{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T10:31:24Z","timestamp":1770287484768,"version":"3.49.0"},"reference-count":38,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2021,12,2]],"date-time":"2021-12-02T00:00:00Z","timestamp":1638403200000},"content-version":"unspecified","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"National Center For Advancing Translational Sciences of the National Institutes of Health","award":["UL1TR002537"],"award-info":[{"award-number":["UL1TR002537"]}]},{"DOI":"10.13039\/100004343","name":"3M","doi-asserted-by":"publisher","award":["ISR74"],"award-info":[{"award-number":["ISR74"]}],"id":[{"id":"10.13039\/100004343","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000133","name":"Agency for Health Research and Quality","doi-asserted-by":"crossref","award":["1R01HS026724-01"],"award-info":[{"award-number":["1R01HS026724-01"]}],"id":[{"id":"10.13039\/100000133","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,10,28]]},"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Approximately 38% of haemodialysis patients carry\n                      <jats:italic>Staphylococcus aureus<\/jats:italic>\n                      in their noses, and carriers have a nearly four-fold increased risk of\n                      <jats:italic>S. aureus<\/jats:italic>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:italic>S. aureus<\/jats:italic>\n                      BSI, defined as a\n                      <jats:italic>S. aureus<\/jats:italic>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04210505\">NCT04210505<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-048830","type":"journal-article","created":{"date-parts":[[2021,12,3]],"date-time":"2021-12-03T11:57:07Z","timestamp":1638532627000},"page":"e048830","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Using nasal povidone-iodine to prevent bloodstream infections and transmission of\n                    <i>Staphylococcus aureus<\/i>\n                    among haemodialysis patients: a stepped-wedge cluster randomised control trial protocol"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04210505","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5751-5422","authenticated-orcid":false,"given":"Ana-Monica","family":"Racila","sequence":"first","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy M J","family":"O\"Shea","sequence":"additional","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rajeshwari","family":"Nair","sequence":"additional","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly","family":"Dukes","sequence":"additional","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Loreen A","family":"Herwaldt","sequence":"additional","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Linda","family":"Boyken","sequence":"additional","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Diekema","sequence":"additional","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melissa A","family":"Ward","sequence":"additional","affiliation":[{"name":"Internal Medicine, The University of Iowa Roy J and Lucille A Carver College of Medicine, Iowa City, Iowa, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Cobb","sequence":"additional","affiliation":[{"name":"Renal Medicine, Emory University School of Medicine, Atlanta, Georgia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jesse","family":"Jacob","sequence":"additional","affiliation":[{"name":"Emory Antibiotic Resistance Center, Emory University School of Medicine, Atlanta, Georgia, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Pegues","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, 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