Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials

被引：7

作者：

Klokker, Louise ^{[1
]}

Berthelsen, Dorthe B. ^{[1
]}

Woodworth, Thasia ^{[3
]}

Andersen, Kathleen M. ^{[11
]}

Furst, Daniel E. ^{[3
]}

Devoe, Dan ^{[17
]}

Williamson, Paula R. ^{[18
]}

Suarez-Almazor, Maria E. ^{[6
]}

Strand, Vibeke

Leong, Amye L. ^{[4
,5
]}

Goel, Niti ^{[7
]}

Boers, Maarten ^{[19
]}

Brooks, Peter M. ^{[15
]}

March, Lyn ^{[16
]}

Sloan, Victor S. ^{[8
,9
]}

Tugwell, Peter ^{[12
,13
,14
]}

Simon, Lee S. ^{[10
]}

Christensen, Robin ^{[2
,20
]}

机构：

[1] Bispebjerg & Frederiksberg Hosp, Parker Inst, Musculoskeletal Stat Unit, Clin Epidemiol, Copenhagen, Denmark

[2] Univ Southern Denmark, Odense Univ Hosp, Dept Clin Res, Res Unit Rheumatol, Odense, Denmark

[3] UCLA, Div Rheumatol, David Geffen Sch Med, Los Angeles, CA USA

[4] Hlth Motivat, Santa Barbara, CA USA

[5] Global Alliance Musculoskeletal Hlth Bone & Joint, Director Strateg Relat, Santa Barbara, CA USA

[6] Univ Texas MD Anderson Canc Ctr, Sect Rheumatol & Clin Immunol, Houston, TX 77030 USA

[7] Duke Univ, Sch Med, Div Rheumatol, Durham, NC USA

[8] UCB Bio Sci Inc, Raleigh, NC USA

[9] Rutgers Robert Wood Johnson Med Sch, Med, New Brunswick, NJ USA

[10] SDG LLC, Cambridge, MA USA

[11] McGill Univ, Dept Family Med, Montreal, PQ, Canada

[12] Univ Ottawa, Div Rheumatol, Dept Med, Ottawa, ON, Canada

[13] Univ Ottawa, Sch Epidemiol & Publ Hlth, Fac Med, Ottawa, ON, Canada

[14] Ottawa Hosp Res Inst, Clin Epidemiol Program, Ottawa, ON, Canada

[15] Univ Melbourne, Ctr Hlth Policy, Melbourne Sch Populat & Global Hlth, Melbourne, Vic, Australia

[16] Univ Sydney, Sydney, NSW, Australia

[17] Univ Calgary, Dept Med, Hlth Serv Res, Cumming Sch Med, Calgary, AB, Canada

[18] Univ Liverpool, Inst Translat Med, Med Stat, Liverpool, Merseyside, England

[19] Vrije Univ Amsterdam Med Ctr, Amsterdam Rheumatol & Immunol Ctr, Dept Epidemiol & Biostat, Clin Epidemiol, Amsterdam, Netherlands

[20] Bispebjerg & Frederiksberg Hosp, Parker Inst, Musculoskeletal Stat Unit, Biostat & Clin Epidemiol, Copenhagen, Denmark

来源：

JOURNAL OF RHEUMATOLOGY | 2019年 / 46卷 / 09期

关键词：

ADVERSE EVENTS; SAFETY; HARM; CORE OUTCOME SET; OMERACT; ARTHRITIS; CLINICAL-TRIALS; STANDARDIZING ASSESSMENT; TOXICITY INDEX;

D O I：

10.3899/jrheum.190196

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective. The Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology. Methods. Systematically searching the MEDLINE database on January 24, 2017, we identified full-text articles that could be used for harm outcomes in rheumatology. Domains/items from the identified instruments were described and the content synthesized to provide a preliminary framework for harm outcomes. Results. From 435 possible references, 24 were read in full text and 9 were included: 7 measurement instruments were identified. Investigation of domains/items revealed considerable heterogeneity in the grouping and approach. Conclusion. The ideal way to assess harm aspects from the patients' perspective has not yet been ascertained.

引用

页码：1173 / 1178

页数：6

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