About the Safety Working Group
Harms provide important context for healthcare practitioners about the benefit-risk ratio of interventions. To improve transparency and credibility in the published results from randomized trials, the reporting of harms associated with an intervention needs to be explicit regarding what is patient-important, which may be different from that reported by clinicians submitting adverse event reports
Following the concerns about inadequate reporting of harm outcomes in randomized trials and systematic reviews the Outcome Measures in Rheumatology (OMERACT) Safety Working Group is advancing the work to identify additional harm aspects for assessment in rheumatology trials
Peter Brooks
Co-Chair
Robin Christensen
Co-Chair
Caroline Flurey
Co-Chair
Lee Simon
Co-Chair
Dorthe Bang Berthelsen
Fellow
Pam Richards
Patient Research Partner
Marieke Scholte-Voshaar
Patient Research Partner
How patients can help the Safety Working Group to improve reporting of side effects from rheumatological medications.
Working Group Publications
Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group
Improving benefit-harm assessment of therapies from the patient perspectives: OMERACT pre-meeting towards consensus on core sets for randomized controlled trials
Patient Perspectives on DMARD Safety Concerns in Rheumatology Trials: Results from Inflammatory Arthritis Patient Focus Groups and OMERACT Attendee Discussions
Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials
Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group
How to Ascertain Drug Safety in the Context of Benefit. Controversies and Concerns
Observations from the OMERACT Drug Safety Summit, May 2008
Standardizing Assessment and Reporting of Adverse Effects in Rheumatology Clinical Trials II: the Rheumatology Common Toxicity Criteria v.2.0
Standardized Assessment of Adverse Events in Rheumatology Clinical Trials: Summary of the OMERACT 7 Drug Safety Module Update
Generic Patient Self-Report and Investigator Report Instruments of Therapeutic Safety and Tolerability
Challenges and Progress in Adverse Event Ascertainment and Reporting in Clinical Trials
Drug Safety Module: Summary and Recommendations
Patient-Based Method of Assessing Adverse Events in CLincial Trials in Rheumatology: The Revised Standford Toxicity Index
The WHO Programme for International Drug Monitoring, its database, and the technical support of the Uppsala Monitoring Center.
Arthritis, Rheumatism, and Aging Medical Information SYstem Post-Marketing Surveillance Program
A proposal for developing a large patient population cohort for longterm safety monitoring in rheumatoid arthritis. OMERACT Drug Safety Working Party.
Standardizing Assessment of Adverse Effects in Rheumatology Clinical Trials. Status of OMERACT Toxicity Working Group March 2000: Towards a Common Understanding of Comparative Toxicity/Safety Profiles for Antirheumatic Therapies
OMERACT 5 Drug Safety Working Group Report: Introduction
Patient-Based Methods for Assessing Adverse Events in Clinical Trials in Rheumatology. Progress Report for the OMERACT Drug Toxicity Working Party
Workshop Report - Part 1 Toxicity of Antirheumatic Drugs
ARAMIS and Toxicity Measurement
A Critical Appraisal of Toxicity Indexes in Rheumatology
Adverse Drug Reactions and their Measurement in the Rheumatic Diseases
The Toxicity of NSAID and Antirheumatic Drugs An Introduction
Working Group Members:
Alessandro Giollo
Amanda Burls
Amye Leong
Andrea Falzon
Anupam Wakhlu
Aya Akmal Amin
Ayano Kelly
Bev Shea
Birthe Mette Pedersen
Caroline Flurey
Catherine Hill
Charmaine Jones
Chris Djurtoft
Clifton (Bing) Bingham
Daniel Devoe
Daniel Furst
Dario Scublinsky
Deb Constien
Denise Bury-Maynard
Dorcas Beaton
Dorthe Bang Berthelsen
Edward Henstridge
Elisabeth Ginnerup Læbo
Emily Schildt
Gabriela Tabaj
Glen Hazelwood
Ilfita Sahbudin
Inna Gaydukova
Jane Hayes
Jasvinder Singh
Javier Rios
Jorge Juan Fragío Gil
Karina Torralba
Khaled Abdelgalil
Laura Dayries
Laura Sergison
Lee Simon
Lyn March
Lynne Matallana
Maarten Boers
Maarten de Wit
Maria Suarez-Almazor
Marianne U. Rasmussen
Marieke Voshaar
Marios Kouloumas
Marita Cross
Maxine Isbel
Nino Tsiskarishvili
Niti Goel
Oliver Kraemer
Orit Schieir
Pam Richards
Patricia Hurley
Patrick Durez
Paula Williamson
Peter Brooks
Peter Tugwell
Phyllis Bass
Randall Stevens
Rebecca Sweet
Robin Christensen
Sabrina M Nielsen
Samar Tharwat Radwan
Stacey Grealis
Susan Bartlett
Susan Goodman
Tamer Gheita
Tanja Schjødt Jørgensen
Thasia Woodworth
Torkell Ellingsen
Vibeke Strand
Yeonhew Kim