Use of Nominal Group Technique to Determine Candidate Items for SLE Classification Criteria Development

Sindhu R. Johnson¹, Dinesh Khanna², Ricard Cervera³, Nathalie Costedoat-Chalumeau⁴, Dafna D. Gladman⁵, Bevra H. Hahn⁶, Falk Hiepe⁷, Jorge Sanchez-Guerrero⁸, Elena Massarotti⁹, Dimitrios Boumpas¹⁰, Karen H. Costenbader¹¹, David I. Daikh¹², David Jayne¹³, Thomas Dörner¹⁴, Diane L. Kamen¹⁵, Marta Mosca¹⁶, Rosalind Ramsey-Goldman¹⁷, Josef S. Smolen¹⁸, David Wofsy¹⁹ and Martin Aringer²⁰, ¹Division of Rheumatology, Toronto Western Hospital, Mount Sinai Hospital, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada, ²University of Michigan, Ann Arbor, MI, ³Department of Autoimmune Diseases, Hospital Clinic, Barcelona, Spain, ⁴Internal Medicine, Cochin University Hospital, Paris, France, ⁵Rheumatology, Centre for Prognosis Studies in the Rheumatic Diseases, Toronto Western Hospital and University of Toronto, Toronto, ON, Canada, ⁶Division of Rheumatology, UCLA David Geffen School of Medicine, Los Angeles, CA, ⁷Charité – Universitätsmedizin, Berlin, Germany, ⁸University of Toronto, Toronto, Canada; Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico city, Mexico, ⁹Rheumatology, Immunology, & Allergy, Harvard Medical School, Brigham & Women's Hosp, Boston, MA, ¹⁰University of Athens, Athens, Greece, ¹¹Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ¹²Rheumatology, UCSF/VA Medical Center, San Francisco, CA, ¹³Medicine, Addenbrooke's Hospital, Cambridge, United Kingdom, ¹⁴Department of Medicine/Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany, ¹⁵Medicine/Rheumatology & Immunology, Medical University of South Carolina, Charleston, SC, ¹⁶Clinical and Experimental Medicine, University of Pisa, Rheumatology Unit, Pisa, Italy, ¹⁷FSM, Northwestern University, Chicago, IL, ¹⁸Medical University of Vienna and Hietzing Hospital, Vienna, Austria, ¹⁹University of California, San Francisco, San Francisco, CA, ²⁰Medicine III, University Medical Center and Faculty of Medicine at the TU Dresden, Dresden, Germany

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: SLE and classification criteria

Session Information

Date: Sunday, November 13, 2016

Title: Systemic Lupus Erythematosus – Clinical Aspects and Treatment - Poster I: Clinical Trial Design and Current Therapies

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Criteria for the classification of SLE are being developed with the support of EULAR and ACR. Two independent exercises (expert-based Delphi exercise and data-driven cohort evaluation of early SLE and controls) were undertaken to generate candidate criteria, and then reduce them to a smaller set. The objective of this study was to select a set of items that maximizes the likelihood of accurate classification of SLE, particularly early disease.

Methods: In the Delphi exercise, 120 international SLE experts proposed 196 items useful for the classification of a broad spectrum of SLE, including early and late stage disease.¹ Features distinguishing early SLE (<3 years) and controls were also evaluated in a cohort from 2 European and 2 North American centers.² The candidate criteria were rated, and low ranking and redundant criteria were removed, leaving 41 criteria.¹An independent panel of seven international SLE experts (reflecting practice in Spain, France, Germany, United States, Canada and Mexico) was asked to rank the 41 candidate criteria. The ranking was presented at a face-to-face meeting of the expert panel and steering committee. A consensus meeting using nominal group technique (NGT) was conducted to reduce the list of criteria for consideration.

Results: The expert panel NGT exercise reduced the candidate criteria for SLE classification from 41 to 21. The panel distinguished potential “entry criteria”, which would be required for classification, from other potential “additive criteria”, summarized in Table 1. Potential entry criteria were ‘ANA ≥1:80 (by HEp 2 immunofluorescence)’ and ‘low C3 and/or low C4.’ The use of low complement as an entry criterion was considered potentially useful in cases with negative ANA. Table 1. Additive Criteria

Lupus nephritis by renal biopsy with immune deposits

Rash with dermoepidermal interface changes and/or immunoglobulin and/or complement deposition on immunofluorescence

Anti-dsDNA antibody

Anti-Smith antibody

Presence of multiple autoantibodies*

Anti-phospholipid antibodies (lupus anti-coagulant, anti-cardiolipin, anti-beta2GPI, or prolonged RVVT)

Leukopenia (<4000/mm³on 2 or more occasions)

Thrombocytopenia <100,000 on 2 or more occasions

Autoimmune hemolytic anemia

Active urine sediment (without UTI)

Persistent proteinuria (≥0.5g/day)

Acute cutaneous lupus: SLICC definition (includes subacute cutaneous lupus)

Chronic cutaneous lupus: SLICC definition

Alopecia with associated scalp inflammation

Arthritis*

Serositis (pleural, pericardial effusion, pleurisy, pericarditis, peritonitis)

Oral mucosal lesions on the hard palate

CNS manifestations (seizures, psychosis, chorea, myelitis, optic neuritis, stroke or acute confusional state)

Fever*

* to be defined. Additional work is needed to refine definitions, to evaluate their independence and relationships within domains, and to ascertain item weights.

Conclusion: The expert panel’s NGT exercise resulted in 21 candidate SLE classification criteria. Refinement of definitions, ability to cluster criteria into domains and weighting of criteria will be ascertained in the next phase. References: ¹ Hoyer BF, Schmajuk G, Aringer M, et al. Multi-Center Delphi Exercise Reveals Important Key Items in Classifying SLE. Arthritis Rheumatol.2015; 67 (suppl 10). ² Mosca M, Touma Z, Costenbader KH, et al. How Do Patients with Newly Diagnosed SLE Present? A Multicenter Cohort Analysis to Inform the Development of New Classification Criteria for SLE. Arthritis Rheumatol. 2015; 67 (suppl 10).

Disclosure: S. R. Johnson, None; D. Khanna, None; R. Cervera, None; N. Costedoat-Chalumeau, None; D. D. Gladman, None; B. H. Hahn, None; F. Hiepe, None; J. Sanchez-Guerrero, None; E. Massarotti, None; D. Boumpas, None; K. H. Costenbader, None; D. I. Daikh, None; D. Jayne, None; T. Dörner, None; D. L. Kamen, None; M. Mosca, None; R. Ramsey-Goldman, None; J. S. Smolen, None; D. Wofsy, None; M. Aringer, None.

To cite this abstract in AMA style:

Johnson SR, Khanna D, Cervera R, Costedoat-Chalumeau N, Gladman DD, Hahn BH, Hiepe F, Sanchez-Guerrero J, Massarotti E, Boumpas D, Costenbader KH, Daikh DI, Jayne D, Dörner T, Kamen DL, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Aringer M. Use of Nominal Group Technique to Determine Candidate Items for SLE Classification Criteria Development [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/use-of-nominal-group-technique-to-determine-candidate-items-for-sle-classification-criteria-development/. Accessed .

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