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Int J Tuberc Lung Dis. 2016 Apr;20(4):442-7. doi: 10.5588/ijtld.15.0318.

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

Author information

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.

PMID:
26970151
PMCID:
PMC4830122
DOI:
10.5588/ijtld.15.0318
[Indexed for MEDLINE]
Free PMC Article

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