ERS statement: a core outcome set for clinical trials evaluating the management of COPD exacerbations.

Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritised for inclusion in the core outcome set through a two-round Delphi survey completed by 1063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in five continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to 1) finalise the core outcome set and 2) prioritise a single measurement instrument to be used for evaluating each of the prioritised outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for at all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, the need for a higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimise some of the selected measurement instruments. The panel did not consider the prioritised set of outcomes and associated measurement instruments to be burdensome for patients and health professionals to use.

Switching COPD patients from the disposable to the new reusable Respimat soft mist inhaler: a real-world study from Switzerland.

OBJECTIVE: The aims of the survey were to assess first experiences of Swiss COPD patients switching from the disposable to the new reusable Respimat inhaler, and to evaluate physicians´ and patients´ views of the new training material. METHODS: Patients with a confirmed diagnosis of COPD using a disposable Respimat inhaler for at least three months were included. Patients´ demographics, COPD stage, current treatment, and comorbidities relevant for the handling of the device were assessed. Further, patients were trained on the reusable Respimat by placebo inhaler, patient brochure, video cards/demo films and SMS reminder service. After at least one cartridge change, patients gave comprehensive feedback on their satisfaction with the reusable Respimat and physicians evaluated the need for re-training. RESULTS: 235 patients participated in the survey. Of these, 37% suffered from comorbidities restricting the handling of the Respimat. 216 (92%) patients had a better overall satisfaction with the reusable than with the disposable Respimat. Dose counter (86%), monthly preparation (81%) and daily handling (77%) were also assessed as better by most of the patients. In 80% of cases, the user ability was stated as better than for the disposable Respimat. Less than 15% of the patients required further training. Placebo inhaler was the mostly preferred training material by both, physicians (in 86% of the patients) and patients (75%). In patients with comorbidities affecting inhaler handling, overall satisfaction was also better in 86% of the patients. CONCLUSION: The majority of patients were satisfied with the new reusable Respimat device and proper handling could be attained using the provided training material, even in patients with restricting comorbidities.

Adherence to GOLD Recommendations among Swiss Pulmonologists and General Practitioners.

Significant variability in adherence to COPD management recommendations has been reported. We aimed to evaluate real-life COPD pharmacotherapy prescribing patterns and adherence to the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) global strategy in Switzerland. A questionnaire-based survey was conducted among Swiss general practitioners (GPs) and pulmonologists (PULs) from May 1 to November 30, 2017. Participants were invited to complete a questionnaire on their next 5-10 consecutive patients already receiving a pharmacological treatment for COPD. They were requested to assess dyspnea using the modified Medical Research Council (mMRC) dyspnea scale and to determine whether a treatment adjustment was indicated. Fifty-three PULs and 39 GPs completed questionnaires on 511 COPD patients. Dyspnea with mMRC grade ≥2 was reported in 62.5% of the patients, and 31.9% had had at least two exacerbations (or at least one with hospital admission) in the last 12 months. The vast majority (87.1%) of GOLD A patients were overtreated. In the GOLD B group, 52.2% of prescriptions were concordant with GOLD 2017 recommendations, but 37% of patients were overtreated. Among GOLD C patients, 49.2% received GOLD-adherent treatment and 47.5% were overtreated. In the GOLD D category, 78.8% of the patients received a treatment consistent with recommendations but 15.2% were undertreated. After reassessment of patient status, treatment was modified in 50.3% of the patients. This study confirms that discordance of real-world prescription patterns with international guidance is frequent. Further educational efforts are required to improve adherence to COPD management recommendations.

Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol.

Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations. For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus. Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS.

[Development of inhaled therapies for COPD and asthma]. / Inhalative Therapie bei COPD und Asthma.

Development of inhaled therapies for COPD and asthma Abstract. Inhaled therapies still represent one of the most important pillars of the COPD and asthma treatments. In recent years, the importance of inhaled corticosteroids in the treatment of COPD changed again and again and currently it seems that they are gaining more importance again. In the future, inhaled therapies will increasingly focus on biomarkers. New to the market are the "triple therapies as a fixed combination", whose success will be evident in the next few years. Despite the great variety of new agents, new combinations and new inhalation systems, it is important to keep a good overview and to focus on the individual benefit of the patients. The goal is to find the products that are suitable for the individual patient in a dosage form that is ideal for him. A correct inhalation technique and a good medication adherence to the prescribed treatment plan is crucial for the success of an inhaled therapy.

[Rare Complication of a Common Disease: Thyroid and Epileptic Seizures]. / Seltene Komplikation einer häufigen Erkrankung: Schilddrüse und epileptische Anfälle.

Rare Complication of a Common Disease: Thyroid and Epileptic Seizures Abstract. A myxedema crisis is a life-threatening complication of hypothyroidism (mortality 20-25 %). The diagnosis is made on clinical grounds and thyroid function tests. Treatment with levothyroxine (possibly combined with T3) should be instituted immediately, along with glucocorticoids, until co-existing adrenal insufficiency has been ruled out. Supportive measures and treatment of underlying diseases should be implemented. We are presenting the case of a patient with myxedema crisis complicated by tonic-clonic seizures and severe hyponatremia as first manifestation of primary hypothyroidism.