he objective was to describe the methodology used to develop new response criteria for adult DM/PM and JDM. Methods: Patient profiles from prospective natural history data and clinical trials were rated by myositis specialists to develop consensus gold-standard ratings of minimal, moderate and major improvement. Experts completed a survey regarding clinically meaningful improvement in the core set measures (CSM) and a conjoint-analysis survey (using 1000Minds software) to derive relative weights of CSM and candidate definitions. Six types of candidate definitions for response criteria were derived using survey results, logistic regression, conjoint analysis, application of conjoint-analysis weights to CSM and published definitions. Sensitivity, specificity and area under the curve were defined for candidate criteria using consensus patient profile data, and selected definitions were validated using clinical trial data.
2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects / Rider, Lisa G.; Ruperto, Nicolino; Pistorio, Angela; Erman, Brian; Bayat, Nastaran; Lachenbruc, Peter A.; Rockette, Howard; Feldman, Brian M.; Huber, Adam M.; Hansen, Paul; Oddis, Chester V.; Lundberg, Ingrid E.; Amato, Anthony A.; Chinoy, Hector; Cooper, Robert G.; Chung, Lorinda; Danko, Katalin; Fiorentino, David; De la Torre, Ignacio García; Reed, Ann M.; Song, Yeong Wook; Cimaz, Rolando; Cuttica, Rubén J.; Pilkington, Clarissa A.; Martini, Alberto; van der Net, Janjaap; Maillard, Susan; Miller, Frederick W.; Vencovsky, Jiri; Aggarwal, Rohit*; Christopher-Stine, Lisa; Criscione-Schreiber, Lisa; Crofford, Leslie; Cronin, Mary E.; Gordon, Patrick; Hengstman, Gerald; Katz, James D.; Mammen, Andrew; Marder, Galina; McHugh, Neil; Schiopu, Elena; Wolfe, Gil; Wortmann, Robert; Apaz, Maria; Bowyer, Suzanne; Constantin, Tamás; Curran, Megan; Davidson, Joyce; Griffin, Thomas; Jones, Olcay; Kim, Susan; Lang, Bianca; Lindsley, Carol; Lovell, Daniel; Magalhaes, Claudia Saad; Pachman, Lauren M.; Ponyi, Andrea; Punaro, Marilynn; Quartier, Pierre; Ramanan, Athimalaipet V.; Ravelli, Angelo; Rennebohm, Robert; Van Royen-Kerkhof, Annet; Sherry, David D.; Silva, Clovis A.; Stringer, Elizabeth; Wallace, Carol; Ascherman, Dana; Barohn, Richard; Benveniste, Olivier; De Bleecker, Jan; Callen, Jeffrey; Charles-Schoeman, Christina; Danoff, Sonye; Dastmalchi, Maryam; Dimachkie, Mazen; Di Martino, Steve; Dourmishev, Lyubomir; Ernste, Floranne; Gono, Takahisa; Isenberg, David; Katsumata, Yasuhiro; Kissel, John; Leff, Richard L.; Levine, Todd; Mann, Herman; Marie, Isabelle; Merola, Joseph; Olesinska, Marzena; Olsen, Nancy; Pipitone, Nicolo; Ramchandren, Sindhu; Rutkove, Seward; Saketkoo, Lesley Ann; Schiffenbauer, Adam; Selva-O'Callaghan, Albert; Shinjo, Samuel Katsuyuki; Shupak, Rachel; Swierkocka, Katarzyna; de Visser, Marianne; Wanschitz, Julia; Werth, Victoria P.; Whitt, Irene; Ytterberg, Steven; Avcin, Tadej; Becker, Mara; Beresford, Michael W.; Dressler, Frank; Dvergsten, Jeffrey; Ferriani, Virginia Paes Leme; Flato, Berit; Gerloni, Valeria; Henrickson, Michael; Hinze, Claas; Hoeltzel, Mark; Ibarra, Maria; Ilowite, Norman; Imundo, Lisa; Kingsbury, Daniel; Magnusson, Bo; Maguiness, Sheilagh; Mathiesen, Pernille; McCann, Liza; Nielsen, Susan; de Oliveira, Sheila Knupp Feitosa; Passo, Murray; Rabinovich, Egla; Rivas-Chacon, Rafael; Robinson, Angela Byun; Rouster-Stevens, Kelly; Russo, Ricardo; Rutkowska-Sak, Lidia; Sallum, Adriana; Sanner, Helga; Schmeling, Heinrike; Selcen, Duygu; Shaham, Bracha; Spencer, Charles H.; Sundel, Robert; Tardieu, Marc; Thatayatikom, Akaluck; Wahezi, Dawn; Zulian, Francesco. - In: RHEUMATOLOGY. - ISSN 1462-0324. - ELETTRONICO. - 56:(2017), pp. 1884-1893. [10.1093/rheumatology/kex226]
2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects
Cimaz, Rolando;Martini, Alberto;
2017
Abstract
he objective was to describe the methodology used to develop new response criteria for adult DM/PM and JDM. Methods: Patient profiles from prospective natural history data and clinical trials were rated by myositis specialists to develop consensus gold-standard ratings of minimal, moderate and major improvement. Experts completed a survey regarding clinically meaningful improvement in the core set measures (CSM) and a conjoint-analysis survey (using 1000Minds software) to derive relative weights of CSM and candidate definitions. Six types of candidate definitions for response criteria were derived using survey results, logistic regression, conjoint analysis, application of conjoint-analysis weights to CSM and published definitions. Sensitivity, specificity and area under the curve were defined for candidate criteria using consensus patient profile data, and selected definitions were validated using clinical trial data.
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