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Optimizing design of research to evaluate antibiotic stewardship interventions; consensus recommendations of a multinational working group

Optimizing design of research to evaluate antibiotic stewardship interventions; consensus recommendations of a multinational working group
Optimizing design of research to evaluate antibiotic stewardship interventions; consensus recommendations of a multinational working group
Scope: antimicrobial stewardship interventions and programmes aim to ensure effective treatment while minimising antimicrobial-associated harms including resistance. Practice in this vital area is undermined by the poor quality of research addressing both what specific antimicrobial use interventions are effective and how antimicrobial use improvement strategies can be implemented into practice. In 2016 we established a working party to identify the key design features which limit translation of existing research into practice and then to make recommendations for how future studies in this field should be optimally designed. The first part of this work has been published as a systematic review. Here we present the working group’s final recommendations.

Methods: an international working group for design of antimicrobial stewardship intervention evaluations was convened in response to the fourth call for leading expert network proposals by the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR). The group comprised clinical and academic specialists in antimicrobial stewardship and clinical trial design from six European countries. Group members completed a structured questionnaire to establish the scope of work and key issues to develop ahead of a first face-to-face meeting which 1) identified the need for a comprehensive systematic review of study designs in the literature and 2) prioritised key areas where research design considerations restrict translation of findings into practice. The working group’s initial outputs were reviewed by independent advisors and additional expertise was sought in specific clinical areas. At a second face-to-face meeting the working group developed a theoretical framework and specific recommendations to support optimal study design. These were finalised by the working group co-ordinators and agreed by all working group members

Recommendations: we propose a theoretical framework in which consideration of the intervention rationale the intervention setting, intervention features and the intervention aims inform selection and prioritization of outcome measures, whether the research sets out to determine superiority or non-inferiority of the intervention measured by its primary outcome(s), the most appropriate study design (e.g. experimental or quasi- experimental) and the detailed design features. We make eighteen specific recommendation in three domains: outcomes, objectives and study design.

Conclusions: researchers, funders and practitioners will be able to draw on our recommendations to most efficiently evaluate antimicrobial stewardship interventions.
1198-743X
Schweitzer, Valengijn A
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Werkhoven, Cornelis H. van
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Rodriguez Bano, Jesus
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Bielicki, Julia
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Harbarth, Stephan
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Hulscher, M.
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Huttner, B.
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Little, Paul
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Pulcini, C.
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Savoldi, A.
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Tacconelli, E.
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Timsit, Jean François
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van Smeden, M.
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Wolkewitz, M.
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Bonten, M.J.M.
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Walker, A.S.
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Llewelyn, M.
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Schweitzer, Valengijn A
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Werkhoven, Cornelis H. van
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Rodriguez Bano, Jesus
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Bielicki, Julia
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Harbarth, Stephan
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Hulscher, M.
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Huttner, B.
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Islam, Jasmin
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Little, Paul
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Pulcini, C.
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Savoldi, A.
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Tacconelli, E.
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Timsit, Jean François
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van Smeden, M.
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Wolkewitz, M.
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Bonten, M.J.M.
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Walker, A.S.
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Llewelyn, M.
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Schweitzer, Valengijn A, Werkhoven, Cornelis H. van, Rodriguez Bano, Jesus, Bielicki, Julia, Harbarth, Stephan, Hulscher, M., Huttner, B., Islam, Jasmin, Little, Paul, Pulcini, C., Savoldi, A., Tacconelli, E., Timsit, Jean François, van Smeden, M., Wolkewitz, M., Bonten, M.J.M., Walker, A.S. and Llewelyn, M. (2019) Optimizing design of research to evaluate antibiotic stewardship interventions; consensus recommendations of a multinational working group. Clinical Microbiology and Infection. (doi:10.1016/j.cmi.2019.08.017).

Record type: Article

Abstract

Scope: antimicrobial stewardship interventions and programmes aim to ensure effective treatment while minimising antimicrobial-associated harms including resistance. Practice in this vital area is undermined by the poor quality of research addressing both what specific antimicrobial use interventions are effective and how antimicrobial use improvement strategies can be implemented into practice. In 2016 we established a working party to identify the key design features which limit translation of existing research into practice and then to make recommendations for how future studies in this field should be optimally designed. The first part of this work has been published as a systematic review. Here we present the working group’s final recommendations.

Methods: an international working group for design of antimicrobial stewardship intervention evaluations was convened in response to the fourth call for leading expert network proposals by the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR). The group comprised clinical and academic specialists in antimicrobial stewardship and clinical trial design from six European countries. Group members completed a structured questionnaire to establish the scope of work and key issues to develop ahead of a first face-to-face meeting which 1) identified the need for a comprehensive systematic review of study designs in the literature and 2) prioritised key areas where research design considerations restrict translation of findings into practice. The working group’s initial outputs were reviewed by independent advisors and additional expertise was sought in specific clinical areas. At a second face-to-face meeting the working group developed a theoretical framework and specific recommendations to support optimal study design. These were finalised by the working group co-ordinators and agreed by all working group members

Recommendations: we propose a theoretical framework in which consideration of the intervention rationale the intervention setting, intervention features and the intervention aims inform selection and prioritization of outcome measures, whether the research sets out to determine superiority or non-inferiority of the intervention measured by its primary outcome(s), the most appropriate study design (e.g. experimental or quasi- experimental) and the detailed design features. We make eighteen specific recommendation in three domains: outcomes, objectives and study design.

Conclusions: researchers, funders and practitioners will be able to draw on our recommendations to most efficiently evaluate antimicrobial stewardship interventions.

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CLM-19-15688R1 FINAL MARKED - Accepted Manuscript
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Accepted/In Press date: 22 August 2019
e-pub ahead of print date: 4 September 2019

Identifiers

Local EPrints ID: 433713
URI: http://eprints.soton.ac.uk/id/eprint/433713
ISSN: 1198-743X
PURE UUID: 3ad263c3-f8d3-465f-a067-d8d0353c514b
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873

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Date deposited: 02 Sep 2019 16:30
Last modified: 12 Jul 2024 04:06

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Contributors

Author: Valengijn A Schweitzer
Author: Cornelis H. van Werkhoven
Author: Jesus Rodriguez Bano
Author: Julia Bielicki
Author: Stephan Harbarth
Author: M. Hulscher
Author: B. Huttner
Author: Jasmin Islam
Author: Paul Little ORCID iD
Author: C. Pulcini
Author: A. Savoldi
Author: E. Tacconelli
Author: Jean François Timsit
Author: M. van Smeden
Author: M. Wolkewitz
Author: M.J.M. Bonten
Author: A.S. Walker
Author: M. Llewelyn

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