Awardee OrganizationCINCINNATI CHILDRENS HOSP MED CTR
Description
Abstract Text
DESCRIPTION (provided by applicant): BACKGROUND: This is a pilot study to evaluate the use of steroids and other medications in children diagnosed with SLE (cSLE). After having revolutionized the prognosis of lupus in the 1950s, steroids remain the mainstay of therapy of cSLE. Recent studies suggest that, despite their proven benefits, steroids contribute to the development of permanent disease damage in both adult and pediatric SLE patients. 10-year patient survival is only at 85%. Preliminary data support that there is a considerable degree of practice variation among pediatric rheumatologists treating cSLE and that these differences in treatment approach may have an impact on patient outcomes. There are no published guidelines of how to best treat cSLE, especially how to use steroids for its the treatment and when to introduce other steroid-sparing medications.
GOALS: 1) To document treatment patterns of pediatric rheumatologists for patients with cSLE in order
a) To identify key factor that prompt physicians to choose a certain steroid dose and document the factors that make
physicians change a given dose of steroids;
b) To identify the key variables that prompt physicians to introduce of immunosuppressive therapies for patients diagnosed with cSLE.
2) To measure quality of life and specific outcomes (damage, costs) associated with the treatment of children and adolescents diagnosed with cSLE.
STUDY DESIGN: A cohort of consecutively sampled patients treated for cSLE (n=70) at 4 pediatric US and Canadian Rheumatology Centers (Chicago, Cincinnati, Minneapolis, Toronto) will be assessed in at least tri-monthly intervals over an 18-month period regarding their disease course (disease activity, number of flares, infection and hospitalization), treatments, and outcomes (damage, quality of life). Key determinants that prompt the physicians to use certain therapies will be recorded. Relevant retrospective patient information will be obtained by chart review. Patient quality of life and treatment costs will be measured. Correlation, regression, multivariable modeling including repeated measure analysis will be used to analyze the relationship of cSLE therapies to outcomes (damage, quality of life, costs) and to key determinants of treatment decisions in cSLE.
SIGNIFICANCE: The proposed pilot study will provide information regarding physician treatment patterns, cost of cSLE and patient quality of life. Data will be collected to support that there are important differences in the approach to cSLE therapy that have a significant impact on patient outcomes. Results of the study will be used to generate hypotheses towards improved treatment approaches for cSLE. The proposed study constitutes a first step towards the development of evidence-based guidelines. Information on HRQL and costs of patients diagnosed with cSLE is required for future cost-effectiveness analyses of treatments for cSLE.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
artificial immunosuppressionchildrenclinical researchconnective tissue disorder chemotherapyconnective tissue pharmacologydecision makingdosagedrug adverse effectdrug screening /evaluationhealth care cost /financinghuman subjecthuman therapy evaluationlongitudinal human studyoutcomes researchpatient care planningpatient oriented researchpharmacokineticsquality of lifequestionnairesstatistics /biometrysteroidssystemic lupus erythematosus
National Institute of Arthritis and Musculoskeletal and Skin Diseases
CFDA Code
846
DUNS Number
071284913
UEI
JZD1HLM2ZU83
Project Start Date
08-May-2003
Project End Date
30-April-2006
Budget Start Date
08-May-2003
Budget End Date
30-April-2004
Project Funding Information for 2003
Total Funding
$74,000
Direct Costs
$50,000
Indirect Costs
$24,000
Year
Funding IC
FY Total Cost by IC
2003
National Institute of Arthritis and Musculoskeletal and Skin Diseases
$74,000
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for 1R03AR049860-01
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 1R03AR049860-01
Patents
No Patents information available for 1R03AR049860-01
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 1R03AR049860-01
Clinical Studies
No Clinical Studies information available for 1R03AR049860-01
News and More
Related News Releases
No news release information available for 1R03AR049860-01
History
No Historical information available for 1R03AR049860-01
Similar Projects
No Similar Projects information available for 1R03AR049860-01