Derivation and Definitions of Clinical Study Variables for Multiple Long Term Conditions in Patients with Chronic Obstructive Pulmonary Disease: Protocol for a Modified Delphi Methods and Consensus Study on Behalf of the International Cardiovascular and Respiratory Alliance

Tobin Joseph,1– 3 Mohit Bhutani,4 Amy Couper,5,6 Rachel Pullen,5 Ramesh Nadarajah,1– 3 Luis Alves,7,8 Maria Felicia Montero-Arias,9,10 Riyad Al-Lehebi,11,12 David D Berg,13 Nathaniel M Hawkins,14 John R Hurst,15 Christine R Jenkins,16,17 Alan Kaplan,5,18,19 Janwillem WH Kocks,5,20– 22 Konstantinos Kostikas,5,23 Carolyn S P Lam,24 Therese S Lapperre,25,26 Chin Kook Rhee,27 Naveed Sattar,28 Daiana Stolz,29 Gary Tse,30,31 Tonya Winders,32 David Price,5,6,33 Chris P Gale1– 3 1Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK; 2Leeds Institute for Data Analytics, University of Leeds, Leeds, UK; 3Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 4Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; 5Observational and Pragmatic Research Institute, Singapore, Singapore; 6Optimum Patient Care Global, Cambridge, UK; 7EPI Unit, Institute of Public Health, University of Porto, Porto, Portugal; 8Laboratory for Integrative and Translational Research in Population Health (ITR), Porto, Portugal; 9Department of Respiratory Medicine, Hospital México, San José, 10107, Costa Rica; 10Hospital Clínica Bíblica, Calle Central Alfredo Volio, San José, 10101, Costa Rica; 11Department of Pulmonology, King Fahad Medical City, Riyadh, Saudi Arabia; 12College of Medicine, Alfaisal University, Riyadh, Saudi Arabia; 13Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; 14Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, Canada; 15UCL Respiratory, University College London, London, UK; 16Head Respiratory Group, The George Institute, Randwick, NSW, Australia; 17University of New South Wales (UNSW), Sydney, Australia; 18Family Physician Airways Group of Canada, Stouffville, Ontario, Canada; 19University of Toronto, Toronto, Canada; 20General Practitioners Research Institute, Groningen, The Netherlands; 21Groningen Research Institute Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; 22Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; 23Respiratory Medicine Department, University of Ioannina, Ioannina, Greece; 24National Heart Centre Singapore in Singapore, Duke-National University of Singapore (C.S.P.L), Singapore; 25Translational Research in Immunology and Inflammation, Laboratory of Experimental Medicine and Pediatrics, University of Antwerp, Antwerp, Belgium; 26Department of Pneumology, Antwerp University Hospital, Edegem, Belgium; 27Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, South Korea; 28School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK; 29Clinic of Respiratory Medicine and Faculty of Medicine, University of Freiburg, Freiburg, Germany; 30School of Nursing and Health Sciences, Hong Kong Metropolitan University, Hong Kong, People’s Republic of China; 31Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, People’s Republic of China; 32Global Allergy & Airways Patient Platform, Vienna, Austria; 33Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UKCorrespondence: Tobin Joseph, Email t.joseph@leeds.ac.ukBackground: Standardized variables and their definitions are essential for robust delivery and reporting of clinical studies and quality improvement in chronic obstructive pulmonary disease (COPD). This protocol describes the rationale and methodology for the derivation and definition of clinical study variables for patients with multimorbidity or at high risk of multimorbidity in COPD.Methods and Analysis: We will follow a four-step process. This will include the formation of an Executive Committee, a Steering Committee and an International Consensus Group. We will conduct a systematic review of the literature from which potential clinical study variables will be extracted and their definitions proposed. Using a modified Delphi process, the Steering Committee will select candidate clinical study variables and as necessary refine their definitions. All three groups will then vote and give feedback on the candidate clinical study variables in a modified Delphi process (with rounds until consensus is achieved) to reach a final suite of internationally agreed hierarchically classified clinical study variables.Ethics and Dissemination: It is anticipated that the results will be published in a peer-reviewed journal and presented in a variety of forums. Ethical approval was not required for this study.Keywords: COPD, data standards, registry, quality improvement, randomized clinical trial, outcomes, multimorbidity

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