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Developing Classification Criteria To Identify Kidney Failure In People With Scleroderma

 

 

Scientific Study Title:

Multicriteria decision analysis with 1000Minds for developing scleroderma renal crisis classification criteria.

 

Study Start Date:

Sept 2023

End Date:

August 2024

 

Why Do This Research?

Scleroderma is a group of autoimmune diseases that may result in changes to the skin, blood vessels, and internal organs. A rare, but serious complication of scleroderma is sudden kidney failure (scleroderma renal crisis). One-third of patients with kidney failure will die within one year. Among those who survive, one-quarter will remain on dialysis (treatment for kidney failure) after one year. (Hudson et al., Seminars Arthritis Rheumatol. 2014).

At present, there is no standardized set of criteria to define scleroderma renal crisis; instead, there are 41 different published sets of criteria (Hoa et al., Autoimmunity Rev. 2017). Not having a common standard has slowed research on this condition, leading to a poor understanding of the problem and a lack of more effective treatments.

The Scleroderma Clinical Trials Consortium is the leading international group that advances standards of research for people with scleroderma. In 2015, they asked us to develop classification criteria for scleroderma renal crisis. The goal is to improve future studies looking at new treatments for scleroderma renal crisis. Since then, we have asked experts to identify a set of items that could be included in the classification criteria (Butler et al. Arthritis Rheumatol. 2019) and we have collected the data for this core set of items from an international group of scleroderma patients with new onset scleroderma renal crisis (our ‘inception cohort’).

 

What Will Be Done?

We are starting the next phase of this project using the data from the core set and the 1000Minds methodology. We will ask a panel of experts to rank cases according to whether the case would be classified as scleroderma renal crisis. Our research team members are world experts when developing classification criteria using this methodology. The research team has also helped create new classification criteria for lupus and antiphospholipid syndrome. We are confident that this new classification criteria for scleroderma renal crisis will become the standard used for all future research and will lead to improved outcomes for people with scleroderma who develop renal crisis.

 

Who Is Involved?

The cohort group that was initiated in 2015 includes Scleroderma patients who developed scleroderma renal crisis. A patient partner will participate on the 1000Minds panel. The Research Team is composed of accomplished researchers leading the fields of scleroderma, scleroderma renal crisis and classification criteria for rheumatic diseases.

 

Research Team

Principal Investigators:

Dr. Marie Hudson, MD, MPH, FRCPC, Research Scientist, Arthritis Research Canada (McGill University)

Sindhu Johnson (University of Toronto)

Christopher Denton (University College London)

Co-Investigators:

1000Minds classification/researchers

Dr. Sabrina Hoa, MD, MPH, FRCPC, Research Scientist Arthritis Research Canada (University of Montreal)
Dr. Edward Stern (St George’s University of London)

 

Who is funding the research?

Canadian Initiative for Outcomes in Rheumatology cAre (CIORA)