title: Changes in chest roentgenogram of sarcoidosis patients during a clinical trial of infliximab therapy: comparison of different methods of evaluation.
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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00073437.
authors.affiliation: University of Cincinnati Medical Center, Cincinnati, OH. Electronic address: bob.baughman@uc.edu.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Baughman
authors.affiliation: University of Cincinnati Medical Center, Cincinnati, OH.
authors.forename: Ralph
authors.initials: R
authors.lastname: Shipley
authors.affiliation: Imperial College of Science, Technology, and Medicine, London, UK.
authors.forename: Sujal
authors.initials: S
authors.lastname: Desai
authors.affiliation: Maastricht University Medical Centre, Maastricht, the Netherlands.
authors.forename: Marjolein
authors.initials: M
authors.lastname: Drent
authors.affiliation: Medical University of South Carolina, Charleston, SC.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Judson
authors.affiliation: Ruhrlandklinik and Medical Faculty, University of Duisburg-Essen, Essen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Costabel
authors.affiliation: Imperial College of Science, Technology, and Medicine, London, UK.
authors.forename: Roland M
authors.initials: RM
authors.lastname: du Bois
authors.affiliation: East Carolina University, Greenville, NC.
authors.forename: Mani
authors.initials: M
authors.lastname: Kavuru
authors.affiliation: Centocor, Inc, Malvern, PA.
authors.forename: Rozsa
authors.initials: R
authors.lastname: Schlenker-Herceg
authors.affiliation: Centocor, Inc, Malvern, PA.
authors.forename: Susan
authors.initials: S
authors.lastname: Flavin
authors.affiliation: Centocor, Inc, Malvern, PA.
authors.forename: Kim Hung
authors.initials: KH
authors.lastname: Lo
authors.affiliation: Centocor, Inc, Malvern, PA.
authors.forename: Elliot S
authors.initials: ES
authors.lastname: Barnathan
mesh_terms: D000328:Adult; D000367:Age Factors; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069285:Infliximab; D008875:Middle Aged; D011336:Probability; D013902:Radiography, Thoracic / Q000379:methods*; D012016:Reference Values; D015203:Reproducibility of Results; D012129:Respiratory Function Tests; D018570:Risk Assessment; D017565:Sarcoidosis, Pulmonary / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D012737:Sex Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab