{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T15:22:04Z","timestamp":1791559324538,"version":"4.3.4"},"reference-count":29,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T00:00:00Z","timestamp":1757635200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Horizon 2020","award":["754803"],"award-info":[{"award-number":["754803"]}]}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["CJASN"],"published-print":{"date-parts":[[2026,1]]},"abstract":"\n Key Points<\/jats:title>\n \n \n \n Coverage of patient characteristics in existing trials of hemodiafiltration versus hemodialysis seems to be broad but incomplete.<\/jats:p>\n <\/jats:list-item>\n \n Randomized trials of hemodiafiltration versus hemodialysis have been primarily limited to Europe.<\/jats:p>\n <\/jats:list-item>\n \n Inconsistencies between trials and registries support further studies using real-world data to explore applicability of existing evidence.<\/jats:p>\n <\/jats:list-item>\n <\/jats:list>\n <\/jats:p>\n <\/jats:sec>\n \n Background<\/jats:title>\n Selection criteria in randomized trials (randomized controlled trials [RCTs]) can lead to differences in key characteristics between trial participants and real-life populations. We evaluated reporting of population characteristics in existing RCTs of hemodiafiltration (HDF) and in real-life populations included in kidney registries to descriptively identify key differences.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We used systematic review methodology to identify existing RCTs of HDF versus hemodialysis (1966 to May 2024). We also searched the Fresenius Quantitative Market Analysis team registry database (2024 update) for existing registries from Europe, the Asia-Pacific region, and America including populations on HDF. Patient characteristics from RCTs and registries were extracted, summarized, and compared descriptively.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Eleven RCTs (\n N<\/jats:italic>\n =5108) and eight registries (\n N<\/jats:italic>\n =1,147,167) were identified. There were no RCTs in the United States and only two small RCTs from Australia (\n N<\/jats:italic>\n =124) and Brazil (\n N<\/jats:italic>\n =195). Most trials were from Europe. Key characteristics consistently reported in both RCTs and registries were only age, sex, diabetes, cardiovascular disease, vascular access type, and dialysis vintage. There was moderate to high heterogeneity for these patient characteristics in RCTs, indicating enrollment of a broad array of people. The proportion of people with diabetes was 26% in RCTs and 43% in registries. The prevalence of arteriovenous fistulas\/graft was 90% in RCTs and 70% in registries.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n There was a broad but incomplete array of patient characteristics in existing RCTs and real-world registries of HDF versus hemodialysis. Data were primarily limited to Europe and only a core set of demographic and clinical variables. Apart for age, sex, diabetes, cardiovascular disease, vascular access type, and dialysis vintage, other patient and treatment relevant characteristics were erratically or not at all reported in RCTs as well as in real-world registries. With potential differences in patient populations, we support the need for studies examining HDF in real-world settings,\n e.g<\/jats:italic>\n ., with target emulation trials.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.2215\/cjn.0000000855","type":"journal-article","created":{"date-parts":[[2025,9,12]],"date-time":"2025-09-12T16:00:29Z","timestamp":1757692829000},"page":"95-107","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":2,"title":["Characteristics of Populations Included in Randomized Controlled Trials of Hemodiafiltration and Registry Real-Life Populations"],"prefix":"10.2215","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5324-0695","authenticated-orcid":false,"given":"Krister","family":"Cromm","sequence":"first","affiliation":[{"name":"Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg, Germany"},{"name":"Department of Psychosomatic Medicine, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-9920-4410","authenticated-orcid":false,"given":"Ngoc","family":"Pham","sequence":"additional","affiliation":[{"name":"Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom","family":"Yuen","sequence":"additional","affiliation":[{"name":"Fresenius Medical Care Asia Pacific Ltd., Global Medical Office, Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hanna","family":"Jaha","sequence":"additional","affiliation":[{"name":"Fresenius Medical Care Deutschland GmbH, Global Medical Office, Bad Homburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valeria","family":"Saglimbene","sequence":"additional","affiliation":[{"name":"Department of Precision and Regenerative Medicine and Ionian Area (Dimepre-J), University of Bari, Bari, Italy"},{"name":"School of Public Health, University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2695-1838","authenticated-orcid":false,"given":"J\u00f6rgen","family":"Hegbrant","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Clinical Sciences, Lund University, Lund, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9800-5296","authenticated-orcid":false,"given":"Mark","family":"Woodward","sequence":"additional","affiliation":[{"name":"School of Public Health, The George Institute for Global Health, Imperial College London, London, United Kingdom"},{"name":"The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4467-6833","authenticated-orcid":false,"given":"Andrew","family":"Davenport","sequence":"additional","affiliation":[{"name":"Division of Medicine, UCL Centre for Bladder and Kidney Health, Royal Free Hospital, University College London, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6854-2816","authenticated-orcid":false,"given":"Bernard","family":"Canaud","sequence":"additional","affiliation":[{"name":"School of Medicine, Montpellier University, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-3458-2575","authenticated-orcid":false,"given":"Claudia","family":"Barth","sequence":"additional","affiliation":[{"name":"Medical Scientific Affairs, B.Braun Avitum, Melsungen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3963-791X","authenticated-orcid":false,"given":"Matthias","family":"Rose","sequence":"additional","affiliation":[{"name":"Department of Psychosomatic Medicine, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4289-632X","authenticated-orcid":false,"given":"Peter J.","family":"Blankestijn","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Hypertension, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2871-9810","authenticated-orcid":false,"given":"Michiel L.","family":"Bots","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni F.M.","family":"Strippoli","sequence":"additional","affiliation":[{"name":"Department of Precision and Regenerative Medicine and Ionian Area (Dimepre-J), University of Bari, Bari, Italy"},{"name":"School of Public Health, University of Sydney, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the CONVINCE Scientific Committee and Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2025,9,12]]},"reference":[{"issue":"3","key":"B1-20260318","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1007\/s11121-014-0513-z","article-title":"Assessing the generalizability of randomized trial results to target populations","volume":"16","author":"Stuart","year":"2015","journal-title":"Prev Sci."},{"issue":"2","key":"B2-20260318","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1111\/j.1467-985X.2010.00673.x","article-title":"The use of propensity scores to assess the generalizability of results from randomized trials","volume":"174","author":"Stuart","year":"2001","journal-title":"J R Stat Soc Ser A Stat Soc."},{"issue":"1","key":"B3-20260318","doi-asserted-by":"crossref","first-page":"sfad247","DOI":"10.1093\/ckj\/sfad247","article-title":"Unmasking the CONVINCE trial: is hemodiafiltration ready to steal the spotlight in real-world practice?","volume":"17","author":"Meena","year":"2024","journal-title":"Clin Kidney J."},{"issue":"8","key":"B4-20260318","doi-asserted-by":"crossref","first-page":"700","DOI":"10.1056\/NEJMoa2304820","article-title":"Effect of hemodiafiltration or hemodialysis on mortality in kidney failure","volume":"389","author":"Blankestijn","year":"2023","journal-title":"N Engl J Med."},{"issue":"10464","key":"B5-20260318","doi-asserted-by":"crossref","first-page":"1742","DOI":"10.1016\/S0140-6736(24)01859-2","article-title":"Haemodiafiltration versus haemodialysis for kidney failure: an individual patient data meta-analysis of randomised controlled trials","volume":"404","author":"Vernooij","year":"2024","journal-title":"Lancet."},{"issue":"2","key":"B6-20260318","doi-asserted-by":"crossref","first-page":"sfae035","DOI":"10.1093\/ckj\/sfae035","article-title":"Actioning the findings of hard end point clinical trials as they emerge in the realm of chronic kidney disease care: a review and a call to action","volume":"17","author":"Strippoli","year":"2024","journal-title":"Clin Kidney J."},{"issue":"5","key":"B7-20260318","doi-asserted-by":"crossref","first-page":"961","DOI":"10.1016\/j.kint.2024.07.014","article-title":"The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration","volume":"106","author":"Rose","year":"2024","journal-title":"Kidney Int."},{"issue":"4","key":"B8-20260318","doi-asserted-by":"crossref","first-page":"728","DOI":"10.1016\/j.kint.2024.12.018","article-title":"A health economic evaluation of the multinational, randomized controlled CONVINCE trial - cost-utility of high-dose online hemodiafiltration compared to high-flux hemodialysis","volume":"107","author":"Schouten","year":"2025","journal-title":"Kidney Int."},{"issue":"5","key":"B9-20260318","first-page":"CD006258","article-title":"Haemodiafiltration, haemofiltration and haemodialysis for end-stage kidney disease","volume":"2015","author":"Nistor","year":"2015","journal-title":"Cochrane Database Syst Rev."},{"issue":"11","key":"B11-20260318","doi-asserted-by":"crossref","first-page":"1539","DOI":"10.1002\/sim.1186","article-title":"Quantifying heterogeneity in a meta-analysis","volume":"21","author":"Higgins","year":"2002","journal-title":"Stat Med."},{"issue":"7414","key":"B12-20260318","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1136\/bmj.327.7414.557","article-title":"Measuring inconsistency in meta-analyses","volume":"327","author":"Higgins","year":"2003","journal-title":"BMJ."},{"issue":"22","key":"B14-20260318","doi-asserted-by":"crossref","first-page":"3127","DOI":"10.1002\/1097-0258(20001130)19:22<3127::AID-SIM784>3.0.CO;2-M","article-title":"A simple method for converting an odds ratio to effect size for use in meta-analysis","volume":"19","author":"Chinn","year":"2000","journal-title":"Stat Med."},{"issue":"4","key":"B16-20260318","doi-asserted-by":"crossref","first-page":"1293","DOI":"10.1038\/ki.1996.441","article-title":"Effects of different membranes and dialysis technologies on patient treatment tolerance and nutritional parameters. The Italian Cooperative Dialysis Study Group","volume":"50","author":"Locatelli","year":"1996","journal-title":"Kidney Int."},{"issue":"suppl 1","key":"B17-20260318","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1093\/oxfordjournals.ndt.a027963","article-title":"On-line haemodiafiltration versus low-flux haemodialysis. A prospective randomized study","volume":"15","author":"Wizemann","year":"2000","journal-title":"Nephrol Dial Transplant."},{"issue":"10","key":"B18-20260318","doi-asserted-by":"crossref","first-page":"1798","DOI":"10.1681\/ASN.2010030280","article-title":"Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD","volume":"21","author":"Locatelli","year":"2010","journal-title":"J Am Soc Nephrol."},{"issue":"6","key":"B19-20260318","doi-asserted-by":"crossref","first-page":"1087","DOI":"10.1681\/ASN.2011121140","article-title":"Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes","volume":"23","author":"Grooteman","year":"2012","journal-title":"J Am Soc Nephrol."},{"issue":"1","key":"B20-20260318","first-page":"26","article-title":"Prospective randomized cross-over long-term comparison of online haemodiafiltration and ultrapure high-flux haemodialysis","volume":"12","author":"Schiffl","year":"2007","journal-title":"Eur J Med Res."},{"issue":"3","key":"B21-20260318","doi-asserted-by":"crossref","first-page":"487","DOI":"10.1681\/ASN.2012080875","article-title":"High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients","volume":"24","author":"Maduell","year":"2013","journal-title":"J Am Soc Nephrol."},{"issue":"1","key":"B22-20260318","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1093\/ndt\/gfs407","article-title":"Mortality and cardiovascular events in online haemodiafiltration (OL-HDF) compared with high-flux dialysis: results from the Turkish OL-HDF study","volume":"28","author":"Ok","year":"2013","journal-title":"Nephrol Dial Transplant."},{"issue":"6","key":"B23-20260318","doi-asserted-by":"crossref","first-page":"1495","DOI":"10.1016\/j.kint.2017.01.013","article-title":"Treatment tolerance and patient-reported outcomes favor online hemodiafiltration compared to high-flux hemodialysis in the elderly","volume":"91","author":"Morena","year":"2017","journal-title":"Kidney Int."},{"issue":"1","key":"B24-20260318","doi-asserted-by":"crossref","first-page":"e023736","DOI":"10.1136\/bmjopen-2018-023736","article-title":"Randomised controlled trial of the impact of haemodiafiltration on uraemic neuropathy: FINESSE study protocol","volume":"9","author":"Smyth","year":"2019","journal-title":"BMJ Open."},{"issue":"6","key":"B25-20260318","doi-asserted-by":"crossref","first-page":"1057","DOI":"10.1093\/ndt\/gfaa173","article-title":"Effect of hemodiafiltration on measured physical activity: primary results of the HDFIT randomized controlled trial","volume":"36","author":"Pecoits-Filho","year":"2021","journal-title":"Nephrol Dial Transplant."},{"issue":"1","key":"B34-20260318","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1186\/1471-2288-14-135","article-title":"Estimating the sample mean and standard deviation from the sample size, median, range and\/or interquartile range","volume":"14","author":"Wan","year":"2014","journal-title":"BMC Med Res Methodol."},{"issue":"6","key":"B35-20260318","doi-asserted-by":"crossref","first-page":"1785","DOI":"10.1177\/0962280216669183","article-title":"Optimally estimating the sample mean from the sample size, median, mid-range, and\/or mid-quartile range","volume":"27","author":"Luo","year":"2018","journal-title":"Stat Methods Med Res."},{"key":"B36-20260318","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1186\/1471-2288-5-13","article-title":"Estimating the mean and variance from the median, range, and the size of a sample","volume":"5","author":"Hozo","year":"2005","journal-title":"BMC Med Res Methodol."},{"issue":"10","key":"B37-20260318","doi-asserted-by":"crossref","first-page":"1924","DOI":"10.1093\/ckj\/sfac153","article-title":"Personalizing treatment in end-stage kidney disease: deciding between haemodiafiltration and haemodialysis based on individualized treatment effect prediction","volume":"15","author":"van Kruijsdijk","year":"2022","journal-title":"Clin Kidney J."},{"issue":"1","key":"B38-20260318","doi-asserted-by":"crossref","first-page":"532","DOI":"10.1186\/s13063-022-06357-y","article-title":"The high-volume haemodiafiltration vs high-flux haemodialysis registry trial (H4RT): a multi-centre, unblinded, randomised, parallel-group, superiority study to compare the effectiveness and cost-effectiveness of high-volume haemodiafiltration and high-flux haemodialysis in people with kidney failure on maintenance dialysis using linkage to routine healthcare databases for outcomes","volume":"23","author":"Caskey","year":"2022","journal-title":"Trials."},{"issue":"10","key":"B39-20260318","doi-asserted-by":"crossref","first-page":"1278","DOI":"10.1001\/jama.289.10.1278","article-title":"Central challenges facing the national clinical research enterprise","volume":"289","author":"Sung","year":"2003","journal-title":"JAMA."},{"issue":"1","key":"B40-20260318","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1007\/s40620-024-02158-5","article-title":"Clinical trial emulation in nephrology","volume":"38","author":"Zoccali","year":"2025","journal-title":"J Nephrol."}],"container-title":["Clinical Journal of the American Society of Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.2215\/CJN.0000000855","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T13:36:49Z","timestamp":1786369009000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.2215\/CJN.0000000855"}},"subtitle":["A Systematic Review"],"short-title":[],"issued":{"date-parts":[[2025,9,12]]},"references-count":29,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026]]}},"URL":"https:\/\/doi.org\/10.2215\/cjn.0000000855","relation":{},"ISSN":["1555-9041","1555-905X"],"issn-type":[{"value":"1555-9041","type":"print"},{"value":"1555-905X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,12]]},"assertion":[{"value":"2025-03-11","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-05","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}