Creating more comparable cohorts in observational palliative care studies: A proposed framework to improve applicability and replicability of research.

BACKGROUND: Palliative care is characterised by heterogeneous patient and caregiver populations who are provided care in different health systems and a research base including a large proportion of observational, mostly retrospective studies. The inherent diversity of palliative care populations and the often inadequate study descriptions challenge the application of new knowledge into practice and reproducibility for confirmatory studies. Being able to define systematically study populations would significantly increase their generalisability and effective translation into practice. PROPOSAL: Based on an informal consensus process by active palliative care researchers challenged by this problem and a review of the current evidence, we propose an approach to creating more comparable cohorts in observational (non-randomised) palliative care studies that relies on defining the study population in relation to a fixed, well-defined event from which analyses are built ('anchoring'). In addition to providing a detailed and complete description of the study population, anchoring is the critical step in creating more comparable cohorts in observational palliative care studies. Anchoring can be done with respect to a single or multiple data points, and can support both prospective and retrospective data collection and analysis. DISCUSSION: Anchoring the cohort to reproducible data points will help create more comparable cohorts in palliative care whilst mitigating its inherent heterogeneity. This, in turn, will help optimise the generalisability, applicability and reproducibility of observational palliative care studies to strengthen the evidence base and improve practice.

Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer.

BACKGROUND: Routine early palliative care (EPC) improves quality of life (QoL) for patients with advanced cancer, but it may not be necessary for all patients. We assessed the feasibility of Symptom screening with Targeted Early Palliative care (STEP) in a phase II trial. METHODS: Patients with advanced cancer were recruited from medical oncology clinics. Symptoms were screened at each visit using the Edmonton Symptom Assessment System-revised (ESAS-r); moderate to severe scores (screen-positive) triggered an email to a palliative care nurse, who called the patient and offered EPC. Patient-reported outcomes of QoL, depression, symptom control, and satisfaction with care were measured at baseline and at 2, 4, and 6 months. The primary aim was to determine feasibility, according to predefined criteria. Secondary aims were to assess whether STEP identified patients with worse patient-reported outcomes and whether screen-positive patients who accepted and received EPC had better outcomes over time than those who did not receive EPC. RESULTS: In total, 116 patients were enrolled, of which 89 (77%) completed screening for ≥70% of visits. Of the 70 screen-positive patients, 39 (56%) received EPC during the 6-month study and 4 (6%) received EPC after the study end. Measure completion was 76% at 2 months, 68% at 4 months, and 63% at 6 months. Among screen-negative patients, QoL, depression, and symptom control were substantially better than for screen-positive patients at baseline (all P<.0001) and remained stable over time. Among screen-positive patients, mood and symptom control improved over time for those who accepted and received EPC and worsened for those who did not receive EPC (P<.01 for trend over time), with no difference in QoL or satisfaction with care. CONCLUSIONS: STEP is feasible in ambulatory patients with advanced cancer and distinguishes between patients who remain stable without EPC and those who benefit from targeted EPC. Acceptance of the triggered EPC visit should be encouraged. CLINICALTRIALS: gov identifier: NCT04044040.

Integration of patient-reported outcomes (PROs) for personalized symptom management in "real-world" oncology practices: a population-based cohort comparison study of impact on healthcare utilization.

BACKGROUND: The use of patient-reported outcomes (PROs) for routine cancer distress screening is endorsed globally as a quality-care standard. However, there is little research on the integration of PROs in "real-world" oncology practices using implementation science methods. The Improving Patient Experience and Health Outcome Collaborative (iPEHOC) intervention was established at multisite disease clinics to facilitate the use of PRO data by clinicians for precision symptom care. The aim of this study was to examine if patients exposed to the intervention differed in their healthcare utilization compared with contemporaneous controls in the same time frame. METHODS: We used a PRE- and DURING-intervention population cohort comparison study design to estimate the effects of the iPEHOC intervention on the difference in difference (DID) for relative rates (RR) for emergency department (ED) visits, hospitalizations, psychosocial oncology (PSO), palliative care visits, and prescription rates for opioids and antidepressants compared with controls. RESULTS: A small significantly lower Difference in Difference (DID) (- 0.223) in the RR for ED visits was noted for the intervention compared with controls over time (0.947, CI 0.900-0.996); and a DID (- 0.0329) for patients meeting ESAS symptom thresholds (0.927, CI 0.869-0.990). A lower DID in palliative care visits (- 0.0097), psychosocial oncology visits (- 0.0248), antidepressant prescriptions (- 0.0260) and an increase in opioid prescriptions (0.0456) in the exposed population compared with controls was also noted. A similar pattern was shown for ESAS as a secondary exposure variable. CONCLUSION: Facilitating uptake of PROs data may impact healthcare utilization but requires examination in larger scale "real-world" trials.

Palliative Medicine-Becoming a Subspecialty of the Royal College of Physicians and Surgeons of Canada.

The discipline of palliative medicine in Canada started in 1975 with the coining of the term "palliative care." Shortly thereafter, the provision of clinical palliative medicine services started, although the education of the discipline lagged behind. In 1993, the Canadian Society of Palliative Care Physicians (CSPCP) started to explore the option of creating an accredited training program in palliative medicine. This article outlines the process by which, over the course of 20 years, palliative medicine training in Canada went from a mission statement of the CSPCP, to a 1 year of added competence jointly accredited by both the Royal College of Physicians and Surgeons of Canada (Royal College) and the College of Family Physicians of Canada, to a 2-year subspecialty of the Royal College with access from multiple entry routes and a formalized accrediting examination.

Engaging Patients as Partners in Developing Patient-Reported Outcome Measures in Cancer-A Review of the Literature.

PURPOSE: Tools to collect patient-reported outcome measures (PROMs) are frequently used in the healthcare setting to collect information that is most meaningful to patients. Due to discordance among how patients and healthcare providers rank symptoms that are considered most meaningful to the patient, engagement of patients in the development of PROMs is extremely important. This review aimed to identify studies that described how patients are involved in the item generation stage of cancer-specific PROM tools developed for cancer patients. METHODS: A literature search was conducted using keywords relevant to PROMs, cancer, and patient engagement. A manual search of relevant reference lists was also conducted. Inclusion criteria stipulated that publications must describe patient engagement in the item generation stage of development of cancer-specific PROM tools. Results were excluded if they were duplicate findings or non-English. RESULTS: The initial search yielded 230 publications. After removal of duplicates and review of publications, 6 were deemed relevant. Fourteen additional publications were retrieved through a manual search of references from relevant publications. A total of 13 unique PROM tools that included patient input in item generation were identified. The most common method of patient engagement was through qualitative interviews or focus groups. CONCLUSIONS: Despite recommendations from international groups and the emphasized importance of incorporating patient feedback in all stages of development of PROMs, few unique tools have incorporated patient input in item generation of cancer-specific tools. Moving forward, a framework of best practices on how to best engage patients in developing PROMs is warranted to support high-quality patient-centered care.

Buspirone for management of dyspnea in cancer patients receiving chemotherapy: a randomized placebo-controlled URCC CCOP study.

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

Is performance status associated with symptom scores? A population-based longitudinal study among cancer outpatients.

BACKGROUND: Symptom scores and performance status are both important measures for patients with cancer. However, since performance status is not often part of routinely collected data, there is interest in exploring whether it can be calculated from symptom scores. METHODS: This was a population-based longitudinal study of cancer outpatients in Ontario, Canada in the year following their cancer diagnosis and among the subset of patients during the last year of their lives. RESULTS: In the first year after diagnosis, there was a significant relationship between performance status and fatigue and appetite; fatigue and well-being had a significant association with performance status in the last year of life. In both periods, the associations, although statistically significant, were not large enough to be clinically meaningful. CONCLUSION: Performance status is an important measurement that cannot be substituted or captured with symptom scores; it is important for healthcare providers to record performance scores on a regular basis.

Initiation of chemotherapy in cancer patients with poor performance status: a population-based analysis.

OBJECTIVE: Practice guidelines indicate that patients who have months to weeks left to live should not be offered chemotherapy. We examined factors associated with clinician-reported poor performance status as determined by the Palliative Performance Scale (PPS) and subsequent initiation of intravenous (IV) chemotherapy in an ambulatory cancer population in Ontario, Canada. METHODS: In this retrospective study, patients who had at least one PPS assessment indicating poor performance status (a PPS score of 50 or lower) comprised the study cohort. Using linked administrative databases, we observed the cohort for initiation of IV chemotherapy within 30 days of the first (index) poor PPS assessment. RESULTS: We excluded patients for whom IV or oral chemotherapy was ongoing or recently completed or whose performance status improved following the index assessment. Of the remaining cohort, 9.3 percent (264/2,842) received IV chemotherapy within 30 days of the index PPS. CONCLUSION: A small number of cancer patients with poor performance status began IV chemotherapy in the month following assessment.

Do patient-reported symptoms predict emergency department visits in cancer patients? A population-based analysis.

STUDY OBJECTIVE: Since 2007 in Ontario, Canada, the Edmonton Symptom Assessment System has been routinely used for cancer outpatients. The purpose of this study is to determine the relationship between individual patient symptoms and symptom severity, with the likelihood of an emergency department (ED) visit. METHODS: The cohort included all cancer patients in Ontario who completed an Edmonton Symptom Assessment System between January 2007 and March 2009. Using multiple linked provincial health databases, we examined the adjusted association between symptom scores and the likelihood of an ED visit within 7 days of assessment. RESULTS: The cohort included 45,118 patients whose first assessment contributed to the study, of whom 3.8% made a subsequent ED visit. A severe well-being score was associated with the highest odds of a subsequent ED visit (adjusted odds ratio [OR] 1.9; 95% confidence interval 1.5 to 2.4). Nausea, drowsiness, and shortness of breath with moderate or severe scores were associated with ED visits (adjusted OR 1.2 to 1.5), whereas pain, tiredness, poor appetite, and well-being had a significant association for mild scores (adjusted OR 1.2, 1.3, 1.2, and 1.3, respectively), moderate scores (adjusted OR 1.3, 1.5, 1.5, and 1.7, respectively), and severe scores (adjusted OR 1.4, 1.7, 1.7, and 1.9, respectively). Anxiety and depression were not associated with ED visits. CONCLUSION: Worsening symptoms contribute to emergency visits in cancer patients. Specific symptoms such as pain are obvious management targets, but constitutional symptoms were associated with even higher odds of ED usage and therefore warrant detailed assessment to optimize both patient outcomes and resource use.

Interventions for Grieving and Bereaved Informal Caregivers: A Scoping Review of the Canadian Literature.

Background: The palliative approach to care is playing a larger role in the healthcare of older adults in Canada. Within (hospice) palliative care, informal caregivers play a crucial role as part of the interdisciplinary care team. Ensuring high quality palliative care includes providing effective grief and bereavement supports for them. Objective: This study aimed to identify current interventions addressing the grief and bereavement experiences of informal caregivers of geriatric patients in the Canadian (hospice) palliative/end-of-life care realm. Methods: A scoping review was undertaken using Arksey and O'Malley's framework. Seven electronic health and social science databases were searched. In addition, several stakeholder organizations' websites were reviewed to identify grey literature sources. Interventions that took place in Canada, were in English, and explored grief and bereavement supports for informal caregivers in an adult/geriatric (hospice) palliative care setting were included. After full text review, data were extracted and charted. Major themes were established following thematic content analysis. Results: Within a total of 18 sources, three themes were identified: (1) Classification of intervention, (2) Format of intervention, and (3) Intervention target. Method of delivery and type of intervention for grief and bereavement supports were aligned with the international literature. There is a need for large-scale evaluations of interventions and informal caregivers should be engaged in this process. Practitioners should be encouraged to direct bereavement interventions toward grieving caregivers, and to collaborate with them to improve access to these interventions. Policy makers should provide additional funding for grief interventions for informal caregivers. Conclusions: It is important to better understand the needs of informal caregivers experiencing grief and bereavement. Interdisciplinary collaborations will be necessary to develop, evaluate, and scale future interventions.

Cancer Care Ontario's experience with implementation of routine physical and psychological symptom distress screening.

OBJECTIVE: In late 2006, Cancer Care Ontario launched a quality improvement initiative to implement routine screening with the Edmonton Symptom Assessment System (ESAS) for cancer patients seen in fourteen Regional Cancer Centres throughout the province. METHODS: A central team: created a provincial project plan and management and evaluation framework; developed common tools and provided expert coaching and guidance, provincial data analysis, progress reporting and program evaluation. Regional Steering Committees and Improvement teams were accountable for planning and coordination within each region and supported by a funded Regional Improvement Coordinator. A hybrid model for quality improvement facilitated process improvements and uptake of screening. RESULTS: Challenges to implementation included: lack of consensus on the chosen screening tool, lack of guidance for assessment or management of high scores, concern of inadequate time or resources to address issues identified by the screening, data entry was labour intensive, resistance to change and challenges to the traditional care model. Essential components for success were: centralized project management, a person dedicated to implementation of the project locally, clinical champions, clearly identified aims, monthly regional data reporting and implementation of quality improvement methodologies with expectations for performance. To achieve screening aims many centres engaged all members of the team, examined the roles of the different members and reorganized workflow and responsibilities and changed booking times. In March 2010, approximately 25,000 ESAS's were completed in the regional cancer centres across Ontario, with 60% of lung cancer patients and almost 40% of all other cancer patients who visited the Regional Cancer Centres screened. CONCLUSION: Routine physical and psychological distress screening is possible within regional cancer centres. Although considerable effort and investment is required, it is worthwhile as it helps create a culture that is more patient-centered.

The Grief and Bereavement Experiences of Informal Caregivers: A Scoping Review of the North American Literature.

Background: Informal caregivers are a significant part of the hospice and palliative care landscape as members of the interdisciplinary care team. Despite this, little is known about the impact this responsibility has on informal caregivers' experiences of grief and bereavement. Objective: To address this, a scoping review of the literature was conducted to explore the current state of knowledge toward grief and bereavement of informal caregivers of adult/geriatric patients in the hospice and palliative/end-of-life care realm within North America. Methods: Using Arksey and O'Malley's 5-step framework, key electronic health care and social sciences databases (eg, CINAHL, MEDLINE, ProQuest Sociological Abstracts, PsycINFO) alongside gray literature sources were searched and screened against inclusion and exclusion criteria. A thematic content analysis was used to identify key themes. Results: 29 articles met the final inclusion criteria with 3 central themes emerging: (1) mediators of grief, (2) grief experiences, and (3) types of grief. Discussion: Informal caregivers encounter unique grief and bereavement experiences: The range of psychosocial outcomes, both negative and positive, can be affected by various mediators such as caregiver burden, demographics, disease type of the patient being cared for, etc. Bereavement interventions must be designed with the mediators of grief in mind. Conclusions: Understanding the nuances of informal caregivers' experiences with grief and bereavement will inform and advance practice, policy, and research. Practitioners/clinicians should be further educated on how to properly acknowledge the complexity of grief and bereavement for informal caregivers, specifically paying attention to mediators. Further research needs to consider the role of culture.

Multistate analysis of interval-censored longitudinal data: application to a cohort study on performance status among patients diagnosed with cancer.

In observational studies on cancer patients, progression of performance status over time can be described by using a multistate model in which state-to-state transitions represent changes in a patient's health condition. Although a patient experiences transitions in continuous time, assessments on the patient are often made at irregularly spaced time points. In this paper, the authors formulate a Markov 4-state model for examining longitudinal data on performance status collected under intermittent observation. The cohort consisted of 11,342 patients diagnosed with cancer in Ontario, Canada, from 2007 to 2009. The authors extend the model to estimate the predicted probability of reaching the absorbing state, death, over various time intervals. The authors also illustrate what happens to the estimated transition intensities if the true observational scheme is overlooked. Methods for multistate analysis should be used by epidemiologists, since they prove particularly useful for examining the complexities of disease processes.

Why do patients with cancer visit the emergency department near the end of life?

BACKGROUND: For patients dying of cancer, a visit to the emergency department can be disruptive, distressing and exhausting. Such visits made near the end of life are considered an indicator of poor-quality cancer care. We describe the most common reasons for visits made to the emergency department during the final six months of life and the final two weeks of life by patients dying of cancer. METHODS: We performed a descriptive, retrospective cohort study using linked administrative sources of health care data. RESULTS: Between 2002 and 2005 in Ontario, 91,561 patients died of cancer. Of these, 76,759 patients made 194,017 visits to the emergency department during the final six months of life. Further, 31,076 patients made 36,600 visits to the emergency department during the final two weeks of life. In both periods, the most common reasons were abdominal pain, lung cancer, dyspnea, pneumonia, malaise and fatigue, and pleural effusion. INTERPRETATION: Many visits made to the emergency department by patients with cancer near the end of life may be avoidable. An understanding of the reasons for such visits could be useful in the development of dedicated interventions for preventing or avoiding their occurrence.

Standards, Guidelines, and Quality Measures for Successful Specialty Palliative Care Integration Into Oncology: Current Approaches and Future Directions.

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

Operationalizing Outpatient Palliative Care Referral Criteria in Lung Cancer Patients: A Population-Based Cohort Study Using Health Administrative Data.

Background: Early referral of cancer patients for palliative care significantly improves the quality of life. It is not clear which patients can benefit from an early referral, and when the referral should occur. A Delphi Panel study proposed 11 major criteria for an outpatient palliative care referral. Objective: To operationalize major Delphi criteria in a cohort of lung cancer patients, using a prospective approach, by linking health administrative data. Design: Population-based observational cohort study. Setting/Subjects: The study population comprised 38,851 cases of lung cancer in the Ontario Cancer Registry, diagnosed from January 1, 2012, to December 31, 2016. Measurements: We operationalized 6 of the 11 major criteria (4 diagnosis or prognosis based and 2 symptom based). Patients were considered eligible (index event) for palliative care if they qualified for any criterion. Among eligible patients, we identified those who received palliative care. Results: Twenty-eight thousand one hundred sixty-four patients were eligible for palliative care by qualifying for either the diagnosis- or prognosis-based criteria (n = 21,036, 76.5%), or for symptom-based criteria (n = 7128, 23.5%). A total of 23,199 (82.4%) patients received palliative care. The median time from palliative care eligibility to the receipt of first palliative care or death or maximum study follow-up was 56 days (range = 17-348). Conclusions: We operationalized six major criteria that identified the majority of lung cancer patients who were eligible for palliative care. Most eligible patients received the palliative care before death. Future research is warranted to test these criteria in other cancer populations.

Palliative Care Integration Project (PCIP) quality improvement strategy evaluation.

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

The Impact of Measuring Patient-Reported Outcome Measures on Quality of and Access to Palliative Care.

BACKGROUND: Measuring performance for palliative care is complex as care is delivered in many sites, over time and jointly to the patient and family. Measures of structural processes do not necessarily capture aspects that are important to patients and families nor reflect holistic multidisciplinary outcomes of care. This article focuses on the question as to whether measurement of patient-reported outcome measures improves the outcomes of quality and access to palliative care. OBJECTIVES: To review the international evidence that measurement of indicators of desired outcomes improves the quality of and access to palliative care, in order to apply them to the Canadian context. DESIGN: Rapid review. SETTING: Canadian context. FINDINGS: This review identified six systematic reviews and forty-seven studies that describe largely national efforts to arrive at a consensus as to what needs to be measured to assess quality of palliative care. Patient-reported outcome measures (PROMs) are becoming more prevalent, with emerging evidence to suggest that their measurement improves outcomes that are important to patients. Several Canadian initiatives are in place, including the Canadian Partnership Against Cancer's efforts, in conjunction with other partners, to develop common quality measures. Results from Australia's Palliative Care Outcomes Collaborative demonstrate that patient-centered improvements in palliative care can be measured by using patient-reported outcomes derived at the point of care and delivered nationally. CONCLUSIONS: Measurement of quality palliative and end-of-life care is very complex. It requires that both administrative data and PROMs be assessed to reflect outcomes that are important to patients and families. Australia's national initiative is a promising exemplar for continued work in this area.