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Clin Microbiol Infect. 2019 Sep 4. pii: S1198-743X(19)30477-X. doi: 10.1016/j.cmi.2019.08.017. [Epub ahead of print]

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

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Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, The Netherlands.
Unit of Infectious Diseases, Clinical Microbiology and Preventive Medicine, Department of Medicine, Hospital Universitario Virgen Macarena, Universidad de Sevilla and Biomedicine Institute of Sevilla (IBiS), Seville, Spain.
Paediatric Infectious Disease Research Group, St George's University of London, London, United Kingdom.
Divisions of Infectious Diseases and Infection Control, Geneva University Hospitals and Faculty of Medicine, Switzerland.
Scientific Center for Quality of Healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Infectious Diseases and Infection Control, Hôpitaux Universitaires de Genève, Switzerland.
Department of Global Health and Infection, Brighton and Sussex Medical School, Falmer, United Kingdom.
Department of Primary Care Research, University of Southampton, Southampton, United Kingdom.
Infectious Diseases Department, Université de Lorraine, CHRU-Nancy, and APEMAC, Université de Lorraine, Nancy, France.
Infectious Diseases, Department of Diagnostic and Public Health, Verona, Italy; University Hospital; Internal Medicine, Tuebingen University, Germany.
University of Paris, IAME; Inserm; Medical and Infectious Diseases ICU (MI2), Bichat Hospital; F75018, Paris France.
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Institute for Medical Biometry and Statistics, University of Freiburg, Germany.
Department of Medical Microbiology, University Medical Center Utrecht, The Netherlands.
MRC Clinical Trials Unit, University College London, London, United Kingdom; Nuffield Department of Medicine, University of Oxford, United Kingdom.
Department of Global Health and Infection, Brighton and Sussex Medical School, Falmer, United Kingdom. Electronic address:



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.


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.


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.


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


antibiotic stewardship; research design

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