Agreement between Patient-reported Pain Medication Use and Electronic Medical Record Data in Surgical Amputation Patients.

Background: Opioid misuse after surgery remains a public health crisis in the United States. Recent efforts have focused on tracking pain medication use in surgical populations. However, accurate interpretations of medication use remain quite challenging given inconsistent usage of different datasets. The purpose of this study was to investigate the agreement between electronic medical records (EMR) versus patient self-reported use of pain medications in a surgical amputation population. Methods: Patients undergoing major lower extremity amputation or amputation-related procedures were included in this study. Both self-reported and EMR data for pain medication intake were obtained for each patient at three time points (preoperatively, 4 months postoperatively, and 12 months postoperatively). Percentage agreement and the kappa statistic were calculated for both usage (yes/no) and dose categories. Results: Forty-five patients were included in this study, resulting in 108 pairs of self-reported and EMR datasets. Substantial levels of agreement (>70% agreement, kappa >0.61) for opioid use was seen at preoperative and 12 months postoperative. However, agreement dropped at 4 months postoperatively. Anticonvulsant medication showed high levels, whereas acetaminophen showed lower levels of agreements at all time points. Conclusions: Either self-reported or EMR data may be used in research and clinical settings for preoperative or 12-month postoperative patients with little concern for discrepancies. However, at time points immediately following the expected end of acute surgical pain, self-reported data may be needed for more accurate medication reporting. With these findings in mind, usage of datasets should be driven by study objectives and the dataset's strength (eg, accuracy, ease, lack of bias).

Ethical Perspectives of Chinese and United States Physicians at Initiation of a Research Collaborative.

Variances in perceived standards regarding research integrity appear to exist between China and the U.S. An established joint institute for translational and clinical research between one Chinese and one U.S. health system provides a valuable venue in which to evaluate these perceptions better. We therefore undertook a survey of 209 physicians at the two institutions in 2013-14. The vast majority of physicians from both institutions understood the necessity of obtaining informed consent from research participants, the need to provide a description of the risks of participation, and the voluntary nature of research participation. However, there were differences in responses between the two sites in willingness to report plagiarism (U.S. 95.65% vs. Chinese 40.21%; p < .0001) and data falsification (U.S. 100% vs. Chinese 81.25%; p < .0001) and in willingness to attend biomedical industry-funded promotional events (U.S. 11.0% vs. Chinese 74.0%; p < .0001). When planning to conduct collaborative clinical research across cultures, particularly when uncertainty regarding the similarity of research cultures exists, exploration of cultural and ethical norms in research may be informative regarding educational needs and the risks of research and academic misconduct.

The Effects of a Pain Psychology and Neuroscience Self-Evaluation Internet Intervention: A Randomized Controlled Trial.

OBJECTIVES: Many patients' chronic musculoskeletal pain is strongly influenced by central nervous system processes such as sensitization or amplification. Education about pain neuroscience can change patients' beliefs but has less consistent effects on pain outcomes. Patients may have greater clinical benefits if the educational intervention is personalized, and they evaluate various psychosocial risk factors with respect to their pain. We developed and tested a brief, internet-based Pain Psychology and Neuroscience (PPN) self-evaluation intervention. MATERIALS AND METHODS: From a patient registry, 104 adults reporting chronic musculoskeletal pain were randomized to the PPN intervention or a matched, active, education control condition. At baseline and 1-month (primary endpoint) and 10-month follow-ups, participants reported pain severity (primary outcome) and multiple secondary outcomes. Primary analyses compared the 2 experimental conditions using analyses of covariances; post hoc exploratory analyses compared the effects of PPN in subgroups of patients who met criteria for fibromyalgia (FM; n=50) or who did not (n=54; primarily spinal pain). RESULTS: At 1-month follow-up, compared with the control condition, PPN led to significantly lower pain severity (ηp =0.05) and interference (ηp =0.04), greater brain (ηp =0.07) and psychological (ηp =0.07) attributions for pain, and greater readiness for pain self-management (ηp =0.08). Effects on distress, pain catastrophizing, kinesiophobia, and life satisfaction were not significant. Exploratory analyses showed that the PPN intervention was especially beneficial for patients without FM but was of less benefit for those with FM. Most of the effects (except attributions) were lost at 10 months. DISCUSSION: A brief PPN self-evaluation intervention, presented on-line, can yield short-term improvements in musculoskeletal pain severity and interference, especially for people with spinal/localized pain rather than FM, perhaps because the psychology/neuroscience perspective is more novel for such patients.

Disclosing Study Information to Children and Adolescents: Is What They Want, What Their Parents Think They Want?

OBJECTIVE: Despite the importance of child assent, there is little consensus on what information should be disclosed and what information is most important to children for decision-making. This study was designed to compare children's/adolescents' priorities for research information with the information parents believe is most important to their children. METHODS: Child-parent dyads completed separate and independent surveys regarding information (risks, benefits, etc) that they perceived to be most important to the child to make decisions about participating in a hypothetical randomized controlled trial. Parents responded in the context of what information they believed their child (not themselves) would think important. RESULTS: Fifty-five parent-child dyads completed surveys. Although all information was deemed important, children/adolescents put greater emphasis on privacy and less on knowing the purpose of the study and the benefits compared with what their parents believed was important to their child. Adolescents (13-17 years old) placed greater importance on knowing the procedures, direct benefits, and the voluntary nature of participation compared with younger children (8-12 years old). Parents of older girls in particular placed greater emphasis on their daughter's need to know the purpose of the study, the procedures, benefits, and voluntary nature, compared with parents of boys. CONCLUSIONS: Results show that the information priorities of children/adolescents considering participation in a randomized controlled trial differ from that which their parents think is important to them. Pediatric researchers can use this knowledge to ensure that parents do not conflate their own expectations/priorities with those of their child and that children receive the information they need.

Development of a consensus operational definition of child assent for research.

BACKGROUND: There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research. METHODS: Based on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel. RESULTS: Consensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children. CONCLUSIONS: It is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children's developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

Brief time-based activity pacing instruction as a singular behavioral intervention was not effective in participants with symptomatic osteoarthritis.

Osteoarthritis (OA) of the lower extremities is a prevalent cause of disability in which symptoms interfere with mobility and activity participation. Behavioral self-management for OA symptomatology is commonly recommended; but these interventions are underutilized, unstandardized in application, and at times, unavailable in the context of clinical care. For people with chronic pain, rehabilitation professionals may select to apply activity pacing instruction as one behavioral strategy to manage symptoms. Activity pacing is widely used in combination with other pharmacological and behavioral interventions but has not been studied as a singular behavioral intervention for people with OA. The purpose of this study was to evaluate the effectiveness of an occupational therapist-delivered, time-based activity pacing program for treatment of pain, fatigue, and physical function in people with symptomatic knee or hip OA. A 3-arm randomized controlled trial was conducted in which 193 people were randomized into tailored activity pacing, general activity pacing, or usual care arms. Assessments were done at 10 weeks and 6 months after baseline. Using linear mixed models, Western Ontario and McMaster Universities Osteoarthritis Index pain scores changed over time, decreasing the most in the general and usual care groups; only the usual care group had decreased pain over 6 months. The tailored and general activity pacing groups reported higher frequency of pacing behaviors than the usual care group at 10 weeks, but pacing was not sustained at 6 months. This trial does not support the use of time-based pacing as a singular behavioral strategy for people with knee or hip OA.

Morphologic changes in the lumbar spine after lumbar medial branch radiofrequency neurotomy: a quantitative radiological study.

BACKGROUND CONTEXT: Medial branch radiofrequency neurotomy (RFN) is a common treatment for zygapophyseal joint pain. The lumbar medial branch innervates these joints and adjacent structures. The impact of the intended neurotomy on these structures remains unclear. No studies have yet verified quantitatively the effect of medial branch RFN on intervertebral discs, facet joints, and multifidus cross-sectional area. PURPOSE: The aim of this study was to determine, using objective radiographic measures, whether there is a quantitative difference in the lumbar multifidus muscle cross-sectional area, facet joint degeneration, or intervertebral disc degeneration after segmental medial branch RFN. STUDY DESIGN/SETTING: This is a retrospective single-cohort study performed at a university spine center. PATIENT SAMPLE: The patient sample consisted of 27 patients treated with lumbar medial branch RFN, with pre- and posttreatment magnetic resonance images available for analysis. OUTCOME MEASURE: The primary study outcome measure was interval change in fat-subtracted multifidus cross-sectional area, and intervertebral disc and zygapophyseal joint degeneration grade. METHODS: In this retrospective study, segmental levels unaffected by RFN treatment were used as controls to compare against levels affected by treatment. RESULTS: Levels affected by RFN demonstrated a significantly greater amount of disc degeneration compared with unaffected levels (14.9% vs. 4.6%; p=.0489). There was no statistical difference in the multifidus cross-sectional area or rates of deterioration in the zygapophyseal joints observed. CONCLUSIONS: The full impact of RFN on multifidus function, morphology, and segmental anatomy is unknown. This retrospective study indicates that measurable changes in segmental morphology may occur after lumbar medial branch RFN. These findings require validation in a prospective, controlled study.

History of abuse and its relationship to pain experience and depression in women with chronic pelvic pain.

OBJECTIVE: We sought to determine the relationship among a history of physical or sexual abuse, pain experience, and depressive symptoms among women with chronic pelvic pain (CPP). STUDY DESIGN: This was a cross-sectional study of women who presented to a tertiary referral center for evaluation of CPP (N = 273). All participants completed standardized questionnaires to assess a history of physical or sexual abuse, pain severity, pain disability, and depressive symptoms. Subjects were grouped by abuse category and compared to CPP participants without history of abuse. Multinomial logistic regression models were used to determine the association between adolescent or adult and childhood physical or sexual abuse with pain intensity, pain-related disability, and depressive symptoms. RESULTS: Logistic regression analyses indicated that, after controlling for age and education, none of the abuse categories was associated with pain severity. However, adolescent or adult sexual abuse predicted greater pain-related disability (odds ratio, 2.39; 95% confidence interval, 1.05-5.40), while both adolescent or adult physical and sexual abuse were associated with higher levels of depression (both P < .05). Level of education was significantly associated with pain intensity, pain disability, and depression. CONCLUSION: For our sample of women with CPP, a history of abuse during childhood or adulthood was not associated with differences in pain intensity, but adolescent or adult sexual abuse was associated with greater pain-related disability. A history of physical abuse or sexual abuse appears to hold a stronger relationship with current depressive symptoms than pain experience for women with CPP. Educational achievement holds a robust relationship with pain morbidity and depression for this population.

Duration of fluoroscopic-guided spine interventions and radiation exposure is increased in overweight patients.

BACKGROUND: The impact of patient body mass index (BMI) on image-guided spine interventions remains unknown. Higher BMI is known to complicate the acquisition of radiographic images. Therefore it can be hypothesized that the patient's body habitus can influence the delivery of a spinal injection. OBJECTIVE: To quantify the impact of patient BMI on the length of fluoroscopy and procedure times during spine interventions. DESIGN: Secondary analysis of 2 prospective observational studies. SETTING: All injections were performed in an outpatient university setting. PARTICIPANTS: A total of 209 patients in whom spine injections were performed (99 women), with a mean age of 54.6 years. METHODS: The fluoroscopy times for 202 participants and total procedure times for 137 participants were recorded. Additional participant characteristics, including age, gender, BMI, and actual procedures performed, also were collected. Analysis of covariance and linear and nonlinear model analysis were performed to assess the effect of BMI on fluoroscopy and procedure times. MAIN OUTCOME MEASUREMENTS: Fluoroscopy time and procedure duration times. RESULTS: Participants had a mean age of 54.6 years, 51% were men, and 77% (n = 155) were overweight (BMI ≥25). Participants received the following interventions: 40 zygapophyseal joint injections, 33 medial branch nerve blocks, 113 transforaminal epidural injections, and 16 combined zygapophyseal joint injections and epidural injections. Gender, procedure number, and procedure type did not differ between groups. The overweight group demonstrated a 30% increase in mean fluoroscopy time and a 35% increase in mean procedure time. Controlling for other variables, we found that differences in fluoroscopy time and procedure time were significant (P = .032 and P = .031, respectively) between the 2 groups. CONCLUSIONS: Significantly prolonged procedure time and fluoroscopy time in overweight patients increase the risks associated with spine interventions, not only to the patients but also to the operating room staff exposed to ionizing radiation.

The Association between Symptoms, Pain Coping Strategies, and Physical Activity Among People with Symptomatic Knee and Hip Osteoarthritis.

Effective use of coping strategies by people with chronic pain conditions is associated with better functioning and adjustment to chronic disease. Although the effects of coping on pain have been well studied, less is known about how specific coping strategies relate to actual physical activity patterns in daily life. The purpose of this study was to evaluate how different coping strategies relate to symptoms and physical activity patterns in a sample of adults with knee and hip osteoarthritis (OA; N = 44). Physical activity was assessed by wrist-worn accelerometry; coping strategy use was assessed by the Chronic Pain Coping Inventory. We hypothesized that the use of coping strategies that reflect approach behaviors (e.g., Task Persistence), would be associated with higher average levels of physical activity, whereas avoidance coping behaviors (e.g., Resting, Asking for Assistance, Guarding) and Pacing would be associated with lower average levels of physical activity. We also evaluated whether coping strategies moderated the association between momentary symptoms (pain and fatigue) and activity. We hypothesized that higher levels of approach coping would be associated with a weaker association between symptoms and activity compared to lower levels of this type of coping. Multilevel modeling was used to analyze the momentary association between coping and physical activity. We found that higher body mass index, fatigue, and the use of Guarding were significantly related to lower activity levels, whereas Asking for Assistance was significantly related to higher activity levels. Only Resting moderated the association between pain and activity. Guarding, Resting, Task Persistence, and Pacing moderated the association between fatigue and activity. This study provides an initial understanding of how people with OA cope with symptoms as they engage in daily life activities using ecological momentary assessment and objective physical activity measurement.

Interventional pain medicine: retreat from the biopsychosocial model of pain.

The field of pain medicine has shifted from multidisciplinary rehabilitation to procedure-focused interventional pain medicine (IPM). Considerable controversy exists regarding the efficacy of IPM and its more narrow focus on nociception as an exclusive target of pain treatment. This topical review aims to examine pain research and treatment outcome studies that support a biopsychosocial model of pain, and to critique the clinical practice of IPM given its departure from the premises of a biopsychosocial model. A modern definition of pain and findings from clinical and basic science studies indicate that pain-related psychological factors are integral to pain perception. The clinical viability of IPM is challenged based upon its biomedical view of peripheral nociception as a primary source of pain and the potential of this viewpoint to foster maladaptive pain attributions and discourage the use of pain coping strategies among chronic pain patients. IPM should adopt a biopsychosocial perspective on pain and operate within a framework of multidisciplinary pain rehabilitation to improve its effectiveness.

Factors contributing to physical activity in a chronic low back pain clinical sample: a comprehensive analysis using continuous ambulatory monitoring.

Back pain is one of the most common causes of disability in industrialized nations. Despite this, the variables that contribute to disability are not well understood and optimal measurement strategies of disability have not yet been determined. The present study sought to comprehensively assess the strongest predictors of physical activity as a proxy for disability. New patients in a chronic pain specialty clinic completed questionnaires to assess the predictors of physical activity and engaged in 5 days of home data collection wearing an accelerometer to assess physical activity in daily life, which is how disability was operationalized in this study. Analysis of repeated measures patient data revealed that, of 3 composite variables each representing a theoretical model, the model representative of operant factors significantly predicted physical activity. Subsequent analyses showed that pain sensitivity, fear avoidance, and solicitous spousal responses account for a significant amount of the variance in physical activity. These findings suggest that external sources of reinforcement or punishment may serve to influence physical behavior beyond that of internal cues such as fear avoidance or pain. Implications for treatment are discussed, including the potential benefits of specifically incorporating the patient's sources of operant reinforcement or punishment into treatment.

Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans.

BACKGROUND: Osteoarthritis (OA) is a prevalent chronic disease and a leading cause of disability in adults. For people with knee and hip OA, symptoms (e.g., pain and fatigue) can interfere with mobility and physical activity. Whereas symptom management is a cornerstone of treatment for knee and hip OA, limited evidence exists for behavioral interventions delivered by rehabilitation professionals within the context of clinical care that address how symptoms affect participation in daily activities. Activity pacing, a strategy in which people learn to preplan rest breaks to avoid symptom exacerbations, has been effective as part of multi-component interventions, but hasn't been tested as a stand-alone intervention in OA or as a tailored treatment using accelerometers. In a pilot study, we found that participants who underwent a tailored activity pacing intervention had reduced fatigue interference with daily activities. We are now conducting a full-scale trial. METHODS/DESIGN: This paper provides a description of our methods and rationale for a trial that evaluates a tailored activity pacing intervention led by occupational therapists for adults with knee and hip OA. The intervention uses a wrist accelerometer worn during the baseline home monitoring period to glean recent symptom and physical activity patterns and to tailor activity pacing instruction based on how symptoms relate to physical activity. At 10 weeks and 6 months post baseline, we will examine the effectiveness of a tailored activity pacing intervention on fatigue, pain, and physical function compared to general activity pacing and usual care groups. We will also evaluate the effect of tailored activity pacing on physical activity (PA). DISCUSSION: Managing OA symptoms during daily life activity performance can be challenging to people with knee and hip OA, yet few clinical interventions address this issue. The activity pacing intervention tested in this trial is designed to help people modulate their activity levels and reduce symptom flares caused by too much or too little activity. As a result of this trial, we will be able to determine if activity pacing is more effective than usual care, and among the intervention groups, if an individually tailored approach improves fatigue and pain more than a general activity pacing approach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01192516.

Ambulatory monitoring as a measure of disability in chronic low back pain populations.

PURPOSE: The link between chronic back pain and disability is well established. Despite this, the literature also reflects an inconsistency in methods of assessing disability, as studies interchangeably use self-report measures, clinical tests, and electronic monitoring. The purpose of this study was to conduct a multimethod comparison of disability measures to identify similarities and differences in the constructs measured by each. METHOD: Twenty chronic back pain patients participated in a clinic visit to complete questionnaires and clinical tests, followed by 5 days of wearing a wrist-worn electronic ambulatory monitoring device to measure activity. RESULTS: Multiple regression analyses were conducted to identify the significant predictors of each disability assessment. Results showed that operant variables were predictive of physical activity, cognitive-behavioral variables were predictive of perceived disability, and no variables were predictive of physical ability. DISCUSSION: The results indicate substantial differences in the types of variables that predict disability when measured through 3 different methods. This is suggestive of differences in the constructs measured by each type of disability assessment. The implications for researchers who assess predictors of disability and clinicians who use disability measures in their assessment of patients are that the measures of disability they select should be carefully matched to the proposed purposes. Strong theoretical and practical considerations support using electronic ambulatory monitoring in future research and clinical service.

A delphi study to establish important aspects of ethics review.

Little research has been done to examine the cost-effectiveness of REC review, or the components of review that make the greatest contributions to the protection of human subjects. We describe a process used to obtain consensus on the important categories and outcomes of REC review using the Delphi method and an array of stakeholders in a limited domain of research (biomedical). Study participants recruited from the University of Michigan Medical School's RECs, REC council, and principal investigators identified the following six categories as being the most important aspects of REC review: (1) A favorable risk/benefit ratio; (2) minimization of risk to subjects; (3) clarity of consent; (4) protection of vulnerable populations; (5) protection of privacy and confidentiality; and (6) review time. We believe that this kind of information can be used to assist in the development of a metric to assess the effectiveness and efficiency of REC review in the various research domains.

A pooled analysis of two randomized, double-blind, placebo-controlled trials of milnacipran monotherapy in the treatment of fibromyalgia.

Milnacipran has been shown to significantly improve the pain, global well-being, and physical function of fibromyalgia (FM), and is approved by the U.S. Food and Drug Administration for the management of this disorder. Post hoc analyses of data from two pivotal trials were conducted to further assess the clinical benefits of milnacipran, to determine the impact of baseline pain severity on treatment outcomes, and to confirm the safety and tolerability of this medication in patients with FM. Patients in these trials were randomized to placebo (n=624), milnacipran 100 mg/day (n=623), or milnacipran 200 mg/day (n=837). Two different composite responder analyses were used to evaluate efficacy: a 2-measure analysis, requiring ≥30% improvement from baseline visual analog scale 24-hour recall pain scores and a Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved"; and a 3-measure analysis, requiring a ≥6-point improvement from baseline in SF-36 Physical Component Summary scores in addition to the pain and PGIC criteria. Additionally, a pooled analysis of mean changes from baseline pain scores was conducted in order to evaluate the efficacy of milnacipran over the entire course of treatment. At 3 months, composite responder rates were significantly higher in the milnacipran treatment groups than in the placebo group (2- and 3-measure composite responder analyses: P ≤ 0.001, both doses vs. placebo). These improvements were not dependent on baseline pain severity. Similar composite responder results were observed in patients who continued treatment for up to 6 months. Significant improvements in mean pain scores were seen with both doses of milnacipran vs. placebo as early as 1 week after treatment initiation and were sustained for up to 6 months of milnacipran treatment. The most common adverse events associated with milnacipran were nausea, headache, and constipation.