OMERACT SLE Delphi

NCT07136090 | Not Yet Recruiting

• 1 other identifier: 24-5926
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

SLE is a chronic multi-systemic autoimmune disease with clinical manifestations characterized by recurrent flares in disease activity and damage in several organs. SLE affects primarily women during child bearing age and is negatively related to productivity, social role participation and health-related quality of life. The multi-systemic nature of SLE and its diverse clinical manifestations have led to many outcome measurements being utilized in SLE clinical trials and longitudinal studies. To standardize measurement in clinical trials and longitudinal studies, the OMERACT SLE Group developed the core domain set for SLE in 1998. A core domain set is a set of outcome measures, capturing all the facets/aspects of the disease, that standardizes measurement and research across clinical trials and longitudinal studies necessary for the advancement of the field. Since development in 1998, many new important domains for SLE have been identified, thus there is an unmet need to update the core domain set. A new OMERACT SLE Working Group has been established to update the SLE core domain set. This is a qualitative study that aims to prioritize domains to include in the SLE core domain set. All participants will be asked to complete a four-round online survey. During rounds 1-3 participants will be asked to rate the importance of each domain to be included; round 4 will ask participants select and rank domains. Participants will also have the option of adding other items or descriptors and to provide any other feedback. Each round of the survey will take approximately 15-20 minutes to complete. Participants will need to participate in round 1 in order to be invited to round 2, and then participate in round 2 in order to be invited to round 3, and final participate in round 3 in order to be invited to round 4.

Conditions

SLE - Systemic Lupus Erythematosus

Keywords

Core Outcome Set

Outcome Measures

Primary Outcomes (1)

• SLE Core Domain Set as determined by a 4-round Delphi survey

  A 4-round Delphi survey will be conducted to ascertain preliminary opinions on the importance of domains measured in SLE to develop a Core Domain Set. Once all 4 rounds of the Delphi are complete the feedback along with the results of all three rounds of the Delphi process will be provided to the Working Group in an anonymous format who will use the data of the voting rounds, the selection of the most important domains, and the comments to make their final evidence-based decisions on the content of Core Domain Set. The draft Core Domain Set will be presented the OMERACT Community for endorsement.

  6 months

Study Arms (2)

Patient cohort

Those with lived experience of systemic lupus erythematosus

Other Stakeholder cohort

Clinicians, researchers, payors, policy makers, pharmaceutical industry, regulators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

As part of developing and implementing a Core Outcome Set engagement of various stakeholders is essential. The working group will work to engage various stakeholders using the framework below as well as representation from a minimum of 3 continents. 200 SLE patients and 200 other stakeholders will be approached for recruitment. Stakeholder groups include: Patients/Public: Individuals receiving or advocating for patient-centered care. Providers: Healthcare professionals and organizations delivering care. Purchasers: Entities underwriting healthcare costs (e.g., employers, governments). Payers: Those reimbursing care (e.g., insurers, Medicare). Policy Makers: Regulatory and legislative bodies (e.g., FDA, HHS). Product Makers: Drug and device manufacturers. Researchers: Principal investigators and their funders.

You may qualify if:

• Males and Females
• and older
• Able to read and understand English, Spanish, French, Italian, Portuguese, Japanese, Arabic, Korean, Hebrew, German, and Chinese
• Have access to email and the internet

You may not qualify if:

• Not able to read and understand English, Spanish, French, Italian, Portuguese, Japanese, Arabic, Korean, Hebrew, German, and Chinese
• Does not have access to email and the internet

Sponsors & Collaborators

• University Health Network, Toronto: lead
• OMERACT: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zahi Touma, MD, PhD

  University Health Network and University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennisse Bonilla

CONTACT

416-603-5800; dennisse.bonilla@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 22, 2025
• Study Start: September 15, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share