{
  "abstract": "Objectives The current lack of accepted definitions of at-risk populations for inclusion in research studies and trials is a substantial roadblock to testing SLE prevention strategies. We are developing and validating a novel risk stratification model of the probability of developing SLE to stratify individuals from low to high risk, and to provide standard definitions and thresholds of likelihood for clinical research.Methods This project will have 4 phases: Phase I will involve qualitative methods and a systematic literature review to define the project construct and generate a comprehensive list of potential risk factors (predictors). This will include expert Delphi panels and patient focus groups to ensure all relevant predictors are considered. Phase II will use a multi-round Delphi with an independent expert group to reduce the item list to the most important, non-redundant, and feasible predictors. Phase III will develop and internally validate data-driven risk stratification models using multivariable regression on a random subset of prospective cohort data. A separate expert consensus exercise then will identify and calibrate clinically meaningful risk thresholds for clinical trial populations. Phase IV will perform independent external validation of the model using reserved prospective cohort data.Results In Delphi exercises, Phase I work is defining the target population as individuals with more than one sign/symptom of SLE and a positive ANA test, and outcome of classification by 2019 EULAR-ACR criteria. Expert consensus is being sought on population inclusion/exclusion criteria, time window, and naming of relevant thresholds for intervention. In a systematic review, we identified 2,949 studies published from 1975-2024 related to SLE risk. We identified 49 studies on potential SLE risk biomarkers (most autoantibodies and cytokine/chemokines), 143 studies on other factors (lifestyle, environmental, clinical), and 249 genetic studies. Results, combined with Delphi findings, will create a comprehensive list of predictors before proceeding with the next phases.Conclusions A large international effort is underway to develop a data-driven and expert consensus-based stratification index for SLE risk over time. Involving medical experts and patient partners, following rigorous, multi-phase methods, this collaborative project aims for high predictive accuracy with thresholds of SLE risk for use in prevention trials and research.",
  "authors": [
    {
      "affiliations": [
        "Brigham and Women’s Hospital/Harvard Medical School, Boston, USA"
      ],
      "name": "Karen Costenbader"
    },
    {
      "affiliations": [
        "Universitätsklinikum Carl Gustav Carus, Dresden, Germany"
      ],
      "name": "Martin Aringer"
    },
    {
      "affiliations": [
        "Universite de Lausanne, Lausanne, Switzerland"
      ],
      "name": "Alice Horisberger"
    },
    {
      "affiliations": [
        "University of Crete, Heraklion, Greece"
      ],
      "name": "George Bertsias"
    },
    {
      "affiliations": [
        "Lupus Europe, Brussels, Belgium"
      ],
      "name": "Jeanette Anderson"
    },
    {
      "affiliations": [
        "Middlemore Hospital, Auckland, New Zealand"
      ],
      "name": "Alison Hendry"
    },
    {
      "affiliations": [
        "Brigham and Women’s Hospital/Harvard Medical School, Boston, USA"
      ],
      "name": "Youngmin Kim"
    },
    {
      "affiliations": [
        "Brigham and Women’s Hospital/Harvard Medical School, Boston, USA"
      ],
      "name": "Emma Materne"
    },
    {
      "affiliations": [
        "DC Klinieken, Amsterdam, The Netherlands"
      ],
      "name": "Jacob Koopman"
    },
    {
      "affiliations": [
        "Brigham and Women’s Hospital/Harvard Medical School, Boston, USA"
      ],
      "name": "Emily Oakes"
    },
    {
      "affiliations": [
        "University of Alberta, Edmonton, Canada"
      ],
      "name": "Justin Smith"
    },
    {
      "affiliations": [
        "Lupus Foundation of America, Washington, DC, USA"
      ],
      "name": "Wendy Rodgers"
    },
    {
      "affiliations": [
        "Sungkyunkwan University, Seoul, South Korea"
      ],
      "name": "Jeong Yee"
    },
    {
      "affiliations": [
        "University of Toronto, Toronto, Canada"
      ],
      "name": "Zahi Touma"
    },
    {
      "affiliations": [
        "University of Pisa, Pisa, Italy"
      ],
      "name": "Marta Mosca"
    }
  ],
  "title": "PT7:04 The development of a novel systemic lupus erythematosus risk stratification index for clinical research",
  "uid": "748b2068-7ec2-5c5c-877c-be0a66400b66"
}