Nephrogenic systemic fibrosis: change in incidence following a switch in gadolinium agents and adoption of a gadolinium policy--report from two U.S. universities.
ABSTRACT To determine the incidence of nephrogenic systemic fibrosis (NSF) in tertiary care centers of two U.S. universities following the switch from the use of gadodiamide to gadobenate dimeglumine and gadopentetate dimeglumine, and the adoption of restrictive gadolinium-based contrast agent (GBCA) policies.
Institutional review board approval with waiver of informed consent was obtained for this Health Insurance Portability and Accountability Act-compliant retrospective study. NSF patients were identified between January 2000 and December 2006 at center A and between October 2003 and February 2007 at center B (preadoption periods); and from June 2007 to June 2008 at both centers (postadoption period). The numbers of patients who underwent gadolinium-enhanced magnetic resonance at each center, patients at risk for NSF at center A, and dialysis patients at center B were identified in the pre- and postadoption periods. Gadodiamide was the only agent used in the preadoption period. Gadobenate dimeglumine and gadopentetate dimeglumine were the agents used in the postadoption period. A restrictive GBCA policy that limits the use and dose of GBCAs in patients with risk factors was adopted in the postadoption period. Follow-up lasted 9 months from July 2008 to March 2009. Corresponding incidences were determined and compared with the Fisher exact test.
Respective total benchmark incidence of NSF at both centers, at-risk incidence of NSF at center A, and dialysis incidence of NSF at center B were 37 of 65 240, 28 of 925, and nine of 312 in the preadoption period and zero of 25 167, zero of 147, and zero of 402 in the postadoption period. All three incidences demonstrated significant differences (P < .0001, .024, and .001, respectively) between the pre- and postadoption periods.
Following the switch from gadodiamide to gadobenate dimeglumine and gadopentetate dimeglumine, and the adoption of restrictive GBCA policies, no NSF cases were observed at either center.
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ABSTRACT: OBJECTIVE: To develop and pilot test a screening tool to identify cases of nephrogenic systemic fibrosis (NSF) among patients exposed to gadolinium-containing contrast agents. METHODS: Sixty English-speaking subjects were enrolled: 10 subjects with diagnosis of NSF; 10 subjects with other fibrosing skin diseases (OFSD); 20 subjects with non-fibrosing skin diseases (NFSD) and 20 subjects without a skin disease. Subjects answered a questionnaire with eight closed-ended ("yes/no") questions focusing on cutaneous and musculoskeletal manifestations of NSF. They were evaluated by a dermatologist for the presence of clinical signs of NSF. We compared the number of affirmative responses in the NSF group to those in the other groups and the optimal cutoff that would differentiate groups was calculated. Discrimination, positive and negative predictive values and internal consistency was also assessed. RESULTS: Subjects in the NSF group tended to provide more affirmative answers. Using a cutoff of three or more affirmative responses yields a sensitivity of 90% and a specificity of 70% with an AUC of 0.85, indicating good discrimination. Sensitivity analysis using modified control group or weighted scores exhibited only slightly better discriminatory power. The positive predictive value of the questionnaire ranged from 0.3% to 39.7% and its negative predictive values ranged from 97% to greater than 99% with the different proposed prevalence estimates. The instrument had high internal consistency. CONCLUSION: This pilot study demonstrates that this questionnaire has both high internal consistency and good discriminatory ability. Thus, it may be used to screen populations for NSF. © 2012 by the American College of Rheumatology.Arthritis care & research. 10/2012;