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BACKGROUND Calciphylaxis is a debilitating dermatological condition associated with high rates of morbidity and mortality. Palliative care offers a multidisciplinary approach to addressing symptoms and goals of care in patients with serious medical diagnoses. Involvement of palliative services for calciphylaxis is infrequently reported in the literature. The purpose of this report is to assess rates of palliative and pain consultation for patients with calciphylaxis. METHODS This is a comprehensive, single-institution retrospective chart review of 121 eligible patients with a diagnosis of calciphylaxis treated at Mayo Clinic in Rochester, Minnesota, from 1999 to 2016. Inclusion criteria were an indisputable diagnosis of calciphylaxis based on clinical, histopathologic, and radiographic features. One hundred twenty-one patients met inclusion criteria. RESULTS Fifty-one patients (42%) received either a palliative (n = 15) or pain (n = 20) consultation, or both (n = 16). Patients with a palliative care consultation were younger compared with those without (mean ages 57 vs. 62 years, P = 0.046). In 104 patients (86%), psychiatric symptoms were not assessed. CONCLUSIONS In this cohort of patients with calciphylaxis, the majority do not receive palliative and pain care consultations. Psychiatric complications are inconsistently addressed. These observations highlight practice gaps in the care of patients with calciphylaxis.

Introduction: Public health emergencies and crises such as the current COVID-19 pandemic can accelerate innovation and place renewed focus on the value of health interventions Capturing important lessons learnt, both positive and negative, is vital We aimed to document the perceived positive changes (silver linings) in cancer care that emerged during the COVID-19 pandemic and identify challenges that may limit their long-term adoption Methods: This study employed a qualitative design Semi-structured interviews (n = 20) were conducted with key opinion leaders from 14 countries The participants were predominantly members of the International COVID-19 and Cancer Taskforce, who convened in March 2020 to address delivery of cancer care in the context of the pandemic The Framework Method was employed to analyse the positive changes of the pandemic with corresponding challenges to their maintenance post-pandemic Results: Ten themes of positive changes were identified which included: value in cancer care, digital communication, convenience, inclusivity and cooperation, decentralisation of cancer care, acceleration of policy change, human interactions, hygiene practices, health awareness and promotion and systems improvement Impediments to the scale-up of these positive changes included resource disparities and variation in legal frameworks across regions Barriers were largely attributed to behaviours and attitudes of stakeholders Conclusion: The COVID-19 pandemic has led to important value-based innovations and changes for better cancer care across different health systems The challenges to maintaining/implementing these changes vary by setting Efforts are needed to implement improved elements of care that evolved during the pandemic

Background: The International Association for Hospice and Palliative Care (IAHPC) developed a consensus-based definition of palliative care (PC) that focuses on the relief of serious health related suffering, a concept put forward by the Lancet Commission Global Access to Palliative Care and Pain Relief. Aim: The objective of this paper is to present the research behind the new definition. Methods: The three-phased consensus process involved health care workers from countries in all income levels. In phase one, 38 PC experts evaluated the components of the World Health Organization (WHO) definition and suggested new/revised ones. In phase two, 412 IAHPC members in 88 countries expressed their level of agreement with the suggested components. In phase three, using results from phase two, the expert panel developed the definition. Results: The consensus-based definition is “Palliative care is the active holistic care of individuals across all ages with serious health-related suffering due to severe illness and especially of those near the end of life. It aims to improve the quality of life of patients, their families and their caregivers.” The definition includes a number of bullet points with additional details as well as recommendations for governments to reduce barriers to palliative care. Conclusions: Participants had significantly different perceptions and interpretations of PC. The greatest challenge faced by the core group was trying to find a middle ground between those who think that PC is the relief of all suffering, and those who believe that PC describes the care of those with a very limited remaining life span.

Section 2 of the 2019 World Health Organization Model List of Essential Medicines includes opioid analgesics formulations commonly used for the control of pain and respiratory distress, as well as sedative and anxiolytic substances such as midazolam and diazepam. These medicines, essential to palliative care, are regulated under the international drug control conventions overseen by United Nations specialized agencies and treaty bodies and under national drug control laws. Those national laws and regulations directly affect bedside availability of Internationally Controlled Essential Medicines (ICEMs). The complex interaction between national regulatory systems and global supply chains (now impacted by COVID-19 pandemic) directly affects bedside availability of ICEMs and patient care. Despite decades of global civil society advocacy in the United Nations system, ICEMs have remained chronically unavailable, inaccessible, and unaffordable in low- and-middle-income countries, and there are recent reports of shortages in high-income countries as well. The most prevalent symptoms in COVID-19 are breathlessness, cough, drowsiness, anxiety, agitation, and delirium. Frequently used medicines include opioids such as morphine or fentanyl and midazolam, all of them listed as ICEMs. This paper describes the issues related to the lack of availability and limited access to ICEMs during the COVID-19 pandemic in both intensive and palliative care patients in countries of all income levels and makes recommendations for improving access.

In the Republic of Georgia, the incidence and prevalence of cancer are increasing, signifying a growing need for palliative care and pain relief, including with controlled opioid medicines. As a signatory to the Single Convention, the Georgian government has a responsibility to ensure the adequate availability of controlled medicines for medical purposes; however, the consumption of morphine is very low, suggesting a high occurrence of unrelieved pain. In Georgia, palliative care development began in the 2000s including the adoption of a policy document in 2005, the creation of the National Palliative Care Coordinator in 2006, and important changes in Georgian legislation in 2007 and 2008, which served to lay a foundation for improving opioid availability. In 2008, a neurologist from the Sarajishvili Institute of Neurology and Neurosurgery in Tbilisi, and member of the Georgia National Association for Palliative Care, was selected to be an International Pain Policy Fellow to focus on improving opioid availability. Working with colleagues, government officials, and international experts, the Fellow contributed to several improvements to opioid availability, such as 1) positive changes to opioid prescribing legislation, 2) clarification of legislative terminology regarding dependence syndrome, 3) initiating the importation of both sustained-release and immediate-release oral morphine, and 4) improvements in the availability of sustained-release morphine. Despite these varied achievements, morphine consumption remains low in Georgia relative to the estimated amounts needed. The Fellow is continuing to study and understand the barriers that are impeding physician's prescription of opioids and patient's acceptance of them.

Managing cancer pain in older adults can be complex and challenging. Understanding the unique needs of older patients with cancer is important to safe and effective pain management. The goals of this review are to discuss the assessment of older adults with cancer-related pain, treatment of cancer pain, and adverse effects or potential risks from treatment that are unique to older patients. A detailed pain assessment and when possible utilizing the geriatric assessment are vital to developing a cancer pain management plan. The geriatric assessment can help clinicians uncover problems not routinely assessed in the standard oncologic evaluation. Opioid pain medications are safe and effective for older adults with cancer pain as long as these medications are closely monitored and titrated slowly. In addition to the well-known adverse effects of opioid medications, clinicians need to be aware of the unique risks in older adults, which could include delirium, polypharmacy, and falls.

Background Despite interest in using virtual humans (VHs) for assessing health care communication, evidence of validity is limited. We evaluated the validity of a VH application, MPathic-VR, for assessing performance-based competence in breaking bad news (BBN) to a VH patient. Methods We used a two-group quasi-experimental design, with residents participating in a 3-hour seminar on BBN. Group A (n=15) completed the VH simulation before and after the seminar, and Group B (n=12) completed the VH simulation only after the BBN seminar to avoid the possibility that testing alone affected performance. Pre- and postseminar differences for Group A were analyzed with a paired t-test, and comparisons between Groups A and B were analyzed with an independent t-test. Results Compared to the preseminar result, Group A’s postseminar scores improved significantly, indicating that the VH program was sensitive to differences in assessing performance-based competence in BBN. Postseminar scores of Group A and Group B were not significantly different, indicating that both groups performed similarly on the VH program. Conclusion Improved pre–post scores demonstrate acquisition of skills in BBN to a VH patient. Pretest sensitization did not appear to influence posttest assessment. These results provide initial construct validity evidence that the VH program is effective for assessing BBN performance-based communication competence., Video abstract

The lack of adequate access to opioids in India as analgesics and for agonist therapies, forces millions to live with severe unalleviated pain, or languish with suffering associated with drug dependence. Although India is a major opium exporter, the excessively prohibitive 1985 narcotics law formulated to control harmful use of drugs, impeded the availability and access to opioids for medical and scientific purposes. Amendment of this law in 2014 established a new national regulatory framework for improved access to essential opioid analgesics. This article reflects on key elements and processes that led to this landmark achievement. Unlike quick timelines associated with effecting policy reforms for law enforcement, realizing the 2014 drug policy change primarily to mitigate human suffering, was a 22-year-long process. The most exacting challenges included recognizing the multilayered complexities of the prior policy framework and understanding their adverse impact on field practices to chart an appropriate and viable path for reform. The evolution of an informal civil society movement involving health care professionals, lawyers, media, policy analysts, government officials, and the public was pivotal in addressing these challenges and garnering momentum for reform. The success of the effort for improving access to opioid medications was underpinned by a three-pronged strategy of 1) persuading the executive arm of the government to take interim enabling measures; 2) leveraging judicial intervention through public interest litigation; and 3) crafting a viable policy document for legislative approval and implementation. We hope our findings are useful for realizing drug policy reforms, given the current transformed global policy mandates emphasizing humanitarian, healthcare, and quality-of-life considerations.

Background Attending to the wide range of communication behaviors that convey empathy is an important but often underemphasized concept to reduce errors in care, improve patient satisfaction, and improve cancer patient outcomes. A virtual human (VH)–based simulation, MPathic-VR, was developed to train health care providers in empathic communication with patients and in interprofessional settings and evaluated through a randomized controlled trial. Objective This mixed methods study aimed to investigate the differential effects of a VH-based simulation developed to train health care providers in empathic patient-provider and interprofessional communication. Methods We employed a mixed methods intervention design, involving a comparison of 2 quantitative measures—MPathic-VR–calculated scores and the objective structured clinical exam (OSCE) scores—with qualitative reflections by medical students about their experiences. This paper is a secondary, focused analysis of intervention arm data from the larger trial. Students at 3 medical schools in the United States (n=206) received simulation to improve empathic communication skills. We conducted analysis of variance, thematic text analysis, and merging mixed methods analysis. Results OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F1,414=6.09; P=.01). Qualitative analysis revealed 3 major positive themes for the MPathic-VR group learners: gaining useful communication skills, learning awareness of nonverbal skills in addition to verbal skills, and feeling motivated to learn more about communication. Finally, the results of the mixed methods analysis indicated that most of the variation between high, middle, and lower performers was noted about nonverbal behaviors. Medium and high OSCE scorers most often commented on the importance of nonverbal communication. Themes of motivation to learn about communication were only present in middle and high scorers. Conclusions VHs are a promising strategy for improving empathic communication in health care. Higher performers seemed most engaged to learn, particularly nonverbal skills.

BACKGROUND Attending to the wide range of communication behaviors that convey empathy is an important but often underemphasized concept to reduce errors in care, improve patient satisfaction, and improve cancer patient outcomes. A virtual human (VH)–based simulation, MPathic-VR, was developed to train health care providers in empathic communication with patients and in interprofessional settings and evaluated through a randomized controlled trial. OBJECTIVE This mixed methods study aimed to investigate the differential effects of a VH-based simulation developed to train health care providers in empathic patient-provider and interprofessional communication. METHODS We employed a mixed methods intervention design, involving a comparison of 2 quantitative measures—MPathic-VR–calculated scores and the objective structured clinical exam (OSCE) scores—with qualitative reflections by medical students about their experiences. This paper is a secondary, focused analysis of intervention arm data from the larger trial. Students at 3 medical schools in the United States (n=206) received simulation to improve empathic communication skills. We conducted analysis of variance, thematic text analysis, and merging mixed methods analysis. RESULTS OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F1,414=6.09; P=.01). Qualitative analysis revealed 3 major positive themes for the MPathic-VR group learners: gaining useful communication skills, learning awareness of nonverbal skills in addition to verbal skills, and feeling motivated to learn more about communication. Finally, the results of the mixed methods analysis indicated that most of the variation between high, middle, and lower performers was noted about nonverbal behaviors. Medium and high OSCE scorers most often commented on the importance of nonverbal communication. Themes of motivation to learn about communication were only present in middle and high scorers. CONCLUSIONS VHs are a promising strategy for improving empathic communication in health care. Higher performers seemed most engaged to learn, particularly nonverbal skills.

Purpose The purpose of this new resource-stratified guideline is to provide expert guidance to clinicians and policymakers on implementing palliative care of patients with cancer and their caregivers in resource-constrained settings and is intended to complement the Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update of 2016. Methods ASCO convened a multidisciplinary, multinational panel of experts in medical oncology, family medicine, radiation oncology, hematology/oncology, palliative and/or hospice care, pain and/or symptom management, patient advocacy, public health, and health economics. Guideline development involved a systematic literature review, a modified ADAPTE process, and a formal consensus-based process with the Expert Panel and additional experts (consensus ratings group). Results The systematic review included 48 full-text publications regarding palliative care in resource-constrained settings, along with cost-effectiveness analyses; the evidence for many clinical questions was limited. These provided indirect evidence to inform the formal consensus process, which resulted in agreement of ≥ 75% (by consensus ratings group including Expert Panel). Recommendations The recommendations help define the models of care, staffing requirements, and roles and training needs of team members in a variety of resource settings for palliative care. Recommendations also outline the standards for provision of psychosocial support, spiritual care, and opioid analgesics, which can be particularly challenging and often overlooked in resource-constrained settings. Additional information is available at www.asco.org/resource-stratified-guidelines . It is the view of ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines.

Context Unplanned cancer-related hospital admissions often herald entry into the final phase of life. Hospitalized patients with advanced cancer have a high symptom burden and a short life expectancy, which may warrant palliative care intervention. Objectives To identify the impact of implementing triggered palliative care consultation (TPCC) as part of standard care for patients admitted to the solid-tumor oncology service with advanced cancer. Methods We conducted a prospective, sequential, three-cohort study to evaluate TPCC feasibility and impact using patient-reported outcomes, electronic medical records to identify resource utilization, and surveys of oncologists' perspectives on TPCC. Results Sixty-five patients were evaluated before TPCC implementation (Cohort 1). Seventy patients (Cohort 2) were evaluated after initiation of TPCC, and 68 patients (Cohort 3) were evaluated after modifications based on implementation barriers identified in Cohort 2. The percentage of patients correctly identifying their cancer as incurable increased from 65% in Cohort 1 to 94% in Cohorts 2 and 3. TPCC had minimal impact on hospice utilization, cost of care, survival, patient-reported symptoms, and patient satisfaction, likely because of the limited nature of the intervention. Implementation was challenging, with only 60% of patients in Cohort 2 and 62% in Cohort 3 receiving TPCC. Overall, the intervention was viewed favorably by 74% of oncologists. Conclusion Although TPCC was viewed favorably, implementation was logistically challenging because of short stays, high-acuity symptoms, and individual provider resistance. TPCC improved patients' understanding of their cancer. This population demonstrates high palliative care needs, warranting further research into how best to deliver care.

Summary Supportive care and palliative care are now recognised as critical components of global cancer control programmes. Many aspects of supportive and palliative care services are already available in some low-income and middle-income countries. Full integration of supportive and palliative care into breast cancer programmes requires a systematic, resource-stratified approach. The Breast Health Global Initiative convened three expert panels to develop resource allocation recommendations for supportive and palliative care programmes in low-income and middle-income countries. Each panel focused on a specific phase of breast cancer care: during treatment, after treatment with curative intent (survivorship), and after diagnosis with metastatic disease. The panel consensus statements were published in October, 2013. This Executive Summary combines the three panels' recommendations into a single comprehensive document covering breast cancer care from diagnosis through curative treatment into survivorship, and metastatic disease and end-of-life care. The recommendations cover physical symptom management, pain management, monitoring and documentation, psychosocial and spiritual aspects of care, health professional education, and patient, family, and caregiver education.

Globally, cancer incidence and mortality are increasing, and most of the burden is shifting to low- and middle-income countries (LMICs), where patients often present with late-stage disease and severe pain. Unfortunately, LMICs also face a disproportionate lack of access to pain-relieving medicines such as morphine, despite the medical and scientific literature that shows morphine to be effective to treat moderate and severe cancer pain. In 2008, an oncologist from Nepal, one of the poorest countries in the world, was selected to participate in the International Pain Policy Fellowship, a program to assist LMICs, to improve patient access to pain medicines. Following the World Health Organization public health model for development of pain relief and palliative care, the Fellow, working with colleagues and mentors, has achieved initial successes: three forms of oral morphine (syrup, immediate-release tablets, and sustained-release tablets) are now manufactured in the country; health-care practitioners are receiving training in the use of opioids for pain relief; and a new national palliative care association has developed a palliative care training curriculum. However, long-term implementation efforts, funding, and technical assistance by governments, philanthropic organizations, and international partners are necessary to ensure that pain relief and palliative care become accessible by all in need in Nepal and other LMICs.

Palliative care has been shown to provide significant and diverse benefits for patients with serious, complex, or life-limiting health problems. Such benefits include the following: Reduced physical, psychological, and spiritual suffering (Abernethy and others 2003; Gwyther and Krakauer 2011; Higginson and others 2014; Krakauer 2008; Singer and others 2016; Temel and others 2010; WHO 2008; Zimmerman and others 2014) Improved quality of life (Singer and others 2016; Zimmerman and others 2014) Prolonged survival in some situations (Connor and others 2007; Temel and others 2010). Palliative care also can lower costs to health care systems (Chalkidou and others 2014; DesRosiers and others 2014; Gomez-Batiste and others 2012; Jamison and others 2013; Knaul and others 2017; Summers 2016). For these reasons, it is recognized globally as an ethical responsibility of all health care systems and a necessary component of universal health coverage (World Health Assembly 2014). Yet palliative care is rarely accessible in low- and middle-income countries (LMICs). This chapter describes an essential package (EP) of palliative care services and treatments that could and should be accessible to everyone everywhere, as well as the sites or platforms where those services and treatments could be offered. Thus, it was necessary to make a preliminary estimate of the burden of health-related suffering requiring palliative care.To roughly estimate the need for palliative care, we identified the serious, complex, or life-limiting conditions listed in the International Classification of Diseases (ICD)-10 that most commonly result in physical, psychological, social, or spiritual suffering (WHO 2015a). We then estimated the types, prevalence, and duration of suffering resulting from each condition. On the basis of this characterization of the burden of suffering, we propose an EP of palliative care and pain control designed to do the following: Prevent or relieve the most common and severe suffering related to illness or injury. Be affordable, even in LMICs. Provide financial risk protection for patients and families by providing a realistic alternative to expensive, low-value treatment. We costed the EP in one low-income country (Rwanda), one lower-middle-income country (Vietnam), and one upper-middle-income country (Mexico) and projected these costs for LMICs in general (Knaul and others 2017). At the conclusion of this chapter, we provide guidance on how to integrate the EP into health systems as an essential element of universal health coverage (UHC) in LMICs. We also discuss how to augment the EP as soon as is feasible to further prevent and relieve suffering.This chapter draws directly on the work of the Lancet Commission on Global Access to Palliative Care and Pain Control (the Lancet Commission) (Knaul and others 2017).

For two decades, the Pain & Policy Studies Group (PPSG), a global research program at the University of Wisconsin Carbone Cancer Center, has worked passionately to fulfill its mission of improving pain relief by achieving balanced access to opioids worldwide. PPSG's early work highlighted the conceptual framework of balance leading to the development of the seminal guidelines and criteria for evaluating opioid policy. It has collaborated at the global level with United Nations agencies to promote access to opioids and has developed a unique model of technical assistance to help national governments assess regulatory barriers to essential medicines for pain relief and amend existing or develop new legislation that facilitates appropriate and adequate opioid prescribing according to international standards. This model was initially applied in regional workshops and individual country projects and then adapted for PPSG's International Pain Policy Fellowship, which provides long-term mentoring and support for several countries simultaneously. The PPSG disseminates its work online in several ways, including an extensive Web site, news alerts, and through several social media outlets. PPSG has become the focal point for expertise on policy governing drug control and medicine and pharmacy practice related to opioid availability and pain relief.

Challenges exist in assimilating palliative care within community-based services for nursing home eligible low-income elders with complex chronic illness as they approach the end of life (EOL). This study assessed the feasibility of a consultation model, with hospice clinicians working with three Care Wisconsin Partnership Program teams. Consults occurred primarily during team meetings and also informally and on joint patient visits and were primarily with the palliative care nurse addressing physical issues. Fifty-seven percent of consultant recommendations were implemented. Benefits of consultation were identified with focus groups of clinical staff as were opportunities and barriers to the implementation. Models of integration are proposed.

Asia is a heterogeneous region with substantial variability in economic, social and palliative care development. While the global consumption of opioids has increased, the consumption in most Asian countries has not increased at the same rate. This is the first comprehensive study of opioid availability and accessibility for cancer patients in Asia. Data are reported on the availability and accessibility of opioids for the management of cancer pain in 20 of 28 countries. The countries in the report represent 2515 million of the region's 2612 million people (96%). With the exception of Japan and South Korea, opioid availability continues to be low throughout most of Asia. Formulary deficiencies are severe in several countries, in particular Bangladesh, Myanmar, Afghanistan, Kazakhstan and Laos. Even when opioids are on formulary, they are often unavailable, particularly in the same countries. Access is significantly impaired by widespread over-regulation that continues to be pervasive across the region.

Introduction: Patients with incurable cancer have poor prognostic awareness. We present a detailed analysis of the dialogue between oncologists and patients in conversations with prognostic implications. Methods: A total of 128 audio-recorded encounters from a large multisite trial were obtained, and 64 involved scan results. We used conversation analysis, a qualitative method for studying human interaction, to analyze typical patterns and conversational devices. Results: Four components consistently occurred in sequential order: symptom-talk, scan-talk, treatment-talk, and logistic-talk. Six of the encounters (19%) were identified as good news, 15 (45%) as stable news, and 12 (36%) as bad news. The visit duration varied by the type of news: good, 15 minutes (07:00-29:00); stable, 17 minutes (07:00-41:00); and bad, 20 minutes (07:00-28:00). Conversational devices were common, appearing in half of recordings. Treatment-talk occupied 50% of bad-news encounters, 31% of good-news encounters, and 19% of stable-news encounters. Scan-talk occupied less than 10% of all conversations. There were only four instances of frank prognosis discussion. Conclusion: Oncologists and patients are complicit in constructing the typical encounter. Oncologists spend little time discussing scan results and the prognostic implications in favor of treatment-related talk. Conversational devices routinely help transition from scan-talk to detailed discussions about treatment options. We observed an opportunity to create prognosis-talk after scan-talk with a new conversational device, the question “Would you like to talk about what this means?” as the oncologist seeks permission to disclose prognostic information while ceding control to the patient.

Despite improvements in cancer therapies, cancer is the leading cause of death worldwide. Many patients experience severe, unnecessary symptoms during treatment as well as at the end of life. Often, patients receive 'aggressive' care at the end of life that is discordant with their preferences. Palliative care is an approach that focuses on communication and quality of life, including treatment of physical, psychosocial, and spiritual suffering. This approach is appropriate for patients with life-limiting cancer, throughout the course of their disease. A growing body of evidence supports the integration of palliative care into routine cancer care, owing to the benefits in symptom control, quality of life, patient satisfaction, and resource utilization. Palliative care can be delivered in inpatient, outpatient, and home-based settings. The specialty and associated infrastructure is expanding rapidly with support from the international medical community. The ideal model of how to incorporate palliative care providers into the care of patients with cancer is yet to be defined; future research is needed to develop delivery systems and improve access to palliative care services. Through collaboration between oncologists and palliative care teams, there is hope of improving the quality of care for patients with both curable and life-limiting cancers.

Background: Many international governmental and nongovernmental organizations regard unrelieved cancer pain as a significant global public health problem. Although opioids such as morphine are considered essential medicines in the provision of palliative care and for treating cancer pain, especially when the pain is severe, low- and middle-income countries often lack such medications. Aim: The primary aim of this study was to examine countries’ government and health-care system influences on opioid availability for cancer pain and palliative care, as a means to identify implications for improving appropriate access to prescription opioids. Design: A multivariate regression of 177 countries’ consumption of opioids (in milligrams/death from cancer and AIDS) contained country-level predictor variables related to public health, including Human Development Index, palliative care infrastructure, and health system resources and expenditures. Results: Results were highly explanatory (adjusted R2 = 82%) and Human Development Index was the most predictive variable when controlling for all other factors in the statistical model (B = 11.875, confidence interval = 10.216, 13.534, p < 0.0001). Conclusions: Study findings demonstrate that a limited number of predictor variables characterizing a country’s government and health-care system infrastructure can explain its opioid consumption level, with the greatest influence being very high Human Development Index. However, Human Development Index is not the most policy-relevant factor, and this finding should be reconciled against the reality that many countries with low or medium Human Development Index have succeeded in creating and sustaining a health-care system to strengthen cancer pain care and palliative care, including through the appropriate use of essential prescription opioids.

In 2011, the World Health Organization (WHO) published a series of 21 guidelines to assist governments in improving their national drug control laws, regulations, and administrative procedures to promote the availability of controlled medicines for pain relief and for a variety of acute and chronic diseases and conditions. These guidelines ultimately are designed to encourage the development of policies designed to fulfill a country's dual obligation concerning these medicines: to prevent their abuse, diversion and trafficking while ensuring access for medical and scientific purposes. This article summarizes each guideline and outlines the constituents who can actively participate in making controlled medicines available to the patients who need them. It is hoped that representatives of governments and medical institutions, as well as health care professionals, will commonly and effectively use the revised WHO guidelines as a policy change tool.

85 Background: The purpose of the new ASCO resource-stratified guideline on global palliative care (Osman H, Shrestha S, Temin S, et al, Palliative Care in the Global Setting: ASCO Resource-Stratified Practice Guideline, JGO, 2018) is to provide expert guidance to clinicians and policymakers on implementing palliative care in resource-constrained settings and was intended to complement the 2016 “Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update”. Methods: ASCO convened a multidisciplinary, multinational panel of experts. Guideline development involved a systematic review, a modified ADAPTE process of existing high-quality guidelines and a formal consensus-based process with the expert panel and additional experts (consensus ratings group), as well as open comment. Results: The systematic review included 48 full-text publications regarding palliative care in resource-constrained settings, along with cost-effectiveness analyses; the evidence for many clinical questions was limited. These provided indirect evidence to inform the formal consensus process, which resulted in agreement of ≥ 75% (by consensus ratings group including expert panel). Conclusions: The recommendations help define: the models of care, staffing requirements, and roles and training needs of team members in a variety of resource settings for palliative care. Recommendations also outline the standards for provision of psychosocial support, spiritual care, and opioid analgesics, which can be particularly challenging and often overlooked in resource-constrained settings.

Caregivers maintain critical roles in cancer patient care. Understanding cancer-related information effects both caregiver involvement and ability to have needs met. This study examines the mediating role caregiver's clinic visit involvement has on the relationships between caregiver's information competence and their need fulfillment and clinic visit satisfaction.Secondary analysis of 112 advanced lung, breast, and prostate cancer caregivers participating in a large clinical trial. Caregiver information competence was assessed at pretest. Involvement, need fulfillment, and visit satisfaction were assessed immediately following the clinic appointment.Involvement correlated with information competence (r=.21, p.05), need fulfillment (r=.48, p.001), and satisfaction (r=.35, p.001). The correlation between information competence and need fulfillment (r=.26, p.01) decreased when controlling for involvement (r=.19, p=.049), demonstrating mediation, and accounted for 24.4% of the variance in need fulfillment. The correlation between information competence and satisfaction (r=.21, p=.04), decreased and was non-significant when controlling for involvement (r=.15, p=.11), demonstrating mediation, and accounted for 13% of variance in visit satisfaction.Caregiver's clinic visit involvement mediates the relationships between their information competence and their need fulfillment and visit satisfaction.Efforts to improve the caregiving experience, and potentially patient outcomes, should focus on system-wide approaches to facilitating caregivers' involvement and assertiveness in clinical encounters.

Previous research has indicated that treatment staff often underestimate the informational needs of cancer patients. In this study, the authors determined the total number of information sources obtained and used to influence treatment decisions, and the clinical and demographic factors associated with the use of specific sources of information in cancer patients. Participants were identified by the statewide cancer registry and diagnosed in 2004 with breast, colorectal, lung, or prostate cancer. A self-administered mailed questionnaire elicited cancer treatments, demographics, and information sources used to make treatment decisions. Of those surveyed, 1,784 (66%) participated and responded to all questions regarding information use. Over 69% of study participants reported obtaining information from a source other than the treatment staff. Significant predictors of using additional information sources included younger age, higher income, higher education, complementary and alternative medicine (CAM) use, and reporting shared decision making (all p values

Objectives To assess advanced communication skills among second-year medical students exposed either to a computer simulation (MPathic-VR) featuring virtual humans, or to a multimedia computer-based learning module, and to understand each group’s experiences and learning preferences. Methods A single-blinded, mixed methods, randomized, multisite trial compared MPathic-VR (N = 210) to computer-based learning (N = 211). Primary outcomes: communication scores during repeat interactions with MPathic-VR’s intercultural and interprofessional communication scenarios and scores on a subsequent advanced communication skills objective structured clinical examination (OSCE). Multivariate analysis of variance was used to compare outcomes. Secondary outcomes: student attitude surveys and qualitative assessments of their experiences with MPathic-VR or computer-based learning. Results MPathic-VR-trained students improved their intercultural and interprofessional communication performance between their first and second interactions with each scenario. They also achieved significantly higher composite scores on the OSCE than computer-based learning-trained students. Attitudes and experiences were more positive among students trained with MPathic-VR, who valued its providing immediate feedback, teaching nonverbal communication skills, and preparing them for emotion-charged patient encounters. Conclusions MPathic-VR was effective in training advanced communication skills and in enabling knowledge transfer into a more realistic clinical situation. Practice implications MPathic-VR’s virtual human simulation offers an effective and engaging means of advanced communication training.

Despite substantial effort and expenditure, at least one-third of patients diagnosed with cancer in high-income countries (HICs) die of their disease within a few years of diagnosis (National Cancer Institute 2009). In low- and middle-income countries (LMICs), two-thirds succumb, because the cancer types prevalent in LMICs tend to have poor prognoses, most cancers are advanced when diagnosed, and even for curable cancers few people have access to effective cancer treatment. For rich and poor everywhere, cancer can cause pain and severe distress, especially during the last few months of life. Cancer-related pain is not the exclusive domain of those who die of cancer. Even many who are cured of their disease live with the long-term effects of the disease and its treatment; many of them live with pain, as do people with a range of chronic conditions other than cancer.For the majority of cancer patients in LMICs, the most effective and feasible intervention for pain control is medication. For mild pain, over-the-counter, inexpensive analgesic medicines can provide adequate relief. When these nonopioids no longer relieve pain, then weak opioids, such as codeine, may work. Cancer patients most often experience worsening pain as their cancer progresses; 70–80 percent progress to severe pain, which only strong opioid medicines can relieve.Other approaches are effective for specific pain indications; the most widely applicable are palliative radiotherapy and surgery. Chemotherapy, neurologic, psychological, and other approaches also can be effective (see Foley and others 2006 for a comprehensive listing). All but analgesic medications and psychological approaches require access to well-developed health care facilities; these are usually available in large urban areas of middle-income countries (MICs), although not necessarily in sufficient numbers, but they may not exist at all in low-income countries (LICs). For example, many countries have no radiotherapy centers, and many have only one center (International Atomic Energy Agency Directory of Radiotherapy Centres, http://www-naweb.iaea.org/nahu/dirac/default.asp ). Palliative surgery and palliative radiotherapy are discussed further in chapters 13 and 14, respectively. The focus of this chapter is pain control medication, which can relieve most cancer pain and can be delivered at home, even in remote areas.Since 1990, the World Health Organization (WHO) and other bodies have offered definitions of palliative care. These definitions differ in specifics but share a common vision of care that emphasizes effective pain relief and a team approach to care throughout the course of the illness (Cleary and Carbone 1997; Foley and Gelband 2001; Morrison and Meier 2011; WHO 1990). The primary goal of palliative care is improving the quality of life of patients and those around them; it is not the prolongation of life or the hastening of death. Access to pain relief has been declared a human right (Brennan, Carr, and Cousins 2007; Gwyther, Brennan, and Harding 2009; International Pain Summit of the International Association for the Study of Pain 2011; Lohman, Schleifer, and Amon 2010).From a global perspective, the growth of palliative care has been largely limited to HICs, which also rank high on the Human Development Index (HDI). The availability of palliative care—using the availability of opioid medicines as a surrogate—is correlated with a country’s HDI. At the low end, the availability is almost nil, and repeated surveys have shown that this availability changed only marginally between 2006 and 2011 (Gilson and others 2013).In the previous edition of Disease Control Priorities in Developing Countries, Foley and others (2006) documented the global problem of low access to adequate pain relief in LMICs. Since then, a few countries have improved access, but these accomplishments are sporadic; in many countries, the change is negligible. Now, there is both cause for optimism and the view of a long road ahead. Efforts to support leaders in reforming policy and clinical practice in LMICs have grown and provide a basis for improvements (Cherny and others 2013; Cleary, Radbruch, and others 2013).This chapter describes the current state of pain relief in LMICs, consistent with WHO’s use of opioid consumption as a surrogate for access to palliative care in the Global Monitoring Framework for Noncommunicable Diseases (WHO 2013a). We describe the gaps in pain control access across countries, analyze the barriers to improving its delivery, and describe the costs and benefits that might accrue from removing the barriers.Evidence summarized in this chapter focuses on the modest costs and substantial benefits of providing pain control, and it supports increased efforts in the short term. Pain control medication and other aspects of palliative care can lead, rather than follow, increased efforts in cancer treatment, relying on interventions that are part of a more advanced cancer control and treatment infrastructure.

Cancer is the second leading cause of death in Serbia, and at least 14,000-16,000 patients experience moderate-to-severe cancer pain every year. Cancer pain relief has been impeded by inadequate availability of opioid analgesics and barriers to their accessibility. In 2006, a Serbian oncologist was selected as an International Pain Policy Fellow. The fellow identified barriers to opioid availability in Serbia and implemented an action plan to address the unavailability of oral morphine, attitudinal and knowledge barriers about opioids, and barriers in the national opioid control policy, in collaboration with the government, local partners, and international experts, including those from the World Health Organization. Collaborative efforts resulted in availability of immediate-release oral morphine, registration of controlled-release hydromorphone, and reimbursement of oral methadone for cancer pain; numerous educational activities aimed at changing inadequate knowledge and negative attitudes toward opioids; recognition of opioids as essential medicines for palliative care in a new National Palliative Care Strategy; and recognition of the medical use of opioids as psychoactive-controlled substances for the relief of pain included in a new national law on psychoactive-controlled substances, and the development of recommendations for updating regulations on prescribing and dispensing opioids. An increase in opioid consumption at the institutional and national levels also was observed. This article outlines a multifaceted approach to improving access to strong opioids for cancer pain management and palliative care in a middle-income country and offers a potential road map to success.

Purpose. Flavopiridol (NSC 649890) is a synthetic flavone possessing significant antitumor activity in preclinical models. Flavopiridol is capable of inducing cell cycle arrest and apoptosis, presumably through its potent, specific inhibition of cyclin-dependent kinases. We conducted a phase I trial and pharmacokinetic study of flavopiridol given as a 72-h continuous intravenous infusion repeated every 2 weeks. Methods. A total of 38 patients were treated at dose levels of 8, 16, 26.6, 40, 50 and 56 mg/m2/24 h. During the first infusion, plasma was sampled at 24, 48 and 72 h to determine steady-state concentrations, and peripheral blood lymphocytes were assessed by flow cytometry for evidence of apoptosis. Additional postinfusion pharmacokinetic sampling was done at the 40 and 50 mg/m2/24 h dose levels. Results. Gastrointestinal toxicity was dose limiting, with diarrhea being the predominant symptom. Symptomatic orthostatic hypotension was also frequently noted. Several patients experienced tumor-specific pain during their infusions. The maximum tolerated dose (MTD) was determined to be 40 mg/m2/24 h. A patient with metastatic gastric cancer at this dose level had a complete response and remained disease-free for more than 48 months after completing therapy. Plasma concentrations at 24 h into the infusion were 94% of those achieved at steady state. Steady-state plasma flavopiridol concentrations at the MTD were 416.6±98.9 µM. These concentrations are at or above those needed to see cell cycle arrest and apoptosis in vitro. The mean clearance of flavopiridol over the dose range was 11.3±3.9 l/h per m2, similar to values obtained preclinically. Elimination was biphasic. The terminal half-life at the MTD was 26.0 h. No significant differences in pharmacokinetic parameters were noted between males and females. Patients taking cholestyramine to ameliorate flavopiridol-induced diarrhea had lower steady-state plasma concentrations. There was no significant change in the cell cycle parameters of peripheral blood lymphocytes analyzed by flow cytometry. Conclusions. The MTD and recommended phase II dose of flavopiridol given by this schedule is 40 mg/m2/24 h. The manageable gastroinestinal toxicity, early signs of clinical activity and lack of hematologic toxicity make further exploration in combination trials warranted.

Corticosteroids are commonly used in cancer medicine. Many chemotherapy regimens, especially those used in the treatment of hematologic malignancies, often include corticosteroids, sometimes athigh-doses.Oftentheimpactofthesuddencessationafter5daysof high-dose corticosteroids was the major adverse effect reported by patients. Even more recently, corticosteroids were included in the patients with cancer demonstrated that corticosteroids were used commonly; 50% of patients with cancer in the palliative care setting received corticosteroids. 5 The most common indications for starting corticosteroids in this survey were appetite loss (37%), fatigue (36%), and poor well-being (33%) while pain was an indication in 25%. A recentreportfromNewZealand 6 showedthatofalmost1,200patients receiving care from seven inpatient hospices, two thirds had received at least one course of corticosteroids during that care. The reasons for corticosteroids were a nonspecific indication (40%), neurologic symptoms (25.3%), and soft-tissue infiltration symptoms (14.4%). Detailed information was recorded for a sample of 260 patients with the agent of choice being dexamethasone with a median dose of 8 mg (dose range, 1 mg-40 mg). Corticosteroids were prescribed for a me- dian duration of 29 days per course. Abrupt stopping occurred in 72 (23.2%) cases; of these 35 (49%) had been on a course of corticoste- roids for more than 3 weeks. Corticosteroid-prescribing guidelines, including cessation titration, were only available in one hospice. Ad- verse effects were recorded in 82 (32%) but only 52% of the 260 had regular monitoring, thus suggesting that adverse events were in fact much more common than reported. But do corticosteroids make a difference? The study by Norwe- gian investigators in the article that accompanies this editorial 7 uses high level evidence from a randomized, double-blind, placebo- controlledtrial.Usingwell-validatedtools,theymeasuredtheeffectof methylprednisone (16 mg twice daily) on pain, fatigue, and appetite over a 1-week period. The study showed no difference in pain scores between the two groups when measured as absolute or percentage differences, and this negative finding was not changed by regression analysis. The study did find significant differences in appetite stimu- lation, fatigue, and overall satisfaction in favor of the corticoste- roid group.

Despite expert recognition that strong opioid analgesics are the cornerstone of treatment for moderate to severe pain, most of the world's population lacks adequate availability of opioids. Moreover, great disparities in availability of opioids continue to exist between higher- and lower-to-middle-income countries. This study examined more than 30 years of consumption data reported to the International Narcotics Control Board, from 1980 to 2011, for five opioids that are indicated for the treatment of moderate to severe pain: fentanyl, hydromorphone, morphine, oxycodone, and pethidine. As such, this study offers a regional and global perspective on opioid consumption, providing an indication of preparedness for treating moderate to severe pain. Countries are categorized according to the World Health Organization's six geographical regions. Morphine equivalence (ME) statistics were calculated for each study drug, allowing for equianalgesic comparisons between consumption of the study opioids and well as the ability to aggregate all study opioids (Total ME). The ME statistic is adjusted for country population, which allows for uniform global-, regional-, and country-level equianalgesic comparisons of consumption of morphine with other opioids. Although overall trend lines revealed general increases by region, profound inequities in opioid consumption continue to abound globally.

Cancer is primarily a disease of the elderly and the palliation of both disease- and treatment-related symptoms is of importance in the practice of cancer medicine in all patients. Many older patients are treated within community hospitals, in which anticancer therapies are less likely to be given and in which the palliation of symptoms should be of primary importance. Many oncologists struggle with the palliation of symptoms in patients who are near the end of life. This is despite the considerable energies that are spent in palliating symptoms in patients who are receiving anticancer therapies at all disease stages. The management of pain has advanced considerably recently with improvements in pain assessment and pharmacologic interventions. However, elderly patients are less likely than younger patients to receive proper pain management. Elderly patients also are less likely to take opioids for pain because of their attitudes and beliefs. Fatigue, dyspnea, and psychologic issues also are of importance in the management of elderly cancer patients both during anticancer therapy and near the time of death. Some elderly cancer patients die in the care of a hospice, although many are not referred to this service. There are many barriers to the provision of palliative medicine and these may be related to health practitioners, to the patients themselves, or to the health care system of which they are part. The increased educational efforts of health professionals are needed to ensure that all patients, including the elderly, have adequate palliation of their cancer-related symptoms.

Purpose To understand changes in pain severity over time and to explore the factors associated with pain changes in ambulatory patients with solid tumors. Patients and Methods We enrolled 3,106 patients with invasive cancer of the breast, prostate, colon/rectum, or lung from multiple sites. At baseline and 4 to 5 weeks later, patients rated their pain level on a 0 to 10 numerical rating scale. A 2-point change in pain score was defined as a clinically significant change in pain. Multivariable logistic models were fitted to examine the effects of pain management and demographic and clinical factors on change in pain severity. Results We analyzed 2,761 patients for changes in pain severity. At initial assessment, 53.0% had no pain, 23.5% had mild pain, 10.3% had moderate pain, and 13.2% had severe pain. Overall, one third of patients with initial pain had pain reduction within 1 month of follow-up, and one fifth had an increase, and the improvement and worsening of pain varied by baseline pain score. Of the patients without pain at initial assessment, 28.4% had pain (8.9% moderate to severe) at the follow-up assessment. Logistic regression analysis showed that inadequate pain management was significantly associated with pain deterioration, as were lower baseline pain level, younger age, and poor health status. Conclusion One third of patients have pain improvement and one fifth experience pain deterioration within 1 month after initial assessment. Inadequate pain management, baseline pain severity, and certain patient demographic and disease characteristics are associated with pain deterioration.

The reports of the Global Opioid Policy Initiative (GOPI) project to evaluate the availability and accessibility of opioids for the management of cancer pain in Africa, Asia, Latin America and the Caribbean, and the Middle East, together with the previous 2010 European Society for Medical Oncology (ESMO)/European Association for Palliative Care (EAPC) report from Europe, have provided critical data in demonstrating the deficiencies in many countries throughout the world. Formulary deficiencies and over-regulation are pandemic and must be addressed. This process is challenging and will require concerted and sustained efforts by clinical leaders and advocacy groups partnering with international and regional organizations and, of course, with national governments and their competent authorities. There is a growing international expertise and infrastructure to coordinate advocacy and strategic planning based on the World Health Organization (WHO) Model of Education, Policy Reform and Medication Availability.

9ESMO Palliative Care Working Group The nations of the Caribbean, Central America and South America form a heterogeneous region with substantial variability in economic, social and palliative care development. Palliative care provision is at varied stages of development throughout the region. The consumption of opioids in Latin America and the Caribbean is variable with moderate levels of consumption by international standards (1–10 mg morphine equivalents/capita/year) observed in Argentine, Brazil, Chile, Colombia, Cuba, Mexico, Costa Rica, Uruguay and most of the Caribbean but relatively low levels of consumption in other countries particularly Guatemala, Honduras and Bolivia. Data for Latin American and Caribbean is reported on the availability and accessibility of opioids for the management of cancer pain in 24 of the 33 countries surveyed. The results of this survey are relevant to 560 million of the region’s 595 million people (94%). Opioid availability continues to be low throughout most of Latin America and the Caribbean. While formularies in this region generally include all recommended morphine formulations, access is significantly impaired by widespread over-regulation that continues to be pervasive across the region.

The Middle East is a heterogeneous region with substantial variability in social development, wealth and palliative care development. The region has few democracies, strong but diverse religious affiliations, and many of the region's counties are involved in political upheavals or regional conflicts. While the global consumption of opioids has increased throughout the last 30 years, there has been little increase in opioid consumption in the Middle East. This is the first comprehensive study of opioid availability and accessibility of opioids in the Middle East. Data are reported on the availability and accessibility of opioids for the management of cancer pain in 16 of 24 countries. The data are relevant to 329 million of the region's 403 million people (82%). The survey found that with the exception of Israel, opioid availability continues to be low throughout most of the Middle East. Formulary deficiencies are severe in several countries in particular Afghanistan, Iraq, Lebanon, Libya, Palestine and Tunisia. Even when opioids are on formulary, they are often unavailable, particularly in these same countries. Access is also significantly impaired by widespread over-regulation that is pervasive across the region.

Informal caregivers (family and friends) of people with cancer are often unprepared for their caregiving role, leading to increased burden or distress. Comprehensive Health Enhancement Support System (CHESS) is a Web-based lung cancer information, communication, and coaching system for caregivers. This randomized trial reports the impact on caregiver burden, disruptiveness, and mood of providing caregivers access to CHESS versus the Internet with a list of recommended lung cancer websites.A total of 285 informal caregivers of patients with advanced nonsmall cell lung cancer were randomly assigned to a comparison group that received Internet or a treatment group that received Internet and CHESS. Caregivers were provided a computer and Internet service if needed. Written surveys were completed at pretest and during the intervention period bimonthly for up to 24 months. Analyses of covariance (ANCOVAs) compared the intervention's effect on caregivers' disruptiveness and burden (CQOLI-C), and negative mood (combined Anxiety, Depression, and Anger scales of the POMS) at 6 months, controlling for blocking variables (site, caregiver's race, and relationship to patient) and the given outcome at pretest.Caregivers randomized to CHESS reported lower burden, t(84) = 2.36, p = .021, d = .39, and negative mood, t(86) = 2.82, p = .006, d = .44, than those in the Internet group. The effect on disruptiveness was not significant.Although caring for someone with a terminal illness will always exact a toll on caregivers, eHealth interventions like CHESS may improve caregivers' understanding and coping skills and, as a result, ease their burden and mood.