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

Louise Klokker1,2, Dorthe B Berthelsen1,2, Thasia Woodworth1,2

  • 1From the Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA), Los Angeles; Division of Immunology and Rheumatology, Stanford University, Stanford; Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Rheumatology, Duke University School of Medicine, Durham; UCB Bio Sciences Inc., Raleigh, North Carolina; Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey; SDG LLC, Cambridge, Massachusetts, USA; Department of Family Medicine, McGill University, Montreal, Quebec; Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne, Melbourne; University of Sydney, Sydney, Australia.

The Journal of Rheumatology
|May 3, 2019
PubMed
Summary

The Outcome Measures in Rheumatology (OMERACT) Safety Working Group aimed to identify harm domains in rheumatology outcome measures. Current instruments show heterogeneity, and patient-reported harm assessment needs further development.

Keywords:
ADVERSE EVENTSARTHRITISCORE OUTCOME SETHARMOMERACTSAFETY

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Area of Science:

  • Rheumatology
  • Clinical Trial Methodology
  • Patient Safety

Background:

  • Assessing harm is crucial in rheumatology clinical trials.
  • Existing outcome measures for harm in rheumatology lack standardization.

Purpose of the Study:

  • To identify and categorize harm domains within existing rheumatology outcome measurements.
  • To develop a preliminary framework for assessing harm in rheumatology.

Main Methods:

  • Systematic literature search of MEDLINE database.
  • Inclusion of full-text articles detailing harm outcome measures.
  • Synthesis of domains and items from identified instruments.

Main Results:

  • Seven measurement instruments for harm were identified from 9 included studies.
  • Significant heterogeneity was observed in the grouping and approach to harm domains.
  • A preliminary framework for harm outcomes was developed.

Conclusions:

  • The current landscape of harm measurement in rheumatology is heterogeneous.
  • Further research is needed to establish optimal methods for assessing patient-reported harm.