What is the “value” of the VALUE Study to patients with chronic pain taking long-term opioids?

Jonelle Elgaway, a patient advocate, recently interviewed Beth Darnall, associate professor of anesthesiology, perioperative and pain medicine and Sean Mackey, professor of anesthesiology, perioperative and and pain medicine, about the VALUE (Patient Voice for Access and Analgesia in Long-Term Pain and Opioid Use) Study. Jonelle submitted questions to Drs. Darnall and Mackey who provided their answers below.

What is the VALUE Study?

We created the VALUE Study in partnership with people with lived experience to bring forward national data to describe the patient experience of those using opioid pain medications to manage long-term pain.

The VALUE Study is an observational study, meaning we do not apply any interventions or change care in any way. Instead, we observe and collect information directly from patients through three surveys, delivered over one year, to help us understand the patient experience over this timeframe.

Specific study details involve asking participants with chronic pain taking prescription opioids to complete three online surveys (at the beginning, or “baseline,” at 6 months, and again, at 12 months) and three brief phone calls with study staff. The surveys ask questions about pain, symptoms, pain coping, medication use, mood, sleep, substance use, general health, and well-being. After each survey, a member of the study staff will call enrollees to confirm their current medications over the phone and answer any questions that they may have. When they complete each survey, they will immediately receive an Amazon gift card.

The study is entirely voluntary, does not impact medical care, and neither medical records nor prescription drug monitoring databases (PDMPs) are accessed. Participants may skip any questions they do not wish to answer. There are many free-text response fields so people can give us ample details about their experiences – an option that is often missing from “forced choice” surveys.

What is the purpose of the VALUE Study?

The VALUE Study seeks to accomplish two goals. The first is to address a series of questions about the long-term use of pain medications such as opioids. These questions include:

• Whether prescription opioids help treat pain and if so, how much;
• Whether patients experience stigma around receiving prescription opioids;
• What problems people may experience with opioids prescribed for chronic pain;
• Whether patients have difficulty accessing opioids that are prescribed to them;
• Whether or not there are significant risks to the use of opioids when used long term, and if so, what they are;
• Whether or not those using prescribed opioids for persistent pain develop problematic use or Substance Use Disorder, and if so, how often.

The second goal is to bring forward the patient voice and experiences about prescription opioids to inform future research and care. The patient experience is often not included in research on the long-term use of pain medications such as opioids, which is a major limitation in our understanding.

Who can enroll in VALUE?

Anyone taking daily prescription opioids at a minimum dose of 10 morphine equivalent daily doses (MEDD) is invited to participate. Enrollees do need to be English-speaking and cannot be pregnant. We do the opioid MEDD conversions and calculate the MEDD amount for enrollees.

What is the maximum number of participants who can enroll in VALUE?

500, though we are hoping to increase this number.

What will be done with the information that you collect?

We will combine the data and analyze the full sample. Then we will also look for subgroups of people and describe them. One of the problems today is that all people/patients with chronic pain are grouped together without appreciation for individual conditions or circumstances. This leads to flawed conclusions that are not only reductive but can be wildly inaccurate for particular subgroups. Subgroup analyses are sometimes done but rarely include information derived directly from patients. Rather, it often is pulled from medical charts or health insurance claims data. Our goal is to bring forward the patient voice and experience, to conduct the most rigorous study possible (while maintaining anonymity) and to publish the results academically and publicly. 

Why is this study so important?

The patient voice has been lacking from research on opioids. Further, few studies have examined patient stigma and patient difficulty accessing opioids. Finally, we are conducting a national study and will have the ability to understand what patients are experiencing across the country.

Sometimes we hear patient skepticism about researchers collecting patient data. However, we cannot address problems if we have poor or no data. Without data, the problem does not exist in the minds of policymakers. When it comes to policy, data is vital. We must provide patient data if we wish to change practices and policies on pain care in the U.S. We have worked closely with patients in designing this study to best ensure privacy protections and anonymity in every way possible.

What will you do with the enrollee’s information?

First, to be included in the VALUE Study, we will need to obtain consent. This consent will outline our use of health information for research purposes. That consent form outlines the details of how the information will be used.

Briefly, each enrollee’s (i.e., participant’s) data is stored in secured servers maintained by Stanford University. Individual information is not reported or shared outside the study team. Participants are assigned identification numbers in the dataset and all data are coded numerically without names. Your information will be combined with hundreds of other people from around the U.S. We will create an aggregated report on the patient experience. Patients can use a pseudonym if they wish. However, they will need to remember their pseudonym because the study staff will call them three times over the 12-month study and ask using the name provided to us. We will not be accessing any medical records or the state prescription drug databases.

Some people have expressed concern that the information they contribute to the study could somehow be used against them or their physicians. Can you offer any thoughts about this? How can subjects be assured that their information will be protected?

We appreciate the concerns that people have about their data and take data security and access seriously. The data use will be restricted to the study principal investigators and the study staff. We will not be releasing any individually identifiable data to other parties. To provide some context, between Dr. Darnall and Dr. Mackey, we have over 40 years of human research experience and collected data on tens of thousands of research participants. To date, we have never released individual data to any person(s) or groups outside the research study team. Over more than 20 years, Dr. Mackey has had perhaps two to three requests from study participant’s attorneys to allow them to review their research data to help the participant “prove” they had chronic pain. Dr. Mackey has even refused these requests as they are outside the research scope of this data. Beyond these few requests, neither Drs. Darnall or Mackey have never been asked to turn in any private data, nor have they.

From where did the funding for VALUE originate?

The funding originated from the Patient-Centered Outcomes Research Institute (PCORI), as a part of large research award given to Stanford University under principal investigator Beth Darnall. The original award is for the EMPOWER Study, which is a voluntary patient-centered opioid reduction study. This study helps people who wish to reduce their opioid doses do so gradually over the course of one year.

Sean Mackey conceived of the idea of VALUE, in part because everyone in EMPOWER is voluntarily tapering and we did not have a parallel group that was continuing opioids. We wanted to be able to report upon what happens when people continue opioids and remain stable. As we went along, we realized that there was so much forced tapering in the U.S. that, in part, we needed to study that phenomenon as well. Dr. Darnall recognized the growing need to include these patients’ voices in research, particularly on this topic and expanded the project's initial scope to include that experience.

Who are the principal investigators involved with this study?  

Beth Darnall is the overall principal investigator for the EMPOWER research award. Sean Mackey is the director of the VALUE Study. While the initial conceptualization for VALUE was his idea and he is leading it, it has evolved to include more of the patient’s experience through the collaboration with Beth Darnall. As a side note, we find that through cross-disciplinary collaborations such as ours (e.g., a physician-scientist working with a psychologist-scientist who are both working with patient advisors), more impactful research can be conducted.

Why is it important that people sign up for studies such as the VALUE Study?

Over 15 years ago, we were intrigued that we had little data on the long-term use of prescription opioids to treat chronic pain. We had patients in our clinics that clearly benefited from opioids, and we had patients that clearly did not. And yet, we had little data to allow us to distinguish these groups of patients to help guide shared clinician-patient treatment planning. While this question of the benefits of long-term opioids is recognized by many, including the NIH, we have noticed less interest in answering this question by funding agencies and researchers. Instead, we see a focus on non-consensual tapering off opioids, believing that opioids play no role in chronic pain—a belief not grounded on quality data. We want to help answer this critical question (and the others we listed above). We need the patient’s help and experiences. We want to better understand the role of long-term prescription opioids to manage chronic pain at both the individual and group levels from our research. This information can help better inform clinical guidelines and policy decisions around the use of long-term opioids to treat chronic pain. Without this data, decisions will continue to be based primarily on beliefs that may or may not be accurate.

We have endeavored to create a study that truly brings forward the patient voice and experience. If patients wish to have their experience count and their voices heard, VALUE (and other studies like VALUE) present such an opportunity.

Are there any other current studies that patients with persistent pain might want to know about so they can take part?

Yes. You can learn more about available studies we are conducting at the Stanford Systems Neuroscience and Pain Lab. Furthermore, you can look more broadly for pain-related studies at ClinicalTrials.gov.

Dr. Darnall and Dr. Mackey, could you tell us about your background? How and why did you get involved with working with people dealing with painful, rare, and incurable diseases?

Dr. Darnall: I am a psychologist-scientist with a career focus that has been entirely dedicated to acute and chronic pain. I started my patient care with an internship in the Veterans Administration, working with veterans with chronic pain. From there, I did a post-doctoral fellowship at The Johns Hopkins University and treated patients with catastrophic burns, spinal cord injuries, post-amputations, and after other major surgeries. The common need was pain management, and I enjoyed working with patients to help them live better with very challenging circumstances. From there, I joined the pain clinic faculty at Oregon Health and Science University (OHSU). I worked with patients for seven years before joining the faculty at Stanford University. After 15 years of direct patient care, I stopped seeing individual patients in the clinic in 2017. Now, I work with patients in large groups and conduct research that aims to provide better access to pain care. A lot of my focus is helping people access resources from the comfort of their own homes. I also do a lot of advocacy work around opioid access for patients who need these medications. I have twice testified to the U.S. Congress about harms caused by forced opioid tapering and the need for patient-centered pain care. I have also testified to the Food and Drug Administration (FDA) about iatrogenic harms associated with forced opioid tapering, was an invited contributor to the 2019 Health and Human Services (HHS) opioid reduction guidance, and am a current member of the Centers for Disease Control (CDC) Opioid Workgroup. My overarching goal is to bring patient-centeredness to the forefront of pain care, where each person is treated as the individual they are, and to ensure the treatments they need are accessible without barriers or stigma.

Dr. Mackey: I am a physician-scientist who initially trained in bioengineering and electrical engineering (MS and PhD, respectively). After my MD training, I completed an anesthesiology residency at Stanford University. I had an epiphany while on a required chronic pain rotation. While during medical school, I observed how hard it was to care for people with chronic pain and how the medical field tended to avoid people with complex pain problems. During this chronic pain rotation, I watched first-hand as the Stanford Pain Medicine faculty could help turn people’s lives around in ways I had not seen before. I also witnessed the incredible unmet need to understand the nature of chronic pain better and to develop safe and effective therapies. So I enrolled and trained in the Stanford Pain Medicine fellowship. There I learned the multidisciplinary skills to assess and treat a variety of chronic pain conditions. While I focus most of my time on research, I still see patients in the clinic (typically with fellows) two to three times per month. The reason for continuing to practice medicine is two-fold. First, I enjoy it and want to help each individual patient. Second, I find that our best research questions come from interacting directly with patients experiencing the condition(s) we are researching. As my career has advanced, I have shifted energies to become more involved with broader public policy efforts to improve the assessment and treatment of pain nationally. For example, I was a co-author of the Institute of Medicine report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research that put forward a blueprint on where we need to go as a country to enact a cultural transformation in pain care, education, and research. Next, I co-chaired the United States National Pain Strategy that puts forward a strategic plan on how to coordinate and implement the necessary cultural transformation called for by the IOM Pain report. I firmly believe in our closing comments of the National Pain Strategy: that if we can work together to achieve its goals, “Americans ... would recognize chronic pain as a complex disease and a threat to public health … significant public resources would be invested in the areas of preventing pain, creating access to evidence-based and high-quality pain assessment and treatment services ... among those with pain … and individuals who live with chronic pain would be viewed and treated with compassion and respect.” We all need to work together to achieve this cultural transformation.