Health-related Quality of Life Measure in Pediatric Lupus
Condition: Systemic Lupus Erythematosus; Quality of Life
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      To examine the psychometric properties of a brief quality of life (QOL) instrument for use in
      pediatric systemic lupus erythematosus (SLE). The purpose of this prospective study is
      primarily to determine the validity and reliability of a new health-related quality of life
      (HRQOL) measure in children with systemic lupus erythematous (SLE). We wish to secondarily
      examine concordance between child- and parent-reports of the HRQOL measure and identify
      factors associated with poorer HRQOL in them.

      Earlier studies have shown that SLE significantly impacts QOL in adults. At present, there is
      no disease-specific instrument for measuring HRQOL in children with SLE. In response to these
      concerns, we developed the "Simple Measure of Impact of Lupus Erythematosus in Youngsters©
      (SMILEY©). Establishing the validity and reliability of SMILEY©, examining child-parent
      agreement and identifying factors associated with poorer HRQOL will enable us to measure the
      impact of SLE in children, and formulate appropriate interventions for this sensitive
      population. We plan the following specific aims:

        1. to determine construct validity and reliability of SMILEY© child and parent versions in
           children with SLE using gold standards (Pediatric Quality of Life inventory - PedsQL
           generic and rheumatology modules, Childhood Health Assessment Questionnaire -CHAQ)

        2. to determine responsiveness of SMILEY©

        3. to examine level of agreement between child- and parent-reports of SMILEY© in children
           with SLE

        4. to identify medical (steroid use, use of disease modifying agents such as cytoxan,
           cellcept, thalidomide, or cyclosporine, disease duration, disease activity and disease
           damage etc.) and psychosocial (self-concept, socioeconomic status) factors that affect
           HRQOL (as measured by child- and parent-reports of SMILEY© and PedsQL generic and
           rheumatology modules) and physical function 5) to translate, adapt and validate SMILEY
           in different languages
    

Detailed description: 
      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.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population will consist of outpatients during clinics visits and inpatients during
        hospitalizations.
      
Keywords: Quality of Life; Pediatric Systemic Lupus Erythematosus