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Variability in objective and subjective measures affects baseline values in studies of patients with COPD
- Anderson, Wayne H;
- Ha, Jae Wook;
- Couper, David J;
- O’Neal, Wanda K;
- Barr, R Graham;
- Bleecker, Eugene R;
- Carretta, Elizabeth E;
- Cooper, Christopher B;
- Doerschuk, Claire M;
- Drummond, M Bradley;
- Han, MeiLan K;
- Hansel, Nadia N;
- Kim, Victor;
- Kleerup, Eric C;
- Martinez, Fernando J;
- Rennard, Stephen I;
- Tashkin, Donald;
- Woodruff, Prescott G;
- Paine, Robert;
- Curtis, Jeffrey L;
- Kanner, Richard E
- Editor(s): Di Stefano, Antonino
- et al.
Published Web Location
https://doi.org/10.1371/journal.pone.0184606Abstract
Rationale
Understanding the reliability and repeatability of clinical measurements used in the diagnosis, treatment and monitoring of disease progression is of critical importance across all disciplines of clinical practice and in clinical trials to assess therapeutic efficacy and safety.Objectives
Our goal is to understand normal variability for assessing true changes in health status and to more accurately utilize this data to differentiate disease characteristics and outcomes.Methods
Our study is the first study designed entirely to establish the repeatability of a large number of instruments utilized for the clinical assessment of COPD in the same subjects over the same period. We utilized SPIROMICS participants (n = 98) that returned to their clinical center within 6 weeks of their baseline visit to repeat complete baseline assessments. Demographics, spirometry, questionnaires, complete blood cell counts (CBC), medical history, and emphysema status by computerized tomography (CT) imaging were obtained.Results
Pulmonary function tests (PFTs) were highly repeatable (ICC's >0.9) but the 6 minute walk (6MW) was less so (ICC = 0.79). Among questionnaires, the Saint George's Respiratory Questionnaire (SGRQ) was most repeatable. Self-reported clinical features, such as exacerbation history, and features of chronic bronchitis, often produced kappa values <0.6. Reported age at starting smoking and average number of cigarettes smoked were modestly repeatable (kappa = 0.76 and 0.79). Complete blood counts (CBC) variables produced intraclass correlation coefficients (ICC) values between 0.6 and 0.8.Conclusions
PFTs were highly repeatable, while subjective measures and subject recall were more variable. Analyses using features with poor repeatability could lead to misclassification and outcome errors. Hence, care should be taken when interpreting change in clinical features based on measures with low repeatability. Efforts to improve repeatability of key clinical features such as exacerbation history and chronic bronchitis are warranted.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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