Core Outcome Measures in Effectiveness Trials

Developing a Core Outcome Set for Safety in Rheumatology Trials Using a Mixed-Methods Approach: Protocol for an OMERACT multicenter study

General Information

Summary:
Introduction: Collection of patients’ self-reported adverse events (e.g. symptoms) is considered mandatory in clinical research to assure patient safety and to understand the risk of harms, yet there is no standard measurement approach for collecting direct patient reports of AEs in rheumatology clinical trials. Our objective is to develop and validate a checklist of potential safety events for use in rheumatology clinical trials.

Methods/Design: This is a mixed-methods study incorporating four distinct phases. The first phase will include a scoping review of the scientific literature to identify domains included in outcome measures developed for use in rheumatology clinical trials. The second phase will involve focus groups with patients diagnosed with an inflammatory arthritis condition, to determine which outcome domains are important to them. The outcome domains elicited from these two stages will inform the third phase of the study, in which a list of domains/items will be ranked in terms of importance using electronic Delphi surveys involving patients and health care professionals. The final phase of the study will involve face-to-face consensus meetings with representatives of key stakeholder groups, to discuss and agree on the outcomes that should be included in the core domain set.

Ethics and dissemination: This study will be carried out in accordance with the Helsinki Declaration. Ethics approvals will be obtained locally, and signed informed consent will be obtained from all participants . We aim to disseminate the results of the study through publication in international peer-reviewed journals and at international conferences, and working with national and international patient advocacy groups and arthritis patient foundations.

Contributors:
Kathleen M. Andersen, Susan Bartlett, Beverley J Shea, Amye L. Leong, Louise Klokker, Dorthe Berthelsen, Thasia Woodworth, Dan Devoe, Paula Williamson, Caroline B. Terwee, Maria E. Suarez-Almazor, Vibeke Strand, Niti Goel, Maarten Boers, Daniel E. Furst, Peter Tugwell, Peter M. Brooks, Lee S. Simon, Robin Christensen (Principal Investigator)

Further Study Information

Current Stage:
Ongoing
Date:
March 2017
Funding source(s):
None

Health Area

Disease Category
Rheumatology

Disease Name
Inflammatory arthritis

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Delphi process
Focus group(s)
Systematic review

This is a mixed-methods study incorporating four distinct phases. The first phase will include a scoping review of the scientific literature to identify domains included in outcome measures developed for use in rheumatology clinical trials. The second phase will involve focus groups with patients diagnosed with an inflammatory arthritis condition, to determine which outcome domains are important to them. The outcome domains elicited from these two stages will inform the third phase of the study, in which a list of domains/items will be ranked in terms of importance using electronic Delphi surveys involving patients and health care professionals. The final phase of the study will involve face-to-face consensus meetings with representatives of key stakeholder groups, to discuss and agree on the outcomes that should be included in the core domain set.


Stakeholders Involved

Clinical experts
Consumers (patients)
Epidemiologists
Pharmaceutical industry representatives
Policy makers
Regulatory agency representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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