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Introduction: Optimal treatment for 'potentially resectable' stage III-N2 non-small cell lung cancer (NSCLC) requires multimodality treatment: local treatment (surgery or radiotherapy) and systemic anticancer therapy. There is no clear evidence of superiority for survival between the two approaches and little research has explored quality of life (QOL). This study will inform the design of a phase III randomised trial of surgery versus no surgery as part of multimodality treatment for stage III-N2 NSCLC with QOL as a primary outcome., Methods and Analysis: Patient participants will be randomised to receive multimodality treatment (1) with surgery OR (2) without surgery. The Quintet Recruitment Intervention will be used to maximise recruitment. Eligible patients will have 'potentially resectable' N2 NSCLC and have received a multidisciplinary team recommendation for multimodality treatment. Sixty-six patients and their carers will be recruited from 8 UK centres. Patient/carer QOL questionnaires will be administered at baseline, weeks 6, 9, 12 and month 6. Semistructured interviews will be conducted. Quantitative data will be analysed descriptively and qualitative data will be analysed using framework analysis., Ethics and Dissemination: Ethical approval has been obtained. Results will be disseminated via publications, national bodies and networks, and patient and public involvement groups., Trial Registration: NCT04540757., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Rationale: Effective cough treatments are a significant unmet need in patients with lung cancer. Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors, a mechanism also implicated in cough. Objectives: To assess aprepitant in patients with lung cancer with cough and evaluate mechanisms in vagal nerve tissue. Methods : Randomized double-blind crossover trial of patients with lung cancer and bothersome cough. They received 3 days of aprepitant or matched placebo; after a 3-day washout, patients crossed to the alternative treatment. The primary endpoint was awake cough frequency measured at screening and Day 3 of each treatment; secondary endpoints included patient-reported outcomes. In vitro , the depolarization of isolated guinea pig and human vagus nerve sections in grease-gap recording chambers, indicative of sensory nerve activation, was measured to evaluate the mechanism. Measurements and Main Results: Twenty patients with lung cancer enrolled, with a mean age 66 years (±7.7); 60% were female and 80% had non-small cell cancer, 50% had advanced stage, and 55% had World Health Organization performance status 1. Cough frequency improved with aprepitant, reducing by 22.2% (95% confidence interval [CI], 2.8-37.7%) over placebo while awake ( P  = 0.03), 30.3% (95% CI, 12.7-44.3) over 24 hours ( P  = 0.002), and 59.8% (95% CI, 15.1-86.0) during sleep ( P  = 0.081). Patient-reported outcomes all significantly improved. Substance P depolarized both guinea pig and human vagus nerve. Aprepitant significantly inhibited substance P-induced depolarization by 78% in guinea pig ( P  = 0.0145) and 94% in human vagus ( P  = 0.0145). Conclusions: Substance P activation of NK-1 receptors appears to be an important mechanism driving cough in lung cancer, and NK-1 antagonists show promise as antitussive therapies.

Health-related quality of life (HRQoL) scores assess symptom burden in pulmonary arterial hypertension (PAH) but data regarding their role in prognostication and risk stratification are limited. We assessed these relationships using the emPHasis-10 HRQoL measure.1745 patients with idiopathic PAH (IPAH), drug-induced PAH (DPAH), heritable PAH (HPAH) (collectively "(I/D/H)PAH"), or connective tissue disease-associated PAH (CTD-PAH), who had completed emPHasis-10 questionnaires at one of six UK referral centres between 2014 and 2017, were identified. Correlations with exercise capacity and World Health Organization (WHO) functional class were assessed, and exploratory risk stratification thresholds were tested.Moderate correlations were seen between emPHasis-10 scores and 6-min walk distance (r=-0.546), incremental shuttle walk distance (r=-0.504) and WHO functional class (r=0.497) (all p<0.0001). Distribution of emPHasis-10 score differed significantly between each WHO functional class (all p<0.0001). On multivariate analysis, emPHasis-10 score, but not WHO functional class, was an independent predictor of mortality. In a risk stratification approach, scores of 0-16, 17-33 and 34-50 identified incident patients with 1-year mortality of 5%, 10% and 23%, respectively. Survival of patients in WHO functional class III could be further stratified using an emPHasis-10 score ≥34 (p<0.01). At follow-up, patients with improved emPHasis-10 scores had improved exercise capacity (p<0.0001) and patients who transitioned between risk groups demonstrated similar survival to patients originally in those risk groups.The emPHasis-10 score is an independent prognostic marker in patients with (I/D/H)PAH or CTD-PAH. It has utility in risk stratification in addition to currently used parameters. Improvement in emPHasis-10 score is associated with improved exercise capacity., Competing Interests: Conflict of interest: R.A. Lewis reports non-financial support for meeting attendance from Actelion Pharmaceuticals, outside the submitted work. Conflict of interest: I. Armstrong has nothing to disclose. Conflict of interest: C. Bergbaum has nothing to disclose. Conflict of interest: M.J. Brewis has nothing to disclose. Conflict of interest: J. Cannon has nothing to disclose. Conflict of interest: A. Charalampopoulos reports grants, personal fees and non-financial support from Actelion Pharmaceuticals, personal fees and non-financial support from Novartis, and grants from Bayer and GSK, outside the submitted work. Conflict of interest: A.C. Church has nothing to disclose. Conflict of interest: J.G. Coghlan has nothing to disclose. Conflict of interest: R.J. Davies has nothing to disclose. Conflict of interest: K. Dimopoulos has nothing to disclose. Conflict of interest: C. Elliot reports personal fees for advisory board work and lectures from Actelion Pharmaceuticals, GlaxoSmithKline and Bayer, as well as grants from Pfizer, Actelion Pharmaceuticals and Bayer, outside the submitted work. Conflict of interest: J.S.R. Gibbs reports personal fees from Acceleron, Arena, Bayer, Complexa, Pfizer and GSK, as well as grants and personal fees from Actelion and United Therapeutics, outside the submitted work. Conflict of interest: W. Gin-Sing has nothing to disclose. Conflict of interest: G. Haji has nothing to disclose. Conflict of interest: A.G. Hameed has nothing to disclose. Conflict of interest: L.S. Howard has nothing to disclose. Conflict of interest: M.K. Johnson reports grants and personal fees for meeting attendance, lectures and advisory board work from Actelion and MSD, outside the submitted work. Conflict of interest: A. Kempny has nothing to disclose. Conflict of interest: D.G. Kiely reports grants, personal fees and non-financial support from Actelion, Bayer and GSK, as well as personal fees and non-financial support from MSD, outside the submitted work. Conflict of interest: F. Lo Giudice has nothing to disclose. Conflict of interest: C. McCabe has nothing to disclose. Conflict of interest: A.J. Peacock has nothing to disclose. Conflict of interest: O. Peleyeju has nothing to disclose. Conflict of interest: J. Pepke-Zaba has nothing to disclose. Conflict of interest: G. Polwarth has nothing to disclose. Conflict of interest: L. Price reports educational grants from Actelion J&J, during the conduct of the study. Conflict of interest: I. Sabroe reports grants and personal fees for advisory board work from AstraZeneca, as well as grants from GSK, outside the submitted work. Conflict of interest: B.E. Schreiber has nothing to disclose. Conflict of interest: K. Sheares reports educational support from Actelion, Bayer and GSK, as well as personal fees for lectures and consultancy from Actelion, outside the submitted work. Conflict of interest: D. Taboada reports fees for lectures and education and travel grants from Actelion, Bayer, GlaxoSmithKline, Lilly, MDS and Pfizer, outside the submitted work. Conflict of interest: A.A.R. Thompson reports grants from the British Heart Foundation (Intermediate Clinical Fellowship FS/18/13/3328), during the conduct of the study, as well as non-financial support for travel to meetings from Actelion Pharmaceuticals Ltd, outside the submitted work. Conflict of interest: M.R. Toshner has nothing to disclose. Conflict of interest: I. Wanjiku has nothing to disclose. Conflict of interest: S.J. Wort has nothing to disclose. Conflict of interest: J. Yorke has nothing to disclose. Conflict of interest: R. Condliffe reports grants, personal fees and non-financial support from Actelion Pharmaceuticals and Bayer, as well as grants from GSK, outside the submitted work., (Copyright ©ERS 2021.)

Rationale: The evidence base for rehabilitation in pulmonary hypertension is expanding, but adoption in clinical practice is limited. Objectives: The World Health Organization International Classification for Functioning, Disability and Health identifies three health domains: Body Functions/Structures, Activity and Participation in society. To ensure that the wider impact of rehabilitation in pulmonary hypertension is accurately assessed, it is important that study endpoints reflect all three domains. Methods: A systematic review of the literature was conducted to identify studies of rehabilitation in patients with pulmonary hypertension from 2006 to 2019. Results: Searches across five databases yielded 2,564 articles, of which 34 met eligibility criteria; 50 different outcome measures (mean = 5, minimum = 1, maximum = 9) were identified. When mapped onto the World Health Organization International Classification for Functioning, Disability and Health, 48% of instances of outcome usage were measures of Body Functions/Structure, 33% were measures of Activity, and 18% were measures of Participation. Measures of Participation were not included in seven studies (21%). Conclusions: Studies of rehabilitation in pulmonary hypertension have focused primarily on measures of Body Functions/Structure; the impact in other health domains is not well characterized. Greater inclusion of outcome measures reflecting Activity and Participation in society is needed to allow assessment of the wider impact of rehabilitation in patients with pulmonary hypertension.

Objective: To explore the needs of children and their families after a child's traumatic injury., Design: Semi-structured qualitative interviews with purposeful sampling for different types of injuries and a theoretical thematic analysis., Participants: 32 participants; 13 children living at home after a traumatic injury, their parents/guardians (n=14) and five parents whose injured child did not participate., Setting: Two Children's Major Trauma Centres (hospitals) in England., Results: Interviews were conducted a median 8.5 months (IQR 9.3) postinjury. Injuries affected the limbs, head, chest, abdomen, spine or multiple body parts. Participants highlighted needs throughout their recovery (during and after the hospital stay). Education and training were needed to help children and families understand and manage the injury, and prepare for discharge. Information delivery needed to be timely, clear, consistent and complete, include the injured child, but take into account individuals' capacity to absorb detail. Similarly, throughout recovery, services needed to be timely and easily accessible, with flexible protocols and eligibility criteria to include injured children. Treatment (particularly therapy) needed to be structured, goal directed and of sufficient frequency to return injured children to their full function. A central point of contact is required after hospital discharge for advice, reassurance and to coordinate ongoing care. Positive partnerships with professionals helped injured children and their families maintain a sense of hope and participate in joint decision making about their care., Conclusion: Throughout the full trajectory of recovery injured children and their families need family centred, accessible, flexible, coordinated health services, with more effective harmonious, communication between professionals, the child and their family. There is a requirement for support from a single point of contact and a system that monitors the needs of the injured child and their family after hospital discharge., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Conflict of interest: A.G. Mathioudakis reports grants from Boehringer Ingelheim outside the submitted work. Conflict of interest: F. Abroug has nothing to disclose. Conflict of interest: A. Agusti reports personal fees from AstraZeneca, grants and personal fees from Menarini, personal fees from Chiesi, grants and personal fees from GSK, and personal fees from Nuvaira, outside the submitted work. Conflict of interest: P. Bakke reports personal fees from GlaxoSmithKline, Chiesi, AstraZeneca and Boehringer Ingelheim outside the submitted work. Conflict of interest: K. Bartziokas has nothing to disclose. Conflict of interest: B. Beghe has nothing to disclose. Conflict of interest: A. Bikov has nothing to disclose. Conflict of interest: T. Bradbury reports being the recipient of an ongoing 3-year top-up scholarship funded by GlaxoSmithKline. Conflict of interest: G. Brusselle reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Teva, outside the submitted work. Conflict of interest: C. Cadus reports support from AstraZeneca and Mundipharma, outside the submitted work. Conflict of interest: C. Coleman is an employee of the European Lung Foundation. Conflict of interest: M. Contoli reports grants from Chiesi, personal fees from Chiesi, AstraZeneca, Boehringer Ingelheim, ALK-Abello, Novartis and Zambon, and grants from University of Ferrara, outside the submitted work. Conflict of interest: A. Corlateanu has nothing to disclose. Conflict of interest: O. Corlateanu has nothing to disclose. Conflict of interest: G. Criner has nothing to disclose. Conflict of interest: B. Csoma has nothing to disclose. Conflict of interest: A. Emelyanov has nothing to disclose. Conflict of interest: R. Faner reports grants from GSK and Menarini outside the submitted work. Conflict of interest: G. Fernandez Romero has nothing to disclose. Conflict of interest: Z. Hammouda has nothing to disclose. Conflict of interest: P. Horváth has nothing to disclose. Conflict of interest: A. Huerta Garcia has nothing to disclose. Conflict of interest: M. Jacobs has nothing to disclose. Conflict of interest: C. Jenkins has nothing to disclose. Conflict of interest: G. Joos reports grants and personal fees from AstraZeneca, personal fees from Bayer, grants from Chiesi, personal fees from Eureca vzw, grants and personal fees from GlaxoSmithKline and personal fees from Teva, outside the submitted work; these grants and fees were paid to his institution. Conflict of interest: O. Kharevich has nothing to disclose. Conflict of interest: K. Kostikas reports grants, personal fees and nonfinancial support from AstraZeneca, Boehringer Ingelheim, Chiesi, ELPEN, GSK, Menarini and Novartis, grants from NuvoAir, and personal fees from Sanofi, outside the submitted work; and was an employee and shareholder of Novartis Pharma AG until 31 October 2018. Conflict of interest: E. Lapteva has nothing to disclose. Conflict of interest: Z. Lazar has nothing to disclose. Conflict of interest: J.D. Leuppi has nothing to disclose. Conflict of interest: C. Liddle has nothing to disclose. Conflict of interest: A. López-Giraldo has nothing to disclose. Conflict of interest: V.M. McDonald reports grants and personal fees from GSK and AstraZeneca, and personal fees from Menarini, outside the submitted work. Conflict of interest: R. Nielsen reports grants and personal fees from AstraZeneca and Boehringer Ingelheim, grants from Novartis, and grants and personal fees from GlaxoSmithKline, outside the submitted work. Conflict of interest: A. Papi reports grants, personal fees, nonfinancial support and other from GlaxoSmithKline; grants, personal fees and nonfinancial support from AstraZeneca; grants, personal fees, nonfinancial support and other from Boehringer Ingelheim; grants, personal fees, nonfinancial support and other from Chiesi Farmaceutici; grants, personal fees, nonfinancial support and other from TEVA; personal fees, non-financial support and other from Mundipharma; personal fees, non-financial support and other from Zambon; personal fees, non-financial support and other from Novartis; grants, personal fees and non-financial support from Menarini; personal fees, non-financial support and other from Sanofi/Regeneron; personal fees from Roche; grants from Fondazione Maugeri; grants from Fondazione Chiesi; and personal fees from Edmondpharma, all outside the submitted work. Conflict of interest: I. Saraiva has nothing to disclose. Conflict of interest: G. Sergeeva has nothing to disclose. Conflict of interest: A. Sioutkou has nothing to disclose. Conflict of interest: P. Sivapalan reports personal fees from Boehringer Ingelheim outside the submitted work. Conflict of interest: E. Stovold has nothing to disclose. Conflict of interest: H. Wang has nothing to disclose. Conflict of interest: F. Wen has nothing to disclose. Conflict of interest: J. Yorke has nothing to disclose. Conflict of interest: P.R. Williamson has nothing to disclose. Conflict of interest: J. Vestbo reports personal fees from AstraZeneca, grants and personal fees from Boehringer-Ingelheim, personal fees from Chiesi, personal fees from GSK, and personal fees from Novartis, outside the submitted work; and his son is an employee of Chiesi. Conflict of interest: J-U. Jensen has nothing to disclose., (Copyright ©ERS 2020.)

Objectives: To better understand the current strategies employed to manage patient agitation by capturing the views and opinions of the multi-disciplinary team within general Adult Critical Care Units in the UK., Research Methodology: Web-based questionnaire survey., Setting: General Adult Critical Care Units in one region of the United Kingdom MAIN OUTCOME: The online survey was circulated to approximately 900 members of staff at eight sites in the UK. The online survey was accessed by 239 (26.5%) clinicians, 163 (18.1%) completed the first two screening questions rendering them valid for inclusion. For those who responded, 98.5% acknowledge the increased risk of harm in the presence of agitation. Additionally, 76.3% felt the management of agitated patients could be improved. Many participants felt equipped in the recognition of delirium and agitation but did not feel they had the knowledge to support decision-making around acute agitation management. There is concern about the use of physical restraint and the over-reliance on sedation. There appears to be inconsistent care delivery exacerbated by staff rotational changes., Conclusion: There are valid concerns raised surrounding the legality of physical restraint and what level of restrictive action is permissible. Currently, we have no robust evidence to determine the effectiveness of one intervention to prevent treatment interruption over another. There is a need to explore the clinical decision-making process that underpins the care of a patient experiencing agitation in Adult Critical Care., (Crown Copyright © 2019. Published by Elsevier Ltd. All rights reserved.)

Combined exercise rehabilitation for chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) is potentially attractive. Uncertainty remains as to the baseline profiling assessments and outcome measures that should be collected within a programme. Current evidence surrounding outcome measures in cardiac and pulmonary rehabilitation were presented by experts at a stakeholder consensus event and all stakeholders ( n = 18) were asked to (1) rank in order of importance a list of categories, (2) prioritise outcome measures and (3) prioritise baseline patient evaluation measures that should be assessed in a combined COPD and CHF rehabilitation programme. The tasks were completed anonymously and related to clinical rehabilitation programmes and associated research. Health-related quality of life, exercise capacity and symptom evaluation were voted as the most important categories to assess for clinical purposes (median rank: 1, 2 and 3 accordingly) and research purposes (median rank; 1, 3 and 4.5 accordingly) within combined exercise rehabilitation. All stakeholders agreed that profiling symptoms at baseline were 'moderately', 'very' or 'extremely' important to assess for clinical and research purposes in combined rehabilitation. Profiling of frailty was ranked of the same importance for clinical purposes in combined rehabilitation. Stakeholders identified a suite of multidisciplinary measures that may be important to assess in a combined COPD and CHF exercise rehabilitation programme.

Background: Dyspnoea-12 is a valid and reliable scale to assess dyspneic symptom, considering its severity, physical and emotional components. However, it is not available in Italian version due to it was not yet translated and validated. For this reason, the aim of this study was to develop an Italian version Dyspnoea-12, providing a cultural and linguistic validation, supported by the quantitative and qualitative content validity., Methods: This was a methodological study, divided into two phases: phase one is related to the cultural and linguistic validation, phase two is related to test the quantitative and qualitative content validity. Linguistic validation followed a standardized translation process. Quantitative content validity was assessed computing content validity ratio (CVR) and index (I-CVIs and S-CVI) from expert panellists response. Qualitative content validity was assessed by the narrative analysis on the answers of three open-ended questions to the expert panellists, aimed to investigate the clarity and the pertinence of the Italian items., Results: The translation process found a good agreement in considering clear the items in both the six involved bilingual expert translators and among the ten voluntary involved patients. CVR, I-CVIs and S-CVI were satisfactory for all the translated items., Conclusions: This study has represented a pivotal step to use Dyspnoea-12 amongst Italian patients. Future researches are needed to deeply investigate the Italian version of  Dyspnoea-12 construct validity and its reliability, and to describe how dyspnoea components (i.e. physical and emotional) impact the life of patients with cardiorespiratory diseases.

Introduction: The National Health Service currently faces significant challenges and must optimise effective workforce planning and management. There are increasing concerns regarding poor workforce planning for respiratory medicine; a greater understanding of the role of respiratory nurse specialists will inform better workforce planning and management., Methods: This was a survey study. Two surveys were administered: an organisational-level survey and an individual respiratory nurse survey., Results: There were 148 and 457 respondents to the organisational and individual nurse survey, respectively. Four main themes are presented: (1) breadth of service provided; (2) patient care; (3) work environment; and (4) succession planning. The majority of work conducted by respiratory nurse specialists relates to patient care outside the secondary care setting including supporting self-management in the home, supporting patients on home oxygen, providing hospital-at-home services and facilitating early discharge from acute care environments. Yet, most respiratory nursing teams are employed by secondary care trusts and located within acute environments. There was evidence of multidisciplinary working, although integrated care was not prominent in the free-text responses. High workload was reported with one-quarter of nursing teams short-staffed. Respiratory nurses reported working unpaid extra hours and a lack of administrative support that often took them away from providing direct patient care. Nearly half of the present sample either plan to retire or are eligible for retirement within 10 years., Conclusions: This survey report provides a current snapshot of the respiratory nurse specialist workforce in the UK. This workforce is an ageing population; the results from this survey can be used to inform succession planning and to ensure a viable respiratory nurse specialist workforce in future., Competing Interests: Competing interests: Most of the authors known to me have worked alongside most for many years.

The aim of this study was to develop a measure of the impact of pulmonary hypertension (PH) on health-related quality of life (HRQoL) as there is a need for a short, validated instrument that can be used in routine clinical practice. Interviews were conducted with 30 PH patients to derive 32 statements, which were presented as a semantic differential six-point scale (0-5), with contrasting adjectives at each end. This item list was completed by patients attending PH clinics across the UK and Ireland. Rasch analysis was applied to identify items fitting a uni-dimensional model. 226 patients (mean age 55.6±14 years; 70% female) with PH (82% had pulmonary arterial hypertension) completed the study questionnaires. 10 of the 32 items demonstrated fit to the Rasch model (Chi-squared 16; p>0.05) and generated the emPHasis-10 questionnaire. Test-retest (intraclass correlation coefficient 0.95, n=33) and internal consistency (Chronbach's α=0.9) were strong. emPHasis-10 scores correlated consistently with other relevant measures and discriminated subgroups of patients stratified by World Health Organization functional class (ANOVA F=1.73; p<0.001). The emPHasis-10 is a short questionnaire for assessing HRQoL in pulmonary arterial hypertension. It has excellent measurement properties and is sensitive to differences in relevant clinical parameters. It is freely available for clinical and academic use.