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Patients with chronic pain prescribed long-term opioid therapy may come to a point where the benefits of the therapy are outweighed by the risks and tapering is indicated. At the 2019 Veterans Health Administration State of the Art Conference, there was an acknowledgment of a lack of clinical guidance with regard to treating this subset of patients. Some of the participants believed clinicians and patients would both benefit from a new diagnostic entity describing this situation.
The aim of this study was to determine if a new diagnostic entity was needed and what the criteria of the diagnostic entity would be. Given the ability of the Delphi method to synthesize input from a broad range of experts, we felt this technique was the most appropriate for this study.
We designed a modified Delphi technique involving 3 rounds. The first round is a series of open-ended questions asking about the necessity of this diagnostic entity, how this condition is different from opioid use disorder, and what its possible diagnostic criteria would be. After synthesizing the responses collected, a second round will be conducted to ask participants to rate the different responses offered by their peers. These ratings will be collected and analyzed, and will generate a preliminary definition for this clinical phenomena. In the third round, we will circulate this definition with the aim of achieving consensus.
The modified Delphi study was initiated in July of 2020 and analysis is currently underway.
This protocol has been approved by the Internal Review Board at the Connecticut Veterans Affairs and the study is in process. This protocol may assist other researchers conducting similar studies.
DERR1-10.2196/33310
Although the number of opioid prescriptions has decreased since 2012 [
Thus, some experts have argued that a new diagnostic entity specifically intended for patients on LTOT for whom harm is outweighing benefit would help advance research and clinical care. These experts believe concurrent opioid dependence and chronic pain are more than the sum of their parts, and a new diagnostic entity could address this complexity [
The objectives of this Delphi study are to (1) explore perspectives on the merits of creating a new diagnostic entity, separate from but not replacing OUD, that better characterizes the scenario of benefits no longer outweighing harm of LTOT for chronic pain and (2) develop consensus on its definition and diagnostic criteria. We will present questions in an open-ended format to avoid bias and allow the responses of the participants to guide the analysis.
The Delphi method is well suited for surveying expert panels to gain consensus on a clinical problem that is not well defined and determine the defining elements of that problem. Consistent with other related studies, we will conduct the Delphi study remotely to promote independent contribution and avoid “bandwagon” or “halo” effects, and generate as many ideas as possible from each individual contributor [
The Delphi study flow is shown in
CONSORT flow diagram for a 3-round Delphi study.
As above, VHA HSR&D convened a 2-day SOTA Conference on effective pain management and opioid safety in September 2019. The purpose of the SOTA Conference was to convene a multidisciplinary group of experts to help HSR&D develop specific research priorities related to increasing access to medications for OUD, managing LTOT for pain including tapering, and treating co-occurring pain and substance use disorders [
We set a date for the completion of each round of the Delphi study and will send out regular reminders to participants who have not completed that round to try to minimize attrition. We do not anticipate significant attrition given that many of the participants are already collaborating on similar projects and have voiced an interest in participating in this type of study. However, if we observe significant attrition (eg, >20%), we will consider alternative data collection methods such as offering to conduct data collection via phone.
All 3 rounds of the survey will be administered by Qualtrics XM (Qualtrics International Inc), which has been licensed to our research team through Yale University. We will send individual emails to participants explaining the Delphi process and why they were selected to participate. In the email, we will acknowledge the discussion at the 2019 VHA HSR&D SOTA Conference that prompted this study. The survey will contain a link to the DSM-5 criteria for OUD for participant reference. We will allow approximately 1 month to complete each round, with some reminder emails if necessary.
The aims of round 1 are as follows: (1) to understand the various expert perspectives on the merits of creating a separate diagnostic entity and (2) to gather information about the defining characteristics of the clinical phenomenon requiring operationalization, as well as information about how the phenomenon relates to OUD via several open-ended questions. We designed a survey that will take approximately 25-30 minutes to complete. Questions such as “Please describe a person who would be diagnosed with Condition X” are meant to prime participants to envision how these patients might present in a clinical setting. We also wanted to encourage participants to consider the bounds of this condition, defining both what it is and what it is not.
The round 1 survey can be found in
Note: Questions 2-9 were only asked of those who said “yes” to question 1.
Do you think a new diagnostic entity is needed for patients on long-term opioid therapy for pain that is related to but distinct from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition’s opioid use disorder definition? (yes/no)
If yes, please explain why. If no, please explain why not.
Please describe a person who would be diagnosed with Condition X (How did he or she present? What were they prescribed? How did the treatment course go? What behaviors manifest themselves over time? How is this person different from a person with opioid use disorder)?
How would you differentiate Condition X from opioid use disorder?
Please complete the sentence “Condition X is defined as ____”
Please list the diagnostic criteria for Condition X:
Should Condition X have different gradations (eg, mild, medium, severe)? (yes/no)
If yes, what gradations would you recommend? How would you distinguish between the different gradations?
If no, why not?
Is Condition X related to opioid use disorder? (yes/no)
If yes, how so?
What are the differences in how Condition X should be treated compared to opioid use disorder?
We have been using the term Condition X as a placeholder for ease of discussion. What do you think this condition should be called?
We will use rapid qualitative analysis [
The objective of the second round will be to begin building consensus on the potential criteria defining the proposed new diagnostic entity. We will ask the participants to evaluate and rate the relevance of each criterion to the diagnostic entity. The experts will have the opportunity to critique the initial responses (that have been analyzed and reformatted) and suggest the criteria that should be retained.
The round 2 survey will list each potential criterion and ask participants to answer, “to what extent do you agree that each of the following features/criteria should be included as a feature/criterion of Condition X?” Participants will answer on a 7-point Likert scale from “strongly disagree” to “strongly agree.” We will also ask participants to comment on their preferred wording among alternatives, and provide suggestions for alternative wording for diagnostic criteria. Finally, we will ask participants to indicate their favored proposed names for the new diagnostic entity.
For each item, we will calculate the mean, standard deviation, median, and interquartile range of ratings. We agreed a priori that diagnostic criteria with a median of 5 or greater will indicate consensus for inclusion, median scores between 3 and 5 will indicate the need for further exploration, and a median score below 3 will indicate that an item should not be included. We will use rapid qualitative analysis to explore the qualitative feedback. Qualitative feedback will be used to identify any additional potential criteria for inclusion in round 3.
This final round will ask panelists to rerate potential criteria in the context of central tendency statistics in an effort to generate further consensus.
We will present to the group the mean, standard deviation, median, and interquartile range of ratings for each proposed criterion from round 2, along with that panelist’s initial response on the 7-point Likert scale. Participants will be asked to rerate each item from round 2 and provide initial ratings for any additional items identified based on round 2 qualitative feedback.
Consistent with prior Delphi studies, items with a median of 5 or greater after round 3 will be recommended for inclusion in the criteria for the new diagnostic entity.
This protocol was approved by the Institutional Review Board of VA Connecticut Healthcare System (approval number: 1624733-3).
Data collection for round 1 began in July 2020; we have completed the first two rounds and are currently collecting round 3 data. We plan to publish qualitative findings from round 1 and overall findings from the entire study.
Herein, we describe a protocol for a Delphi study designed to develop criteria to characterize the phenomenon experienced by patients with chronic pain prescribed LTOT when benefits of the therapy no longer outweigh harms. The protocol uses rigorous methods to iteratively generate consensus among a diverse group of subject matter experts; as such, it holds promise in providing momentum forward on a topic that has become increasingly relevant during the United States’ efforts to improve the safety of opioid prescribing, including tapering when harm outweighs benefit.
Criteria for the novel diagnostic entity may be used to standardize the definition of the new entity, promote targeted research, inform clinical practice guidelines for its treatment, and ultimately improve quality of care. The Delphi method provides the process to accomplish this goal by iteratively developing expert consensus regarding the definition of the entity and a preliminary list of its diagnostic criteria.
If consensus is achieved around a definition and list of criteria for a new diagnostic entity, the next steps may include convening a work group to refine the criteria and evaluating the criteria in practice with regard to sensitivity and specificity. Identification of an entity distinct from OUD could inform practice specific to that entity. Future work will include exploring best pathways for disseminating our findings to frontline clinicians who work with patients prescribed LTOT, and determining how to use our findings to inform future research, policy work, and clinical care, such as developing better treatments for patients with chronic pain prescribed LTOT and helping frontline clinicians assess and provide tailored treatment options.
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
Health Services Research and Development
long-term opioid therapy
opioid use disorder
State of the Art
Veterans Health Administration
This work was partially supported by the Center for Innovation to Implementation at the Palo Alto VA Medical Center via the Office of Academic Affiliation’s Big Data Scientist Training Enhancement Program and the Pain Research, Informatics, Medical Comorbidities, and Education Center of Innovation of the VA Connecticut Healthcare System.
This material is based on work supported by the Pain/Opioid Consortium of Research (CORE), funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Health Services Research and Development.
We thank Brent Moore, PhD, Alicia Heapy, PhD, and Erin Krebs, MD, for their assistance with this work.
The views expressed in this publication do not represent the views of the Veterans Health Administration or the United States Government.
None declared.