Different thresholds for detecting osteophytes and joint space narrowing exist between the site investigators and the centralized reader in a multicenter knee osteoarthritis study—data from the Osteoarthritis Initiative
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Abstract
Objective
To evaluate how the reading of knee radiographs by site investigators differs from that by an expert musculoskeletal radiologist who trained and validated them in a multicenter knee osteoarthritis (OA) study.
Materials and methods
A subset of participants from the Osteoarthritis Initiative progression cohort was studied. Osteophytes and joint space narrowing (JSN) were evaluated using Kellgren-Lawrence (KL) and Osteoarthritis Research Society International (OARSI) grading. Radiographs were read by site investigators, who received training and validation of their competence by an expert musculoskeletal radiologist. Radiographs were re-read by this radiologist, who acted as a central reader. For KL and OARSI grading of osteophytes, discrepancies between two readings were adjudicated by another expert reader.
Results
Radiographs from 96 subjects (49 women) and 192 knees (138 KL grade ≥ 2) were included. The site reading showed moderate agreement for KL grading overall (kappa = 0.52) and for KL ≥ 2 (i.e., radiographic diagnosis of “definite OA”; kappa = 0.41). For OARSI grading, the site reading showed substantial agreement for lateral and medial JSN (kappa = 0.65 and 0.71), but only fair agreement for osteophytes (kappa = 0.37). For KL grading, the adjudicator’s reading showed substantial agreement with the centralized reading (kappa = 0.62), but only slight agreement with the site reading (kappa = 0.10).
Conclusion
Site investigators over-graded osteophytes compared to the central reader and the adjudicator. Different thresholds for scoring of JSN exist even between experts. Our results suggest that research studies using radiographic grading of OA should use a centralized reader for all grading.
Keywords
Osteoarthritis Radiography X-ray Knee Centralized readingAbbreviations
- OA
Osteoarthritis
- OAI
Osteoarthritis Initiative
- KL
Kellgren-Lawrence
- OARSI
Osteoarthritis Research Society International
- JSN
Joint space narrowing
- MRI
Magnetic resonance imaging
- FDA
Food and Drug Administration
- EMEA
European Medicines Agency
Notes
Funding sources
The Osteoarthritis Initiative (OAI) is a public-private partnership comprised of five contracts (N01-AR-2-2258; N01-AR-2-2259; N01-AR-2-2260; N01-AR-2-2261; N01-AR-2-2262) funded by the National Institutes of Health (NIH), a branch of the Department of Health and Human Services, and conducted by the OAI study investigators. Private funding partners include Merck Research Laboratories; Novartis Pharmaceuticals Corporation, GlaxoSmithKline; and Pfizer, Inc. Private sector funding for the OAI is managed by the Foundation for the National Institutes of Health. This manuscript was prepared using an OAI public use data set and does not necessarily reflect the opinions or views of the OAI investigators, the NIH, or the private funding partners. The central radiographic readings and adjudications (i.e., data collection) were funded by Eli Lilly & Company. The sponsors did not have any role in study design, analysis, and interpretation of data; writing of the manuscript; or the decision to submit the manuscript for publication.
Competing interests
Ali Guermazi received grants from General Electric Healthcare and National Institute of Health. He is the President of Boston Imaging Core Lab, LLC; consultant to MerckSerono, Facet Solutions, Novartis, Genzyme, and Stryker. Felix Eckstein is CEO of Chondrometrics, GmbH, and provides consulting services to MerckSerono and Novartis. Olivier Benichou has a full time employment with Lilly & Co, IN. Other authors declared nothing to disclose.
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