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      Using nasal povidone-iodine to prevent bloodstream infections and transmission of Staphylococcus aureus among haemodialysis patients: a stepped-wedge cluster randomised control trial protocol

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          Abstract

          Introduction

          Approximately 38% of haemodialysis patients carry Staphylococcus aureus in their noses, and carriers have a nearly four-fold increased risk of S. aureus access-related bloodstream infections (BSIs) compared with non-carriers. Our objective is to determine the clinical efficacy and effectiveness of a novel intervention using nasal povidone-iodine (PVI) to prevent BSIs among patients in haemodialysis units. We will survey patients and conduct qualitative interviews with healthcare workers to identify barriers and facilitators to implementing the intervention.

          Methods and analysis

          We will perform an open-label, stepped-wedge cluster randomised trial to assess the effectiveness of nasal PVI compared with standard care. Sixteen outpatient haemodialysis units will participate in the study. The 3-year trial period will be divided into a 4-month baseline period and eight additional 4-month time blocks. The primary outcome of the study will be S. aureus BSI, defined as a S. aureus positive blood culture collected in the outpatient setting or within one calendar day after a hospital admission. The study team will evaluate characteristics of individual patients and the clusters by exposure status (control or intervention) to assess the balance between groups, and calculate descriptive statistics such as average responses separately for control and intervention survey questions.

          Ethics and dissemination

          This study has received IRB approval from all study sites. A Data Safety and Monitoring Board will monitor this multicentre clinical trial. We will present our results at international meetings. The study team will publish findings in peer-reviewed journals and make each accepted peer-reviewed manuscript publicly available.

          Trial registration number

          NCT04210505.

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          Most cited references38

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          Worldwide access to treatment for end-stage kidney disease: a systematic review.

          End-stage kidney disease is a leading cause of morbidity and mortality worldwide. Prevalence of the disease and worldwide use of renal replacement therapy (RRT) are expected to rise sharply in the next decade. We aimed to quantify estimates of this burden.
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            Design and analysis of stepped wedge cluster randomized trials.

            Cluster randomized trials (CRT) are often used to evaluate therapies or interventions in situations where individual randomization is not possible or not desirable for logistic, financial or ethical reasons. While a significant and rapidly growing body of literature exists on CRTs utilizing a "parallel" design (i.e. I clusters randomized to each treatment), only a few examples of CRTs using crossover designs have been described. In this article we discuss the design and analysis of a particular type of crossover CRT - the stepped wedge - and provide an example of its use.
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              The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2021
                3 December 2021
                : 11
                : 12
                : e048830
                Affiliations
                [1 ]departmentInternal Medicine , The University of Iowa Roy J and Lucille A Carver College of Medicine , Iowa City, Iowa, USA
                [2 ]departmentRenal Medicine , Emory University School of Medicine , Atlanta, Georgia, USA
                [3 ]departmentEmory Antibiotic Resistance Center , Emory University School of Medicine , Atlanta, Georgia, USA
                [4 ]departmentDepartment of Medicine , University of Pennsylvania Perelman School of Medicine , Philadelphia, Pennsylvania, USA
                [5 ]departmentDivision of Infectious Diseases , University of Illinois College of Medicine , Chicago, Illinois, USA
                [6 ]departmentDivision of Nephrology , Washington University School of Medicine in Saint Louis , St Louis, Missouri, USA
                [7 ]departmentClinical Research Unit , The University of Iowa Hospitals and Clinics , Iowa City, Iowa, USA
                [8 ]departmentBiostatistics, Epidemiology, and Informatics , University of Pennsylvania Perelman School of Medicine , Philadelphia, Pennsylvania, USA
                [9 ]departmentDivision of Infectious Diseases , Emory University School of Medicine , Atlanta, Georgia, USA
                [10 ]departmentDepartment of Medicine , University of Illinois College of Medicine , Chicago, Illinois, USA
                Author notes
                [Correspondence to ] Dr Ana-Monica Racila; ana-monica-racila@ 123456uiowa.edu
                Author information
                http://orcid.org/0000-0002-5751-5422
                Article
                bmjopen-2021-048830
                10.1136/bmjopen-2021-048830
                8647395
                34862278
                37c4b620-e38e-45ea-850d-64c89bffe0a7
                © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 14 January 2021
                : 28 October 2021
                Funding
                Funded by: National Center For Advancing Translational Sciences of the National Institutes of Health;
                Award ID: UL1TR002537
                Funded by: FundRef http://dx.doi.org/10.13039/100004343, 3M;
                Award ID: ISR74
                Funded by: Agency for Health Research and Quality (AHRQ);
                Award ID: 1R01HS026724-01
                Categories
                Infectious Diseases
                1506
                1706
                Protocol
                Custom metadata
                unlocked

                Medicine
                infection control,nephrology,dialysis,qualitative research
                Medicine
                infection control, nephrology, dialysis, qualitative research

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