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BackgroundNeuropsychopharmacologic effects of long-term opioid therapy (LTOT) in the context of chronic pain may result in subjective anhedonia coupled with decreased attention to natural rewards. Yet, there are no known efficacious treatments for anhedonia and reward deficits associated with chronic opioid use. Mindfulness-Oriented Recovery Enhancement (MORE), a novel behavioral intervention combining training in mindfulness with savoring of natural rewards, may hold promise for treating anhedonia in LTOT.MethodsVeterans receiving LTOT (N = 63) for chronic pain were randomized to 8 weeks of MORE or a supportive group (SG) psychotherapy control. Before and after the 8-week treatment groups, we assessed the effects of MORE on the late positive potential (LPP) of the electroencephalogram and skin conductance level (SCL) during viewing and up-regulating responses (i.e. savoring) to natural reward cues. We then examined whether these neurophysiological effects were associated with reductions in subjective anhedonia by 4-month follow-up.ResultsPatients treated with MORE demonstrated significantly increased LPP and SCL to natural reward cues and greater decreases in subjective anhedonia relative to those in the SG. The effect of MORE on reducing anhedonia was statistically mediated by increases in LPP response during savoring.ConclusionsMORE enhances motivated attention to natural reward cues among chronic pain patients on LTOT, as evidenced by increased electrocortical and sympathetic nervous system responses. Given neurophysiological evidence of clinical target engagement, MORE may be an efficacious treatment for anhedonia among chronic opioid users, people with chronic pain, and those at risk for opioid use disorder.

Successful treatment of opioid misuse among people with chronic pain has proven elusive. Guidelines recommend nonopioid therapies, but the efficacy of mindfulness-based interventions for opioid misuse is uncertain.To evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) for the reduction of opioid misuse and chronic pain.This interviewer-blinded randomized clinical trial enrolled patients from primary care clinics in Utah between January 4, 2016, and January 16, 2020. The study included 250 adults with chronic pain receiving long-term opioid therapy who were misusing opioid medications.Treatment with MORE (comprising training in mindfulness, reappraisal, and savoring positive experiences) or supportive group psychotherapy (control condition) across 8 weekly 2-hour group sessions.Primary outcomes were (1) opioid misuse assessed by the Drug Misuse Index (self-report, interview, and urine screen) and (2) pain severity and pain-related functional interference, assessed by subscale scores on the Brief Pain Inventory through 9 months of follow-up. Secondary outcomes were opioid dose, emotional distress, and ecological momentary assessments of opioid craving. The minimum intervention dose was defined as 4 or more completed sessions of MORE or supportive group psychotherapy.Among 250 participants (159 women [63.6%]; mean [SD] age, 51.8 [11.9] years), 129 were randomized to the MORE group and 121 to the supportive psychotherapy group. Overall, 17 participants (6.8%) were Hispanic or Latino, 218 (87.2%) were White, and 15 (6.0%) were of other races and/or ethnicities (2 American Indian, 3 Asian, 1 Black, 2 Pacific Islander, and 7 did not specify). At baseline, the mean duration of pain was 14.7 years (range, 1-60 years), and the mean (SD) morphine-equivalent opioid dose was 101.0 (266.3) mg (IQR, 16.0-90.0 mg). A total of 203 participants (81.2%) received the minimum intervention dose (mean [SD], 5.7 [2.2] sessions); at 9 months, 92 of 250 participants (36.8%) discontinued the study. The overall odds ratio for reduction in opioid misuse through the 9-month follow-up period in the MORE group compared with the supportive psychotherapy group was 2.06 (95% CI, 1.17-3.61; P = .01). At 9 months, 36 of 80 participants (45.0%) in the MORE group were no longer misusing opioids compared with 19 of 78 participants (24.4%) in the supportive psychotherapy group. Mixed models demonstrated that MORE was superior to supportive psychotherapy through 9 months of follow-up for pain severity (between-group effect: 0.49; 95% CI, 0.17-0.81; P = .003) and pain-related functional interference (between-group effect: 1.07; 95% CI, 0.64-1.50; P .001). Participants in the MORE group reduced their opioid dose to a greater extent than those in the supportive psychotherapy group. The MORE group also had lower emotional distress and opioid craving.In this randomized clinical trial, among adult participants in a primary care setting, the MORE intervention led to sustained improvements in opioid misuse and chronic pain symptoms and reductions in opioid dosing, emotional distress, and opioid craving compared with supportive group psychotherapy. Despite attrition caused by the COVID-19 pandemic and the vulnerability of the sample, MORE appeared to be efficacious for reducing opioid misuse among adults with chronic pain.ClinicalTrials.gov Identifier: NCT02602535.

Aim: We conducted a preliminary evaluation of a newly developed, time-based visual time analog (VITA) scale for measuring pain in chronic pain patients. Materials & methods: 40 patients with chronic back pain rated their pain over four visits using numerical (pain) rating scale (NRS) and VITA assessing pain intensity by distributing the amount of time spent on ‘not aware of pain’ (blue), ‘aware of nothing but pain’ (red) and time in between (yellow). Results: The NRS scores were correlated with the VITA Red but not with VITA Blue. The psychometric analyses revealed that VITA achieved greater reliability and sensitivity than did NRS. Conclusion: The results provide preliminary support for VITA scale for assessing pain intensity in patients with chronic pain.

Background: A subset of chronic pain patients misuse prescription opioids as a means of regulating negative emotions. However, opioid misuse may result in deficits in emotion regulation strategies ...

OBJECTIVE: First, to describe communication of home hospice nurse visits to cancer patient-caregiver dyads. Second, to assess change in communication related to domains of care over the course of visits. METHODS: Multi-site prospective observational longitudinal study of audio-recorded home hospice visits (N = 537 visits; 101 patient-caregiver dyads; 58 nurses). Communication was coded using the Roter Interaction Analysis System to describe content and process. Conversation representing three care domains (physical, psychosocial/daily life, and emotional) was calculated from RIAS categories across speakers and analyzed to assess change in communication over time. RESULTS: On average, nurses spoke 54% of total utterances, caregivers 29%, and patients 17%. For all participants, the predominant conversational focus was on physical care. Linear mixed effects models indicated that combined participant emotional talk showed a small systematic decrease over time; however, the results for all domains indicated variability unexplained by time or speaker effects. CONCLUSIONS: Home hospice conversations are predominantly focused on physical care. Systematic change in communication versus responsiveness to the dynamic effects of patient death and family response over time are discussed. PRACTICE IMPLICATIONS: Communication strategies already in use by hospice nurses could be leveraged and expanded upon to better facilitate family competence and confidence.

Objective To evaluate the safety of and long-term pain relief due to intravenous lidocaine infusion for the treatment of chronic pain in a tertiary pain management clinic. Design Retrospective chart review. Methods Medical records were reviewed from 233 adult chronic pain patients who underwent one to three lidocaine infusions. The initial lidocaine challenge consisted of 1,000 mg/h administered intravenously for up to 30 minutes until infusion was complete, full pain resolution, the patient requested to stop, side effects (SEs) became intolerable, and/or if there were any safety concerns. Subsequent infusions were tailored to patient response. Data reviewed included pain diagnosis, lidocaine dose, SEs, and duration of pain relief documented at a follow-up visit. Results Patients primarily had neuropathic pain (80%), were 94% white, 58% were female, and there was an average pain duration of 7.9 years. SEs were usually mild and transient, including perioral tingling, dizziness, tinnitus, and nausea/vomiting, and they were uncommon after the initial infusion. Overall, 41% of patients showed long-lasting pain relief, with positive response to the initial infusion associated with receiving and benefitting from subsequent infusions. Benefit by pain diagnoses varied from 32% to 58%. Conclusions Our retrospective study in a heterogeneous population with chronic pain suggests that intravenous lidocaine is a safe treatment. Data also suggest long-term pain relief in a significant proportion of patients. Additional study is important in order to delineate patient selection, determine optimal dosing and treatment frequency, assess pain reduction and duration, and treatment cost-effectiveness.

The primary aim of this study was to evaluate activity rhythms in fibromyalgia syndrome (FMS) and their association with FMS-related symptoms. We hypothesized that stronger and more consistent activity rhythms would be associated with reduced symptom severity and presentation in FMS. Two hundred ninety-two patients with FMS (mean age = 45.1 ± 11.1; 272 women) provided a 7-day actigraphy recording and responses to questionnaires addressing degree of pain, fatigue, mood, and physical impairment. Using a simple cosine model, we extracted Amplitude (activity range), Phi (time at maximum), Mesor (mean activity), and their variabilities (across days) from each participant's actigraphy. The clinical and actigraphic measures were operationally independent. There was a significant canonical relationship between activity rhythm parameters and clinical FMS measures (r = 0.376, R = 0.14, P < 0.001). The set of Mesor, Amplitude, and Phi activity parameters remained associated with clinical measures when controlled statistically for both demographics and activity variability (P < 0.001). Each activity parameter provided unique discrimination of the clinical set by multivariate test (P = 0.003, 0.018, and 0.007 for Amplitude, Phi, and Mesor, respectively). These results revealed that better pain, fatigue, mood, physical impairment, and sleep outcomes were associated with higher activity range and more rhythmicity (Amplitude), increased mean activity (Mesor), and with earlier timing of peak activity (Phi). Exploratory analyses revealed significantly worse sleep for individuals with low Amplitude and more delayed Phi.

Aims (1) Determine the content validity of the Fear of Older Adult Falling Questionnaire-Caregivers using a panel of gerontological experts and a target sample of family caregivers (Stage 1) and (2) Examine the response patterns of the Fear of Older Adult Falling Questionnaire-Caregivers and compare it with older adult version of Fear of Falling Questionnaire Revised using graded-response modelling (Stage 2). Design Cross-sectional mixed-method design. Methods Five content experts and 10 family caregivers were involved in the Stage 1 study and 53 family caregiver-older adult dyads (N = 106) were included in the Stage 2 study. The content-validity index and graded-response modelling were used to analyse data. Results Among experts, the Fear of Older Adult Falling Questionnaire-Caregivers content-validity index for relevancy, importance, and clarity of individual items and total scale ranged from 0.60-1.00 and from 0.77-0.87, respectively. Among family caregivers, the ratings of the item and scale level content-validity index for relevancy, importance, and clarity ranged from 0.90-1.00 and from 0.95-0.97, respectively. Combining feedback from both groups, we revised one item. Subsequently, the graded-response modelling revealed that a 1-factor, 3-item version of the Fear of Older Adult Falling Questionnaire-Caregivers had acceptable psychometric properties. Conclusions The brief 3-item version of the Fear of Older Adult Falling Questionnaire-Caregivers is promising for assessing caregivers' fear of their older adult care recipient falling. Impact A significant concern for family caregivers is fearing that older adult care recipients will fall, but a lack of validated measures limits the study of this phenomena. A 3-item version of the Fear of Older Adult Falling Questionnaire-Caregivers has the potential to identify family caregivers with high fear of older adult falling so that fall risk can be appropriately assessed and addressed.

Background and Objective older adults have increased risk of social isolation, loneliness and cognitive functioning impairment, but the relationships among these factors are not conclusive. We investigated the potential mediation mechanism of loneliness on the association between social isolation and cognitive functioning among Chinese older adults within their cultural context. Design secondary analysis of the baseline wave (2011–12) of the harmonised China Health and Retirement Longitudinal Study. Setting and Subjects community-dwelling older adults in China (N = 7,410 participants aged 60–101 years). Methods we applied a multiple indicator multiple cause approach to determine whether the construct of social isolation is well defined by four indicators (social activity engagement, weekly adult children contact, caregiving for grandchildren and living alone) and used structural equation modelling to examine the direct and indirect effects among variables of interest. Results the results demonstrated that social activity engagement, weekly adult children contact and caregiving for grandchildren were significantly related to social isolation (β = −0.26 to −0.28) (Living alone was fixed to 1 for model identification.) The indirect effect of social isolation on cognitive functioning through loneliness was significant (β = −0.15), indicating loneliness was an important mediator. However, the direct effect of social isolation on cognitive functioning also remained significant (β = −0.83), suggesting a partial mediation effect. Conclusions our study highlights the mediation role of loneliness in the relationship between social isolation and cognitive functioning among Chinese older adults. The findings support the beneficial effects of maintaining social relations and coping with feelings of loneliness on older adults’ cognitive functioning.

Objective: To examine changes in patient outcome variables, length of stay (LOS), and mortality after implementation of computerized provider order entry (CPOE). Materials and Methods: A 5-year retrospective pre-post study evaluated 66 186 patients and 104 153 admissions (49 683 pre-CPOE, 54 470 post-CPOE) at an academic medical center. Generalized linear mixed statistical tests controlled for 17 potential confounders with 2 models per outcome. Results: After controlling for covariates, CPOE remained a significant statistical predictor of decreased LOS and mortality. LOS decreased by 0.90 days, P Discussion: This study examined CPOE at multiple levels. Given the inability to randomize CPOE assignment, these results may only be applicable to the local setting. Temporal trends found in this study suggest that hospital-wide implementations may have impacted nursing staff and new residents. Differences in the results were noted at the patient care unit and room levels. These differences may partly explain the mixed results from previous studies. Conclusion: Controlling for confounders, CPOE implementation remained a statistically significant predictor of LOS and mortality at this site. Mortality appears to be a sensitive outcome indicator with regard to hospital-wide implementations and should be further studied.

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.

Older adults have increased risk of social isolation, loneliness, and cognitive functioning decline, but the relationships among these factors are not conclusive. We used the 2011 and 2012 waves of the harmonized China Health and Retirement Longitudinal Study to: 1) measure the association between social isolation and cognitive functioning among Chinese older adults within their cultural context, and 2) investigate the potential mediation mechanism of loneliness on this association. Specifically, we applied a multiple indicator multiple cause approach to determine whether the construct of social isolation is well defined by four indicators (social activity engagement, weekly adult children contact, caregiving for grandchildren, and living alone). We used structural equation modeling to examine the direct and indirect effects among variables of interest. The results demonstrated that three indicators of social isolation were significantly associated with cognitive functioning (β =-0.26 to -0.28, all ps

Past studies examining the relationship between preparedness for loss and bereavement outcomes among caregivers of spouses/partners with life-limiting illness did not adequately account for preloss caregiver attributes that could potentially confound the relationship. Using a sample of spouse/partner cancer caregivers ( N = 226), we examined how preloss caregiver attributes were associated with how prepared one felt for loss and their role in the relationship between preparedness and later bereavement outcomes. Nearly half reported they were not emotionally prepared, and 35% were not prepared for the practical challenges associated with the loss. Although attributes such as depression, anxiety, competence in daily activities, and financial adequacy were associated with both preparedness and bereavement outcomes, regression analyses revealed that preparedness remained the strongest predictor in all models. We suggest that early interventions enhancing caregivers’ preparedness for loss may hold considerable promise for improved bereavement outcome.

BACKGROUND Successful diabetes management requires ongoing lifelong self-care and can require that individuals with diabetes become experts in translating care recommendations into real-life day-to-day diabetes self-care strategies. The diabetes online community comprises multiple websites that include social media sites, blogs, and discussion groups for people with diabetes to chat and exchange information. Online communities can provide disease-specific practical advice and emotional support, allow users to share experiences, and encourage self-advocacy and patient empowerment. However, there has been little research about whether diabetes online community use is associated with better diabetes self-care or quality of life. OBJECTIVE The aim of this study was to survey adults with diabetes who participated in the diabetes online community to better understand and describe who is using the diabetes online community, how they are using it, and whether the use of the diabetes online community was associated with health indicators. METHODS We recruited adults diagnosed with diabetes who used at least one of 4 different diabetes-related online communities to complete an online survey. Participants’ demographics, reported glycated hemoglobin (HbA1c), health-related quality of life (SF-12v2), level of diabetes self-care (Self-Care Inventory-Revised), and diabetes online community use (level of intensity and engagement) were collected. We examined the relationships between demographics, diabetes online community use, and health indicators (health-related quality of life, self-care, and HbA1c levels). We used binary logistic regression to determine the extent to which diabetes online community use predicted an HbA1c RESULTS A total of 183 adults participated in this study. Participants were mostly female (71.6%, 131/183), white (95.1%, 174/183), US citizens (82.5%, 151/183), had type 1 diabetes (69.7%, 129/183), with a mean age of 44.7 years (SD 14) and diabetes duration of 18.2 years (SD 14.6). Participants had higher diabetes self-care (P CONCLUSIONS Our results suggest that individuals highly engaged with diabetes online community are more likely to have better glycemic levels compared with those with lower engagement. Furthermore, diabetes online community users have high health-related quality of life and diabetes self-care levels. Supplementing usual healthcare activities with diabetes online community use may encourage knowledge and support among a population that needs to optimize its diabetes self-care. Further studies are needed to determine how diabetes online community engagement may affect health outcomes.

Background: Successful diabetes management requires ongoing lifelong self-care and can require that individuals with diabetes become experts in translating care recommendations into real-life day-to-day diabetes self-care strategies. The diabetes online community comprises multiple websites that include social media sites, blogs, and discussion groups for people with diabetes to chat and exchange information. Online communities can provide disease-specific practical advice and emotional support, allow users to share experiences, and encourage self-advocacy and patient empowerment. However, there has been little research about whether diabetes online community use is associated with better diabetes self-care or quality of life. Objective: The aim of this study was to survey adults with diabetes who participated in the diabetes online community to better understand and describe who is using the diabetes online community, how they are using it, and whether the use of the diabetes online community was associated with health indicators. Methods: We recruited adults diagnosed with diabetes who used at least one of 4 different diabetes-related online communities to complete an online survey. Participants’ demographics, reported glycated hemoglobin (HbA1c), health-related quality of life (SF-12v2), level of diabetes self-care (Self-Care Inventory-Revised), and diabetes online community use (level of intensity and engagement) were collected. We examined the relationships between demographics, diabetes online community use, and health indicators (health-related quality of life, self-care, and HbA1c levels). We used binary logistic regression to determine the extent to which diabetes online community use predicted an HbA1c

Mind-Body Bridging (MBB) has been shown to be effective for improving disturbed sleep. In this prospective randomized controlled trial, we evaluated the efficacy of sleep-focused MBB compared with sleep education control (SED) for improving sleep in previously deployed Gulf War veterans.US military service members with sleep and physical health complaints who were deployed in 1990-1991 were randomized to receive three weekly sessions of either MBB (n = 33) or SED (n = 27) between 2012 and 2015. The primary outcome of Medical Outcomes Study Sleep Scale was completed at baseline, weekly during treatment, postintervention, and 3-month follow-up. Secondary outcome measures for posttraumatic stress disorder, depression, fatigue, quality of life, symptom severity, and mindfulness were completed at baseline, postintervention and 3-month follow-up. Salivary samples were collected at five time points per day at each visit for cortisol and α-amylase assessment. Clinician-administered assessments of sleep and co-occurring conditions were conducted at baseline and postintervention.MBB was significantly more efficacious than SED in reducing disturbed sleep at follow-up (F(1,180.54) = 4.04, p = .046). In addition, self-reported posttraumatic stress disorder (F(1,56.42) = 4.50, p = .038) for the treatment effect, depression (F(1,93.70) = 4.44, p = .038), and fatigue symptoms (F(1,68.58) = 3.90, p = .050) at follow-up improved in MBB compared with those in SED. Consistently higher percentages of veterans in MBB reported improvements of sleep, pain, and composite sleep/general co-occurring symptoms at the postclinical evaluation, as compared with veterans in SED. Finally, the mean waking level of salivary α-amylase in the MBB declined to a greater extent than that in the SED, at follow-up (F(1,88.99) = 3.78, p = .055), whereas no effects were found on cortisol.Sleep-focused MBB can improve sleep and possibly also co-occurring symptoms in Gulf War veterans.Clinicaltrials.gov, NCT01543997.

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.

© 2016, Springer International Publishing Switzerland. 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.

BACKGROUND Studies addressing physical and psychosocial symptoms among hospitalized children and adolescents with cancer are limited. Understanding commonly occurring symptoms and their associated characteristics across the hospitalization is needed to guide symptom management strategies. OBJECTIVE This study described the symptom experience of hospitalized children and adolescents with cancer. The study explored the frequencies of individual symptoms and the severity, duration, and associated distress of symptoms during the course of the hospitalization. METHODS Participants completed the Memorial Symptom Assessment Scale 7-12 during each 12-hour shift of the 3-day/3-night data collection period. RESULTS Participants were 50 children and adolescents (mean age, 12.6 years; range, 7.1-18.6 years) receiving inpatient chemotherapy. Participants reported a mean of 2.75 symptoms at each assessment point and a mean of 5.42 different symptoms during their hospitalization. Mixed model analyses identified a significant fixed effect for study day, with participants reporting fewer symptoms (F = 8.4, P < .01), less symptom severity (F = 5.81, P < .01), and shorter duration (F = 6.67, P < .01) on day 3 relative to days 1 and 2. A fixed effect for study day was not present for symptom distress. CONCLUSIONS Children and adolescents receiving inpatient chemotherapy experience multiple physical and psychosocial symptoms of moderate or greater severity and duration throughout the course of their hospitalization. Symptoms of greatest severity may not be those that are most distressing to the patient. IMPLICATIONS FOR PRACTICE Ongoing assessment that incorporates the multidimensional nature of symptoms is needed. Prioritizing interventions for symptoms that are most distressing to the patient may support a more meaningful, patient-centric approach to care.

Summary 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.

High-quality relationships may be protective for family caregivers. This study focuses on relationship quality categories (supportive and ambivalent) in spouse caregivers in cancer home hospice. The goals of this article are to, first, describe relationship quality categories among end-of-life caregivers and, second, test the effects of relationship quality categories on caregiver burden and distress within a stress process model. Using questionnaire data collected at entry to home hospice, we found relationship quality categories were proportionally similar to those seen in noncaregiver older adults. Relationship quality significantly predicted caregiver burden, which completely mediated the relationship between caregiver relationship quality and distress. Caregivers whose social contexts place them at risk for greater distress may benefit from increased clinical attention or intervention.

Background Breast cancer survivors regularly interact with providers during routine surveillance medical oncology visits, discussing uncertainty and anxiety about potential cancer recurrence for many years after treatment. Physiologic alteration can also occur as a stress response, triggered by an upcoming surveillance visit. Survivor-provider communication can theoretically allay emotional distress. Objective The aim of this study was to evaluate associations between emotional (uncertainty, anxiety, concerns about recurrence) and physiologic responses (cytokine levels, lymphocyte counts), and survivor-provider communication (women's plans for their visit, negotiation of decision-making roles). Methods Twenty-seven community-dwelling breast cancer survivors participated. Blood specimens, and self-reported data focusing on the previous month, were collected immediately before and the morning after a regularly scheduled medical oncology visit. Results Global concerns about cancer recurrence and acute anxiety and uncertainty were associated with changes in immune status before and after the visit. Postvisit natural killer cells increased in 70% of women, and uncertainty/anxiety decreased. Thirty-three percent of women reported a previous minor illness. Most women had a visit plan; 66% successfully negotiated decision-making roles with providers. Conclusions Triggered by an upcoming medical oncology visit, women experience uncertainty, anxiety, and altered immunity, potentially placing them at risk of disease exacerbations. Implications for practice Not all women respond similarly to a routine surveillance visit; thus, providers must determine who may be at increased risk of emotional distress and physiologic alteration. Survivor-provider communication facilitates immediate resolution of concerns. Explanations of symptom meaning reduce anxiety and uncertainty and by extension may help resolve immune alteration. Between visits, this could be done by nurse-operated telephone-based "help lines."

Research addressing the effect of finasteride, an inhibitor of 5α-reductase (the enzyme that converts testosterone to dihydrotestosterone), on health-related quality of life has been conducted primarily in the context of two medical conditions: benign prostatic hyperplasia and alopecia. Three studies that addressed the effects of finasteride on benign prostatic hyperplasia (1–3) were generally well-powered, with a measurement focus on disease-specific symptoms; improvement associated with finasteride was observed for disease-specific symptoms (except for sexual function) and impact on daily activities or bother items. Less change was observed in these studies for more general measures of health-related quality of life, such as global health-related quality of life, life satisfaction, and worry or concern. Two small studies addressed the impact of finasteride on depression among patients treated for alopecia: one study reported moderate to severe depression or mood disturbance in 19 of 23 patients (4); the other, a single-arm study with 144 patients, reported a statistically significant increase in two measures of depression (ie, more depression) 2 months after treatment with finasteride (5). However, the results of the alopecia studies were preliminary and require confirmation in more patients. The Prostate Cancer Prevention Trial (PCPT) was a 7-year double-blind, placebo-controlled randomized trial of finasteride as a preventive agent for prostate cancer (6–9). There was a 24.8% reduction in the prevalence of prostate cancer over the 7-year trial duration associated with finasteride treatment (9). In that initial report (9), finasteride was associated with increased sexual dysfunction; however, a subsequent publication demonstrated that the level of sexual dysfunction was minimal and decreased over time (10). Given the sparse data regarding long-term finasteride use and health-related quality of life, we felt that it was important to monitor this outcome in the PCPT. We have previously reported the baseline health-related quality of life of men who entered the PCPT (11) and on changes in sexual functioning according to PCPT study arm assignment (10). In this report, we examine the effect of finasteride treatment on health-related quality of life, with particular focus on physical function results, over the course of the 7-year study. In this article, we refer to the physical function domain as measured by the Physical Functioning scale.

Chronic pain produces major functional disability and quality-of-life impairment. Monitoring of health-related quality of life (HRQoL) outcomes in chronic pain patients during treatment is of great importance. Nevertheless, monitoring individual chronic pain patients remains a challenge due to the lack of a validated and efficient HRQoL assessment instrument. The Treatment Outcomes in Pain Survey (TOPS) is a validated HRQoL tool with sufficient accuracy and sensitivity to monitor the overall pain experience of individual patients while receiving multidisciplinary chronic pain management. However, the amount of time required to complete the TOPS questionnaire limits routine clinical utility and patient compliance. The full 14 TOPS scales are not needed to monitor routine clinical outcomes. Therefore, we developed and initially validated a shortened and restructured instrument, the S-TOPS, for individual patient monitoring in multidisciplinary chronic pain treatment. The reliability and validity of the S-TOPS were analyzed using data from 964 chronic pain patients who were treated in a single interdisciplinary pain clinic and completed >1 TOPS. The 7 scales of the S-TOPS have excellent construct validity, high reliabilities, and improved sensitivity to change for monitoring individual patient outcomes. Patients accepted the S-TOPS well, finding it brief enough for routine repeated administration.

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.

Investigating dose-dependent effects of placebo analgesia (PA) in laboratory subjects undergoing pain testing, we evaluated 2 hypotheses: (1) greater expectancy for relief produces greater PA, and (2) cued expectancy for relief triggered by a predictive cue leads to more enhanced analgesia than does passive expectancy (no predictive cue). We used conditioning procedures in which 84 subjects experienced reduced stimulation intensity following the application of purported analgesic creams to the 2 experimental fingers, while the control finger received the same levels of stimulation as in the baseline block. The dose of placebos was manipulated by creating 2 levels of expectations for relief. The form of expectation (cued vs uncued) was also manipulated by a predictive cue specifying the next finger to be stimulated. Subjective reports and psychophysiological responses served as critical indicators for evaluating impacts of the placebo manipulation on subsequent pain processing. The dose-dependent PA was unambiguously demonstrated by the predicted ordering of the 3 fingers (ie, manipulated expectation levels) in terms of both response sensitivity and average response magnitude, in mixed-effects analysis of 3 outcome indicators (evoked potential, skin conductance response, pain report). Greater expectation for relief led to both (1) greater reductions in the average dependent variable slope (response sensitivity) as a function of stimulus intensity, and (2) greater reductions in average response magnitude. Unexpectedly, uncued expectation led to a slightly larger PA than did cued expectation. The study provided clear evidence that PA can occur in a "dose"-dependent manner, mediated by the levels of expectancy for pain relief.

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.

Engaged attention, including music listening, has shown mixed results when used as a method for reducing pain. Applying the framework of constructivism, we extend the concept of engagement beyond attention/distraction to include all cognitive and emotional/motivational processes that may be recruited in order to construct an alternative experience to pain and thus reduce pain. Using a music-listening task varying in task demand, we collected stimulus-evoked potentials, pupil dilation, and skin conductance responses to noxious electrocutaneous stimulations as indicators of central and peripheral arousal, respectively. Trait anxiety (Spielberger State-Trait Anxiety Inventory) and absorption (Tellegen Absorption Scale) provided indicators of individual differences. One hundred and fifty-three healthy, normal volunteers participated in a test session in which they received 3 stimulus intensity levels while listening to background tones (No Task) or performing a music-listening task. Linear slopes indicating net engagement (change in stimulus arousal relative to task performance) decreased with increasing task demand and stimulus level for stimulus-evoked potentials. Slopes for pupil dilation response and skin conductance response varied with task demand, anxiety, and absorption, with the largest engagement effect occurring for high anxiety/high absorption participants. Music engagement reduces pain responses, but personality factors like anxiety and absorption modulate the magnitude of effect. Perspective Engaging in music listening can reduce responses to pain, depending on the person: people who are anxious and can become absorbed in activities easily may find music listening especially effective for relieving pain. Clinicians should consider patients’ personality characteristics when recommending behavioral interventions like music listening for pain relief.

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.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.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.Adding gemcitabine to paclitaxel for the treatment of metastatic breast cancer is more likely to improve global HRQL over time compared to monotherapy treatment.

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 that 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.

This document reports the consensus of an interdisciplinary panel of research and clinical experts charged with reviewing the use of opioids for chronic noncancer pain (CNCP) and formulating guidelines for future research. Prescribing opioids for chronic noncancer pain has recently escalated in the United States. Contrasting with increasing opioid use are: 1) The lack of evidence supporting long-term effectiveness; 2) Escalating misuse of prescription opioids including abuse and diversion; and 3) Uncertainty about the incidence and clinical salience of multiple, poorly characterized adverse drug events (ADEs) including endocrine dysfunction, immunosuppression and infectious disease, opioid-induced hyperalgesia and xerostomia, overdose, falls and fractures, and psychosocial complications. Chief among the limitations of current evidence are: 1) Sparse evidence on long-term opioid effectiveness in chronic pain patients due to the short-term time frame of clinical trials; 2) Insufficiently comprehensive outcome assessment; and 3) Incomplete identification and quantification of ADEs. The panel called for a strategic interdisciplinary approach to the problem domain in which basic scientists and clinicians cooperate to resolve urgent issues and generate a comprehensive evidence base. It offered 4 recommendations in 3 areas: 1) A research strategy for studying the effectiveness of long-term opioid pharmacotherapy; 2) Improvements in evidence-generation methodology; and 3) Potential research topics for generating new evidence. Perspective Prescribing opioids for CNCP has outpaced the growth of scientific evidence bearing on the benefits and harms of these interventions. The need for a strong evidence base is urgent. This guideline offers a strategic approach to creating a comprehensive evidence base to guide safe and effective management of CNCP.

Objective. This exploratory investigation compared patterns of postoperative pain over 6 days in normal patients recovering from surgery with those of patients using opioid medications for chronic pain. It tested the following hypotheses: 1) Chronic pain patients have a different pattern of postoperative pain than normals; 2) Women have a different pattern of postoperative pain resolution than men. Patients. Normal (N = 96) and chronic pain (N = 42) patients undergoing surgery served as subjects. Design. The study employed a linear mixed effects model to compare repeated measures of pain in the two patient groups. Outcome Measures. Patients rated pain daily following surgery over 6 days. Each patient's pain pattern is a linear trend having an intercept (initial pain level) and a slope (rate of pain change over days). Results. The chronic pain patients initially reported a higher mean pain level, and they differed from normal patients in their average postoperative pain patterns ( P < 0.001), as did men and women ( P = 0.039). Whereas normals decreased in pain report over the 6 days of recovery at an average rate of −0.35 units per day, chronic pain patients changed at an average rate of only −0.06 units per day ( P < 0.001). Women began at day 0 with greater average pain than men (6.15 vs 5.16, P = 0.029) but resolved their pain more rapidly (−0.291 points per day vs −0.118 points per day, P = 0.017). Conclusions. Surgical patients who have chronic pain and use opioid medications for that pain have more postoperative pain than normals and resolve that pain more slowly.

Coherent clinical care depends on answering a basic question: is a patient getting worse, getting better, or staying about the same? This can prove surprisingly difficult to answer confidently. Patient-reported outcomes (PROs) could potentially help by providing quantifiable evidence. But quantifiable evidence is not necessarily good evidence, as this article details. The fundamental mandate of measurement requires that errors in making an assessment be smaller than the distinctions to be measured. This mandate implies that numerical observations of patients may be poor measurements. Individual assessments require high measurement precision and reliability. Group-averaged comparisons cancel out measurement error, but individual PROs do not. Individual PROs generate numbers, to be sure, but the numbers may fall short of what we should demand of measurements. When typical errors of measurement are large, it is not possible to answer confidently even the modest question of whether a patient is getting worse or getting better. This article explains some theory behind the mandate of measurement, provides several examples based on clinical research, and suggests strategies to measure and monitor individual patient outcomes more precisely. These include more frequent low-burden assessments, more realistic confidence levels, and strengthened measurement that integrates population data.

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.

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.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.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.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.

The purpose of this mixed method study is to evaluate the effects of participation in the development and implementation of ethnodrama about possible selves on nursing student attitudes toward older adults and older adult attitudes to aging. Twelve nursing students and 12 older adult long-term care residents collaborated in a transformational learning experience involving interviews on the topic of possible selves culminating in the presentation of an ethnodrama developed from these data. Longitudinal data from student surveys about attitudes toward older adults were analyzed using growth modeling, whereas older adult pre–post data on attitudes toward aging were analyzed with a paired samples t test. Video of group discussions and open-ended feedback on the overall experience were analyzed to provide qualitative understanding of change in student attitudes over time. Although positive overall, student attitudes varied in initial status and rate of change. Students who interacted most frequently with older adults had more neutral attitudes. Older adult attitudes surrounding psychosocial loss improved over the course of the intervention. Normalizing attitudes may be as important as improving attitudes; neutrality may be more representative of realistic perceptions of older adults and late-life potential.

In advanced-stage disease, palliation can be the most important objective. Quality-of-life (QoL) outcomes provide an intuitively reasonable way to monitor palliation from the patient’s perspective. However, patients with advanced-stage disease are often unable to complete a series of QoL assessments because of deteriorating health. This introduces a possible bias in a clinical trial because patients who are healthy enough to complete the assessments may not represent the target population. In this issue, Brown et al report QoL outcomes from a non–small-cell lung cancer trial comparing supportive care regimens with and without chemotherapy. The analysis of completers only was based on half the baseline sample, and the proportion of completers differed by treatment arms. Despite comprehensive descriptions of the missing data problems and sensitivity analyses designed to cope with them, considerable uncertainty remains. Uncertainty is inevitable with this degree of missing data, but a few key questions can both sharpen focus and suggest practical steps to limit the impact of missing data.

The objective of this study was to examine the relationship of work loss associated with gastro- the relationship of work loss associated with gastro- the relationship of work loss associated with gastro-esophageal reflux disease (GERD) and peptic ulcer disease (GERD) and peptic ulcer disease (PUD) in a large population of employed individuals in the United States (US) and quantify the individuals in the United States (US) and quantify the economic impact of these diseases to the employer.A proprietary database that contained work place absence, disability and workers' compensation data in addition to prescription drug and medical claims was used to answer the objectives. Employees with a medical claim with an ICD-9 code for GERD or PUD were identified from 1 January 1997 to 31 December 2000. A cohort of controls was identified for the same time period using the method of frequency matching on age, gender, industry type, occupational status, and employment status. Work absence rates and health care costs were compared between the groups after adjusting for demo graphic, and employment differences using analysis of covariance models.There were significantly lower (p0.05) prescription, and outpatient costs in the controls compared to the disease groups, although the eta-square values were very low. The mean work absence attributed to sick days was 2.8 (+/- 2.3) for controls, 3.4 (+/- 2.5) for GERD, 3.2 (+/- 2.6) for PUD, and 3.2 (+/- 2.3) days for GERD + PUD. For work loss, a significantly higher (p0.05) rate of adjusted all-cause absenteeism and sickness-related absenteeism were observed between the disease groups versus the controls. In particular, controls had an average of 1.2 to 1.6 days and 0.4 to 0.6 lower all-cause and sickness-related absenteeism compared to the disease groups. The incremental economic impact projected to a hypothetical employed population was estimated to be $3441 for GERD, $1374 for PUD, and $4803 for GERD + PUD per employee per year compared to employees without these diseases.Direct medical cost and work absence in employees with GERD, PUD and GERD + PUD represent a significant burden to employees and employers.

We believe that many adverse events following hematopoietic stem cell transplantation (HSCT), particularly relapse and chronic graft-versus-host disease (CGVHD), are preceded by a subclinical period of development that is accessible by frequent psychometric assessment. Documenting these associations could improve future clinical care by extending the potential window for intervention. However, conventional methods of assessing quantity of lite (QOL) in patients in their homes, typically by mailed self-assessment questionnaires, are impractical for very frequent administration. We have developed and implemented a web-based system for measuring short-term (dynamic) changes in QOL by employing brief, online, daily QOL assessments and more extensive, monthly online assessments from patients' homes. Here we report the feasibility of collecting very frequent patient home self-assessments of QOL via the web for a 52 week participation period; we detail incidence of home web access, accrual, compliance, and satisfaction with the system in an HSCT patient sample. We also describe our integrated web-systems for administering patient recruitment, scheduling, monitoring, and analysis. Our results suggest that very frequent routine collection of QOL outcomes is entirely feasible using our web-based home assessment tool, with good patient compliance and high user satisfaction. We believe our methodology shows great promise for use with other cancer and health populations.

To evaluate the validity of change in visual analog Scale (VAS) as a measure of pain relief using a verbal descriptor Scale (VDS) of change in pain.A prospective observational study of emergency department patients measured pain with VAS and recorded verbal report of change in pain.One thousand four hundred ninety patients yielded 1999 comparisons between change in VAS and VDS. Correlation of change in VAS and VDS of change in pain was rho = 0.667 ( P.001). A wide range of change in VAS, large standard deviations for the mean change in VAS, and discordance in the direction of change in VAS were present within each verbal descriptor category.Change in VAS is moderately correlated with a VDS of change in pain. Wide variability in change in VAS and discordance with a VDS demonstrate that change in VAS is not a valid indicator of pain relief for individual patients.

The defense response theory implies that individuals should respond to increasing levels of painful stimulation with correlated increases in affectively mediated psychophysiological responses. This paper employs structural equation modeling to infer the latent processes responsible for correlated growth in the pain report, evoked potential amplitudes, pupil dilation, and skin conductance of 92 normal volunteers who experienced 144 trials of three levels of increasingly painful electrical stimulation. The analysis assumed a two-level model of latent growth as a function of stimulus level. The first level of analysis formulated a nonlinear growth model for each response measure, and allowed intercorrelations among the parameters of these models across individuals. The second level of analysis posited latent process factors to account for these intercorrelations. The best-fitting parsimonious model suggests that two latent processes account for the correlations. One of these latent factors, the activation threshold, determines the initial threshold response, while the other, the response gradient, indicates the magnitude of the coherent increase in response with stimulus level. Collectively, these two second-order factors define the defense response, a broad construct comprising both subjective pain evaluation and physiological mechanisms.