require patients to generate sufficient peak inspiratory flow (PIF) to ensure optimal drug delivery to the airways. Effectiveness of therapy also requires a good inhalation technique and adequate medication adherence. For patients with chronic obstructive pulmonary disease (COPD), recent studies conducted in tertiary care suggest that DPI users with suboptimal PIF have poorer COPD-related health status and increased exacerbation risk versus those with optimal PIF. The PIFotal study will investigate the impact of PIF, inhalation technique and medication adherence on patient-reported outcomes in patients with COPD in primary care using a DPI for their maintenance therapy. METHODS AND ANALYSIS: This cross-sectional observational study will assess 1200 patients (aged ≥ 40 years, diagnosed with COPD and using a DPI for COPD maintenance therapy for ≥ 3 months) from the Netherlands, Spain, Portugal, Poland, Greece and Australia. Assessments will consist of (1) PIF measurements (usual patient inhalation manoeuvre, maximal PIF against resistance of own inhaler, and maximal PIF against low resistance); (2) Clinical COPD Questionnaire (CCQ), COPD Assessment Test and Test of Adherence to Inhalers scores; and (3) video recordings of patient inhalation technique. Dependent variables include health status (CCQ score), number of self-reported exacerbations in previous 12 months, and healthcare resource utilisation in previous 6 months. Independent variables include PIF values, inhalation technique errors, medication adherence, and demographic and clinical characteristics. In the primary analysis, the mean difference in CCQ score between patients (1) with optimal/suboptimal PIF, (2) exhibiting/not exhibiting inhalation technique errors, and (3) adhering/not adhering to medication will be examined in a multivariable linear mixed model. ETHICS: The study protocol was approved by ethics committees/institutional review boards of all participating sites prior to enrolment; written informed consent was obtained from all study participants. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT04532853.

Patient perceptions of the re-usable Respimatt® Soft Mist™ inhaler in current users and those switching to the device: A real-world, non-interventional COPD study.

PLAIN LANGUAGE SUMMARY: Inhalers are often used to treat patients with chronic obstructive pulmonary disease (COPD). However, there are many available, which can lead to confusion and poor inhaler technique. It is important for a patient to be happy with their inhaler. This study looked at how patients liked the re-usable Respimat® Soft Mist™ inhaler vs. their previous inhaler. It also asked whether they would be willing to continue using the device at the end of the study period.After 4-6 weeks of using the re-usable device, patients reported that they were happy with the inhaler and most would be willing to carry on using it.Overall, these results show that doctors can prescribe Respimat re-usable to patients, even if the patient has not used the inhaler before.

Rational selection of inhalation devices in the treatment of chronic obstructive pulmonary disease by means of the System of Objectified Judgement Analysis (SOJA).

OBJECTIVES: The large number of available medicines and devices makes it almost impossible to have sufficient knowledge of each individual medicine and device, especially for general practitioners. This may lead to suboptimal treatment, more exacerbations, hospitalisations and higher treatment costs. Reducing the number of medicines and devices, based on rational criteria, allows physicians and pharmacists to build experience with a more limited set of medicines and to standardise the inhalation instructions. METHODS: In this study inhalers are compared by means of the System of Objectified Judgement Analysis (SOJA) method. The following selection criteria were applied: uniformity in device, number of steps per inhalation, risk of errors, hygienic aspects, feedback mechanism, and risk of inhalation with an empty inhaler. RESULTS: Substantial differences were seen in the overall scores, with the Ellipta device showing the highest score, followed by Diskus/Accuhaler, Genuair and Nexthaler. Several devices require more or less identical techniques, such Ellipta and Diskus/Accuhaler as well as Genuair and Novolizer. When patients use these devices in combination this increases their uniformity, because additional medicines become available for the devices: starting therapy with Diskus or Novolizer and follow-up with Ellipta or Genuair. The resistance of Respimat and Breezhaler is lower than that of other devices, which makes these devices suitable for patients who cannot generate sufficient inhalation flow. CONCLUSIONS: A substantial reduction of inhalers, combined with optimal and standardised instructions, should improve the care of patients with chronic obstructive pulmonary disease.

Spacers and Valved Holding Chambers-The Risk of Switching to Different Chambers.

Spacers are pressurized metered-dose inhaler (pMDI) accessory devices developed to reduce problems of poor inhaler technique with pMDIs. Spacers that feature a 1-way inspiratory valve are termed valved holding chambers (VHCs); they act as aerosol reservoirs, allowing the user to actuate the pMDI device and then inhale the medication in a 2-step process that helps users overcome challenges in coordinating pMDI actuation with inhalation. Both spacers and VHCs have been shown to increase fine particle delivery to the lungs, decrease oropharyngeal deposition, and reduce corticosteroid-related side effects such as throat irritation, dysphonia, and oral candidiasis commonly seen with the use of pMDIs alone. Spacers and VHCs are not all the same, and also are not interchangeable: the performance may vary according to their size, shape, material of manufacture and propensity to become electrostatically charged, their mode of interface with the patient, and the presence or otherwise of valves and feedback devices. Thus, pairing of a pMDI plus a spacer or a VHC should be considered as a unique delivery system. In this Rostrum we discuss the risk potential for a patient getting switched to a spacer or VHC that delivers a reduced dose medication.

"Can do" versus "do do": A Novel Concept to Better Understand Physical Functioning in Patients with Chronic Obstructive Pulmonary Disease.

BACKGROUND: Physical capacity (PC) and physical activity (PA) represent associated but separate domains of physical function. It remains unknown whether this framework may support a better understanding of the impaired physical function in patients with chronic obstructive pulmonary disease (COPD). The current study had two aims: (1) to determine the distribution of patients with COPD over the PC-PA quadrants, and (2) to explore whether differences exist in clinical characteristics between these quadrants. METHODS: In this retrospective study, PC was measured using the six-minute walk distance (6MWD), and PA was assessed with an accelerometer. Moreover, patients' clinical characteristics were obtained. Patients were divided into the following quadrants: (I) low PC (6MWD <70% predicted), low PA, using a step-defined inactivity index (<5000 steps/day, "can't do, don't do" quadrant); (II) preserved PC, low PA ("can do, don't do" quadrant); (III) low PC, preserved PA ("can't do, do do" quadrant); and (IV) preserved PC, preserved PA ("can do, do do" quadrant). RESULTS: The distribution of the 662 COPD patients over the quadrants was as follows: "can't do, don't do": 34%; "can do, don't do": 14%; "can't do, do do": 21%; and "can do, do do": 31%. Statistically significant differences between quadrants were found for all clinical characteristics, except for educational levels. CONCLUSIONS: This study proves the applicability of the PC-PA quadrant concept in COPD. This concept serves as a pragmatic clinical tool, that may be useful in the understanding of the impaired physical functioning in COPD patients and therefore, may improve the selection of appropriate interventions to improve physical function.

Evaluation of the COPDnet integrated care model in patients with COPD: the study protocol.

Background: Projections on the future suggest a further rise in the prevalence of patients with COPD, and in COPD related morbidity, mortality, and health care costs worldwide. Given the substantial impact on the individual and on society, it is important to establish a care process that maximizes outcomes in relation to the costs and efforts made. In an attempt to bridge this gap, we set out to develop an evidence-based model of integrated care for patients with COPD, named the COPDnet integrated care model. Purpose: The current study protocol sets out to 1) evaluate the feasibility of employing the COPDnet model in present real-life care within the context of the Dutch health care system, 2) explore the potential health status benefits, and 3) analyze the costs of care of this model. Patients and methods: In this prospective study, feasibility and health status changes will be evaluated with an experimental before and after study design. The costs of the diagnostic trajectory will be calculated according to a standard economic health care evaluation approach. Furthermore, the feasibility and cost of care studies will comprise both quantitative and qualitative data collection. For the studies on the feasibility and change in health status, all new patients qualifying for shared care by primary and secondary care professionals according to the Dutch Standard of Care for COPD, and patients referred by their general practitioners to one of the COPDnet hospitals will be included. To evaluate the feasibility and costs of care, semi-structured interviews will be held with patients, hospital personnel, health care professionals in the affiliated primary care region, and hospital and primary care group managers. Conclusions: The COPDnet integrated care model for COPD patients has been designed according to the current insights regarding effective care for patients with a chronic condition in general, and for patients with COPD in particular. It will be evaluated for its feasibility, potential health status benefits, and the costs of care of the diagnostic trajectory in secondary care.

The COPDnet integrated care model.

Introduction: This research project sets out to design an integrated disease management model for patients with COPD who were referred to a secondary care setting and who qualified for pharmacological and nonpharmacological intervention options. Theory and methods: The integrated disease management model was designed according to the guidelines of the European Pathway Association and the content founded on the Chronic Care Model, principles of integrated disease management, and knowledge of quality management systems. Results: An integrated disease management model was created, and comprises 1) a diagnostic trajectory in a secondary care setting, 2) a nonmedical intervention program in a primary care setting, and 3) a pulmonary rehabilitation service in a tertiary care setting. The model also includes a quality management system and regional agreements about exacerbation management and palliative care. Discussion: In the next phase of the project, the COPDnet model will be implemented in at least two different regions, in order to assess the added value of the entire model and its components, in terms of feasibility, health status benefits, and costs of care. Conclusion: Based on scientific theories and models, a new integrated disease management model was developed for COPD patients, named COPDnet. Once the model is stable, it will be evaluated for its feasibility, health status benefits, and costs.

Addressing the Impact and Unmet Needs of Nonadherence in Asthma and Chronic Obstructive Pulmonary Disease: Where Do We Go From Here?

Nonadherence to treatment, and its associated health and economic burden, is particularly problematic in asthma and chronic obstructive pulmonary disease management because of heterogeneous patient populations and the need for an inhaled route of drug administration. Symptom variability, comorbidities, and device switching further add to suboptimal adherence rates. As opposed to controlled clinical trials, real-life studies show consistently low inhaler adherence in daily practice, yet exact adherence rates have long been affected by disagreement on standardized definitions. The recently developed Ascertaining Barriers to Compliance taxonomy helps to address adherence research disparities by identifying 3 phases of adherence (initiation, implementation [including correct inhaler technique], and discontinuation). This review considers the reasons for and impact of suboptimal adherence, together with summaries of key studies that demonstrate how improving adherence can reduce exacerbations, inhaled corticosteroid use (in cases of better inhaler technique), hospitalizations, and treatment costs. Strategies to help ensure optimal adherence are discussed, including the choice of a patient-tailored inhaler, patient empowerment, education and training, and the potential of electronic monitoring and digital technology. It is concluded that a combined effort from payers, health care professionals, and manufacturers could make a real difference to asthma and chronic obstructive pulmonary disease control, as well as to health care budgets.

Critical inhaler errors in asthma and COPD: a systematic review of impact on health outcomes.

BACKGROUND: Inhaled drug delivery is the cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). However, use of inhaler devices can be challenging, potentially leading to critical errors in handling that can significantly reduce drug delivery to the lungs and effectiveness of treatment. METHODS: A systematic review was conducted to define 'critical' errors and their impact on health outcomes and resource use between 2004 and 2016, using key search terms for inhaler errors in asthma and COPD (Search-1) and associated health-economic and patient burden (Search-2). RESULTS: Search-1 identified 62 manuscripts, 47 abstracts, and 5 conference proceedings (n = 114 total). Search-2 identified 9 studies. We observed 299 descriptions of critical error. Age, education status, previous inhaler instruction, comorbidities and socioeconomic status were associated with worse handling error frequency. A significant association was found between inhaler errors and poor disease outcomes (exacerbations), and greater health-economic burden. CONCLUSIONS: We have shown wide variations in how critical errors are defined, and the evidence shows an important association between inhaler errors and worsened health outcomes. Given the negative impact diminished disease outcomes impose on resource use, our findings highlight the importance of achieving optimal inhaler technique, and a need for a consensus on defining critical and non-critical errors.

Misuse and/or treatment delivery failure of inhalers among patients with asthma or COPD: A review and recommendations for the conduct of future research.

BACKGROUND: Asthma and chronic obstructive pulmonary disease (COPD) are widespread chronic conditions with medication frequently delivered by inhalers. These can be challenging to use correctly, but the scale of misuse and the specific aspects of failure are unclear. METHODS: We used systematic review methods to search 9 databases in May 2015 to identify and review studies that assessed adults (18 years or older) with asthma or COPD using inhalers of various types including pressurised metered dose inhalers (pMDIs), dry powder inhalers and the Respimat inhaler. Studies must have reported the scale of inhaler misuse, variation by type of inhaler or which steps patients had difficulty completing accurately. RESULTS: The types of inhalers, inhaler interventions and definitions of failure and misuse varied widely in the 38 studies identified. It was not possible to draw conclusions on the differential failure rates between different types of inhalers or any patient characteristics. Of the studies reporting failure or misuse rates, the majority ranged between 0 and 20%. Studies were inconsistent regarding the number of inhaler steps collected, reported and labelled as critical. CONCLUSIONS: There is evidence for all identified inhalers that some people may be using them incorrectly, but it is unclear which inhalers have higher rates of misuse or which steps within the inhaler technique are most difficult for patients. The optimal techniques for using inhalers are not standardised. Researchers undertaking future inhaler studies are respectfully directed to our recommendations for future research.

Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids.

PURPOSE: Extrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone). METHODS: This historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change. RESULTS: Each cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) µg/day and 500 (250-500) µg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide. CONCLUSIONS: In this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS.

Consistency of medical record reporting of a set of indicators for proactive palliative care in patients with chronic obstructive pulmonary disease.

To identify patients hospitalized for an acute exacerbation of chronic obstructive pulmonary disease (COPD) who have a poor prognosis and might benefit from proactive palliative care, a set of indicators had been developed from the literature. A patient is considered eligible for proactive palliative care when meeting ≥2 criteria of the proposed set of 11 indicators. In order to develop a doctor-friendly and patient-convenient tool, our primary objective was to examine whether these indicators are documented consistently in the medical records. Besides, percentage of patients with a poor prognosis and prognostic value were explored. We conducted a retrospective medical record review of 33 patients. Five indicators; non-invasive ventilation (NIV), comorbidity, body mass index (BMI), previous admissions for acute exacerbation COPD and age were always documented. Three indicators; hypoxaemia and/or hypercapnia, professional home care and actual forced expiratory volume1% (FEV1%) were documented in more than half of the records, whereas the clinical COPD questionnaire (CCQ), medical research council dyspnoea (MRC dyspnoea) and the surprise question were never registered. Besides, 78.8% of the patients met ≥2 criteria and there was a significant association between meeting ≥2 criteria and mortality within 1 year (one-sided Fisher's exact test, p = 0.04). The set of indicators for proactive palliative care in patients with COPD appeared to be user-friendly and feasible.

Effectiveness of initiating extrafine-particle versus fine-particle inhaled corticosteroids as asthma therapy in the Netherlands.

BACKGROUND: Most randomised clinical trials typically exclude a significant proportion of asthma patients, including those at higher risk of adverse events, with comorbidities, obesity, poor inhaler technique and adherence, or smokers. However, these patients might differentially benefit from extrafine-particle inhaled corticosteroids (ICS). This matched cohort, database study, compared the effectiveness of extrafine-particle with fine-particle ICS in a real-life population initiating ICS therapy in the Netherlands. METHODS: Data were from the Pharmo Database Network, comprising pharmacy and hospital discharge records, representative of 20 % of the Dutch population. The study population included patients aged 12 - 60, with a General Practice-recorded diagnosis for asthma (International Classification of Primary Care code R96), when available, ≥2 prescriptions for asthma therapy at any time in their recorded history, and receiving first prescription of ICS therapy as either extrafine-particle (ciclesonide or hydrofluoroalkane beclomethasone dipropionate [BDP]) or fine-particle ICS (fluticasone propionate or non-extrafine-particle-BDP). Patients were matched (1:1) on relevant demographic and clinical characteristics over 1-year baseline. Primary outcomes were severe exacerbation rates, risk domain asthma control and overall asthma control during the year following first ICS prescription. Secondary outcomes, treatment stability and being prescribed higher versus lower category of short-acting ß2 agonists (SABA) dose, were compared over a 1-year outcome period using conditional logistic regression models. RESULTS: Following matching, 1399 patients were selected in each treatment cohort (median age: 43 years; males: 34 %). Median (interquartile range) initial ICS doses (fluticasone-equivalents in µg) were 160 (160 - 320) for extrafine-particle versus 500 (250 - 500) for fine-particle ICS (p < 0.001). Following adjustment for residual confounders, matched patients prescribed extrafine-particle ICS had significantly lower rates of exacerbations (adjusted rate ratio [95 % CI], 0.59 [0.47-0.73]), and significantly higher odds of achieving asthma control and treatment stability in the year following initiation than those prescribed fine-particle ICS, and this occurred at lower prescribed doses. Patients prescribed extrafine-particle ICS had lower odds of being prescribed higher doses of SABA (0.50 [0.44-0.57]). CONCLUSION: In this historical, matched study, extrafine-particle ICS was associated with better odds of asthma control than fine-particle ICS in patients prescribed their first ICS therapy in the Netherlands. Of importance, this was reached at significantly lower prescribed dose.