Health-related Quality of Life Measure in Pediatric Lupus

Pediatric lupus is a chronic multisystem rheumatic disease, associated with significant
medical and psychosocial implications. Frequent physician visits for routine, urgent or
emergent care, limitation of activities, medication side effects, change in body image, fear
of the future, and missing school are all disruptive to the patients and parents and impact
all spheres of their lives. There is no lupus-specific questionnaire designed to measure the
well-being of children with this disease. We developed a brief questionnaire, "Simple
Measure of Impact of Lupus Erythematosus in Youngsters© (SMILEY©) with both child and parent
versions. We conducted further research about how children/parents feel about having/their
children having lupus and used those responses to modify the preliminary SMILEY©. After
several iterations, the SMILEY with 26 questions was developed with parallel child- and
parent-versions with responses in the form of 5 faces-scale denoting different expressions,
in order to ensure easy comprehension across different ages and cultures.

During their visit, information about their lupus will be collected from the children and
parents, and they will be asked to complete the SMILEY© and questionnaires measuring quality
of life, physical function, self-esteem and behavior. They will be given an additional copy
of SMILEY©, which they will be asked to complete within 10 days of their initial evaluation
and return by mail (self-addressed, stamped envelope will be provided). Then both children
and legal guardians will again be asked to complete questionnaires including SMILEY© during
their subsequent visits at least every 3-6 month intervals or earlier if there has been a
change in disease activity as determined by the physician. Medication use, disease activity
and disease severity assessments will be made by the physician with initial and subsequent
evaluations. We will determine the psychometrics properties of SMILEY and responsiveness to
change in disease activity.

Both national and international sites will be included in the study. SMILEY in addition will
be translated and adapated to different languages and subsequently validated. This study
will provide valuable information about the impact of lupus on their overall well-being.
Being a brief, valid, reliable and easy to administer instrument, SMILEY© would be suitable
for use across different age groups, languages and cultures. SMILEY© will be used as an
important clinical outcome tool in both clinical and research arenas, thus enabling us to
formulate appropriate interventions.

Inclusion Criteria:

- (1) Willing to participate

- (2) Have a child with SLE that meets eligibility criteria for the study

Exclusion Criteria:

- (1) Subjects who are not well enough to complete the questionnaires

- (2) Physical or mental disabilities which would seriously affect the individual's
ability to understand the informed consent or study questionnaires

- (3) Refusal to participate