Methodology Core
The methodology core is directed by Edward H. Giannini, MSc, DrPH. Other members of the methodology core include Bin Huang, PhD, and Hermine I. Brunner, MD, MSc.
Dr. Giannini oversees the output of all collaborations. During the past year he has dealt more with methodological problems and initiatives, and development of outcome assessment tools for JRA and idiopathic inflammatory myopathies, in the field generally defined as clinical epidemiology.
Dr. Brunner performs as a medical advisor, computer database management expert, programmer and biostatistician. She has published important work in the assessment of tools used in patients with SLE and has a special interest in health related quality of life research.
Dr. Huang assists in a multitude of projects requiring advanced statistical expertise. Dr. Huang is particularly well versed in longitudinal data analysis, and the emerging field of "accommodating missing data."
The Aims of the methodology core are:
- To provide clinical investigators with a resource for obtaining conceptual, practical and technical assistance related to methodological and biostatistical issues of clinical investigation.
- To design and implement an independent process for data and safety monitoring for MCRC clinical trials to include the following.
- To promote interdisciplinary clinical research among persons and skill areas already in existence within the research base that results in synergism.
- To offer regularly scheduled and informal educational opportunities in clinical research methodology for investigators, fellows, graduate students and other staff.
Selected Recent Publications with Significant Participation of the Methods Core
Lovell DJ, Giannini EH, Reiff A, Jones OY, Schneider R, Olson JC, Stein LD, Gedalia A, Ilowite NT, Wallace CA, Lange M, Finck BK, Burge DJ. Long-term efficacy and safety of etanercept in children with polyarticular course juvenile rheumatoid arthritis. Arthritis and Rheumatism 2003; 48:218-226.
Rider LG, Giannini EH, Harris-Love M, et al: Workshop Report: Defining clinical improvement in adult and juvenile myositis. Journal of Rheumatology 2003; 30:603-617.
Brunner HI, Giannini EH: Health-related quality of life in children with rheumatic diseases. Current Opinion in Rheumatology 2003; 15:602-12.
Giannini EH, Martini A For the Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group. International consensus for disease activity and disease damage core sets of outcome measures for juvenile systemic lupus erythematosus and juvenile dermatomyositis. Rheumatology 2003; 42:1452-1459.
Moroldo MB, Glass DN, Chaudhari M, Thompson SD, Shear E, Giannini EH: JRA Affected Sib-Pairs: Extent of clinical phenotype concordance. Arthritis & Rheumatism, 2004; 50:1928-1934.
Rider LG, Giannini EH, Brunner H, Ruperto N, James-Newton L, Reed AM, Lachenbruch PA, Miller FW For the International Myositis Assessment and Clinical Studies Group (IMACS). International consensus on preliminary definitions of improvement for adult and juvenile myositis. Arthritis Rheumatism 2004; 50:2281-2290.
Barnes MG, Aronow BJ, Luyrink LK, Moroldo MB, Pavlidis P, Passo MH, Grom AA, Hirsch R, Giannini EH, Colbert RA, Glass DN, Thompson SD. Gene expression in juvenile arthritis and spondyloarthropathy: proangiogenic ELR+ chemokine genes relate to course of arthritis. Rheumatology 2004; 43:973-979.
Thompson SD, Moroldo MB, Guyer L, Ryan M, Tombragel EM, Shear ES, Prahalad S, Sudman M, Keddache MA, Brown WM, Giannini EH, Langefeld CD, Rich SS, Nichols W, Glass DN. A genome wide scan for juvenile rheumatoid arthritis (JRA) in affected sib pair families provides evidence for linkage. Arthritis and Rheumatism 2004; 50:2920-30.
Wallace CA, Ruperto N, Giannini EH, For the Childhood Arthritis and Rheumatology Research Alliance (CARRA), the Pediatric Rheumatology InterNational Trials Organization (PRINTO), and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Preliminary criteria for clinical remission for selected categories of juvenile idiopathic arthritis. Journal of Rheumatology 2004; 31:2290-2294.
Villanueva J, Lee S, Giannini EH, Graham TB, Passo M, Grom AA: Natural killer cell dysfunction is a distinguishing feature of systemic onset juvenile rheumatoid arthritis and macrophage activation syndrome. Arthritis Research and Therapy 2005;7:R30-37.
Brunner HI, Klein-Gitelman MS, Miller MJ, Barron A, Baldwin N, Trombley M, Johnson AL, Kress A, Lovell DJ, Giannini EH. Minimal clinically important differences of the childhood health assessment questionnaire (CHAQ). Journal of Rheumatology 2005; 32:150-161.
Brunner HI, Giannini EH: Health-related quality of life in children with rheumatic diseases. Current Opinion in Rheumatol 2003; 15:602-12.)
Brunner HI, Feldman, BM, et al: Item weighting for the systemic lupus International Collaborating Clinics/ACR Disease Damage Index using Rasch analysis do not lead to an important improvement. J Rheumatol 2003;30:292-7.
Brunner HI, Silverman ED, Bombardier C, et al: European consensus Lupus Activity Measurement is sensitive to change in disease activity in childhood-onset SLE. Arthritis Rheum 2003; 49:335-41.
Brunner HI, Maker D, Grundland B, et al: Preference-based measurement of health-related quality of life (HRQL) in children with chronic musculoskeletal disorders. Med Decis Making 2003; 23:314-22.
Brunner HI, Jones OY, Lovell DJ, et al: Lupus headaches in childhood-onset SLE: relationship to disease acivity index (SLEDAI) and disease damage. Lupus 2003:12:600-06.
Huang B, Sivaganesan, S, Succop, P, Goodman E. Statistical assessment of mediational effects for logistic mediational models. Stat Med 2004; 23:2713-28.
