title: Discordance between patient and clinician reports of adverse reactions to MDR-TB treatment.
abstract: METHODS
  An urban out-patient clinic in Durban, South Africa, providing community-based treatment for drug-resistant tuberculosis (TB).
  
  
  OBJECTIVE
  To describe concordance between patient report and clinician documentation of adverse drug reactions (ADRs) to treatment for multidrug-resistant TB (MDR-TB).
  
  
  METHODS
  ADRs were documented by interview using an 18-item symptom checklist and medical record data abstraction during a cross-sectional parent study with 121 MDR-TB patients, 75% of whom were co-infected with the human immunodeficiency virus. Concordance was analyzed using Cohen's κ statistic, Gwet's agreement coefficient (AC) 1, and McNemar's test.
  
  
  RESULTS
  ADRs were reported much more frequently in patient interviews (μ = 8.6) than in medical records (μ = 1.4). Insomnia was most common (67% vs. 2%), followed by peripheral neuropathy (65% vs. 18%), and confusion (61 vs. 4%). κ scores were very low, with the highest degree of concordance found in hearing loss (κ = 0.23), which was the only ADR not found to be significantly different between the two data sources (P = 0.34).
  
  
  CONCLUSIONS
  Our study showed a lack of concordance between patient report and clinician documentation of ADRs. These findings indicate the need for improved documentation of ADRs to better reflect patients' experiences during MDR-TB treatment. These data have important implications for country-level pharmacovigilance programs that rely on clinician documentation of ADRs for MDR-TB policy formation.
authors.affiliation: Columbia University School of Nursing, New York, New York, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Kelly
authors.affiliation: Michigan State University College of Nursing, East Lansing, Michigan, USA.
authors.forename: B
authors.initials: B
authors.lastname: Smith
authors.affiliation: Michigan State University Department of Epidemiology and Biostatistics, East Lansing, Michigan, USA.
authors.forename: Z
authors.initials: Z
authors.lastname: Luo
authors.affiliation: Michigan State University College of NursingEast Lansing, Michigan, USA.
authors.forename: B
authors.initials: B
authors.lastname: Given
authors.affiliation: Michigan State University College of NursingEast Lansing, Michigan, USA.
authors.forename: T
authors.initials: T
authors.lastname: Wehrwein
authors.affiliation: King Dinuzulu Hospital Complex, Durban, South Africa.
authors.forename: I
authors.initials: I
authors.lastname: Master
authors.affiliation: Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Farley
mesh_terms: D000293:Adolescent; D000328:Adult; D000995:Antitubercular Agents / Q000009:adverse effects* / Q000627:therapeutic use; D060085:Coinfection / Q000188:drug therapy; D003221:Confusion / Q000139:chemically induced / Q000503:physiopathology; D003430:Cross-Sectional Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced / Q000503:physiopathology; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced / Q000503:physiopathology; D013019:South Africa; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents