A M Kelly1, B Smith2, Z Luo3, B Given4, T Wehrwein4, I Master5, J E Farley6. 1. Columbia University School of Nursing, New York, New York, USA. 2. Michigan State University College of Nursing, East Lansing, Michigan, USA. 3. Michigan State University Department of Epidemiology and Biostatistics, East Lansing, Michigan, USA. 4. Michigan State University College of NursingEast Lansing, Michigan, USA. 5. King Dinuzulu Hospital Complex, Durban, South Africa. 6. Johns Hopkins University School of Nursing, Baltimore, Maryland, USA.
Abstract
SETTING: 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). 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 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.
SETTING: 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). 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-TBpatients, 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.
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