{
  "abstract": "Introduction Digital ulcers (DUs) are one of the most painful and disabling complications of systemic sclerosis (SSc). Nonetheless, good-quality interventional studies on SSc-DUs remain limited, heterogeneous in design, and inconsistent in definitions and outcome reporting. This lack of standardization impairs the comparability of studies, hinders meta-analyses, and limits translation into clinical practice. At the same time, this field is evolving, with approved drugs and earlier vascular interventions already changing the phenotype of SSc-DUs and calling for more refined assessment. To address these issues, the World Scleroderma Foundation (WSF) convened an international panel of experts to develop points to consider for standardized reporting of SSc-DUs in interventional studies.Material and Methods A steering committee of SSc experts was established under the WSF DU ad hoc group. Three systematic literature reviews (local non-surgical, surgical, and systemic treatments for SSc-DUs) were conducted to inform the process. Draft points to consider were developed and refined through iterative discussion until consensus was achieved.Results Seven domains were identified as essential for the standardized reporting of SSc-DUs in clinical trials ( table 1): 1) Standardized definition and classification: uniform definitions distinguishing ischemic ulcers from other digital lesions and classification by pathophysiology and chronicity. 2) Clear inclusion and exclusion criteria: enrolment should be limited to patients with defined ulcer duration, confirmed SSc by established criteria, and stable background therapy. Patients with active infection should only be included after resolution. 3)Standardized outcome measures: the primary outcome measure in DU studies should be clearly defined such as the healing of the cardinal ulcer or 50% improvement in cardinal ulcer and improvement in function by HIDSS-DU. Secondary outcomes should also include pain and patients’ reported outcomes.; ‘prevention’ DU studies e.g., reduction in number of new DUs by a specified %. Secondary outcomes should be encouragd and likely including pain, function, quality of life, and patient-reported outcomes. 4) Background and concomitant therapies: detailed reporting of systemic and local treatments is necessary to avoid confounding. 5) Local wound management protocols: standardization of debridement methods, topical agents, and dressings across sites. 6) Timing and frequency of assessments: prespecified intervals and long-term follow-up for ulcer recurrence. 7) Seasonal and environmental factors: consideration of climate and seasonal variation in trial design and analysis.Conclusions Adoption of these points to consider may enhance the quality, consistency, and interpretability of SSc-DU interventional studies. Standardized reporting will facilitate more robust meta-analyses, improve comparability across trials, and ultimately support the development of effective, patient-centred therapeutic strategies.Conclusions Initial therapy was associated with improved survival and reduced PAH progression in SSc-PAH, with consistent effects across haemodynamic thresholds and risk strata. These findings support guideline-recommended early intervention, highlight the importance of high-quality observational data in rare diseases, and underscore the need for RCTs to clarify treatment effects in patients with milder haemodynamic impairment.Abstract OC.11 Table 1Recommendations for points to consider for reporting digital ulcers in interventional studies of systemic sclerosis",
  "authors": [
    {
      "affiliations": [
        "Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Hospital, Vita-Salute San Ra, Milan, Italy"
      ],
      "name": "Corrado Campochiaro"
    },
    {
      "affiliations": [
        "University of Ottawa, Ottawa, ON, Canada, Ottawa, Canada"
      ],
      "name": "Nancy Maltez"
    },
    {
      "affiliations": [
        "Assiut University Hospital, Egypt, Assiut, Egypt"
      ],
      "name": "Yossra Suliman"
    },
    {
      "affiliations": [
        "Department of Life, Health & Environmental Sciences, University of L’Aquila and Internal Medicine and Nephrology Unit, L’Aquila, Italy"
      ],
      "name": "Alessia Alunno"
    },
    {
      "affiliations": [
        "Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, Leeds, UK"
      ],
      "name": "Begonya Alcacer-Pitarch"
    },
    {
      "affiliations": [
        "Paris Descartes University, Paris, France, Paris, France"
      ],
      "name": "Yannick Allanore"
    },
    {
      "affiliations": [
        "Jewish General Hospital, McGill University, Montreal, Quebec, Canada, Montreal, Canada"
      ],
      "name": "Murray Baron"
    },
    {
      "affiliations": [
        "Stanford University School of Medicine and Palo Alto VA Health Care System, Palo Alto, CA, USA, Palo Alto, USA"
      ],
      "name": "Lorinda Chung"
    },
    {
      "affiliations": [
        "Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom, Leeds, UK"
      ],
      "name": "Francesco Del Galdo"
    },
    {
      "affiliations": [
        "University College London, London, United Kingdom, London, UK"
      ],
      "name": "Christopher P Denton"
    },
    {
      "affiliations": [
        "Department of Rheumatology, University Hospital Zurich University of Zurich, Zurich, Switzerland, Zurich, Switzerland"
      ],
      "name": "Oliver Distler"
    },
    {
      "affiliations": [
        "University of California, Los Angeles, Los Angeles, CA, USA, Los Angeles, USA"
      ],
      "name": "Daniel Furst"
    },
    {
      "affiliations": [
        "FESCA Federation of European Associations, Belgium, Milan, Italy"
      ],
      "name": "Ilaria Galetti"
    },
    {
      "affiliations": [
        "University of Modena and Reggio Emilia, Department of Medical and Surgical Sciences for Children and Adults, Italy, Modena, Italy"
      ],
      "name": "Dilia Giuggioli"
    },
    {
      "affiliations": [
        "University of Michigan, Ann Arbor, MI, USA, Michigan, USA"
      ],
      "name": "Dinesh Khanna"
    },
    {
      "affiliations": [
        "Department of Dermatology and Venereology, University Hospital of Cologne, Cologne, Germany, Cologne, Germany"
      ],
      "name": "Thomas Krieg"
    },
    {
      "affiliations": [
        "Nippon Medical School, Tokyo, Japan, Tokyo, Japan"
      ],
      "name": "Pia Moinzadeh"
    },
    {
      "affiliations": [
        "Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada, London, Canada"
      ],
      "name": "Masataka Kuwana"
    },
    {
      "affiliations": [
        "Unit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), IRCCS San Raffaele Hospital, Vita-Salute San Ra, Milan, Italy"
      ],
      "name": "Marco Matucci-Cerinic"
    },
    {
      "affiliations": [
        "Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada, London, Canada"
      ],
      "name": "Janet Pope"
    },
    {
      "affiliations": [
        "Division of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester Academic Health Sc, Manchester, UK"
      ],
      "name": "Michael Hughes"
    }
  ],
  "title": "OC.11 Points to consider for reporting outcomes measures in systemic sclerosis interventional studies on digital ulcers: an initiative from the world scleroderma foundation digital ulcer ad hoc committee",
  "uid": "b1a98d7d-020e-517f-a9b5-3d749f31da42"
}