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In low- and middle-income countries, fewer than 1 in 10 people with mental health conditions are estimated to be accurately diagnosed in primary care. This is despite more than 90 countries providing mental health training for primary healthcare workers in the past two decades. The lack of accurate diagnoses is a major bottleneck to reducing the global mental health treatment gap. In this commentary, we argue that current research practices are insufficient to generate the evidence needed to improve diagnostic accuracy. Research studies commonly determine accurate diagnosis by relying on self-report tools such as the Patient Health Questionnaire-9. This is problematic because self-report tools often overestimate prevalence, primarily due to their high rates of false positives. Moreover, nearly all studies on detection focus solely on depression, not taking into account the spectrum of conditions on which primary healthcare workers are being trained. Single condition self-report tools fail to discriminate among different types of mental health conditions, leading to a heterogeneous group of conditions masked under a single scale. As an alternative path forward, we propose improving research on diagnostic accuracy to better evaluate the reach of mental health service delivery in primary care. We recommend evaluating multiple conditions, statistically adjusting prevalence estimates generated from self-report tools, and consistently using structured clinical interviews as a gold standard. We propose clinically meaningful detection as ‘good-enough’ diagnoses incorporating multiple conditions accounting for context, health system and types of interventions available. Clinically meaningful identification can be operationalized differently across settings based on what level of diagnostic specificity is needed to select from available treatments. Rethinking research strategies to evaluate accuracy of diagnosis is vital to improve training, supervision and delivery of mental health services around the world.

Abstract Background There are increasing efforts for the integration of mental health services into primary care settings in low- and middle-income countries. However, commonly used approaches to train primary care providers (PCPs) may not achieve the expected outcomes for improved service delivery, as evidenced by low detection rates of mental illnesses after training. One contributor to this shortcoming is the stigma among PCPs. Implementation strategies for training PCPs that reduce stigma have the potential to improve the quality of services. Design In Nepal, a type 3 hybrid implementation-effectiveness cluster randomized controlled trial will evaluate the implementation-as-usual training for PCPs compared to an alternative implementation strategy to train PCPs, entitled Reducing Stigma among Healthcare Providers (RESHAPE). In implementation-as-usual, PCPs are trained on the World Health Organization Mental Health Gap Action Program Intervention Guide (mhGAP-IG) with trainings conducted by mental health specialists. In RESHAPE, mhGAP-IG training includes the added component of facilitation by people with lived experience of mental illness (PWLE) and their caregivers using PhotoVoice, as well as aspirational figures. The duration of PCP training is the same in both arms. Co-primary outcomes of the study are stigma among PCPs, as measured with the Social Distance Scale at 6 months post-training, and reach, a domain from the RE-AIM implementation science framework. Reach is operationalized as the accuracy of detection of mental illness in primary care facilities and will be determined by psychiatrists at 3 months after PCPs diagnose the patients. Stigma will be evaluated as a mediator of reach. Cost-effectiveness and other RE-AIM outcomes will be assessed. Twenty-four municipalities, the unit of clustering, will be randomized to either mhGAP-IG implementation-as-usual or RESHAPE arms, with approximately 76 health facilities and 216 PCPs divided equally between arms. An estimated 1100 patients will be enrolled for the evaluation of accurate diagnosis of depression, generalized anxiety disorder, psychosis, or alcohol use disorder. Masking will include PCPs, patients, and psychiatrists. Discussion This study will advance the knowledge of stigma reduction for training PCPs in partnership with PWLE. This collaborative approach to training has the potential to improve diagnostic competencies. If successful, this implementation strategy could be scaled up throughout low-resource settings to reduce the global treatment gap for mental illness. Trial registration ClinicalTrials.gov, NCT04282915 . Date of registration: February 25, 2020.