A Personalized Decision Aid to Help Women with Lupus Nephritis from Racially and Ethnically Diverse Backgrounds Make Decisions about Taking Immune-Blocking Medicines

Abstract

............................................................................................................................ 3 BACKGROUND ....................................................................................................................... 5 PARTICIPATION OF PATIENTS AND OTHER STAKEHOLDERS IN RESEARCH DESIGN, CONDUCT, AND DISSEMINATION OF FINDINGS ....................................................................................... 9 Study Intervention Development ............................................................................................................................ 12 Study Design, Population, and Setting: Randomized Trial ...................................................................................... 26 Randomized Trial Study Intervention ...................................................................................................................... 27 Baseline and Follow-up Study Visits ........................................................................................................................ 27 Outcome Measures ................................................................................................................................................. 28 Statistical Analyses .................................................................................................................................................. 31 Conduct of the Study ............................................................................................................................................... 32 RESULTS .............................................................................................................................. 33 1. Primary Outcome ................................................................................................................................................ 40 2. Primary Outcome ................................................................................................................................................ 42 3. Secondary Outcome ............................................................................................................................................ 43 4. Secondary Outcome ............................................................................................................................................ 44 5. Secondary Outcome ............................................................................................................................................ 44 DISCUSSION ........................................................................................................................ 51 Context for Study Result.......................................................................................................................................... 51 Generalizability of the Findings ............................................................................................................................... 55 Implementation of Study Results ............................................................................................................................ 55 Subpopulation Considerations ................................................................................................................................ 57 Study Strengths and Limitations.............................................................................................................................. 57 Future Research ...................................................................................................................................................... 59 CONCLUSION ....................................................................................................................... 61 ACKNOWLEDGMENTS .......................................................................................................... 62 REFERENCES ........................................................................................................................ 63