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Original Research |

The Inaccuracy of Patient Recall for COPD Exacerbation Rate Estimation and its Implications: Results from Central Adjudication

Anja Frei, PhD; Lara Siebeling, PhD; Callista Wolters, MD; Leonhard Held, Prof; Patrick Muggensturm, MD; Alexandra Strassmann, MSc; Marco Zoller, MD; Gerben ter Riet, PhD; Milo A. Puhan, Prof
Author and Funding Information

Funding: This study is part of the prospective ICE COLD ERIC cohort study which was supported by the Swiss National Science Foundation (grant # 3233B0/115216/1), Lung Foundation Netherlands (grant # 3.4.07.045), Stichting Astmabestrijding (grant # SAB 2012/043 and Zurich Lung League (unrestricted grant).

Conflict of interest: The authors declare that they have no conflicts of interests.

Prior abstract publication: Parts of the results from this manuscript have been presented at the European Respiratory Society Annual Congress 2012 in Vienna.

Clinical Trial Registration: www.ClinicalTrials.gov, NCT00706602

1Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Switzerland

2Department of General Practice, Academic Medical Center, University of Amsterdam, the Netherlands

3Institute of General Practice and Health Services Research, University of Zurich, Switzerland

Anja Frei, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Hirschengraben 84, 8001 Zürich, Switzerland.


Copyright 2016, . All Rights Reserved.


Chest. 2016. doi:10.1016/j.chest.2016.06.031
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Abstract

Background  COPD exacerbation incidence rates are often ascertained retrospectively, through patient recall and self-reports. We compared exacerbation ascertainment through patient self-reports and single physician chart review to central adjudication by a committee and explored determinants and consequences of misclassification.

Methods  Self-reported exacerbations (event-based definition) in 409 primary care COPD patients participating in the ICE COLD ERIC cohort were ascertained 6-monthly over 3 years. Exacerbations were adjudicated by single experienced physicians and an adjudication committee who had information from patient charts. We assessed the accuracy (sensitivities and specificities) of self-reports and single physician chart review against a central adjudication committee (reference standard). We used multinomial logistic regression and bootstrap stability analyses to explore determinants of misclassifications.

Results  The adjudication committee identified 648 exacerbations, corresponding with an incidence rate of 0.60±0.83 exacerbations/patient-year and a cumulative incidence proportion of 58.9%. Patients self-reported 841 exacerbations (incidence rate 0.75±1·01, incidence proportion 59.7%). Sensitivity/specificity of self-reports were 84%/76%, those of single physician chart review between 89-96% and 87-99%. The multinomial regression model and bootstrap selection showed that having experienced more exacerbations was the only factor consistently associated with under- and over-reporting of exacerbations (under-reporters: relative risk ratio 2.16, 95% CI 1.76-2.65; over-reporters: relative risk ratio 1.67, 95% CI 1.39-2.00).

Conclusions  Patient 6-month recall of exacerbation events are inaccurate. This may lead to inaccurate estimates of incidence measures and underestimation of treatment effects. The use of multiple data sources combined with event adjudication could substantially reduce sample size requirements and possibly cost of studies.


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