title: Validation of the National Institutes of Health chronic GVHD Oral Mucosal Score using component-specific measures.
abstract: Oral chronic GVHD (cGVHD) is a common, late complication of alloSCT that is associated with significant patient morbidity. The NIH Oral Mucosal Score (NIH OMS) was developed to assess oral cGVHD therapeutic response, but has not been fully validated. This study's purpose was to conduct a rigorous construct validity and internal consistency analysis of this score and its components (erythema, lichenoid, ulcers, mucoceles) using established measures of oral pain, oral function, oral-related quality-of-life, nutrition and laboratory parameters in 198 patients with cGVHD. The construct validity of the NIH OMS was supported: a moderate correlation was observed between NIH OMS and mouth pain (rho=0.43), while a weaker correlation was observed with low albumin (rho=-0.26). Total NIH OMS, erythema and lichenoid components were associated with malnutrition, oral pain and impaired oral QOL, while ulcers were only associated with oral pain. No associations were found between mucoceles and any indicator evaluated, including salivary function or xerostomia. Kappa determined between scale components was low overall (all 0.35), supporting a conclusion that each component measures a distinct manifestation of oral cGVHD. This study supports the use of the NIH OMS and its components (erythema, lichenoid and ulcerations) to measure clinician-reported severity of oral cGVHD.
authors.affiliation: National Institute of Dental and Craniofacial Research, NIH, Bethesda, MD, USA.
authors.forename: C W
authors.initials: CW
authors.lastname: Bassim
authors.affiliation: 1] Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA [2] Tufts University School of Dental Medicine, Boston, MA, USA.
authors.forename: H
authors.initials: H
authors.lastname: Fassil
authors.affiliation: National Institute of Dental and Craniofacial Research, NIH, Bethesda, MD, USA.
authors.forename: J W
authors.initials: JW
authors.lastname: Mays
authors.affiliation: National Institute of Dental and Craniofacial Research, NIH, Bethesda, MD, USA.
authors.forename: D
authors.initials: D
authors.lastname: Edwards
authors.affiliation: Pediatric Oncology Branch National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: K
authors.initials: K
authors.lastname: Baird
authors.affiliation: Biostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Steinberg
authors.affiliation: Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: K M
authors.initials: KM
authors.lastname: Williams
authors.affiliation: Dermatology Branch National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: E W
authors.initials: EW
authors.lastname: Cowen
authors.affiliation: Outcomes Research Branch, Division of Cancer Control and Population Sciences, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: S A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: K
authors.initials: K
authors.lastname: Cole
authors.affiliation: Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: T
authors.initials: T
authors.lastname: Taylor
authors.affiliation: Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: D
authors.initials: D
authors.lastname: Avila
authors.affiliation: Biostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: D
authors.initials: D
authors.lastname: Zhang
authors.affiliation: 1] Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA [2] Division of Hematology, Department of Internal Medicine, Clinical Hospital Center Zagreb, Zagreb, Croatia.
authors.forename: D
authors.initials: D
authors.lastname: Pulanic
authors.affiliation: 1] Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA [2] Division of Hematology, Department of Internal Medicine, Clinical Hospital Center Zagreb, Zagreb, Croatia.
authors.forename: L
authors.initials: L
authors.lastname: Grkovic
authors.affiliation: Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: D
authors.initials: D
authors.lastname: Fowler
authors.affiliation: Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: R E
authors.initials: RE
authors.lastname: Gress
authors.affiliation: Experimental Transplantation and Immunology Branch, National Cancer Institute, NIH, Bethesda, MD, USA.
authors.forename: S Z
authors.initials: SZ
authors.lastname: Pavletic
mesh_terms: D000293:Adolescent; D000328:Adult; D000418:Albumins / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D005260:Female; D006086:Graft vs Host Disease / Q000175:diagnosis* / Q000503:physiopathology; D006402:Hematologic Diseases / Q000150:complications* / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D007249:Inflammation; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000503:physiopathology*; D009316:National Institutes of Health (U.S.); D009752:Nutritional Status; D019226:Oral Ulcer / Q000150:complications / Q000175:diagnosis; D010146:Pain / Q000150:complications / Q000175:diagnosis; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D014481:United States; D055815:Young Adult
chemical_list: D000418:Albumins