title: High Accuracy of Common HIV-Related Oral Disease Diagnoses by Non-Oral Health Specialists in the AIDS Clinical Trial Group.
abstract: OBJECTIVE
  Many studies include oral HIV-related endpoints that may be diagnosed by non-oral-health specialists (non-OHS) like nurses or physicians. Our objective was to assess the accuracy of clinical diagnoses of HIV-related oral lesions made by non-OHS compared to diagnoses made by OHS.
  
  
  METHODS
  A5254, a cross-sectional study conducted by the Oral HIV/AIDS Research Alliance within the AIDS Clinical Trial Group, enrolled HIV-1-infected adults participants from six clinical trial units (CTU) in the US (San Francisco, New York, Chapel Hill, Cleveland, Atlanta) and Haiti. CTU examiners (non-OHS) received standardized training on how to perform an oral examination and make clinical diagnoses of specific oral disease endpoints. Diagnoses by calibrated non-OHS were compared to those made by calibrated OHS, and sensitivity and specificity computed.
  
  
  RESULTS
  Among 324 participants, the majority were black (73%), men (66%), and the median CD4+ cell count 138 cells/mm(3). The overall frequency of oral mucosal disease diagnosed by OHS was 43% in US sites, and 90% in Haiti. Oral candidiasis (OC) was detected in 153 (47%) by OHS, with erythematous candidiasis (EC) the most common type (39%) followed by pseudomembranous candidiasis (PC; 26%). The highest prevalence of OC (79%) was among participants in Haiti, and among those with CD4+ cell count ≤ 200 cells/mm(3) and HIV-1 RNA > 1000 copies/mL (71%). The sensitivity and specificity of OC diagnoses by non-OHS were 90% and 92% (for EC: 81% and 94%; PC: 82% and 95%). Sensitivity and specificity were also high for KS (87% and 94%, respectively), but sensitivity was < 60% for HL and oral warts in all sites combined. The Candida culture confirmation of OC clinical diagnoses (as defined by ≥ 1 colony forming unit per mL of oral/throat rinse) was ≥ 93% for both PC and EC.
  
  
  CONCLUSIONS
  Trained non-OHS showed high accuracy of clinical diagnoses of OC in comparison with OHS, suggesting their usefulness in studies in resource-poor settings, but detection of less common lesions may require OHS.
authors.affiliation: Department of Orofacial Sciences, School of Dentistry, University of California San Francisco, San Francisco, California, United States of America.
authors.forename: Caroline H
authors.initials: CH
authors.lastname: Shiboski
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Cambridge, Massachusetts, United States of America.
authors.forename: Huichao
authors.initials: H
authors.lastname: Chen
authors.affiliation: Centres GHESKIO, Port-au-Prince, Haiti.
authors.forename: Rode
authors.initials: R
authors.lastname: Secours
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Cambridge, Massachusetts, United States of America.
authors.forename: Anthony
authors.initials: A
authors.lastname: Lee
authors.affiliation: Department of Dental Ecology, School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America; Department of Microbiology and Immunology, and Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Webster-Cyriaque
authors.affiliation: Center for Medical Mycology, Department of Dermatology, Case Medical Center and Case Western Reserve University, Cleveland, Ohio, United States of America.
authors.forename: Mahmoud
authors.initials: M
authors.lastname: Ghannoum
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard School of Public Health, Cambridge, Massachusetts, United States of America.
authors.forename: Scott
authors.initials: S
authors.lastname: Evans
authors.affiliation: Centres GHESKIO, Port-au-Prince, Haiti.
authors.forename: Daphné
authors.initials: D
authors.lastname: Bernard
authors.affiliation: Grady Health System, Atlanta Georgia, United States of America; Emory University School of Medicine, Atlanta, Georgia, United States of America.
authors.forename: David
authors.initials: D
authors.lastname: Reznik
authors.affiliation: Department of Microbiology and Immunology, and Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.
authors.forename: Dirk P
authors.initials: DP
authors.lastname: Dittmer
authors.affiliation: Social and Scientific Systems, Inc., Silver Spring, Maryland, United States of America.
authors.forename: Lara
authors.initials: L
authors.lastname: Hosey
authors.affiliation: Centres GHESKIO, Port-au-Prince, Haiti.
authors.forename: Patrice
authors.initials: P
authors.lastname: Sévère
authors.affiliation: Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York, United States of America; Department of Medicine, New York University School of Medicine, New York, New York, United States of America.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Aberg
mesh_terms: D000328:Adult; D000368:Aged; D018791:CD4 Lymphocyte Count; D002138:Calibration; D002983:Clinical Competence; D003430:Cross-Sectional Studies; D003756:Dental Hygienists; D003815:Dentists; D003945:Diagnosis, Oral / Q000193:education; D003951:Diagnostic Errors; D005260:Female; D015658:HIV Infections / Q000150:complications*; D015497:HIV-1; D006205:Haiti / Q000453:epidemiology; D006282:Health Personnel; D006801:Humans; D008297:Male; D008875:Middle Aged; D009059:Mouth Diseases / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D019242:Oral Medicine; D010036:Otolaryngology; D015995:Prevalence; D012680:Sensitivity and Specificity; D013038:Specialization; D014481:United States / Q000453:epidemiology; D019562:Viral Load; D000078329:Workforce; D055815:Young Adult