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Logo of bmcmudisBioMed Centralsearchsubmit a manuscriptregisterthis articleBMC Musculoskeletal Disorders
 
BMC Musculoskelet Disord. 2012; 13: 85.
Published online May 31, 2012. doi:  10.1186/1471-2474-13-85
PMCID: PMC3403943
Malignancy validation in a United States registry of rheumatoid arthritis patients
Mark C Fisher,corresponding author1 Victoria Furer,2 Marc C Hochberg,3 Jeffrey D Greenberg,4 Joel M Kremer,5 Jeff R Curtis,6 George Reed,7 Leslie Harrold,8 and Daniel H Solomon9
1Massachusetts General Hospital, 55 Fruit St., Boston, MA, 02114, USA
2Department of Rheumatology, New York University (NYU) Hospital for Joint Diseases, 301 East 17th Street, Suite 1410, New York, NY, 10003, USA
3Departments of Medicine and Epidemiology and Preventive Medicine, University of Maryland School of Medicine, 10 S. Pine St., MSTF 8-34, Baltimore, MD, 21201, USA
4Department of Rheumatology, New York University (NYU) Hospital for Joint Diseases, 301 East 17th Street, Suite 1410, New York, NY, 10003, USA
5Center for Rheumatology, Albany Medical College, State University of New York, 1367 Washington Avenue, Albany, NY, 12206, USA
6Department of Medicine, University of Alabama, 510 20th St. South FOT 805D, Birmingham, AL, 35294, USA
7Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, 377 Plantation Street, Worcester, MA, 01605, USA
8Department of Medicine, University of Massachusetts Medical School, 377 Plantation Street, Worcester, MA, 01605, USA
9Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, 1620 Tremont Street, Suite 3030, Boston, MA, 02120, USA
corresponding authorCorresponding author.
Mark C Fisher: mfisher6/at/partners.org; Victoria Furer: vikushf/at/gmail.com; Marc C Hochberg: mhochber/at/medicine.umaryland.edu; Jeffrey D Greenberg: jeffrey.greenberg/at/nyumc.org; Joel M Kremer: jkremer/at/joint-docs.com; Jeff R Curtis: jeffrey.curtis/at/ccc.uab.edu; George Reed: George.Reed/at/umassmed.edu; Leslie Harrold: Leslie.Harrold/at/umassmed.edu; Daniel H Solomon: DSOLOMON/at/partners.org
Received January 16, 2012; Accepted May 31, 2012.
Abstract
Background
Physician reporting is commonly used to ascertain adverse events or outcomes measured in epidemiologic studies. However, little is known on the accuracy of physician reported malignancies compared to pertinent medical record review in large cohort studies.
Methods
The Consortium of Rheumatology Researchers of North America (CORRONA) registry gathers physician-completed questionnaires for rheumatoid arthritis (RA) patients, including request for information on incident malignancies, approximately every three months. For incident malignancies reported from October 1st, 2001, through December 31st, 2007, we retrospectively requested completion of a Targeted Adverse Event (TAE) form for additional information as well as primary source documents to adjudicate the malignancy reports. CORRONA has employed a prospective request for source documentation for these events since 2008. We classified each malignancy as definite, probable, possible, or not a malignancy.
Results
From 20,837 RA patients enrolled in CORRONA, 461 incident malignancies were initially reported on physician questionnaires. After review of returned source documents with adjudication, 234 were deemed definite, 69 probable, 101 possible, and 57 not an incident malignancy. The positive predictive value (PPV) of initial physician report of a malignancy versus “definite or probable” malignancy based on adjudication was 0.66 (95% CI 0.61 - 0.70). The PPV was 0.68 (95% CI 0.63 – 0.72) when the subsequent TAE form also confirmed the presence of malignancy. When possible malignancies were included, the PPV of physician-reported malignancies without a subsequent TAE form increased to 0.86 (0.83 – 0.89), and with a subsequent TAE form, 0.89 (0.85-0.91).
Conclusion
Twelve percent of initial physician reports of incident malignancy could not be confirmed with review of source documents. The most common reason for lack of confirmation was inability to obtain documents or insufficient data in source materials. These results suggest that timely collection of relevant medical records and an adjudication process are required to improve the accuracy of cancer reporting in epidemiologic studies.
Keywords: Malignancy, Rheumatoid arthritis, Registry, Validation
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