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Proposal 998

Title of the Proposed Research

Determination of minimally important difference for short form 36 and Facit Fatigue for Systemic lupus erythematosus

Lead Researcher

Meenakshi Jolly, MD, MSCP

Affiliation

Rush University Medical Center
Chicago, IL
USA

Funding Source

None

Potential Conflicts of Interest

Lead Researcher: Copyrights to LupusPRO and LIT. However, either of these tools were not used in BLYSS studies and thus unlikely to have conflicts of Interest.

Management of Real or Potential Conflicts of Interest: HoweLIT, LupusPRO were not used in BLYSS studies and thus unlikely to have conflicts of Interest.
All analysis will be scientifically performed

Data Sharing Agreement Date

20 May 2015

Lay Summary

In medical intervention studies, it is advisable to include assessment of a patient’s perspective on improvement or worsening in their health status in response to the intervention. This is done using patient reported outcome surveys (e.g. short form 36). However, it is important for the investigators to ensure that the patient reported survey tool does capture even minimal but significant changes in health status in response.

Establishing minimally important differences (MID) values for the patient reported outcome survey tool is therefore important. MID for the same tool can vary by groups of patients e.g. by disease. MID for SF36 for osteoarthritis and rheumatoid arthritis are different, as are for FACIT-Fatigue. MID for short form 36 has been not been established for SLE, and currently we use generic template based MID set for small effect size for SF36 in SLE. Herein, we propose to systematically determine the MID for SF36 and FACIT-Fatigue from longitudinal belimumab study data. The information thus calculated will provide significant advancement in clinical trials designs and interventional trials in SLE in the future.

Study Data Provided

Study HGS1006-C1056: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)
Study HGS1006-C1057: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Statistical Analysis Plan

This will be added after the research is published.

Publication Citation