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Nature reviews. Nephrology
08, 2022;18 (8): 514-523.

Patient-centred clinical trial design.

Allison Tong, Nicole Scholes-Robertson, Carmel Hawley, Andrea K Viecelli, Simon A Carter, Adeera Levin, Brenda R Hemmelgarn, Tess Harris, Jonathan C Craig
Author Information
  1. Allison Tong: Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia. Allison.tong@sydney.edu.au. ORCID
  2. Nicole Scholes-Robertson: Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  3. Carmel Hawley: Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
  4. Andrea K Viecelli: Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. ORCID
  5. Simon A Carter: Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.
  6. Adeera Levin: Division of Nephrology, University of British Columbia, Vancouver, BC, Canada.
  7. Brenda R Hemmelgarn: Faculty of Medicine and Dentistry at University of Alberta, Edmonton, AB, Canada.
  8. Tess Harris: PKD International, London, United Kingdom.
  9. Jonathan C Craig: College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.
PMID: 35668231 DOI: 10.1038/s41581-022-00585-w

Abstract

Patient involvement in clinical trial design can facilitate the recruitment and retention of participants as well as potentially increase the uptake of the tested intervention and the impact of the findings on patient outcomes. Despite these benefits, patients still have very limited involvement in designing and conducting trials in nephrology. Many trials do not address research questions and outcomes that are important to patients, including patient-reported outcomes that reflect how patients feel and function. This limitation can undermine the relevance, reliability and value of trial-based evidence for decision-making in clinical practice and health policy. However, efforts to involve patients with kidney disease are increasing across all stages of the trial process from priority setting, to study design (including selection of outcomes and approaches to improve participant recruitment and retention) and dissemination and implementation of the findings. Harnessing the patient voice in designing trials can ensure that efforts and resources are directed towards patient-centred trials that address the needs, concerns and priorities of patients living with kidney disease with the aim of achieving transformative improvements in care and outcomes.

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MeSH Term

Clinical Trials as Topic
Humans
Kidney Diseases
Nephrology
Patient Participation
Patient-Centered Care
Reproducibility of Results
Journal Article Review
Article has an altmetric score of 32

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