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. 2017 Mar 13;4(2):112-123.
doi: 10.15326/jcopdf.4.2.2017.0128.

The COPD Biomarkers Qualification Consortium Database: Baseline Characteristics of the St George's Respiratory Questionnaire Dataset

Maggie Tabberer  1 , Victoria S Benson  1 , Heather Gelhorn  2 , Hilary Wilson  2 , Niklas Karlsson  3 , Hana Müllerova  1 , Shailendra Menjoge  4 , Stephen I Rennard  5   6 , Ruth Tal-Singer  7 , Debora Merrill  8 , Paul W Jones  1   9
Affiliations

The COPD Biomarkers Qualification Consortium Database: Baseline Characteristics of the St George's Respiratory Questionnaire Dataset

Maggie Tabberer et al. Chronic Obstr Pulm Dis. .

Abstract

The COPD Biomarkers Qualification Consortium (CBQC) is a public-private partnership formed in 2010 with a goal of qualifying biomarkers and clinical assessment tools for use in clinical or nonclinical decision-making and particularly within the regulatory context. The St George's Respiratory Questionnaire (SGRQ) is a measure of health-related quality of life widely used in clinical research. The aim of the CBQC working group on SGRQ was to construct an individual patient level database of clinical trial data that included the SGRQ, to use this to confirm the reliability and validity of the SGRQ as an outcome measure of health status, and investigate its use as a predictor of future events (exacerbations and mortality). This manuscript describes the formulation of the CBQC database and presents the baseline demographic and clinical characteristics of the integrated SGRQ database overall, and by study type (short-term [≤1 year], medium-term [2-4 years] and observational studies). Distribution of baseline SGRQ scores varied little by demographic determinants except for income region in the observational data set (low-middle income countries +10 units compared with high income, p<0.0001) and this observation held across studies. SGRQ scores increased with increasing modified Medical Research Council dyspnea scores (mean differences ranged 6.9-17.9 units) and with increasing airflow limitations (Global initiative for chronic Obstructive Lung Disease grades 1 to 4; differences ranged 4.5-16.1 units), consistent across study types. As a method of cross-sectional comparison, the SGRQ appears to be relatively free of bias from demographic factors although care should be taken when making cross sectional comparisons of scores between patients in countries at different levels of socio-economic development/.

Keywords: CBQC; COPD Biomarker Qualification Consortium; SGRQ dataset; St George’s Respiratory Questionnaire; baseline characteristics.

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Conflict of interest statement

MT, VSB, NK, HM, SM, SIR, RTS, and PWJ are employees of the pharma companies who funded this analysis. SIR is also an employee of the University of Nebraska Medical Center. HG and HW are 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.

References

    1. Kochanek KD,Murphy SL,Xu J ,Tejada-Vera B. Deaths: Final data for 2014. Nat Vital Stat Rep. 2016;65(4). - PubMed
    1. Lopez AD,Shibuya K,Rao C,et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006;27(2):397-412. doi: https://doi.org/10.1183/09031936.06.00025805 - PubMed
    1. Mathers CD,Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3:e442. doi: https://doi.org/10.1371/journal.pmed.0030442 - PMC - PubMed
    1. Global Initiative for Chronic Lung Disease (GOLD) Global Strategy for the Diagnosis, Management and Prevention of COPD. GOLD website. http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-preve... Published 2017 Accessed January 2017.
    1. Casaburi R,Celli B,Crapo J,et al. The COPD Biomarker Qualification Consortium (CBQC). COPD. 2013;10(3):367-377. doi: https://doi.org/10.3109/15412555.2012.752807 - PubMed

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