Web-Based Cognitive Behavior Therapy for Chronic Pain Patients with Aberrant Drug-Related Behavior: Outcomes from a Randomized Controlled Trial.

Objective: There is high unmet need for effective behavioral treatments for chronic pain patients at risk for or with demonstrated histories of opioid misuse. Despite growing evidence supporting technology-based delivery of self-management interventions for chronic pain, very few such programs target co-occurring chronic pain and aberrant drug-related behavior. This randomized controlled trial evaluated the effectiveness of a novel, web-based self-management intervention, grounded in cognitive behavior therapy, for chronic pain patients with aberrant drug-related behavior. Methods: Opioid-treated chronic pain patients at a specialty pain practice who screened positive for aberrant drug-related behavior (N = 110) were randomized to receive treatment as usual plus the web-based program or treatment as usual alone. The primary outcomes of pain severity, pain interference, and aberrant drug-related behavior, and the secondary outcomes of pain catastrophizing and pain-related emergency department visits, were assessed during the 12-week intervention and at one and three months postintervention. Results: Patients assigned to use the web-based program reported significantly greater reductions in aberrant drug-related behavior, pain catastrophizing, and pain-related emergency department visits-but not pain severity or pain interference-relative to those assigned to treatment as usual. The positive outcomes were observed during the 12-week intervention and for three months postintervention. Conclusions: A web-based self-management program, when delivered in conjunction with standard specialty pain treatment, was effective in reducing chronic pain patients' aberrant drug-related behavior, pain catastrophizing, and emergency department visits for pain. Technology-based self-management tools may be a promising therapeutic approach for the vulnerable group of chronic pain patients who have problems managing their opioid medication.

Efficacy Outcome Measures for Pediatric Procedural Sedation Clinical Trials: An ACTTION Systematic Review.

Objective evaluations comparing different techniques and approaches to pediatric procedural sedation studies have been limited by a lack of consistency among the outcome measures used in assessment. This study reviewed those existing measures, which have undergone psychometric analysis in a pediatric procedural sedation setting, to determine to what extent and in what circumstances their use is justified across the spectrum of procedures, age groups, and techniques. The results of our study suggest that a wide range of measures has been used to assess the efficacy and effectiveness of pediatric procedural sedation. Most lack the evidence of validity and reliability that is necessary to facilitate rigorous clinical trial design, as well as the evaluation of new drugs and devices. A set of core pediatric sedation outcome domains and outcome measures can be developed on the basis of our findings. We believe that consensus among all stakeholders regarding appropriate domains and measures to evaluate pediatric procedural sedation is possible and that widespread implementation of such recommendations should be pursued.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.

Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy.

INTRODUCTION: No treatments for axonal peripheral neuropathy are approved by the United States Food and Drug Administration (FDA). Although patient- and clinician-reported outcomes are central to evaluating neuropathy symptoms, they can be difficult to assess accurately. The inability to identify efficacious treatments for peripheral neuropathies could be due to invalid or inadequate outcome measures. METHODS: This systematic review examined the content validity of symptom-based measures of diabetic peripheral neuropathy, HIV neuropathy, and chemotherapy-induced peripheral neuropathy. RESULTS: Use of all FDA-recommended methods to establish content validity was only reported for 2 of 18 measures. Multiple sensory and motor symptoms were included in measures for all 3 conditions; these included numbness, tingling, pain, allodynia, difficulty walking, and cramping. Autonomic symptoms were less frequently included. CONCLUSIONS: Given significant overlap in symptoms between neuropathy etiologies, a measure with content validity for multiple neuropathies with supplemental disease-specific modules could be of great value in the development of disease-modifying treatments for peripheral neuropathies. Muscle Nerve 55: 366-372, 2017.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks public-private partnership with the US Food and Drug Administration, convened a meeting of sedation experts from a variety of clinical specialties and research backgrounds with the objective of developing recommendations for procedural sedation research. Four core outcome domains were recommended for consideration in sedation clinical trials: (1) safety, (2) efficacy, (3) patient-centered and/or family-centered outcomes, and (4) efficiency. This meeting identified core outcome measures within the efficacy and patient-centered and/or family-centered domains. Safety will be addressed in a subsequent meeting, and efficiency will not be addressed at this time. These measures encompass depth and levels of sedation, proceduralist and patient satisfaction, patient recall, and degree of pain experienced. Consistent use of the recommended outcome measures will facilitate the comprehensive reporting across sedation trials, along with meaningful comparisons among studies and interventions in systematic reviews and meta-analyses.

The ACTTION-APS-AAPM Pain Taxonomy (AAAPT) Multidimensional Approach to Classifying Acute Pain Conditions.

Objective: With the increasing societal awareness of the prevalence and impact of acute pain, there is a need to develop an acute pain classification system that both reflects contemporary mechanistic insights and helps guide future research and treatment. Existing classifications of acute pain conditions are limiting, with a predominant focus on the sensory experience (e.g., pain intensity) and pharmacologic consumption. Consequently, there is a need to more broadly characterize and classify the multidimensional experience of acute pain. Setting: Consensus report following expert panel involving the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), American Pain Society (APS), and American Academy of Pain Medicine (AAPM). Methods: As a complement to a taxonomy recently developed for chronic pain, the ACTTION public-private partnership with the US Food and Drug Administration, the APS, and the AAPM convened a consensus meeting of experts to develop an acute pain taxonomy using prevailing evidence. Key issues pertaining to the distinct nature of acute pain are presented followed by the agreed-upon taxonomy. The ACTTION-APS-AAPM Acute Pain Taxonomy will include the following dimensions: 1) core criteria, 2) common features, 3) modulating factors, 4) impact/functional consequences, and 5) putative pathophysiologic pain mechanisms. Future efforts will consist of working groups utilizing this taxonomy to develop diagnostic criteria for a comprehensive set of acute pain conditions. Perspective: The ACTTION-APS-AAPM Acute Pain Taxonomy (AAAPT) is a multidimensional acute pain classification system designed to classify acute pain along the following dimensions: 1) core criteria, 2) common features, 3) modulating factors, 4) impact/functional consequences, and 5) putative pathophysiologic pain mechanisms. Conclusions: Significant numbers of patients still suffer from significant acute pain, despite the advent of modern multimodal analgesic strategies. Mismanaged acute pain has a broad societal impact as significant numbers of patients may progress to suffer from chronic pain. An acute pain taxonomy provides a much-needed standardization of clinical diagnostic criteria, which benefits clinical care, research, education, and public policy. For the purposes of the present taxonomy, acute pain is considered to last up to seven days, with prolongation to 30 days being common. The current understanding of acute pain mechanisms poorly differentiates between acute and chronic pain and is often insufficient to distinguish among many types of acute pain conditions. Given the usefulness of the AAPT multidimensional framework, the AAAPT undertook a similar approach to organizing various acute pain conditions.

Development and Preliminary Evaluation of an Integrated Cognitive-Behavior Treatment for Chronic Pain and Substance Use Disorder in Patients with the Hepatitis C Virus.

OBJECTIVE: Individuals with the hepatitis C virus (HCV) have high rates of both chronic pain and substance use disorder (SUD). Despite high comorbidity, there are limited data available on effective methods of treatment for co-occurring chronic pain and SUD. In this study, we sought to develop and conduct preliminary testing of an integrated cognitive-behavior therapy (CBT) for chronic pain and SUD in patients with HCV. DESIGN: Descriptive, including pretreatment, posttreatment, and follow-up testing. SETTING AND PATIENTS: Outpatient clinic as part of one VA Medical Center. PARTICIPANTS: Veterans with chronic pain, SUD, and HCV. INTERVENTION: Eight-session integrated group CBT for chronic pain and SUD in patients with HCV. METHODS: Participants completed standardized measures of pain, function, depression severity, and alcohol and substance use at baseline, post-treatment, and 3-month follow-up. RESULTS: Generalized estimating equations identified improvements in pain interference, reducing cravings for alcohol and other substances, and decreasing past-month alcohol and substance use. The proportion of participants who met diagnostic criteria for current SUD demonstrated a four-fold decrease over the course of the study from 24% at baseline to 15% at post-treatment and 6% at 3-month follow-up. On response to a global impression of change, 94% of participants noted improvement from baseline. CONCLUSIONS: Results from this pilot study suggest that a customized CBT for patients with both chronic pain and SUD (CBT-cp.sud) may be beneficial in improving important pain and addiction-related outcomes in patients with HCV. Larger scale investigations of this intervention appear warranted.

Efficacy Outcome Measures for Procedural Sedation Clinical Trials in Adults: An ACTTION Systematic Review.

Successful procedural sedation represents a spectrum of patient- and clinician-related goals. The absence of a gold-standard measure of the efficacy of procedural sedation has led to a variety of outcomes being used in clinical trials, with the consequent lack of consistency among measures, making comparisons among trials and meta-analyses challenging. We evaluated which existing measures have undergone psychometric analysis in a procedural sedation setting and whether the validity of any of these measures support their use across the range of procedures for which sedation is indicated. Numerous measures were found to have been used in clinical research on procedural sedation across a wide range of procedures. However, reliability and validity have been evaluated for only a limited number of sedation scales, observer-rated pain/discomfort scales, and satisfaction measures in only a few categories of procedures. Typically, studies only examined 1 or 2 aspects of scale validity. The results are likely unique to the specific clinical settings they were tested in. Certain scales, for example, those requiring motor stimulation, are unsuitable to evaluate sedation for procedures where movement is prohibited (e.g., magnetic resonance imaging scans). Further work is required to evaluate existing measures for procedures for which they were not developed. Depending on the outcomes of these efforts, it might ultimately be necessary to consider measures of sedation efficacy to be procedure specific.

Attitudes and Beliefs of Working and Work-Disabled People with Chronic Pain Prescribed Long-Term Opioids.

OBJECTIVE: This study was designed to gain insight into the apparent contradiction between the perspectives of researchers and policy makers, who have questioned the efficacy and safety of chronic opioid therapy for non-cancer pain patients, and the patients themselves, who often indicate that the therapy has value. SUBJECTS: A convenience sample of 54 patients on chronic opioid therapy was studied. METHODS: Participants completed a questionnaire specifically designed for the study, and also several standard instruments that addressed functional interference, emotional functioning, and possible misuse of opioids. Their treating physicians rated the participants on the severity of their disability and the success of their opioid therapy. RESULTS: Although participants reported significant ongoing pain, they gave positive global ratings to their opioid therapy, and reported little concern about addiction or side effects of opioids. They strongly endorsed the beliefs that opioids helped them control their pain and allowed them to participate in important activities such as work. They expressed the belief that their pain would be severe if they did not have access to opioids, and reported negative experiences with tapering or discontinuing opioids in the past. Work-disabled participants reported higher levels of affective distress, catastrophizing, and functional interference than working participants, and were judged by their physicians to be relatively less successful in managing their pain. CONCLUSION: The results of this study suggest several tentative hypotheses about why patients on chronic opioid therapy value opioids, and identified several areas for systematic investigation in the future.

Core outcome domains for clinical trials in non-specific low back pain.

PURPOSE: Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP. METHODS: An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions. RESULTS: A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain 'number of deaths'. CONCLUSIONS: The following outcome domains were included in this updated COS: 'physical functioning', 'pain intensity', 'health-related quality of life' and 'number of deaths'. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.

Associations between prescription opioid use and sleep impairment among veterans with chronic pain.

OBJECTIVE: Chronic pain is associated with impairments in sleep; however, the relationship between prescription opioid status and sleep is unclear. The primary aim of this study was to examine differences in self-reported sleep quality between groups of patients who varied based on chronic pain and prescription opioid status. DESIGN: This is a cross-sectional study with retrospective review of patient medical records. SETTING: The study was performed in a single VA medical center located in the Pacific Northwest. SUBJECTS: Participants with chronic pain and a current prescription for opioid medications (N=72), chronic pain and no opioid prescription (N=104), or who did not report current chronic pain or opioid prescription (N=91) were included. METHODS: All participants completed self-report questionnaires assessing demographic characteristics, sleep parameters, pain-related variables, and psychiatric symptoms. Data on prescription opioid use were extracted from patients' medical records. RESULTS: In unadjusted analyses, patients with chronic pain who were prescribed opioids were more likely to have sleep apnea diagnoses in their medical record and reported more impairment on sleep global score and across four sleep parameter subscales (subjective sleep quality, sleep latency, sleep disturbance, and use of sleeping medications). In linear regression analyses controlling for demographic and clinical covariates, prescription opioid status was associated with sleep latency, and opioid dose was significantly associated with sleep latency and sleep global score. CONCLUSIONS: Prescription opioid status and dose were associated with impairment in self-reported sleep. For patients with chronic pain, consideration should be given to use of nonpharmacological interventions to improve sleep.

Physicians' beliefs and likelihood of prescribing opioid tamper-resistant formulations for chronic noncancer pain patients.

BACKGROUND: Tamper-resistant opioid formulations (TRFs) have recently been the target of active development in an effort to deter opioid misuse and abuse. OBJECTIVE: To understand factors that are predictive of physicians' likelihoods of prescribing TRFs to patients with chronic noncancer pain (CNCP). DESIGN: A cross-sectional survey was conducted, utilizing a questionnaire of clinicians' attitudes and opinions about opioids for CNCP (Clinicians' Attitudes about Opioids Scale) to explore beliefs about and likelihood of prescribing TRFs. SUBJECTS: A nationally representative sample of 1,535 practicing physicians throughout the United States. METHODS: A stepwise hierarchical multiple linear regression analysis was conducted to estimate if physician characteristics, opinions, or geographic region categorized according to state rates of mortality by drug overdose and milligrams of opioids prescribed by state were predictive of the likelihood of prescribing TRFs. RESULTS: Board certification in Pain Medicine and prescribing opioids to a higher volume of CNCP patients were significantly predictive of a reported likelihood of prescribing TRFs, in addition to concerns about possible misuse and abuse of opioids, beliefs in the effectiveness of opioids for CNCP, and greater satisfaction with education and training in pain management this set of factors accounted for 21% of the model variance. Rates of mortality by drug overdose and opioid prescription volume by location were not predictive of TRF usage. CONCLUSIONS: Reducing physician concerns about potential misuse and abuse of opioids through additional education in pain management and dissemination of information about the potential benefits and availability of TRFs should influence physicians' attitudes about and the adoption of TRFs.

Biopsychosocial factors associated with pain in veterans with the hepatitis C virus.

Little research has examined etiological factors associated with pain in patients with the hepatitis C virus (HCV). The purpose of this study was to evaluate the relationship between biopsychosocial factors and pain among patients with HCV. Patients with HCV and pain (n = 119) completed self-report measures of pain, mental health functioning, pain-specific psychosocial variables (pain catastrophizing, self-efficacy for managing pain, social support), prescription opioid use, and demographic characteristics. In multivariate models, biopsychosocial factors accounted for 37% of the variance in pain severity and 56% of the variance in pain interference. In adjusted models, factors associated with pain severity include pain catastrophizing and social support, whereas variables associated with pain interference were age, pain intensity, prescription opioid use, and chronic pain self-efficacy (all p values <0.05). The results provide empirical support for incorporating the biopsychosocial model in evaluating and treating chronic pain in patients with HCV.

Use of patient-reported global assessment measures in clinical trials of chronic pain treatments: ACTTION systematic review and considerations.

ABSTRACT: Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.

Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement.

ABSTRACT: Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations.

ABSTRACT: In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.

Redesigning delivery of opioids to optimize pain management, improve outcomes, and contain costs.

INTRODUCTION: Chronic pain is a public health concern, and in the last decade, there has been a dramatic increase in the use and abuse of prescription opioids for chronic non-cancer pain. METHODS: We present an overview of a five-component model of pain management implemented at the University of Washington Division of Pain Medicine designed to facilitate recent state guidelines to reduce the risks associated with long-term use of prescription opioids. RESULTS: Central to the model described are guidelines for best clinical practice, a collaborative care approach, telehealth solutions, comprehensive prescription-monitoring, and measurement-based care. DISCUSSION: The model presented is a patient-centered, efficient, and cost-effective approach to the management of chronic pain.

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain.

OBJECTIVES: To describe the development of an interactive, web-based self-management intervention for opioid-treated, chronic pain patients with aberrant drug-related behavior. METHODS: Fifty-three chronic pain patients participated in either focus groups (N = 23) or individual feedback sessions (N = 30). Focus groups probed interest in and relevance of the planned content and structure of the program. Individual session participants reviewed draft program modules and provided feedback on acceptability, ease of use, and usefulness. Focus group transcripts were thematically analyzed, and summary statistics were performed on feedback data. RESULTS: Focus group participants stressed the need for additional pain management strategies and emphasized themes consistent with planned program content related to: 1) ambivalence about opioids; 2) reciprocal relationships among cognition, mood, and pain; 3) importance of recognizing physical limitations; and 4) effectiveness of goal setting for increasing motivation and functioning. Participants also offered insights on: 5) the loss of identity due to chronic pain; and 6) the desire to connect with pain peers to share strategies for managing daily life. Feedback session data demonstrate that participants believed that a web-based tool would be potentially useful and acceptable, and that exposure to program sections significantly increased participants' knowledge of key topics related to self-management of chronic pain. CONCLUSIONS: Results suggest the potential value of self-management for chronic pain patients and the potential acceptability of web-based delivery of intervention content. Focus group and feedback methodologies highlight the usefulness of including potential program users in intervention development.