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      A complex ePrescribing-based Anti-Microbial Stewardship (ePAMS+) intervention for hospitals combining technological and behavioural components: protocol for a feasibility trial

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          Abstract

          Background

          Antimicrobial resistance is a leading global public health threat, with inappropriate use of antimicrobials in healthcare contributing to its development. Given this urgent need, we developed a complex ePrescribing-based Anti-Microbial Stewardship intervention (ePAMS+).

          Methods

          ePAMS+ includes educational and organisational behavioural elements, plus guideline-based clinical decision support to aid optimal antimicrobial use in hospital inpatients. ePAMS+ particularly focuses on prompt initiation of antimicrobials, followed by early review once test results are available to facilitate informed decision-making on stopping or switching where appropriate. A mixed-methods feasibility trial of ePAMS+ will take place in two NHS acute hospital care organisations. Qualitative staff interviews and observation of practice will respectively gather staff views on the technical component of ePAMS+ and information on their use of ePAMS+ in routine work. Focus groups will elicit staff and patient views on ePAMS+; one-to-one interviews will discuss antimicrobial stewardship with staff and will record patient experiences of receiving antibiotics and their thoughts on inappropriate prescribing. Qualitative data will be analysed thematically. Fidelity Index development will enable enactment of ePAMS+ to be measured objectively in a subsequent trial assessing the effectiveness of ePAMS+. Quantitative data collection will determine the feasibility of extracting data and deriving key summaries of antimicrobial prescribing; we will quantify variability in the primary outcome, number of antibiotic defined daily doses, to inform the future larger-scale trial design.

          Discussion

          This trial is essential to determine the feasibility of implementing the ePAMS+ intervention and measuring relevant outcomes, prior to evaluating its clinical and cost-effectiveness in a full scale hybrid cluster-randomised stepped-wedge clinical trial. Findings will be shared with study sites and with qualitative research participants and will be published in peer-reviewed journals and presented at academic conferences.

          Trial registration

          The qualitative and Fidelity Index research were approved by the Health and Research Authority and the North of Scotland Research Ethics Service (ref: 19/NS/0174). The feasibility trial and quantitative analysis (protocol v1.0, 15 December 2021) were approved by the London South East Research Ethics Committee (ref: 22/LO/0204) and registered with ISRCTN ( ISRCTN 13429325) on 24 March 2022

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s40814-022-01230-w.

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          Most cited references20

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          Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

          Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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            Understanding the mechanisms and drivers of antimicrobial resistance.

            To combat the threat to human health and biosecurity from antimicrobial resistance, an understanding of its mechanisms and drivers is needed. Emergence of antimicrobial resistance in microorganisms is a natural phenomenon, yet antimicrobial resistance selection has been driven by antimicrobial exposure in health care, agriculture, and the environment. Onward transmission is affected by standards of infection control, sanitation, access to clean water, access to assured quality antimicrobials and diagnostics, travel, and migration. Strategies to reduce antimicrobial resistance by removing antimicrobial selective pressure alone rely upon resistance imparting a fitness cost, an effect not always apparent. Minimising resistance should therefore be considered comprehensively, by resistance mechanism, microorganism, antimicrobial drug, host, and context; parallel to new drug discovery, broad ranging, multidisciplinary research is needed across these five levels, interlinked across the health-care, agriculture, and environment sectors. Intelligent, integrated approaches, mindful of potential unintended results, are needed to ensure sustained, worldwide access to effective antimicrobials.
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              • Article: not found

              Outpatient antibiotic use in Europe and association with resistance: a cross-national database study.

              Resistance to antibiotics is a major public-health problem and antibiotic use is being increasingly recognised as the main selective pressure driving this resistance. Our aim was to assess outpatient use of antibiotics and the association with resistance. We investigated outpatient antibiotic use in 26 countries in Europe that provided internationally comparable distribution or reimbursement data, between Jan 1, 1997, and Dec 31, 2002, by calculating the number of defined daily doses (DDD) per 1000 inhabitants per day, according to WHO anatomic therapeutic chemical classification and DDD measurement methodology. We assessed the ecological association between antibiotic use and antibiotic resistance rates using Spearman's correlation coefficients. Prescription of antibiotics in primary care in Europe varied greatly; the highest rate was in France (32.2 DDD per 1000 inhabitants daily) and the lowest was in the Netherlands (10.0 DDD per 1000 inhabitants daily). We noted a shift from the old narrow-spectrum antibiotics to the new broad-spectrum antibiotics. We also recorded striking seasonal fluctuations with heightened winter peaks in countries with high yearly use of antibiotics. We showed higher rates of antibiotic resistance in high consuming countries, probably related to the higher consumption in southern and eastern Europe than in northern Europe. These data might provide a useful method for assessing public-health strategies that aim to reduce antibiotic use and resistance levels.
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                Author and article information

                Contributors
                Christopher.Weir@ed.ac.uk
                Journal
                Pilot Feasibility Stud
                Pilot Feasibility Stud
                Pilot and Feasibility Studies
                BioMed Central (London )
                2055-5784
                28 January 2023
                28 January 2023
                2023
                : 9
                : 18
                Affiliations
                [1 ]GRID grid.4305.2, ISNI 0000 0004 1936 7988, Edinburgh Clinical Trials Unit, , Usher Institute, University of Edinburgh, ; Edinburgh, UK
                [2 ]GRID grid.4305.2, ISNI 0000 0004 1936 7988, Usher Institute, University of Edinburgh, ; Edinburgh, UK
                [3 ]GRID grid.420004.2, ISNI 0000 0004 0444 2244, Newcastle upon Tyne Hospitals NHS Foundation Trust, ; Newcastle, UK
                [4 ]GRID grid.4305.2, ISNI 0000 0004 1936 7988, Institute for the Study of Science, Technology and Innovation, , University of Edinburgh, ; Edinburgh, UK
                [5 ]GRID grid.5685.e, ISNI 0000 0004 1936 9668, Department of Health Sciences, , University of York, ; York, UK
                [6 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, Institute of Clinical Sciences, , University of Birmingham, ; Birmingham, UK
                [7 ]GRID grid.6572.6, ISNI 0000 0004 1936 7486, University of Birmingham, ; Birmingham, UK
                [8 ]NHS Covid Vaccine North East and North Cumbria, Carlisle, UK
                [9 ]GRID grid.451052.7, ISNI 0000 0004 0581 2008, NHS England, ; London, UK
                [10 ]GRID grid.1006.7, ISNI 0000 0001 0462 7212, School of Pharmacy, , Newcastle University, ; Newcastle, UK
                [11 ]GRID grid.7372.1, ISNI 0000 0000 8809 1613, Warwick Medical School, , University of Warwick, ; Coventry, UK
                [12 ]GRID grid.5337.2, ISNI 0000 0004 1936 7603, School of Psychological Science, , University of Bristol, ; Bristol, UK
                [13 ]GRID grid.5491.9, ISNI 0000 0004 1936 9297, School of Psychology, , University of Southampton, ; Southampton, UK
                Author information
                http://orcid.org/0000-0002-6494-4903
                https://orcid.org/0000-0002-2873-3682
                https://orcid.org/0000-0002-9044-4611
                https://orcid.org/0000-0001-6634-9537
                https://orcid.org/0000-0002-7122-8403
                https://orcid.org/0000-0002-0344-4075
                https://orcid.org/0000-0002-0634-984X
                https://orcid.org/0000-0002-9731-7041
                https://orcid.org/0000-0002-0646-5939
                https://orcid.org/0000-0002-7591-3256
                https://orcid.org/0000-0002-0339-846X
                https://orcid.org/0000-0001-9210-4082
                https://orcid.org/0000-0001-7022-3056
                Article
                1230
                10.1186/s40814-022-01230-w
                9883604
                36709308
                bfd521c6-1b10-4f37-9b91-86008b7c1416
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 23 May 2022
                : 16 December 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007602, Programme Grants for Applied Research;
                Award ID: NIHR RP-PG-0617-20009
                Award Recipient :
                Funded by: NIHR Applied Research Collaboration (ARC)-West
                Funded by: NIHR HPRU for Behavioural Science and Evaluation
                Funded by: FundRef http://dx.doi.org/10.13039/501100022419, National Institute for Health Research Southampton Biomedical Research Centre;
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2023

                health informatics,bacteriology,infectious diseases,microbiology,decision support

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