Simulating Study Data to Support Expected Value of Sample Information Calculations: A Tutorial.
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SUBMITTER: Heath A
PROVIDER: S-EPMC8793320 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDecisions about new health technologies are increasingly being made while trials are still in an early stage, which may result in substantial uncertainty around key decision drivers such as estimates of life expectancy and time to disease progression. Additional data collection can reduce uncertainty, and its value can be quantified by computing the expected value of sample information (EVSI), which has typically been described in the context of designing a future trial. In this article, we develop new methods for computing the EVSI of extending an existing trial's follow-up, first for an assumed survival model and then extending to capture uncertainty about the true survival model.MethodsWe developed a nested Markov Chain Monte Carlo procedure and a nonparametric regression-based method. We compared the methods by computing single-model and model-averaged EVSI for collecting additional follow-up data in 2 synthetic case studies.ResultsThere was good agreement between the 2 methods. The regression-based method was fast and straightforward to implement, and scales easily to include any number of candidate survival models in the model uncertainty case. The nested Monte Carlo procedure, on the other hand, was extremely computationally demanding when we included model uncertainty.ConclusionsWe present a straightforward regression-based method for computing the EVSI of extending an existing trial's follow-up, both where a single known survival model is assumed and where we are uncertain about the true survival model. EVSI for ongoing trials can help decision makers determine whether early patient access to a new technology can be justified on the basis of the current evidence or whether more mature evidence is needed.HighlightsDecisions about new health technologies are increasingly being made while trials are still in an early stage, which may result in substantial uncertainty around key decision drivers such as estimates of life-expectancy and time to disease progression. Additional data collection can reduce uncertainty, and its value can be quantified by computing the expected value of sample information (EVSI), which has typically been described in the context of designing a future trial.In this article, we have developed new methods for computing the EVSI of extending a trial's follow-up, both where a single known survival model is assumed and where we are uncertain about the true survival model. We extend a previously described nonparametric regression-based method for computing EVSI, which we demonstrate in synthetic case studies is fast, straightforward to implement, and scales easily to include any number of candidate survival models in the EVSI calculations.The EVSI methods that we present in this article can quantify the need for collecting additional follow-up data before making an adoption decision given any decision-making context.
| S-EPMC9189722 | biostudies-literature
Project description:Health economic decision-analytic models are used to estimate the expected net benefits of competing decision options. The true values of the input parameters of such models are rarely known with certainty, and it is often useful to quantify the value to the decision maker of reducing uncertainty through collecting new data. In the context of a particular decision problem, the value of a proposed research design can be quantified by its expected value of sample information (EVSI). EVSI is commonly estimated via a 2-level Monte Carlo procedure in which plausible data sets are generated in an outer loop, and then, conditional on these, the parameters of the decision model are updated via Bayes rule and sampled in an inner loop. At each iteration of the inner loop, the decision model is evaluated. This is computationally demanding and may be difficult if the posterior distribution of the model parameters conditional on sampled data is hard to sample from. We describe a fast nonparametric regression-based method for estimating per-patient EVSI that requires only the probabilistic sensitivity analysis sample (i.e., the set of samples drawn from the joint distribution of the parameters and the corresponding net benefits). The method avoids the need to sample from the posterior distributions of the parameters and avoids the need to rerun the model. The only requirement is that sample data sets can be generated. The method is applicable with a model of any complexity and with any specification of model parameter distribution. We demonstrate in a case study the superior efficiency of the regression method over the 2-level Monte Carlo method.
| S-EPMC4471064 | biostudies-literature
Project description:Value of information (VOI) analyses can help policy makers make informed decisions about whether to conduct and how to design future studies. Historically a computationally expensive method to compute the expected value of sample information (EVSI) restricted the use of VOI to simple decision models and study designs. Recently, 4 EVSI approximation methods have made such analyses more feasible and accessible. Members of the Collaborative Network for Value of Information (ConVOI) compared the inputs, the analyst's expertise and skills, and the software required for the 4 recently developed EVSI approximation methods. Our report provides practical guidance and recommendations to help inform the choice between the 4 efficient EVSI estimation methods. More specifically, this report provides: (1) a step-by-step guide to the methods' use, (2) the expertise and skills required to implement the methods, and (3) method recommendations based on the features of decision-analytic problems.
| S-EPMC8183576 | biostudies-literature
Project description:The partial expected value of perfect information (EVPI) quantifies the expected benefit of learning the values of uncertain parameters in a decision model. Partial EVPI is commonly estimated via a 2-level Monte Carlo procedure in which parameters of interest are sampled in an outer loop, and then conditional on these, the remaining parameters are sampled in an inner loop. This is computationally demanding and may be difficult if correlation between input parameters results in conditional distributions that are hard to sample from. We describe a novel nonparametric regression-based method for estimating partial EVPI that requires only the probabilistic sensitivity analysis sample (i.e., the set of samples drawn from the joint distribution of the parameters and the corresponding net benefits). The method is applicable in a model of any complexity and with any specification of input parameter distribution. We describe the implementation of the method via 2 nonparametric regression modeling approaches, the Generalized Additive Model and the Gaussian process. We demonstrate in 2 case studies the superior efficiency of the regression method over the 2-level Monte Carlo method. R code is made available to implement the method.
| S-EPMC4819801 | biostudies-other
Project description:BACKGROUND:The expected value of sample information (EVSI) can help prioritize research but its application is hampered by computational infeasibility, especially for complex models. We investigated an approach by Strong and colleagues to estimate EVSI by applying generalized additive models (GAM) to results generated from a probabilistic sensitivity analysis (PSA). METHODS:For 3 potential HIV prevention and treatment strategies, we estimated life expectancy and lifetime costs using the Cost-effectiveness of Preventing AIDS Complications (CEPAC) model, a complex patient-level microsimulation model of HIV progression. We fitted a GAM-a flexible regression model that estimates the functional form as part of the model fitting process-to the incremental net monetary benefits obtained from the CEPAC PSA. For each case study, we calculated the expected value of partial perfect information (EVPPI) using both the conventional nested Monte Carlo approach and the GAM approach. EVSI was calculated using the GAM approach. RESULTS:For all 3 case studies, the GAM approach consistently gave similar estimates of EVPPI compared with the conventional approach. The EVSI behaved as expected: it increased and converged to EVPPI for larger sample sizes. For each case study, generating the PSA results for the GAM approach required 3 to 4 days on a shared cluster, after which EVPPI and EVSI across a range of sample sizes were evaluated in minutes. The conventional approach required approximately 5 weeks for the EVPPI calculation alone. CONCLUSION:Estimating EVSI using the GAM approach with results from a PSA dramatically reduced the time required to conduct a computationally intense project, which would otherwise have been impractical. Using the GAM approach, we can efficiently provide policy makers with EVSI estimates, even for complex patient-level microsimulation models.
| S-EPMC5771838 | biostudies-literature
Project description:Expected value of information methods evaluate the potential health benefits that can be obtained from conducting new research to reduce uncertainty in the parameters of a cost-effectiveness analysis model, hence reducing decision uncertainty. Expected value of partial perfect information (EVPPI) provides an upper limit to the health gains that can be obtained from conducting a new study on a subset of parameters in the cost-effectiveness analysis and can therefore be used as a sensitivity analysis to identify parameters that most contribute to decision uncertainty and to help guide decisions around which types of study are of most value to prioritize for funding. A common general approach is to use nested Monte Carlo simulation to obtain an estimate of EVPPI. This approach is computationally intensive, can lead to significant sampling bias if an inadequate number of inner samples are obtained, and incorrect results can be obtained if correlations between parameters are not dealt with appropriately. In this article, we set out a range of methods for estimating EVPPI that avoid the need for nested simulation: reparameterization of the net benefit function, Taylor series approximations, and restricted cubic spline estimation of conditional expectations. For each method, we set out the generalized functional form that net benefit must take for the method to be valid. By specifying this functional form, our methods are able to focus on components of the model in which approximation is required, avoiding the complexities involved in developing statistical approximations for the model as a whole. Our methods also allow for any correlations that might exist between model parameters. We illustrate the methods using an example of fluid resuscitation in African children with severe malaria.
| S-EPMC4948652 | biostudies-literature
Project description:When making decisions, individuals must often compensate for cognitive limitations, particularly in the face of advanced age. Recent findings suggest that age-related variability in striatal activity may increase financial risk-taking mistakes in older adults. In two studies, we sought to further characterize neural contributions to optimal financial risk taking and to determine whether decision aids could improve financial risk taking. In Study 1, neuroimaging analyses revealed that individuals whose mesolimbic activation correlated with the expected value estimates of a rational actor made more optimal financial decisions. In Study 2, presentation of expected value information improved decision making in both younger and older adults, but the addition of a distracting secondary task had little impact on decision quality. Remarkably, provision of expected value information improved the performance of older adults to match that of younger adults at baseline. These findings are consistent with the notion that mesolimbic circuits play a critical role in optimal choice, and imply that providing simplified information about expected value may improve financial risk taking across the adult life span.
| S-EPMC3073388 | biostudies-literature
Project description:Few if any natural resource systems are completely understood and fully observed. Instead, there almost always is uncertainty about the way a system works and its status at any given time, which can limit effective management. A natural approach to uncertainty is to allocate time and effort to the collection of additional data, on the reasonable assumption that more information will facilitate better understanding and lead to better management. But the collection of more data, either through observation or investigation, requires time and effort that often can be put to other conservation activities. An important question is whether the use of limited resources to improve understanding is justified by the resulting potential for improved management. In this paper we address directly a change in value from new information collected through investigation. We frame the value of information in terms of learning through the management process itself, as well as learning through investigations that are external to the management process but add to our base of understanding. We provide a conceptual framework and metrics for this issue, and illustrate them with examples involving Florida scrub-jays (Aphelocoma coerulescens).
| S-EPMC6025880 | biostudies-literature
Project description:Invasive electrophysiological and neuroanatomical studies in nonhuman mammalian experimental preparations have helped elucidate the lamina (layer) dependence of neural computations and interregional connections. Noninvasive functional neuroimaging can, in principle, resolve cortical laminae (layers), and thus provide insight into human neural computations and interregional connections. However human neuroimaging data are noisy and difficult to interpret; biologically realistic simulations can aid experimental interpretation by relating the neuroimaging data to simulated neural activity. We illustrate the potential of laminar neuroimaging by upgrading an existing large-scale, multiregion neural model that simulates a visual delayed match-to-sample (DMS) task. The new laminar-based neural unit incorporates spiny stellate, pyramidal, and inhibitory neural populations which are divided among supragranular, granular, and infragranular laminae (layers). We simulated neural activity which is translated into local field potential-like data used to simulate conventional and laminar fMRI activity. We implemented the laminar connectivity schemes proposed by Felleman and Van Essen (Cerebral Cortex, 1991) for interregional connections. The hemodynamic model that we employ is a modified version of one due to Heinzle et al. (Neuroimage, 2016) that incorporates the effects of draining veins. We show that the laminar version of the model replicates the findings of the existing model. The laminar model shows the finer structure in fMRI activity and functional connectivity. Laminar differences in the magnitude of neural activities are a prominent finding; these are also visible in the simulated fMRI. We illustrate differences between task and control conditions in the fMRI signal, and demonstrate differences in interregional laminar functional connectivity that reflect the underlying connectivity scheme. These results indicate that multi-layer computational models can aid in interpreting layer-specific fMRI, and suggest that increased use of laminar fMRI could provide unique and fundamental insights to human neuroscience.
| S-EPMC5911248 | biostudies-literature
Project description:This tutorial presents the application of an R package, RxODE, that facilitates quick, efficient simulations of ordinary differential equation models completely within R. Its application is illustrated through simulation of design decision effects on an adaptive dosing regimen. The package provides an efficient, versatile way to specify dosing scenarios and to perform simulation with variability with minimal custom coding. Models can be directly translated to Rshiny applications to facilitate interactive, real-time evaluation/iteration on simulation scenarios.
| S-EPMC4728294 | biostudies-literature