We partnered with a group of accomplished patient advocates who advised us on the design of VALUE and the questions we included to address the issues that are most important to patients. Indeed, they helped us design a study that is inclusive and best captures the patient voice and experience.
Roughly 100 million Americans are living with ongoing pain and an estimated 20 million live with high-impact chronic pain with substantially restricted work, social, and self-care activities. For the past 15 years, prescription opioids have been a mainstay treatment for chronic pain. Data from 2014 revealed that roughly 11 million Americans were then taking daily prescription opioids, or 3.4% of the US population. At that time, prescription opioids were one of the most used treatments for chronic pain. Furthermore, some studies show that long-term use can be associated with significant negative side effects, including risk of overdose, misuse, abuse, and addiction. However, stable doses of opioids may provide extended pain relief for a subgroup of patients with minimal side effects. Consequently, a poor risk to benefit ratio in a large patient population may obscure a positive profile in a subgroup of opioid-responsive people with chronic pain.
Many of these studies on the use of opioids in chronic pain are limited in value because they either access large insurance datasets that lack individual granularity and patient-reported outcomes, rely on electronic medical records (EMRs), which have notoriously poor data quality and are not designed to be pragmatic, prospective, or fully characterize the longitudinal trajectory of pain and opioid use. The lack of precision data for pain and opioid use has contributed to a ‘one-size-fits-all’ approach in medicine that fails to identify and account for individual characteristics.
Additionally, the design and implementation of most of the clinical trials characterizing the role of opioids in chronic pain missed a key stakeholder group—those people on opioids experiencing pain. There is growing interest in clinical research to engage researchers, patients, clinicians, managers, and other healthcare system users as coproducers of evidence. The coproduction model was developed outside of health care with the goal to shift from the exclusive notion of research as the sole domain of the academic researchers, to an expanded view that aligns with the patient's priorities, goals and concerns. In other words, we are giving greater voice to the people in pain and partnering with them to find solutions that work for them.
Patient advocate partners who shaped the design of VALUE include Andrea Anderson; Amy Lynn (who created the study name and acronym); Anne Fuqua, BSN; Terri Lewis, PhD; and Lelena Peacock. We learned from our patient and family stakeholders that, in addition to our main question on the long-term safety and efficacy of opioids, the following questions were also critically important:
With our patient partners in mind, we designed the VALUE Study. Stakeholder partner Andrea Anderson describes what makes VALUE unique: “The VALUE study is critical because it centers around the patient experience of long-term opioid therapy, and will provide rich data to describe how people are benefitting from opioid medications, as well as detailing any stigma or issues they may face.” Similarly, Terri Lewis stated, “As a clinical educator, and a care partner to a family member with a complex, chronic medical history that includes pain symptom management, it is long past time to include the patient voice in evaluation of outcomes related to the entire environment of opioid prescribing.”
The VALUE Study is conducted remotely so people from all over the U.S. are being enrolled. The study preserves participant confidentiality; there is no checking of medical records or any databases. VALUE only involves us collecting the information participants provide to us. Participants complete three online surveys and three brief phone calls with a study staff to confirm medication information provided to us by the participant. Online surveys are administered at baseline, 6 months and 12 months. Each survey takes about 45 minutes to complete. The survey will ask questions about pain, symptoms, pain coping, medication use, stigma, access to prescribed medications, mood, sleep, substance use, general health and well-being. After each survey, a study staff calls to confirm current medications over the phone and answer any questions. Participants are emailed an Amazon gift card upon completion of each survey.
With VALUE we hope to transcend the current ‘one-size-fits-all’ approach and better understand the risks and benefits of long-term opioid prescribing for chronic pain through the patient voice. We want to help future patients, families, and doctors make medical decisions about the best treatment for chronic pain. We expect our findings will have broad policy implications at local, state and national levels in making opioid prescribing guidelines more patient-centered, effective and safe.
Disclosures: Sean Mackey, MD, PhD is a salaried faculty member at Stanford University. He is principal investigator for research funded by the National Institutes of Health and Food and Drug Administration. He does not receive additional personal monies because of these grants. He does not receive any industry funds. Beth Darnall, PhD is salaried faculty at Stanford University and is principal investigator for research funded by the National Institutes of Health and the Patient-Centered Outcomes Research Institute (PCORI). VALUE is funded by PCORI. She does not receive additional personal monies because of these grants. She developed a single-session pain intervention (“Empowered Relief”; owned by Stanford University) and clinicians may obtain training and professional certification through Stanford University to deliver this manualized intervention. Fees that are charged for the two-day intensive professional training and certification workshop belong to Stanford University and cover costs associated with CE/CME clinicians receive, clinician training, workshop operations, and ongoing access to all intervention materials (available in four languages, provided at no additional cost to certified instructors). She is also chief science advisor at AppliedVR, serves on the board of directors at the Institute for Brain Potential, and is a member of the Centers for Disease Control (CDC) Opioid Work Group. The views expressed in this article represent the personal views of Drs. Mackey and Darnall. They are not official statements from Stanford University, Stanford School of Medicine or Stanford Health Care, nor any of the aforementioned organizations.