Novel trial strategies to enhance the relevance, efficiency, effectiveness, and impact of nephrology research

Dansie, Kathryn; Viecelli, Andrea K.; Pascoe, Elaine M.; Johnson, David W.; McDonald, S.; Clayton, Philip; Hawley, Carmel

doi:10.1016/j.kint.2020.04.050

Cited by 5 publications

(4 citation statements)

References 28 publications

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“…Despite this, few studies in nephrology report patient engagement and there is a lack of experience and knowledge about how to engage patients. 52 A lack of awareness and resources have been identified as key barriers to greater patient involvement in kidney research. 53 We suggest that the co-creation of health data infrastructure with patients is essential to patient-centered research and the capture of patient-centered outcomes.…”

Section: Discussionmentioning

confidence: 99%

Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders

Nicholls

Carroll

Weijer

et al. 2020

Can J Kidney Health Dis

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Background: Pragmatic cluster randomized trials (CRTs) offer an opportunity to improve health care by answering important questions about the comparative effectiveness of treatments using a trial design that can be embedded in routine care. There is a lack of empirical research that addresses ethical issues generated by pragmatic CRTs in hemodialysis. Objective: To identify stakeholder perceptions of ethical issues in pragmatic CRTs conducted in hemodialysis. Design: Qualitative study using semi-structured interviews. Setting: In-person or telephone interviews with an international group of stakeholders. Participants: Stakeholders (clinical investigators, methodologists, ethicists and research ethics committee members, and other knowledge users) who had been involved in the design or conduct of a pragmatic individual patient or cluster randomized trial in hemodialysis, or their role would require them to review and evaluate pragmatic CRTs in hemodialysis. Methods: Interviews were conducted in-person or over the telephone and were audio-recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts and field notes were analyzed using a thematic analysis approach. Results: Sixteen interviews were conducted with 19 individuals. Interviewees were largely drawn from North America (84%) and were predominantly clinical investigators (42%). Six themes were identified in which pragmatic CRTs in hemodialysis raise ethical issues: (1) patients treated with hemodialysis as a vulnerable population, (2) appropriate approaches to informed consent, (3) research burdens, (4) roles and responsibilities of gatekeepers, (5) inequities in access to research, and (6) advocacy for patient-centered research and outcomes. Limitations: Participants were largely from North America and did not include research staff, who may have differing perspectives. Conclusions: The six themes reflect concerns relating to individual rights, but also the need to consider population-level issues. To date, concerns regarding inequity of access to research and the need for patient-centered research have received less coverage than other, well-known, issues such as consent. Pragmatic CRTs offer a potential approach to address equity concerns and we suggest future ethical analyses and guidance for pragmatic CRTs in hemodialysis embed equity considerations within them. We further note the potential for the co-creation of health data infrastructure with patients which would aid care but also facilitate patient-centered research. These present results will inform planned future guidance in relation to the ethical design and conduct of pragmatic CRTs in hemodialysis. Trial Registration: Registration is not applicable as this is a qualitative study.

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Section: Discussionmentioning

confidence: 99%

Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders

Nicholls

Carroll

Weijer

et al. 2020

Can J Kidney Health Dis

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“… 13 , 15 Future studies of cancer in kidney transplant recipients would therefore require consideration of novel trial designs, such as registry-based randomized trials where comprehensive data collection can occur over an extended period of time, and innovative ways to identify individuals at higher risk of developing cancer such as through risk stratification and risk prediction strategies. 16 …”

Section: Discussionmentioning

confidence: 99%

Scope and Consistency of Cancer Outcomes Reported in Randomized Trials in Kidney Transplant Recipients

Wong²,

Tong³

et al. 2023

Kidney International Reports

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“…2,3 Accordingly, there have been calls for methodological innovation to address this deficiency. 4 Pragmatic cluster randomized trials (CRTs), which randomize intact groups (eg, entire hemodialysis facilities or shifts) to different interventions can facilitate the evaluation of treatment protocols or strategies that are implemented at the institutional level. 5 The randomization of whole facilities can also reduce logistical complexities as staff within facilities only need to administer a single intervention.…”

Section: Introductionmentioning

confidence: 99%

Patient Partner Perspectives Regarding Ethically and Clinically Important Aspects of Trial Design in Pragmatic Cluster Randomized Trials for Hemodialysis

Nicholls

Carroll

Goldstein

et al. 2021

Can J Kidney Health Dis

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Background: Cluster randomized trials (CRTs) are trials in which intact groups such as hemodialysis centers or shifts are randomized to treatment or control arms. Pragmatic CRTs have been promoted as a promising trial design for nephrology research yet may also pose ethical challenges. While randomization occurs at the cluster level, the intervention and data collection may vary in a CRT, challenging the identification of research participants. Moreover, when a waiver of patient consent is granted by a research ethics committee, there is an open question as to whether and to what degree patients should be notified about ongoing research or be provided with a debrief regarding the nature and results of the trial upon completion. While empirical and conceptual research exploring ethical issues in pragmatic CRTs has begun to emerge, there has been limited discussion with patients, families, or caregivers of patients undergoing hemodialysis. Objective: To explore with patients and families with experience of hemodialysis research the challenges raised by different approaches to designing pragmatic CRTs in hemodialysis. Specifically, their perceptions of (1) the use of a waiver of consent, (2) notification processes and information provided to participants, and (3) any other concerns about cluster randomized designs in hemodialysis. Design: Focus group and interview discussions of hypothetical clinical trial designs. Setting: Focus groups and interviews were conducted in-person or via videoconference or telephone. Participants: Patient partners in hemodialysis research, defined as patients with personal experience of dialysis or a family member who had experience supporting a patient receiving hemodialysis, who have been actively involved in discussions to advise a research team on the design, conduct, or implementation of a hemodialysis trial. Methods: Participants were invited to participate in focus groups or individual discussions that were audio recorded with consent. Recorded interviews were transcribed verbatim prior to analysis. Transcripts were analyzed using a thematic analysis approach. Results: Two focus groups, three individual interviews, and one interview involving a patient and family member were conducted with 17 individuals between February 2019 and May 2020. Participants expressed support for approaches that emphasized patient choice. Disclosure of patient-relevant risks and information were key themes. Both consent and notification processes served to generate trust, but bypassing patient choice was perceived as undermining this trust. Participants did not dismiss the option of a waiver of consent. They were, however, more restrictive in their views about when a waiver of consent may be acceptable. Patient partners were skeptical of claims to impracticability based on costs or the time commitments for staff. Limitations: All participants were from Canada and had been involved in the design or conduct of a trial, limiting the degree to which results may be extrapolated. Conclusions: Given the preferences of participants to be afforded the opportunity to decide about trial participation, we argue that investigators should thoroughly investigate approaches that allow participants to make an informed choice regarding trial participation. In keeping with the preference for autonomous choice, there remains a need to further explore how consent approaches can be designed to facilitate clinical trial conduct while meeting their ethical requirements. Finally, further work is needed to define the limited circumstances in which waivers of consent are appropriate.

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Novel trial strategies to enhance the relevance, efficiency, effectiveness, and impact of nephrology research

Cited by 5 publications

References 28 publications

Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders

Ethical Issues in the Design and Conduct of Pragmatic Cluster Randomized Trials in Hemodialysis Care: An Interview Study With Key Stakeholders

Scope and Consistency of Cancer Outcomes Reported in Randomized Trials in Kidney Transplant Recipients

Patient Partner Perspectives Regarding Ethically and Clinically Important Aspects of Trial Design in Pragmatic Cluster Randomized Trials for Hemodialysis

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