Publication

How to design a study to evaluate therapeutic drug monitoring in infectious diseases?

Märtson, A-G., Sturkenboom, M. G. G., Stojanova, J., Cattaneo, D., Hope, W., Marriott, D., Patanwala, A. E., Peloquin, C. A., Wicha, S. G., van der Werf, T. S., Tängdén, T., Roberts, J. A., Neely, M. N. & Alffenaar, J-W. C., Aug-2020, In : Clinical Microbiology and Infection. 26, 8, p. 1008-1016 9 p.

Research output: Contribution to journalReview articleAcademicpeer-review

APA

Märtson, A-G., Sturkenboom, M. G. G., Stojanova, J., Cattaneo, D., Hope, W., Marriott, D., Patanwala, A. E., Peloquin, C. A., Wicha, S. G., van der Werf, T. S., Tängdén, T., Roberts, J. A., Neely, M. N., & Alffenaar, J-W. C. (2020). How to design a study to evaluate therapeutic drug monitoring in infectious diseases? Clinical Microbiology and Infection, 26(8), 1008-1016. https://doi.org/10.1016/j.cmi.2020.03.008

Author

Märtson, Anne-Grete ; Sturkenboom, Marieke G G ; Stojanova, Jana ; Cattaneo, Dario ; Hope, William ; Marriott, Deborah ; Patanwala, Asad E ; Peloquin, Charles A ; Wicha, Sebastian G ; van der Werf, Tjip S ; Tängdén, Thomas ; Roberts, Jason A ; Neely, Michael N ; Alffenaar, Jan-Willem C. / How to design a study to evaluate therapeutic drug monitoring in infectious diseases?. In: Clinical Microbiology and Infection. 2020 ; Vol. 26, No. 8. pp. 1008-1016.

Harvard

Märtson, A-G, Sturkenboom, MGG, Stojanova, J, Cattaneo, D, Hope, W, Marriott, D, Patanwala, AE, Peloquin, CA, Wicha, SG, van der Werf, TS, Tängdén, T, Roberts, JA, Neely, MN & Alffenaar, J-WC 2020, 'How to design a study to evaluate therapeutic drug monitoring in infectious diseases?', Clinical Microbiology and Infection, vol. 26, no. 8, pp. 1008-1016. https://doi.org/10.1016/j.cmi.2020.03.008

Standard

How to design a study to evaluate therapeutic drug monitoring in infectious diseases? / Märtson, Anne-Grete; Sturkenboom, Marieke G G; Stojanova, Jana; Cattaneo, Dario; Hope, William; Marriott, Deborah; Patanwala, Asad E; Peloquin, Charles A; Wicha, Sebastian G; van der Werf, Tjip S; Tängdén, Thomas; Roberts, Jason A; Neely, Michael N; Alffenaar, Jan-Willem C.

In: Clinical Microbiology and Infection, Vol. 26, No. 8, 08.2020, p. 1008-1016.

Research output: Contribution to journalReview articleAcademicpeer-review

Vancouver

Märtson A-G, Sturkenboom MGG, Stojanova J, Cattaneo D, Hope W, Marriott D et al. How to design a study to evaluate therapeutic drug monitoring in infectious diseases? Clinical Microbiology and Infection. 2020 Aug;26(8):1008-1016. https://doi.org/10.1016/j.cmi.2020.03.008


BibTeX

@article{d9426a8a2c174506a184487fa4efae24,
title = "How to design a study to evaluate therapeutic drug monitoring in infectious diseases?",
abstract = "Background: Therapeutic drug monitoring (TDM) is a tool to personalize and optimize dosing by measuring the drug concentration and subsequently adjusting the dose to reach a target concentration or exposure. The evidence to support TDM is however often ranked as expert opinion. Limitations in study design and sample size have hampered definitive conclusions of the potential added value of TDM. Objectives: We aim to give expert opinion and discuss the main points and limitations of available data from antibiotic TDM trials and emphasize key elements for consideration in design of future clinical studies to quantify the benefits of TDM. Sources: The sources were peer-reviewed publications, guidelines and expert opinions from the field of TDM. Content: This review focuses on key aspects of antimicrobial TDM study design: describing the rationale for a TDM study, assessing the exposure of a drug, assessing susceptibility of pathogens and selecting appropriate clinical endpoints. Moreover we provide guidance on appropriate study design. Implications: This is an overview of different aspects relevant for the conduct of a TDM study. We believe that this paper will help researchers and clinicians to design and conduct high-quality TDM studies.",
keywords = "Drug exposure, Personalized dosing study design, Pharmacodynamics, Pharmacokinetics, Randomized controlled trials, Therapeutic drug monitoring, CRITICALLY-ILL PATIENTS, PROFICIENCY TESTING PROGRAM, QUASI-EXPERIMENTAL DESIGNS, BETA-LACTAM ANTIBIOTICS, EPITHELIAL LINING FLUID, QUALITY-CONTROL PROGRAM, POPULATION PHARMACOKINETICS, COST-EFFECTIVENESS, VANCOMYCIN, TUBERCULOSIS",
author = "Anne-Grete M{\"a}rtson and Sturkenboom, {Marieke G G} and Jana Stojanova and Dario Cattaneo and William Hope and Deborah Marriott and Patanwala, {Asad E} and Peloquin, {Charles A} and Wicha, {Sebastian G} and {van der Werf}, {Tjip S} and Thomas T{\"a}ngd{\'e}n and Roberts, {Jason A} and Neely, {Michael N} and Alffenaar, {Jan-Willem C}",
note = "Copyright {\textcopyright} 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.",
year = "2020",
month = aug,
doi = "10.1016/j.cmi.2020.03.008",
language = "English",
volume = "26",
pages = "1008--1016",
journal = "Clinical Microbiology and Infection",
issn = "1198-743X",
publisher = "ELSEVIER SCI LTD",
number = "8",

}

RIS

TY - JOUR

T1 - How to design a study to evaluate therapeutic drug monitoring in infectious diseases?

AU - Märtson, Anne-Grete

AU - Sturkenboom, Marieke G G

AU - Stojanova, Jana

AU - Cattaneo, Dario

AU - Hope, William

AU - Marriott, Deborah

AU - Patanwala, Asad E

AU - Peloquin, Charles A

AU - Wicha, Sebastian G

AU - van der Werf, Tjip S

AU - Tängdén, Thomas

AU - Roberts, Jason A

AU - Neely, Michael N

AU - Alffenaar, Jan-Willem C

N1 - Copyright © 2020 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

PY - 2020/8

Y1 - 2020/8

N2 - Background: Therapeutic drug monitoring (TDM) is a tool to personalize and optimize dosing by measuring the drug concentration and subsequently adjusting the dose to reach a target concentration or exposure. The evidence to support TDM is however often ranked as expert opinion. Limitations in study design and sample size have hampered definitive conclusions of the potential added value of TDM. Objectives: We aim to give expert opinion and discuss the main points and limitations of available data from antibiotic TDM trials and emphasize key elements for consideration in design of future clinical studies to quantify the benefits of TDM. Sources: The sources were peer-reviewed publications, guidelines and expert opinions from the field of TDM. Content: This review focuses on key aspects of antimicrobial TDM study design: describing the rationale for a TDM study, assessing the exposure of a drug, assessing susceptibility of pathogens and selecting appropriate clinical endpoints. Moreover we provide guidance on appropriate study design. Implications: This is an overview of different aspects relevant for the conduct of a TDM study. We believe that this paper will help researchers and clinicians to design and conduct high-quality TDM studies.

AB - Background: Therapeutic drug monitoring (TDM) is a tool to personalize and optimize dosing by measuring the drug concentration and subsequently adjusting the dose to reach a target concentration or exposure. The evidence to support TDM is however often ranked as expert opinion. Limitations in study design and sample size have hampered definitive conclusions of the potential added value of TDM. Objectives: We aim to give expert opinion and discuss the main points and limitations of available data from antibiotic TDM trials and emphasize key elements for consideration in design of future clinical studies to quantify the benefits of TDM. Sources: The sources were peer-reviewed publications, guidelines and expert opinions from the field of TDM. Content: This review focuses on key aspects of antimicrobial TDM study design: describing the rationale for a TDM study, assessing the exposure of a drug, assessing susceptibility of pathogens and selecting appropriate clinical endpoints. Moreover we provide guidance on appropriate study design. Implications: This is an overview of different aspects relevant for the conduct of a TDM study. We believe that this paper will help researchers and clinicians to design and conduct high-quality TDM studies.

KW - Drug exposure

KW - Personalized dosing study design

KW - Pharmacodynamics

KW - Pharmacokinetics

KW - Randomized controlled trials

KW - Therapeutic drug monitoring

KW - CRITICALLY-ILL PATIENTS

KW - PROFICIENCY TESTING PROGRAM

KW - QUASI-EXPERIMENTAL DESIGNS

KW - BETA-LACTAM ANTIBIOTICS

KW - EPITHELIAL LINING FLUID

KW - QUALITY-CONTROL PROGRAM

KW - POPULATION PHARMACOKINETICS

KW - COST-EFFECTIVENESS

KW - VANCOMYCIN

KW - TUBERCULOSIS

U2 - 10.1016/j.cmi.2020.03.008

DO - 10.1016/j.cmi.2020.03.008

M3 - Review article

C2 - 32205294

VL - 26

SP - 1008

EP - 1016

JO - Clinical Microbiology and Infection

JF - Clinical Microbiology and Infection

SN - 1198-743X

IS - 8

ER -

ID: 121091252