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Background: Breathlessness frequently becomes severe among people with respiratory disease. Mirtazapine, a widely used antidepressant, has shown promise in the modulation of respiratory sensation and the response to it, as well as reducing feelings of panic, which often accompanies breathlessness. We aimed to determine the effectiveness of mirtazapine to alleviate severe persisting breathlessness., Methods: This international, multicentre, phase 3, parallel-group, double-blind, randomised, placebo-controlled trial across 16 centres in seven countries (Australia, Germany, Ireland, Italy, New Zealand, Poland, and the UK), recruited adults with chronic obstructive pulmonary disease (COPD), interstitial lung diseases, or both, and grade 3 or 4 of the modified Medical Research Council breathlessness scale. Consenting participants were randomly assigned (1:1) to receive oral mirtazapine or matching placebo for 56 days. Randomisation was by minimisation. The initial mirtazapine dose was 15 mg, escalating to a maximum of 45 mg per day, tapered at treatment end. Participants, caregivers, assessors, and investigators were masked to group assignment. The primary outcome was worst breathlessness in the preceding 24 h measured on a 0-10 numerical rating scale (NRS), at 56 days post-treatment start, with follow-up to 180 days. The primary analysis was performed in the modified intention-to-treat population using multivariable multi-level repeated measures model. This trial was registered with ISRCTN (ISRCTN10487976 and ISRCTN15751764 [Australia and New Zealand]) and EudraCT (2019-002001-21) and is complete., Findings: Between Feb 4, 2021 and March 28, 2023, we enrolled 225 eligible participants (148 men and 77 women, 113 to the mirtazapine group and 112 to the placebo group). The median age was 74 years (IQR 67-78). No evidence of a difference was found in worst breathlessness at day 56 between mirtazapine and placebo (difference in adjusted mean NRS score was 0·105 [95% CI -0·407 to 0·618]; p=0·69). Although the study was underpowered, the primary endpoint effect did not reach the pre-specified treatment effect of 0·55 for worst breathlessness score reduction that the study was powered to detect for the primary analysis. There were 215 adverse reactions in 72 (64%) of 113 participants in the mirtazapine group versus 116 in 44 (40%) of 110 participants in the placebo group; 11 serious adverse events in six (5%) participants in the mirtazapine group versus eight in seven (6%) participants in the placebo group; and one (1%) suspected unexpected serious adverse reaction in the mirtazapine group. At day 56, there were three deaths in the mirtazapine group and two deaths in the placebo group. At day 180, there were seven deaths in the mirtazapine group and 11 deaths in the placebo group., Interpretation: Our findings suggested that mirtazapine of doses 15 to 45 mg daily over 56 days does not improve severe breathlessness among patients with COPD or interstitial lung diseases and might cause adverse reactions. Based on these findings, we do not recommend mirtazapine as a treatment to alleviate severe breathlessness., Funding: EU Horizon 2020 (grant agreement No. 825319); Cicely Saunders International Breathlessness Programme; National Institute for Health and Care Research Applied Research Collaboration South London; Australian National Health and Medical Research Council-EU (application ID: APP1170731)., Competing Interests: Declaration of interests IJH reports grants from EU, Marie Curie Cancer Care, and National Institute for Health and Care Research (NIHR), and is Scientific Director of Cicely Saunders International, NIHR Emeritus Senior Investigator, and is an Honorary Clinical Consultant in Palliative Medicine for hospitals under Kings College Hospital National Health Service Foundation Trust outside of the submitted work. CEB reports grants from the EU, NIHR, AstraZeneca as well as an industry collaboration and a personal fee from Roche outside of the submitted work. JMBr reports grants from the EU and reports being an uncompensated NIHR Health Technology Assessment Funding Committee Chair outside of the submitted work. DCC reports personal fees from Helsinn Pharmaceuticals, Mayne Pharma International, Nous Group, iCare Dust Disease Board, and an unpaid consultant to Chris O'Brien Lighthouse outside of the submitted work. BF reports grants from the Wellcome Trust and is a member of the Ethics Advisory Board Our Future Health, Assurance Board member Cass Review, EU appointed Ethics Advisor to the River EU project, Advisory Board Member Italian MS ConCure project, Advisory Group for Monash University, and Advisory Panel Member for Economic and Social Research Council outside of the submitted work. SPH reports personal fees from Trevi Therapeutics, Boehringer Ingelheim, Chiesi, and is a Trustee for Action for Pulmonary Fibrosis outside of the submitted work. CB, MJJ, AOO, KR, and STS report grants from the EU. MM reports grants from the EU, UKRI, and NIHR. MK and PJ report grants from the EU and Poland Ministry of Science and Higher Education for participation in Horizon 2020. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objectives: To explore formal and informal care costs in the last 3 months of life for people with dementia, and to evaluate the association between transitions to hospital and usual place of care with costs., Design: Cross-sectional study using pooled data from 3 mortality follow-back surveys., Setting and Participants: People who died with dementia., Methods: The Client Service Receipt Inventory survey was used to derive formal (health, social) and informal care costs in the last 3 months of life. Generalized linear models were used to explore the association between transitions to hospital and usual place of care with formal and informal care costs., Results: A total of 146 people who died with dementia were included. The mean age was 88.1 years (SD 6.0), and 98 (67.1%) were female. The usual place of care was care home for 85 (58.2%). Sixty-five individuals (44.5%) died in a care home, and 85 (58.2%) experienced a transition to hospital in the last 3 months. The mean total costs of care in the last 3 months of life were £31,224.7 (SD 23,536.6). People with a transition to hospital had higher total costs (£33,239.2, 95% CI 28,301.8-39,037.8) than people without transition (£21,522.0, 95% CI 17,784.0-26,045.8), mainly explained by hospital costs. People whose usual place of care was care homes had lower total costs (£23,801.3, 95% CI 20,172.0-28,083.6) compared to home (£34,331.4, 95% CI 27,824.7-42,359.5), mainly explained by lower informal care costs., Conclusions and Implications: Total care costs are high among people dying with dementia, and informal care costs represent an important component of end-of-life care costs. Transitions to hospital have a large impact on total costs; preventing these transitions might reduce costs from the health care perspective, but not from patients' and families' perspectives. Access to care homes could help reduce transitions to hospital as well as reduce formal and informal care costs., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Context: Evidence of symptom control outcomes in severe COVID is scant., Objectives: To determine changes in symptoms among people severely ill or dying with COVID supported by palliative care, and associations with treatments and survival., Methods: Multicentre cohort study of people with COVID across England and Wales supported by palliative care services, during the pandemic in 2020 and 2021. We analysed clinical, demographic and survival data, symptom severity at baseline (referral to palliative care, first COVID assessment) and at three follow-up assessments using the Integrated Palliative care Outcome Scale - COVID version., Results: We included 572 patients from 25 services, mostly hospital support teams; 496 (87%) were newly referred to palliative care with COVID, 75 (13%) were already supported by palliative care when they contracted COVID. At baseline, patients had a mean of 2.4 co-morbidities, mean age 77 years, a mean of five symptoms, and were often bedfast or semiconscious. The most prevalent symptoms were: breathlessness, weakness/lack of energy, drowsiness, anxiety, agitation, confusion/delirium, and pain. Median time in palliative care was 46 hours; 77% of patients died. During palliative care, breathlessness, agitation, anxiety, delirium, cough, fever, pain, sore/dry mouth and nausea improved; drowsiness became worse. Common treatments were low dose morphine and midazolam. Having moderate to severe breathlessness, agitation and multimorbidity were associated with shorter survival., Conclusion: Symptoms of COVID quickly improved during palliative care. Breathlessness, agitation and multimorbidity could be used as triggers for timelier referral, and symptom guidance for wider specialities should build on treatments identified in this study., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Context: The growth of patient reported outcome measures data in palliative care provides an opportunity for machine learning to identify patterns in patient responses signifying different phases of illness., Objectives: The study will explore if machine learning and network analysis can identify phases in patient palliative status through symptoms reported on the Integrated Palliative Care Outcome Scale (IPOS)., Methods: A partly cross-sectional and partially longitudinal observational study was undertaken using the Australasian Karnofsky Performance Scale (AKPS); Integrated Palliative Care Outcome Scale (IPOS); Phase of Illness (POI). Patient palliative records (n = 1507, 65% stable, 20% unstable, 9% deteriorating, 2% terminal) from 804 adult patients enrolled in a New Zealand palliative care service were analysed using a combination of statistical, machine learning and network analysis techniques., Results: Data from IPOS showed considerable variation with phase. Also, network analysis showed clear associations between items by phase. Six machine learning techniques identified the most important variables for predicting possible transition between phases of illness. Network analysis for all patients showed that Poor Appetite and Loss of Energy were central IPOS items, with Loss of Energy linked to Drowsiness, Shortness of Breath and Lack of Mobility on the one hand, and Poor Appetite linked to Nausea, Vomiting, Constipation and Sore and Dry Mouth on the other., Conclusion: These preliminary results, when coupled with the latest technological developments in mobile apps and wearable technology, could point the way to increased use of digital therapeutics in continuous palliative care monitoring., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Context: Systematic data on the care of people dying with COVID-19 are scarce., Objectives: To understand the response of and challenges faced by palliative care services during the COVID-19 pandemic, and identify associated factors., Methods: We surveyed palliative care and hospice services, contacted via relevant organizations. Multivariable logistic regression identified associations with challenges. Content analysis explored free text responses., Results: A total of 458 services responded; 277 UK, 85 rest of Europe, 95 rest of the world; 81% cared for patients with suspected or confirmed COVID-19, 77% had staff with suspected or confirmed COVID-19; 48% reported shortages of Personal Protective Equipment (PPE), 40% staff shortages, 24% medicines shortages, 14% shortages of other equipment. Services provided direct care and education in symptom management and communication; 91% changed how they worked. Care often shifted to increased community and hospital care, with fewer admissions to inpatient palliative care units. Factors associated with increased odds of PPE shortages were: charity rather than public management (OR 3.07, 95% CI 1.81-5.20), inpatient palliative care unit rather than other settings (OR 2.34, 95% CI 1.46-3.75). Being outside the UK was associated with lower odds of staff shortages (OR 0.44, 95% CI 0.26-0.76). Staff described increased workload, concerns for their colleagues who were ill, whilst expending time struggling to get essential equipment and medicines, perceiving they were not a front-line service., Conclusion: Palliative care services were often overwhelmed, yet felt ignored in the COVID-19 response. Palliative care needs better integration with health care systems when planning and responding to future epidemics/pandemics., Competing Interests: Conflict of Interest IJH is a National Institute for Health Research (NIHR) Emeritus Senior Investigator and is supported by the NIHR Applied Research Collaboration (ARC) South London (SL) at King's College Hospital National Health Service Foundation Trust. IJH leads the Palliative and End of Life Care theme of the NIHR ARC SL and co-leads the national theme in this. MM is funded by a NIHR Career Development Fellowship (CDF-2017-10-009) and NIHR ARC SL. LF is funded by a NIHR Career Development Fellowship (CDF-2018-11-ST2-002). KS is funded by a NIHR Clinician Scientist Fellowship (CS-2015-15-005). RC is funded by Cicely Saunders International. FEM is a NIHR Senior Investigator. MBH is supported by the NIHR ARC SL. The views expressed in this article are those of the authors and not necessarily those of the NIHR, or the Department of Health and Social Care., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Context: Managing activities of daily living is important to people with advanced cancer or chronic obstructive pulmonary disease (COPD). Understanding disability in activities of daily living may inform service planning., Objective: To identify the prevalence of disability in activities of daily living, associations and change over time, in older people with advanced cancer or COPD., Methods: Secondary analysis of International Access, Rights and Empowerment (IARE) studies in adults aged ≥65 years with advanced disease in the United Kingdom, Ireland, and United States, using cross-sectional (IARE I & II) and longitudinal (IARE II, 3 timepoints over 6 months) data. Measures included disability in activities of daily living (Barthel Index), symptom severity (Palliative Outcome Scale), and assistive device use (self-reported). Logistic regression was used to identify relationships between disability and age, sex, living alone, diagnosis, and symptom burden; visual graphical analysis explores individual disability trajectories., Results: One hundred fifty-nine participants were included (140 cancer, 19 COPD). Sixty-five percent had difficulty climbing stairs, 48% bathing, 39% dressing, and 36% mobilizing. Increased disability was independently associated with increased symptom burden (odds ratio, 1.08 [95% CI:1.02-1.15], P = 0.01) and walking unaided (z = 2.35, P = 0.02), but not with primary diagnosis (z = -0.47, P = 0.64). Disability generally increased over time but with wide interindividual variation., Conclusion: Disability in activities of daily living in advanced cancer or COPD is common, associated with increased symptom burden, and may be attenuated by use of assistive devices. Individual disability trajectories vary widely, with diverse disability profiles. Services should include rehabilitative interventions, guided by disability in individual activities of daily living., (Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Palliative care is an essential component of the coronavirus disease 2019 (COVID-19) pandemic response but is overlooked in national and international preparedness plans. The preparedness and capacity of African palliative care services to respond to COVID-19 is unknown., Objectives: To evaluate the preparedness and capacity of African palliative care services to respond to the COVID-19 pandemic., Methods: We developed, piloted, and conducted a cross-sectional online survey guided by the 2005 International Health Regulations. It was electronically mailed to the 166 African Palliative Care Association's members and partners. Descriptive analyses were conducted., Results: About 83 participants from 21 countries completed the survey. Most services had at least one procedure for the case management of COVID-19 or another infectious disease (63%). Respondents reported concerns over accessing running water, soap, and disinfectant products (43%, 42%, and 59%, respectively) and security concerns for themselves or their staff (52%). Two in five services (41%) did not have any or make available additional personal protective equipment. Most services (80%) reported having the capacity to use technology instead of face-to-face appointment, and half (52%) reported having palliative care protocols for symptom management and psychological support that could be shared with nonspecialist staff in other health care settings., Conclusion: Our survey suggests that African palliative care services could support the wider health system's response to the COVID-19 pandemic with greater resources such as basic infection control materials. It identified specific and systemic weaknesses impeding their preparedness to respond to outbreaks. The findings call for urgent measures to ensure staff and patient safety., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Cases of coronavirus disease 2019 (COVID-19) are escalating rapidly across the globe, with the mortality risk being especially high among those with existing illness and multimorbidity. This study aimed to synthesize evidence for the role and response of palliative care and hospice teams to viral epidemics/pandemics and inform the COVID-19 pandemic response. We conducted a rapid systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines in five databases. Of 3094 articles identified, 10 were included in this narrative synthesis. Included studies were from West Africa, Taiwan, Hong Kong, Singapore, the U.S., and Italy. All had an observational design. Findings were synthesized using a previously proposed framework according to systems (policies, training and protocols, communication and coordination, and data), staff (deployment, skill mix, and resilience), space (community provision and use of technology), and stuff (medicines and equipment as well as personal protective equipment). We conclude that hospice and palliative services have an essential role in the response to COVID-19 by responding rapidly and flexibly; ensuring protocols for symptom management are available, and training nonspecialists in their use; being involved in triage; considering shifting resources into the community; considering redeploying volunteers to provide psychosocial and bereavement care; facilitating camaraderie among staff and adopting measures to deal with stress; using technology to communicate with patients and carers; and adopting standardized data collection systems to inform operational changes and improve care., (Copyright © 2020. Published by Elsevier Inc.)

Hospital palliative care is an essential part of the COVID-19 response but data are lacking. We identified symptom burden, management, response to treatment, and outcomes for a case series of 101 inpatients with confirmed COVID-19 referred to hospital palliative care. Patients (64 men, median [interquartile range {IQR}] age 82 [72-89] years, Elixhauser Comorbidity Index 6 [2-10], Australian-modified Karnofsky Performance Status 20 [10-20]) were most frequently referred for end-of-life care or symptom control. Median [IQR] days from hospital admission to referral was 4 [1-12] days. Most prevalent symptoms (n) were breathlessness (67), agitation (43), drowsiness (36), pain (23), and delirium (24). Fifty-eight patients were prescribed a subcutaneous infusion. Frequently used medicines (median [range] dose/24 hours) were opioids (morphine, 10 [5-30] mg; fentanyl, 100 [100-200] mcg; alfentanil, 500 [150-1000] mcg) and midazolam (10 [5-20] mg). Infusions were assessed as at least partially effective for 40/58 patients, while 13 patients died before review. Patients spent a median [IQR] of 2 [1-4] days under the palliative care team, who made 3 [2-5] contacts across patient, family, and clinicians. At March 30, 2020, 75 patients had died; 13 been discharged back to team, home, or hospice; and 13 continued to receive inpatient palliative care. Palliative care is an essential component to the COVID-19 response, and teams must rapidly adapt with new ways of working. Breathlessness and agitation are common but respond well to opioids and benzodiazepines. Availability of subcutaneous infusion pumps is essential. An international minimum data set for palliative care would accelerate finding answers to new questions as the COVID-19 pandemic develops., (Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

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., (Copyright © 2019 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Accurate assessment of a patient's palliative care needs is essential for the timely provision of treatment and support. The Integrated Palliative Care Outcome Scale (IPOS) is an ordinal measure possessing acceptable psychometric properties, but its ability to discriminate precisely between individual symptom levels has not been rigorously investigated., Objectives: The study aimed to conduct Rasch analysis of the IPOS to evaluate and enhance precision of the instrument., Methods: Responses of 300 community-dwelling palliative care patients were subjected to Rasch analysis using the partial credit model., Results: Initial analysis supported the use of the Rasch model and acceptable reliability (person separation index = 0.77) was observed; however, unsatisfactory model fit was found. Local dependency between items was resolved through the creation of super-items, which increased model fit, reliability (person separation index = 0.80), and unidimensionality. There were no misfitting super-items or differential item functioning by age, rater, sex, or ethnicity. The IPOS showed satisfactory coverage of symptoms within the present clinical sample, with the ability to assess higher severity patients., Conclusion: The modified IPOS showed excellent reliability for a clinical measure in assessing the overall palliative care needs of a patient. The provided ordinal-to-interval conversion table accounts for unique contribution of each symptom to the overall symptom burden and easy to use without the need to modify the original IPOS format., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Context: Breathlessness is common and distressing in advanced illness. It is a challenge to assess, with few effective treatment options. To evaluate new treatments, appropriate outcome measures that reflect the concerns of people experiencing breathlessness are needed., Objectives: The objective of this study was to systematically review and synthesize the main concerns of people with advanced illness experiencing breathlessness to guide comprehensive clinical assessment and inform future outcome measurement in clinical practice and research., Methods: This is a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology. MEDLINE (1946-2017), PsycINFO (1806-2017), and EMBASE (1974-2017), as well as key journals, gray literature, reference lists, and citation searches, identified qualitative studies exploring the concerns of people living with breathlessness. Included studies were quality-assessed using the Critical Appraisal Skills Program checklist and analyzed using thematic synthesis., Results: We included 38 studies with 672 participants. Concerns were identified across six domains of "total" breathlessness: physical, emotional, spiritual, social, control, and context (chronic and episodic breathlessness). Four of these have been previously identified in the concept of "total dyspnea." Control and context have been newly identified as important, particularly in their influence on coping and help-seeking behavior. The importance of social participation, impact on relationships, and loss of perceived role within social and spiritual domains also emerged as being significant to individuals., Conclusion: People with advanced illness living with breathlessness have concerns in multiple domains, supporting a concept of "total breathlessness." This adapted model can help to guide comprehensive clinical assessment and inform future outcome measurement in clinical practice and research., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

Context: Discrete choice experiment (DCE) is a quantitative method that helps determine which service attributes are most valued by people and consequently improve their well-being., Objectives: The objective of this study was to test a new DCE on home palliative care (HPC)., Methods: Cross-sectional survey using the DCE method with adult patients and their family caregivers, users of three HPC services in Portugal. Service attributes were based on a Cochrane review, a meta-ethnography, and the few existing DCEs on HPC: 1) team's availability, 2) support for family caregivers, 3) homecare support, 4) information and planning, and 5) waiting time. The experimental design consisted in three blocks of eight choice sets where participants chose between two service alternatives that combined different levels of each attribute. We piloted the DCE using cognitive interviewing. Interviews were analyzed for difficulties using Tourangeau's model of information processing., Results: The DCE was conducted with 21 participants of 37 eligible (10 patients with median Palliative Performance Scale score = 45, 11 caregivers). Most participants found the DCE easy (median 2 from 1 to 5), although two patients did not finish the exercise. Key difficulties related to comprehension (e.g., waiting time sometimes understood as response time for visit instead of time from referral to care start) and judgment (e.g., indecision due to similar service alternatives)., Conclusion: The DCE method is feasible and acceptable but not all patients are able to participate. In the main study phase, we will give more attention to the explanation of the waiting time attribute., (Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: People with cancer frequently report limitation in Activities of Daily Living (ADLs); essential activities required to live independently within society. Although several studies have assessed ADL related disability, variability in assessment, setting, and population means evidence is difficult to interpret. We aimed to determine the prevalence of ADL related disability, overall and by setting, and the most commonly affected ADLs in people living with cancer., Methods: We searched twelve databases to June 2016 for observational studies assessing ADL disability in adults with cancer. Data on study design, population, ADL instruments and disability (difficulty with or requiring assistance in ≥1 activity) were extracted, summarised, and pooled to estimate disability prevalence with 95% confidence intervals (95% CI) overall and by setting., Results: Forty-three studies comprising 19,246 patients were included. Overall, 36.7% (95% CI 29.8-44.3, 18 studies) and 54.6% (95% CI 46.5-62.3, 15 studies) of patients respectively reported disability relating to basic and instrumental ADLs. Disability was marginally more prevalent in inpatient compared to outpatient settings. The Katz Index (18 studies) and Lawton IADL Scale (11 studies) were the most commonly used instruments. Across the activities studied, the most frequently affected basic ADLs were personal hygiene, walking and transfers, and instrumental ADLs were housework, shopping and transportation., Conclusions: About one-third and half of adults with cancer respectively have difficulty or require assistance to perform basic and instrumental ADLs. These findings highlight the need for rehabilitation focused on functional independence, and underscore the importance of professionals skilled in occupational assessment and therapy within cancer services., (Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.)

People with advanced chronic obstructive pulmonary disease (COPD) have distressing physical and psychological symptoms, often have limited understanding of their disease, and infrequently discuss end-of-life issues in routine clinical care. These are strong indicators for expert multidisciplinary palliative care, which incorporates assessment and management of symptoms and concerns, patient and caregiver education, and sensitive communication to elicit preferences for care towards the end of life. The unpredictable course of COPD and the difficulty of predicting survival are barriers to timely referral and receipt of palliative care. Early integration of palliative care with respiratory, primary care, and rehabilitation services, with referral on the basis of the complexity of symptoms and concerns, rather than prognosis, can improve patient and caregiver outcomes. Models of integrated working in COPD could include: services triggered by troublesome symptoms such as refractory breathlessness; short-term palliative care; and, in settings with limited access to palliative care, consultation only in specific circumstances or for the most complex patients., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Context: As most end-of-life care is provided by health care providers who are generalists rather than specialists in palliative care, effective communication skills training for generalists is essential., Objectives: To determine the effect of communication training interventions for generalist palliative care providers on patient-reported outcomes and trainee behaviors., Methods: Systematic review from searches of 10 databases to December 2015 (MEDLINE, EMBASE, PsycINFO, ERIC, CINAHL, CENTRAL, Web of Science, ICTRP, CORDIS, and OpenGrey) plus hand searching. Randomized controlled trials of training interventions intended to enhance generalists' communication skills in end-of-life care were included. Two authors independently assessed eligibility after screening, extracted data, and graded quality. Data were pooled for meta-analysis using a random-effects model. PRISMA guidelines were followed., Results: Nineteen of 11,441 articles were eligible, representing 14 trials. Eleven were included in meta-analyses (patients n = 3144, trainees n = 791). Meta-analysis showed no effect on patient outcomes (standardized mean difference [SMD] = 0.10, 95% CI -0.05 to 0.24) and high levels of heterogeneity (chi-square = 21.32, degrees of freedom [df] = 7, P = 0.003; I 2  = 67%). The effect on trainee behaviors in simulated interactions (SMD = 0.50, 95% CI 0.19-0.81) was greater than in real patient interactions (SMD = 0.21, 95% CI -0.01 to 0.43) with moderate heterogeneity (chi-square = 8.90, df = 5, P = 0.11; I 2  = 44%; chi-square = 5.96, df = 3, P = 0.11; I 2  = 50%, respectively). Two interventions with medium effects on showing empathy in real patient interactions included personalized feedback on recorded interactions., Conclusions: The effect of communication skills training for generalists on patient-reported outcomes remains unclear. Training can improve clinicians' ability to show empathy and discuss emotions, at least in simulated consultations. Personalized feedback on recorded patient interactions may be beneficial., Registration Number: CRD42014014777., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Context: End-of-life care (EoLC) communication skills training for generalist palliative care providers is recommended in policy guidance globally. Although many training programs now exist, there has been no comprehensive evidence synthesis to inform future training delivery and evaluation., Objectives: To identify and appraise how EoLC communication skills training interventions for generalist palliative care providers are developed, delivered, evaluated, and reported., Methods: Systematic review. Ten electronic databases (inception to December 2015) and five relevant journals (January 2004 to December 2015) were searched. Studies testing the effectiveness of EoLC communication skills training for generalists were included. Two independent authors assessed study quality. Descriptive statistics and narrative synthesis are used to summarize the findings., Results: From 11,441 unique records, 170 reports were identified (157 published, 13 unpublished), representing 160 evaluation studies of 153 training interventions. Of published papers, eight were of low quality, 108 medium, and 41 high. Few interventions were developed with service user involvement (n = 7), and most were taught using a mixture of didactics (n = 123), reflection and discussion (n = 105), and role play (n = 86). Evaluation designs were weak: <30% were controlled, <15% randomized participants. Over half (n = 85) relied on staff self-reported outcomes to assess effectiveness, and 49% did not cite psychometrically validated measures. Key information (e.g., training duration, participant flow) was poorly reported., Conclusions: Despite a proliferation of EoLC communication skills training interventions in the literature, evidence is limited by poor reporting and weak methodology. Based on our findings, we present a CONSORT statement supplement to improve future reporting and encourage more rigorous testing., (Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.)

Context: Dignity is poorly conceptualized and little empirically explored in end-of-life care. A qualitative evaluation of a service offering integrated palliative and respiratory care for patients with advanced disease and refractory breathlessness uncovered an unexpected outcome, it enhanced patients' dignity., Objectives: To analyze what constitutes dignity for people suffering from refractory breathlessness with advanced disease, and its implications for the concept of dignity., Methods: Qualitative study of cross-sectional interviews with 20 patients as part of a Phase III evaluation of a randomized controlled fast-track trial. The interviews were transcribed verbatim, imported into NVivo, and analyzed through constant comparison. The findings were compared with Chochinov et al.'s dignity model. The model was adapted with the themes and subthemes specific to patients suffering from breathlessness., Results: The findings of this study underscore the applicability of the conceptual model of dignity for patients with breathlessness. There were many similarities in themes and subthemes. Differences specifically relevant for patients suffering from severe breathlessness were as follows: 1) physical distress and psychological mechanisms are interlinked with the disability and dependence breathlessness causes, in the illness-related concerns, 2) stigma is an important component of the social dignity inventory, 3) conditions and perspectives need to be present to practice self-care in the dignity-conserving repertoire., Conclusion: Dignity is an integrated concept and can be affected by influences from other areas such as illness-related concerns. The intervention shows that targeting the symptom holistically and equipping patients with the means for self-care realized the outcome of dignity., (Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Episodic breathlessness causes additional distress to breathless patients with advanced disease, but management is still insufficient and there is a lack of knowledge on effective coping strategies., Objectives: The aim was to explore patients' self-management strategies for episodic breathlessness., Methods: In-depth interviews with patients suffering from episodic breathlessness as a result of chronic heart failure, chronic obstructive pulmonary disease, lung cancer, or motor neuron disease were conducted. Interviews were transcribed verbatim and analyzed guided by the analytic hierarchy of Framework analysis., Results: A total of 51 participants were interviewed (15 chronic heart failure, 14 chronic obstructive pulmonary disease, 13 lung cancer, and nine motor neuron disease; age, mean [SD], 68 [12], 41% women, median Karnofsky index 60%). They described six main strategies for coping with episodes of breathlessness: reduction of physical exertion, cognitive and psychological strategies, breathing techniques and positions, air and oxygen, drugs and medical devices, and environmental and other strategies. Some strategies were used in an opposing way, e.g., concentrating on the breathing vs. distraction from any thoughts of breathlessness or laying down flat vs. standing up and raising hands., Conclusion: Patients used a number of different strategies to cope with episodic breathlessness, adding more detailed understanding of existing strategies for breathlessness. The findings, therefore, may provide a valuable aid for health care providers, affected patients, and their relatives., (Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: The Palliative care Outcome Scale (POS) and the Support Team Assessment Schedule (STAS) are two outcome measures used in palliative care settings to assess palliative concerns, needs, and quality of care., Objectives: This systematic review builds on the findings of a previous review to appraise the use of the POS and STAS since 2010, particularly the context and nature of their use., Methods: MEDLINE, Embase, PsycINFO, British Nursing Index, and CINAHL were searched for studies published between February 2010 and June 2014. Relevant authors were contacted, and reference lists of included studies were searched. Studies reporting validation or the use of the POS or STAS were included, and data on sample population, how the outcome measure was being used, study design, study aim, and results of the study were extracted., Results: Forty-three studies were included (POS n = 35, STAS n = 8). There was an increase in the use of the POS and STAS in Europe and Africa with the publication of 13 new translations of the POS. Most studies focused on the use, rather than further validation, of the POS and STAS. There has been increasing use of these measures within non-cancer patient groups., Conclusion: The POS and STAS are now used in a wide variety of settings and countries. These tools may be used in the future to compare palliative care needs and quality of care across diverse contexts and patient groups., (Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.)

Background & Aims: Bioelectrical impedance analysis (BIA) provides a simple method to assess changes in body composition. Raw BIA variables such as phase angle provide direct information on cellular mass and integrity, without the assumptions inherent in estimating body compartments, e.g. fat-free mass (FFM). Phase angle is a strong functional and prognostic marker in many disease states, but data in COPD are lacking. Our aims were to describe the measurement of phase angle in patients with stable COPD and determine the construct and discriminate validity of phase angle by assessing its relationship with established markers of function, disease severity and prognosis., Methods: 502 outpatients with stable COPD were studied. Phase angle and FFM by BIA, quadriceps strength (QMVC), 4-m gait speed (4MGS), 5 sit-to-stand time (5STS), incremental shuttle walk (ISW), and composite prognostic indices (ADO, iBODE) were measured. Patients were stratified into normal and low phase angle and FFM index., Results: Phase angle correlated positively with FFM and functional outcomes (r = 0.35-0.66, p < 0.001) and negatively with prognostic indices (r = -0.35 to -0.48, p < 0.001). In regression models, phase angle was independently associated with ISW, ADO and iBODE whereas FFM was removed. One hundred and seventy patients (33.9% [95% CI, 29.9-38.1]) had a low phase angle. Phenotypic characteristics included lower QMVC, ISW, and 4MGS, higher 5STS, ADO and iBODE scores, and more exacerbations and hospital days in past year. The proportion of patients to have died was significantly higher in patients with low phase angle compared to those with normal phase angle (8.2% versus 3.6%, p = 0.02)., Conclusion: Phase angle relates to markers of function, disease severity and prognosis in patients with COPD. As a directly measured variable, phase angle offers more useful information than fat-free mass indices., (Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Context: Measurement and improvement of informal caregiver burden are central aims of policy and intervention. Burden itself is a complex construct, and total burden can differ by patient diagnosis, although how diagnosis affects different aspects of caregiver subjective burden is unclear., Objectives: To compare the subjective burden of caregivers across three diagnostic groups using the 22-item Zarit Burden Inventory., Methods: We performed a secondary analysis of pooled cross-sectional data from four U.K. studies of informal caregivers of patients with advanced cancer (n = 105), dementia (n = 131), and acquired brain injury (ABI) (n = 215). Zarit Burden Inventory totals, subscales (personal and role strain), and individual mean scores were compared between diagnostic groups using the general linear model, adjusting for caregiver characteristics., Results: Caregiver age (mean years [SD]: cancer 66.1 [12.0]; dementia 61.9 [13.4]; and ABI 53.8 [10.9]) differed significantly across diagnostic groups (P < 0.001); 81.9%, 36.6%, and 59.1% of caregivers were spouse/partners, respectively (P < 0.001). Total burden was highest in ABI caregivers and lowest in cancer (mean total score [SD]: cancer 23.3 [13.4]; dementia 27.9 [16.4]; and ABI 39.1 [17.3]) (P < 0.001). Subscale scores showed similar patterns (mean personal and role subscale scores [SD]: cancer 11.8 [6.9], 5.8 [4.8]; dementia 14.4 [8.8], 7.3 [5.7]; and ABI 18.7 [9.1], 11.8 [6.0]) (P < 0.001 for both subscales). Most (17 of 22) individual item scores differed by diagnosis group (P < 0.05), except concepts of duty, responsibility, and perception of financial situation., Conclusion: Our data show that total, subscale, and most individual elements of caregiver subjective burden differ between cancer, dementia, and ABI caregivers. This should be considered when designing future intervention strategies to reduce caregiver burden in these groups., (Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Objectives: Rasch analysis has largely replaced impact factor methodology for developing health status measures. The aim of this study was to develop a health status questionnaire for patients with interstitial lung disease (ILD) using impact factor methodology and to compare its validity with that of another version developed using Rasch analysis., Study Design and Setting: A preliminary 71-item questionnaire was developed and evaluated in 173 patients with ILD. Items were reduced by the impact factor method (King's Brief ILD questionnaire, KBILD-I) and Rasch analysis (KBILD-R). Both questionnaires were validated by assessing their relationship with forced vital capacity (FVC) and St Georges Respiratory Questionnaire (SGRQ) and by evaluating internal reliability, repeatability, and longitudinal responsiveness., Results: The KBILD-R and KBILD-I comprised 15 items each. The content of eight items differed between the KBILD-R and KBILD-I. Internal and test-retest reliability was good for total scores of both questionnaires. There was a good relationship with SGRQ and moderate relationship with FVC for both questionnaires. Effect sizes were comparable. Both questionnaires discriminated patients with differing disease severity., Conclusion: Despite considerable differences in the content of retained items, both KBILD-R and KBILD-I questionnaires demonstrated acceptable measurement properties and performed comparably in a clinical setting., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Context: Over the history of palliative care provision in Ireland, services have predominantly provided care to those with cancer. Previous estimates of palliative care need focused primarily on specialist palliative care and included only a limited number of nonmalignant diseases., Objectives: The primary aim of this study was to estimate the potential population with generalist and/or specialist palliative care needs in Ireland using routine mortality data inclusive of nonmalignant conditions. The secondary aim was to consider the quality of Irish data available for this population-based estimate., Methods: Irish routine mortality data (2007-2011) were analyzed for malignant and nonmalignant conditions recognized as potentially requiring palliative care input, using specific International Statistical Classification of Diseases and Related Health Problems-10th Revision codes. The method developed by Murtagh et al. was used to give a population-based palliative care needs estimate, encompassing generalist and specialist palliative care need., Results: During the period 2007-2011, there were 141,807 deaths. Eighty percent were from conditions recognized as having associated palliative care needs, with 41,253 (30%) deaths from cancer and 71,226 (50%) deaths from noncancer conditions. The majority of deaths, 81% (91,914), were among those ≥65 years. There was a 13.9% (901) increase in deaths of those ≥85 years. Deaths from dementia increased by 51.3%, with an increase in deaths from neurodegenerative disease (42.8%) and cancer (9.5%)., Conclusion: Future palliative care policy decisions in Ireland must consider the rapidly aging Irish population with the accompanying increase in deaths from cancer, dementia, and neurodegenerative disease and associated palliative care need. New models of palliative care may be required to address this., (Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Patient-centered outcome measures (PCOMs) are an important way of promoting patient-professional communication. However, evidence regarding their implementation in palliative care is limited, as is evidence of the impact on care quality and outcomes., Objectives: The aim was to systematically review evidence on capture and feedback of PCOMs in palliative care populations and determine the effects on processes and outcomes of care., Methods: We searched Medline, Embase, CINAHL, BNI, PsycINFO, and gray literature from 1985 to October 2013 for peer-reviewed articles focusing on collection, transfer, and feedback of PCOMs in palliative care populations. Two researchers independently reviewed all included articles. Review articles, feasibility studies, and those not measuring PCOMs in clinical practice were excluded. We quality assessed articles using modified Edwards criteria and undertook narrative synthesis., Results: One hundred eighty-four articles used 122 different PCOMs in 70,466 patients. Of these, 16 articles corresponding to 13 studies met the full inclusion criteria. Most evidence was from outpatient oncology. There was strong evidence for an impact of PCOMs feedback on processes of care including better symptom recognition, more discussion of quality of life, and increased referrals based on PCOMs reporting. There was evidence of improved emotional and psychological patient outcomes but no effect on overall quality of life or symptom burden., Conclusion: In palliative care populations, PCOMs feedback improves awareness of unmet need and allows professionals to act to address patients' needs. It consequently benefits patients' emotional and psychological quality of life. However, more high-quality evidence is needed in noncancer populations and across a wider range of settings., (Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Depression is common among patients with advanced disease but often difficult to detect., Objectives: To assess the Palliative care Outcome Scale (POS) (10 items) against the Geriatric Depression Scale (GDS)-10 total score and the Hospital Anxiety and Depression Scale (HADS)-Depression subscale total score and determine if the POS has appropriate items to screen for depression among people with advanced disease., Methods: This was a secondary analysis performed on five studies. Four psychometric properties were assessed: data quality, scaling assumptions, acceptability, and internal consistency (reliability). Receiver operating characteristic (ROC) curves were used to determine the area under the curve. Sensitivity, specificity, positive and negative predictive values, false positive and negative rates, and positive and negative likelihood ratios were computed., Results: The overall sample had 416 patients from Germany and England: 144 had cancer and 267 had nonmalignant conditions. Prevalence of depression across the sample was 17.5%. Floor and ceiling effects were rare. Cronbach's alpha coefficients for POS items 7 and 8 summed, GDS-10 and HADS-Depression items varied: 0.61 (heart failure) and 0.80 (cancer). Two items combined (Item 7-feeling depressed and Item 8-feeling good about yourself) consistently presented the highest area under the ROC curve, ranging from 0.76 (95% CI 0.60, 0.93) (Germany, lung cancer) to 0.97 (95% CI 0.91, 1.0) (heart failure), highest negative predictive value, and lowest false negative rate. For the overall sample, the cutoff 2/3 presented a negative predictive value of 89.4% (95% CI 84.7, 92.8) and false negative rate of 10.6 (95% CI 7.2, 15.3)., Conclusion: POS items 7 and 8 summed are potentially useful to screen for depression in advanced disease populations., (Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Breathlessness is a common and distressing symptom, which increases in many diseases as they progress and is difficult to manage. We assessed the effectiveness of early palliative care integrated with respiratory services for patients with advanced disease and refractory breathlessness., Methods: In this single-blind randomised trial, we enrolled consecutive adults with refractory breathlessness and advanced disease from three large teaching hospitals and via general practitioners in South London. We randomly allocated (1:1) patients to receive either a breathlessness support service or usual care. Randomisation was computer generated centrally by the independent Clinical Trials Unit in a 1:1 ratio, by minimisation to balance four potential confounders: cancer versus non-cancer, breathlessness severity, presence of an informal caregiver, and ethnicity. The breathlessness support service was a short-term, single point of access service integrating palliative care, respiratory medicine, physiotherapy, and occupational therapy. Research interviewers were masked as to which patients were in the treatment group. Our primary outcome was patient-reported breathlessness mastery, a quality of life domain in the Chronic Respiratory Disease Questionnaire, at 6 weeks. All analyses were by intention to treat. Survival was a safety endpoint. This trial is registered with ClinicalTrials.gov, number NCT01165034., Findings: Between Oct 22, 2010 and Sept 28, 2012, 105 consenting patients were randomly assigned (53 to breathlessness support service and 52 to usual care). 83 of 105 (78%) patients completed the assessment at week 6. Mastery in the breathlessness support service group improved compared with the control (mean difference 0·58, 95% CI 0·01-1·15, p=0·048; effect size 0·44). Sensitivity analysis found similar results. Survival rate from randomisation to 6 months was better in the breathlessness support service group than in the control group (50 of 53 [94%] vs 39 of 52 [75%]) and in overall survival (generalised Wilcoxon 3·90, p=0·048). Survival differences were significant for patients with chronic obstructive pulmonary disease and interstitial lung disease but not cancer., Interpretation: The breathlessness support service improved breathlessness mastery. Our findings provide robust evidence to support the early integration of palliative care for patients with diseases other than cancer and breathlessness as well as those with cancer. The improvement in survival requires further investigation., Funding: UK National Institute for Health Research (NIHR) and Cicely Saunders International., (Copyright © 2014 Higginson et al. Open Access article distributed under the terms of CC BY. Published by .. All rights reserved.)

Context: Although sub-Saharan Africa suffers the greatest burden of progressive illness, there are few outcome measures with adequate properties to measure needs and outcomes., Objectives: To examine the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) among people receiving palliative care in three African countries., Methods: Adult patients in South Africa, Kenya, and Uganda gave self-reported data to the core FACIT-G plus Pal subscale. Data were subjected to factor analysis, corrected item-total correlations, and Cronbach's α for full scale and subscales., Results: The resulting four factors bear a strong similarity to the original Functional Assessment of Cancer Therapy-General in our sample of 461: physical symptoms, functional well-being, friends and family, and emotional well-being. Cronbach's α for the full 27-item scale was 0.90 and for the physical well-being, social/family well-being, emotional well-being, and functional well-being subscales, it was 0.83, 0.78, 0.80, and 0.87, respectively. Varimax rotation of the 19-item FACIT-Pal scale showed three clear interpretable factors. Factor 1, a sense of purpose and meaning in life; Factor 2, physical symptoms; and Factor 3, social integration. For the 19-item FACIT-Pal, Cronbach's α was 0.81, and individual corrected item-total correlations ranged from 0.24 to 0.61. Cronbach's α for the eight items comprising Factor 1 (meaning in life) was 0.83. For the other two factors, it was 0.70 (physical symptoms, six items) and 0.68 (social integration, three items)., Conclusion: The FACIT-Pal is a reliable multidimensional scale for people with life-limiting incurable diseases in sub-Saharan Africa, and the observed factors are interpretable and clinically meaningful., (Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: If access to effective palliative care is to extend beyond cancer patients, an understanding of the comparative prevalence of palliative care problems among cancer and non-cancer patients is necessary., Objectives: This systematic review aimed to describe and compare the prevalence of seventeen palliative care-related problems across the four palliative care domains among adults with advanced cancer, acquired immune deficiency syndrome, chronic heart failure, end-stage renal disease (ESRD), chronic obstructive pulmonary disease, multiple sclerosis, motor neuron disease, Parkinson's disease, and dementia., Methods: Three databases were searched using three groups of keywords. The results of the extraction of the prevalence figures were summarized., Results: The electronic searches yielded 4697 hits after the removal of 1784 duplicates. Of these hits, 143 met the review criteria. The greatest number of studies were found for advanced cancer (n=57) and ESRD patients (n=47), and 75 of the 143 studies used validated scales. Few data were available for people living with multiple sclerosis (n=2) and motor neuron disease (n=3). The problems with a prevalence of 50% or more found across most of the nine studied diagnostic groups were: pain, fatigue, anorexia, dyspnea, and worry., Conclusion: There are commonalities in the prevalence of problems across cancer and non-cancer patients, highlighting the need for palliative care to be provided irrespective of diagnosis. The methodological heterogeneity across the studies and the lack of non-cancer studies need to be addressed in future research., (Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Breathlessness is a distressing symptom in advanced disease. Understanding its patterns, burden, and palliative care (PC) needs over time is important to improve patients' quality of life., Objectives: To describe and compare the courses of refractory breathlessness, functional status, distress, and PC needs in patients with advanced chronic obstructive pulmonary disease (COPD) or lung cancer (LC) over time., Methods: This was a cohort study of patients with COPD (Stage III/IV) or LC. Data were assessed monthly with up to 12 telephone interviews, using the modified Borg Scale, Karnofsky Performance Status Scale, Distress Thermometer, and Palliative care Outcome Scale as outcomes measures. Descriptive analysis compared all outcomes between COPD and LC at baseline and over time (forward from study entry and backward from death)., Results: A total of 82 patients (50 COPD and 32 LC), mean (SD) age of 67.2 (7.8), and 36% female were included (8 COPD and 23 LC deceased). The patients with COPD perceived higher levels of breathlessness and distress at lower functional status steadily over time. The LC patients' breathlessness, distress, and PC needs increased, whereas functional status decreased toward death. The PC needs were similar between disease groups. Breathlessness was negatively correlated with functional status (COPD=mean r=-0.20, P=0.012; LC=mean r=-0.277, P=0.029) and positively correlated with PC needs in COPD patients (mean r=0.343, P<0.001). Death was significantly predicted by diagnosis (LC: hazard ratio=7.84, P<0.001) and functional status (10% decline: hazard ratio=1.52, P=0.001)., Conclusion: The PC needs of patients with advanced COPD are comparable with LC patients, and breathlessness severity and distress are even higher. The care for COPD patients requires further improvement to address symptom burden and PC needs., (Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Context: Episodic breathlessness is a common and distressing symptom in patients with advanced disease. Still, it is not yet clearly defined., Objectives: The aim of this work was to develop an international definition, categorization, and terminology of episodic breathlessness., Methods: An online Delphi survey was conducted with international breathlessness experts. We used a structured questionnaire to identify specific aspects and reach agreement on a definition, categorization, and terminology (five-point Likert scale). Consensus was defined in advance as ≥70% agreement., Results: Thirty-one of 68 (45.6%), 29 of 67 (43.3%), and 33 of 67 (49.3%) experts responded in the first, second, and third rounds, respectively. Participants were 20-79 years old, about 60% male, and more than 75% rated their own breathlessness expertise as moderate to high. After three rounds, consensus was reached on a definition, categorization, and terminology (84.4%, 96.3%, and 92.9% agreement). The final definition includes general and qualitative aspects of the symptom, for example, time-limited severe worsening of intensity or unpleasantness of breathlessness in the patient's perception. Categories are predictable or unpredictable, depending on whether any triggers can be identified., Conclusion: There is high agreement on clinical and operational aspects of episodic breathlessness in advanced disease among international experts. The consented definition and categorization may serve as a catalyst for clinical and basic research to improve symptom control and patients' quality of life., (Copyright © 2014 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Background: The quality of care provided to patients with cancer who are dying in hospital and their families is suboptimum. The UK Liverpool Care Pathway (LCP) for patients who are dying was developed with the aim of transferring the best practice of hospices to hospitals. We therefore assessed the effectiveness of LCP in the Italian context (LCP-I) in improving the quality of end-of-life care for patients with cancer in hospitals and for their family., Methods: In this pragmatic cluster randomised trial, 16 Italian general medicine hospital wards were randomly assigned to implement the LCP-I programme or standard health-care practice. For each ward, we identified all patients who died from cancer in the 3 months before randomisation (preintervention) and in the 6 months after the completion of the LCP-I training programme. The primary endpoint was the overall quality of care toolkit scale. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01081899., Findings: During the postintervention assessment, data were gathered for 308 patients who died from cancer (147 in LCP-I programme wards and 161 in control wards). 232 (75%) of 308 family members were interviewed, 119 (81%) of 147 with relatives cared for in the LCP-I wards (mean cluster size 14·9 [range eight to 22]) and 113 (70%) of 161 in the control wards (14·1 [eight to 22]). After implementation of the LCP-I programme, no significant difference was noted in the distribution of the overall quality of care toolkit scores between the wards in which the LCP-I programme was implemented and the control wards (score 70·5 of 100 vs 63·0 of 100; cluster-adjusted mean difference 7·6 [95% CI -3·6 to 18·7]; p=0·186)., Interpretation: The effect of the LCP-I programme in our study is less than the effects noted in earlier phase 2 trials. However, if the programme is implemented well it has the potential to reduce the gap in quality of care between hospices and hospitals. Further research is needed to ascertain what components of the LCP-I programme might be effective and to develop and assess a wider range of approaches to quality improvement in hospital care for people at the end of their lives and for their families., Funding: Italian Ministry of Health and Maruzza Lefebvre D'Ovidio Foundation-Onlus., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Context: A major barrier to widening and sustaining palliative care service provision is the requirement for better selection and use of outcome measures. Service commissioning is increasingly based on patient, carer, and service outcomes as opposed to service activity., Objectives: To generate recommendations and consensus for research in palliative and end-of-life care on the properties of the best outcome measures, enhancing the validity of proxy-reported data and optimal data collection time points., Methods: An international expert "workshop" was convened and an online consensus survey was undertaken using the MORECare Transparent Expert Consultation to generate recommendations and level of agreement. We focused on three areas: 1) measurement properties, 2) use of proxies, and 3) measurement timing. Data analysis comprised descriptive analysis of aggregate scores and collation of narrative comments., Results: There were 31 workshop attendees; 29 recommendations were included in the online survey, completed by 28 experts. The top three recommendations by area were the following: 1) the properties of the best outcome measures are responsive to change over time and capture clinically important data, 2) to enhance the validity of proxy data requires clear and specific guidelines to aid lay individuals' and/or professionals' completion of proxy measures, and 3) data collection time points need clear identification to establish a baseline., Conclusion: Outcome measurement in palliative and end-of-life care requires the use of psychometrically robust measures that are clinically responsive, with defined data collection time points to establish a baseline and clear administration guidelines to complete proxy measures. To further the field requires clinical imperatives to more closely inform recommendations on outcome measurement., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Health status and forced vital capacity (FVC) are widely used outcome measures of interstitial lung disease (ILD) but there is a paucity of studies reporting the minimal clinically meaningful change in these parameters. A study was undertaken to assess the minimal important difference (MID) of an ILD specific health status questionnaire, the King's Brief ILD questionnaire (K-BILD) and that of FVC in a range of ILDs. 57 patients with ILD (17 idiopathic pulmonary fibrosis; IPF) completed the K-BILD (score range 0-100) at 2 separate clinic visits. Patients underwent spirometry at both visits. The MID was determined by a range of distribution methods (Standard error of mean: SEM and 0.3× Effect size: ES) and anchor based methods (objective: FVC and subjective: global rating of change questionnaires, GRCQ). The MID was derived by calculating an average of all methods. Health status was reduced at baseline in all patients, mean (SD) K-BILD total score 62(23). The average MID for K-BILD total score incorporating all methods was an 8 unit change (range 6-10). The average MID for FVC was a 6% change of baseline (range 4-7%). The K-BILD is a responsive patient reported outcome measure for patients with ILD. It can potentially be used to assess patients in the clinic and evaluate the response to therapy. The MID of the K-BILD total score is 8 units. The MID for FVC for a range of ILDs was 6%, similar to that reported recently for patients with IPF. Our findings will facilitate the clinical interpretation of health status and FVC data in ILD., (Copyright © 2013. Published by Elsevier Ltd.)

Context: Most patient-reported outcome measurement tools in multiple sclerosis (MS) are geared toward less severely affected patients. Palliative care outcome measures have not been validated in patients with MS., Objectives: To assess the psychometric properties of the Core-Palliative Care Outcome Scale (Core-POS) and POS-MS-Symptoms (POS-MS-S) in patients severely affected by MS., Methods: Secondary analyses were conducted on data from a Phase II trial of palliative care in MS. Patients completed assessments using the following five scales: Core-POS, POS-MS-S, the Multiple Sclerosis Impact Scale, the United Kingdom Neurological Disability Scale, and the Expanded Disability Status Scale. Data quality, scaling assumptions, acceptability, internal consistency, and construct validity of the Core-POS and POS-MS-S were determined using standard psychometric methods., Results: The 46 participants had a mean ±SD age of 52.8 ±10.6 years. The mean Expanded Disability Status Scale score was 7.9 ± 1.2. Missing data were low (0 and 0.2% for the Core-POS and POS-MS-S, respectively), and floor and ceiling effects were absent. Internal consistency was good (Cronbach's alpha for the Core-POS and POS-MS-S were 0.72 [95% CI 0.56-0.84] and 0.81 [95% CI 0.72-0.89], respectively). Construct validity was consistent with a priori hypotheses 17 of 20 times., Conclusion: Psychometric analyses confirm that the Core-POS and POS-MS-S are acceptable, reliable, and valid in patients severely affected by MS., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Context: Unlike pain, where the concept of breakthrough and background pain has been widely characterized and defined, breathlessness as a symptom has not yet been fully explored and has been rarely categorized., Objectives: To explore patients' experiences and descriptions of breathlessness to categorize breathlessness., Methods: Qualitative study using in-depth interviews with patients suffering from four life-limiting and advanced diseases (chronic heart failure, chronic obstructive pulmonary disease, lung cancer, and motor neuron disease). Interviews were tape-recorded, transcribed verbatim, and analyzed using Framework analysis., Results: A total of 51 participants were interviewed (mean ± SD age 68.2 ± 11.6 years; 30 of 51 male; median Karnofsky 60%; mean ± SD breathlessness intensity 3.2 ± 1.7 of 10). Episodic breathlessness and continuous breathlessness were the main categories, with subcategories of triggered and non-triggered episodic breathlessness and continuous breathlessness for short and long periods. Episodic breathlessness triggered by exertion, non-triggered episodic breathlessness, and continuous breathlessness for a long period ("constant variable") were the most frequent and important categories with a high impact on daily living. Exertional breathlessness occurred in nearly all participants. Participants could differentiate episodic breathlessness (seconds, minutes, or hours) and continuous breathlessness (days, weeks, or months) by time. Episodic breathlessness occurred in isolation or in conjunction with continuous breathlessness., Conclusion: Participants categorize their breathlessness by time and triggers. The categorization needs further verification, similar to that already established in pain, and can be used as a new evidence-based categorization to advance our understanding of this under-researched, yet high impact, symptom to optimize management., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Context: Participants in a Phase II randomized controlled trial of Dignity Therapy felt that the intervention had helped them; however, the processes underlying this are not known., Objectives: To explore intervention and control participants' perceptions of the benefits of taking part in an evaluation of Dignity Therapy within the frame of the underlying model of the intervention., Methods: We interviewed 29 patients at one-week follow-up and 20 at four-week follow-up. We also interviewed nine family members of patients in the intervention group. We used the Framework approach to qualitative analysis. This comprised five stages: familiarization, identifying a thematic framework, indexing, charting, and mapping and interpretation. The analysis was both deductive (a priori themes from the model informing the content and therapeutic tone of the intervention) and inductive (from participants' views)., Results: There was support for five of the seven themes from the model underlying Dignity Therapy: "generativity," "continuity of self," "maintenance of pride," "hopefulness," and "care tenor." With the exception of generativity, all were evident in both groups. Prevalent emergent themes for the intervention group were "reminiscence" and "pseudo life review." "Making a contribution" was prevalent in the control group., Conclusion: Patients with advanced cancer and their families found that Dignity Therapy had helped them in many ways; however, patients in the control group sometimes perceived similar benefits from taking part in the study, highlighting elements of Dignity Therapy that are common to dignity conserving care., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Context: The incidence of life-limiting progressive disease in sub-Saharan Africa presents a significant clinical and public health challenge. The ability to easily measure patient outcomes is essential to improving care., Objectives: The present study aims to determine the specific factors (if any) that underpin the African Palliative Care Association African Palliative Outcome Scale to assist the analysis of data in routine clinical care and audit., Methods: Using self-reported data collected from patients with HIV infection in eastern and southern Africa, an exploratory factor analysis was undertaken with 1337 patients; subsequently, a confirmatory analysis was done on two samples from separate data sets (n = 445)., Results: Using exploratory factor analysis initially, both two- and three-factor solutions were examined and found to meet the criteria for simple structure and be readily interpretable. Then using confirmatory factor analysis on two separate samples, the three-factor solution demonstrated better fit, with Goodness-of-Fit Index values greater than 0.95 and Normative Fit Index values close to 0.90. The resulting three factors were 1) physical and psychological well-being, 2) interpersonal well-being, and 3) existential well-being., Conclusion: This analysis presents an important new opportunity in the analysis of outcome data for patients with progressive disease. It has advantages over both the total scoring of multidimensional scaling (which masks differences between domains) and of item scoring (which requires repeated analyses). The three factors map well onto the underlying concept and clinical goals of palliative care, and will enable audit of facility care., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Context: Although episodic breathlessness (EB) is reported to be highly prevalent in advanced disease, our understanding about it is limited., Objectives: The aim of this study was to systematically review and synthesize the evidence on EB regarding definition, characteristics, and patients' experiences., Methods: Systematic review using searches in six databases, hand search, and personal contacts with authors in the field. Search terms included the combination of "episodic" and "breathlessness" (and synonyms) with five different diseases. Selection criteria included patients with advanced disease and information about EB based on original research. All retrieved studies were reviewed by two independent investigators., Results: Twenty-seven studies (of 7584) were included in this review. Only eight studies explored EB as a primary outcome. EB is poorly defined. It is characterized by high prevalence (81%-85%), high frequency (daily), short duration (often less than 10 minutes), and severe peak intensity. EB either develops without any known trigger or is triggered by physical exertion, emotions, or environmental influences., Conclusion: EB is a common symptom in patients with advanced disease, but information about characteristics and experiences is limited. As there is no common terminology, an agreed definition is needed to foster research to develop effective treatments for EB., (Copyright © 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Context: Culture has a profound influence on our understanding of what is appropriate care for patients at the end of life (EoL), but the evidence base is largely nonexistent., Objectives: An international workshop was organized to compile a research agenda for cultural issues in EoL research, and assess challenges and implications of the integration of the culture concept in different contexts., Methods: Participant experts were identified from the expert network established through an Internet-based call for expertise on culture and EoL care and from meetings. The workshop comprised presentations of research priorities from country and disciplinary perspectives, and group discussions. Analysis used all data gathered in the workshop and applied standard qualitative techniques., Results: Thirty experts participated in the workshop and identified the following priorities for cross-cultural research: 1) clarifying the concepts of culture and cultural competence; 2) defining EoL in a context of social and cultural diversity, with a focus on concepts of EoL care and bioethics, experiences of receiving and giving EoL care, and care practices in different settings; and 3) developing appropriate methodologies and outcome measurements that address diversity., Conclusion: This first pan-European meeting compiled a research agenda, identifying key areas for future research focusing on culture, diversity, and their operationalization. This requires international and multidisciplinary collaboration, which is necessary in the current efforts to synthesize best practices in EoL care., (Copyright © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

Context: Despite HIV remaining life limiting and incurable, very little clinical research focus has been given to the prevalence and related burden of physical and psychological symptoms for those accessing palliative care. Despite evidence of problems persisting throughout the trajectory and alongside treatment, scant attention has been paid to these manageable problems., Objectives: This study aimed to measure the seven-day period prevalence and correlates of physical and psychological symptoms, and their associated burden, in HIV-infected individuals attending palliative care centers in sub-Saharan Africa., Methods: Consecutive patients in five care centers across two countries completed the Memorial Symptom Assessment Scale-Short Form, with additional demographic and disease-oriented variables., Results: Two hundred twenty-four patients participated. The most common symptoms were pain in the physical dimension (82.6%) and worry in the psychological dimension (75.4%). Interestingly, 71.4% reported hunger. Women, and those with worse physical function, were more likely to experience burden. However, being on antiretroviral therapy (ART) was not associated with global, physical, or psychological symptom burden., Conclusion: This study is the first to report physical and psychological symptom burden in HIV-infected populations receiving palliative care in sub-Saharan Africa. Despite increasing access to ART, these burdensome and manageable problems persist. The assessment of these problems is essential alongside assessment of ART virological outcomes., (Copyright © 2012 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)