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Bridging the gap between efficacy trials and model-based impact evaluation for new tuberculosis vaccines.

ABSTRACT: In Tuberculosis (TB), given the complexity of its transmission dynamics, observations of reduced epidemiological risk associated with preventive interventions can be difficult to translate into mechanistic interpretations. Specifically, in clinical trials of vaccine efficacy, a readout of protection against TB disease can be mapped to multiple dynamical mechanisms, an issue that has been overlooked so far. Here, we describe this limitation and its effect on model-based evaluations of vaccine impact. Furthermore, we propose a methodology to analyze efficacy trials that circumvents it, leveraging a combination of compartmental models and stochastic simulations. Using our approach, we can disentangle the different possible mechanisms of action underlying vaccine protection effects against TB, conditioned to trial design, size, and duration. Our results unlock a deeper interpretation of the data emanating from efficacy trials of TB vaccines, which renders them more interpretable in terms of transmission models and translates into explicit recommendations for vaccine developers.

SUBMITTER: Tovar M

PROVIDER: S-EPMC6884451 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Bridging the gap between efficacy trials and model-based impact evaluation for new tuberculosis vaccines.

Tovar Mario M Arregui Sergio S Marinova Dessislava D Martín Carlos C Sanz Joaquín J Moreno Yamir Y

Nature communications 20191129 1

In Tuberculosis (TB), given the complexity of its transmission dynamics, observations of reduced epidemiological risk associated with preventive interventions can be difficult to translate into mechanistic interpretations. Specifically, in clinical trials of vaccine efficacy, a readout of protection against TB disease can be mapped to multiple dynamical mechanisms, an issue that has been overlooked so far. Here, we describe this limitation and its effect on model-based evaluations of vaccine imp ...[more]

PMID: 31784512

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Project description:BackgroundTraining programs for advanced practice providers (APP) often have significant variability in their curriculum, including electrocardiogram (ECG) education. Despite limitations in formal ECG training, APPs in the emergency department (ED) may be the first practitioner to interpret an ECG. Foundations of Emergency Medicine (FoEM) offers free, open-access curricula that are widely used for resident education. We sought to improve APP ECG interpretation skills by implementing the FoEM ECG I course.MethodsThis was a single-site, pre- and post-intervention study of 23 APPs at our high-acuity, urban ED. In the fall of 2020, APP learners enrolled in a FoEM ECG I course led by faculty and senior resident instructors. The course consisted of six virtual, small-group, active-learning ECG workshops. Participants completed a 15-question multiple-choice test before, immediately after, and six months post-intervention to quantify knowledge acquisition. Additionally, a pre- and post-intervention knowledge, attitudes, and practices survey was administered on ECG interpretation skills and to evaluate the course. We evaluated change in ECG knowledge scores using a Wilcoxon signed-rank test. Changes in self-assessed knowledge were evaluated using an ordinal logistic mixed-effects regression.ResultsA total of 23 APPs enrolled in the course. Knowledge assessments showed APPs improved from the pre-test (median 9/15, interquartile range [IQR] 7-11) to the post-test (median 12/15, IQR 10-13; P = 0.001). Test scores did not significantly change from the post-test to the delayed post-test (median 12/15, IQR 12-13; P = 0.30). Respondents' subjective rating of their skill did not significantly change (P = 0.06). Respondents reported no change in their likelihood of approaching an attending when uncertain of the correct interpretation of an ECG (P = 0.16). Overall, 91% were satisfied with the course and 96% agreed that the course difficulty was appropriate.ConclusionThe FoEM ECG course provided a standardized curriculum that improved APP knowledge for interpreting ECGs. Despite this, the course did not alter APPs' willingness to approach physicians for guidance with interpretation of abnormal ECGs. These findings may inform expansion of this concept for other programs who desire formalized APP ECG education.

Dataset Information

Bridging the gap between efficacy trials and model-based impact evaluation for new tuberculosis vaccines.

Publications

Bridging the gap between efficacy trials and model-based impact evaluation for new tuberculosis vaccines.

Similar Datasets

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