Impact of an automated, remote monitoring and coaching intervention in reducing hospice cancer family caregiving burden: A multisite randomized controlled trial.

BACKGROUND: Care for those with life-limiting cancer heavily involves family caregivers who may experience significant physical and emotional burden. The purpose of this study was to test the impact of Symptom Care at Home (SCH), an automated digital family caregiver coaching intervention, during home hospice, when compared to usual hospice care (UC) on the primary outcome of overall caregiver burden. Secondary outcomes included Caregiver Burden at weeks 1 and 8, Mood and Vitality subscales, overall moderate-to-severe caregiving symptoms, and sixth month spouse/partner bereavement outcomes. METHODS: Using a randomized, multisite, nonblinded controlled trial, 332 cancer family caregivers were enrolled and analyzed (159 SCH vs. 173 UC). Caregivers were primarily White (92%), female (69%), and spouse caregivers (53%). Caregivers provided daily reports on severity levels (0-10 scale) for their anxiety, depressed mood, fatigue, disturbed sleep, and caregiving interference with normal activities. These scores combined constituted the Caregiver Burden primary outcome. Based on reported symptoms, SCH caregivers received automated, tailored coaching about improving their well-being. Reports of moderate-to-severe caregiving symptoms also triggered hospice nurse notification. Secondary outcomes of Mood and Vitality were subcomponents of the Caregiver Burden score. A combined bereavement adjustment tool captured sixth month bereavement. RESULTS: The SCH intervention reduced overall Caregiver Burden compared to UC (p < .001), with a 38% reduction at 8 weeks and a medium-to-large effect size (d = .61). SCH caregivers experienced less (p < .001) disruption in both Mood and Vitality. There were higher levels of moderate-to-severe caregiving symptoms overtime in UC (OR, 2.722). All SCH caregivers benefited regardless of caregiver: sex, caregiver relationship, age, patient diagnosis and family income. SCH spouse/partner caregivers achieved better sixth month bereavement adjustment than UC (p < .007). CONCLUSIONS: The SCH intervention significantly decreased caregiving burden over UC and supports the maintenance of family caregiver mood and vitality throughout caregiving with extended benefit into bereavement.

Descending Control of Nociception Poorly Predicts the Development of Persistent Postsurgical Pain-like Behavior in Consomic Dahl S Rat Strains.

BACKGROUND: Chronic postsurgical pain is a poorly recognized outcome of surgery where patients experience pain long after healing from the surgical insult. Descending control of nociception, a phenomenon whereby application of a strong nociceptive stimulus to one part of the body of animals inhibits pain in remote body regions, offers one strategy to identify a propensity to develop chronic postsurgical pain-like behavior. Here, consomic rat panel was used to test the hypothesis that pain persistence is mechanistically linked to ineffective descending control of nociception. METHODS: Male and female Brown Norway, Dahl S, and eight consomic strains (SS-xBN) were used to determine the presence of chronic postsurgical pain-like behaviors by using paw-withdrawal threshold evaluation (von Frey method) in the area adjacent to a hind paw plantar incision. Descending control of nociception was assessed by measuring hind paw-withdrawal thresholds (Randall-Selitto method) after capsaicin (125 µg) injection into a forepaw. Consomic rats were developed by introgressing individual Brown Norway chromosomes on the Dahl S rat genetic background, as Dahl S rats lack preoperative descending control of nociception. RESULTS: Substitution of several chromosomes from the "pain-resistant" Brown Norway to the "pain-prone" Dahl S/Medical College of Wisconsin reduced mechanical nociceptive sensitivity and increased endogenous pain modulation capacity by differing degrees. Statistical modeling of these data revealed that descending control of nociception is a poor general predictor of the propensity to develop chronic postsurgical pain-like behavior (poor fit for model 1). However, a significant strain-by-descending control of nociception interaction was revealed (model 3, -2*log likelihood; 550.668, -2ll change; 18.093, P = 0.034) with SS-13BN and SS-15BN strains showing a negative descending control of nociception relationship with chronic postsurgical pain-like behavior. CONCLUSIONS: Descending control of nociception poorly predicted which rat strains developed chronic postsurgical pain-like behavior despite controlling for genetic, environmental, and sex differences. Two consomic strains that mimic clinical chronic postsurgical pain criteria and display a strong negative correlation with descending control of nociception were identified, offering novel candidates for future experiments exploring mechanisms that lead to chronic postsurgical pain.

Patient-reported outcomes for patients with metastatic castration-resistant prostate cancer receiving docetaxel and Atrasentan versus docetaxel and placebo in a randomized phase III clinical trial (SWOG S0421).

Background: SWOG S0421 was a large randomized trial comparing docetaxel/prednisone plus placebo (DPP) to docetaxel/prednisone plus atrasentan over 12 cycles for patients with metastatic castration-resistant prostate cancer (mCRPC). The current report presents the PRO results for this trial, an important secondary endpoint. Methods: The trial specified two primary PRO endpoints. Palliation of worst pain was based on the Brief Pain Inventory (BPI), where a 2 point difference is defined as clinically meaningful. Improvement of functional status was based on the Functional Assessment of Cancer Therapy - Prostate Cancer Trial Outcome Index (FACT-P TOI); a 5-point difference has been defined as clinically meaningful. We compared rates by arm using chi-square tests. Longitudinal analyses using linear mixed models addressed changes by arm over time. Results: Four-hundred eighty-nine patients on each arm were evaluable for PRO endpoint data. There were no differences by arm in clinically meaningful pain palliation (41.7% for DPP vs. 44.0% for DPA, p = .70) or functional status (24.2% for DPP vs. 28.7% for DPA, p = .13). Longitudinal comparisons indicated no differences over time by arm for BPI Worst Pain scores (0.13 points, p = .23). Patients on the DPA arm had improved functional status of 1.78 points on average, a statistically significant (p = .02) but not clinically meaningful difference. Conclusions: The SWOG S0421 PRO data showed little evidence of clinically meaningful differences by arm in either pain palliation or functional status.

The challenge of measuring intra-individual change in fatigue during cancer treatment.

PURPOSE: To evaluate how well three different patient-reported outcomes (PROs) measure individual change. METHODS: Two hundred and fourteen patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT Fatigue scale, a 7-item PROMIS® Fatigue Short Form (PROMIS 7a), and the PROMIS® Fatigue computer adaptive test (CAT) were administered monthly online for 6 months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate of change to the estimated total variance of measured individual differences in rate of change. Precision of individual measured change, the standard error of measurement of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months. RESULTS: A linear model for measured change showed the following by 6 and 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change. CONCLUSIONS: These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.

Caregiver, patient, and nurse visit communication patterns in cancer home hospice.

OBJECTIVE: Few studies have examined the triadic communication between patients, spouse caregivers, and nurses in the home hospice setting. Thus, little is known about the types of communication patterns that unfold. The goals of the study were to, first, identify common patterns of communication in nurse-patient-caregiver home hospice visits and, second, to identify nurse, caregiver-patient dyad, and visit characteristics that predict visit communication patterns. METHOD: Nurses (N = 58) and hospice cancer patient and spouse caregiver dyads (N = 101; 202 individuals) were recruited from 10 hospice agencies. Nurses audio recorded visits to patient/caregiver homes from study enrollment until patient death. All patient, caregiver, and nurse utterances from the audio recordings were coded using an adapted Roter interaction analysis system. Using identified codes, cluster analysis was conducted to identify communication patterns within hospice visits. Logistic regression was used with demographic variables to predict visit communication patterns. RESULTS: Six visit communication patterns were identified and were defined largely by 2 dimensions: (1) either the patient, the caregiver, or the patient and caregiver dyad interacting with the nurse and (2) the relatively high or low expression of distress during the visit. Time until death significantly predicted several clusters. CONCLUSION: This study leads the way in outlining triadic communication patterns in cancer home hospice visits. Our findings have implications for nursing education, letting future nurses know what to expect, and lays the foundation for future research to determine effectiveness and interventions to improve health care communication.

Breast Cancer Risk Perceptions among Relatives of Women with Uninformative Negative BRCA1/2 Test Results: The Moderating Effect of the Amount of Shared Information.

The most common result of BRCA1/2 mutation testing when performed in a family without a previously identified mutation is an uninformative negative test result. Women in these families may have an increased risk for breast cancer because of mutations in non-BRCA breast cancer predisposition genes, including moderate- or low-risk genes, or shared environmental factors. Genetic counselors often encourage counselees to share information with family members, however it is unclear how much information counselees share and the impact that shared information may have on accuracy of risk perception in family members. We evaluated 85 sisters and daughters of women who received uninformative negative BRCA1/2 results. We measured accuracy of risk perception using a latent variable model where accuracy was represented as the correlation between perceived risk (indicators = verbal and quantitative measures) and calculated risk (indicators = Claus and BRCAPRO). Participants who reported more information was shared with them by their sister or mother about her genetic counseling session had greater accuracy of risk perception (0.707, p = 0.000) than those who reported little information was shared (0.326, p = 0.003). However, counselees shared very little information; nearly 20 % of family members reported their sister or mother shared nothing with them about her genetic counseling. Family members were generally not aware of the existence of a genetic counseling summary letter. Our findings underscore the need for effective strategies that facilitate counselees to share information about their genetic counseling sessions. Such communication may help their relatives better understand their cancer risks and enhance risk appropriate cancer prevention.

Gene Expression Factor Analysis to Differentiate Pathways Linked to Fibromyalgia, Chronic Fatigue Syndrome, and Depression in a Diverse Patient Sample.

OBJECTIVE: To determine if independent candidate genes can be grouped into meaningful biologic factors, and whether these factors are associated with the diagnosis of chronic fatigue syndrome (CFS) and fibromyalgia syndrome (FMS), while controlling for comorbid depression, sex, and age. METHODS: We included leukocyte messenger RNA gene expression from a total of 261 individuals, including healthy controls (n = 61), patients with FMS only (n = 15), with CFS only (n = 33), with comorbid CFS and FMS (n = 79), and with medication-resistant (n = 42) or medication-responsive (n = 31) depression. We used exploratory factor analysis (EFA) on 34 candidate genes to determine factor scores and regression analysis to examine whether these factors were associated with specific diagnoses. RESULTS: EFA resulted in 4 independent factors with minimal overlap of genes between factors, explaining 51% of the variance. We labeled these factors by function as 1) purinergic and cellular modulators, 2) neuronal growth and immune function, 3) nociception and stress mediators, and 4) energy and mitochondrial function. Regression analysis predicting these biologic factors using FMS, CFS, depression severity, age, and sex revealed that greater expression in factors 1 and 3 was positively associated with CFS and negatively associated with depression severity (Quick Inventory for Depression Symptomatology score), but not associated with FMS. CONCLUSION: Expression of candidate genes can be grouped into meaningful clusters, and CFS and depression are associated with the same 2 clusters, but in opposite directions, when controlling for comorbid FMS. Given high comorbid disease and interrelationships between biomarkers, EFA may help determine patient subgroups in this population based on gene expression.

An Exploratory Study of the Effects of Mind-Body Interventions Targeting Sleep on Salivary Oxytocin Levels in Cancer Survivors.

Cancer survivors experience high levels of distress, associated with a host of negative psychological states, including anxiety, depression, and fear of recurrence, which often lead to sleep problems and reduction in quality of life (QOL) and well-being. As a neuropeptide hormone associated with affiliation, calmness, and well-being, oxytocin may be a useful biological measure of changes in health outcomes in cancer survivors. In this exploratory study, which comprised a subset of participants from a larger study, we evaluated (a) the feasibility and reliability of salivary oxytocin (sOT) levels in cancer survivors and (b) the effects of 2 sleep-focused mind-body interventions, mind-body bridging (MBB) and mindfulness meditation (MM), compared with a sleep hygiene education (SHE) control, on changes in sOT levels in 30 cancer survivors with self-reported sleep disturbance. Interventions were conducted in 3 sessions, once per week for 3 weeks. Saliva samples were collected at baseline, postintervention (~1 week after the last session), and at the 2-month follow-up. In this cancer survivor group, we found that intra-individual sOT levels were fairly stable across the 3 time points, of about 3 months' duration, and mean baseline sOT levels did not differ between females and males and were not correlated with age. Correlations between baseline sOT and self-report measures were weak; however, several of these relationships were in the predicted direction, in which sOT levels were negatively associated with sleep problems and depression and positively associated with cancer-related QOL and well-being. Regarding intervention effects on sOT, baseline-subtracted sOT levels were significantly larger at postintervention in the MBB group as compared with those in SHE. In this sample of cancer survivors assessed for sOT, at postintervention, greater reductions in sleep problems were noted for MBB and MM compared with that of SHE, and increases in mindfulness and self-compassion were observed in the MBB group compared with those in SHE. The findings in this exploratory study suggest that sOT may be a reliable biological measure over time that may provide insight into the effects of mind-body interventions on health outcomes in cancer survivors.

Reduction in salivary α-amylase levels following a mind-body intervention in cancer survivors--an exploratory study.

OBJECTIVE: The main aim of this exploratory study was to assess whether salivary α-amylase (sAA) and salivary cortisol levels would be positively modulated by sleep-focused mind-body interventions in female and male cancer survivors. METHODS: We conducted a randomized controlled trial in which 57 cancer survivors with self-reported sleep disturbance received either a Sleep Hygiene Education (SHE; n=18) control, or one of two experimental mind-body interventions, namely, Mind-Body Bridging (MBB; n=19) or Mindfulness Meditation (MM; n=20). Interventions were three sessions each conducted once per week for three consecutive weeks. Saliva cortisol and sAA were measured at baseline and 1 week after the last session. Participants also completed a sleep scale at the same time points when saliva was collected for biomarker measurement. RESULTS: Our study revealed that at post-intervention assessment, mean sAA levels upon awakening ("Waking" sample) declined in MBB compared with that of SHE. Mean Waking cortisol levels did not differ among treatment groups but declined slightly in SHE. Self-reported sleep improved across the three interventions at Post-assessment, with largest improvements in the MBB intervention. CONCLUSION: In this exploratory study, sleep focused mind-body intervention (MBB) attenuated Waking sAA levels, suggesting positive influences of a mind-body intervention on sympathetic activity in cancer survivors with sleep disturbance.

Investigating efficacy of two brief mind-body intervention programs for managing sleep disturbance in cancer survivors: a pilot randomized controlled trial.

PURPOSE: After completing treatment, cancer survivors may suffer from a multitude of physical and mental health impairments, resulting in compromised quality of life. This exploratory study investigated whether two mind-body interventions, i.e., Mind-Body Bridging (MBB) and Mindfulness Meditation (MM), could improve posttreatment cancer survivors' self-reported sleep disturbance and comorbid symptoms, as compared to sleep hygiene education (SHE) as an active control. METHODS: This randomized controlled trial examined 57 cancer survivors with clinically significant self-reported sleep disturbance, randomly assigned to receive MBB, MM, or SHE. All interventions were conducted in three sessions, once per week. Patient-reported outcomes were assessed via the Medical Outcomes Study Sleep Scale and other indicators of psychosocial functioning relevant to quality of life, stress, depression, mindfulness, self-compassion, and well-being. RESULTS: Mixed effects model analysis revealed that mean sleep disturbance symptoms in the MBB (p = .0029) and MM (p = .0499) groups were lower than in the SHE group, indicating that both mind-body interventions improved sleep. In addition, compared with the SHE group, the MBB group showed reductions in self-reported depression symptoms (p = .040) and improvements in overall levels of mindfulness (p = .018), self-compassion (p = .028), and well-being (p = .019) at postintervention. CONCLUSIONS: This study provides preliminary evidence that brief sleep-focused MBB and MM are promising interventions for sleep disturbance in cancer survivors. Integrating MBB or MM into posttreatment supportive plans should enhance care of cancer survivors with sleep disturbance. Because MBB produced additional secondary benefits, MBB may serve as a promising multipurpose intervention for posttreatment cancer survivors suffering from sleep disturbance and other comorbid symptoms. IMPLICATIONS FOR CANCER SURVIVORS: Two brief sleep-focused mind-body interventions investigated in the study were effective in reducing sleep disturbance and one of them further improved other psychosocial aspects of the cancer survivors' life. Management of sleep problems in survivors is a high priority issue that demands more attention in cancer survivorship.

Confirmatory factor analysis of the pain care quality surveys (PainCQ©).

OBJECTIVE: To examine the reliability and validity and to decrease the battery of items in the Pain Care Quality (PainCQ(©) ) Surveys. DATA SOURCES/STUDY SETTING: Patient-reported data were collected prospectively from 337 hospitalized adult patients with pain on medical/surgical oncology units in four hospitals in three states. STUDY DESIGN: This methodological study used a cross-sectional survey design. Each consenting patient completed two PainCQ(©) Surveys, the Brief Pain Inventory-Short Form, and demographic questions. Clinical data were extracted from the medical record. DATA COLLECTION/EXTRACTION METHODS: All data were double entered into a Microsoft Access database, cleaned, and then extracted into SPSS, AMOS, and Mplus for analysis. PRINCIPAL FINDINGS: Confirmatory factor analysis using Structural Equation Modeling supported the initial factor structure. Modification indices guided decisions that resulted in a superior, parsimonious model for the PainCQ-Interdisciplinary Care Survey (six items, two subscales) and the PainCQ-Nursing Care Survey (14 items, three subscales). Cronbach's alpha coefficients all exceeded .80. CONCLUSIONS: Cumulative evidence supports the reliability and validity of the companion PainCQ(©) Surveys in hospitalized patients with pain in the oncology setting. The tools may be relevant in both clinical research and quality improvement. Future research is recommended in other populations, settings, and with more diverse groups.

Pain uncertainty in patients with fibromyalgia, yoga practitioners, and healthy volunteers.

BACKGROUND: Uncertainty about potentially painful events affects how pain is experienced. Individuals with fibromyalgia (FM) often exhibit anxiety and catastrophic thoughts regarding pain and difficulties dealing with pain uncertainty. OBJECTIVES: The effects of pain uncertainty in predictably high odds (HO), predictably low odds (LO), and even odds (EO) conditions on subjective ratings of pain (PR) and skin conductance responses (SCR) following the administration of a painful stimulus were examined for individuals with fibromyalgia (IWFM), healthy volunteers (HVs), and yoga practitioners (YPs). We hypothesized IWFM would demonstrate the greatest physiological reactivity to pain uncertainty, followed by HVs and YPs, respectively. METHODS: Nine IWFM, 7 YPs, and 10 HVs participated. RESULTS: Custom contrast estimates comparing responses for HO, LO, and EO pain conditions showed higher SCR for IWFM (CE = 1.27, p = 0.01) but not for HVs or for YPs. PR for the EO condition were significantly greater than for HO and LO conditions for IWFM (CE = 0.60, p = 0.012) but not for HVs or YPs. YPs had lower SCR and PR than did HVs. CONCLUSIONS: Results show that uncertainty regarding pain increases the experience of pain, whereas certainty regarding pain may reduce pain ratings for individuals with fibromyalgia.

Health-related quality-of-life findings for the prostate cancer prevention trial.

BACKGROUND: The Prostate Cancer Prevention Trial (PCPT)-a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate cancer-offered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial. METHODS: We assessed three health-related quality-of-life domains (measured with the Health Survey Short Form-36: Physical Functioning, Mental Health, and Vitality scales) via questionnaires completed by PCPT participants at enrollment (3 months before randomization), at 6 months after randomization, and annually for 7 years. Covariate data obtained at enrollment from patient-completed questionnaires were included in our model. Mixed-effects model analyses and a cross-sectional presentation at three time points began at 6 months after randomization. All statistical tests were two-sided. RESULTS: For the physical function outcome (n = 16 077), neither the finasteride main effect nor the finasteride interaction with time were statistically significant. The effects of finasteride on physical function were minor and accounted for less than a 1-point difference over time in Physical Functioning scores (mixed-effect estimate = 0.07, 95% confidence interval [CI] = -0.28 to 0.42, P = .71). Comorbidities such as congestive heart failure (estimate = -5.64, 95% CI = -7.96 to -3.32, P < .001), leg pain (estimate = -2.57, 95% CI = -3.04 to -2.10, P < .001), and diabetes (estimate = -1.31, 95% CI = -2.04 to -0.57, P < .001) had statistically significant negative effects on physical function, as did current smoking (estimate = -2.34, 95% CI = -2.97 to -1.71, P < .001) and time on study (estimate = -1.20, 95% CI = -1.36 to -1.03, P < .001). Finasteride did not have a statistically significant effect on the other two dependent variables, mental health and vitality, either in the mixed-effects analyses or in the cross-sectional analysis at any of the three time points. CONCLUSION: Finasteride did not negatively affect SF-36 Physical Functioning, Mental Health, or Vitality scores.

Postoperative pain trajectories in cardiac surgery patients.

Poorly controlled postoperative pain is a longstanding and costly problem in medicine. The purposes of this study were to characterize the acute pain trajectories over the first four postoperative days in 83 cardiac surgery patients with a mixed effects model of linear growth to determine whether statistically significant individual differences exist in these pain trajectories, and to compare the quality of measurement by trajectory with conventional pain measurement practices. The data conformed to a linear model that provided slope (rate of change) as a basis for comparing patients. Slopes varied significantly across patients, indicating that the direction and rate of change in pain during the first four days of recovery from surgery differed systematically across individuals. Of the 83 patients, 24 had decreasing pain after surgery, 24 had increasing pain, and the remaining 35 had approximately constant levels of pain over the four postoperative days.

Evaluating health-related quality-of-life therapeutic effectiveness in a clinical trial with extensive nonignorable missing data and heterogeneous response: results from a phase III randomized trial of gemcitabine plus paclitaxel versus paclitaxel monotherapy in patients with metastatic breast cancer.

PURPOSE: This manuscript presents health-related quality of life (HRQL) results from a phase III trial of gemcitabine-paclitaxel (GT) versus paclitaxel (T) in metastatic breast cancer patients. METHODS: Patients completed the Rotterdam Symptom Checklist (RSCL) and Brief Pain Inventory (BPI) at baseline and at the end of each cycle. Sensitivity analyses for six longitudinal pattern mixture models (PMMs) assessed potential bias due to informative dropout. Cumulative probability plots with 50% confidence intervals indicated the proportion of patients whose HRQL was likely to improve, decline, or stay the same. RESULTS: Sensitivity analyses addressing nonignorable missing RSCL data included 351 patients. The mean RSCL global HRQL score for GT was significantly and consistently better than that for T (all PMMs P < 0.040). The slope estimate of 1.5 points (100-point scale) per cycle from one PMM translated to a clinically significant 9-point improvement over six cycles with GT versus T. For GT, ~25% of patients were more likely than not to have improved HRQL, whereas that proportion for T was ~5%. PMMs showed no consistent treatment arm differences for BPI or other RSCL outcomes. CONCLUSIONS: Adding gemcitabine to paclitaxel for the treatment of metastatic breast cancer is more likely to improve global HRQL over time compared to monotherapy treatment.

Postoperative pain trajectories in chronic pain patients undergoing surgery: the effects of chronic opioid pharmacotherapy on acute pain.

UNLABELLED: For 2 weeks following surgery, 55 patients with preexisting chronic pain (CP) reported daily postoperative pain with movement and at rest. Of these, 30 CP patients used opioid pharmacotherapy for CP management and 25 did not. We modeled pain resolution in each patient using a linear fit so that each patient yielded 2 scores for each pain rating: 1) an intercept, or initial level of pain, immediately after surgery; and 2) a slope, or rate of pain resolution. The patients not using opioid pharmacotherapy had a mean pain with movement intercept of 5.4 and a slope of -.20, while the patients using opioid pharmacotherapy had a significantly higher mean intercept of 7.68 (P = .001) and a slope of -.21, sustaining higher pain levels over days. The opioid pharmacotherapy patients had the same rate of pain resolution as the other CP patients, and both groups resolved their pain more slowly than normal surgery patients. Preexisting CP may predispose a patient undergoing surgery to a slower rate of postoperative pain resolution. Chronic pain patients who use opioids share this predisposition but in addition, they are at risk for markedly higher postoperative pain across the entire pain resolution trajectory. PERSPECTIVE: This is an observational rather than a randomized controlled study, and as such is less definitive. Nonetheless, these findings are consistent with those of animal studies showing that prolonged exposure to opioids can produce opioid-induced hyperalgesia. Patients with opioid pharmacotherapy for chronic pain who undergo surgery merit special attention for acute pain management.

Improving individual measurement of postoperative pain: the pain trajectory.

UNLABELLED: The purpose of this study was to demonstrate a method for increasing the precision and information yield of postoperative pain assessment. We recorded pain intensity ratings over 6 days after surgery in 502 elective surgery patients and examined individual pain trajectories. A linear fit of an individual patient's scores defines a trajectory with two features: (1) the intercept or initial pain intensity; and (2) the slope, or rate of pain resolution. Three pain trajectory patterns emerged from examination of the pain trajectory slopes. Most patients (63% of the sample) demonstrated a negative slope trajectory characterized by a decline in pain intensity over days after surgery. Other patients (25% of the sample) demonstrated a flat trajectory with no meaningful change over 6 days from pain they reported initially. A third patient group (12% of the sample) had a positive slope trajectory in which pain scores increased over 6 days after surgery. Measures derived from individual pain trajectories yielded much lower standard errors of measurement and therefore had better measurement precision than did conventional pain assessment methods. Pain trajectory measures proved sufficiently precise to characterize pain patterns reliably in individual patients. PERSPECTIVE: Progress in acute pain management requires effective pain assessment. The acute pain trajectory quantifies rate of pain resolution as well as pain intensity. It affords more precise measurement than conventional pain assessment and can identify abnormal postoperative pain resolution.

Sequential analyses of daily symptoms in women with fibromyalgia syndrome.

UNLABELLED: Fibromyalgia syndrome (FMS) is a chronic musculoskeletal pain disorder characterized by generalized pain, chronic fatigue, sleep disturbance, and a range of other symptoms having no definitive pathology. Consequently, patient evaluations rely on self-report. Ecological Momentary Assessment (EMA) allows frequent real-time collection of self-report measures, removing recall bias and increasing external validity. We studied 81 females with FMS aged 18 to 42 years. Participants carried EMA devices (Palm Pilot M100) programmed to request ratings to 8 FMS symptoms/conditions 3 times daily for 30 days. Completeness of response rates varied across participants and over time. Controlling for immediately previous fatigue (ie, fatigue rating from the immediately preceding rating), unit increases in immediately previous pain and immediately previous emotional distress predicted 9 and 7% increases, respectively, in current fatigue. Controlling for immediately previous emotional distress, a unit increase in immediately previous pain predicted 7% increase in current emotional distress. Controlled for immediately previous pain, a unit increase in immediately previous fatigue predicted a 7% increase in current pain, enhanced by prior diurnal effects; immediately previous emotional distress was not significant. Collectively these results suggest an asymmetry in which emotional stress and pain may increase fatigue, fatigue but not emotional distress may increase pain, and pain but not fatigue may increase emotional distress. Despite small effects and person-to-person variability, these findings suggest that longitudinal data collection by EMA may reveal sequential or causal explanatory patterns with important clinical implications. PERSPECTIVE: Understanding how multiple symptoms covary in FMS is essential for optimal treatment planning. Our results show small but significant temporal relations among pain, fatigue, and emotional distress. Our results also provide support for the use of EMA as a viable data collection method that allows longitudinal, real-time assessment of multiple FMS symptoms.

Relationship between fibromyalgia and obesity in pain, function, mood, and sleep.

UNLABELLED: Fibromyalgia syndrome (FMS) is a prevalent and disabling chronic pain disorder. Past research suggests that obesity is a common comorbidity and may be related to the severity of FMS. The main objective of the present study was to evaluate the relationships between FMS and obesity in the multiple FMS-related domains: hyperalgesia, symptoms, physical abilities, and sleep. A total of 215 FMS patients completed a set of self-report inventories to assess FMS-related symptoms and underwent the tender point (TP) examination, physical performance testing, and 7-day home sleep assessment. Forty-seven percent of our sample was obese and an additional 30% was overweight. Obesity was related significantly to greater pain sensitivity to TP palpation particularly in the lower body areas, reduced physical strength and lower-body flexibility, shorter sleep duration, and greater restlessness during sleep. The results confirmed that obesity is a prevalent comorbidity of FMS that may contribute to the severity of the problem. Potential mechanisms underlying the relationship are discussed. PERSPECTIVE: This report presents how obesity may be interrelated to fibromyalgia pain, disability, and sleep. We found that obesity is common in FMS. Approximately half of our patients were obese and an additional 30% were overweight. We also found that obesity in FMS was associated with greater pain sensitivity, poorer sleep quality, and reduced physical strength and flexibility. The results suggest that obesity may aggregate FMS and weight management may need to be incorporated into treatments.