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001-es BibID:BIBFORM103936
035-os BibID:(WoS)000868254300009 (Scopus)85143055930
Első szerző:Aggarwal, Rohit
Cím:Trial of Intravenous Immune Globulin in Dermatomyositis / Aggarwal Rohit, Charles-Schoeman Christina, Schessl Joachim, Bata-Csörgő Zsuzsanna, Dimachkie Mazen M., Griger Zoltan, Moiseev Sergey, Oddis Chester, Schiopu Elena, Vencovsky Jiri, Beckmann Irene, Clodi Elisabeth, Bugrova Olga, Dankó Katalin, Ernste Floranne, Goyal Namita A., Heuer Marvin, Hudson Marie, Hussain Yessar M., Karam Chafic, Magnolo Nina, Nelson Ronald, Pozur Nataliia, Prystupa Liudmyla, Sárdy Miklós, Valenzuela Guillermo, van der Kooi Anneke J., Vu Tuan, Worm Margitta, Levine Todd, ProDERM Trial Group
Dátum:2022
ISSN:0028-4793
Megjegyzések:Background: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated. Methods: We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS ?40) and major improvement (TIS ?60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index. Results: A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events. Conclusions: In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.).
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
folyóiratcikk
Megjelenés:New England Journal Of Medicine. - 387 : 14 (2022), p. 1264-1278. -
További szerzők:Charles-Schoeman, Christina Schessl, Joachim Bata-Csörgő Zsuzsanna Dimachkie, Mazen M. Griger Zoltán (1979-) (belgyógyász, allergológus és klinikai immunológus, reumatológus) Moiseev, Sergey Oddis, Chester V. Schiopu, Elena Vencovsky, Jiri Beckmann, Irene Clodi, Elisabeth Bugrova, Olga Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Ernste, Floranne Goyal, Namita A. Heuer, Marvin Hudson, Marie Hussain, Yessar M. Karam, Chafic Magnolo, Nina Nelson, Ronald Pozur, Nataliia Prystupa, Liudmyla Sárdy Miklós Valenzuela, Guillermo van der Kooi, Anneke J. Vu, Tuan Worm, Margitta Levine, Todd ProDERM Trial Group
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2.

001-es BibID:BIBFORM073208
035-os BibID:(WoS)000398387200006 (Scopus)85019025865
Első szerző:Aggarwal, Rohit
Cím:2016 American College of Rheumatology/European League Against Rheumatism criteria for minimal, moderate, and major clinical response in adult dermatomyositis and polymyositis / Rohit Aggarwal, Lisa G. Rider, Nicolino Ruperto, Nastaran Bayat, Brian Erman, Brian M. Feldman, Chester V. Oddis, Anthony A. Amato, Hector Chinoy, Robert G. Cooper, Maryam Dastmalchi, David Fiorentino, David Isenberg, James D. Katz, Andrew Mammen, Marianne de Visser, Steven R. Ytterberg, Ingrid E. Lundberg, Lorinda Chung, Katalin Danko, Ignacio García-De la Torre, Yeong Wook Song, Luca Villa, Mariangela Rinaldi, Howard Rockette, Peter A. Lachenbruch, Frederick W. Miller, Jiri Vencovsky, International Myositis Assessment and Clinical Studies Group, Paediatric Rheumatology International Trials Organisation
Dátum:2017
ISSN:0003-4967
Megjegyzések:To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM). Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus. Consensus was reached for a conjoint analysis-based continuous model using absolute per cent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ?20, ?40, and ?60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (p<0.001). The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute per cent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Dermatomyositis
Polymyositis
Treatment
Megjelenés:Annals Of The Rheumatic Diseases. - 76 : 5 (2017), p. 792-801. -
További szerzők:Rider, Lisa G. Ruperto, Nicolino Bayat, Nastaran Erman, Brian Feldman, Brian M. Oddis, Chester V. Amato, Anthony A. Chinoy, Hector Cooper, Robert G. Dastmalchi, Maryam Fiorentino, David Isenberg, David A. Katz, James D. Mammen, Andrew Visser, Marianne de Ytterberg, Steven R. Lundberg, Ingrid Chung, Lorinda Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Torre, Ignacio García-De la Song, Yeong Wook Villa, Luca Rinaldi, Mariangela Rockette, Howard Lachenbruch, Peter A. Miller, Frederick W. Vencovsky, Jiri International Myositis Assessment and Clinical Studies Group Paediatric Rheumatology International Trials Organisation (PRINTO)
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3.

001-es BibID:BIBFORM073210
Első szerző:Aggarwal, Rohit
Cím:2016 American College of Rheumatology/European League Against Rheumatism Criteria for Minimal, Moderate, and Major Clinical Response in Adult Dermatomyositis and Polymyositis: An International Myositis Assessment and Clinical Studies Group/Paediatric Rheu / Rohit Aggarwal, Lisa G. Rider, Nicolino Ruperto, Nastaran Bayat, Brian Erman, Brian M. Feldman, Chester V. Oddis, Anthony A. Amato, Hector Chinoy, Robert G. Cooper, Maryam Dastmalchi, David Fiorentino, David Isenberg, James D. Katz, Andrew Mammen, Marianne de Visser, Steven R. Ytterberg, Ingrid E. Lundberg, Lorinda Chung, Katalin Danko, Ignacio García-De la Torre, Yeong Wook Song, Luca Villa, Mariangela Rinaldi, Howard Rockette, Peter A. Lachenbruch, Frederick W. Miller, Jiri Vencovsky, International Myositis Assessment and Clinical Studies Group, Paediatric Rheumatology International Trials Organisation
Dátum:2017
ISSN:2326-5191
Megjegyzések:OBJECTIVE:To develop response criteria for adult dermatomyositis (DM) and polymyositis (PM).METHODS:Expert surveys, logistic regression, and conjoint analysis were used to develop 287 definitions using core set measures. Myositis experts rated greater improvement among multiple pairwise scenarios in conjoint analysis surveys, where different levels of improvement in 2 core set measures were presented. The PAPRIKA (Potentially All Pairwise Rankings of All Possible Alternatives) method determined the relative weights of core set measures and conjoint analysis definitions. The performance characteristics of the definitions were evaluated on patient profiles using expert consensus (gold standard) and were validated using data from a clinical trial. The nominal group technique was used to reach consensus.RESULTS:Consensus was reached for a conjoint analysis-based continuous model using absolute percent change in core set measures (physician, patient, and extramuscular global activity, muscle strength, Health Assessment Questionnaire, and muscle enzyme levels). A total improvement score (range 0-100), determined by summing scores for each core set measure, was based on improvement in and relative weight of each core set measure. Thresholds for minimal, moderate, and major improvement were ?20, ?40, and ?60 points in the total improvement score. The same criteria were chosen for juvenile DM, with different improvement thresholds. Sensitivity and specificity in DM/PM patient cohorts were 85% and 92%, 90% and 96%, and 92% and 98% for minimal, moderate, and major improvement, respectively. Definitions were validated in the clinical trial analysis for differentiating the physician rating of improvement (P?<?0.001).CONCLUSION:The response criteria for adult DM/PM consisted of the conjoint analysis model based on absolute percent change in 6 core set measures, with thresholds for minimal, moderate, and major improvement.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Arthritis & Rheumatology 69 : 5 (2017), p. 898-910. -
További szerzők:Rider, Lisa G. Ruperto, Nicolino Bayat, Nastaran Erman, Brian Feldman, Brian M. Oddis, Chester V. Amato, Anthony A. Chinoy, Hector Cooper, Robert G. Dastmalchi, Maryam Fiorentino, David Isenberg, David A. Katz, James D. Mammen, Andrew Visser, Marianne de Ytterberg, Steven R. Lundberg, Ingrid Chung, Lorinda Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Torre, Ignacio García-De la Song, Yeong Wook Villa, Luca Rinaldi, Mariangela Rockette, Howard Lachenbruch, Peter A. Miller, Frederick W. Vencovsky, Jiri International Myositis Assessment and Clinical Studies Group Paediatric Rheumatology International Trials Organisation (PRINTO)
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4.

001-es BibID:BIBFORM073206
Első szerző:Bottai, Matteo
Cím:EULAR/ACR classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups : a methodology report / Matteo Bottai, Anna Tjärnlund, Giola Santoni, Victoria P. Werth, Clarissa Pilkington, Marianne de Visser, Lars Alfredsson, Anthony A. Amato, Richard J. Barohn, Matthew H. Liang, Jasvinder A. Singh, Rohit Aggarwal, Snjolaug Arnardottir, Hector Chinoy, Robert G. Cooper, Katalin Danko, Mazen M. Dimachkie, Brian M. Feldman, Ignacio García-De La Torre, Patrick Gordon, Taichi Hayashi, James D. Katz, Hitoshi Kohsaka, Peter A. Lachenbruch, Bianca A. Lang, Yuhui Li, Chester V. Oddis, Marzena Olesinka, Ann M. Reed, Lidia Rutkowska-Sak, Helga Sanner, Albert Selva-O'Callaghan, Yeong Wook Song, Jiri Vencovsky, Steven R. Ytterberg, Frederick W. Miller, Lisa G. Rider, Ingrid E. Lundberg, International Myositis Classification Criteria Project consortium, Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository
Dátum:2017
ISSN:2056-5933
Megjegyzések:OBJECTIVE:To describe the methodology used to develop new classification criteria for adult and juvenile idiopathic inflammatory myopathies (IIMs) and their major subgroups.METHODS:An international, multidisciplinary group of myositis experts produced a set of 93 potentially relevant variables to be tested for inclusion in the criteria. Rheumatology, dermatology, neurology and paediatric clinics worldwide collected data on 976 IIM cases (74% adults, 26% children) and 624 non-IIM comparator cases with mimicking conditions (82% adults, 18% children). The participating clinicians classified each case as IIM or non-IIM. Generally, the classification of any given patient was based on few variables, leaving remaining variables unmeasured. We investigated the strength of the association between all variables and between these and the disease status as determined by the physician. We considered three approaches: (1) a probability-score approach, (2) a sum-of-items approach criteria and (3) a classification-tree approach.RESULTS:The approaches yielded several candidate models that were scrutinised with respect to statistical performance and clinical relevance. The probability-score approach showed superior statistical performance and clinical practicability and was therefore preferred over the others. We developed a classification tree for subclassification of patients with IIM. A calculator for electronic devices, such as computers and smartphones, facilitates the use of the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria.CONCLUSIONS:The new EULAR/ACR classification criteria provide a patient's probability of having IIM for use in clinical and research settings. The probability is based on a score obtained by summing the weights associated with a set of criteria items
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
autoimmune diseases
dermatomyositis
polymyositis
Megjelenés:RMD Open. - 3 : 2 (2017), p. 1-10. -
További szerzők:Tjärnlund, Anna Santoni, Giola Werth, Victoria P. Pilkington, Clarissa Visser, Marianne de Alfredsson, Lars Amato, Anthony A. Barohn, Richard J. Liang, Matthew H. Singh, Jasvinder A. Aggarwal, Rohit Arnardottir, Snjolaug Chinoy, Hector Cooper, Robert G. Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Dimachkie, Mazen M. Feldman, Brian M. Torre, Ignacio García-De la Gordon, Patrick Hayashi, Taichi Katz, James D. Kohsaka, Hitoshi Lachenbruch, Peter A. Lang, Bianca A. Li, Yuhui Oddis, Chester V. Olesinka, Marzena Reed, Ann M. Rutkowska-Sak, Lidia Sanner, Helga Selva-O'Callaghan, Albert Song, Yeong Wook Vencovsky, Jiri Ytterberg, Steven R. Miller, Frederick W. Rider, Lisa G. Lundberg, Ingrid International Myositis Classification Criteria Project consortium Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository
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5.

001-es BibID:BIBFORM073201
Első szerző:Lundberg, Ingrid
Cím:2017 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Adult and Juvenile Idiopathic Inflammatory Myopathies and Their Major Subgroups / Ingrid E. Lundberg, Anna Tjärnlund, Matteo Bottai, Victoria P. Werth, Clarissa Pilkington, Marianne de Visser, Lars Alfredsson, Anthony A. Amato, Richard J. Barohn, Matthew H. Liang, Jasvinder A. Singh, Rohit Aggarwal, Snjolaug Arnardottir, Hector Chinoy, Robert G. Cooper, Katalin Danko, Mazen M. Dimachkie, Brian M. Feldman, Ignacio Garcia-De La Torre, Patrick Gordon, Taichi Hayashi, James D. Katz, Hitoshi Kohsaka, Peter A. Lachenbruch, Bianca A. Lang, Yuhui Li, Chester V. Oddis, Marzena Olesinska, Ann M. Reed, Lidia Rutkowska-Sak, Helga Sanner, Albert Selva-O'Callaghan, Yeong-Wook Song, Jiri Vencovsky, Steven R. Ytterberg, Frederick W. Miller, Lisa G. Rider, International Myositis Classification Criteria Project Consortium, Euromyositis Register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository
Dátum:2017
ISSN:2326-5191
Megjegyzések:OBJECTIVE:To develop and validate new classification criteria for adult and juvenile idiopathic inflammatory myopathies (IIM) and their major subgroups.METHODS:Candidate variables were assembled from published criteria and expert opinion using consensus methodology. Data were collected from 47 rheumatology, dermatology, neurology, and pediatric clinics worldwide. Several statistical methods were utilized to derive the classification criteria.RESULTS:Based on data from 976 IIM patients (74% adults; 26% children) and 624 non-IIM patients with mimicking conditions (82% adults; 18% children), new criteria were derived. Each item is assigned a weighted score. The total score corresponds to a probability of having IIM. Subclassification is performed using a classification tree. A probability cutoff of 55%, corresponding to a score of 5.5 (6.7 with muscle biopsy) "probable IIM," had best sensitivity/specificity (87%/82% without biopsies, 93%/88% with biopsies) and is recommended as a minimum to classify a patient as having IIM. A probability of ?90%, corresponding to a score of ?7.5 (?8.7 with muscle biopsy), corresponds to "definite IIM." A probability of <50%, corresponding to a score of <5.3 (<6.5 with muscle biopsy), rules out IIM, leaving a probability of ?50-<55% as "possible IIM."CONCLUSION:The European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for IIM have been endorsed by international rheumatology, dermatology, neurology, and pediatric groups. They employ easily accessible and operationally defined elements, and have been partially validated. They allow classification of "definite," "probable," and "possible" IIM, in addition to the major subgroups of IIM, including juvenile IIM. They generally perform better than existing criteria.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Arthritis & Rheumatology 69 : 12 (2017), p. 2271-2282. -
További szerzők:Tjärnlund, Anna Bottai, Matteo Werth, Victoria P. Pilkington, Clarissa Visser, Marianne de Alfredsson, Lars Amato, Anthony A. Barohn, Richard J. Liang, Matthew H. Singh, Jasvinder A. Aggarwal, Rohit Arnardottir, Snjolaug Chinoy, Hector Cooper, Robert G. Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Dimachkie, Mazen M. Feldman, Brian M. Torre, Ignacio García-De la Gordon, Patrick Hayashi, Taichi Katz, James D. Kohsaka, Hitoshi Lachenbruch, Peter A. Lang, Bianca A. Li, Yuhui Oddis, Chester V. Olesinka, Marzena Reed, Ann M. Rutkowska-Sak, Lidia Sanner, Helga Selva-O'Callaghan, Albert Song, Yeong Wook Vencovsky, Jiri Ytterberg, Steven R. Miller, Frederick W. Rider, Lisa G. International Myositis Classification Criteria Project consortium Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository
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6.

001-es BibID:BIBFORM073202
035-os BibID:(WoS)000417061500008 (Scopus)85037677819
Első szerző:Lundberg, Ingrid
Cím:2017 European League Against Rheumatism/American College of Rheumatology classification criteria for adult and juvenile idiopathic inflammatory myopathies and their major subgroups / Ingrid E. Lundberg, Anna Tjärnlund, Matteo Bottai, Victoria P. Werth, Clarissa Pilkington, Marianne de Visser, Lars Alfredsson, Anthony A. Amato, Richard J. Barohn, Matthew H. Liang, Jasvinder A. Singh, Rohit Aggarwal, Snjolaug Arnardottir, Hector Chinoy, Robert G. Cooper, Katalin Dankó, Mazen M. Dimachkie, Brian M. Feldman, Ignacio Garcia-De La Torre, Patrick Gordon, Taichi Hayashi, James D. Katz, Hitoshi Kohsaka, Peter A. Lachenbruch, Bianca A. Lang, Yuhui Li, Chester V. Oddis, Marzena Olesinska, Ann M. Reed, Lidia Rutkowska-Sak, Helga Sanner, Albert Selva-O'Callaghan, Yeong-Wook Song, Jiri Vencovsky, Steven R. Ytterberg, Frederick W. Miller, Lisa G. Rider, International Myositis Classification Criteria Project consortium, Euromyositis register and The Juvenile Dermatomyositis Cohort Biomarker Study and Repository
Dátum:2017
ISSN:0003-4967
Megjegyzések:OBJECTIVE:To develop and validate new classification criteria for adult and juvenile idiopathic inflammatory myopathies (IIM) and their major subgroups.METHODS:Candidate variables were assembled from published criteria and expert opinion using consensus methodology. Data were collected from 47 rheumatology, dermatology, neurology and paediatric clinics worldwide. Several statistical methods were used to derive the classification criteria.RESULTS:Based on data from 976 IIM patients (74% adults; 26% children) and 624 non-IIM patients with mimicking conditions (82% adults; 18% children), new criteria were derived. Each item is assigned a weighted score. The total score corresponds to a probability of having IIM. Subclassification is performed using a classification tree. A probability cut-off of 55%, corresponding to a score of 5.5 (6.7 with muscle biopsy) 'probable IIM', had best sensitivity/specificity (87%/82% without biopsies, 93%/88% with biopsies) and is recommended as a minimum to classify a patient as having IIM. A probability of ?90%, corresponding to a score of ?7.5 (?8.7 with muscle biopsy), corresponds to 'definite IIM'. A probability of <50%, corresponding to a score of <5.3 (<6.5 with muscle biopsy), rules out IIM, leaving a probability of ?50?to <55% as 'possible IIM'.CONCLUSIONS:The European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for IIM have been endorsed by international rheumatology, dermatology, neurology and paediatric groups. They employ easily accessible and operationally defined elements, and have been partially validated. They allow classification of 'definite', 'probable' and 'possible' IIM, in addition to the major subgroups of IIM, including juvenile IIM. They generally perform better than existing criteria.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
autoimmune disease
dermatomyositis
polymyositis
Megjelenés:Annals of The Rheumatic Diseases. - 76 : 12 (2017), p. 1955-1964. -
További szerzők:Tjärnlund, Anna Bottai, Matteo Werth, Victoria P. Pilkington, Clarissa Visser, Marianne de Alfredsson, Lars Amato, Anthony A. Barohn, Richard J. Liang, Matthew H. Singh, Jasvinder A. Aggarwal, Rohit Arnardottir, Snjolaug Chinoy, Hector Cooper, Robert G. Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Dimachkie, Mazen M. Feldman, Brian M. Torre, Ignacio García-De la Gordon, Patrick Hayashi, Taichi Katz, James D. Kohsaka, Hitoshi Lachenbruch, Peter A. Lang, Bianca A. Li, Yuhui Oddis, Chester V. Olesinka, Marzena Reed, Ann M. Rutkowska-Sak, Lidia Sanner, Helga Selva-O'Callaghan, Albert Song, Yeong Wook Vencovsky, Jiri Ytterberg, Steven R. Miller, Frederick W. Rider, Lisa G. International Myositis Classification Criteria Project consortium Euromyositis register and the Juvenile Dermatomyositis Cohort Biomarker Study and Repository
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7.

001-es BibID:BIBFORM073197
Első szerző:Rider, Lisa G.
Cím:2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects / Lisa G. Rider, Nicolino Ruperto, Angela Pistorio, Brian Erman, Nastaran Bayat, Peter A. Lachenbruch, Howard Rockette, Brian M. Feldman, Adam M. Huber, Paul Hansen, Chester V. Oddis, Ingrid E. Lundberg, Anthony A. Amato, Hector Chinoy, Robert G. Cooper, Lorinda Chung, Katalin Danko, David Fiorentino, Ignacio García-De la Torre, Ann M. Reed, Yeong Wook Song, Rolando Cimaz, Rubén J. Cuttica, Clarissa A. Pilkington, Alberto Martini, Janjaap van der Net, Susan Maillard, Frederick W. Miller, Jiri Vencovsky, Rohit Aggarwal, International Myositis Assessment and Clinical Studies Group, Paediatric Rheumatology International Trials Organisation
Dátum:2017
ISSN:1462-0324
Megjegyzések:OBJECTIVE:The 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.RESULTS:Myositis specialists defined the degree of clinically meaningful improvement in CSM for minimal, moderate and major improvement. The conjoint-analysis survey established the relative weights of CSM, with muscle strength and Physician Global Activity as most important. Many candidate definitions showed excellent sensitivity, specificity and area under the curve in the consensus profiles. Trial validation showed that a number of candidate criteria differentiated between treatment groups. Top candidate criteria definitions were presented at the consensus conference.CONCLUSION:Consensus methodology, with definitions tested on patient profiles and validated using clinical trials, led to 18 definitions for adult PM/DM and 14 for JDM as excellent candidates for consideration in the final consensus on new response criteria for myositis.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
1000Minds software
conjoint analysis
dermatomyositis
hybrid measure
juvenile dermatomyositis
outcome assessment
polymyositis
response criteria
Megjelenés:Rheumatology 56 : 11 (2017), p. 1884-1893. -
További szerzők:Ruperto, Nicolino Pistorio, Angela Erman, Brian Bayat, Nastaran Lachenbruch, Peter A. Rockette, Howard Feldman, Brian M. Huber, Adam M. Hansen, Paul Oddis, Chester V. Lundberg, Ingrid Amato, Anthony A. Chinoy, Hector Cooper, Robert G. Chung, Lorinda Dankó Katalin (1952-2021) (belgyógyász, allergológus és klinikai immunológus) Fiorentino, David Torre, Ignacio García-De la Reed, Ann M. Song, Yeong Wook Cimaz, Rolando Cuttica, Ruben Pilkington, Clarissa Martini, Alberto Net, Janjaap van der Maillard, Susan Miller, Frederick W. Vencovsky, Jiri Aggarwal, Rohit International Myositis Assessment and Clinical Studies Group Paediatric Rheumatology International Trials Organisation (PRINTO)
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