HOPE for Better Pain Relief for People on Hemodialysis

Patient advisors for the HOPE Trial

Dember credits much of the study’s success to the involvement of the patient advisors, which began at the earliest planning stages of the study and continued throughout its conduct. Two of the patient advisors were Ms. Dawn Edwards, who previously was a member of the HEAL Community Partner Committee, and Mr. David White, who is a member of the U.S. Food and Drug Administration’s Patient Engagement Advisory Committee and other patient engagement efforts. Both have been living with end-stage kidney disease for many years. 

Compared to their prior advocacy experience, both Edwards and White were impressed with the level of inclusion and acceptance they experienced in the HOPE study. They noted that patient engagement began in the earliest planning stages. And during the study’s kickoff meeting, Paul Kimmel, M.D., from the National Institute of Diabetes and Digestive and Kidney Diseases, who oversaw the HOPE Trial, immediately invited the patient advisors to sit at the same table as the researchers, rather than somewhere in the back, to indicate that they were full partners in the study. Moreover, everybody just used first names—no titles involved. “That set the tone for the rest of the study,” Edwards says.

White agrees that the study team made it very easy for patient advisors to become involved and contribute to the study. “It was a very genuine approach,” he says, noting that the researchers’ willingness to embed them in the study from the beginning provided a sense of security that their voices were being heard. White is an author on the study’s recent peer-reviewed publication in JAMA Internal Medicine. 

One area where the patient advisors were instrumental was recruitment of study participants. “Meeting enrollment targets on time is always a challenge,” Dember says. It can be especially difficult to ensure that study participants represent the population of people with the condition being studied. 

To encourage participant enrollment, the patient advisors helped create the “informed consent” forms that people must sign to participate in a study. These forms provide information on what the study, and the intervention being tested, are about and what potential risks may exist. The patient advisors’ input ensured that the form was clear, free of jargon, and understandable to potential participants. “We started from scratch, and we put our voice in it,” says Edwards. 

And that was only the beginning. The patient advisors also provided feedback on the enrollment process, about when and how researchers should approach individuals about participating in the study to make this process more successful. Four patient advisors from different demographics created a video explaining to people with kidney disease why participation of individuals from a variety of backgrounds in the study was important. And the patient advisors provided input on the actual intervention, what it included, and when and where it was delivered. 

The value of patient engagement

According to Dember, these contributions are responsible for a substantial portion of the study’s success. “Their help with the design of the intervention so that it would appeal to patients, address something important to patients, and be acceptable to patients translated into very good recruitment and also was helpful for maintaining high adherence to the intervention,” she says. 

The patient advisors’ roles continued to evolve during the study. White eventually was invited to join the study’s Executive Committee. Even after the official end of the study, the patient advisors remained engaged with the researchers—for example, in writing groups that summarize and present findings in scientific publications or at conferences. For Edwards, it was also important to relay both her experiences and the study findings back to her community.

Dember, Edwards, and White all agreed that engaging people with lived and living experiences as advisors in clinical studies benefits both researchers and patients. By offering the real-life perspectives of people with a given condition, patient advisors can help researchers design studies that are relevant to their intended participants and encourage them to enroll in trials. This ultimately results in more successful studies and improved patient care. It also can build trust of people with lived and living experience in research and its findings.

Meaningful engagement of patient advisors is not yet always a matter of course. White noted that researchers often seem afraid to approach or engage people with lived or living experience. Dember agrees that it does take some getting used to. But, she says, “It’s very worthwhile to do so. It’s energy and time very well spent.”