Integrating PROMIS in SLE Clinical Care- Part 2

Institutional Review Board, Hospital for Special Surgery

April 15, 2019

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Lisa A. Mandl, MD, MPH

Co-Investigators

Jessica R. Berman, MD
David R. Fernandez, MD
Kyriakos A. Kirou, MD, DSc, FACP
Lisa R. Sammaritano, MD
Dina Sheira

Summary

65 patients, 1 year enrollment period, follow up for 2 visits after enrollment

Inclusion/Exclusion Criteria

Inclusion Criteria:

• ≥ 18 years of age
• Be able to speak, read, and write in English.
• Fulfill American College of Rheumatology (ACR)35 or Systemic Lupus International Collaborating Clinics (SLICC)36 criteria for SLE
• Receive ongoing SLE care at Tufts Medical Center or Hospital for Special Surgery, specifically, a minimum of 2 visits with the same provider in the previous year.
• Pregnant women will be eligible for the study.

Exclusion Criteria:

• Any active malignancy other than non-melanomatous skin cancer.
• Current hemodialysis treatment.
• Inability to understand and complete required study instruments.

Contact Information

Lisa A. Mandl, MD, MPH
mandll@hss.edu
212.774.2555

Dina Sheira
sheirad@hss.edu
212.774.2754