Background: Few studies have specifically assessed the scope, nature and challenges of palliative and end-of-life care in rural general practice. These knowledge gaps limit the development of evidence-based policies and services for patients in the last months of life. This study aimed to explore the perspectives of general practitioners (GPs) and other stakeholders on rural GPs' involvement and challenges in providing palliative and end-of-life care in regional Australia.
Methods: A qualitative study involving five focus groups with 26 GPs based in rural/regional Western Australia together with 15 individual telephone interviews with four GPs and 11 other stakeholders involved in end-of-life care across Australia.
Results: The rural GPs' central role in end-of-life care was recognized by the majority of participants but multiple challenges were also identified. Some challenges were comparable to those found in urban settings but others were more pronounced, including resource limitations and lack of training. Inappropriate payment models discouraged GPs' involvement in some aspects of end-of-life care, such as case conferences and home visits. Compared to GPs in urban settings, those in rural/regional communities often reported closer doctor-patient relationships and better care integration and collaboration. These positive aspects of care could be further developed to enhance service provision. Our study highlighted the importance of regular interactions with other professionals and patients in providing end-of-life care, but many GPs and other stakeholders found such interactions more challenging than the more "technical" aspects of care.
Conclusions: Rural/regional GPs appear to be disproportionately affected by inappropriate payment models and limited resources, but may benefit from closer doctor-patient relationships and better care integration and collaboration relative to urban GPs. Systematic collection of empirical data on GP management at end-of-life is required to build on these strengths and address the challenges.
Aim: To develop and implement a region wide skills matrix for palliative care and district nurses in rural Victoria in order to identify and address individual learning needs and appropriate professional development strategies based on the Australian National Palliative Care Standards. This study is the first in a series of papers discussing and evaluating the development and implementation of a skills matrix. Future papers will report on participants’ data reporting.
Methods: The development and implementation of a skills matrix for palliative care nurses was based on using several evidence-based strategies involving four main stages. There were: stakeholder consultation, collaboration, consolidation and implementation. The initial stage of development of the matrix involved consultation with regional stakeholders to establish and refine the project objectives. The second stage involved collection of information from regional stakeholders; brainstorming and discussion of the technical skills required for palliative care and the cross over with district nursing. The third stage involved a facilitated process whereby action plans were devised and the final stage involved a plan for the survey dissemination and evaluation of the training needs. Other evidence-based strategies used were Benner’s theoretical model of clinical competence, the Australian National Palliative Care Standards and the triple C model of project implementation.
Results: This study reported on the development and implementation of a self-assessment of competencies skills matrix for nurses working in palliative care based on the Australian National Standards of palliative care used by services. The matrix included all the aspects covered by the Australian National Palliative Care Standards and mapped them to various competencies using Benner’s model ranging from novice to expert. The availability of a skills matrix tool to self-assess is important to keep track of the clinical competencies gained by palliative care nurses. Targeted educational interventions identified by the skills matrix have the potential to improve quality of care provided in the palliative care setting.
Conclusion: The successful development and implementation of the palliative skills matrix across the Gippsland region relied on using several evidence-based strategies to standardise the competencies across the palliative care setting in rural Victoria, Australia. Examples of these strategies included using Benner’s theoretical competency model, the Australian National Palliative Standards and the triple C model, which included stakeholders’ consultation, collaboration and consolidation.
Aim: To explore medication safety issues faced by general and palliative care community nurses working in rural and remote palliative care domiciliary settings.
Method: An online survey for nurses working in rural communities was conducted across the South East region of rural Victoria, Australia. Nurses from 18 community based health care organisations across the region were invited to participate in an anonymous survey addressing medication safety issues in the palliative care settings. Qualitative data obtained from the open-ended survey questions were analysed inductively.
Results: A total of 29 nurses completed the survey (response rate 28% from potential respondents). Most of the nurses were working in a rural practice providing a mixed model of community palliative care and community nursing. Medication safety issues raised by the nurses included; errors associated with dose administration aids, frequency of medications reviews undertaken by clinical pharmacists of clients’ medications, high occurrence of medications error reporting, lack of awareness of medications initiated by nurses and cytotoxic medications handling.
Conclusion: Targeted interventions addressing the identified issues raised by community general and palliative care nurses have the potential to improve medication safety in the domiciliary palliative care setting.
Background: Advanced care planning (ACP) is a process that involves thinking about what medical care one would like should individuals be seriously ill and cannot communicate decisions about treatment for themselves. The literature indicates that ACP leads to increased satisfaction from both patients and healthcare professionals. Despite the well-known benefits of ACP, it is still underutilised in Australia.
Methods: The aim of this study is to investigate the effects of normalising ACP in acute and community settings with the use of specially trained normalisation agents. This is a quasi-experimental study, involving 16 sites (8 intervention and 8 control) in two health districts in Australia. A minimum of total 288 participants will be recruited (144 intervention, 144 control). We will train four registered nurses as normalisation agents in the intervention sites, who will promote and facilitate ACP discussions with adult patients with chronic conditions in hospital and community settings. An audit of the prevalence of ACP and Advanced Care Directives (ACDs) will be conducted before and after the 6-month intervention period at the 16 sites to assess the effects of the ACP service delivered by these agents. We will also collect interview and survey data from patients and families who participate, and healthcare professionals who are involved in this service to capture their experiences with ACP.
Discussion: This study will potentially contribute to better patient outcomes with their health care services. Completion of ACDs will allow patients to express their wishes for care and receive the care that they wish for, as well as ease their family from the burden of making difficult decisions. The study will contribute to development of a new best practice model to normalise ACP that is sustainable and transferable in the processes of: 1) initiation of conversation; 2) discussion of important issues; 3) documentation of the wishes; 4) storage of the documented wishes; and 5) access and execution of the documented wishes. The study will generate new evidence on the challenges, strategies and benefits of normalising ACP into practice in acute and community settings.
BACKGROUND: The provision of end-of-life care remains a significant component of work for clinicians in critical care settings. Critical care nurses report that this area of practice receives limited attention in education and training.
OBJECTIVES: The objective of this study was to identify and describe the end-of-life care content in postgraduate critical care nursing programs in Australia.
METHODS: Using a descriptive exploratory research design, an Internet search was undertaken in August 2015, identifying 17 education providers offering postgraduate critical care nursing programs. Thirteen individuals agreed to participate in a structured telephone interview regarding end-of-life content in their postgraduate program. Descriptive statistics were calculated to summarise the data obtained.
RESULTS: Twelve participants reported that end-of-life care content was explicitly addressed in their postgraduate critical care nursing programs, yet variation in actual content areas covered was evident. The majority of programs addressed content related to organ donation (92%) and legal and ethical issues (77%). However, content least commonly identified as covered pertained to the work of the nurse in providing direct clinical care to the patient at the end of life and his or her family, including the physical changes experienced by the dying patient (31%), respiratory management encompassing withdrawal of ventilation and symptom management (23%), emotional support of family (23%), care of the body after death (23%), and the process of withdrawing life-sustaining treatment (15%). Participants (92%) agreed that end-of-life content was important in postgraduate critical care nursing programs, with 77% of participants agreeing that more time should be allocated to end-of-life content.
CONCLUSIONS: This study provides preliminary evidence of the variation in end-of-life content in postgraduate critical care nursing programs in Australia. Addressing gaps in end-of-life care content in formal education, including clinical care of the dying patient, is urgently needed to address the complexity of this phase of care that is so frequently provided in critical care units.
This article presents qualitative data to explore the experience of farming family members faced with accidental or suicide death and understand how this is experienced within the farming context. Individual semistructured interviews were conducted with 25 members of Australian farming families bereaved by suicide or accidental death. Qualitative data was thematically analyzed. Three interconnected themes were identified: acceptance of risk, normalization of death, pragmatic behavior patterns and connection to place. Bereavement and reconstruction of meaning following suicide or accidental death for farming families is influenced by the cultural, social, geographical, and psychological contexts of farming families. This article challenges traditional conceptions of suicide and accidental death as necessarily experienced as “violent” or “traumatic,” bereavement as experienced similarly across western cultures, and the reaction to suicide or accidental death as one that challenges people’s understanding of their world and leaves them struggling to find a reason why the death occurred.
PURPOSE: The scope of hospice or palliative care has expanded since its inception, which has significant ramifications for the AH workforce. This study sought to elicit allied health (AH) clinicians' understanding and views about palliative care and its relevance to their clinical practice and to identify their educational needs. Results from analysis of free text survey responses to a single open-ended question from a larger survey are presented.
METHODS: An online survey was distributed to AH clinicians via email lists for the CareSearch Allied Health Hub, Allied Health Professions Australia, and other groups. Descriptive statistics and content analysis of free text responses were used to analyse the data.
RESULTS: A total of 217 AH clinicians responded to an email survey and 187 useable responses were analysed. Four themes were identified: 1) palliative care employs a client-centred model of care, 2) acknowledgement of living whilst dying, 3) interdisciplinary palliative care interventions provide active care in a range of domains, and 4) characteristics of palliative care teams and settings.
CONCLUSION: AH clinicians plan an active role in physical, social, and psycho-spiritual care of palliative care patients and caregivers. Burgeoning numbers of palliative care patients in nonspecialist palliative care settings require AH clinicians to develop skills and competencies to work with people who have advanced disease.
There are few studies on interment preferences and practices for people in remote and rural regions of developed countries. This mixed methods study in rural Australia collated data on funeral and interment practices with an ethnographic exploration of the post-death preferences of terminally-ill rural residents. In the region, between February 2015 and May 2016, 44% of decedents were cremated. Burial preferences reflected family traditions, generational connections to historic cemeteries, and the wish to instantiate belonging to people and place. Cremation provided the opportunity for ashes to be scattered at personally-significant places. Funeral planning was important for patients and family caregivers, and funerals are valued rural community rituals.
AIM: To report a population-based analysis of both radiotherapy and active systemic therapy (AST) delivery rates along with patterns of treatment within the last 14 and 30 days of life.
METHODS: The Evaluation of Cancer Outcomes (ECO) Registry records clinical information on all newly diagnosed cancer patients for the Barwon South West Region of Victoria, Australia. Diagnosis details, tumour type and stage as well as core treatment details and date of death were extracted for all patients diagnosed from 2009-2015 inclusive.
RESULTS: A total of 12,760 cancers were recorded. The median age of all cases was 68.8 and 53% were male. AST was received by 3699 (29%) of patients and radiotherapy by 3811 (30%). Patient deaths within 14 and 30 days of treatment for AST were 4.3% and 8.7% respectively and deaths within 14 and 30 days of treatment for radiotherapy 3.8% and 8.0% respectively. Factors associated with death within 30 days of AST and/or radiotherapy were male gender, age greater than 70 years and higher disease stage (all p<0.01). Treatment rates within 30 days of death were highest for lung cancer (23% of cases) and lowest for breast cancer (2% of cases).
CONCLUSIONS: This population-based analysis of AST and radiotherapy treatment within the last 30 days of life within a region of Australia has shown overall treatment rates below 10%. Treatment rates appear influenced by both patient and tumour characteristics. Future focus on subgroups with high rates of late intervention may help minimise treatment unlikely to add benefit. This article is protected by copyright. All rights reserved.
OBJECTIVES: Report the use of an objective tool, UK Gold Standards Framework (GSF) criteria, to describe the prevalence, recognition and outcomes of patients with palliative care needs in an Australian acute health setting. The rationale for this is to enable hospital doctors to identify patients who should have a patient-centred discussion about goals of care in hospital.
DESIGN: Prospective, observational, cohort study.
PARTICIPANTS: Adult in-patients during two separate 24h periods.
MAIN OUTCOME MEASURES: Prevalence of in-patients with GSF criteria, documentation of treatment limitations, hospital and 1 year survival, admission and discharge destination and multivariate regression analysis of factors associated with the presence of hospital treatment limitations and 1 year survival.
RESULTS: Of 626 in-patients reviewed, 171 (27.3%) had at least one GSF criterion, with documentation of a treatment limitation discussion in 60 (30.5%) of those patients who had GSF criteria. Hospital mortality was 9.9%, 1 year mortality 50.3% and 3-year mortality 70.2% in patients with GSF criteria. One-year mortality was highest in patients with GSF cancer (73%), renal failure (67%) and heart failure (60%) criteria. Multivariate analysis revealed age, hospital length of stay and presence of the GSF chronic obstructive pulmonary disease criteria were independently associated with the likelihood of an in-hospital treatment limitation. Non-survivors at 3 years were more likely to have a GSF cancer (25% vs 6%, p=0.004), neurological (10% vs 3%, p=0.04), or frailty (45% vs 3%, p=0.04) criteria. After multivariate logistic regression GSF cancer criteria, renal failure criteria and the presence of two or more GSF clinical criteria were independently associated with increased risk of death at 3 years. Patients returning home to live reduced from 69% (preadmission) to 27% after discharge.
CONCLUSIONS: The use of an objective clinical tool identifies a high prevalence of patients with palliative care needs in the acute tertiary Australian hospital setting, with a high 1 year mortality and poor return to independence in this population. The low rate of documentation of discussions about treatment limitations in this population suggests palliative care needs are not recognised and discussed in the majority of patients.
TRIAL REGISTRATION NUMBER: 11/121.
BACKGROUND: There are few quantitative studies on palliative care provision to Indigenous Australians, a population known to experience distinctive barriers to quality healthcare and to have poorer health outcomes than other Australians.
OBJECTIVES: To investigate equity of specialist palliative care service provision through characterising and comparing Indigenous and non-Indigenous patients at entry to care.
METHODS: Using data (01/01/2010-30/06/2015) from all services participating in the multi-jurisdictional Palliative Care Outcomes Collaboration, Indigenous and non-Indigenous patients entering palliative care were compared on proportions vis-à-vis those expected from national statutory datasets, demographic characteristics, and entry-to-care status across fourteen 'problem' domains (e.g., pain, functional impairment) after matching by age, sex, and specific diagnosis.
RESULTS: Of 140,267 patients, 1,465 (1.0%, much lower than expected from statutory data) were Indigenous, 133,987 (95.5%) non-Indigenous, and 4,905 (3.5%) had a missing identifier. The proportion of patients with a missing identifier diminished markedly over the study period, without a corresponding increase in the proportion identified as Indigenous. Indigenous compared with non-Indigenous patients were younger (mean 62.8 versus 73.0 years, p<0.001), a higher proportion were female (51.5% versus 46.3%; p<0.001) or resided outside major cities (44.2% versus 21.5%, p<0.001). Across all domains, Indigenous compared with matched non-Indigenous patients had lower or equal risk of status requiring prompt intervention.
CONCLUSIONS: Indigenous patients (especially those residing outside major cities) are substantially under-represented in care by services participating in the nationwide specialist palliative care Collaboration, likely reflecting widespread access barriers. However, the similarity of status indicators among Indigenous and non-Indigenous patients at entry to care suggests that Indigenous patients who are able to access these services do not disproportionately experience clinically important impediments to care initiation.
BACKGROUND: It is often suggested that terminally ill patients favour end-of-life care at home. Yet, it is unclear how these preferences are formed, if the process is similar for patients and family caregivers, and if there are discrepancies between preferences for place of care and place of death. Understanding these nuances is essential to support people in their decision-making and ultimately provide better care at the end-of-life.
AIM: To gain an in-depth understanding of how terminally ill patients and their family caregivers make decisions about preferred place of care and place of death.
DESIGN: Semi-structured interviews with patients and family caregivers, which were analysed thematically using qualitative description.
SETTING/PARTICIPANTS: A total of 17 participants (8 patients and 9 caregivers) recruited from an acute palliative care hospital ward, a sub-acute hospice unit, and a palliative homecare organisation in Melbourne, Australia.
RESULTS: The process of forming location preferences was shaped by uncertainty relating to the illness, the caregiver and the services. Patients and caregivers dealt with this uncertainty on a level of thoughts, emotions, and actions. At the end of this process, patients and caregivers expressed their choices as contextual, personal, relational, conditional and flexible preferences.
CONCLUSIONS: These findings suggest that in many cases end-of-life decision-making does not conclude with a clear and stable choice. Understanding the reasons for the malleability of preferences and the process of how they are formed has implications for both clinicians and researchers.
Background: Many organizations provide support to people affected by suicide-related behavior, for example, those bereaved by suicide, those who have attempted suicide, and their informal carers. However, evidence regarding how well used, and acceptable, these resources are is lacking. Aims: To investigate the views about and experiences with support and resources of people with lived experience of suicide bereavement, suicide attempt, or caring.
Method: The study was conducted in Queensland, Australia. In total, 175 people completed the survey. Data were analyzed using SPSS Statistics 22.
Results: Participants found resources helpful and user-friendly, but many had never searched for support, did not know it was available, or felt no better after using it. Respondents who had attempted suicide were more likely to look for resources, but less likely to feel better after using them and endorsed more barriers to accessing support.
Limitations: This study used a convenience sample of individuals living in Queensland, was biased toward help-seeking populations, and included mostly women, and therefore it was not representative.
Conclusion: Support and resources that are more flexible and accessible, and are offered in a more proactive manner could improve the user experiences of people affected by suicide-related behavior.
BACKGROUND: Guidelines for device-based therapy of cardiac rhythm abnormalities were updated in 2008 including discussions prior to implantation with implantable cardioverter defibrillator (ICD) recipients regarding end-of-life (EOL) choices.
OBJECTIVES: To explore patients' knowledge of the function of the ICD at EOL.
METHODS: ICD recipients from Central Kentucky and Melbourne, Australia completed the Experiences, Attitudes, and Knowledge of EOL.
RESULTS: Of the 240 ICD recipients, 76% reported that they have never had discussions with their health care provider regarding the withdrawal of defibrillation therapy. A total of 38% believed that turning off the ICD shocks was the same as active euthanasia and that disabling defibrillation therapy required surgical intervention; 37% believed that once defibrillation was disabled, it could not be enabled again.
CONCLUSIONS: Adherence to guidelines regarding EOL discussions with ICD recipients was minimal from the patients' perspective. Most patients may hold alarming misperceptions that could interfere with optimal EOL care.
BACKGROUND: Patients want community-based palliative care, but there was no continuity of care for patients at the Sydney Adventist Hospital to receive palliative and end-of-life care within a community setting. A nurse practitioner (NP)-led community palliative care service was developed.
AIMS: To present the background, design, function, and essential elements of the Sydney Adventist Hospital Community Palliative Care Service (SanCPCS).
METHODS: Semi-structured and cyclical discussions with key informants alongside internal document reviews.
FINDINGS: This is the first description of an NP-led community palliative care service model. The NP role ensured specialist training and extended clinical practice within the community setting. The SanCPCS delivers accessible, continuous, community-based palliative care throughout the patient's palliative and end-of-life journey.
CONCLUSION: NP-led models for palliative and end-of-life care in the outpatient or community setting are a logical direction to meet patient need.
OBJECTIVE: To increase knowledge of how doctors perceive futile treatments and scarcity of resources at the end of life. In particular, their perceptions about whether and how resource limitations influence end-of-life decision making. This study builds on previous work that found some doctors include resource limitations in their understanding of the concept of futility.
SETTING: Three tertiary hospitals in metropolitan Brisbane, Australia.
DESIGN: Qualitative study using in-depth, semistructured, face-to-face interviews. Ninety-six doctors were interviewed in 11 medical specialties. Transcripts of the interviews were analysed using thematic analysis.
RESULTS: Doctors' perceptions of whether resource limitations were relevant to their practice varied, and doctors were more comfortable with explicit rather than implicit rationing. Several doctors incorporated resource limitations into their definition of futility. For some, availability of resources was one factor of many in assessing futility, secondary to patient considerations, but a few doctors indicated that the concept of futility concealed rationing. Doctors experienced moral distress due to the resource implications of providing futile treatment and the lack of administrative supports for bedside rationing.
CONCLUSIONS: Doctors' ability to distinguish between futility and rationing would be enhanced through regulatory support for explicit rationing and strategies to support doctors' role in rationing at the bedside. Medical policies should address the distinction between resource limitations and futility to promote legitimacy in end-of-life decision making.
OBJECTIVE: Hospital use increases in the last 3 months of life. We aimed to examine its association with where people live and its variation across a large health jurisdiction.
METHODS: We studied a number of emergency department presentations and days spent in hospital, and in-hospital deaths among decedents who were hospitalized within 30 days of death across 153 areas in New South Wales (NSW), Australia, during 2010-2015.
RESULTS: Decedents' demographics and health status were associated with hospital use. Primary care and aged care supply had no or minimal influence, as opposed to the varying effects of areal factors-socioeconomic status, remoteness, and distance to hospital last admitted. Overall, there was an approximate 20% difference in hospital use by decedents across areas. In all, 18% to 57% of areas had hospital use that differed from the average.
DISCUSSION: The observed disparity can inform targeted local efforts to strengthen the use of community care services and reduce the burden of end-of-life care on hospitals.
Context: Advance care planning (ACP) documentation needs to be available at the point of care to guide and inform medical treatment decision-making.
Objective: To examine concordance between self-reported completion of ACP documentation and self-reported storage of the documentation at the person's current point of care with the availability of the documentation in that person's health record.
Methods: A national multicenter audit of health records and a self-report survey of eligible audit participants in 51 Australian health and residential aged care services. The audit assessed availability of ACP documentation in the health record, whereas the survey assessed self-reported completion and storage of the ACP documentation at the person's current place of care. To ascertain concordance, survey and audit data were cross-tabulated and concordance rates and kappa statistics were calculated overall and by health care sector and ACP documentation type.
Results: The audit included 2285 people, of whom 1082 were eligible for the survey. Of 507 who completed the survey (response rate = 47%), 272 (54%) reported completing ACP documentation, of whom 130 (48%) had documentation identified in the audit. Conversely, 39 of 235 people (17%) who reported not completing ACP documentation had documentation identified (concordance rate = 64%; = 0.303, P < .001). The concordance rate increased to 79% when self-reported storage of ACP documentation at the person's current point of care was compared with the existence of the document in their health record ( = 0.510, P < .001). Concordance varied by health care setting and type of ACP documentation.
Conclusion: Discrepancies exist between self-reported completion of ACP documentation and the presence of these documents in the health records of older adults, representing a significant patient safety issue. Public education campaigns and improvements to systems for document storage and accessibility are required to support person-centered medical and end-of-life care.
BACKGROUND: Worldwide, operating rooms have seen the re-emergence of donation after cardiac death organ donors to increase the number of available organs. There is limited information on the issues perioperative nurses encounter when caring for donor patients after cardiac death who proceed to organ procurement surgery.
OBJECTIVES: The purpose of this paper is to report a subset of findings derived from a larger study highlighting the difficulties experienced by perioperative nurses when encountering donation after cardiac death organ donors and their family within the operating room during organ procurement surgery from an Australian perspective.
METHODS: A qualitative grounded theory method was used to explore perioperative nurses’ (n = 35) experiences of participating in multi-organ procurement surgery.
RESULTS: This paper reports a subset of findings of the perioperative nurses' experiences directly related to donation after cardiac death procedures drawn from a larger grounded theory study. Participants revealed four aspects conceptualised as: 'witnessing the death of the donation after cardiac death donor'; 'exposure to family'; 'witnessing family grief' and 'stepping into the family's role by default'.
CONCLUSION: Perioperative nurses' experiences with donation after cardiac death procedures are complex, challenging and demanding. Targeted support, education and training will enhance the perioperative nurses' capabilities and experiences of caring for the donation after cardiac death donor and their family with the operating room context.
BACKGROUND: The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on survival, oncological outcomes, toxicity, and quality of life in patients with a controlled primary tumour and one to five oligometastatic lesions.
METHODS: This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0-1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1-3 vs 4-5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided a of 0·20 (wherein p<0·20 designates a positive trial). All analyses were intention to treat. This study is registered with ClinicalTrials.gov, number NCT01446744.
FINDINGS: 99 patients were randomised between Feb 10, 2012, and Aug 30, 2016. Of 99 patients, 33 (33%) were assigned to the control group and 66 (67%) to the SABR group. Two (3%) patients in the SABR group did not receive allocated treatment and withdrew from the trial; two (6%) patients in the control group also withdrew from the trial. Median follow-up was 25 months (IQR 19-54) in the control group versus 26 months (23-37) in the SABR group. Median overall survival was 28 months (95% CI 19-33) in the control group versus 41 months (26-not reached) in the SABR group (hazard ratio 0·57, 95% CI 0·30-1·10; p=0·090). Adverse events of grade 2 or worse occurred in three (9%) of 33 controls and 19 (29%) of 66 patients in the SABR group (p=0·026), an absolute increase of 20% (95% CI 5-34). Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group.
INTERPRETATION: SABR was associated with an improvement in overall survival, meeting the primary endpoint of this trial, but three (4·5%) of 66 patients in the SABR group had treatment-related death. Phase 3 trials are needed to conclusively show an overall survival benefit, and to determine the maximum number of metastatic lesions wherein SABR provides a benefit.
FUNDING: Ontario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant.