Classification of Patients for Whom Benefit of Long-term Opioid Therapy No Longer Outweighs Harm: Protocol for a Delphi Study

Background: 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. Objective: 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. Methods: 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. Results: The modified Delphi study was initiated in July of 2020 and analysis is currently underway. Conclusions: 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.