Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study.

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Title: Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study.
Authors: Murea M; Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA., Foley KL; Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA., Gautam SC; Department of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA., Flythe JE; University of North Carolina Kidney Center, Division of Nephrology and Hypertension, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA., Raimann JG; Renal Research Institute, New York, New York, USA., Abdel-Rahman E; Division of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA., Awad AS; Division of Nephrology, University of Florida, Jacksonville, Florida, USA., Niyyar VD; Department of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA., Kovach C; Department of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA., Roberts GV; External Relations and Patient Engagement, Kidney Research Institute and Center for Dialysis Innovation, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA., Jefferson NM; Home Dialyzors United, Columbia, Missouri, USA., Conway PT; American Association of Kidney Patients, Tampa, Florida, USA., Rosales LM; Renal Research Institute, New York, New York, USA., Woldemichael J; Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA., Sheikh HI; Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA., Raman G; Department of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA., Huml AM; Department of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA., Knicely DH; Division of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA., Hasan I; Division of Nephrology, University of Florida, Jacksonville, Florida, USA., Makadia B; Division of Nephrology, University of Florida, Jacksonville, Florida, USA., Lea J; Department of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA., Daugirdas JT; Division of Nephrology, Department of Medicine, University of Illinois College of Medicine at Chicago, Chicago, Illinois, USA., Gencerliler N; Department of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA., Divers J; Department of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA., Kotanko P; Renal Research Institute, New York, New York, USA.; Icahn School of Medicine at Mount Sinai, New York, New York, USA., Nwaozuru UC; Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA nwaozur2@gmail.com.
Corporate Authors: TwoPlus Research Consortium
Source: BMJ open [BMJ Open] 2025 Nov 28; Vol. 15 (11), pp. e094392. Date of Electronic Publication: 2025 Nov 28.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
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  Data: Protocol for the process evaluation of a randomised clinical trial of incremental-start versus conventional haemodialysis: the TwoPlus study.
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  Data: <searchLink fieldCode="AU" term="%22Murea+M%22">Murea M</searchLink>; Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Foley+KL%22">Foley KL</searchLink>; Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Gautam+SC%22">Gautam SC</searchLink>; Department of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Flythe+JE%22">Flythe JE</searchLink>; University of North Carolina Kidney Center, Division of Nephrology and Hypertension, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Raimann+JG%22">Raimann JG</searchLink>; Renal Research Institute, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Abdel-Rahman+E%22">Abdel-Rahman E</searchLink>; Division of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA.<br /><searchLink fieldCode="AU" term="%22Awad+AS%22">Awad AS</searchLink>; Division of Nephrology, University of Florida, Jacksonville, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Niyyar+VD%22">Niyyar VD</searchLink>; Department of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA.<br /><searchLink fieldCode="AU" term="%22Kovach+C%22">Kovach C</searchLink>; Department of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA.<br /><searchLink fieldCode="AU" term="%22Roberts+GV%22">Roberts GV</searchLink>; External Relations and Patient Engagement, Kidney Research Institute and Center for Dialysis Innovation, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.<br /><searchLink fieldCode="AU" term="%22Jefferson+NM%22">Jefferson NM</searchLink>; Home Dialyzors United, Columbia, Missouri, USA.<br /><searchLink fieldCode="AU" term="%22Conway+PT%22">Conway PT</searchLink>; American Association of Kidney Patients, Tampa, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Rosales+LM%22">Rosales LM</searchLink>; Renal Research Institute, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Woldemichael+J%22">Woldemichael J</searchLink>; Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Sheikh+HI%22">Sheikh HI</searchLink>; Department of Internal Medicine, Section on Nephrology, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Raman+G%22">Raman G</searchLink>; Department of Medicine, Division of Nephrology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Huml+AM%22">Huml AM</searchLink>; Department of Kidney Medicine, Medical Specialties Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA.<br /><searchLink fieldCode="AU" term="%22Knicely+DH%22">Knicely DH</searchLink>; Division of Nephrology, University of Virginia Health System, Charlottesville, Virginia, USA.<br /><searchLink fieldCode="AU" term="%22Hasan+I%22">Hasan I</searchLink>; Division of Nephrology, University of Florida, Jacksonville, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Makadia+B%22">Makadia B</searchLink>; Division of Nephrology, University of Florida, Jacksonville, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Lea+J%22">Lea J</searchLink>; Department of Nephrology, Emory University School of Medicine, Atlanta, Georgia, USA.<br /><searchLink fieldCode="AU" term="%22Daugirdas+JT%22">Daugirdas JT</searchLink>; Division of Nephrology, Department of Medicine, University of Illinois College of Medicine at Chicago, Chicago, Illinois, USA.<br /><searchLink fieldCode="AU" term="%22Gencerliler+N%22">Gencerliler N</searchLink>; Department of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Divers+J%22">Divers J</searchLink>; Department of Foundations of Medicine, Division of Health Services Research, New York University Grossman School of Medicine, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Kotanko+P%22">Kotanko P</searchLink>; Renal Research Institute, New York, New York, USA.; Icahn School of Medicine at Mount Sinai, New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Nwaozuru+UC%22">Nwaozuru UC</searchLink>; Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA nwaozur2@gmail.com.
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