title: National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report.
abstract: This consensus document is intended to serve 3 functions. First, it standardizes the criteria for diagnosis of chronic graft-versus-host disease (GVHD). Second, it proposes a new clinical scoring system (0-3) that describes the extent and severity of chronic GVHD for each organ or site at any given time, taking functional impact into account. Third, it proposes new guidelines for global assessment of chronic GVHD severity that are based on the number of organs or sites involved and the degree of involvement in affected organs (mild, moderate, or severe). Diagnosis of chronic GVHD requires the presence of at least 1 diagnostic clinical sign of chronic GVHD (e.g., poikiloderma or esophageal web) or the presence of at least 1 distinctive manifestation (e.g., keratoconjunctivitis sicca) confirmed by pertinent biopsy or other relevant tests (e.g., Schirmer test) in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD. The Working Group recognized 2 main categories of GVHD, each with 2 subcategories. The acute GVHD category is defined in the absence of diagnostic or distinctive features of chronic GVHD and includes (1) classic acute GVHD occurring within 100 days after transplantation and (2) persistent, recurrent, or late acute GVHD (features of acute GVHD occurring beyond 100 days, often during withdrawal of immune suppression). The broad category of chronic GVHD includes (1) classic chronic GVHD (without features or characteristics of acute GVHD) and (2) an overlap syndrome in which diagnostic or distinctive features of chronic GVHD and acute GVHD appear together. It is currently recommended that systemic therapy be considered for patients who meet criteria for chronic GVHD of moderate to severe global severity.
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio 45229, USA. lisa.filipovich@cchmc.org
authors.forename: Alexandra H
authors.initials: AH
authors.lastname: Filipovich
authors.forename: Daniel
authors.initials: D
authors.lastname: Weisdorf
authors.forename: Steven
authors.initials: S
authors.lastname: Pavletic
authors.forename: Gerard
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authors.lastname: Socie
authors.forename: John R
authors.initials: JR
authors.lastname: Wingard
authors.forename: Stephanie J
authors.initials: SJ
authors.lastname: Lee
authors.forename: Paul
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authors.lastname: Martin
authors.forename: Jason
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authors.lastname: Chien
authors.forename: Donna
authors.initials: D
authors.lastname: Przepiorka
authors.forename: Daniel
authors.initials: D
authors.lastname: Couriel
authors.forename: Edward W
authors.initials: EW
authors.lastname: Cowen
authors.forename: Patricia
authors.initials: P
authors.lastname: Dinndorf
authors.forename: Ann
authors.initials: A
authors.lastname: Farrell
authors.forename: Robert
authors.initials: R
authors.lastname: Hartzman
authors.forename: Jean
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authors.lastname: Henslee-Downey
authors.forename: David
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authors.lastname: Jacobsohn
authors.forename: George
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authors.lastname: McDonald
authors.forename: Barbara
authors.initials: B
authors.lastname: Mittleman
authors.forename: J Douglas
authors.initials: JD
authors.lastname: Rizzo
authors.forename: Michael
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authors.lastname: Robinson
authors.forename: Mark
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authors.lastname: Schubert
authors.forename: Kirk
authors.initials: K
authors.lastname: Schultz
authors.forename: Howard
authors.initials: H
authors.lastname: Shulman
authors.forename: Maria
authors.initials: M
authors.lastname: Turner
authors.forename: Georgia
authors.initials: G
authors.lastname: Vogelsang
authors.forename: Mary E D
authors.initials: ME
authors.lastname: Flowers
mesh_terms: D002908:Chronic Disease; D002986:Clinical Trials as Topic; D032921:Consensus; D015975:Consensus Development Conferences, NIH as Topic; D003937:Diagnosis, Differential; D005260:Female; D006086:Graft vs Host Disease / Q000175:diagnosis* / Q000473:pathology; D006801:Humans; D008297:Male; D009316:National Institutes of Health (U.S.); D014481:United States