Document Detail


Changes in chest roentgenogram of sarcoidosis patients during a clinical trial of infliximab therapy: comparison of different methods of evaluation.
MedLine Citation:
PMID:  19395578     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Robert P Baughman; Ralph Shipley; Sujal Desai; Marjolein Drent; Marc A Judson; Ulrich Costabel; Roland M du Bois; Mani Kavuru; Rozsa Schlenker-Herceg; Susan Flavin; Kim Hung Lo; Elliot S Barnathan;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-04-24
Journal Detail:
Title:  Chest     Volume:  136     ISSN:  1931-3543     ISO Abbreviation:  Chest     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-11     Completed Date:  2009-09-02     Revised Date:  2014-07-30    
Medline Journal Info:
Nlm Unique ID:  0231335     Medline TA:  Chest     Country:  United States    
Other Details:
Languages:  eng     Pagination:  526-35     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00073437
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MeSH Terms
Descriptor/Qualifier:
Adult
Age Factors
Anti-Inflammatory Agents / administration & dosage*
Antibodies, Monoclonal / administration & dosage*
Confidence Intervals
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Humans
Middle Aged
Probability
Radiography, Thoracic / methods*
Reference Values
Reproducibility of Results
Respiratory Function Tests
Risk Assessment
Sarcoidosis, Pulmonary / drug therapy*,  pathology,  radiography
Severity of Illness Index
Sex Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents; 0/Antibodies, Monoclonal; 0/infliximab

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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