Robert P Baughman1, Ralph Shipley2, Sujal Desai3, Marjolein Drent4, Marc A Judson5, Ulrich Costabel6, Roland M du Bois3, Mani Kavuru7, Rozsa Schlenker-Herceg8, Susan Flavin8, Kim Hung Lo8, Elliot S Barnathan8. 1. University of Cincinnati Medical Center, Cincinnati, OH. Electronic address: bob.baughman@uc.edu. 2. University of Cincinnati Medical Center, Cincinnati, OH. 3. Imperial College of Science, Technology, and Medicine, London, UK. 4. Maastricht University Medical Centre, Maastricht, the Netherlands. 5. Medical University of South Carolina, Charleston, SC. 6. Ruhrlandklinik and Medical Faculty, University of Duisburg-Essen, Essen, Germany. 7. East Carolina University, Greenville, NC. 8. Centocor, Inc, Malvern, PA.
Abstract
BACKGROUND: The best method to interpret the chest roentgenogram and its sensitivity to detect effect of treatment for sarcoidosis remains unclear. In a double-blind, randomized trial of infliximab for chronic pulmonary sarcoidosis, changes in serial chest roentgenograms were examined by radiologists, blinded to order or treatment. METHODS: Chest roentgenograms were obtained at 0, 6, and 24 weeks of therapy with either placebo, 3 mg/kg infliximab, or 5 mg/kg infliximab. Films were reviewed in random order by two independent radiologists, unaware of treatment. The films were compared using two methods: the prespecified objective assessment, a scoring system previously proposed by Muers; and the post hoc assessment, a 5-point Likert scale global assessment between two films. RESULTS: Of 138 patients enrolled in the study, chest roentgenograms for all studies were available on 130 patients. There was only fair agreement between the two radiologists in the original stage of the chest roentgenogram (weighted kappa = 0.43; 95% confidence interval [CI], 0.32 to 0.54). For the Likert scale of global assessment of change, there was good agreement between the two readers (weighted kappa = 0.61; 95% CI, 0.51 to 0.71). There was good correlation between the two readers for the various components of the Muers score, especially the reticulonodular (R) score (R = 0.578; p < 0.05). The initial R score was positively correlated with improvement in FVC with infliximab therapy (R = 0.239; p < 0.05). CONCLUSION: Global assessment and the Muers scoring system were associated with good agreement between two expert readers. Improvement in both scores correlated with improvement in FVC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00073437.
RCT Entities:
BACKGROUND: The best method to interpret the chest roentgenogram and its sensitivity to detect effect of treatment for sarcoidosis remains unclear. In a double-blind, randomized trial of infliximab for chronic pulmonary sarcoidosis, changes in serial chest roentgenograms were examined by radiologists, blinded to order or treatment. METHODS: Chest roentgenograms were obtained at 0, 6, and 24 weeks of therapy with either placebo, 3 mg/kg infliximab, or 5 mg/kg infliximab. Films were reviewed in random order by two independent radiologists, unaware of treatment. The films were compared using two methods: the prespecified objective assessment, a scoring system previously proposed by Muers; and the post hoc assessment, a 5-point Likert scale global assessment between two films. RESULTS: Of 138 patients enrolled in the study, chest roentgenograms for all studies were available on 130 patients. There was only fair agreement between the two radiologists in the original stage of the chest roentgenogram (weighted kappa = 0.43; 95% confidence interval [CI], 0.32 to 0.54). For the Likert scale of global assessment of change, there was good agreement between the two readers (weighted kappa = 0.61; 95% CI, 0.51 to 0.71). There was good correlation between the two readers for the various components of the Muers score, especially the reticulonodular (R) score (R = 0.578; p < 0.05). The initial R score was positively correlated with improvement in FVC with infliximab therapy (R = 0.239; p < 0.05). CONCLUSION: Global assessment and the Muers scoring system were associated with good agreement between two expert readers. Improvement in both scores correlated with improvement in FVC. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00073437.
Authors: D A Van den Heuvel; P A de Jong; P Zanen; H W van Es; J P van Heesewijk; M Spee; J C Grutters Journal: Eur Radiol Date: 2015-04-09 Impact factor: 5.315
Authors: Elliott D Crouser; Rachel M Smith; Daniel A Culver; Mark W Julian; Karen Martin; Joanne Baran; Christopher Diaz; Barbaros Selnur Erdal; Erinn M Hade Journal: Chest Date: 2021-05-23 Impact factor: 10.262