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Table of Contents:


Introduction

We've all heard "there is no evidence that opioids work long-term for pain."  This is where the VALUE study comes in. We have answers to your questions here. Much of this information came from an interview Jonelle Elgaway did with the directors of the study, Dr. Beth Darnall and Dr. Sean Mackey. The questions are answered by Dr. Darnall and Dr. Mackey.

We also include a letter from Andrea Anderson answering some frequently asked questions including what you will encounter in the VALUE Study questionnaires, why they are there, and how you can respond comfortably. 

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 will be done with the information that they collect?

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.

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. 

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.


Why is this study (and others like this) 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.

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.


Some are concerned the information they share will be used against them. Is that possible or will their info. 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.


If I enrolled what can I expect? Clarifying some confusing regarding the VALUE Study

A letter from Andrea Anderson, answering some frequently asked questions:

"Due to some concerns and confusion about a few questions in the VALUE study, I wanted to take this opportunity to explain what you will encounter in the Value Study questionnaires, why they are there, and how you can respond comfortably. 
This study, funded by the federal research organization PCORI, required us to include 4 different questionnaires from several other federal agencies. All 4 of those questionnaires are about different substance use/misuse from alcohol or types of substance use/misuse/abuse. These 4 agency questionnaires are often repetitive because they have similar questions. However, the funders of the study required that we use those questionnaires, and we cannot change the wording of those questions. This is because in federal research, all researchers have to use the same standardized questions so that comparisons, replication, and analyses are possible by others. 
I want to assure you that you can skip any question you don't want to answer. if a question is poorly worded or difficult to answer, you can always just skip it. Doing so won’t hurt you or hurt the study in any way. You’re not obligated to answer the same question over and over, which can be irritating. There is also nomenclature about drug use that comes from a substance misuse perspective. You might encounter a question such as, “do you think about your drug use often?” You can skip it, or just answer truthfully. E.g., If the answer is, “no, I don’t,” then just answer it that way. That’s what I did. 
Last, there is a free “text box” provided at multiple sites throughout the study. In those “free text” boxes, you can provide feedback and/or answer questions that were difficult to answer in the actual questionnaire.
 
For example, there is one compound question that asks about two subjects, constipation and something else. There’s no way to answer it easily. I have talked with the study designers about it, and I believe they tried to add some clarifying language, but we can’t change the question for the reasons I gave above, as well as being unable to change questions in the process of an ongoing research survey. 
You can use the free text box to write an answer in your own words.
If you have any questions, please feel free to ask Vicki Bright

Thank you so much for your participation! We all appreciate you so much. 
Warmly,
Andrea"

Content created by Bev Schechtman on August 6, 2022

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