In March 2022, the World Health Organization (WHO) Global Tuberculosis Programme published new consolidated guidelines on the management of TB in children and adolescents, along with an operational handbook.
One of the new recommendations in the consolidated guidelines is on the use of integrated treatment decision algorithms in children with presumptive pulmonary TB attending health care facilities to diagnose pulmonary TB. Integrated treatment decision algorithms are flowcharts which allocate evidence-based scores to microbiological, clinical and radiological features that allow clinicians to make decisions regarding starting TB treatment in children. For this recommendation, the WHO-convened Guideline Development Group (GDG) reviewed evidence on several treatment decision algorithms. The GDG made a generic recommendation on the use of treatment decision algorithms, considering the important role these algorithms could play to reduce the large case detection gap in children. Therefore, this recommendation was formulated by WHO as an interim, conditional recommendation, considering the need for additional evidence. Evidence will need to be generated to review the recommendation in the future.
Following the GDG meeting, two new integrated treatment decision algorithms were developed and internally validated, using an individual patient database of paediatric diagnostic studies from geographically diverse high TB burden settings. These algorithms have been included in the operational handbook on the management of tuberculosis in children and adolescents (see chapter 4 from page 73 and annex 5).
WHO’s Global TB Programme, together with the Special Programme for Research and Training in Tropical Diseases (TDR) aim to facilitate the generation of evidence through external validation and associated studies to inform a future review of the generic recommendation in the 2022 WHO consolidated guidelines on the management of TB in children and adolescents.
The type of studies to generate the evidence include the following:
1. External validation studies on the diagnostic accuracy of the two integrated treatment decision algorithms, including for specific subpopulations and in various settings. These validation studies would ideally also include:
a. qualitative or quantitative sub studies including on feasibility, acceptability and equity,
b. economic sub-studies to determine resource requirements and cost-effectiveness.
Potential adaptations of the algorithms might also be considered depending on the epidemiological settings (such as settings with differing burdens of TB, different health care settings, including settings with limited access to CXR) and subpopulations.
2. Modelling studies to determine the potential impact of the newly developed treatment decision algorithms on case detection and treatment initiation.
Therefore, WHO’s Global TB Programme and the Special Programme for Research and Training in Tropical Diseases (TDR) are seeking expressions of interest from independent researchers/research groups, academic institutions or other entities with relevant expertise and experience in conducting research on paediatric TB diagnostic approaches, to generate the data listed above. Research projects should be conducted in a relatively short period (no more than 2 years) in order to inform the revision of current guidelines.
The expression of interest should contain:
· A concept note (max. 5 pages) of the proposed research including the objectives, research question(s), study designs, setting or countries where the proposed research will be conducted, a summary of the research team (including the principal investigator(s)), expected impacts, budget (or proposed plan to mobilize funding) and timeline;
· The CV of the principal investigator should also be attached.
Please note that WHO’s Global TB Programme and the Special Programme for Research and Training in Tropical Diseases (TDR) will not be funding the studies and applicants should outline their plans to fund the research if funds are not already available.
Please send your submissions to the WHO Global TB Programme at gtbprogamme@who.int by 22 July 2022.
After reviewing the expressions of interest, the WHO Global TB Programme, together with the Special Programme for Research and Training in Tropical Diseases (TDR) will convene a meeting with selected researchers to harmonize research methods and data collection efforts.