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

Globally, treatment success for multidrug-resistant tuberculosis (MDR-TB) remains alarmingly low, approximately 50%, in many settings.1 With an estimated 480,000 new cases of MDR-TB diagnosed each year, treatment default and failure represent a major public health crisis.1 Tolerability of the regimen is a large part of the problem,2 with patients describing the treatment as “worse than the illness itself”.3 Adverse drug reactions (ADRs) continue to be one of the greatest challenges to treating MDR-TB,4 especially in high HIV-burden populations found in sub-Saharan Africa.5,6 The Stop TB Strategy outlined by the World Health Organization (WHO) to reach the 2015 Millennium Development Goals emphasized the need for patient-centered models of care.7 While MDR-TB care has been decentralized to community settings to help meet this goal, there has been a lack of research on patient-reported outcomes.8 The majority of studies on MDR-TB treatment-related ADRs have been retrospective cohorts utilizing medical record data abstraction of clinician report of ADRs.9 Several studies outside the MDR-TB context have shown a lack of concordance between patient report and clinician medical record documentation.10–14 The WHO has called for greater emphasis on the detection, assessment, management, and prevention of ADRs during TB treatment, which is referred to as pharmacovigilance.15,16 The incidence of ADRs is generally obtained from the medical records and thus relies entirely on clinician documentation. Since there is considerable under-reporting of ADRs by clinicians, this is a major drawback of pharmacovigilance, as it can lead to an inaccurate representation of actual outcomes.17,18 Patient-reported outcomes are subjective reports of a patient’s health status obtained directly from the patient without interpretation from the clinician. Symptoms are the way patients experience ADRs; hence, patient self-report is the gold standard for recording symptoms.19 Clinicians are often unaware of patient symptoms, especially those that cannot be objectively measured, or may discount symptoms of which they are aware.20,21 Yet, patient-reported outcomes have been found valid and reliable in comparison to objective measures,22,23 able to detect serious ADRs earlier than clinician report,24 and to be significantly associated with nonadherence.25 A cross-sectional, observational study was conducted in 2014 to document patient-reported outcomes during MDR-TB treatment. This paper provides an analysis of the discordance found in that parent study between ADRs reported during patient interviews and ADRs documented by the clinicians in the medical record.