There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.

Some 21 million adults and children are labor-trafficked or sex-trafficked through force, fraud, or coercion. In recognition of the interface between trafficking victims and the healthcare setting, over the last 10 years there has been a notable increase in training of health care professionals (HCPs) on human trafficking (HT) and its health implications. Many organizations have developed curricula and offered training in various clinical settings. However, methods and content of this education on trafficking vary widely, and there is little evaluation of the impact of the training. The goal of this study was to assess the gaps and strengths in HT education of HCPs in the US. This mixed-method study had two components. The first component consisted of structured interviews with experts in human trafficking HCP education. The second portion of the study involved an analysis of data from HCP calls to the National Human Trafficking Resource Center (NHTRC). The interviews captured trainer-specific data on types of HT training, duration and frequency, key content areas, presence of evaluation approaches and indicators, as well as an assessment of barriers and strengths in HT training for HCP. NHTRC call database analysis demonstrated increasing trends since 2008 in calls by HCPs. Overall findings revealed the need for standardization of HT training content to assure correct information, trauma-informed and patient-centered care, and consistent messaging for HCPs. Evaluation metrics for HT training need to be developed to demonstrate behavior change and impact on service delivery and patient-centered outcomes for HT victims, according to our proposed adapted Kirkpatrick’s Pyramid model. HT training and evaluation would benefit from an agency or institution at the national level to provide consistency and standardization of HT training content as well as to guide a process that would develop metrics for evaluation and the building of an evidence base. Abbreviations: AAP: American Academy of Pediatrics; ACF: Administration for Children and Families; CME: Continuing medical education; ED: Emergency department; HCP: Health care professional; HEAL: Health, Education, Advocacy, and Linkage; HHS: United States Department of Health and Human Services; HT: Human trafficking; IOM: United States Institute of Medicine; MH: Mental health; NHTRC: National Human Trafficking Resource Center; SOAR: Stop, Observe, Ask, and Respond to Health and Wellness Training

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Children represent a significant proportion of the global tuberculosis (TB) burden, and may be disproportionately more affected by its most severe clinical manifestations. Currently available treatments for pediatric drug-susceptible (DS) and drug-resistant (DR) TB, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxicities, and an overall lack of suitable, child-friendly formulations. The complex and burdensome nature of administering the existing regimens to treat DS TB also contributes to the rise of DR TB strains. Despite the availability and use of these therapies for decades, a dearth of dosing evidence in children underscores the importance of sustained efforts for TB drug development to better meet the treatment needs of children with TB. Several new TB drugs and regimens with promising activity against both DS and DR TB strains have recently entered clinical development and are in various phases of clinical evaluation in adults or have received marketing authorization for adults. However, initiation of clinical trials to evaluate these drugs in children is often deferred, pending the availability of complete safety and efficacy data in adults or after drug approval. This document summarizes consensus statements from an international panel of childhood TB opinion leaders which support the initiation of evaluation of new TB drugs and regimens in children at earlier phases of the TB Drug development cycle.

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