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Supplemental material, sj-pdf-1-tar-10.1177_17534666221148663 for Standardized airway wall thickness Pi10 from routine CT scans of COPD patients as imaging biomarker for disease severity, lung function decline, and mortality by Kathrin Kahnert, Rudolf A. Jörres, Hans-Ulrich Kauczor, Peter Alter, Franziska C. Trudzinski, Felix Herth, Bertram Jobst, Oliver Weinheimer, Sebastian Nauck, Pontus Mertsch, Diego Kauffmann-Guerrero, Jürgen Behr, Robert Bals, Henrik Watz, Klaus F. Rabe, Tobias Welte, Claus F. Vogelmeier and Jürgen Biederer in Therapeutic Advances in Respiratory Disease

Supplemental material, sj-docx-2-tar-10.1177_17534666221148663 for Standardized airway wall thickness Pi10 from routine CT scans of COPD patients as imaging biomarker for disease severity, lung function decline, and mortality by Kathrin Kahnert, Rudolf A. Jörres, Hans-Ulrich Kauczor, Peter Alter, Franziska C. Trudzinski, Felix Herth, Bertram Jobst, Oliver Weinheimer, Sebastian Nauck, Pontus Mertsch, Diego Kauffmann-Guerrero, Jürgen Behr, Robert Bals, Henrik Watz, Klaus F. Rabe, Tobias Welte, Claus F. Vogelmeier and Jürgen Biederer in Therapeutic Advances in Respiratory Disease

Additional file 1: Table S1. Results of the Random Forest and AdaBoost procedures for different sets of variables included. The table shows the variables in the rank order of importance according to the criterion of the mean decrease in accuracy (Random Forest) and the importance measure defined in the AdaBoost procedure. The overall classification error refers to 10-fold cross-validation in the case of AdaBoost and CHAID. SGRQ4 “I have attacks of wheezing”, SGRQ5 “How many attacks of chest trouble did you have during the last year?”, SGRQ8, “How would you describe your chest condition?”, SGRQ11 sub-item 5 “I have become frail or an invalid because of my chest”, SGRQ12 sub-item 1 “I take a long time to get washed or dressed”, SGRQ12 sub-item 3 “I walk slower than other people, or I stop for rests”, SGRQ12 sub-item 4 “Jobs such as housework take a long time, or I have to stop for rests”, SGRQ13 sub-item 1 “I cannot play sports or games”, SGRQ14 “How does your chest trouble affect you? Table S2. Technical details of the CT assessment. The acquisition protocol is given in the upper part and details on the scanner models in the lower part of the table. *Vendor-specific generic names for Siemens/GE/Philips. Table S3. Items from the “St. George’s Respiratory Questionnaire” (SGRQ) that turned out to be informative in the single decision trees. Table S4. Items from the COPD Assessment test (CAT). Table S5. Modified Medical Research Council (mMRC) scale. This self-rating questionnaire is used to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4.

Recent cases involving controversial actions taken by federal agencies under the Trump Administration have highlighted a preliminary procedural nuance unique to litigation under the Administrative Procedure Act of 1946 (APA): the “administrative record.” The APA provides for liberal judicial review of federal agency actions, but limits that review to the “whole record, or those parts of it cited by a party.” This “record rule” limits judicial review to the “administrative record” before the agency when it made the decision at issue. The APA defines the administrative record for agency action subject to its formal procedural requirements, but leaves open the question of what an administrative record consists of for informal agency action not subject to those procedural requirements but nevertheless subject to judicial review. Lower courts, without definitive statutory text, legislative history, or Supreme Court precedent for guidance, have developed a divergent and sometimes inconsistent body of case law addressing the proper scope of an administrative record for informal agency action. The traditional approach generally would focus on those materials directly considered by the agency decisionmaker alone while categorically excluding most, if not all, internal documents. But more recently, some lower courts have begun to apply an expansive construction of the record rule, requiring agencies subject to litigation to submit any material considered by agency personnel involved in the decision-making process, including an array of internal materials. Two recent cases, involving the Department of Homeland Security’s attempted revocation of the Deferred Action for Childhood Arrivals (DACA) program and Secretary of Commerce Wilbur Ross’s attempts to add a citizenship question to the 2020 Department of Commerce, illustrate the wider movement towards an expansive construction of the record rule for informal agency action. In this Note, I argue that the expansive approach to the record rule for informal agency action becoming popular in some lower courts is correct, both in terms of the judicial review provisions of the APA it serves and the principles of administrative law the APA furthers. The broader adoption of an expansive approach to the record rule has implications for any area of law touched by federal agencies. Indeed, as the DACA and 2020 Census litigation demonstrate, the composition of an administrative record can have significant consequences for issues of national importance.

Stefan Andreas,1,2 Ulrich Bothner,3 Alberto de la Hoz,3 Isabel Kloer,3 Matthias Trampisch,3 Peter Alter4 1Department of Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany; 2LungClinic Immenhausen, Immenhausen, Germany, Member of the German Center for Lung Research (DZL); 3Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 4Department of Medicine, Pulmonary and Critical Care Medicine, Philipps University of Marburg (UMR), Member of the German Center for Lung Research (DZL), Marburg, GermanyCorrespondence: Stefan Andreas Department of Cardiology and PneumologyUniversity Medical Center Göttingen, Robert-Koch-Str. 40, Göttingen, GermanyTel +49 05673 501 1112Fax +49 05673-501-1101Email stefan.andreas@med.uni-goettingen.deBackground: Patients with chronic obstructive pulmonary disease (COPD) are at risk of developing cardiac arrhythmias and elevated heart rate. A theoretical mechanistic association based on the interaction of long-acting β2-agonists (LABAs) with adrenoreceptors in the heart and vasculature is assumed as a potential class-related risk. Therefore, we performed a pooled analysis of Holter electrocardiogram (ECG) data from four 48-week, randomized, double-blind, placebo-controlled, parallel-group, Phase III clinical trials evaluating olodaterol (5 μg or 10 μg) or formoterol (12 μg) versus placebo.Methods: We analyzed Holter ECG data from a representative subset of 775 patients with Global Initiative for Chronic Obstructive Lung Disease stage 2– 4 COPD from four studies (1222.11– 14) assessing olodaterol (5 μg and 10 μg) and formoterol (12 μg) versus placebo.Results: No statistically significant (P> 0.3) or clinically relevant differences in the shift from baseline of premature supraventricular or ventricular beats were observed among the active treatment and the placebo groups. Minor and transient differences were observed in the adjusted mean heart rate from baseline during treatment in all groups. There was a numerically small but statistically significant increase for formoterol at Week 24, olodaterol 5 μg at Weeks 12 and 40, and olodaterol 10 μg at Week 40 (all less than 3.0 beats per minute). Mean heart rates returned to a statistically non-significant change at Week 48 for all treatment groups. No increase in major adverse cardiovascular events was observed.Conclusion: Treatment with olodaterol or formoterol is not associated with arrhythmias or a persistent increase in heart rate as assessed by Holter ECG in patients with COPD.Trial Registration: ClinicalTrials.gov identifiers: NCT00782210 (1222.11); NCT00782509 (1222.12); NCT00793624 (1222.13); NCT00796653 (1222.14).Keywords: olodaterol, formoterol, arrhythmia, Holter ECG, heart rate

Additional file 1: Table S1 displays the baseline characteristics according to the blood eosinophils of patients in whom systemic steroids were administered only after the blood samples had been taken. Continuous parameters are displayed as Median and (IQR). Chi-Square test was performed to compare gender between the groups. For continuous parameters: Mann-Whitney test was calculated for two groups comparisons, Kruskal-Wallis test with Dunn’s test for three groups comparisons. * significant between 300; $ significant between 100 and 300 and > 300; § significant between 300; $ significant between 100 and 300 and > 300; § significant between 300; $ significant between 100 and 300 and > 300; § significant between 300; $ significant between 100 and 300 and > 300; § significant between

A recent editorial in the European Respiratory Journal highlighted the strategic importance of the Clinical Research Collaborations (CRCs) launched in 2013 by the European Respiratory Society (ERS) [1]. These have the aim of 1) promoting the exchange of research ideas among clinicians and affiliated scientists in Europe and/or globally; 2) building an infrastructure for prospective clinical research; 3) securing additional funding through national and European Union funding streams; and 4) facilitating the planning, implementation, evaluation and publication of clinical and translational studies at pan-European level and beyond. So far, there are currently 17 ongoing CRCs that cover eight major respiratory disease domains (airway diseases, interstitial lung diseases, pulmonary vascular diseases, sleep and breathing disorders, respiratory critical care, paediatric respiratory diseases, respiratory infections and thoracic oncology), all of them linked to one or more ERS assemblies [2–12]. CADSET, an acronym that stands for “Chronic Airway Diseases Early Stratification”, is the latest addition to the list of ongoing CRCs (www.ersnet.org/research/clinical-research-collaborations). This editorial presents the rationale, goals and research strategy for CADSET.

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Supplementary methods, results and discussion. (DOCX 225 kb)

difference and peripheral vascular disease: cross-sectional study. Fam Pract 2007;24:5420–6. [3] Clark CE, Taylor RS, Shore AC, Ukoumunne OC, Campbell JL. Association of a difference in systolic blood pressure between arms with vascular disease and mortality: a systematic review and meta-analysis. Lancet 2012;379:905–14. [4] Sun H, Li P, Su H, et al. The detection rates of inter-arm systolic blood pressure difference vary with blood pressure levels in hypertensive patients under antihypertensive therapy. Int J Cardiol Jan 1