Mindfulness-Oriented Recovery Enhancement for Veterans and Military Personnel on Long-Term Opioid Therapy for Chronic Pain: A Randomized Clinical Trial.

OBJECTIVE: This randomized clinical trial evaluated the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) among past and present U.S. military personnel with prescriptions for long-term opioid therapy for chronic pain. METHODS: In this clinical trial, 230 past and present military personnel with prescriptions for long-term opioid therapy were randomized in a 1:1 ratio to MORE or supportive psychotherapy (initially delivered in person and then via videoconferencing after the onset of the COVID-19 pandemic). Primary outcomes were chronic pain, measured by the Brief Pain Inventory, and aberrant drug-related behaviors, measured by the Current Opioid Misuse Measure, through 8 months of follow-up. Opioid dose was a key secondary outcome. Other outcomes included psychiatric symptoms, catastrophizing, positive affect, ecological momentary assessments of opioid craving, and opioid attentional bias. RESULTS: MORE was superior to supportive psychotherapy through the 8-month follow-up in reducing pain-related functional interference, pain severity, and opioid dose. MORE reduced daily opioid dose by 20.7%, compared with a dose reduction of 3.9% with supportive psychotherapy. Although there was no overall between-group difference in opioid misuse, the in-person MORE intervention outperformed supportive psychotherapy for reducing opioid misuse. MORE reduced anhedonia, pain catastrophizing, craving, and opioid attentional bias and increased positive affect to a greater extent than supportive psychotherapy. MORE also modulated therapeutic processes, including mindful reinterpretation of pain sensations, nonreactivity, savoring, positive attention, and reappraisal. CONCLUSIONS: Among past and present U.S. military personnel, MORE led to sustained decreases in chronic pain, opioid use, craving, and opioid cue reactivity. MORE facilitated opioid dose reduction while preserving adequate pain control and preventing mood disturbances, suggesting its utility for safe opioid tapering.

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.

Mindfulness-Oriented Recovery Enhancement remediates anhedonia in chronic opioid use by enhancing neurophysiological responses during savoring of natural rewards.

BACKGROUND: Neuropsychopharmacologic 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. METHODS: Veterans 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. RESULTS: Patients 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. CONCLUSIONS: MORE 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.

"Being careful": How much caution is enough? The relational context of fear of older adult falling in older adult-family caregiver dyads.

Family caregivers play an important role in coping with older adult falls; however, their perspectives on fear of older adult falling are lacking from the falls prevention literature. A mixed-method design (N=25 dyads) with interview and survey data examined linguistic characteristics and coping strategies used by older adult and family caregiver dyads to manage fear of older adult falling. Fear of older adult falling consisted of both affective (e.g., worry) and cognitive (e.g., cautious) properties. Family caregivers more frequently used affective words and first-person plural pronouns ("we" language) when talking about fear of older adult falling, while older adults more frequently used cognitive and first-and-second person singular pronouns ("I", "you"). The concept of "being careful" was shared within dyads. However, dyad partners differed in their perspectives of what constituted "being careful" and the possibilities of future falling. Findings suggest that the need for family-centered interventions to prevent falls are needed.

Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy for Co-occurring Opioid Misuse and Chronic Pain in Primary Care: A Randomized Clinical Trial.

IMPORTANCE: 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. OBJECTIVE: To evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) for the reduction of opioid misuse and chronic pain. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02602535.

The visual time analog scale: simple, novel measurement approach to assess pain in patients with chronic pain.

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.

Fear of older adult falling questionnaire for caregivers (FOAFQ-CG): Evidence from content validity and item-response theory graded-response modelling.

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.

Loneliness as a mediator of the impact of social isolation on cognitive functioning of Chinese older adults.

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 (ß = -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 (ß = -0.15), indicating loneliness was an important mediator. However, the direct effect of social isolation on cognitive functioning also remained significant (ß = -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.

Effect of Diabetes Online Community Engagement on Health Indicators: Cross-Sectional Study.

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 <7% or ≥7% after controlling statistically for other variables in the model. 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<.001, mean 72.4, SD 12.1) and better health-related quality of life (physical component summary P<.001, mean 64.8, SD 19; mental component summary P<.001, mean 66.6, SD 21.6) when compared with norms for diabetes. Diabetes online community engagement was a strong predictor of A1c, reducing the odds of having an A1c ≥7% by 33.8% for every point increase in diabetes online community engagement (0-5). Our data also indicated that study participants are oftentimes (67.2%, 123/183) not informing their healthcare providers about their diabetes online community use even though most (91.2%, 161/181) are seeing their healthcare provider on a regular basis. 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.

Reappraisal deficits promote craving and emotional distress among chronic pain patients at risk for prescription opioid misuse.

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 like reappraisal by virtue of the deleterious effects of chronic opioid exposure. Aims: The aim of this study was to characterize differences in reappraisal use among chronic pain patients at risk for opioid misuse and those who report taking opioids as prescribed. Methods: A sample of 127 pain patients receiving chronic opioid analgesic pharmacotherapy were classified as at risk for opioid misuse (n = 62) or taking opioids as prescribed (n = 65) using the Current Opioid Misuse Measure (COMM). The Emotion Regulation Questionnaire (ERQ) characterized use of emotion regulation strategies including reappraisal and expressive suppression. Participants also reported levels of opioid craving, emotional distress, and pain severity. Results: Patients at risk for opioid misuse reported significantly less reappraisal use (M = 25.31, SD = 7.33) than those who reportedly took opioids as prescribed (M = 30.28, SD = 7.50), p<.001, but did differ with regard to suppression strategies. Reduced reappraisal use was associated with higher opioid craving and emotional distress that mediated the association between reappraisal deficits and opioid misuse risk. Further, there was a significant indirect effect of opioid misuse on emotional distress via reappraisal use. Discussion: Opioid misuse risk was associated with reduced use of reappraisal, which in turn was associated with dysregulated negative emotions and increased appetitive drive towards consuming opioids. Studying individual differences in emotion regulation may yield efficacious intervention and prevention approaches to stem the rising tide of the prescription opioid crisis.

Tertiary Care Clinical Experience with Intravenous Lidocaine Infusions for the Treatment of Chronic Pain.

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.

Investigating Clinical Benefits of a Novel Sleep-Focused Mind-Body Program on Gulf War Illness Symptoms: A Randomized Controlled Trial.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Sleep-focused MBB can improve sleep and possibly also co-occurring symptoms in Gulf War veterans. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT01543997.

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.

Impact of computerized provider order entry (CPOE) on length of stay and mortality.

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 < .0001. Mortality decrease varied by model: 1 death per 1000 admissions (pre = 0.006, post = 0.0005, P < .001) or 3 deaths (pre = 0.008, post = 0.005, P < .01). Mortality and LOS decreased in medical and surgical units but increased in intensive care units. 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.

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.