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      St George’s Respiratory Questionnaire Score Predicts Outcomes in Patients with COPD: Analysis of Individual Patient Data in the COPD Biomarkers Qualification Consortium Database

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          Abstract

          Background: We aimed to estimate the usefulness of a disease specific health status measure, the St George’s Respiratory Questionnaire (SGRQ), to predict outcomes in patients with chronic obstructive pulmonary disease (COPD).

          Methods: Individual patient-data of 12043 patients from long-term randomized clinical trials (2-4 years’ duration) in the COPD Biomarkers Qualification Consortium database were analyzed. The adverse COPD outcomes were: exacerbations of COPD, hospital admissions due to exacerbation and all-cause mortality. Cox proportional hazards regression was used to calculate adjusted hazard ratios (HR) and 95% confidence intervals (CIs) for quartiles of SGRQ scores at baseline and time to first event, and time from first to second event, where appropriate.

          Results: The risk of adverse COPD outcomes increased with each increasing quartile of SGRQ score for all time to first event analyses. When comparing the lowest versus the highest quartile, the event risk (HRs [95% CIs]) increased by 40% for exacerbations (1.40 [1.29, 1.51]); 2-fold for hospital admissions (2.01 [1.78, 2.28]) and more than 2-fold for all-cause mortality (2.30 [1.91, 2.78]). For second event analyses in a subset of eligible patients, these trends persisted albeit with reduced risk estimates for exacerbations.

          Conclusions: Among patients with COPD, health status measured by a SGRQ score predicted exacerbations of COPD, hospital admissions due to exacerbations and their recurrence and death after adjustment. These data support the rationale for a health status measure use as a drug development tool and suggest that a health status measure may also have a role in risk assessment for COPD patients in routine medical care.

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          Author and article information

          Journal
          Chronic Obstr Pulm Dis
          Chronic Obstr Pulm Dis
          Chronic Obstr Pulm Dis
          Chronic Obstructive Pulmonary Diseases
          COPD Foundation Inc (Miami, USA )
          2372-952X
          2017
          28 March 2017
          : 4
          : 2
          : 141-149
          Affiliations
          [1]Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom
          [2]Evidera, Bethesda, Maryland
          [3]Research and Development, AstraZeneca, Gothenburg, Sweden
          [4]Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
          [5]Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha
          [6]AstraZeneca, Cambridge, United Kingdom
          [7]Respiratory Therapy Area Unit, Research and Development, GlaxoSmithKline, King of Prussia, Pennsylvania
          [8]COPD Foundation, Washington, D.C.
          [9]Institute of Infection and Immunity, St George’s University of London, United Kingdom
          Author notes
          [ Address correspondence to: Hana Müllerová, PhD ] Respiratory Epidemiology Research and Development GlaxoSmithKline Stockley Park West 1-3 Ironbridge Road Uxbridge, Middlesex, UB11 1BT United Kingdom hana.x.muellerova@ 123456gsk.com

          The authors would like to thank Debbie Merrill, COPD Foundation, for managing the review process, and the CBQC for their role in aggregating the data. They would also like to thank Tom Martin of Novartis and Katja Rüdell of Pfizer for their review and oversight through the CBQC Steering Committee, and Pfizer for supporting the CBQC.

          HM, VSB, MT, RTS, PWJ, NK, SM and SIR are employees of the pharma companies who funded this analysis. SIR is an employee of the University of Nebraska Medical Center. HG and HW participated in this project as employees of Evidera, a company which performs work for hire for multiple pharmaceutical and device companies in outcomes research, and were funded by the CBQC consortium. DM has nothing to declare.

          Article
          PMC5559113 PMC5559113 5559113
          10.15326/jcopdf.4.2.2017.0131
          5559113
          28848923
          d3429866-c08d-4ad7-bc68-12e08a7f0633
          JCOPDF © 2017
          History
          : 1 February 2017
          Funding
          Funding for this COPD Biomarkers Qualification Consortium working group was provided by AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, Novartis and Pfizer.
          Categories
          Original Research

          COPD outcomes,SGRQ,St George’s Respiratory Questionnaire,CBQC,COPD Biomarkers Qualification Consortium,predictive validity

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