Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018

doi:10.1177/2054358119894394

. 2019 Dec 26:6:2054358119894394.

doi: 10.1177/2054358119894394. eCollection 2019.

Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018

Elliot J Lee¹, Aakil Patel¹, Rey R Acedillo^{2

3}, Jovina C Bachynski⁴, Ian Barrett⁵, Erika Basile⁶, Marisa Battistella^{7

8}, Derek Benjamin⁹, David Berry¹⁰, Peter G Blake^{2

11}, Patricia Chan¹², Clara J Bohm¹³, Kristin K Clemens^{1

3

14

15}, Charles Cook¹⁶, Laura Dember¹⁷, Jade S Dirk¹, Stephanie Dixon^{1

3}, Elisabeth Fowler¹⁸, Leah Getchell¹⁹, Nazanine Gholami²⁰, Cory Goldstein²¹, Emma Hahn¹, Betty Hogeterp²², Susan Huang², Michelle Hughes²³, Meg J Jardine²⁴, Shasikara Kalatharan¹⁹, Shane Kilburn¹, Eduardo Lacson Jr²⁵, Sean Leonard¹, Channing Liberty²⁶, Craig Lindsay²⁷, Jennifer M MacRae²⁸, Braden J Manns²⁹, Janice McCallum^{11

30}, Christopher W McIntyre^{31

32}, Amber O Molnar^{1

33}, Reem A Mustafa³⁴, Gihad E Nesrallah³⁵, Matthew J Oliver³⁶, Michael Pandes³⁷, Sanjay Pandeya³⁸, Malvinder S Parmar³⁹, Elijah Z Rabin⁴⁰, Johnathan Riley⁴¹, Samuel A Silver⁴², Jessica M Sontrop^{1

2

31}, Manish M Sood^{1

43}, Rita S Suri^{44

45}, Navdeep Tangri^{46

47}, Daniel J Tascona^{11

23}, Alison Thomas⁵, Ron Wald^{5

36}, Michael Walsh^{33

48}, Charles Weijer^{3

21}, Matthew A Weir^{1

2

31}, Hans Vorster¹¹, Deborah Zimmerman⁴³, Amit X Garg^{1

2

3

31}

Affiliations

¹ ICES, ON, Canada.
² Division of Nephrology, Department of Medicine, London Health Sciences Centre, ON, Canada.
³ Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
⁴ Halton Healthcare Services, Oakville, ON, Canada.
⁵ St. Michael's Hospital, Toronto, ON, Canada.
⁶ Office of Human Research Ethics, Western University, London, ON, Canada.
⁷ Department of Pharmacy, University Health Network, Toronto, ON, Canada.
⁸ Leslie Dan Faculty of Pharmacy, University of Toronto, ON, Canada.
⁹ Royal Victoria Regional Health Centre, Barrie, ON, Canada.
¹⁰ Algoma Regional Renal Program, Sault Area Hospital, Sault Ste. Marie, ON, Canada.
¹¹ Ontario Renal Network, Cancer Care Ontario, Toronto, Canada.
¹² Division of Nephrology, Department of Medicine, Michael Garron Hospital, Toronto, ON, Canada.
¹³ Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.
¹⁴ Division of Endocrinology and Metabolism, Department of Medicine, Western University, London, ON, Canada.
¹⁵ St. Joseph's Health Care London, ON, Canada.
¹⁶ Transplant Ambassador Program, Grand River Hospital, Kitchener, ON, Canada.
¹⁷ Renal, Electrolyte and Hypertension Division, Perelman School of Medicine, Philadelphia, PA, USA.
¹⁸ The Kidney Foundation of Canada, Montreal, QC, Canada.
¹⁹ Can-SOLVE CKD Network, Vancouver, BC, Canada.
²⁰ St. Joseph's Health Centre, Toronto, ON, Canada.
²¹ Rotman Institute of Philosophy, Western University, London, ON, Canada.
²² Lakeridge Health Oshawa, ON, Canada.
²³ Orillia Soldiers' Memorial Hospital, ON, Canada.
²⁴ Innovation & Kidney Research, The George Institute for Global Health, UNSW Sydney, Newtown, NSW, Australia.
²⁵ Tufts Medical Center, Boston, MA, USA.
²⁶ The Ottawa Hospital, ON, Canada.
²⁷ Scarborough Health Network, Toronto, ON, Canada.
²⁸ Division of Nephrology, Department of Medicine, University of Calgary, AB, Canada.
²⁹ Department of Medicine, Cumming School of Medicine, University of Calgary, AB, Canada.
³⁰ Renal Services, London Health Sciences Centre, ON, Canada.
³¹ Kidney Clinical Research Unit, Lawson Health Research Institute, London, ON, Canada.
³² Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
³³ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
³⁴ Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, USA.
³⁵ Division of Nephrology, Department of Medicine, Humber River Hospital, Toronto, ON, Canada.
³⁶ Division of Nephrology, Department of Medicine, University of Toronto, ON, Canada.
³⁷ Mackenzie Health, Richmond Hill, ON, Canada.
³⁸ Halton Healthcare, Oakville, ON, Canada.
³⁹ Kidney Care Centre, Timmins and District Hospital, ON, Canada.
⁴⁰ Niagara Health System, St. Catharines, ON, Canada.
⁴¹ Ontario SPOR SUPPORT Unit, Toronto, ON, Canada.
⁴² Division of Nephrology, Kingston Health Sciences Center, Queen's University, Kingston, ON, Canada.
⁴³ Division of Nephrology, Department of Medicine, University of Ottawa, ON, Canada.
⁴⁴ Division of Nephrology, Department of Medicine, McGill University, Montreal, QC, Canada.
⁴⁵ Canadian Nephrology Trials Network, Canada.
⁴⁶ Chronic Disease Innovation Centre, Winnipeg, MB, Canada.
⁴⁷ Department of Internal Medicine, University of Manitoba, Winnipeg, Canada.
⁴⁸ Population Health Research Institute, Hamilton, ON, Canada.

PMID: 31903190
PMCID: PMC6933546
DOI: 10.1177/2054358119894394

Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018

Elliot J Lee et al. Can J Kidney Health Dis. 2019.

. 2019 Dec 26:6:2054358119894394.

doi: 10.1177/2054358119894394. eCollection 2019.

Authors

Affiliations

¹ ICES, ON, Canada.
² Division of Nephrology, Department of Medicine, London Health Sciences Centre, ON, Canada.
³ Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
⁴ Halton Healthcare Services, Oakville, ON, Canada.
⁵ St. Michael's Hospital, Toronto, ON, Canada.
⁶ Office of Human Research Ethics, Western University, London, ON, Canada.
⁷ Department of Pharmacy, University Health Network, Toronto, ON, Canada.
⁸ Leslie Dan Faculty of Pharmacy, University of Toronto, ON, Canada.
⁹ Royal Victoria Regional Health Centre, Barrie, ON, Canada.
¹⁰ Algoma Regional Renal Program, Sault Area Hospital, Sault Ste. Marie, ON, Canada.
¹¹ Ontario Renal Network, Cancer Care Ontario, Toronto, Canada.
¹² Division of Nephrology, Department of Medicine, Michael Garron Hospital, Toronto, ON, Canada.
¹³ Department of Internal Medicine, Max Rady College of Medicine, University of Manitoba, Winnipeg, Canada.
¹⁴ Division of Endocrinology and Metabolism, Department of Medicine, Western University, London, ON, Canada.
¹⁵ St. Joseph's Health Care London, ON, Canada.
¹⁶ Transplant Ambassador Program, Grand River Hospital, Kitchener, ON, Canada.
¹⁷ Renal, Electrolyte and Hypertension Division, Perelman School of Medicine, Philadelphia, PA, USA.
¹⁸ The Kidney Foundation of Canada, Montreal, QC, Canada.
¹⁹ Can-SOLVE CKD Network, Vancouver, BC, Canada.
²⁰ St. Joseph's Health Centre, Toronto, ON, Canada.
²¹ Rotman Institute of Philosophy, Western University, London, ON, Canada.
²² Lakeridge Health Oshawa, ON, Canada.
²³ Orillia Soldiers' Memorial Hospital, ON, Canada.
²⁴ Innovation & Kidney Research, The George Institute for Global Health, UNSW Sydney, Newtown, NSW, Australia.
²⁵ Tufts Medical Center, Boston, MA, USA.
²⁶ The Ottawa Hospital, ON, Canada.
²⁷ Scarborough Health Network, Toronto, ON, Canada.
²⁸ Division of Nephrology, Department of Medicine, University of Calgary, AB, Canada.
²⁹ Department of Medicine, Cumming School of Medicine, University of Calgary, AB, Canada.
³⁰ Renal Services, London Health Sciences Centre, ON, Canada.
³¹ Kidney Clinical Research Unit, Lawson Health Research Institute, London, ON, Canada.
³² Department of Medical Biophysics, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
³³ Division of Nephrology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
³⁴ Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Center, Kansas City, USA.
³⁵ Division of Nephrology, Department of Medicine, Humber River Hospital, Toronto, ON, Canada.
³⁶ Division of Nephrology, Department of Medicine, University of Toronto, ON, Canada.
³⁷ Mackenzie Health, Richmond Hill, ON, Canada.
³⁸ Halton Healthcare, Oakville, ON, Canada.
³⁹ Kidney Care Centre, Timmins and District Hospital, ON, Canada.
⁴⁰ Niagara Health System, St. Catharines, ON, Canada.
⁴¹ Ontario SPOR SUPPORT Unit, Toronto, ON, Canada.
⁴² Division of Nephrology, Kingston Health Sciences Center, Queen's University, Kingston, ON, Canada.
⁴³ Division of Nephrology, Department of Medicine, University of Ottawa, ON, Canada.
⁴⁴ Division of Nephrology, Department of Medicine, McGill University, Montreal, QC, Canada.
⁴⁵ Canadian Nephrology Trials Network, Canada.
⁴⁶ Chronic Disease Innovation Centre, Winnipeg, MB, Canada.
⁴⁷ Department of Internal Medicine, University of Manitoba, Winnipeg, Canada.
⁴⁸ Population Health Research Institute, Hamilton, ON, Canada.

PMID: 31903190
PMCID: PMC6933546
DOI: 10.1177/2054358119894394

Abstract
in English, French

Hemodialysis is a life-sustaining treatment for persons with kidney failure. However, those on hemodialysis still face a poor quality of life and a short life expectancy. High-quality research evidence from large randomized controlled trials is needed to identify interventions that improve the experiences, outcomes, and health care of persons receiving hemodialysis. With the support of the Canadian Institutes of Health Research and its Strategy for Patient-Oriented Research, the Innovative Clinical Trials in Hemodialysis Centers initiative brought together Canadian and international kidney researchers, patients, health care providers, and health administrators to participate in a workshop held in Toronto, Canada, on June 2 and 3, 2018. The workshop served to increase knowledge and awareness about the conduct of innovative, pragmatic, cluster-randomized registry trials embedded into routine hemodialysis care and provided an opportunity to discuss and build support for new trial ideas. The workshop content included structured presentations, facilitated group discussions, and expert panel feedback. Partnerships and promising trial ideas borne out of the workshop will continue to be developed to support the implementation of future large-scale trials.

L’hémodialyse constitue un traitement essentiel au maintien de la vie pour les personnes atteintes d’insuffisance rénale. Les patients hémodialysés voient cependant leur qualité et leur espérance de vie réduites. Des données de recherches probantes, provenant de vastes essais cliniques contrôlés à répartition aléatoire, sont nécessaires pour améliorer l’expérience, les résultats et les soins des patients hémodialysés. Grâce au soutien des Instituts de recherche en santé du Canada (IRSC) et de leur Stratégie de recherche axée sur le patient (SRAP), l’initiative sur les essais cliniques novateurs (ECN) en centres d’hémodialyse a réuni divers intervenants en santé rénale (chercheurs, patients, fournisseurs de soins et administrateurs), du Canada et de partout dans le monde, lors d’un colloque qui s’est tenu à Toronto les 2 et 3 juin 2018. Ce colloque a permis d’accroître la sensibilisation et les connaissances sur la conduite d’essais cliniques novateurs, répartis en grappes, pragmatiques et intégrés aux soins d’hémodialyse de routine. Cette rencontre a également fourni une occasion de discuter de nouvelles idées d’essais cliniques et de susciter les appuis nécessaires à leur réalisation. Le colloque s’est déroulé sous forme de présentations structurées, de discussions animées en groupe et de rétroaction de la part d’un comité d’experts. Les idées de recherche prometteuses et les partenariats issus de ce colloque continueront d’être développés pour soutenir la réalisation d’essais cliniques futurs de grande envergure.

Keywords: chronic kidney disease; cluster randomized; hemodialysis; patient-oriented research; pragmatic; randomized controlled trial; registry-based; workshop.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

**Figure 1.**
Word cloud of overall workshop experience.

See this image and copyright information in PMC

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[1] Collins AJ, Foley RN, Herzog C, et al. US renal data system 2012 annual data report. Am J Kidney Dis. 2013;61:A7. - PubMed

[2] Collins AJ, Foley RN, Herzog C, et al. US renal data system 2012 annual data report. Am J Kidney Dis. 2013;61:A7. - PubMed

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[10] Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010;39:477-485. - PubMed

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Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018

Affiliations

Cultivating Innovative Pragmatic Cluster-Randomized Registry Trials Embedded in Hemodialysis Care: Workshop Proceedings From 2018

Authors

Affiliations

Abstract
in English, French

Conflict of interest statement

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References

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Abstract in English, French

Conflict of interest statement

Figures

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Cited by

References

Grants and funding

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Abstract
in English, French