Discordance between patient and clinician reports of adverse reactions to MDR-TB treatment

A. M. Kelly, B. Smith, Z. Luo, B. Given, T. Wehrwein, I. Master, Jason Farley

Research output: Contribution to journalArticle


An urban out-patient clinic in Durban, South Africa, providing community-based treatment for drugresistant 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). DESIGN: 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 coinfected with the human immunodeficiency virus. Concordance was analyzed using Cohen's j statistic, Gwet's agreement coefficient (AC) 1, and McNemar's test. RESULT S : ADRs were reported much more frequently in patient interviews (l=8.6) than in medical records (l = 1.4). Insomnia was most common (67% vs. 2%), followed by peripheral neuropathy (65% vs. 18%), and confusion (61 vs. 4%). j scores were very low, with the highest degree of concordance found in hearing loss (j= 0.23), which was the only ADR not found to be significantly different between the two data sources (P = 0.34). CONCLUS IONS : 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.

Original languageEnglish (US)
Pages (from-to)442-447
Number of pages6
JournalInternational Journal of Tuberculosis and Lung Disease
Issue number4
Publication statusPublished - Apr 1 2016



  • Community-based
  • HIV
  • MDR-TB
  • Side effects
  • South Africa

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Infectious Diseases

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