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Titolo:
Proposed preliminary core set measures for disease outcome assessment in adult and juvenile idiopathic inflammatory myopathies
Autore:
Miller, FW; Rider, LG; Chung, YL; Cooper, R; Danko, K; Farewell, V; Lundberg, I; Morrison, C; Oakley, L; Oakley, I; Pilkington, C; Vencovsky, J; Vincent, K; Scott, DL; Isenberg, DA;
Indirizzi:
US FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA US FDA Bethesda MD USAUS FDA, Ctr Biol Evaluat & Res, Bethesda, MD USA Hammersmith Hosp, MRI Unit, London W12 0HS, England Hammersmith Hosp London England W12 0HS RI Unit, London W12 0HS, England Hope Hosp, Ctr Rheumat Dis, Salford M6 8HD, Lancs, England Hope Hosp Salford Lancs England M6 8HD is, Salford M6 8HD, Lancs, England Debrecen Univ Med, Dept Internal Med, Debrecen, Hungary Debrecen Univ MedDebrecen Hungary Dept Internal Med, Debrecen, Hungary Univ Coll London, London WC1E 6BT, England Univ Coll London London England WC1E 6BT ondon, London WC1E 6BT, England Karolinska Inst, Dept Med, Rheumatol Unit, S-17176 Stockholm, Sweden Karolinska Inst Stockholm Sweden S-17176 Unit, S-17176 Stockholm, Sweden Kings Coll Hosp Dulwich, Dept Rheumatol, London SE22 8PT, England Kings Coll Hosp Dulwich London England SE22 8PT London SE22 8PT, England Dermatomyositis & Polymyositis Support Grp, Southampton SO19 9HR, Hants, England Dermatomyositis & Polymyositis Support Grp Southampton Hants England SO19 9HR Middlesex Hosp, Ctr Rheumatol, London W1P 9PL, England Middlesex Hosp London England W1P 9PL Rheumatol, London W1P 9PL, England Inst Rheumatol, Prague 12850 2, Czech Republic Inst Rheumatol Prague Czech Republic 12850 2 gue 12850 2, Czech Republic Weston Educ Ctr, Dept Acad Rheumatol GKT, London SE5 9PJ, England Weston Educ Ctr London England SE5 9PJ atol GKT, London SE5 9PJ, England Kings Coll Hosp Dulwich, London W1P 9PG, England Kings Coll Hosp Dulwich London England W1P 9PG , London W1P 9PG, England Univ Coll London Hosp, Ctr Rheumatol, London W1P 9PC, England Univ Coll London Hosp London England W1P 9PC ol, London W1P 9PC, England
Titolo Testata:
RHEUMATOLOGY
fascicolo: 11, volume: 40, anno: 2001,
pagine: 1262 - 1273
SICI:
1462-0324(200111)40:11<1262:PPCSMF>2.0.ZU;2-8
Fonte:
ISI
Lingua:
ENG
Soggetto:
SYSTEMIC LUPUS-ERYTHEMATOSUS; INTRAVENOUS GAMMA-GLOBULIN; RHEUMATOLOGY DAMAGE INDEX; INCLUSION-BODY MYOSITIS; POLYMYOSITIS-DERMATOMYOSITIS; REFRACTORY POLYMYOSITIS; CONTROLLED TRIAL; THERAPY; CHILDREN; IMMUNOGLOBULIN;
Keywords:
idiopathic inflammatory myopathies; outcome measures;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
57
Recensione:
Indirizzi per estratti:
Indirizzo: Miller, FW NIEHS, Environm Autoimmun Grp, Off Clin Res, NIH, 9 Mem Dr,Room1W101,MSC 0958, Bethesda, MD 20892 USA NIEHS 9 Mem Dr,Room 1W101,MSC 0958 Bethesda MD USA 20892 92 USA
Citazione:
F.W. Miller et al., "Proposed preliminary core set measures for disease outcome assessment in adult and juvenile idiopathic inflammatory myopathies", RHEUMATOLOG, 40(11), 2001, pp. 1262-1273

Abstract

In order to develop a preliminary core set of disease outcome measures foruse in clinical trials of idiopathic inflammatory myopathies (IIM), we evaluated those measures used in previous trials, assessed the validation of published instruments and discussed these at an international consensus conference. The initial proposals were further refined by a multidisciplinary group of adult and paediatric specialists experienced in IIM using the Delphi method. The proposed preliminary core set of disease activity measures consists of five domains: physician and patient parent global assessments of disease activity; muscle strength: physical function, serum activity of muscle enzymes; and an assessment tool to capture extra-skeletal muscle disease activity. The group recommended further development of a core set of disease damage measures for assessment of persistent changes in anatomy, pathology and function of at least 6 months' duration. The group recommended thatpatient-reported outcomes should include generic health-related quality oflife assessments using the Medical Outcomes Study 36-item Short Form (SF-36) health survey in adult IIM patients and a validated quality of life instrument for paediatric patients. We propose the core set of outcome measuresas a minimum group of assessments to include in all IIM therapeutic studies. The use of this core set should assist in standardizing outcome measurement and in optimizing therapeutic trials in myositis.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 18/01/20 alle ore 02:05:43