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.

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.

Validation of the portable Bluetooth® Air Next spirometer in patients with different respiratory diseases.

BACKGROUND: Chronic respiratory diseases constitute a considerable part in the practice of pulmonologists and primary care physicians; spirometry is integral for the diagnosis and monitoring of these diseases, yet remains underutilized. The Air Next spirometer (NuvoAir, Sweden) is a novel ultra-portable device that performs spirometric measurements connected to a smartphone or tablet via Bluetooth®. METHODS: The objective of this study was to assess the accuracy and validity of these measurements by comparing them with the ones obtained with a conventional desktop spirometer. Two hundred subjects were enrolled in the study with various spirometric patterns (50 patients with asthma, 50 with chronic obstructive pulmonary disease and 50 with interstitial lung disease) as well as 50 healthy individuals. RESULTS: For the key spirometric parameters in the interpretation of spirometry, i.e. FEV1, FVC, FEV1/FVC and FEF25-75%, Pearson correlation and Interclass Correlation Coefficient were greater than 0.94, exhibiting perfect concordance between the two spirometers. Similar results were observed in an exploratory analysis of the subgroups of patients. Using Bland-Altman plots we have shown good reproducibility in the measurements between the two devices, with small mean differences for the evaluated spirometric parameters and the majority of measurements being well within the limits of agreement. CONCLUSIONS: Our results support the use of Air Next as a reliable spirometer for the screening and diagnosis of various spirometric patterns in clinical practice.