Maggie Tabberer1, Sebastian Gonzalez-McQuire2,3, Hana Muellerova4, Andrew H Briggs5,3, Maureen P M H Rutten-van Mölken6, Mike Chambers7, David A Lomas8. 1. Value Evidence and Outcomes, GSK R&D, Stockley Park, UK (MT). 2. Formerly Global Health Outcomes, GSK R&D, Stockley Park, UK (SGM). 3. ICON Health Economics, Morristown, NJ, USA (AHB). 4. Worldwide Epidemiology, GSK R&D, Stockley Park, UK (HM). 5. Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK (AHB). 6. Institute for Medical Technology Assessment, Erasmus University/Erasmus Medical Centre, Rotterdam, The Netherlands (MPMHRvM). 7. MC Healthcare Evaluation, St Albans, UK (MC). 8. Wolfson Institute for Biomedical Research, University College London, London, UK (DAL).
Abstract
BACKGROUND: To develop and validate a new conceptual model (CM) of chronic obstructive pulmonary disease (COPD) for use in disease progression and economic modeling. The CM identifies and describes qualitative associations between disease attributes, progression and outcomes. METHODS: A literature review was performed to identify any published CMs or literature reporting the impact and association of COPD disease attributes with outcomes. After critical analysis of the literature, a Steering Group of experts from the disciplines of health economics, epidemiology and clinical medicine was convened to develop a draft CM, which was refined using a Delphi process. The refined CM was validated by testing for associations between attributes using data from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE). RESULTS: Disease progression attributes included in the final CM were history and occurrence of exacerbations, lung function, exercise capacity, signs and symptoms (cough, sputum, dyspnea), cardiovascular disease comorbidities, 'other' comorbidities (including depression), body composition (body mass index), fibrinogen as a biomarker, smoking and demographic characteristics (age, gender). Mortality and health-related quality of life were determined to be the most relevant final outcome measures for this model, intended to be the foundation of an economic model of COPD. CONCLUSION: The CM is being used as the foundation for developing a new COPD model of disease progression and to provide a framework for the analysis of patient-level data. The CM is available as a reference for the implementation of further disease progression and economic models.
BACKGROUND: To develop and validate a new conceptual model (CM) of chronic obstructive pulmonary disease (COPD) for use in disease progression and economic modeling. The CM identifies and describes qualitative associations between disease attributes, progression and outcomes. METHODS: A literature review was performed to identify any published CMs or literature reporting the impact and association of COPD disease attributes with outcomes. After critical analysis of the literature, a Steering Group of experts from the disciplines of health economics, epidemiology and clinical medicine was convened to develop a draft CM, which was refined using a Delphi process. The refined CM was validated by testing for associations between attributes using data from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE). RESULTS: Disease progression attributes included in the final CM were history and occurrence of exacerbations, lung function, exercise capacity, signs and symptoms (cough, sputum, dyspnea), cardiovascular disease comorbidities, 'other' comorbidities (including depression), body composition (body mass index), fibrinogen as a biomarker, smoking and demographic characteristics (age, gender). Mortality and health-related quality of life were determined to be the most relevant final outcome measures for this model, intended to be the foundation of an economic model of COPD. CONCLUSION: The CM is being used as the foundation for developing a new COPD model of disease progression and to provide a framework for the analysis of patient-level data. The CM is available as a reference for the implementation of further disease progression and economic models.
Authors: Afisi S Ismaila; Nancy Risebrough; Melanie Schroeder; Dhvani Shah; Alan Martin; Emma C Goodall; Kerigo Ndirangu; Gerard Criner; Mark Dransfield; David Mg Halpin; MeiLan K Han; David A Lomas Journal: Int J Chron Obstruct Pulmon Dis Date: 2019-11-29
Authors: Melanie Schroeder; Nicole Benjamin; Laura Atienza; Chandroday Biswas; Alan Martin; John D Whalen; José Luis Izquierdo Alonso; Juan Antonio Riesco Miranda; Juan José Soler-Cataluña; Alicia Huerta; Afisi S Ismaila Journal: Int J Chron Obstruct Pulmon Dis Date: 2020-07-10
Authors: Mafalda Ramos; Mark Lamotte; Laetitia Gerlier; Per Svangren; Anna Miquel-Cases; John Haughney Journal: Int J Chron Obstruct Pulmon Dis Date: 2019-01-15
Authors: M T Driessen; J Whalen; B Seewoodharry Buguth; L A Vallejo-Aparicio; I P Naya; Y Asukai; B Alcázar-Navarrete; M Miravitlles; F García-Río; N A Risebrough Journal: Respir Res Date: 2018-11-20