Dataset Information

Towards a Model-Based Dose Recommendation for Doxorubicin in Children.

ABSTRACT: Following the publication of our paper regarding a population-based model of doxorubicin pharmacokinetics in children in Clinical Pharmacokinetics last year (Voller et al. 54:1139-1149, 2015), we have received many inquiries on the practical clinical consequences of this model; however, a population-based model is only one of the aspects to be taken into account when developing dosing algorithms. In addition, any new method of dose calculation would need clinical validation and, subsequently, a new clinical trial. However, such a trial, especially with regard to burden to the children involved, requires optimal preparation and the selection of the best hypotheses. The European Paediatric Oncology Off-Patent Medicines Consortium (EPOC), represented by the authors, would therefore like to initiate an interdisciplinary discussion on the clinical and pharmacological goals for dose calculation. This current opinion summarizes the existing knowledge on the pharmacokinetics and pharmacodynamics of doxorubicin. Our aim was to define the clinical needs as precisely as possible, with the intention of stimulating discussion between the clinical pediatric oncologist and the pediatric pharmacologist. By doing so, we hope to define surrogates for best practice of a common doxorubicin dose in children. The intent is for a trial to validate a rational dose calculation rule, leading to a regulatory process and subsequent labeling.

SUBMITTER: Voller S

PROVIDER: S-EPMC5315724 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Towards a Model-Based Dose Recommendation for Doxorubicin in Children.

Völler Swantje S Hempel Georg G Würthwein Gudrun G Boddy Alan V AV Krischke Miriam M André Nicolas N D'Incalci Maurizio M Bisogno Gianni G Boos Joachim J

Clinical pharmacokinetics 20170301 3

Following the publication of our paper regarding a population-based model of doxorubicin pharmacokinetics in children in Clinical Pharmacokinetics last year (Voller et al. 54:1139-1149, 2015), we have received many inquiries on the practical clinical consequences of this model; however, a population-based model is only one of the aspects to be taken into account when developing dosing algorithms. In addition, any new method of dose calculation would need clinical validation and, subsequently, a ...[more]

PMID: 27641152

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Project description:Background: This survey aims to identify the relative value and the critical components of anesthesiology letters of recommendation(LORs) from the perspective of Program Directors (PDs) and Associate/Assistant Program Directors (APDs). Knowledge and insights originating from this survey might add to the understanding of the anesthesiology residency selection process and mitigate unintended linguistic biases.Methodology: Anonymous online surveys were sent to anesthesiology PDs/APDs from the Accreditation Council for Graduate Medical Education (ACGME) accredited anesthesiology residency Programs in the USA (US), as listed on the ACGME website and the American Medical Association Fellowship and Residency Electronic Interactive Database (AMA FREIDA) Residency Program Database. The survey authors were blinded to the identity of the respondents.Results: 62 out of 183 (33.8%) invited anesthesiology PDs/APDs completed the survey anonymously. In our survey, LORs are reported as more important in granting an interview than in making the rank list. 64% of respondents prefer narrative LORs. 77.4% of respondents look for specific keywords in LORs. Keywords such as 'top % of students' and 'we are recruiting this candidate' indicate a strong letter of recommendation while keywords such as 'I recommend to your program' or non-superlative descriptions indicate a weak letter of recommendation. Other key components of LORs include the specialty of the letter-writer, according to 84% of respondents, with anesthesiology as the most valuable specialty. Although narrative LORs are preferred, 55.1% of respondents are not satisfied with the content of narrative LORs.Conclusion: LORs containing specific keywords play an important role in the application to anesthesiology residency, particularly when submitted by an anesthesiologist. While narrative LORs are still the preferred format, most of our respondents feel they need improvements. The authors suggest specific LOR improvements including creating formalized LOR training, adding a style guide, and applying comparative scales, with standardized vocabulary in the narrative LOR.

Dataset Information

Towards a Model-Based Dose Recommendation for Doxorubicin in Children.

Publications

Towards a Model-Based Dose Recommendation for Doxorubicin in Children.

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