Including People with Lived Experience of Pain in the Research Process: Do It Early and Often

Patient partner

Investigators studying musculoskeletal pain and other pain conditions have seen the fruits of patient engagement for better research, care and treatment. Image credit: Gloria Rosazza/123RF Stock Photo.

Published December 13, 2020

Over the last few decades, researchers have made great strides in understanding the basic neurobiology underlying chronic musculoskeletal (MSK) pain conditions ranging from arthritis to low back pain to fibromyalgia and beyond. And they’ve hoped that this new insight would translate into more effective treatments for these as well as other pain conditions. Yet, according to the US Centers for Disease Control and Prevention (CDC), more than 20% of adults in the US live with a chronic pain condition, many of whom do not find sufficient relief from the persistent pain they experience. Millions more suffer from pain throughout the world.

Unfortunately, the statistics suggest a profound disconnect between what researchers are learning about pain and real-life outcomes for patients. Increasingly, investigators in the pain field are realizing that one explanation for this could be that patients themselves – who everyone agrees should be the ultimate beneficiaries of new knowledge – have often been left out of the research enterprise. The absence of patients from research endeavors also poses a practical problem for researchers: funders, healthcare organizations and journals themselves are increasingly requiring patient partnership in research (see related discussion on the IASP Pain Research Forum).

“More and more, we see the value of taking a more patient-centered approach, at every step of the research process,” said Captain Robyn Bent, director of the ongoing Patient-Focused Drug Development (PFDD) initiative, which was established at the US Food and Drug Administration (FDA) in 2012. “In the early stages, that patient input can help researchers understand the impact of the disease and existing treatments, helping us better understand what we need to measure to see if something has worked or not. Once we get to clinical trials, patients can help us understand what aspects of those trials need to be better tailored to fit the needs of the people who will end up participating in those trials. And once a treatment is available, patients can help us understand how to best communicate information to both patients and doctors to facilitate shared decision-making.”

Bent said that, from day one, input from people with chronic pain is critical for any research or drug development program that aims to help them. Having that kind of participation can help guide scientists and clinicians so they know where and how to best invest their time and resources. A number of long-running efforts designed to include patients as partners in research shows that musculoskeletal (MSK) pain researchers, as well as investigators in other areas of the pain field, have taken that perspective to heart – and it has paid big dividends.

Focusing on what matters to patients
Jason Beneciuk, of the University of Florida, Gainesville, US, and Brooks Rehabilitation, Jacksonville, US, said he has always believed patient input was something that was missing from his research efforts. As a physical therapist who studies what kinds of targeted treatment approaches can best help people living with MSK pain, he said he often worked with clinicians to come up with different research questions – but not with patients themselves.

“We have this opportunity to work with patients to really identify the issues and questions that are most important to them,” he said. “But, I think, like many researchers, I knew this was important, but I wasn’t really sure how to get patients involved with providing their perspectives about research questions.”

After receiving a grant from the Patient-Centered Outcomes Research Institute (PCORI), Beneciuk and colleagues decided to work on an “infrastructure and capacity building” project focused on how to best create a stakeholder framework, including patients, researchers, and clinicians, to help determine future research priorities with regard to management of MSK pain.

As described in a paper published earlier this year by Beneciuk and colleagues, the project included six patient partners with lived experience of MSK pain who were dissatisfied with their current or past healthcare experiences and recruited from a local post-acute rehabilitation health system; six clinician partners from the same health system representing physical therapy, clinical psychology, and family medicine disciplines; and four researchers from the University of Florida interested in different aspects of MSK pain. The group met regularly for lunch meetings and more formalized workshops to identify and prioritize future research questions and projects.

“It was really important to come up with a process right at the start,” said Beneciuk. “I think the patients were worried that a lot of the discussion would be driven by researchers and clinicians. The clinicians were a little nervous about patients directing the research. But, after the first few meetings, everyone was on board and really took the time to listen to one another. Soon enough, we saw that patients, in this context, weren’t just patients. They were our research partners. And, working in an equal collaboration, they offered us a unique perspective we wouldn’t have received otherwise.”

Case in point: Beneciuk said the discussion about what outcomes are most important to patient partners opened his eyes. Quite often, the outcomes that researchers focus on are a participant’s pain ratings or some type of specific functional outcome, such as improving the range of motion in a specific joint, in order to determine whether an intervention was successful. But he said that working with the group of patient partners helped him realize just how essential self-efficacy for self-management of symptoms was, in terms of whether the patient viewed a particular treatment as something that actually helped. Self-efficacy, which refers to the resiliency and confidence people have in their own ability to self-manage their symptoms, was in this specific case an outcome that he and other researchers and clinicians had previously neglected.

“So often, we fail to step back and ask if the outcomes we collect in studies are really important to patients,” he said. “We talk a lot about self-efficacy as being a predictor of outcomes for patients. We know it’s important. But we don’t measure it as a primary outcome in research studies and, in clinical practice, it’s hardly ever assessed on a routine basis. As a result of this feedback from our patient partners, we have attempted to integrate pain self-efficacy as an outcome in research grants. I refer back to our patient engagement work and say this is something that patients say is important to them and I am going to stand by that.”

Looking to patient partners to improve research and change policy in Europe
The aims of the European League Against Rheumatism (EULAR) are to “reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention, and rehabilitation of musculoskeletal diseases.” This non-profit scientific and educational association not only works with scientists and healthcare professionals to further those goals, but also with people across the continent living with arthritis/rheumatism.

The group has long had its own standing network, People with Arthritis and Rheumatism in Europe (PARE), made up of more than 60 volunteer patient partners hailing from different countries in Europe. Dieter Wiek, EULAR vice president representing PARE and vice president of Deutsche Rheuma-Liga, the German patient organization in EULAR, said the network has long been highlighting the importance of including patients in all of EULAR’s research initiatives.

“In 2008, I was invited to the Canadian Arthritis Network and this participation aroused my interest in patient involvement in research,” he said. “Back in 2010, EULAR started a training course showing how patients can be effectively involved in research, and then soon after, it mandated that all EULAR-funded studies would need to have two patients involved. We focus on having patient involvement from the very beginning of studies, when the proposal is being written, and now are involved in pan-European consortia projects for rheumatic and musculoskeletal diseases funded by the European Union.”

PARE meets each year during the EULAR annual congress as well as at a yearly PARE meeting to consider how patients, researchers, and clinicians can work together to improve the quality of life for the more than 120 million people in Europe who have rheumatic and MSK diseases. PARE also offers training and educational programs for patients and educational material for researchers about the importance of patient engagement and the best ways to engage. Wiek said PARE takes a strong user-led approach to not only help direct future research but also to work directly with policymakers in European countries to inspire initiatives that can make a real difference in the lives of people living with chronic rheumatic and MSK pain.

“The patient is the most experienced person when it comes to a disease and they have a lot they can contribute by working directly with doctors, scientists, and policymakers,” Wiek explained. “What we see is that these networks of patient partners are something that offer benefit for everyone, with the shared goal of helping people who have these different conditions live higher quality lives.”

A digital connection
Kassim Javaid, of the University of Oxford, UK, said that it can be challenging to involve patients in research projects, particularly when studying MSK pain stemming from rarer conditions. An epidemiologist who works at the National Institute for Health Research’s Oxford Biomedical Research Centre in the UK, Javaid heads the ongoing Rare UK Diseases of bone, joints, and blood vessels (RUDY) project, an online platform that brings patients and researchers together (read more about RUDY here).

“We wanted to capture the patient experience of rare diseases and measure things that are actually important to patients,” Javaid said. “But one challenge is accessibility. It’s not always easy to find the patients you need. You can try to recruit patient partners at the hospital but so many patients will never go to the hospital. That often means you end up with a very select group of people who may not give you as full a picture of the disease you are studying as you would like. It’s important to find ways to reach out to all patients who may want to participate.”

The goal of the RUDY study is to understand, in detail, how rare diseases affect the people who live with them, and to document differences between people with the same diagnosis, including variations in their experience of pain. Using an online platform that can be accessed via a patient’s computer or mobile phone allows researchers like Javaid to interact with patients as he and other investigators work on designing and carrying out new research projects. It also provides a secure portal for patients to enter data about their disease experience over time, giving them a way to monitor their conditions over the long term. Javaid said his team of researchers collected a remarkable amount of data and are learning a lot more about the clinical picture of different rare conditions like multiple myeloma, sickle cell anemia, and polymyalgia rheumatica, a rare inflammatory disorder that causes muscle pain and stiffness, usually in the shoulders.

“Through the RUDY platform, we’ve learned a lot more about the impact of issues around sleep and pain,” he said. “While we generally ask about pain, clinicians don’t always ask about sleep. Once we understood how big of an issue sleep was for patients, we now regularly include an assessment. If you ask about things that patients are actually experiencing, they are more likely to think you know what is going on with them and are in a position to help them feel better.”

The RUDY platform also offers users an active patient forum on the site, allowing patients to connect with other people living with the same diagnosis. Put it all together, Javaid said, and you have a digital platform that not only gives researchers and clinicians new insights into these rare conditions but also gives something important back to patients as well.

“Many patients living with rare conditions can feel quite isolated,” he said. “Most general practitioners only see their patients for, maybe, 45 minutes every six months. Often that visit occurs in an unusual circumstance. But, by having this platform, patients can talk to one another about what matters most to them, and we can get a glimpse into that lived experience over time. There are benefits for everyone involved.”

Partnering with kids and their families: A patient engagement example from the pediatric pain research world
Patient engagement may seem challenging for researchers, including those who study pediatric pain. Perri Tutelman, of Dalhousie University, Halifax, Canada, said that, as a PhD student, she saw the importance of patient engagement from observing the work of her supervisor, Christine Chambers, a professor and clinical pediatric pain researcher at Dalhousie University and the IWK Health Centre. Chambers developed a social media campaign to disseminate evidence-based information about pain management to the parents of children with cancer. Tutelman said, by including parents in the process, as well as young adult survivors of childhood cancer, she and the research team were able to make sure the information was “relevant and understandable.”

“That showed me just how powerful partnering with patients can be,” Tutelman said. “They really guided what kind of content should be shared in this campaign and how it should be shared. I knew then I wanted to continue that kind of engagement in my own work.”

Some researchers might shy away from working with parents, who already have so much on their plate caring for a sick child. Recruiting young adults with lived experience of pain resulting from cancer can also seem daunting. Do these individuals, who have overcome so much, really want to participate in such initiatives?

“This is such a sensitive and personal experience. You have to wonder if people even want to talk to you about it,” said Tutelman. “But there is a lot we can learn about pain and pain management from lived experience. Many patients are very willing to partner in research because it gives meaning to their experiences and may help others in the future, so it is important to provide the opportunity. The question then becomes how to do it in the most appropriate way.”

Tutelman worked closely with a patient partner, Maya Stern, to help design the right questions to ask pediatric cancer survivors for a research project she was working on (see related RELIEF interview with Tutelman and Stern here). She said it not only provided the sensitivity needed to delve into such a serious subject with study participants but also helped her uncover questions she wouldn’t have thought to ask during her research.

“One of my questions was, how do you tell your parents that you have pain,” Tutelman said. “My research partner told me that sometimes she didn’t want to tell her parents she had pain because of the way her parents would react to it. I hadn’t considered that before. So, we added a question to the interview: Do you ever not tell your parents that you experienced pain?”

Tutelman also added that having patient research partners has been instrumental in recruiting patients for research studies.

“They’ve been instrumental in helping to design recruitment materials – coming up with the right words and images to make sure we are conveying the right information to potential participants,” she said. “Having really authentic engagement, with people who are true partners, really can inform and improve every aspect of the research process.”

Moving toward new treatments
Patient engagement is also critical as potential new treatments reach clinical trials. The FDA’s Captain Bent said that patient input has been instrumental in the development of new therapies, particularly non-opioid therapies, for chronic pain, an area of interest to the National Institutes of Health’s Helping to End Addiction Long-Term (HEAL) Initiative.

One of the goals of the HEAL effort is to deliver the best solutions for patients, practitioners, family members, caregivers, and the overall community. Without patient engagement, that would be all but impossible.

“Patients are helping us to really understand the challenges and opportunities involved in coming up with new treatments,” she said. “Many times, we’ve learned clinical trials are just not measuring the endpoints that really matter to patients. That’s something we need to know. Patient partners can also help us increase participant retention in trials and decrease protocol amendments. They can speak to the readability and understandability of informed consent. They really do offer so much, especially when they are involved from the very start of the process.”

Bent added that she’s found that patients really do want to be involved as equal partners, not only in their care but in the development of new interventions.

“Just reaching out, being transparent, and ensuring these people with lived experience have a seat at the table makes a huge difference,” she said. “It doesn’t have to be expensive. It doesn’t have to be difficult. You just need to let them know that their voices do matter and there are opportunities to contribute to the healthcare community’s knowledge of chronic pain or any other medical condition.”

At last, researchers and providers are realizing that the people they are trying to help make them better at what they do.

“I’ve been a healthcare provider for over 20 years and I never fail to learn something from the meetings we have with patients,” she said. “I go into them thinking I know what I am going to hear, and I’m always surprised.”

Kayt Sukel is a freelance writer based outside Houston, Texas.