Patients with chronic kidney disease (CKD) and their caregivers who have participated in CKD research shared factors that may encourage or discourage others from enrolling in clinical studies, highlighting the ways that investigators can better involve patients in research.
Interviews from adults with chronic kidney disease (CKD) and their caregivers who have been involved in kidney disease research revealed various factors that encouraged involvement or made participation challenging, according to a recent study1.
The study, published in the Clinical Journal of the American Society of Nephrology, highlights how researchers need to step up their efforts to involve patients in clinical research as well as how clinical studies need to give more consideration to what patients and caregivers find important.
“These findings highlight the need to include us—consumers—as early and as often as possible in the study design, bringing about benefits for the study, the researchers, and the consumers….I have learnt so much as a consumer involved in many different types of research,” said coauthor Nicole Scholes-Robertson, BAppSci, a physiotherapist and a PhD candidate at the University of Sydney, in a statement2.
“Without speaking directly to patients and their families and actively including them in our research, we are missing an enormous opportunity to optimize our resources and make our research more meaningful,” continued lead study author Talia Gutman, a PhD candidate and research officer at the University of Sydney.
Although there are more efforts to include patients and caregivers in CKD research, only 20% of clinical studies address the top 10 patient priorities. Additionally, patients with CKD may have several changeable factors that can impede trial involvement, such as inflexible schedules and unpredictable symptoms or complications. Caregivers may also have considerable responsibilities that limit their ability to be involved in research. However, there is limited evidence on the perspectives of patients with CKD and caregivers on research involvement.
Between September 2017 and March 2021, the investigators interviewed 23 individuals who were patients with CKD or caregivers of patients with CKD. The participants had to be aged 18 years or older and had to have completed at least 1 stage of the research process in any role. The participants were known to the investigators and were identified through patients and professional networks and the Standardized Outcomes in Nephrology Internal Network.
In total, the cohort included 18 patients and 5 caregivers, 57% of whom were women and 83% were White. Ten participants were from Australia, 10 were from the United States, 2 lived in the United Kingdom, and 1 was from Denmark.
The investigators identified 6 themes:
Under the first theme, subthemes regarded how overwhelmed patients and caregivers felt by the disease burden. The participants also shared that they felt silenced by CKD stigma and shame and that there was an absence of advocacy and awareness surrounding the disease.
The participants also expressed concerns over the autonomy of their own care, how forced they felt to be proactive at accessing opportunities, and the infrastructural support to interact with researchers and other patients.
Some participants felt that their knowledge or skills weren’t being utilized in research and that studies should have a bigger focus on understanding patient needs.
Howevers, some participants viewed themselves as advocates for other patients and caregivers when being involved in research, feeling responsibility to represent the broader patient voice, especially for underserved CKD populations, such as children with CKD.
In addition to the long list of possible solutions that the investigators suggested, the investigators stressed that researchers need to acknowledge the inherent power imbalance patients and caregivers encounter in research settings and implement formal mechanisms codesigned with those communities to counterbalance any barriers to participation. They should also be able to recognize invisible challenges patients and caregivers face such as limited research experience, unfamiliarity with jargon and acronyms, and intimidation by experts.
“Optimizing involvement in these ways may serve to better align research priorities, produce higher quality research of greater importance to all stakeholders, and enhance implementation of findings to practice, resulting in better care and health outcomes for patients,” the investigators wrote.
The study had some limitations, including that all the participants were from high-income countries, reached high levels of education, and spoke English, which may not be typical for the general CKD population. Additionally, barriers that impact disadvantaged groups, such as those from low-income settings, were not included in the study.