IFIGENIA-study: methods, patient characteristics and diagnostic confirmation by independent HRCT and histology committees
M. Demedts, M. Thomeer, J. Verschakelen, F. Laurent, C. D. R. Flower, A. G. Nicholson, E. K. Verbeken, F. Capron, U. Costabel, J. Behr, B. Wallaert, I. Lankhorst, A. Ardia, G. Corvasce, the IFIGENIA Study Group ()
Source: Annual Congress 2002 - Interstitial lung disease
Session: Interstitial lung disease
Session type: Oral Presentation
Number: 3680
Disease area: Interstitial lung diseases
Abstract The inclusion period of the prospective, double blind, placebo-controlled Ifigenia-study (on the one-year effects of 1800 mg NAC, added to prednisone 0,5 mg/kg/day and azathioprine 2 mg/kg/day in 7 European countries) has been extended till the summer of 2002. The reason is that for inclusion of 150 patients with IPF, as anticipated by the power analysis, about 170 patients have to be recruited, because in about 10% the diagnosis of IPF (ATS/ERS guidelines: Am.J.Respir.Crit.Care Med.2000; 161-646) has not been confirmed by the independent panel of 3 HRCT and/or 3 histology experts. The non-confirmed patients tended to be younger, more current smokers, with better lung function and exercise capacity, and higher lymphocytosis on BAL. The level of agreement for the diagnosis of IPF between the HRCT readers (reader A, B and C) and between the histology readers (reader D and E, reader F was only solicited if there was disagreement between D and E) was calculated using Cohen's Kappa. A total of 137 HRCT's were independently reviewed and a kappa between reader A-B of 0.39 (p = 0.000), between A-C of 0.18 (p=0.031) and between B-C of 0.22 (p=0.22) was found. The kappa between the histology readers D-E was 0.43 (p= 0.001) after having independently reviewed 59 thoracoscopic and open lung biopsies . Our conclusion is that the independent HRCT and histology committees were extremely valuable to assure an accurate diagnosis of IPF in the confirmed patients.
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M. Demedts, M. Thomeer, J. Verschakelen, F. Laurent, C. D. R. Flower, A. G. Nicholson, E. K. Verbeken, F. Capron, U. Costabel, J. Behr, B. Wallaert, I. Lankhorst, A. Ardia, G. Corvasce, the IFIGENIA Study Group (). IFIGENIA-study: methods, patient characteristics and diagnostic confirmation by independent HRCT and histology committees. Eur Respir J 2002; 20: Suppl. 38, 3680
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