Educating Social Workers in Palliative and End-of-Life Care: Development and Implementation of a New National Training Program.

Background: Educating Social Workers in Palliative and End-of-Life Care (ESPEC) is a nationally scalable continuing education program designed to improve the knowledge and skills of frontline health social workers caring for patients with serious illness. Objectives: This article describes ESPEC's rationale, development, and initial implementation. Design: Following the creation of consensus-derived core primary palliative care competencies for health primary care social workers based on the eight domains of palliative care outlined in the National Consensus Project Guidelines for Quality Palliative Care, an evidence-based curriculum was developed. This was used to develop a hybrid training model with a self-study component, synchronous instructor-led skills-based training, leadership training, and mentorship. The interactive curriculum incorporates patient scenarios highlighting the health social work role. Training targets high-impact skills-the biopsychosocial-spiritual assessment, advance care planning, family meetings, and interprofessional communication-and professional development. Settings/Subjects: ESPEC was launched in the United States in collaboration with the National Association of Social Workers (NASW) and the Social Work Hospice and Palliative Care Network (SWHPN). Results: The preliminary launch demonstrated high user acceptability, positive ratings for content and format, and gains in knowledge and competence. Conclusions: Data suggest that ESPEC can increase health social workers' knowledge and confidence as providers of palliative care interventions. National dissemination is ongoing.

Delivery of an at-home transcranial direct current stimulation intervention to mitigate pain in patients with end-stage kidney disease receiving hemodialysis (ESKD/HD).

Background: Poorly controlled pain remains a problem for many patients with end-stage kidney disease requiring hemodialysis (ESKD/HD) and customary approaches to pain management (e.g., opioids, non-steroidals) confer substantial risk. Accordingly, non-pharmacologic therapies are needed for use in this population. Non-invasive transcranial Direct Current Simulation (tDCS) constitutes a promising nonpharmacologic method for pain management in affected individuals. Aims: This study seeks to: 1) determine the effects of an 8-week course of at-home tDCS vs. sham tDCS on pain intensity, pain interference, medication usage, quality of life, and mood; 2) determine if tDCS effects vary by race/ethnicity; and 3) ascertain patient satisfaction with device use. Methods: This double-blind, randomized, sham-controlled clinical trial will enroll 100 ESKD/HD patients with moderate-to-severe (≥4 on 0-10 scale) chronic pain. The active study intervention consists of 20 min of tDCS delivered over the primary motor cortex 5 days/week for 8 weeks. The comparator is a sham procedure that provides no effective stimulation. The primary outcome analysis will evaluate efficacy of tDCS for pain reduction after two months of stimulation. We will also assess the effects of treatment on analgesic consumption, pain interference, depressed mood, and quality of life. The statistical plan will include fixed classification factors for treatment (vs. sham), clinic sites, and assessment time, and the interaction of these factors adjusting for covariates (e.g., race/ethnicity, pain level). Conclusion: At-home tDCS constitutes a promising nonpharmacologic treatment for pain mitigation in persons with ESKD/HD. This unique RCT could transform the way pain is managed in this vulnerable population. Trial Registration: NCT05311956.

Family Meetings in Palliative Care: Benefits and Barriers.

OPINION STATEMENT: Specialists in palliative care view the family meeting as a means to engage patients and their families in a serious illness discussion that may clarify the values of patients and caregivers, provide information, determine care preferences, and identify sources of illness-related distress and burden. The family meeting is considered the best practice for achieving patient- and family-centered care in palliative care. Although studies of the family meeting are limited, those extant suggest that these interventions may reduce caregiver distress, mitigate the perception of unmet needs, prepare family members for caregiving, and improve bereavement outcomes. The experience of palliative care specialists further suggests that the family meeting may reinforce the therapeutic alliance with families, promote consensus, and reduce the need for ad hoc meetings. Physician satisfaction may be enhanced when the treatment plan includes the opportunity to show empathy and see the family's perspective-core elements of the clinical approach to the family meeting. In the oncology setting, the potential to achieve these positive outcomes supports the integration of the family meeting into practice. Clinical skills for the planning and running of family meetings should be promoted with consideration of a standardized protocol for routine family meetings at critical points during the illness and its treatment using an interdisciplinary team. Further research is needed to refine understanding of the indications for the family meeting and determine the optimal timing, structure, and staffing models. Outcome studies employing validated measures are needed to better characterize the impact of family meetings on patient and family distress and on treatment outcomes. Although better evidence is needed to guide the future integration of the family meeting into oncology practice, current best practices can be recommended based on available data and the extensive observations of palliative care specialists.

Feasibility and Acceptability of a Pharmacogenomic Decision Support System in Palliative Care.

Context: Pharmacogenomic analysis may improve the efficacy or safety of the drugs used in palliative care. Decision support systems may promote clinical integration of this information. Objectives: To determine the feasibility and acceptability of a pharmacist-directed pharmacogenomic decision support system in the care of patients with advanced illness and explore the drug-gene and drug-drug interactions that occur in this population. Methods: Physicians or nurse practitioners from two U.S. hospice agencies identified opioid-treated patients receiving multiple other drugs. Buccal samples and clinical data were obtained from consenting patients. A pharmacist used the proprietary MedWise™ platform to evaluate the current medications in terms of genotype and phenotype, created a standardized report describing potential interactions and recommended actions that may reduce the associated risk. Clinicians could access the report online and completed Likert-type scales to assess use and satisfaction with the system. Results: Twenty clinicians and 100 patients participated. The reports revealed that 74 drugs were subject to 462 drug-gene interactions and 77 were involved in 691 drug-drug interactions; only 4 and 16 patients, respectively, had no drug-gene or drug-drug interactions. Clinicians routinely checked the reports and used the information to change ≥1 treatments in 55 (55%) patients. Almost all clinicians rated the system likely to improve the quality of care and all "agreed" or "strongly agreed" to recommend the system to colleagues. Conclusion: This pharmacist-directed pharmacogenomic decision support system was perceived positively and was integrated into practice. Further studies are warranted to its clinical integration and its outcomes.

Neurostimulation for cognitive enhancement in Alzheimer's disease (the NICE-AD study): a randomized clinical trial.

New therapies for symptoms in Alzheimer's disease (AD) are urgently needed. Prior studies suggest that transcranial direct current stimulation (tDCS), a noninvasive neuromodulatory method, may be a safe and potentially effective treatment, but conclusions have been limited by small-sample sizes and brief stimulation protocols. This double-blind randomized trial involving 100 older adults with mild-to-moderate AD examines effects of 6 months of at-home active tDCS or sham delivered over the dorsolateral prefrontal cortex. The primary outcome is global cognitive performance. Secondary outcomes include executive-control/spatial selective attention, functional neuroplasticity, depressive symptoms, quality of life and the durability of effects 3 months after the stimulation period. The results will provide evidence on the efficacy of multimonth at-home tDCS in the AD treatment. =Clinical trial identifier NCT04404153 (Clinicaltrials.gov).

Understanding the Chameleonic Breakthrough Cancer Pain.

Breakthrough cancer pain (BTcP) is a variegated phenomenon, that often presents in different ways in each individual, and may change its presentation in the same individual during the course of disease. An appropriate assessment is fundamental for depicting the pattern of BTcP in individuals. This information is determinant for a personalised management of BTcP. The use of opioids as needed, is recommended for the management of BTcP. There are several options which should be chosen according to the individual pattern of BTcP. In general, a drug with a short onset and offset should be preferred. Although oral opioids may still have specific indications, fentanyl products have been found to be more rapid and effective, providing analgesia in 5-15 min. The most controversial point regards the opioid dose to be used. The presence of tolerance suggests using a dose that is proportional to the dose used for background analgesia. In contrast, regulatory studies have suggested using the minimal available dose to be titrated until the effective dose. Further large studies should definitely settle this never-ending question.

Providing End-of-Life Care for Patients With Left Ventricular Assist Devices: Experience of a Hospice Agency.

CONTEXT: Patients with left ventricular assist devices (LVADs) need expert palliative care at the end of life. In the U.S., hospice may provide this care, but few patients enroll, and information about hospice experience with LVAD-implanted patients is limited. OBJECTIVE: To describe hospice experience with LVAD-implanted patients. METHODS: This is a retrospective descriptive study of all LVAD-implanted patients admitted to a hospice agency. Data were extracted from the electronic health record. RESULTS: The 13 patients had a mean age of 63 years (range 20-89) and a mean LVAD duration of 32.5 months (range 8.2-70.0). Hospice diagnosis was heart failure in 10 patients and cancer in three patients; all patients were multimorbid. Eight patients enrolled in hospice on one occasion, four had two enrollments, and one had five. All patients received services for <180 days, three for <7 days, and four patients for >90 days. Just-in-time inservicing was used to prepare hospice teams for challenging care needs, including bleeding, delirium, infections, and mechanical failure. Of the nine patients who died while receiving hospice services, one enrolled with a plan to deactivate the LVAD immediately after hospice enrollment, and six died after discontinuation of the LVAD or other life-sustaining therapy during the course of hospice care. Five deaths occurred in a hospice inpatient unit. CONCLUSION: To provide specialist palliative care to LVAD-implanted patients, hospices must be prepared to manage complex and highly varied needs. To do this, hospices must have adequate staff support and access to acute care.

A Practical Approach to Using Adjuvant Analgesics in Older Adults.

The adjuvant analgesics are a large and diverse group of drugs that were developed for primary indications other than pain and are potentially useful analgesics for one or more painful conditions. The "adjuvant" designation reflects their early use as opioid co-analgesics for cancer pain. During the past 3 decades, their role in pain management has changed with the advent of many new entities, emerging data from numerous analgesic trials, and growing clinical experience. Many of these drugs are now used as primary analgesics for specific types of chronic pain. With proper patient selection and cautious administration, they can potentially contribute meaningfully to the management of chronic pain in older adults. A practical approach categorizes the many adjuvant analgesics by broad indications: multipurpose drugs and drugs that target neuropathic pain, musculoskeletal pain, and cancer pain, respectively. This article reviews the status of the evidence supporting the analgesic potential of the adjuvant analgesics and discusses best practices in terms of drug selection and dosing. J Am Geriatr Soc 68:691-698, 2020.

Addressing the burden of illness in adults with cystic fibrosis with screening and triage: An early intervention model of palliative care.

BACKGROUND: Novel models that improve generalist-level palliative care for cystic fibrosis (CF) are needed to address the burden of this illness. A screening-and-triage model has the potential to identify clinical problems requiring immediate follow-up by CF professionals. This study describes such a model and its immediate impact on care delivery for CF patients during a two-year period. METHODS: Eligible adults completed monthly online screening for sources of distress. If results revealed one or more "indicators of concern" on two consecutive screenings, this triggered an attempted triage by a social worker. Completed triages led to prompt follow-up by CF professionals for clinical problems, if indicated. Process data were summarized and generalized linear mixed models were used to evaluate baseline patient characteristics (symptom distress, quality of life, and sociodemographics) associated with the need for prompt follow-up. RESULTS: A total of 1,015 monthly surveys were completed by 74 patients; 634 (66 patients) had >1 indicators of concern; and 164 surveys (46 patients) had >1 indicators for two consecutive surveys (e.g., global distress, pain, dyspnea, and psychological symptoms). The 164 attempted triages yielded 84 completed triages (51.2%), of which 39 (46.4%) required prompt follow-up. In multivariable analyses, older patients and those with higher symptom distress at baseline were more likely to require prompt follow-up (p < .05). CONCLUSIONS: Web-based screening that assesses varied domains of distress or burden can identify a subset of CF patients whose clinical problems may benefit from immediate medical or psychological attention. Additional investigations should improve screening efficiency.

Intention-to-Treat Analyses for Randomized Controlled Trials in Hospice/Palliative Care: The Case for Analyses to be of People Exposed to the Intervention.

CONTEXT: Minimizing bias in randomized controlled trials (RCTs) includes intention-to-treat analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomization and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered nonresponders. OBJECTIVES: This study aimed to quantify the impact within intention-to-treat principles. METHODS: A theoretical model was developed to assess the impact of withdrawals between randomization and first exposure on study power and effect sizes. Ten reported hospice/palliative care studies had power recalculated accounting for such withdrawal. RESULTS: In the theoretical model, when 5% of withdrawals occurred between randomization and first exposure to the intervention, change in power was demonstrated in binary outcomes (2.0%-2.2%), continuous outcomes (0.8%-2.0%), and time-to-event outcomes (1.6%-2.0%), and odds ratios were changed by 0.06-0.17. Greater power loss was observed with larger effect sizes. Withdrawal rates were 0.9%-10% in the 10 reported RCTs, corresponding to power losses of 0.1%-2.2%. For studies with binary outcomes, withdrawal rates were 0.3%-1.2% changing odds ratios by 0.01-0.22. CONCLUSION: If blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomization and first exposure to the intervention minimizes one bias. This is the safety population as defined by the International Committee on Harmonization. When planning for future trials, minimizing the time between randomization and first exposure to the intervention will minimize the problem. Power should be calculated on people who receive the intervention.

Pain-related distress among patients referred to a community-based palliative care program.

OBJECTIVE: Numerous studies have characterized the pain reported by patients with advanced illness in terms of descriptors such as severity, but few have measured pain-related distress. Distress may be important in the clinical approach to pain. To evaluate pain-related distress among adult patients with advanced illness and pain following enrollment in an urban, specialist-level, community-based palliative care program. METHOD: In a retrospective cross-sectional analysis, data were extracted from the electronic health records of all patients who were able to complete the pain item from the Condensed Memorial Symptom Assessment Scale at the start of care. Bivariate and multivariate analyses evaluated the associations between distress and both sociodemographics and disease-related information. RESULTS: The 506 patients completing the pain item had a mean (SD) age of 70.7 years (13.8); 64.2% were women, 32.1% were Hispanic, 32.6% were white, and 27.7% were black. Of the 503 patients who indicated some level of distress on a 0-4 scale, 221 (43.7%) had high distress, defined as a score ≥3 ("quite a bit" or "very much"). Cancer diagnosis and poor performance status (unable to care for self) were predictors of high pain-related distress (both p < 0.05).Significance of resultsAmong patients with advanced illness who reported pain at the start of care by a specialist palliative care program, high pain-related distress was common, particularly among those with cancer or poor physical function. Further studies are needed to explore the extent to which pain-related distress should inform the assessment and management of pain.

Defining Core Competencies for Generalist-Level Palliative Social Work.

CONTEXT: Care provided to seriously ill patients by frontline social workers is a component of generalist-level palliative care. The core competencies for high-quality generalist-level palliative social work are necessary to promote training curricula and best practices but have not yet been defined in the U.S. OBJECTIVE: The objective of this study was to develop consensus-derived core competencies for generalist-level palliative social work. METHODS: Fifty-five proposed social work competencies were categorized by the eight domains of palliative care identified by the National Consensus Project for Quality Palliative Care. The competencies were rated by 41 regionally dispersed, Master's level social workers selected through purposive and snowball sampling using a Delphi method. Each was rated as essential for generalist-level palliative social work, acceptable with modifications, or rejected based on the judgment that it was not essential for generalist-level palliative social work or was outside the scope of practice. Consensus was defined as >70% agreement to accept or reject a competency. Three review rounds were needed to achieve consensus on all competencies. RESULTS: Two competencies were added to the original list. Of the 57 proposed competencies, 41 were accepted (19 after modification) and 16 were rejected. Competencies in the social, spiritual, cultural, and ethical/legal aspects of care domains were relatively more likely to be accepted compared with those in structure and processes of care, physical care, psychological care, and care of patient at the end of life. CONCLUSION: The 41 consensus-derived competencies for generalist-level palliative social work may inform the development of training curricula and standards for high-quality care.

At-Home Transcranial Direct Current Stimulation (tDCS) With Telehealth Support for Symptom Control in Chronically-Ill Patients With Multiple Symptoms.

Transcranial direct current stimulation (tDCS) delivered in multiple sessions can reduce symptom burden, but access of chronically ill patients to tDCS studies is constrained by the burden of office-based tDCS administration. Expanded access to this therapy can be accomplished through the development of interventions that allow at-home tDCS applications. Objective: We describe the development and initial feasibility assessment of a novel intervention for the chronically ill that combines at-home tDCS with telehealth support. Methods: In the developmental phase, the tDCS procedure was adjusted for easy application by patients or their informal caregivers at home, and a tDCS protocol with specific elements for enhanced safety and remote adherence monitoring was created. Lay language instructional materials were written and revised based on expert feedback. The materials were loaded onto a tablet allowing for secure video-conferencing. The telehealth tablet was paired with an at-home tDCS device that allowed for remote dose control via electronic codes dispensed to patients prior to each session. tDCS was delivered in two phases: once daily on 10 consecutive days, followed by an as needed regimen for 20 days. Initial feasibility of this tDCS-telehealth system was evaluated in four patients with advanced chronic illness and multiple symptoms. Change in symptom burden and patient satisfaction were assessed with the Condensed Memorial Symptom Assessment Scale (CMSAS) and a tDCS user survey. Results: The telehealth-tDCS protocol includes one home visit and has seven patient-tailored elements and six elements enhancing safety monitoring. Replicable electrode placement at home without 10-20 EEG measurement is achieved via a headband that holds electrodes in a pre-determined position. There were no difficulties with patients' training, protocol adherence, or tolerability. A total of 60 tDCS sessions were applied. No session required discontinuation, and there were no adverse events. Data collection was feasible and there were no missing data. Satisfaction with the tDCS-telehealth procedure was high and the patients were comfortable using the system. Conclusion: At-home tDCS with telehealth support appears to be a feasible approach for the management of symptom burden in patients with chronic illness. Further studies to evaluate and optimize the protocol effectiveness for symptom-control outcomes are warranted.

Cancer Pain Syndromes.

Patients with cancer experience many acute and chronic pain syndromes, the identification of which may be helpful in the assessment and treatment of pain. Syndromes are defined by the relationship with the cancer, the pain pathophysiology, and the clinical characteristics of the pain. The most common pain syndromes are directly related to the tumor; bone pain syndromes are most common. Neuropathic pain syndromes may involve cancer-related injury at any level of the peripheral nervous system. Treatment-related pain syndromes may follow any type of antineoplastic therapy. This article reviews the phenomenology of common acute and chronic cancer pain syndromes.

Web-Based Cognitive Behavior Therapy for Chronic Pain Patients with Aberrant Drug-Related Behavior: Outcomes from a Randomized Controlled Trial.

Objective: There is high unmet need for effective behavioral treatments for chronic pain patients at risk for or with demonstrated histories of opioid misuse. Despite growing evidence supporting technology-based delivery of self-management interventions for chronic pain, very few such programs target co-occurring chronic pain and aberrant drug-related behavior. This randomized controlled trial evaluated the effectiveness of a novel, web-based self-management intervention, grounded in cognitive behavior therapy, for chronic pain patients with aberrant drug-related behavior. Methods: Opioid-treated chronic pain patients at a specialty pain practice who screened positive for aberrant drug-related behavior (N = 110) were randomized to receive treatment as usual plus the web-based program or treatment as usual alone. The primary outcomes of pain severity, pain interference, and aberrant drug-related behavior, and the secondary outcomes of pain catastrophizing and pain-related emergency department visits, were assessed during the 12-week intervention and at one and three months postintervention. Results: Patients assigned to use the web-based program reported significantly greater reductions in aberrant drug-related behavior, pain catastrophizing, and pain-related emergency department visits-but not pain severity or pain interference-relative to those assigned to treatment as usual. The positive outcomes were observed during the 12-week intervention and for three months postintervention. Conclusions: A web-based self-management program, when delivered in conjunction with standard specialty pain treatment, was effective in reducing chronic pain patients' aberrant drug-related behavior, pain catastrophizing, and emergency department visits for pain. Technology-based self-management tools may be a promising therapeutic approach for the vulnerable group of chronic pain patients who have problems managing their opioid medication.

Development and Field Test of an Audit Tool and Tracer Methodology for Clinician Assessment of Quality in End-of-Life Care.

CONTEXT: Quality improvement in end-of-life care generally acquires data from charts or caregivers. "Tracer" methodology, which assesses real-time information from multiple sources, may provide complementary information. OBJECTIVES: The objective of this study was to develop a valid brief audit tool that can guide assessment and rate care when used in a clinician tracer to evaluate the quality of care for the dying patient. METHODS: To identify items for a brief audit tool, 248 items were created to evaluate overall quality, quality in specific content areas (e.g., symptom management), and specific practices. Collected into three instruments, these items were used to interview professional caregivers and evaluate the charts of hospitalized patients who died. Evidence that this information could be validly captured using a small number of items was obtained through factor analyses, canonical correlations, and group comparisons. A nurse manager field tested tracer methodology using candidate items to evaluate the care provided to other patients who died. RESULTS: The survey of 145 deaths provided chart data and data from 445 interviews (26 physicians, 108 nurses, 18 social workers, and nine chaplains). The analyses yielded evidence of construct validity for a small number of items, demonstrating significant correlations between these items and content areas identified as latent variables in factor analyses. Criterion validity was suggested by significant differences in the ratings on these items between the palliative care unit and other units. The field test evaluated 127 deaths, demonstrated the feasibility of tracer methodology, and informed reworking of the candidate items into the 14-item Tracer EoLC v1. CONCLUSION: The Tracer EoLC v1 can be used with tracer methodology to guide the assessment and rate the quality of end-of-life care.

Trajectories of caregiver burden in families of adult cystic fibrosis patients.

ABSTRACTObjectives:Little is known about the experience of family caregivers of adults with cystic fibrosis (CF). This information is important for the identification of caregivers at risk for burden. METHODS: This was a longitudinal analysis of survey data obtained from caregivers of adult CF patients participating in an early intervention palliative care trial. Caregivers completed the validated Brief Assessment Scale for Caregivers (BASC) repeatedly over a 28-month period. Mixed-effects modeling evaluated multivariate associations with positive and negative caregiver perceptions over time. RESULTS: Of the 54 caregivers, 47.9% were spouses. The mean age was 50.9 years (SD = 13.2); 72.2% were women; 75.9% were married; and 63.0% were employed. At baseline, the BASC revealed large variations in positive and negative perceptions of caregiving. Although average scores over time were unchanging, variation was greater across caregivers than within caregivers (0.49 vs. 0.27, respectively). At baseline, the positive impact of caregiving in the sample was higher than the negative impact. Multivariate analysis revealed that patients' baseline pulmonary function and their full-time employment status predicted caregiver burden over time. SIGNIFICANCE OF RESULTS: Caregivers of CF patients varied in their positive and negative caregiving experiences, although burden levels in individual caregivers were stable over time. When the disease was advanced, caregivers of CF patients experienced more overall burden but also more positive impact. This suggests that the role of caregivers may become more meaningful as disease severity worsens. In addition, full-time patient employment was associated with lower caregiver burden regardless of disease severity. This suggests that burden in CF caregivers may be predicted by financial strain or benefits conferred by patient employment. These associations require further investigation to determine whether highly burdened caregivers can be identified and assisted using tailored interventions.

Hospice Enrollment After Referral to Community-Based, Specialist Palliative Care: Impact of Telephonic Outreach.

CONTEXT: In the U.S., palliative care programs improve access to hospice through enhanced communication and efficiencies in hospice eligibility review and enrollment. For community-based programs, this task may begin with telephone contact. OBJECTIVES: To evaluate the incidence and predictors of hospice enrollment following telephonic outreach by a nurse after referral to a community-based, specialist palliative care program. METHODS: During 2012-2014, 299 consecutive patients who were referred to a palliative care program and subsequently enrolled in hospice provided electronic health record data for a retrospective cohort study. Those who elected hospice after telephonic outreach and before the first palliative care home visit, were compared with those who enrolled in hospice after palliative care visits began, using both bivariate and multivariate analyses. RESULTS: Mean (SD) age was 74.1 (18.7) years; 60.2% were women, 44.4% were White, 22.5% were Hispanic, 20.9% were Black, and 9.6% were Asian. In total, 177 patients (59.2%) elected hospice following telephonic outreach and 122 (40.8%) enrolled after home visits began. The former group received a mean of 4.5 calls (median = 3.0) before hospice election. In multivariate analysis, hospice enrollment following telephonic outreach alone was associated with hospital or nursing home referral, not married status, and poor performance status (all P < 0.05). CONCLUSION: More than half of patients electing hospice after referral to a palliative care program did so following telephonic outreach alone. Both sociodemographic and clinical characteristics predicted this outcome. Palliative care programs can improve hospice access through initial telephonic outreach by trained professionals.

Repurposing Medications for Hospice/Palliative Care Symptom Control Is No Longer Sufficient: A Manifesto for Change.

The World Health Organization essential medications list for hospice/palliative care reflects that, with the judicious use of currently available medications, the majority of symptoms can be lessened, and some controlled completely. Even with optimal use of current medications, symptom control is still unacceptable for many people. Currently available medications offer great benefit to a minority of patients, some benefit to an additional group, and no benefit or harms to others. In symptom control, development of new drugs is advancing at a glacial pace, contrasting to the rapid advances seen in many other disciplines. Specialists in palliative care should agree on several principles consequently: 1) Access to symptom-control drugs codified in the World Health Organization Essential Medicines list deserves the strongest support from national policies and professional guidelines, especially in resource-challenged countries. 2) The optimal use of currently available symptom-control drugs cannot yield acceptably high rates of net benefits. 3) There is a compelling need to identify patient subgroups that are likely to benefit from available medications and provide rigorous empirical support for indications, dosing, and route of administration for clinical practice. 4) New therapies are needed requiring an accelerated effort to investigate further the pathophysiology, neurobiology, and pharmacogenetics of distressing symptoms, and factors contributing to variations in drug response. This development requires a lengthy lead time. 5) Smarter ways to promote new knowledge into practice are needed as no drug will be suitable for all patients. We need to improve clinical characterization and biomarker technology to bring the best drugs to the right patients every time.

Breakthrough cancer pain: twenty-five years of study.

Breakthrough cancer pain (BTcP) is an episode of severe pain that "breaks through" a period of persistent pain at least partly controlled by a stable opioid regimen. Although mentioned in the literature decades ago, it has been only 25 years since the first effort to define and measure it. Controversy about the definition of BTcP continues despite an international effort to achieve consensus. Nevertheless, common approaches to measurement of BTcP have led to a robust literature, including many surveys that have described prevalence, characteristics, and association with adverse outcomes. Measurement also has been important for clinical trials of new drug formulations specifically designed for BTcP. Several approaches have been reported in the literature, although most of them have never been substantiated with appropriate studies. Administration of an opioid as needed is the most common treatment. Twenty-five years of research has produced a more refined understanding of the safety and efficacy of oral opioids in this context, and provided the clinical trials data necessary to attain regulatory approval of multiple new formulations specifically developed for BTcP. Transmucosal formulations of fentanyl may provide meaningful analgesia within 5 to 15 minutes. Given the difference in cost, transmucosal formulations should be considered in a subset of patients with BTcP, including those with pain that are not adequately controlled with an oral drug and those with distress associated with the rapid pain onset. The long-term use of opioids for BTcP remains to be clarified. Future studies should assess the potential of personalized treatment of BTcP.