Sarah Wilke1, Paul W Jones2, H Müllerova3, Jørgen Vestbo4, Ruth Tal-Singer5, Frits M E Franssen1, Alvar Agusti6, Per Bakke7, Peter M Calverley8, Harvey O Coxson9, Courtney Crim10, Lisa D Edwards10, David A Lomas11, William MacNee12, Stephen I Rennard13, Julie C Yates10, Emiel F M Wouters14, Martijn A Spruit15. 1. Department of Research & Education, CIRO+, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands. 2. Division of Clinical Science, St George's University of London, London, UK. 3. Respiratory Epidemiology, GlaxoSmithKline, Uxbridge, UK. 4. Department of Respiratory Medicine, Gentofte Hospital Hellerup, Gentofte, Denmark Research Group, Manchester Academic Health Sciences Centre, University Hospital South Manchester NHS Foundation, Manchester, UK. 5. Research and Development, GlaxoSmithKline, King of Prussia, UK. 6. Thorax Institute, Hospital Clinic, IDIBAPS, Universitat de Barcelona and CIBER Enfermedades Respiratorias (CIBERES), Barcelona, Spain. 7. Department of Thoracic Medicine, Institute of Clinical Science, University of Bergen, Haukeland University Hospital, Bergen, Norway. 8. Division of Infection and Immunity Clinical Sciences Centre, University Hospital Aintree, Liverpool, UK. 9. Department of Radiology, Vancouver General Hospital, University of British Columbia, Vancouver, Canada. 10. GlaxoSmithKline, Research Triangle Park, North Carolina, USA. 11. Wolfson Institute for Biomedical Research, University College London, London, UK. 12. MRC Centre for Inflammation Research, The Queen's Medical Research Institute, University of Edinburgh, Edingburgh, UK. 13. Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center, Omaha, USA. 14. Department of Research & Education, CIRO+, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands Department of Respiratory Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands. 15. Department of Research & Education, CIRO+, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands Faculty of Medicine and Life Sciences, REVAL-Rehabilitation Research Center, BIOMED-Biomedical Research Institute, Hasselt University, Diepenbeek, Belgium.
Abstract
BACKGROUND: Poor health status has been associated with morbidity and mortality in patients with COPD. To date, the impact of changes in health status on these outcomes remains unknown. AIMS: To explore the relationship of clinically relevant changes in health status with exacerbation, hospitalisation or death in patients with COPD. METHODS: Characteristics and health status (St George's Respiratory Questionnaire, SGRQ) were assessed over a period of 3 years in 2138 patients with COPD enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study: a longitudinal, prospective, observational study. Associations between change in health status (=4 units in SGRQ score) during year 1 and time to first exacerbation, hospitalisation and death during 2-year follow-up were assessed using Kaplan-Meier plots and log-rank test. RESULTS: 1832 (85.7%) patients (age 63.4±7.0 years, 65.4% male, FEV1 48.7±15.6% predicted) underwent assessment at baseline and 1 year. Compared with those who deteriorated, patients with improved or stable health status in year 1 have a lower likelihood of exacerbation (HR 0.78 (95% CI 0.67 to 0.89), p<0.001 and 0.84 (0.73 to 0.97), p=0.016, respectively), hospitalisation (0.72 (0.58 to 0.90), p=0.004 and 0.77 (0.62 to 0.96), p=0.023, respectively) or dying (0.61 (0.39 to 0.95), p=0.027 and 0.58 (0.37 to 0.92), p=0.019, respectively) during 2-year follow-up. This effect persisted after stratification for age and the number of exacerbations and hospitalisations during the first year of the study. CONCLUSIONS: Patients with stable or improved health status during year 1 of ECLIPSE had a lower likelihood of exacerbation, hospitalisation or dying during 2-year follow-up. Interventions that stabilise and improve health status may also improve outcomes in patients with COPD. TRIAL REGISTRATION NUMBER: NCT00292552, registered at ClinicalTrials.gov. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
BACKGROUND: Poor health status has been associated with morbidity and mortality in patients with COPD. To date, the impact of changes in health status on these outcomes remains unknown. AIMS: To explore the relationship of clinically relevant changes in health status with exacerbation, hospitalisation or death in patients with COPD. METHODS: Characteristics and health status (St George's Respiratory Questionnaire, SGRQ) were assessed over a period of 3 years in 2138 patients with COPD enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study: a longitudinal, prospective, observational study. Associations between change in health status (=4 units in SGRQ score) during year 1 and time to first exacerbation, hospitalisation and death during 2-year follow-up were assessed using Kaplan-Meier plots and log-rank test. RESULTS: 1832 (85.7%) patients (age 63.4±7.0 years, 65.4% male, FEV1 48.7±15.6% predicted) underwent assessment at baseline and 1 year. Compared with those who deteriorated, patients with improved or stable health status in year 1 have a lower likelihood of exacerbation (HR 0.78 (95% CI 0.67 to 0.89), p<0.001 and 0.84 (0.73 to 0.97), p=0.016, respectively), hospitalisation (0.72 (0.58 to 0.90), p=0.004 and 0.77 (0.62 to 0.96), p=0.023, respectively) or dying (0.61 (0.39 to 0.95), p=0.027 and 0.58 (0.37 to 0.92), p=0.019, respectively) during 2-year follow-up. This effect persisted after stratification for age and the number of exacerbations and hospitalisations during the first year of the study. CONCLUSIONS:Patients with stable or improved health status during year 1 of ECLIPSE had a lower likelihood of exacerbation, hospitalisation or dying during 2-year follow-up. Interventions that stabilise and improve health status may also improve outcomes in patients with COPD. TRIAL REGISTRATION NUMBER: NCT00292552, registered at ClinicalTrials.gov. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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