Patients and their caregivers invariably represent the individuals best positioned to benefit from high-quality comparative effectiveness research in kidney stone disease. Yet, despite this obvious conclusion, patients and caregivers are rarely included as stakeholders during the research cycle, especially for benign urological disease. There are many possible reasons for this omission. Stakeholder engagement is unfamiliar to many researchers and many may have legitimate questions or concerns about the process such as:

How do I ensure productive engagement?

What happens if our visions do not align?

What are the regulatory implications of stakeholder engagement in research?

Additionally, patients and caregivers may have questions such as:

Will my voice and time be valued?

What resources do I have to help me understand the research process?

What will my commitment be for this work?

Fortunately, several successful models of stakeholder engagement have been published, including exceptional work within urology.^1,2 However, it is important to remember that each patient group may have their own unique needs and situations that need to be considered in order to optimize meaningful engagement. To this end, we would like to introduce the Kidney Stone Engagement Core (KSEC), a dedicated group of patients, caregivers, advocates, clinicians, and researchers who are working to enhance stakeholder-engagement in kidney stone research currently through research agenda development. This work—Patient-Centered Research Agenda for Comparative Effectiveness Trials in Children and Adults over the Lifespan of Kidney Stone Disease (PRACTICAL)—has been funded through a PCORI (Patient Centered Outcomes Research Institute) stakeholder capacity building award and aims to create an actionable research agenda for kidney stone disease while simultaneously building a foundational core of engaged stakeholders poised to collaborate in future research efforts.

KSEC is a group of 14 individuals including 5 patients, 1 caregiver, 1 patient advocate, 4 urologists, 1 dietician, and 1 nephrologist, each with unique lived-experience related to kidney stone disease. Our diverse perspectives on kidney stones, including experiences with idiopathic and genetic kidney stone disease, multiple surgical interventions, and prevention strategies, have helped shape our dedication to these initiatives. KSEC is currently working on a broad-based stakeholder-engagement strategy to elicit, refine, and prioritize research themes in kidney stone disease to develop a patient-prioritized list of research topics for future study. Through these efforts, KSEC has developed engagement materials (ie, flyers, surveys, and interview guides), provided insight into engagement strategies (ie, clinical approach and social medial presence), and engaged in interpretation of thematic results.

Figure. A conceptual framework for the lived experiences of kidney stone disease, emphasizing thematic relationships across stages of care. MET indicates medical expulsive therapy.

Key to any stakeholder-engagement plan is a strategy to ensure continuous and meaningful engagement. Because many stakeholders have not previously been exposed to research jargon, regulatory processes, or methodology, modular training is often requested to onboard and familiarize participants with these facets of the research process. Our team used the Fyreworks platform (https://www.fyreworkstraining.com), previously developed for adolescents and caregivers participating in stakeholder-research partnerships but appropriate for a diverse stakeholder complement. Additionally, prospectively outlining a fair and reasonable payment structure, roles and expectations, and meeting times will help to codify stakeholder participation.

The first task of the KSEC was to develop a survey designed to elicit research themes from patients, caregivers, researchers, and clinicians who have experience with kidney stones. The survey was developed using KSEC input and a previously published list of research topics identified by the National Institute of Diabetes and Digestive and Kidney Diseases-National Institutes of Health as knowledge gaps in kidney stone disease. These surveys have been completed by 74 individuals in both English and Spanish, identifying 3 new themes in addition to the 7 a priori identified themes. From this list of thematic elements, a codebook for themes was established and an interview guide created for use in small group sessions to further refine these thematic elements. To date, a total of 21 small group participants have contributed to 7 small group sessions, which resulted in thematic saturation as well as creation of 3 new themes, all of which also reached saturation (see Table). Next, the KSEC will review the elicitation responses in more detail in order to generate final research topics for prioritization.

Table. Saturation of Kidney Stone Research Themes Across Small Group Sessions

This work has resulted in meaningful and timely input both from the KSEC and the target stakeholder audience, keeping the current project on time and under budget. Thus, stakeholder engagement need not slow down the process nor create undue resource burden, especially when well considered from the onset. More importantly, however, is the context provided by the KSEC when interpreting the survey and focus group input in creating research themes. For instance, the focus on unique and often underrepresented stakeholder groups has amplified the voices of those with rare genetic diseases as well as those who have struggled with kidney stones through a unique lens, such as pregnancy, while the patient perspective has emphasized the importance of concepts such as shared decision making, as highlighted in the conceptual framework developed for themes across stages of care (see Figure).

Stakeholder partnerships for kidney stone research represent an important evolution in producing knowledge that matters most to our patients. While this avenue seems at first glance to be a wide departure from the traditional research process, we find that engagement can arise organically. After all, it is from our patients’ experiences that surgeon-scientists find their inspiration. Remembering a few key tenets can help to ensure a productive and meaningful stakeholder engagement plan. First, not every stakeholder is needed at every step of the research process. One must determine in the beginning what perspectives are needed, from whom, and at which points in the project. Second, be structured but pragmatic. The most valuable resource anyone on your team can provide is their time, and this includes your stakeholder partners. Ensure that their engagement program is thought through, so as to minimize unnecessary meetings but also to maximize their presence when needed most. Finally, and most importantly, be prepared to listen, react, and be challenged. One of the most damaging pitfalls in stakeholder engagement is ultimately failing to give all voices the platforms they are due. Stakeholder-engagement, when done well, will surprise and inspire. While these discussions can be challenging, they ultimately are likely the most rewarding aspect of stakeholder-engagement. Readers who wish to seek further resources focused on patient engagement in research can access the Clinical Trials Transformative Initiative (https://ctti-clinicaltrials.org/our-work/patient-engagement/) or the PCORI Engagement Tool and Resource Repository (https://www.pcori.org/engagement/engagement-resources/Engagement-Tool-Resource-Repository).