All analyses were conducted using SAS 9.2 (SAS Institute, Inc., Cary, NC) and Stata 11 (Stata Corp., College Station, TX). The NASH CRN studies were designed by subcommittees of the NASH CRN Steering Committee, MAPK Inhibitor Library cell assay the latter composed of principal investigators from each clinical site, the two cochairs of the Pathology Committee, the principal investigator from the Data Coordinating Center, and the NIDDK scientific officer. [All investigators in the NASH CRN and their positions and locations are listed in the appendix.] After approval by the Steering Committee, studies were approved by the respective institutional review boards at
all involved sites. All enrolled patients gave written informed consent before data collection with special consent for genetic testing. The clinical protocols, consent forms, and manual of operations were also reviewed and approved by a Data Safety Monitoring Board established by the NIDDK specifically for the NASH CRN. All studies were in compliance with Good Clinical Practice guidelines for human research quality standards. Investigators, coordinators, and ancillary staff involved in data collection and entry were click here trained and certified for quality assurance. In addition, monthly data audits were performed by comparing entered data with source documents by the Data Coordinating Center throughout the NASH CRN
studies. A total of 1266 adults were enrolled into the NASH CRN Database (n = 1019) or PIVENS trial (n = 247) between October 2004 and February 2008. Of these, 698 had a liver biopsy obtained within 6 months of clinical data collection (contemporaneous biopsy group), 403 had a biopsy more than 6 months before study data was collected, and 165 did not have biopsy data available. Of those classified as having contemporaneous liver biopsies, 53% had biopsies within 1 week of having blood tests, 60% within 4 weeks, 81% within 3 months, and the remaining 19% between 3 and 6 months. For non-PIVENS patients with more
than one biopsy, only the last biopsy was used for analysis. For PIVENS patients, the entry biopsy and contemporaneous laboratory and clinical data obtained within 6 months of the biopsy were used. The characteristics, laboratory test results, and biopsy features selleckchem of the NASH CRN adult patients are given in Table 1. Additional data describing this cohort and the correlations between clinical data and histological changes can be found online in supporting Tables 1 through 6. Overall, the median age was 50 years, 82% of patients were white, and 12% were Hispanic. The median BMI was 33 kg/m2 and median waist circumference was 108 cm; 49% had hypertension and 31% had type 2 diabetes. Combining these features, 61% met the National Cholesterol Education Program (NCEP) criteria13 for the metabolic syndrome.