TY - JOUR
T1 - Optimizing design of research to evaluate antibiotic stewardship interventions
T2 - consensus recommendations of a multinational working group
AU - Schweitzer, Valentijn A
AU - van Werkhoven, Cornelis H
AU - Rodríguez Baño, Jesús
AU - Bielicki, Julia
AU - Harbarth, Stephan
AU - Hulscher, Marlies
AU - Huttner, Benedikt
AU - Islam, Jasmin
AU - Little, Paul
AU - Pulcini, Celine
AU - Savoldi, Alessia
AU - Tacconelli, Evelina
AU - Timsit, Jean-Francois
AU - van Smeden, Maarten
AU - Wolkewitz, Martin
AU - Bonten, Marc J M
AU - Sarah Walker, A
AU - Llewelyn, Martin J
N1 - Funding Information:
The authors declare no conflicts of interest. The presented work was supported by a grant (JPIAMRWG-010) from the Joint Programming Initiative on Antimicrobial Resistance. A.S.W. is supported by the NIHR Oxford Biomedical Research Centre and the Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford in partnership with Public Health England (PHE) [HPRU-2012-10041], and is an NIHR Senior Investigator. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health or PHE.
Funding Information:
The authors declare no conflicts of interest. The presented work was supported by a grant ( JPIAMRWG-010 ) from the Joint Programming Initiative on Antimicrobial Resistance . A.S.W. is supported by the NIHR Oxford Biomedical Research Centre and the Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance at the University of Oxford in partnership with Public Health England (PHE) [ HPRU-2012-10041 ], and is an NIHR Senior Investigator. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, the Department of Health or PHE.
Publisher Copyright:
© 2019 The Author(s)
PY - 2020/1
Y1 - 2020/1
N2 - Background: Antimicrobial stewardship interventions and programmes aim to ensure effective treatment while minimizing 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 that 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 that (a) identified the need for a comprehensive systematic review of study designs in the literature and (b) prioritized 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 finalized by the working group co-ordinators and agreed by all working group members. Results: 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 18 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.
AB - Background: Antimicrobial stewardship interventions and programmes aim to ensure effective treatment while minimizing 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 that 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 that (a) identified the need for a comprehensive systematic review of study designs in the literature and (b) prioritized 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 finalized by the working group co-ordinators and agreed by all working group members. Results: 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 18 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.
KW - Antimicrobial resistance
KW - Antimicrobial stewardship
KW - Appropriate antimicrobial use
KW - Methodology
KW - Quality
KW - Research design
UR - http://www.scopus.com/inward/record.url?scp=85073208098&partnerID=8YFLogxK
U2 - 10.1016/j.cmi.2019.08.017
DO - 10.1016/j.cmi.2019.08.017
M3 - Article
C2 - 31493472
SN - 1198-743X
VL - 26
SP - 41
EP - 50
JO - Clinical Microbiology and Infection
JF - Clinical Microbiology and Infection
IS - 1
ER -