The validity of the patient health Questionnaire-9 to screen for depression in patients with type-2 diabetes mellitus in non-communicable diseases clinics in Malawi

Background: Depression is a global problem, affecting populations worldwide, but is too often under-diagnosed. The identification of depression among patients with diabetes is important because depression is prevalent in this group and can complicate diabetes management. Objectives: The aim of the study was to determine the sensitivity and specificity of the PHQ-9 in the detection of depression among patients with type-2 diabetes mellitus attending non-communicable diseases (NCD) clinics in Malawi. Methods: We conducted a validation study of the Patient Health Questionnaire (PHQ-9) among 323 patients with type-2 diabetes mellitus who attended two NCD clinics in one of the 28 districts of Malawi. The participants were screened consecutively using the nine-item PHQ-9 in Chichewa by a research assistant and completed a diagnostic interview using the Structured Clinical Interview for DSM-IV (SCID) for depression with a mental health clinician. We evaluated both content validity based on expert judgement and criterion validity of the Patient Health Questionnaire (PHQ-9) based on performance against the SCID. The PHQ-9 cutpoint that maximized sensitivity plus specificity was selected to report test characteristics. Results: Using the SCID for depression, the prevalence of minor or major depression was 41% (133/323). The internal consistency estimate for the PHQ-9 was 0.83, with an area under the receiver operator curve (AUC) of 0.93 (95% CI, [0.91-0.96]). Using the optimal cut-point of ≥9, the PHQ-9 had a sensitivity of 64% and a specificity of 94% in detecting both minor and major depression, with likelihood ratio-positive = 10.1 and likelihood ratio negative =0.4 as well as overall correct classification (OCC) rate of 81%. Conclusions: This is the first validation study of the PHQ-9 in NCD clinics in Malawi. Depression was highly prevalent in this sample. The PHQ-9 demonstrated reasonable accuracy in identifying cases of depression and is a useful screening tool in this setting. Health care workers in NCD clinics can use the PHQ-9 to identify depression among their patients with those having a positive screen followed up by additional diagnostic assessment to confirm diagnosis. Trial registration: PACTR201807135104799. Retrospectively registered on 12 July 2018.