Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study.

INTRODUCTION: Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design. METHODS AND ANALYSIS: A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients' and carers' experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients' acceptability of the methodology, as well as providing a signal of whether this area should be further investigated. ETHICS AND DISSEMINATION: Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820. TRIAL REGISTRATION NUMBER: ANZCTR ACTRN12617000747325.

Older Persons' and Their Caregivers' Perspectives and Experiences of Research Participation With Impaired Decision-Making Capacity: A Scoping Review.

BACKGROUND AND OBJECTIVES: Human research ethics statements support the equitable inclusion of diverse groups. Yet older people are underrepresented in clinical research, especially those with impaired decision-making capacity. The aim of this study was to identify the perspectives and experiences of older persons and their caregivers of research participation with impaired decision-making capacity. RESEARCH DESIGN AND METHODS: Scoping review of the literature and online sources in January-February 2019 (updated June 2020) according to Joanna Briggs Institute methodology and PRISMA Extension for Scoping Reviews. English-language peer-reviewed research articles and Australian online narratives were included. Data were tabulated and narratively synthesized. RESULTS: From 4,171 database records and 93 online resources, 22 articles (2000-2019, 82% United States, 16 first authors) and one YouTube webinar (2018) were initially included; updated searches yielded an additional article (2020) and YouTube webinar (2020). Studies were heterogeneous in terminology, methods, and foci, with hypothetical scenarios, quantitative analyses, and examination of proxy consent predominating. Participants (N = 7,331) were older persons (71%), caregivers of older persons with dementia/cognitive impairment (23%), and older persons with dementia/cognitive impairment (6%). Synthesis identified 2 themes: willingness to participate and decision-making approaches. DISCUSSION AND IMPLICATIONS: Research participation by older persons with dementia may be optimized through reducing risks and burdens and increasing benefits for participants, greater consumer input into study development, and shared and supported decision-making. Older persons' and caregivers' perspectives and experiences of research participation with impaired decision-making capacity require investigation in a greater range of countries and conditions other than dementia, and dissemination through more varied media.

Patients Receiving Palliative Care and Their Families' Experiences of Participating in a "Patient-Centered Family Meeting": A Qualitative Substudy of the Valuing Opinions, Individual Communication, and Experience Feasibility Trial.

Background: Family meetings are used in palliative care to facilitate discussion between palliative patients, their families, and the clinical team. However, few studies have undertaken qualitative assessment of the impact of family meetings on patients and their families. Objectives: To explore inpatients receiving palliative care and their families' experiences of participation in a patient-centered family meeting ("Meeting"), where the patient sets the Meeting agenda. Design: This qualitative study used the constant comparative method for thematic content analysis of the data. Setting/Participants: The setting was a specialist palliative care (SPC) inpatient unit in Australia. Nine palliative care inpatients and nine family members were interviewed. Measurements: Semistructured interviews were used evaluate the patients' and their families' experiences and perceptions of the Meeting. Results: Three overarching themes described the experiences of participating in a patient-focused family meeting, namely that the Meeting: (1) provides a forum for inpatients receiving SPC to speak openly about their end-of-life concerns, clarify issues, and is of comfort to patients; (2) provides the family members with a voice, and an opportunity to discuss their concerns and have their needs addressed; and (3) helps to ensure that everyone is "on the same page" and patient care plans can be discussed. Conclusions: These Meetings are a potentially effective means of supporting certain palliative care patients and their families to articulate, confront, and address end-of-life issues in the presence of the interdisciplinary team. It is important to undertake further research to further examine the evidence for this Meeting model and to identify the patients and families who would most benefit from this type of Meeting.

Patients', caregivers' and clinicians' understandings of an advance care planning process: the example of ambulance palliative care plans.

BACKGROUND: With the introduction of New South Wales Ambulance Authorised Palliative Care Plans within a metropolitan palliative care service, the perspectives of patients, caregivers and clinicians and their understandings of the processes involved in completing the Plans were investigated. METHODS: This qualitative sub-study used semi-structured interviews. Nineteen patients and caregivers who had received an Ambulance Palliative Care Plan and 10 clinicians who completed the Plans were interviewed (n=4) or participated in a focus group (n=6). Grounded theory provided theoretical and procedural direction. Thematic content analysis utilized the constant comparative method. RESULTS: Thematic analysis of patient/caregiver interviews revealed four major themes (I) a lack of involvement in signing the Plan; (II) a need for clear communication about the Plan; (III) trust in the handing over of difficult decisions to family; and (IV) control over where to receive end of life care. Patients indicated that they had little understanding or memory of what the document was or of its purpose, and there were some significant caregiver anxieties about the Plans. Those who were clear on the rationale for the Ambulance Palliative Care Plan demonstrated more prognostic awareness about their condition and the benefits or burdens of resuscitation and treatment. Clinicians identified the main benefit as avoidance of Emergency Department (ED) admission and for patients to be able to choose their preferred place of death. Barriers were mainly systemic and included a lack of clarity around the signature processes and the early implementation of the Plan where the palliative care service was new to patients and families. CONCLUSIONS: The Ambulance Palliative Care Plans are a complex intervention that are sometimes misunderstood by patients, particularly those who are very unwell or who have little prognostic awareness. Clinicians perceive the major benefit to be avoidance of admission to the emergency department.

Words describing feelings about death: A comparison of sentiment for self and others and changes over time.

Understanding public attitudes towards death is needed to inform health policies to foster community death awareness and preparedness. Linguistic sentiment analysis of how people describe their feelings about death can add to knowledge gained from traditional self-reports. This study provided the first description of emotive attitudes expressed towards death utilising textual sentiment analysis for the dimensions of valence, arousal and dominance. A linguistic lexicon of sentiment norms was applied to activities conducted in an online course for the general-public designed to generate discussion about death. We analysed the sentiment of words people chose to describe feelings about death, for themselves, for perceptions of the feelings of 'others', and for longitudinal changes over the time-period of exposure to a course about death (n = 1491). The results demonstrated that sadness pervades affective responses to death, and that inevitability, peace, and fear were also frequent reactions. However, words chosen to represent perceptions of others' feelings towards death suggested that participants perceived others as feeling more negative about death than they do themselves. Analysis of valence, arousal and dominance dimensions of sentiment pre-to-post course participation demonstrated that participants chose significantly happier (more positive) valence words, less arousing (calmer) words, and more dominant (in-control) words to express their feelings about death by the course end. This suggests that the course may have been helpful in participants becoming more emotionally accepting in their feelings and attitude towards death. Furthermore, the change over time appeared greater for younger participants, who showed more increase in the dominance (power/control) and pleasantness (valence) in words chosen at course completion. Sentiment analysis of words to describe death usefully extended our understanding of community death attitudes and emotions. Future application of sentiment analysis to other related areas of health policy interest such as attitudes towards Advance Care Planning and palliative care may prove fruitful.

"Standing Shoulder to Shoulder to Tell the Family What Was Really Going On": A Qualitative Study Exploring Palliative Care Clinicians' Perceptions of "Patient-Centered Family Meetings".

Background: Family meetings are often conducted in palliative care, but there is no universal agreed or accepted model. A new model of Patient-Centered Family Meetings is proposed whereby the patient sets the agenda. Aim: To seek palliative care clinicians' perceptions and experiences of Patient-Centered Family Meetings ("Meetings") and their acceptability and feasibility in the inpatient specialist palliative care setting. Design: A qualitative study used semistructured interviews. Theoretical and procedural direction was taken from grounded theory with thematic content analysis using the constant comparative method. Setting/Participants: Interviews were conducted with clinicians (n = 10) at the intervention site who had participated in a Meeting. Results: Four themes were identified: (1) a patient-set agenda gives patients a "voice"; (2) a patient-set agenda and the Meeting model enhances clinicians' understanding of patients and families; (3) the Meeting model was perceived to be acceptable; and (4) the Meeting model was perceived to be only feasible for selected patients. Conclusion: Clinicians perceived that a patient-set meeting agenda with defined questions enhanced their knowledge of the patient's issues and their understanding of the patient and their family's needs. The patients' most important issues often differed from the clinicians' expectations of what might be important to individual patients. There were contrasting views about the acceptability and feasibility of these Meetings as standard practice due to clinician time constraints and the Meeting not being required or relevant to all patients. Given the perceived benefits, the identification of patients and families who would most benefit is an important research priority.

A randomized, double-blind, crossover, dose ranging study to determine the optimal dose of oral opioid to treat breakthrough pain for patients with advanced cancer already established on regular opioids.

BACKGROUND: Pain in people with advanced cancer is prevalent. When a stable dose of opioids is established, people still experience episodic breakthrough pain for which dosing of an immediate release opioid is usually a proportion of the total daily dose. METHODS: This multi-site, double blind, randomized trial tested three dose proportions (1/6, 1/8, 1/12 of total daily dose) in two blocks, each block with three dose proportions in random order (6 numbered bottles in total). When participants required opioid breakthrough doses and it was their first breakthrough dose for that study day, they took the next numbered bottle rather than their usual breakthrough dose. (Subsequent doses on that day reverted to their usual dose.) RESULTS: Eighty-five people were randomized in this study of whom 81 took at least one dose and 73 (90%) took at least block one (one of each dose proportion). No dose was found to be optimal at 30 min with approximately one-third of participants showing maximal reduction with each dose proportion. Median time to pain relief was 120 min. There were no differences in harms: drowsiness, confusion, nausea or vomiting at 30, 60 or 120 min. CONCLUSIONS: This adequately powered study did not show any difference with three dose proportions for reduction in pain intensity, time to pain relief, pain control on the subsequent day nor any difference in harms. From first principles, this suggests 1/12 the 24 hourly dose should be used as the lowest dose that delivers benefit. Future studies should include a placebo arm. SIGNIFICANCE: Despite the widespread use of immediate release morphine solution for breakthrough cancer pain, the ideal dose derived from background dose has not been determined in an adequately powered randomized, double-blind, crossover, dose ranging study. This study tested three dose levels in people with advanced cancer. Given no differences in time to onset, level of analgesia achieved, nor side effects, the lowest dose tested (1/12th of the daily dose) should be used.

Can Exposure to Online Conversations About Death and Dying Influence Death Competence? An Exploratory Study Within an Australian Massive Open Online Course.

A Massive Open Online Course, Dying2Learn, was designed to foster community death conversations and strengthen community awareness of palliative care and death as a normal process. This exploratory study used a pre-post prospective design to determine if participation in Dying2Learn and exposure to online conversations about death and dying resulted in any significant influence on death competence in 134 participants who completed the Coping-with-Death-Scale both at the beginning and end of the course in 2016. Death competence refers to a range of attitudes and capabilities people have for dealing with death. Results at the end of the course indicated that engagement in Dying2Learn led to significant improvements in death competence scores over time (medium-to-large effect size). The positive impact was greater for those who completed more of the course, and effectiveness did not depend on sociodemographic characteristics. In conclusion, this study found that an online learning platform in the form of a Massive Open Online Course could engage community members in meaningful social discussion about death and dying, and that exposure to these conversations was beneficial for all participants regardless of previous exposure to death. Further exploration is required to determine whether this change in death competence will have an impact on participant's behavior in the community regarding death conversations and preparedness.

"I want to die in my sleep"-how people think about death, choice, and control: findings from a Massive Open Online Course.

BACKGROUND: Complex social and ethical debates about voluntary assisted dying (euthanasia), palliative care, and advance care planning are presently being worked through in many developed countries, and the policy implications of these discussions for palliative care are potentially very significant. However, community attitudes to death and dying are complex, multilayered, and contain many mixed messages. METHODS: Participants posted comments in a Massive Open Online Course (MOOC) on death and dying, entitled Dying2Learn. This provided an opportunity to explore societal and personal attitudes to wishes and beliefs around death and dying. For one activity in the MOOC, participants responded to a question asking them about "the best way to go". RESULTS: Responses were subjected to thematic analysis, during which they were coded for conceptual categories. This analysis showed how acceptance of death as a natural and normal process, and as a shared event that affects a whole social network, may nonetheless be accompanied by deep reluctance to address the physical process of dying (i.e., "avoidant acceptance"). CONCLUSIONS: Our findings highlighted a desire for choice and control in relation to dying, which is a common element in discussions of both advance care planning and palliative care. This same focus may contribute to a perception that voluntary assisted dying/euthanasia is a necessary strategy for ensuring that people have control over their dying process. We discuss the paradox of individuals wanting to have control whilst preferring not to know that they are dying.

Correlates of perceived death competence: What role does meaning-in-life and quality-of-life play?

OBJECTIVE: Understanding factors that are associated with more adaptive death attitudes and competencies can inspire future health-promoting palliative care strategies and inform approaches to training and development for health professionals. The potential importance of meaning, purpose, quality, and values in life for promoting adaptive death attitudes has been highlighted, but there is limited research in this area, particularly in relation to death competence. The purpose of this cross-sectional study was to develop an understanding of demographic and life-related factors associated with perceived death competence, such as meaning in life and quality of life. METHOD: During the course enrollment period of a Massive-Online-Open-Course about death and dying, 277 participants completed questionnaires on death competence, meaning in life, quality of life, and sociodemographic background. RESULT: Findings indicated that greater presence of meaning in life, quality of life, age, death experience, and carer experience were each statistically significant unique predictors of death competence scores. Life-related variables were more strongly associated with death competence than demographic variables. Bereavement experience and experience caring for the dying was associated with greater death competence, but there were no differences on death competence between health professionals and the general community. Above all other factors, the presence of meaning in life was the strongest predictor of higher perceived competence in coping with death. SIGNIFICANCE OF RESULTS: The findings demonstrate important interconnections between our attitudes about life and death. Knowledge of factors associated with poorer death competence may help identify those at risk of greater distress when facing death, and might prove useful additions to bereavement risk assessments. Understanding factors associated with greater death competence in health professionals and volunteers may help predict or prevent burnout and compassion fatigue, and help identify who would benefit from additional training and support. Future longitudinal studies including both health professionals and the general community are needed to determine the effect adaptive attitudes toward meaning in life can potentially have on bolstering subsequent adaptive coping and competence regarding death and dying.

Lidocaine for Cancer Pain in Adults: A Systematic Review and Meta-Analysis.

BACKGROUND: Internationally, use of lidocaine infusions to treat cancer pain varies by center. Existing systematic reviews do not adequately inform use of lidocaine in cancer pain. OBJECTIVE: To assess the effects of systemic sodium channel blockers on cancer pain in adults, review the dose protocols for administration, and assess toxicity. DESIGN: Databases CENTRAL, MEDLINE, Embase, LILACS, CareSearch, and OpenGrey were searched from inception to 2016. Conference abstracts and reference lists were handsearched, and the lead investigators of included trials and Australian manufacturers were contacted. Included studies were randomized controlled trials evaluating one or more of lidocaine via intravenous or subcutaneous route, or mexiletine, flecainide, or tocainide via oral route; delivered at a site distant to the pain locus. The methodological quality of studies was assessed using the "risk of bias" domain-based evaluation by Jadad. Protocol is available on PROSPERO:CRD42016047092. RESULTS: One positive (n = 50) and three negative (n = 10 each) crossover trials evaluated lidocaine versus placebo, and one trial (n = 16) compared lidocaine with dexmedetomidine. Meta-analysis of pooled data in 60 patients demonstrated a significant benefit of lidocaine infusion of 4-5 mg/kg over 30-80 minutes compared with placebo for >50% reduction in cancer pain. Secondary outcomes did not show a significant difference. DISCUSSION: Based on the current available evidence, lidocaine infusion could be considered in refractory cancer pain where agents with level 1 evidence are ineffective. Further research is necessary to understand the protocol and population in which lidocaine may improve cancer pain and capitalize on the promising opportunities identified.

Survey of procedural and resuscitation requirements for paediatricians working in a non-tertiary centre: Implications for training.

AIM: There are minimal data to guide the continuing medical education (CME) of general paediatricians working in non-tertiary hospitals. The aim of this study was to determine the procedural and resuscitation skills required by non-tertiary paediatricians and the frequency with which these skills are utilised. METHODS: Over a 12-month period (December 2012 to December 2013), each of the 11 paediatricians involved in acute inpatient care at University Hospital Geelong (UHG) completed a weekly online survey regarding their inpatient clinical experience. This included procedures performed or directly supervised as well as their resuscitation involvement. RESULTS: Each of the 11 paediatricians who managed inpatients on a regular or semi-regular basis during the study period agreed to participate, and each completed all of the weekly surveys. There were seven UHG paediatricians with an inpatient appointment (each with a 0.27 full-time equivalent (FTE) paediatrician workload) and four paediatricians providing inpatient cover on a locum basis. Over the course of 12 months, each 0.27 FTE paediatrician was, on average, involved in 11.3 neonatal, 1.7 infant and 2.4 child resuscitations and performed 0.9 intubations. CONCLUSIONS: Paediatricians working at non-tertiary hospitals are required to perform and supervise critical procedural and resuscitation skills but have limited opportunities to maintain proficiency in such skills. General paediatric training and consultant paediatrician CME programmes should ensure the acquisition and maintenance of the procedural and resuscitation skills required for the management of seriously ill children in non-tertiary acute care settings.

The VOICE Study: Valuing Opinions, Individual Communication and Experience: building the evidence base for undertaking Patient-Centred Family Meetings in palliative care - a mixed methods study.

BACKGROUND: Despite family meetings being widely used to facilitate discussion among patients, families, and clinicians in palliative care, there is limited evidence to support their use. This study aims to assess the acceptability and feasibility of Patient-Centred Family Meetings in specialist inpatient palliative care units for patients, families, and clinicians and determine the suitability and feasibility of validated outcome measures from the patient and family perspectives. METHODS: The study is a mixed-methods quasi-experimental design with pre-planned Patient-Centred Family Meetings at the intervention site. The patient will set the meeting agenda a priori allowing an opportunity for their issues to be prioritised and addressed. At the control site, usual care will be maintained which may include a family meeting. Each site will recruit 20 dyads comprising a terminally ill inpatient and their nominated family member. Pre- and post-test administration of the Distress Thermometer, QUAL-EC, QUAL-E, and Patient Health Questionnaire-4 will assess patient and family distress and satisfaction with quality of life. Patient, family, and clinician interviews post-meeting will provide insights into the meeting feasibility and outcome measures. Recruitment percentages and outcome measure completion will also inform feasibility.Descriptive statistics will summarise pre- and post-meeting data generated by the outcome measures. SPSS will analyse the quantitative data. Grounded theory will guide the qualitative data analysis. DISCUSSION: This study will determine whether planned Patient-Centred Family Meetings are feasible and acceptable and assess the suitability and feasibility of the outcome measures. It will inform a future phase III randomised controlled trial. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001083482 on 11 August 2016.

The contribution of a MOOC to community discussions around death and dying.

BACKGROUND: Advances in medicine have helped many to live longer lives and to be able to meet health challenges. However death rates are anticipated to increase given the ageing population and chronic disease progression. Being able to talk about death is seen to be important in normalising death as part of life and supporting preparedness for death. Massive Open Online Courses (MOOCs) provide opportunities for the community to engage in collaborative learning. A 5 week MOOC was developed covering four main topics (language and humour, representations of death, medicalisation of dying, and digital dying) aiming: To enable participants to openly and supportively discuss and learn about issues around living, death and dying, To explore the normally unheard opinions and views of Australians around death and dying, and To determine what effect online learning and discussions offered through the MOOC had on participants' feelings and attitudes towards death and dying. METHODS: Data was captured on engagement rates in the various MOOC activities. Death Attitudes were measured by five items representing the MOOC's learning objectives and completed at enrolment and conclusion. MOOC Satisfaction was measured with six items at the end of the MOOC. Descriptive statistics were produced for each variable and Chi-Square Tests of Independence assessed the extent of the relationship between categorical variables. Socio-demographic variables were examined as predictors of the outcome variables of MOOC engagement, MOOC satisfaction, and death attitudes. Ethical approval was received from Flinders University Social and Behavioural Research Ethics Committee (Project No. 7247). RESULTS: One thousand one hundred fifty six people enrolled in the Dying2Learn MOOC with 895 participating in some way. Enrolees were primarily female (92.1%). Age ranged from 16 to 84 (mean = 49.5, SD = 12.3). MOOC satisfaction scores were high. Responses to the experience of participating in the MOOC were very positive, with mean scores ranging from 4.3 to 4.6 (aligning with agreement and strong agreement to statements on the value of participating). Death Attitudes were positive at commencement but increased significantly following participation. CONCLUSIONS: The Dying2Learn MOOC provided an environment that enabled open and supportive discussion around death and dying and influenced attitudinal change.

Patient-centered family meetings in palliative care: a quality improvement project to explore a new model of family meetings with patients and families at the end of life.

BACKGROUND: Family meetings in palliative care can enhance communication with family members and identify unmet needs. However, the patient's voice may not be heard. METHODS: This pre and post-test quality improvement project was conducted from 2013-2014 and investigated a patient-centered family meeting, which is a different approach to palliative care family meetings, to determine its feasibility and acceptability for patients, family and the palliative care team. Newly admitted patients to an Australian in-patient specialist palliative care unit were invited to ask anyone they wished to join them in a meeting with the palliative care team and to identify issues they wished to discuss. Consenting inpatients were interviewed shortly after admission; participated in a family meeting and re-interviewed 2-3 days after the meeting. Family members provided feedback at the end of the meeting. A focus group was held with staff for feedback on this new approach for family meetings. Meetings were observed, documented and thematically analyzed. RESULTS: Thirty-one newly admitted patients were approached to participate in a family meeting. Eighty-four percent had family meetings and the majority (96%) was attended by the patient. Thematic analysis revealed 69% of patient-centered meetings raised end-of-life concerns and 54% were "family-focused". CONCLUSIONS: Patient-centered family meetings in palliative care were shown to be feasible and acceptable for staff, patients and family members. Many patients and families spontaneously shared end-of-life concerns. A patient-centered approach to family meetings that includes active patient involvement may provide additional and valued opportunities for patients and families to: express mutual concerns, deliver messages of comfort and appreciation, and prepare for death. Further investigation of this approach, including families' bereavement outcomes, is warranted.

Never say die: death euphemisms, misunderstandings and their implications for practice.

BACKGROUND: A Massive Open Online Course (MOOC) on death and dying was conducted to open the dialogue around death and dying. In one activity, participants were asked to engage with language and to think of alternative words (or euphemisms) that are used to describe death. AIM: To reflect from a nursing perspective how language enables and sometimes disguises important messages and conversations. METHODS: Four hundred and seventy one participants provided 3053 euphemisms. FINDINGS: Euphemisms were varied, with many providing commentary on their purpose and use. DISCUSSION: As a society we have become quite creative in the use of euphemisms, but need to be mindful of misunderstandings and misinterpretations which can cause embarrassment and distress in clinical situations. CONCLUSION: This paper describes some of the euphemisms that were provided, examining why they are used and how their use can be easily misconstrued in daily life and in clinical practice.

Sleep disturbances in caregivers of patients with advanced cancer: A systematic review.

OBJECTIVE: Sleep disturbances are a common issue for those who provide informal care to someone with a life-limiting condition. The negative consequences of poor sleep are well documented. The purpose of the present study was to determine the sleep patterns of caregivers of patients with advanced cancer. METHOD: An extensive systematic review of studies reporting empirical sleep data was undertaken in 2015 in accordance with the PRISMA Statement. A total of eight electronic databases were searched, with no date restrictions imposed. Additionally, a search of the bibliographies of the studies identified during the electronic search was conducted. Search terms included: "sleep," "insomnia," "sleep disturbance," "circadian rhythm," "caregiver," "carer," "advanced cancer," "palliative cancer," and MESH suggestions. The inclusion criteria required studies to be in English and to report primary qualitative and/or quantitative research that examined sleep in caregivers of patients with advanced cancer. Unpublished studies, conference papers, and dissertations were excluded. RESULTS: Overall, 10 studies met the inclusion criteria and were included in the review. Two major findings emerged from the data synthesis. First, at least 72% of caregivers reported moderate to severe sleep disturbance as measured by the Pittsburgh Sleep Quality Index. Second, objective measurement of caregivers' sleep identified that some caregivers experienced up to a 44% reduction in their total sleep time compared to the recommended eight hours. SIGNIFICANCE OF RESULTS: Reduction in total sleep time appears to be the biggest issue facing caregivers' sleep. Future studies need to explore the specific factors that cause these sleep disturbances and thus help to identify interventions to optimize sleep.

Efficacy of Oral Risperidone, Haloperidol, or Placebo for Symptoms of Delirium Among Patients in Palliative Care: A Randomized Clinical Trial.

Importance: Antipsychotics are widely used for distressing symptoms of delirium, but efficacy has not been established in placebo-controlled trials in palliative care. Objective: To determine efficacy of risperidone or haloperidol relative to placebo in relieving target symptoms of delirium associated with distress among patients receiving palliative care. Design, Setting, and Participants: A double-blind, parallel-arm, dose-titrated randomized clinical trial was conducted at 11 Australian inpatient hospice or hospital palliative care services between August 13, 2008, and April 2, 2014, among participants with life-limiting illness, delirium, and a delirium symptoms score (sum of Nursing Delirium Screening Scale behavioral, communication, and perceptual items) of 1 or more. Interventions: Age-adjusted titrated doses of oral risperidone, haloperidol, or placebo solution were administered every 12 hours for 72 hours, based on symptoms of delirium. Patients also received supportive care, individualized treatment of delirium precipitants, and subcutaneous midazolam hydrochloride as required for severe distress or safety. Main Outcome and Measures: Improvement in mean group difference of delirium symptom score (severity range, 0-6) between baseline and day 3. Five a priori secondary outcomes: delirium severity, midazolam use, extrapyramidal effects, sedation, and survival. Results: Two hundred forty-seven participants (mean [SD] age, 74.9 [9.8] years; 85 women [34.4%]; 218 with cancer [88.3%]) were included in intention-to-treat analysis (82 receiving risperidone, 81 receiving haloperidol, and 84 receiving placebo). In the primary intention-to-treat analysis, participants in the risperidone arm had delirium symptom scores that were significantly higher than those among participants in the placebo arm (on average 0.48 Units higher; 95% CI, 0.09-0.86; P = .02) at study end. Similarly, for those in the haloperidol arm, delirium symptom scores were on average 0.24 Units higher (95% CI, 0.06-0.42; P = .009) than in the placebo arm. Compared with placebo, patients in both active arms had more extrapyramidal effects (risperidone, 0.73; 95% CI, 0.09-1.37; P = .03; and haloperidol, 0.79; 95% CI, 0.17-1.41; P = .01). Participants in the placebo group had better overall survival than those receiving haloperidol (hazard ratio, 1.73; 95% CI, 1.20-2.50; P = .003), but this was not significant for placebo vs risperidone (hazard ratio, 1.29; 95% CI, 0.91-1.84; P = .14). Conclusions and Relevance: In patients receiving palliative care, individualized management of delirium precipitants and supportive strategies result in lower scores and shorter duration of target distressing delirium symptoms than when risperidone or haloperidol are added. Trial Registration: anzctr.org.au Identifier: ACTRN12607000562471.

What is the evidence for conducting palliative care family meetings? A systematic review.

BACKGROUND: Structured family meeting procedures and guidelines suggest that these forums enhance family-patient-team communication in the palliative care inpatient setting. However, the vulnerability of palliative patients and the resources required to implement family meetings in accordance with recommended guidelines make better understanding about the effectiveness of this type of intervention an important priority. Aim and design: This systematic review examines the evidence supporting family meetings as a strategy to address the needs of palliative patients and their families. The review conforms to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. DATA SOURCES: Six medical and psychosocial databases and "CareSearch," a palliative care-specific database, were used to identify studies reporting empirical data, published in English in peer-reviewed journals from 1980 to March 2015. Book chapters, expert opinion, and gray literature were excluded. The Cochrane Collaboration Tool assessed risk of bias. RESULTS: Of the 5051 articles identified, 13 met the inclusion criteria: 10 quantitative and 3 qualitative studies. There was low-level evidence to support family meetings. Only two quantitative pre- and post-studies used a validated palliative care family outcome measure with both studies reporting significant results post-family meetings. Four other quantitative studies reported significant results using non-validated measures. CONCLUSION: Despite the existence of consensus-based family meeting guidelines, there is a paucity of evidence to support family meetings in the inpatient palliative care setting. Further research using more robust designs, validated outcome measures, and an economic analysis are required to build the family meeting evidence before they are routinely adopted into clinical practice.