Children and Teens 8 to 18 Needed for Lupus Outcomes Research Study
What is the purpose of this study?
The purpose of this research study is to support the Pediatric Patient Reported Outcomes Measurement Information System (PROMIS) Item Banks for pediatric systematic lupus erythematosus (pSLE) and compare its performance to other quality of life measures previously proven for pSLE.
Who can participate?
Children and teenagers 8 to 18 years old who:
• Have been diagnosed with pSLE before the age of 17
• Are able to speak and read English
• Are able to see and use the computer
A parent or legal guardian will also participate.
What is involved?
You and your child will be in the research study for up to one year. Participation will involve three study visits at the time of routine clinic visits. A detailed list of procedures will be provided to parents or guardians interested in knowing more about this study. Here are some of the procedures:
You and your child will be asked to:
• Complete questionnaires on a computer
• The questionnaires involve measures of physical function, pain, disability, assessment of well-being and quality of life
What are the benefits?
Your child will not receive a direct medical benefit. However, the information gained from this study may help patients with chronic medical conditions in the future by improving the way the health status from the patient’s point of view is measured. Also, the information learned from this research study may benefit other patients with pSLE in the future.
Will I get all the facts about the study?
You, as a participant or parent interested in having their child participate, will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the risks and discomforts of the study?
There are no physical risks associated with this study. Other possible discomforts or risks will be discussed with parents or guardians interested in learning more about the study.
Do participants receive pay, compensation or reimbursement?
The child or teenager will receive $10 for each completed study visit.
Who should I contact for more information?
Hermine Brunner, MD
Division of Rheumatology
Cincinnati Children’s Hospital Medical Center