Abstract
Model-informed precision dosing (MIPD) software tools are used to optimize dosage regimens in individual patients, aiming to achieve drug exposure targets associated with desirable clinical outcomes. Over the last few decades, numerous MIPD software tools have been developed. However, they have still not been widely integrated into clinical practice. This study focuses on identifying the requirements for and evaluating the performance of the currently available MIPD software tools. First, a total of 22 experts in the field of precision dosing completed a web survey to assess the importance (from 0; do not agree at all, to 10; completely agree) of 103 pre-established software tool criteria organized in eight categories: user-friendliness and utilization, user support, computational aspects, population models, quality and validation, output generation, privacy and data security, and cost. Category mean ± pooled standard deviation importance scores ranged from 7.2 ± 2.1 (user-friendliness and utilization) to 8.5 ± 1.8 (privacy and data security). The relative importance score of each criterion within a category was used as a weighting factor in the subsequent evaluation of the software tools. Ten software tools were identified through literature and internet searches: four software tools were provided by companies (DoseMeRx, InsightRX Nova, MwPharm++, and PrecisePK) and six were provided by non-company owners (AutoKinetics, BestDose, ID-ODS, NextDose, TDMx, and Tucuxi). All software tools performed well in all categories, although there were differences in terms of in-built software features, user interface design, the number of drug modules and populations, user support, quality control, and cost. Therefore, the choice for a certain software tool should be made based on these differences and personal preferences. However, there are still improvements to be made in terms of electronic health record integration, standardization of software and model validation strategies, and prospective evidence for the software tools’ clinical and cost benefits.
Highlights
“First, do no harm” is a fundamental dictum in pharmacotherapy
modelinformed precision dosing (MIPD) software tools were identified through searching PubMed, Google, Google Scholar, Web of Science, and the Population Approach Group in Europe (PAGE) website until February 2020 by using the following Medical Subject Headings (MeSH) terms and free text variations of these terms: “software”, “software tool”, “dosing software”, “dashboard”, “precision dosing”, “model-informed precision dosing”, “model-based precision dosing”, “therapeutic drug monitoring”, “target concentration intervention”, “adaptive feedback control”, “concentration control”, and “Bayesian”
The MIPD software tools identified through these searches had to meet the following selection criteria: (i) the software is available and actively updated, (ii) the software has a graphical user interface (GUI), (iii) the software is capable of Bayesian forecasting, (iv) the software supports more than one drug module, and (v) the software provider accepts participation in this study
Summary
“First, do no harm” is a fundamental dictum in pharmacotherapy. we may want to raise the bar and aim for optimal efficacy with minimal toxicity in all patients. In the past few years, MIPD has gained renewed attention as a result of the increasing awareness that one dose does not fit the needs of all patients, especially in special populations, such as frail elderly patients, pediatric patients, patients with renal or hepatic impairment, and critically ill patients (Kohn et al, 2014; Collins and Varmus, 2015) This renewed attention is evidenced by the publication of opinion papers, the scheduling of various dedicated conference sessions (ASCPT, PAGE, ACoP, and ACCP), the creation of a special interest group within ISoP (“Applied Clinical Pharmacometrics”), and most importantly the release of new MIPD software tools (Keizer et al, 2018). This information can assist health care professionals in selecting the software tool that fits best their specific needs
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