{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,19]],"date-time":"2025-09-19T09:31:12Z","timestamp":1758274272566,"version":"3.37.3"},"reference-count":6,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T00:00:00Z","timestamp":1664496000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,9,30]],"date-time":"2022-09-30T00:00:00Z","timestamp":1664496000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"crossref","award":["APP1170021","APP2014258","APP1106716","APP1092957","APP1092957","APP1194485"],"award-info":[{"award-number":["APP1170021","APP2014258","APP1106716","APP1092957","APP1092957","APP1194485"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1115259"],"award-info":[{"award-number":["APP1115259"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1168994"],"award-info":[{"award-number":["APP1168994"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["APP1147657"],"award-info":[{"award-number":["APP1147657"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>This update summarises key changes made to the protocol since the publication of the original protocol for the NAVKIDS<jats:sup>2<\/jats:sup> trial of patient navigators for children with chronic kidney disease (CKD) experiencing social disadvantage and provides the statistical analysis plan (SAP) which has not previously been published.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods\/design<\/jats:title>\n                <jats:p>The original protocol was published in <jats:italic>BMC Nephrology<\/jats:italic> (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"doi\" xlink:href=\"10.1186\/s12882-019-1325-y\">https:\/\/doi.org\/10.1186\/s12882-019-1325-y<\/jats:ext-link>) prior to the commencement of trial recruitment. During the course of the trial, some key methodological changes needed to be made including changes to eligibility criteria (addition of patients with CKD stages 1\u20132, broadening of financial status eligibility criterion, addition of patients living in rural\/remote areas, modification of age eligibility to 0\u201316 years, addition of limits related to the language spoken by family, guidance regarding families with multiple eligible children), changes to sites, reduction of sample size, addition of virtual options for consent and study procedures in response to the COVID-19 pandemic, removal of staggered recruitment across sites, addition of outcomes, and changes to the timing and number of assessments. This update summarises the changes made and their rationale and provides the detailed plan for statistical analysis of the trial. These changes have been finalised prior to the completion of study follow-up and the commencement of data analysis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Australian New Zealand Clinical Trials Registry (ANZCTR) <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.anzctr.org.au\/Trial\/Registration\/TrialReview.aspx?id=375543&amp;isReview=true\">ACTRN12618001152213<\/jats:ext-link>. Prospectively registered on 12 July 2018<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-022-06783-y","type":"journal-article","created":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T23:04:02Z","timestamp":1664492642000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease \u2014 statistical analysis plan and update to the protocol"],"prefix":"10.1186","volume":"23","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4564-5825","authenticated-orcid":false,"given":"Anita","family":"van Zwieten","sequence":"first","affiliation":[]},{"given":"Elizabeth G.","family":"Ryan","sequence":"additional","affiliation":[]},{"given":"Patrina","family":"Caldwell","sequence":"additional","affiliation":[]},{"given":"Kirsten","family":"Howard","sequence":"additional","affiliation":[]},{"given":"Allison","family":"Tong","sequence":"additional","affiliation":[]},{"given":"Jonathan C.","family":"Craig","sequence":"additional","affiliation":[]},{"given":"Stephen I.","family":"Alexander","sequence":"additional","affiliation":[]},{"given":"Martin","family":"Howell","sequence":"additional","affiliation":[]},{"given":"Armando","family":"Teixeira-Pinto","sequence":"additional","affiliation":[]},{"given":"Carmel M.","family":"Hawley","sequence":"additional","affiliation":[]},{"given":"Shilpanjali","family":"Jesudason","sequence":"additional","affiliation":[]},{"given":"Amanda","family":"Walker","sequence":"additional","affiliation":[]},{"given":"Fiona","family":"Mackie","sequence":"additional","affiliation":[]},{"given":"Sean E.","family":"Kennedy","sequence":"additional","affiliation":[]},{"given":"Steven","family":"McTaggart","sequence":"additional","affiliation":[]},{"given":"Hugh J.","family":"McCarthy","sequence":"additional","affiliation":[]},{"given":"Simon A.","family":"Carter","sequence":"additional","affiliation":[]},{"given":"Siah","family":"Kim","sequence":"additional","affiliation":[]},{"given":"Reginald","family":"Woodleigh","sequence":"additional","affiliation":[]},{"given":"Anna","family":"Francis","sequence":"additional","affiliation":[]},{"given":"Alistair R.","family":"Mallard","sequence":"additional","affiliation":[]},{"given":"Am\u00e9lie","family":"Bernier-Jean","sequence":"additional","affiliation":[]},{"given":"David W.","family":"Johnson","sequence":"additional","affiliation":[]},{"given":"Deirdre","family":"Hahn","sequence":"additional","affiliation":[]},{"given":"Donna","family":"Reidlinger","sequence":"additional","affiliation":[]},{"given":"Elaine","family":"Pascoe","sequence":"additional","affiliation":[]},{"given":"Julie","family":"Varghese","sequence":"additional","affiliation":[]},{"given":"Charani","family":"Kiriwandeniya","sequence":"additional","affiliation":[]},{"given":"Liza","family":"Vergara","sequence":"additional","affiliation":[]},{"given":"Nicholas","family":"Larkins","sequence":"additional","affiliation":[]},{"given":"Luke","family":"Macauley","sequence":"additional","affiliation":[]},{"given":"Michelle","family":"Irving","sequence":"additional","affiliation":[]},{"given":"Rabia","family":"Khalid","sequence":"additional","affiliation":[]},{"given":"Chandana","family":"Guha","sequence":"additional","affiliation":[]},{"given":"Germaine","family":"Wong","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2022,9,30]]},"reference":[{"issue":"1","key":"6783_CR1","doi-asserted-by":"publisher","first-page":"134","DOI":"10.1186\/s12882-019-1325-y","volume":"20","author":"A van Zwieten","year":"2019","unstructured":"van Zwieten A, Caldwell P, Howard K, Tong A, Craig JC, Alexander S, et al. NAV-KIDS2 trial: protocol for a multi-centre, staggered randomised controlled trial of a patient navigator intervention in children with chronic kidney disease. BMC Nephrol. 2019;20(1):134.","journal-title":"BMC Nephrol."},{"issue":"7","key":"6783_CR2","doi-asserted-by":"publisher","first-page":"1237","DOI":"10.1007\/s00467-019-04209-7","volume":"34","author":"M Didsbury","year":"2019","unstructured":"Didsbury M, van Zwieten A, Chen K, James LJ, Francis A, Kim S, et al. The association between socioeconomic disadvantage and parent-rated health in children and adolescents with chronic kidney disease\u2014the Kids with CKD (KCAD) study. Pediatr Nephrol. 2019;34(7):1237\u201345.","journal-title":"Pediatr Nephrol."},{"key":"6783_CR3","doi-asserted-by":"publisher","first-page":"693","DOI":"10.1007\/s00467-021-05362-8","volume":"37","author":"M Didsbury","year":"2022","unstructured":"Didsbury M, van Zwieten A, Chen K, James LJ, Francis A, Kim S, et al. Correction to: The association between socioeconomic disadvantage and parent-rated health in children and adolescents with chronic kidney disease\u2014the Kids with CKD (KCAD) study. Pediatr Nephrol. 2022;37:693\u20136.","journal-title":"Pediatr Nephrol."},{"issue":"6","key":"6783_CR4","doi-asserted-by":"publisher","first-page":"1011","DOI":"10.1007\/s00467-015-3279-z","volume":"31","author":"A Francis","year":"2016","unstructured":"Francis A, Didsbury M, Lim WH, Kim S, White S, Craig JC, et al. The impact of socioeconomic status and geographic remoteness on access to pre-emptive kidney transplantation and transplant outcomes among children. Pediatr Nephrol. 2016;31(6):1011\u20139.","journal-title":"Pediatr Nephrol."},{"issue":"3","key":"6783_CR5","doi-asserted-by":"publisher","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","volume":"158","author":"A-W Chan","year":"2013","unstructured":"Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, G\u00f8tzsche PC, Krle\u017ea-Jeri\u0107 K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Internal Med. 2013;158(3):200\u20137.","journal-title":"Ann Internal Med"},{"issue":"23","key":"6783_CR6","doi-asserted-by":"publisher","first-page":"2337","DOI":"10.1001\/jama.2017.18556","volume":"318","author":"C Gamble","year":"2017","unstructured":"Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Dor\u00e9 C, et al. Guidelines for the content of statistical analysis plans in clinical trials. Jama. 2017;318(23):2337\u201343.","journal-title":"Jama."}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-022-06783-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-022-06783-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-022-06783-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T23:15:38Z","timestamp":1664493338000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-022-06783-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,30]]},"references-count":6,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["6783"],"URL":"https:\/\/doi.org\/10.1186\/s13063-022-06783-y","relation":{},"ISSN":["1745-6215"],"issn-type":[{"type":"electronic","value":"1745-6215"}],"subject":[],"published":{"date-parts":[[2022,9,30]]},"assertion":[{"value":"28 June 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 July 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 September 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval has been obtained from the Sydney Children\u2019s Hospital Network Human Research Ethics Committee (approval number: HREC\/18\/SCHN\/325) and the University of Queensland Human Research Ethics Committee (clearance number 2019002528). Informed and voluntary written or verbal consent will be obtained from all participating caregivers (and assent from participating children where appropriate to their age), as detailed in the \u201cconsent process\u201d section.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"RW is the Program Director of CanCare, a patient navigation programme for cancer patients run by the Prostate and Breast Cancer Foundation, Australia. DJ has received consultancy fees; research grants; speaker\u2019s honoraria and travel sponsorships from Baxter Healthcare and Fresenius Medical Care; consultancy fees from Astra Zeneca, Bayer and AWAK; speaker\u2019s honoraria from ONO and BI & Lilly; and travel sponsorships from Ono and Amgen. The other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"824"}}