Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.

OBJECTIVE: Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology. METHODS: EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions. CONCLUSION: The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.

An analysis of the root causes for opioid-related overdose deaths in the United States.

OBJECTIVE: A panel of experts in pain medicine and public policy convened to examine root causes and risk factors for opioid-related poisoning deaths and to propose recommendations to reduce death rates. METHODS: Panelists reviewed results from a search of PubMed and state and federal government sources to assess frequency, demographics, and risk factors for opioid-related overdose deaths over the past decade. They also reviewed results from a Utah Department of Health study and a summary of malpractice lawsuits involving opioid-related deaths. RESULTS: National data demonstrate a pattern of increasing opioid-related overdose deaths beginning in the early 2000s. A high proportion of methadone-related deaths was noted. Although methadone represented less than 5% of opioid prescriptions dispensed, one third of opioid-related deaths nationwide implicated methadone. Root causes identified by the panel were physician error due to knowledge deficits, patient non-adherence to the prescribed medication regimen, unanticipated medical and mental health comorbidities, including substance use disorders, and payer policies that mandate methadone as first-line therapy. Other likely contributors to all opioid-related deaths were the presence of additional central nervous system-depressant drugs (e.g., alcohol, benzodiazepines, and antidepressants) and sleep-disordered breathing. CONCLUSIONS: Causes of opioid-related deaths are multifactorial, so solutions must address prescriber behaviors, patient contributory factors, nonmedical use patterns, and systemic failures. Clinical strategies to reduce opioid-related mortality should be empirically tested, should not reduce access to needed therapies, should address risk from methadone as well as other opioids, and should be incorporated into any risk evaluation and mitigation strategies enacted by regulators.

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol.

Growing concerns about the safety of long-term opioid therapy and its uncertain efficacy for non-cancer pain have led to relatively rapid opioid deprescribing in chronic pain patients who have been taking opioid for years. To date, empirically supported processes for safe and effective opioid tapering are lacking. Opioid tapering programs have shown high rates of dropouts and increases in patient distress and suicidal ideation. Therefore, safe strategies for opioid deprescribing that are more likely to succeed are urgently needed. In response to this demand, the EMPOWER study has been launched to examine the effectiveness of behavioral medicine strategies within the context of patient-centered opioid tapering in outpatient settings (https://empower.stanford.edu/). The EMPOWER protocol requires an efficient process for ensuring that collaborative opioid tapering would be offered to the most appropriate patients while identifying patients who should be offered alternate treatment pathways. As a first step, clinicians need a screening tool to identify patients with Opioid Use Disorder (OUD) and to assess for OUD severity. Because such a tool is not available, the study team composed of eight chronic pain and/or addiction experts has extended a validated screening instrument to develop a brief and novel consensus screening tool to identify OUD and assess for OUD severity for treatment stratification. Our screening tool has the potential to assist busy outpatient clinicians to assess OUD among patients receiving long-term opioid therapy for chronic pain.

Patient-centered prescription opioid tapering in community outpatients with chronic pain: 2- to 3-year follow-up in a subset of patients.

OBJECTIVE: We previously reported promising results for a 4-month patient-centered voluntary opioid tapering study. Key questions remain about the durability of effects and possible risks after opioid reduction. We provide the longest follow-up data to date for prospective opioid tapering: 2- to 3-year follow-up for pain intensity and daily opioid use in a subset of patients from our original 4-month opioid tapering study. METHODS: Twenty-three patients (44% of original sample) responded to contact attempts through telephone and reported their average pain intensity and current opioid use. Opioid doses were converted to morphine equivalent daily dose (MEDD). Data were analyzed within a repeated-measures model where time (baseline, 4 months, and 2-3 years) was the within-subject factor. RESULTS: Among reachable patients, the effect of time on change in MEDD from baseline to 4 months to 2 to 3 years was significant. Since baseline, 20 (95%) of the current sample reduced MEDD, and 15 (71%) further reduced MEDD at 2- to 3-year follow-up. There was no effect of time on change in pain intensity from baseline to 4 months to 2 to 3 years. Since baseline, 11 (52%) of the current sample reported pain reduction, and 12 (57%) reported reduced pain from the 4-month follow-up to the 2- to 3-year follow-up. Five (24%) reported increased pain intensity. CONCLUSION: Study findings reveal continued MEDD reduction and enduring pain stability 2 to 3 years after a patient-centered voluntary opioid tapering program for a substantial fraction of patients. Notably, we were not able to verify current opioid use through medical records and were limited by self-report.

The disability determination dilemma: toward a multiaxial solution.

Recently the United States Social Security Administration Commission on the Evaluation of Pain recommended that a set of criteria be developed that could be used to determine 'impairment due primarily to pain.' The intention was to provide a specific and equitable system for determination of disability of social security claimants who alleged that they were disabled primarily by pain. In this paper, the social security disability determination process is described, criteria for the proposed listing of 'impairment due primarily to pain' are reviewed, and a multiaxial taxometric system for determining disability due primarily to pain is described. The social implications of the proposed listing as well as a multiaxial taxometric approach for the social security disability system are described. Impediments to solutions to the disability determination problems confronting the Social Security Administration are discussed, and a scientific approach is contrasted with the current legal decision making process, as it relates to the awarding of Social Security disability benefits.

Quantification of biomedical findings of chronic pain patients: development of an index of pathology.

Difficulties in assessing and quantifying the biomedical signs and symptoms that may be related to patients' reports of pain are well recognized. Although there appears to be some consensus among physicians as to the potential utility of examination and diagnostic tests frequently used to evaluate chronic pain patients, little attention has been paid to the reliability of interpreting the results of these procedures. Moreover, the integration of biomedical findings to form a general index of pathology associated with chronic pain has been a difficult problem to solve because not all biomedical procedures used to evaluate pain patients are necessarily relevant or indicated for a specific patient. Two studies are presented that were designed to evaluate the reliability of 23 biomedical procedures commonly used to evaluate chronic pain patients and to determine if findings on these procedures can effectively be combined to form a reliable index of physical pathology. The results of study 1 suggest that 17 of the 23 procedures can be applied in clinical setting with acceptable levels of reliability. Study 2 provides evidence that an innovative weighted scoring approach, based on current medical consensus, can be used to produce a reliable, general index of pathology that is independent of the number of procedures used to evaluate patients. The utility of this quantification approach to biomedical findings for clinical and research purposes is discussed.