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Vasculitis
Original research
Development and preliminary validation of the Behçet’s syndrome Overall Damage Index (BODI)
  1. Matteo Piga1,
  2. Alberto Floris1,
  3. Gerard Espinosa2,
  4. Luísa Serpa Pinto3,
  5. Nikolaos Kougkas4,
  6. Andrea Lo Monaco5,
  7. Giuseppe Lopalco6,
  8. Ida Orlando7,
  9. Vittorio Pirani8,
  10. Ernestina Santos9,10,
  11. George Bertsias4,
  12. Luca Cantarini7,
  13. Alberto Cauli1,
  14. Ricard Cervera2,
  15. João Correia3,
  16. Marcello Govoni5,
  17. Florenzo Iannone6,
  18. Piergiorgio Neri8,11,
  19. Ana Martins Silva9,
  20. Carlos Vasconcelos10,
  21. Monica Muntoni12 and
  22. Alessandro Mathieu1
  23. and the BODI Project Group
    1. 1Rheumatology Unit, AOU University Clinic of Cagliari, Cagliari, Italy
    2. 2Department of Autoimmune Diseases, Hospital Clinic, Institut d’Investigacions Biomediques August Pi I Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain
    3. 3Hospital Santo Antonio Centro Hospitalar Do Porto, Unidade De Imunologia Clinica, Porto, Portugal
    4. 4Rheumatology, Clinical Immunology and Allergy Unit, University of Crete, Heraklion, Greece
    5. 5Rheumatology Unit - AOU, S. Anna, Ferrara, University of Ferrara, Ferrara, Italy
    6. 6Rheumatology Unit, University of Bari, Bari, Italy
    7. 7University of Siena, Rheumatology Unit, Siena, Italy
    8. 8Ophthalmology Clinic, Università Politecnica Delle Marche, Ancona, Italy
    9. 9Centro Hospitalar Do Porto/Hospital De Santo António, Neurology Department, Porto, Portugal
    10. 10UMIB Abel Salazar Biomedical Sciences Institute, University of Porto, Porto, Portugal
    11. 11Eye Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates
    12. 12Associazione Italiana Sindrome E Malattia Di Behçet (SIMBA), Pontedera, Italy
    1. Correspondence to Matteo Piga; matteopiga{at}unica.it

    Abstract

    Objective To develop and validate the evidence-based and consensus-based Behçet’s Syndrome Overall Damage Index (BODI).

    Methods Starting from 120 literature-retrieved preliminary items, the BODI underwent multiple Delphi rounds with an international multidisciplinary panel consisting of rheumatologists, internists, ophthalmologists, neurologists, and patient delegates until consensus was reached on the final content. The BODI was validated in a cross-sectional multicentre cohort of 228 patients with Behçet’s syndrome (BS) through the study of (a) correlation between BODI and Vasculitis Damage Index (VDI) and (b) correlation between BODI and disease activity measures (ie, Behçet’s Disease Current Activity Form (BDCAF), Physician Global Assessment (PGA), Patient Global Assessment (PtGA)), c) content and face validity and (d) feasibility.

    Results The final BODI consists of 4 overarching principles and 46 unweighted-items grouped into 9 organ domains. It showed good to excellent reliability, with a mean Cohen’s k of 0.84 (95% CI 0.78 to 0.90) and a mean intra-class correlation coefficient of 0.88 (95% CI 0.80 to 0.95). Overall, 128 (56.1%) patients had a BODI score ≥1, with a median score of 1.0 (range 0–14). The BODI significantly correlated with the VDI (r=0.693, p<0.001), demonstrating to effectively measure damage (construct validity), but had greater sensitivity in identifying major organ damage and did not correlate with disease activity measures (ie, BDCAF: p=0.807, PGA: p=0.820, PtGA: p=0.794) discriminating damage from the major confounding factor. The instrument was deemed credible (face validity), complete (content validity) and feasible by an independent group of clinicians.

    Conclusions Pending further validation, the BODI may be used to assess organ damage in patients with BS in the context of observational and controlled trials.

    • Behcet’s disease
    • Outcomes research
    • Systemic vasculitis
    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

    https://doi.org/10.1136/rmdopen-2020-001192

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      Footnotes

      • Twitter Gerard Espinosa @gerardespinosa5.

      • Collaborators The BODI Project group, Nestor Avgoustidis, Elisabetta Chessa, Giovanni Ciancio, Mattia Congia, Raquel Faria, Roberto Rios Garcés, Giulio Guerrini, Gema Lledó Ibáñez, Piero Mascia, Ignasi Rodriguez Pinto, Vincenzo Venerito, Antonio Vitale.

      • Contributors Study conception: MP, AM, AF. Substantial contributions to study design: MP, AM, AF, GB, LC, AC, RC, MG, FI, PN, AMS, CV. Substantial contributions to the acquisition, analysis and interpretation of the data: MP, AF, GE, LSP, NK, ALM, GL, IO, VP, ES, GB, LC, AC, RC, JC, MG, FI, PN, AMS, CV, MM, AM. Drafting the article or revising it critically for important intellectual content: MP, AF, GE, LSP, NK, ALM, GL, IO, VP, ES, GB, LC, AC, RC, JC, MG, FI, PN, AMS, CV, MM, AM. Final approval of the version of the article to be published: MP, AF, GE, LSP, NK, ALM, GL, IO, VP, ES, GB, LC, AC, RC, JC, MG, FI, PN, AMS, CV, MM, AM.

      • Funding The BODI Project was partly supported by a grant from the Italian Behçet’s syndrome patient association (SIMBA ONLUS).

      • Competing interests None declared.

      • Patient consent for publication Not required.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information.