The journal of pain : official journal of the American Pain Society
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The Patient Global Impression of Change (PGIC) measure has frequently been used as an indicator of meaningful change in treatments for chronic pain. However, limited research has examined the validity of PGIC items despite their wide adoption in clinical trials for pain. Additionally, research has not yet examined predictors of PGIC ratings following psychologically based treatment for pain. The purpose of the present study was to examine the validity, factor structure, and predictors of PGIC ratings following an interdisciplinary psychologically based treatment for chronic pain. Patients with chronic pain (N = 476) completed standard assessments of pain, daily functioning, and depression before and after a 4-week treatment program based on the principles of acceptance and commitment therapy. Following the program, patients rated 1 item assessing their impression of change overall and several items assessing their impression of more specific changes: physical and social functioning, work-related activities, mood, and pain. Results indicated that the global and specific impression of change items represent a single component. In the context of the acceptance and commitment therapy-based treatment studied here, overall PGIC ratings appeared to be influenced to a greater degree by patients' experienced improvements in physical activities and mood than by improvements in pain. The findings suggest that in addition to a single overall PGIC rating, domain-specific items may be relevant for some treatment trials. ⋯ This article reports on the validity and predictors of patients' impression of change ratings following interdisciplinary psychologically based treatment for pain. In addition to a single overall PGIC rating, domain-specific items may be important for clinicians and researchers to consider depending on the focus of treatment.
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Immediate-release (IR) hydrocodone/acetaminophen is the most prescribed opioid in the United States; however, patterns of use, including long-term treatment and dose, are not well described. Duration of use, including the percentage of patients on long-term treatment (>90 days of continuous use), was assessed for patients newly prescribed IR hydrocodone/acetaminophen compared to other opioid analgesics in a national commercial insurance database (January 2008-September 2013). Though only a small percentage of IR hydrocodone/acetaminophen patients continued treatment long-term (1.7%), the number was large (104,839) and was nearly 5 times the number receiving extended-release (ER) morphine (n = 22,338) and nearly 4 times the number receiving ER oxycodone (n = 26,946) long-term. Using a less conservative allowable gap in treatment increased the number of patients meeting the criteria for long-term use (approximately 160,000 for IR hydrocodone/acetaminophen vs <30,000 for ER morphine and ER oxycodone). Most patients meeting these criteria received IR hydrocodone doses between >20 and ≤60 mg/d (n = 56,220, 53.6%) in month 4; 5.5% (n = 5,743) received doses >60 mg/d. Moreover, approximately 15% of IR hydrocodone/acetaminophen patients (n > 900,000) were prescribed total daily acetaminophen doses exceeding 4 g (the limit recommended by the U.S. Food and Drug Administration) at their initial IR hydrocodone/acetaminophen prescription or any time during therapy. ⋯ Although most patients were prescribed IR hydrocodone/acetaminophen for acute pain, the number of patients prescribed long-term therapy exceeds the number of patients prescribed ER opioids. It is important to consider the benefits and risks inherent with long-term opioid therapy, whether with IR or ER opioids, to ensure safe use of these products.
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Black individuals have a lower tolerance for experimental pain than white individuals. Black and white individuals also differ in their use of pain coping strategies, which may explain the race differences in pain sensitivity. We examined the extent to which situation-specific pain coping mediated black-white differences in pain sensitivity. We hypothesized that 1) black participants would demonstrate lower pain tolerance than white participants, 2) black participants would use different pain coping strategies than white participants, and 3) the differential use of these strategies would mediate the relationship between race and pain tolerance. Healthy college undergraduates (N = 190) participated in a cold pressor task and then completed the Coping Strategies Questionnaire-Revised to assess their situation-specific pain coping. Compared with white participants, black participants demonstrated lower pain tolerance, engaged in more situation-specific catastrophizing and praying, and ignored pain less frequently. Catastrophizing and praying were inversely related to pain tolerance and were significant mediators of the relationship between race and pain tolerance. The indirect effect of praying was stronger than that of catastrophizing. Race differences in pain sensitivity may be due, in part, to differences in the use of catastrophizing and praying as coping strategies. These results may help guide treatments addressing maladaptive pain coping. ⋯ This study suggests that race differences in pain sensitivity may be due, in part, to the differential use of catastrophizing and praying strategies. Psychosocial treatments for pain should encourage patients to take an active role in their pain management.
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Measurement of inappropriate medication use events (eg, abuse or misuse) in clinical trials is important in characterizing a medication's abuse potential. However, no gold standard assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (ie, content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and nonopioid prescription medications to identify any that meet U.S. and European regulatory agencies' rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the life span rather than current use, including items that did not directly assess inappropriate use (eg, questions about anger), or failing to capture information pertinent to inappropriate use events (eg, intention and route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, nonstandardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. ⋯ This systematic review evaluates the measurement properties of inappropriate medication use (eg, abuse or misuse) instruments to determine whether any meet regulatory standards for clinical trial outcome measures to assess abuse potential.
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Studies indicate that improving sleep decreases reported pain in patients with knee osteoarthritis, but it is unclear if this association extends to experimentally induced pain responses. A community-based sample of 88 African American and 52 non-Hispanic white adults (45-76 years) with knee osteoarthritis completed the Insomnia Severity Index and the arousal subscale of the Sleep Hygiene and Practices Scale. Participants underwent quantitative sensory testing, including measures of pain sensitivity and facilitation at the knee, and pain inhibition. Outcomes were analyzed with multiple Tobit hierarchical regression models, with adjustment for relevant covariates. Ethnicity and sex by sleep interactions were also entered into the models. After covariate adjustment, main associations were not observed. However, sex interacted with insomnia severity to predict greater temporal summation of heat and punctate pressure pain among women and lower heat temporal summation among men. Men and women who engaged in frequent arousal-associated sleep behaviors demonstrated higher and lower heat temporal summation, respectively. Non-Hispanic whites with greater insomnia severity displayed lower pressure pain thresholds and pain inhibition. Our findings are the first to demonstrate that disrupted sleep is associated with altered pain processing differentially by sex and ethnicity/race among people with knee osteoarthritis. ⋯ This article presents the association between insomnia severity, maladaptive sleep behaviors, and experimentally induced pain responses among people with knee osteoarthritis. Disrupted sleep was associated with altered pain processing by sex and ethnicity/race. Offering sleep interventions may help ameliorate pain, but treatment may need to be tailored by sex and ethnicity/race.