Recruitment and retention in clinical trials in chronic kidney disease: report from national workshops with patients, caregivers and health professionals.

Allied Health Personnel / psychology Caregivers / psychology Clinical Trials as Topic Female Humans Male Motivation Patient Participation / psychology Patient Selection Renal Insufficiency, Chronic / therapy Research Subjects / psychology
chronic kidney disease clinical trials patient recruitment patient retention research

Journal

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
ISSN: 1460-2385
Titre abrégé: Nephrol Dial Transplant
Pays: England
ID NLM: 8706402

Informations de publication

Date de publication:
01 05 2020
Historique:
received: 13 01 2020
pubmed: 3 4 2020
medline: 13 11 2020
entrez: 3 4 2020
Statut: ppublish

Résumé

Slow recruitment and poor retention jeopardize the reliability and statistical power of clinical trials, delaying access to effective interventions and increasing costs, as commonly observed in nephrology trials. Involving patients in trial design, recruitment and retention is infrequent but potentially transformational. We conducted three workshops involving 105 patients/caregivers and 43 health professionals discussing patient recruitment and retention in clinical trials in chronic kidney disease. We identified four themes. 'Navigating the unknown'-patients described being unaware of the research question, confused by technical terms, sceptical about findings and feared the risk of harm. 'Wary of added burden'-patients voiced reluctance to attend additional appointments, were unsure of the commitment required or at times felt too unwell and without capacity to participate. 'Disillusioned and disconnected'-some patients felt they were taken for granted, particularly if they did not receive trial results. Participants believed there was no culture of trial participation in kidney disease and an overall lack of awareness about opportunities to participate. To improve recruitment and retention, participants addressed 'Building motivation and interest'. Investigators should establish research consciousness from the time of diagnosis, consider optimal timing for approaching patients, provide comprehensive information in an accessible manner, emphasize current and future relevance to them and their illness, involve trusted clinicians in recruitment and minimize the burden of trial participation. Participation in clinical trials was seen as an opportunity for people to give back to the health system and for future people in their predicament.

Sections du résumé

BACKGROUND
Slow recruitment and poor retention jeopardize the reliability and statistical power of clinical trials, delaying access to effective interventions and increasing costs, as commonly observed in nephrology trials. Involving patients in trial design, recruitment and retention is infrequent but potentially transformational.
METHODS
We conducted three workshops involving 105 patients/caregivers and 43 health professionals discussing patient recruitment and retention in clinical trials in chronic kidney disease.
RESULTS
We identified four themes. 'Navigating the unknown'-patients described being unaware of the research question, confused by technical terms, sceptical about findings and feared the risk of harm. 'Wary of added burden'-patients voiced reluctance to attend additional appointments, were unsure of the commitment required or at times felt too unwell and without capacity to participate. 'Disillusioned and disconnected'-some patients felt they were taken for granted, particularly if they did not receive trial results. Participants believed there was no culture of trial participation in kidney disease and an overall lack of awareness about opportunities to participate. To improve recruitment and retention, participants addressed 'Building motivation and interest'.
CONCLUSIONS
Investigators should establish research consciousness from the time of diagnosis, consider optimal timing for approaching patients, provide comprehensive information in an accessible manner, emphasize current and future relevance to them and their illness, involve trusted clinicians in recruitment and minimize the burden of trial participation. Participation in clinical trials was seen as an opportunity for people to give back to the health system and for future people in their predicament.

Identifiants

DOI: 10.1093/ndt/gfaa044 PMID: 32240311
pubmed: 32240311
pii: 5815235
doi: 10.1093/ndt/gfaa044
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

755-764

Informations de copyright

© The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Auteurs

Patrizia Natale (P)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.
Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.

Talia Gutman (T)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.

Martin Howell (M)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.

Kathryn Dansie (K)

Australia and New Zealand Dialysis and Transplant Registry, SA Health and Medical Research Institute, Adelaide, South Australia, Australia.

Carmel M Hawley (CM)

Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia.
Translational Research Institute, Brisbane, Queensland, Australia.
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.

Yeoungjee Cho (Y)

Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia.
Translational Research Institute, Brisbane, Queensland, Australia.
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.

Andrea K Viecelli (AK)

Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia.
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.

Jonathan C Craig (JC)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.
College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.

Shilpanjali Jesudason (S)

Central and Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Kidney Health Australia, Victoria, Melbourne, Australia.
Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.

Jeremy R Chapman (JR)

Westmead Clinical School, Westmead Institute for Medical Research, New South Wales, Westmead, Australia.

David W Johnson (DW)

Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia.
Translational Research Institute, Brisbane, Queensland, Australia.
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.

Lisa Murphy (L)

Kidney Health Australia, Victoria, Melbourne, Australia.

Donna Reidlinger (D)

Australasian Kidney Trials Network, University of Queensland, Brisbane, Queensland, Australia.
Translational Research Institute, Brisbane, Queensland, Australia.

Sally Crowe (S)

Crowe Associates Ltd, Oxford, UK.

Emily Duncanson (E)

Australia and New Zealand Dialysis and Transplant Registry, SA Health and Medical Research Institute, Adelaide, South Australia, Australia.

Shyamsundar Muthuramalingam (S)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Australia and New Zealand Dialysis and Transplant Registry, SA Health and Medical Research Institute, Adelaide, South Australia, Australia.

Nicole Scholes-Robertson (N)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.

Amber Williamson (A)

BEAT-CKD Consumer Advisory Board, Sydney, New South Wales, Australia.
Kidney Health Australia, Queensland Consumer Consultative Committee, Brisbane, Queensland, Australia.

Stephen McDonald (S)

Australia and New Zealand Dialysis and Transplant Registry, SA Health and Medical Research Institute, Adelaide, South Australia, Australia.
Central and Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia.

Germaine Wong (G)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.
Westmead Clinical School, Westmead Institute for Medical Research, New South Wales, Westmead, Australia.

Armando Teixeira-Pinto (A)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.

Giovanni F M Strippoli (GFM)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Cochrane Kidney and Transplant, Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.

Allison Tong (A)

Sydney School of Public Health, University of Sydney, New South Wales, Sydney, Australia.
Centre for Kidney Research, Children's Hospital at Westmead, New South Wales, Westmead, Australia.

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Classifications MeSH

questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Personnel de santé › Auxiliaires de santé › Recruitment and retention in clinical trials...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Personnel de santé › Aidants › Recruitment and retention in clinical trials...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Recruitment and retention in clinical trials...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Recruitment and retention in clinical trials...
questionsmedicales.fr › Comportement et mécanismes comportementaux › Personnalité › Intelligence › Intelligence émotionnelle › Motivation › Recruitment and retention in clinical trials...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Attitude envers la santé › Adhésion et observance thérapeutiques › Acceptation des soins par les patients › Participation des patients › Recruitment and retention in clinical trials...
questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Sélection de patients › Recruitment and retention in clinical trials...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Caractéristiques de la maladie › Maladie chronique › Insuffisance rénale chronique › Recruitment and retention in clinical trials...
questionsmedicales.fr › Personnes › Personnes se prêtant à la recherche › Recruitment and retention in clinical trials...