Malignancy validation in a United States registry of rheumatoid arthritis patients

Abstract

BackgroundPhysician 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.MethodsThe 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.ResultsFrom 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).ConclusionTwelve 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.

Longterm, Real-world Safety of Adalimumab in Rheumatoid Arthritis: Analysis of a Prospective US-based Registry

“…A subset of questionnaires is also studied for expert adjudication. This methodology has been supported by previous validation studies, which found positive predictive values of Targeted Adverse Event forms to be 96% for CV events 27 , 86% for malignancies 28 , and 71% for serious infectious events 29 .…”

A Comparison of the Malignancy Incidence Among Patients With Psoriatic Arthritis and Patients With Rheumatoid Arthritis in a Large US Cohort

“…In addition, all reported cases went through a structured confirmation process using multiple reviewers. This is one of the major strengths of our study design, because patient or physician reporting alone may not be accurate enough for large epidemiologic studies of cancer incidence ().…”

“…We used a previously validated structured adjudication process, as described elsewhere (). Briefly, we examined cases of physician‐reported malignancies that were initially reported at followup study visits and subsequently confirmed using an adverse event form completed by the rheumatologist at the reporting site.…”

One-year risk of serious infection in patients treated with certolizumab pegol as compared with other TNF inhibitors in a real-world setting: data from a national U.S. rheumatoid arthritis registry

“…These questionnaires, alongside supporting documents appropriate to the event (e.g., hospitalization records, pathology reports), are submitted to Corrona for validation, with a subset triaged for expert adjudication. Previous validation of Corrona’s AE reporting has found positive predictive values of 86% for malignancies [ 29 ], 96% for CVEs [ 30 ], and 71% for SIEs [ 31 ].…”