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CONTEXT: Activity limitation and dyspnea are the dominant symptoms of chronic obstructive pulmonary disease (COPD). Traditionally, efforts to alleviate these symptoms have focused on improving ventilatory mechanics, reducing ventilatory demand, or both of these in combination. Nevertheless, many patients with COPD remain incapacitated by dyspnea and exercise intolerance despite optimal therapy. OBJECTIVES: To determine the effect of single-dose inhalation of nebulized fentanyl citrate (a [mu]-opioid agonist drug) on exercise tolerance and dyspnea in COPD. METHODS: In a randomized, double-blind, placebo-controlled, crossover study, 12 stable patients with COPD (mean±standard error of the mean post-[beta](2)-agonist forced expiratory volume in one second [FEV(1)] and FEV(1) to forced vital capacity ratio of 69%±4% predicted and 49%±3%, respectively) received either nebulized fentanyl citrate (50mcg) or placebo on two separate days. After each treatment, patients performed pulmonary function tests and a symptom-limited constant work rate cycle exercise test at 75% of their maximum incremental work rate. RESULTS: There were no significant postdose differences in spirometric parameters or plethysmographic lung volumes. Neither the intensity nor the unpleasantness of perceived dyspnea was, on average, significantly different at isotime (5.0±0.6 minutes) or at peak exercise after treatment with fentanyl citrate vs. placebo. Compared with placebo, fentanyl citrate was associated with 1) increased exercise endurance time by 1.30±0.43 minutes or 25%±8% (P=0.01); 2) small but consistent increases in dynamic inspiratory capacity by ~0.10L at isotime and at peak exercise (both P<=0.03); and 3) no concomitant change in ventilatory demand, breathing pattern, pulmonary gas exchange, and/or cardiometabolic function during exercise. The mean rate of increase in dyspnea intensity (1.2±0.3 vs. 2.9±0.8 Borg units/minute, P=0.03) and unpleasantness ratings (0.5±0.2 vs. 2.9±1.3 Borg units/minute, P=0.06) between isotime and peak exercise was less after treatment with fentanyl citrate vs. placebo. CONCLUSION: Single-dose inhalation of fentanyl citrate was associated with significant and potentially clinically important improvements in exercise tolerance in COPD. These improvements were accompanied by a delay in the onset of intolerable dyspnea during exercise near the limits of tolerance. [ABSTRACT FROM AUTHOR]

Although robust evidence demonstrates that specialty palliative care integrated into oncology care improves patient and health system outcomes, few clinicians are familiar with the standards, guidelines, and quality measures related to integration. These types of guidance outline principles of best practice and provide a framework for assessing the fidelity of their implementation. Significant advances in the understanding of effective methods and procedures to guide integration of specialty palliative care into oncology have led to a proliferation of guidance documents around the world, with several areas of commonality but also some key differences. Commonalities originate from a shared vision for integration; differences arise from diverse roles of palliative care specialists within cancer care globally. In this review we discuss three of the most cited standards/guidelines, as well as quality measures related to integrated palliative and oncology care. We also recommend changes to the quality measurement framework for palliative care and a new way to match palliative care services to patients with advanced cancer on the basis of care complexity and patient needs, irrespective of prognosis.

Context: Breast cancer survivors often experience activity-related dyspnea and exercise intolerance, but the underlying mechanisms remain unknown., Objectives: We evaluated physiological contributors to reduced peak oxygen uptake (VO2), with particular attention to the role of respiratory impairment., Methods: We compared symptom assessments, respiratory and peripheral muscle strength, pulmonary function, and ventilatory responses to symptom-limited incremental treadmill exercise in 29 women who had survived breast cancer and 29 age-matched healthy controls., Results: Peak VO2 was reduced more than 20%, on average, in the cancer group compared with controls (P < 0.001). Slopes of dyspnea intensity ratings over ventilation or VO2 were >50% greater in the cancer group compared to controls (P < 0.05). Women with breast cancer had lower lung diffusing capacity for carbon monoxide (DLCO), respiratory and limb muscle strength, and ventilatory thresholds during exercise compared with controls (all P < 0.05). During exercise, indices of ventilatory efficiency were similar to controls, but inspiratory capacity (IC) was lower and breathing pattern was more rapid and shallow in the cancer group (P < 0.05). The lower peak VO2 in the cancer group was associated with greater dyspnea intensity, and lower DLCO, IC and ventilatory threshold (all P < 0.05)., Conclusion: Breast cancer survivors had greater peripheral and respiratory muscle weakness, greater reduction of IC, impaired lung diffusion, and evidence of deconditioning compared with controls. Exercise intolerance was multifactorial and correlated well with the combination of these factors as well as with exertional dyspnea. Individualized physiological testing in breast cancer survivors can identify important contributors to exercise intolerance which can be targeted for treatment., (Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: Cancer-related dyspnea is a common, distressing, and difficult-to-manage symptom in cancer patients, resulting in diminished quality of life and poor prognosis. Buspirone, a non-benzodiazepine anxiolytic which does not suppress respiration and has proven efficacy in the treatment of generalized anxiety disorder, has been suggested to relieve the sensation of dyspnea in patients with COPD. The main objective of our study was to evaluate whether buspirone alleviates dyspnea in cancer patients., Methods: We report on a randomized, placebo-controlled trial of 432 patients (mean age 64, female 51%, lung cancer 62%) from 16 participating Community Clinical Oncology Program (CCOP) sites with grade 2 or higher dyspnea, as assessed by the Modified Medical Research Council Dyspnea Scale. Dyspnea was assessed by the Oxygen Cost Diagram (OCD; higher scores are better) and anxiety by the state subscale of the State-Trait Anxiety Inventory (STAI-S; lower scores are better) at baseline and after the 4-week intervention (post-intervention)., Results: Mean scores from baseline to post-intervention for buspirone were OCD 8.7 to 9.0 and STAI-S 40.5 to 40.1 and for placebo were OCD 8.4 to 9.3 and STAI-S 40.9 to 38.6 with raw improvements over time on both measures being greater in the placebo group. Analysis of covariance (ANCOVA) controlling for baseline scores showed no statistically significant difference between groups for OCD (P = 0.052) or STAI-S (P = 0.062)., Conclusion: Buspirone did not result in significant improvement in dyspnea or anxiety in cancer patients. Thus, buspirone should not be recommended as a pharmacological option for dyspnea in cancer patients.

The delivery of optimal palliative care requires an integrated and coordinated approach of many health care providers across the continuum of care. In response to identified gaps in the region, the Palliative Care Integration Project (PCIP) was developed to improve continuity and decrease variability of care to palliative patients with cancer. The infrastructure for the project included multi-institutional and multisectoral representation on the Steering Committee and on the Development, Implementation and Evaluation Working Groups. After review of the literature, five Collaborative Care Plans and Symptom Management Guidelines were developed and integrated with validated assessment tools (Edmonton Symptom Assessment System and Palliative Performance Scale). These project resources were implemented in the community, the palliative care unit, and the cancer center. Surveys were completed by frontline health professionals (defined as health professionals providing direct care), and two independent focus groups were conducted to capture information regarding: 1) the development of the project and 2) the processes of implementation and usefulness of the different components of the project. Over 90 individuals from more than 30 organizations were involved in the development, implementation, and evaluation of the PCIP. Approximately 600 regulated health professionals and allied health professionals who provided direct care, and over 200 family physicians and medical residents, received education/training on the use of the PCIP resources. Despite unanticipated challenges, frontline health professionals reported that the PCIP added value to their practice, particularly in the community sector. The PCIP showed that a network in which each organization had ownership and where no organization lost its autonomy, was an effective way to improve integration and coordination of care delivery.

This study evaluated the effectiveness of implementation of common assessment tools, collaborative care plans, and symptom management guidelines for cancer patients as a strategy to improve the quality, coordination, and integration of palliative care service across organizations and health care sectors. A pre-post design to measure the impact on symptom management, caregiver burden and satisfaction with care delivery, and service utilization was used. Two cohorts of eligible patients and caregivers completed Edmonton Symptom Assessment Scales, Caregiver Reaction Assessment and FAMCARE Scales and chart audits were conducted. Administrative data from each participating site were examined for utilization trends. Audits of 53 charts preimplementation and 63 postimplementation showed an increase in documentation of pain from 24.5% to 74.6% (P<0.001) of charts. Administrative data showed a decrease in the percentage of patients with at least one emergency room visit from 94.3% to 84.8% (P<0.001), in the percentage of patients with at least one admission to the acute care hospital (P<0.001), and deaths in acute care 43.1%-35.7% (P=0.133). There was minimal change in the intensity of symptoms (P=0.591), and no change in the burden on the caregiver (P=0.086) or caregiver satisfaction with care (P=0.942). This study showed that implementation of common assessment tools, collaborative care plans, and symptom management guidelines across health sectors can result in some increased documentation of symptoms and efficiencies in care. Future projects should consider imbedding a continuous quality improvement methodology and longer timelines into their projects to improve outcomes.

Exertional dyspnea is an important symptom in cancer patients, and, in many cases, its cause remains unexplained after careful clinical assessment. To determine mechanisms of exertional dyspnea in a variety of cancer types, we evaluated cancer outpatients with clinically important unexplained dyspnea (CD) at rest and during exercise and compared the results with age-, sex-, and cancer stage-matched control cancer (CC) patients and age- and sex-matched healthy control participants (HC). Participants (n = 20/group) were screened to exclude clinical cardiopulmonary disease and then completed dyspnea questionnaires, anthropometric measurements, muscle strength testing, pulmonary function testing, and incremental cardiopulmonary treadmill exercise testing. Dyspnea intensity was greater in the CD group at peak exercise and for a given ventilation and oxygen uptake (P < 0.05). Peak oxygen uptake was reduced in CD compared with HC (P < 0.05), and breathing pattern was more rapid and shallow in CD than in the other groups (P < 0.05). Reduced tidal volume expansion during exercise correlated with reduced inspiratory capacity, which, in turn, correlated with reduced inspiratory muscle strength. Patients with cancer had a relatively reduced diffusing capacity of the lung for carbon monoxide, reduced skeletal muscle strength, and lower ventilatory thresholds during exercise compared with HC (P < 0.05). There were no significant between-group differences in measurements of airway function, pulmonary gas exchange, or cardiovascular function during exercise. In the absence of evidence of airway obstruction or restrictive interstitial lung disease, the shallow breathing pattern suggests ventilatory muscle weakness as one possible explanation for increased dyspnea intensity at a given ventilation in CD patients.

This multicenter trial examined the efficacy and safety of dextromethorphan (DM) as an enhancer of analgesia and modulator of opioid tolerance in cancer patients with pain. Eligible patients were randomized to slow-release morphine plus DM or slow-release morphine plus placebo. The initial DM dose was 60 mg four times daily for seven days, with an increase to 120 mg four times daily, if tolerated, for another seven days. During the study, patients recorded medications and scores for pain, nausea, drowsiness, and insomnia. Sixty-five patients were randomized. Although average pain scores (12.6 vs. 15.8), number of breakthrough doses (9 vs. 11.3), and change in total morphine consumption (550.9 mg vs. 597.1mg) were less in the DM group than placebo group, the differences were not statistically significant (P=0.31-0.33). Side-effect scores were not statistically significantly different. Dizziness was greater in the DM (58%) than placebo (36%) group. This study showed a statistically nonsignificant enhancement of analgesia or modulation of opioid tolerance in cancer patients with pain when DM was added to morphine. Participants receiving the DM also had more toxicity, particularly dizziness. This toxicity and the limited evidence of effect do not support the use of DM to enhance opioid analgesia or to modulate opioid tolerance in cancer patients.

The treatment of incident pain in terminally ill cancer patients receiving long-term opioid therapy remains a challenge. Self-administered inhaled nitrous oxide has been used for short-term analgesia in this setting, with mixed results. It is unclear whether nitrous oxide exhibits cross-tolerance with opioids, and there is the possibility of a strong placebo effect in previous unblinded reports. We report on a double-blind crossover case series, in which seven patients received either nitrous oxide/oxygen or a placebo air/oxygen mixture on each day of a two-day trial. Outcome indices were obtained before, during and after each use of the gas for anticipated incident pain. The patient population was very heterogeneous with respect to disease, pain scores and concurrent treatments. Nitrous oxide was beneficial during incidents in five of seven patients; the remaining two patients reported an overall preference for the nitrous oxide day. We conclude that a trial of self-administered inhaled nitrous oxide should be considered in patients with difficult incident pain.

A novel system for home oral hygiene, the IntelliClean System from Sonicare and Crest is an integrated sonic toothbrush and liquid-toothpaste dispensing system. New research has established the ability of this system to reduce plaque, especially in interproximal regions, and to reduce gingivitis. The unique capability for the user to reapply liquid toothpaste during brushing (ie, re-dose) allows for a greater reduction in bacteria in the sulcus and an enhanced in-use experience that leads to improved compliance with brushing instruction, specifically longer brushing times. Through in vitro and in vivo studies, the system and its constituents have been shown to be safe for daily use.

Purpose: To determine differences in interproximal plaque mass and fluoride retention with different modes of toothbrushing and flossing., Materials and Methods: Forty-seven subjects in good health used four treatments in a four-period, randomized, crossover design: 1) manual brushing only; 2) manual brushing and daily flossing; 3) electric brushing using a rotational oscillation toothbrush; and 4) electric brushing using a sonic toothbrush. Subjects used a standard sodium fluoride dentifrice during the eight-day experimental periods and a fluoride-free dentifrice during the seven-day washout periods between treatments. Interproximal plaque samples were taken on Day 1 and on Day 8, weighed, and analyzed for fluoride content., Results: The amount of interproximal plaque was lowest with sonic brushing, which left 43-65% less plaque than all other treatments. Manual brushing and flossing yielded less plaque than manual brushing alone and rotational oscillation brushing. Differences were statistically significant (p < 0.05) for treatment; there was no time effect on plaque mass. For fluoride retention, at Day 1 sonic brushing gave at least 54% more fluoride in the interproximal plaque than all other treatments, which was significant. All treatments demonstrated a significant increase in fluoride concentration with time except manual brushing and flossing, which showed a significant decrease. At Day 8, the fluoride concentration was significantly higher for sonic brushing than for manual brushing or rotational oscillation brushing by over 40%, and all treatments exhibited significantly greater fluoride than the manual brushing and flossing combination., Conclusion: The mode of toothbrushing may impact the amount of plaque retained interproximally and its fluoride concentration.

Dental researchers have only recently begun to regard dental plaque as a biofilm. Dental plaque biofilm is a complex, heterogeneous structure of bacteria cells, a sticky extracellular matrix, and fluid channels. The biofilm must be modeled accurately for laboratory studies to be meaningful. To that end, researchers have compared the sonicare toothbrush to the Braun Oral-B 3D Excel Plaque Remover for the removal of interproximal dental plaque biofilm in an in vitro model. This article defines the concept of biofilms in the oral cavity and reviews how biofilm modeling is showing differences in toothbrush performance.

Dyspnea, like pain, is a subjective experience that incorporates physical elements and affective components. Management of breathlessness in patients with cancer requires expertise that includes an understanding and assessment of the multidimensional components of the symptom, knowledge of the pathophysiologic mechanisms and clinical syndromes that are common in cancer, and familiarity with the indications and limitations of the available therapeutic approaches. Relief of breathlessness should be the goal of treatment at all stages of cancer. Good control of dyspnea will improve the patient's quality of life.

The purposes of this cross-sectional study of 75 outpatients of a general oncology clinic were to assess the subjective and objective factors associated with dyspnea in cancer patients and to characterize factors that might contribute to respiratory muscle weakness demonstrated in a previous study. Patients with moderate to severe shortness of breath completed visual analogue scales (VAS) of shortness of breath (SOB) and anxiety; other data were acquired from pulmonary function tests, including maximum inspiratory pressure (MIP) and expiratory pressures; chest radiography; arterial blood gases; measurement of hemoglobin, serum potassium, phosphate, calcium, albumin, and magnesium; and ultrasound study of the diaphragm for thickness and excursion. The correlation coefficient between SOB VAS and anxiety VAS was 0.26 (P = 0.03). In stepwise multiple regression analyses, only the regression coefficient for anxiety remained significant at P < 0.05 in the multivariate model with SOB VAS as the dependent variable. The multivariate model using MIP (a measure of respiratory muscle strength) as the dependent variable, found significance for total diaphragmatic excursion, hemoglobin, phosphate, residual volume over total lung volume, vital capacity, percent predicted total lung capacity, oxygen saturation, and forced vital capacity. The regression coefficients for these variables were significant at P < 0.05 and the model accounted for 58% of the variance of MIP.

The objectives of this study were to determine the prevalence of dyspnea in the general cancer population, the intensity of the symptom as perceived by the patient, and the patient characteristics associated with the presence of dyspnea. Nine hundred and twenty-three cancer outpatients completed visual analogue scales (VAS) and verbal rating scales (VRS-D) to assess the intensity of their dyspnea. Baseline data included variables that were known covariates of dyspnea. Forty-six percent of the patients had some shortness of breath. Only 4% had a diagnosis of lung cancer and 5.4% lung metastases. Risk factors found to be significantly related to the presence of dyspnea were history of smoking; asthma or chronic obstructive pulmonary disease (COPD); lung irradiation; or a history of exposure to asbestos, coal dust, cotton dust or grain dust (P values from 0.001 to 0.038). The prevalence of dyspnea was strongly related to the number of risk factors a patient had (P < 0.0001). The VAS and VRS-D were significantly correlated, establishing concurrent validity for the VRS-D.

To ensure quality of care, palliative care programs need to document the effectiveness of their relief of physical and psychological distress. The Edmonton Symptom Assessment Scale (ESAS) is a validated, reliable instrument developed to measure 9 different symptoms in palliative care patients. To see if symptom management could be compared across institutions, we first reviewed the charts of 188 successive admissions to the palliative care unit at St. Boniface General Hospital, Winnipeg, Manitoba. Our study showed that the ESAS is a useful audit tool for assessing patterns of palliative symptom control that allows for institutional comparisons. Procedures that ensure completeness of data collection remain to be developed.

Optimal management of dyspnea in terminal cancer patients requires an understanding of the responsible pathophysiological mechanisms. This prospective study assessed visual analogue scales (VAS) of shortness of breath (SOB) and anxiety, bedside spirometry, maximum inspiratory pressure (MIP), chest radiography, arterial blood gases, hemoglobin, and electrocardiogram, if indicated, in 100 terminally ill cancer patients. Forty-nine percent of the patients had lung cancer. The median VAS scores for SOB and anxiety were 53 mm and 29 mm, respectively. Spirometry was abnormal in 93% of patients, with 5% having obstructive, 41% restrictive, and 47% mixed patterns. The median MIP was 16 cm H2O. Sixty-five percent of the patients had parenchymal or pleural involvement on chest radiograph. Twenty-nine percent had evidence of cardiac ischemia, recent or current myocardial infarction or atrial fibrillation. Patients had a median of five different abnormalities that could have contributed to their shortness of breath. Only anxiety (p = 0.001), a history of smoking (p = 0.02), and pCO2 levels were statistically significantly correlated with SOB VAS scores. The potentially correctable causes of dyspnea included hypoxia (40%), anemia (20%), and bronchospasm (52%). The finding of very low MIPs suggests severe respiratory muscle weakness may contribute significantly to dyspnea in this patient population. Further studies are needed to confirm this finding and characterize the underlying pathophysiology.

The understanding and treatment of dyspnea in the cancer patient are where the science of pain management was 15 or 20 years ago. Very few studies have examined the pathophysiologic mechanisms that cause dyspnea in cancer patients, and few investigators have evaluated therapeutic strategies to control dyspnea in this patient group. The optimal therapy for dyspnea is treatment of the underlying cause. When this is not possible, opioids and phenothiazines provide effective symptomatic relief in most cases, but many unanswered questions remain. Are these the optimal drugs, and what are their optimal doses? What are the effects of chronic dosing? Which is the best route of administration? How serious are the risks of respiratory depression? A clear consensus supports the aggressive treatment of pain in terminally ill cancer patients, even if death is hastened as an unintended consequence. No such position has yet been reached in the management of dyspnea in the same population. As a result, dyspnea is addressed only very late in the course of the disease, perhaps reducing the patient's quality of life and function at earlier stages and resulting in a very small "therapeutic window" in the terminal phase. Clearly, a need exists for more research to determine the most effective management of this common and very distressing symptom.

This cross-sectional study compared the prevalence and intensity of needs expressed by cancer patients at the time of first recurrence (n = 75) with those of patients at the time of disease progression (n = 75). On a 72-item Likert-type scale participants rated from "none" to "very much" the severity of physical symptoms; emotional, psychological, and social problems; and difficulties with activities of daily living. The progressive disease group reported more problems than the first recurrence group in 11 of 24 (47%, p < 0.05) symptom-related questions. The progressive disease group also expressed greater needs in 19% of the function-related questions. There were no differences in reported psychological problems, responses to recurrence, or greatest concern between the two groups. These results support the need for palliative care throughout the entire course of illness.

Palliative or hospice care developed as a new discipline because the needs of the dying patient and family were not adequately met by the established health care system. The focus on the technological aspects of medicine for diagnosis and treatment has resulted in the neglect of the social, emotional and spiritual problems experienced by patients suffering from a terminal disease. Care of the dying is an active process that requires frequent assessments and the aggressive pursuit of appropriate therapies to control both physical and emotional symptoms. Models of practice used by medicine and nursing are compared and related to the delivery of effective and compassionate care to the dying.

Background: Advanced non-Hodgkin lymphoma (NHL) usually is treated with doxorubicin-based combination chemotherapy. Because doxorubicin is excreted by the biliary route, many authorities recommend alternative initial interventions in patients with NHL causing obstructive jaundice., Methods: The authors retrospectively reviewed the records of patients at Rochester General Hospital with NHL between 1983 and 1989 with obstructive jaundice at initial diagnosis., Results: Five patients with obstructive jaundice due to intermediate-grade NHL were treated with combination chemotherapy without prior surgical or endoscopic biliary decompression, or radiation therapy. Three received higher doses of doxorubicin than called for in standard dose modification tables. Jaundice was relieved rapidly in all five patients without unexpected toxic effects, and all five patients entered remission (three had partial remission and two complete remission)., Conclusions: Because biliary obstruction resolves rapidly after administration of chemotherapy for this disease, it is possible that standard dose reductions for doxorubicin and vincristine that are appropriate for patients with hepatocellular disease may be excessive for patients with obstructive jaundice resulting from lymphoma. The results of this study indicate that combination chemotherapy is appropriate initial therapy for patients with newly diagnosed NHL with obstructive jaundice.

Typical inferential statistical procedures, such as the t-test and analysis of variance, compare differences in mean values of variables. This approach can sometimes obscure rather than illuminate research data. Here we present and discuss alternative data analytic techniques. Potential advantages of box plots over conventional t-tests for understanding data are shown by comparing the area under high and low frequencies from spectral curves of autonomic changes following chemotherapy treatment. Typical t-tests provide information regarding statistical significance in terms of the differences in group means; box plots and related exploratory techniques provide information regarding the characteristics of the distributions within the groups as well as examination of potential outliers. Multivariate analysis of variance (MANOVA) and other multivariate techniques are commonly used to deal with potentially complex data sets with multiple outcome measures. The potential advantages of visual clustering techniques such as star plots, Chernoff faces, and Andrew's Function Plots are demonstrated by examining changes in facial pallor caused by chemotherapy-induced nausea and vomiting. Typical MANOVA approaches can identify potential differences in mean values between groups; visual clustering approaches do this by graphically presenting complex interrelationships for individual cases. This approach enhances the visual interpretation of potential interactions that would be obscured by simply focusing on overall mean values. Preliminary data from a meta-analysis on the effect of metoclopramide on chemotherapy-induced vomiting demonstrates the potential uses and advantages of this summary technique over simple tabular summaries. We found significant relationships between the effect size of the drug and variables such as the year of study publication and whether the publication was an article or an abstract. While none of these techniques are meant to replace traditional inferential statistics, they offer advantages in terms of data exploration and understanding relationships within data sets that are not clearly addressed by other methods. They are potentially valuable alternatives worthy of exploration. Finally, we discuss issues of interim analyses and multiple endpoint assessment for clinical trials.