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

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Abstract

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.

Abrégé

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.

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Most cited references 39

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The levels of evidence and their role in evidence-based medicine.

Patricia B Burns, Rod J Rohrich, Kevin C Chung (2011)

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Polypharmacy in elderly patients.

Emily Hajjar, Angela Cafiero, Joseph Hanlon (2007)

Polypharmacy (ie, the use of multiple medications and/or the administration of more medications than are clinically indicated, representing unnecessary drug use) is common among the elderly. The goal of this research was to provide a description of observational studies examining the epidemiology of polypharmacy and to review randomized controlled studies that have been published in the past 2 decades designed to reduce polypharmacy in older adults. Materials for this review were gathered from a search of the MEDLINE database (1986-June 2007) and International Pharmaceutical Abstracts (1986-June 2007) to identify articles in people aged >65 years. We used a combination of the following search terms: polypharmacy, multiple medications, polymedicine, elderly, geriatric, and aged. A manual search of the reference lists from identified articles and the authors' article files, book chapters, and recent reviews was conducted to identify additional articles. From these, the authors identified those studies that measured polypharmacy. The literature review found that polypharmacy continues to increase and is a known risk factor for important morbidity and mortality. There are few rigorously designed intervention studies that have been shown to reduce unnecessary polypharmacy in older adults. The literature review identified 5 articles, which are included here. All studies showed an improvement in polypharmacy. Many studies have found that various numbers of medications are associated with negative health outcomes, but more research is needed to further delineate the consequences associated with unnecessary drug use in elderly patients. Health care professionals should be aware of the risks and fully evaluate all medications at each patient visit to prevent polypharmacy from occurring.

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The prevalence of symptoms in end-stage renal disease: a systematic review.

Fliss E M Murtagh, Julia Addington-Hall, Irene J Higginson (2007)

Symptoms in end-stage renal disease (ESRD) are underrecognized. Prevalence studies have focused on single symptoms rather than on the whole range of symptoms experienced. This systematic review aimed to describe prevalence of all symptoms, to better understand total symptom burden. Extensive database, "gray literature," and hand searches were undertaken, by predefined protocol, for studies reporting symptom prevalence in ESRD populations on dialysis, discontinuing dialysis, or without dialysis. Prevalence data were extracted, study quality assessed by use of established criteria, and studies contrasted/combined to show weighted mean prevalence and range. Fifty-nine studies in dialysis patients, one in patients discontinuing dialysis, and none in patients without dialysis met the inclusion criteria. For the following symptoms, weighted mean prevalence (and range) were fatigue/tiredness 71% (12% to 97%), pruritus 55% (10% to 77%), constipation 53% (8% to 57%), anorexia 49% (25% to 61%), pain 47% (8% to 82%), sleep disturbance 44% (20% to 83%), anxiety 38% (12% to 52%), dyspnea 35% (11% to 55%), nausea 33% (15% to 48%), restless legs 30% (8%to 52%), and depression 27% (5%to 58%). Prevalence variations related to differences in symptom definition, period of prevalence, and level of severity reported. ESRD patients on dialysis experience multiple symptoms, with pain, fatigue, pruritus, and constipation in more than 1 in 2 patients. In patients discontinuing dialysis, evidence is more limited, but it suggests they too have significant symptom burden. No evidence is available on symptom prevalence in ESRD patients managed conservatively (without dialysis). The need for greater recognition of and research into symptom prevalence and causes, and interventions to alleviate them, is urgent.

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Author and article information

Journal

Journal ID (nlm-ta): Can J Kidney Health Dis

Journal ID (iso-abbrev): Can J Kidney Health Dis

Journal ID (publisher-id): CJK

Journal ID (hwp): spcjk

Title: Canadian Journal of Kidney Health and Disease

Publisher: SAGE Publications (Sage CA: Los Angeles, CA )

ISSN (Electronic): 2054-3581

Publication date (Electronic): 26 December 2019

Publication date Collection: 2019

Volume: 6

Electronic Location Identifier: 2054358119894394

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 ]Orillia Soldiers’ Memorial Hospital, ON, Canada

[49 ]Population Health Research Institute, Hamilton, ON, Canada

Author notes

[*]Amit X. Garg, Victoria Hospital, 800 Commissioners Road, Room ELL-215, London, ON, Canada N6A 5W9. Email: amit.garg@ 123456lhsc.on.ca

Author information

Elliot J. Lee https://orcid.org/0000-0001-9320-195X

Braden J. Manns https://orcid.org/0000-0002-8823-6127

Amber O. Molnar https://orcid.org/0000-0003-4549-0202

Manish M. Sood https://orcid.org/0000-0002-9146-2344

Ron Wald https://orcid.org/0000-0003-4411-8169

Amit X. Garg https://orcid.org/0000-0003-3398-3114

Article

Publisher ID: 10.1177_2054358119894394

DOI: 10.1177/2054358119894394

PMC ID: 6933546

PubMed ID: 31903190

SO-VID: be25b7e5-5d12-47e6-abb0-bf164b8dc891

License:

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

History

Date received : 22 July 2019

Date accepted : 24 October 2019

Funding

Funded by: government of ontario, FundRef https://doi.org/10.13039/100013873;

Funded by: Canadian Institutes of Health Research, FundRef https://doi.org/10.13039/501100000024;

Award ID: MyG – 151209

Funded by: ICES Kidney, Dialysis and Transplantation, ;

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cover-date January-December 2019

typesetter ts1

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

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

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

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Abstract

Abrégé

Related collections

Electronic Workshops in Computing (eWiC)

Most cited references 39

The levels of evidence and their role in evidence-based medicine.

Polypharmacy in elderly patients.

The prevalence of symptoms in end-stage renal disease: a systematic review.

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