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Developing WHO guidelines: Time to formally include evidence from mathematical modelling studies.

ABSTRACT: In recent years, the number of mathematical modelling studies has increased steeply. Many of the questions addressed in these studies are relevant to the development of World Health Organization (WHO) guidelines, but modelling studies are rarely formally included as part of the body of evidence. An expert consultation hosted by WHO, a survey of modellers and users of modelling studies, and literature reviews informed the development of recommendations on when and how to incorporate the results of modelling studies into WHO guidelines. In this article, we argue that modelling studies should routinely be considered in the process of developing WHO guidelines, but particularly in the evaluation of public health programmes, long-term effectiveness or comparative effectiveness. There should be a systematic and transparent approach to identifying relevant published models, and to commissioning new models. We believe that the inclusion of evidence from modelling studies into the Grading of Recommendations Assessment, Development and Evaluation (GRADE) process is possible and desirable, with relatively few adaptations. No single "one-size-fits-all" approach is appropriate to assess the quality of modelling studies. The concept of the 'credibility' of the model, which takes the conceptualization of the problem, model structure, input data, different dimensions of uncertainty, as well as transparency and validation into account, is more appropriate than 'risk of bias'.

SUBMITTER: Egger M

PROVIDER: S-EPMC5829466 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Developing WHO guidelines: Time to formally include evidence from mathematical modelling studies.

Egger Matthias M Johnson Leigh L Althaus Christian C Schöni Anna A Salanti Georgia G Low Nicola N Norris Susan L SL

F1000Research 20170829

In recent years, the number of mathematical modelling studies has increased steeply. Many of the questions addressed in these studies are relevant to the development of World Health Organization (WHO) guidelines, but modelling studies are rarely formally included as part of the body of evidence. An expert consultation hosted by WHO, a survey of modellers and users of modelling studies, and literature reviews informed the development of recommendations on when and how to incorporate the results o ...[more]

PMID: 29552335

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Project description:BackgroundMalnourished and young children are particularly susceptible to severe forms of tuberculosis and poor treatment response. WHO dosing guidelines for drugs for tuberculosis treatment are based only on weight, which might lead to systematic underdosing and poor outcomes in these children. We aimed to assess and quantify the population effect of WHO guidelines for drug-susceptible tuberculosis in children in the 20 countries with the highest disease burden.MethodsWe used an integrated model that linked country-specific demographic data at the individual level from the 20 countries with the highest disease burden to pharmacokinetic, outcome, and epidemiological models. We estimated tuberculosis treatment outcomes in children younger than 5 years following WHO guidelines (children are dosed by weight bands corresponding to the number of fixed-dose combination tablets [75 mg rifampicin, 50 mg isoniazid, 150 mg pyrazinamide]) and two alternative dosing strategies: one based on a proposed algorithm that uses age, weight, and available formulations, in which underweight children would receive the same drug doses as would normal weight children of the same age; and another based on an individualised algorithm without dose limitations, in which derived doses results in target exposure attainment for the typical child.FindingsWe estimated that 57 234 (43%) of 133 302 children younger than 5 years who were treated for tuberculosis in 2017 were underdosed with WHO dosing and only 47% of children would reach the rifampicin exposure target. Underdosing and subtherapeutic exposures were more common among malnourished children than among age-matched healthy children. The proposed dosing approach improved estimated rifampicin target exposure attainment to 62% and equalised outcomes by nutritional status. An estimated third of unfavourable treatment outcomes might be resolved with this dosing strategy, saving the lives of a minimum of 2423 children in these countries annually. With individualised dosing approaches, almost all children could achieve adequate exposure for cure.InterpretationThis work shows that a simple change in dosing procedure to include age and nutritional status, requiring no additional measurements or new drug formulations, is one approach to improve tuberculosis treatment outcomes in children, especially malnourished children who are at high risk of mortality.FundingEunice Kennedy Shriver National Institute of Child Health and Human Development and UK Medical Research Council.

Project description:BackgroundNamibia is now ready to begin mass drug administration of praziquantel and albendazole against schistosomiasis and soil-transmitted helminths, respectively. Although historical data identifies areas of transmission of these neglected tropical diseases (NTDs), there is a need to update epidemiological data. For this reason, Namibia adopted a new protocol for mapping of schistosomiasis and geohelminths, formally integrating rapid diagnostic tests (RDTs) for infections and morbidity. In this article, we explain the protocol in detail, and introduce the concept of 'mapping resolution', as well as present results and treatment recommendations for northern Namibia.Methods/findings/interpretationThis new protocol allowed a large sample to be surveyed (N = 17,896 children from 299 schools) at relatively low cost (7 USD per person mapped) and very quickly (28 working days). All children were analysed by RDTs, but only a sub-sample was also diagnosed by light microscopy. Overall prevalence of schistosomiasis in the surveyed areas was 9.0%, highly associated with poorer access to potable water (OR = 1.5, P<0.001) and defective (OR = 1.2, P<0.001) or absent sanitation infrastructure (OR = 2.0, P<0.001). Overall prevalence of geohelminths, more particularly hookworm infection, was 12.2%, highly associated with presence of faecal occult blood (OR = 1.9, P<0.001). Prevalence maps were produced and hot spots identified to better guide the national programme in drug administration, as well as targeted improvements in water, sanitation and hygiene. The RDTs employed (circulating cathodic antigen and microhaematuria for Schistosoma mansoni and S. haematobium, respectively) performed well, with sensitivities above 80% and specificities above 95%.Conclusion/significanceThis protocol is cost-effective and sensitive to budget limitations and the potential economic and logistical strains placed on the national Ministries of Health. Here we present a high resolution map of disease prevalence levels, and treatment regimens are recommended.

Project description:ObjectivesThe Mathematical and Economic Modelling for Vaccination and Immunisation Evaluation (MEMVIE) programme aimed to explore, capture and support the potential contribution of the public to mathematical and economic modelling, in order to identify the values that underpin public involvement (PI) in modelling and co-produce a framework that identifies the nature and type of PI in modelling and supports its implementation.MethodsWe established a PI Reference Group, who worked collaboratively with the academic contributors to create a deliberative knowledge space, which valued different forms of knowledge, expertise and evidence. Together, we explored the key steps of mathematical and economic methods in 21 meetings during 2015-2020. These deliberations generated rich discussion, through which we identified potential points of public contribution and the values that underpin PI in modelling. We iteratively developed a framework to guide future practice of PI in modelling.ResultsWe present the MEMVIE Public Involvement Framework in two forms: a short form to summarise key elements, and a long form framework to provide a detailed description of each potential type of public contribution at each stage of the modelling process. At a macro level, the public can contribute to reviewing context, reviewing relevance, assessing data and justifying model choice, troubleshooting, and interpreting and reviewing outcomes and decision making. The underpinning values that drive involvement include the public contributing to the validity of the model, potentially enhancing its relevance, utility and transparency through diverse inputs, and enhancing the credibility, consistency and continuous development through scrutiny, in addition to contextualising the model within a wider societal view.Discussion and conclusionPI in modelling is in its infancy. The MEMVIE Framework is the first attempt to identify potential points of collaborative public contribution to modelling, but it requires further evaluation and refinement that we are undertaking in a subsequent study.

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Developing WHO guidelines: Time to formally include evidence from mathematical modelling studies.

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Developing WHO guidelines: Time to formally include evidence from mathematical modelling studies.

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