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.

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.

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.

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.

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.

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.

Delirium prevalence, incidence, and implications for screening in specialist palliative care inpatient settings: a systematic review.

BACKGROUND: Delirium is a serious neuropsychiatric syndrome frequently experienced by palliative care inpatients. This syndrome is under-recognized by clinicians. While screening increases recognition, it is not a routine practice. AIM AND DESIGN: This systematic review aims to examine methods, quality, and results of delirium prevalence and incidence studies in palliative care inpatient populations and discuss implications for delirium screening. DATA SOURCES: A systematic search of the literature identified prospective studies reporting on delirium prevalence and/or incidence in inpatient palliative care adult populations from 1980 to 2012. Papers not in English or those reporting the occurrence of symptoms not specifically identified as delirium were excluded. RESULTS: Of the eight included studies, the majority (98.9%) involved participants (1079) with advanced cancer. Eight different screening and assessment tools were used. Delirium incidence ranged from 3% to 45%, while delirium prevalence varied, with a range of: 13.3%-42.3% at admission, 26%-62% during admission, and increasing to 58.8%-88% in the weeks or hours preceding death. Studies that used the Diagnostic and Statistical Manual-Fourth Edition reported higher prevalence (42%-88%) and incidence (40.2%-45%), while incidence rates were higher in studies that screened participants at least daily (32.8%-45%). Hypoactive delirium was the most prevalent delirium subtype (68%-86% of cases). CONCLUSION: The prevalence and incidence of delirium in palliative care inpatient settings supports the need for screening. However, there is limited consensus on assessment measures or knowledge of implications of delirium screening for inpatients and families. Further research is required to develop standardized methods of delirium screening, assessment, and management that are acceptable to inpatients and families.

The "therapeutic footprint" of medical, complementary and alternative therapies and a doctor's duty of care.

Complex societal factors unrelated to evidence of efficacy influence the increasing use of complementary and alternative therapies, which can be viewed as one form of health consumerism. The "therapeutic footprint" is a conceptual model that "plots" medical therapies and complementary and alternative therapies in relationship to one another and to their levels of risk and supporting evidence, acknowledging that medical therapies also entail risks. Philosophies about management of risk and adverse effects differ between complementary and alternative therapies and standard medical care, due to fundamental differences between professionalism within medicine and the demands of health consumerism. In standard medical care, patients' risks are mediated prior to treatment via the doctor-patient relationship and informed consent. With complementary and alternative therapies, protection mechanisms for consumers come into effect mainly after a problem has occurred. Understanding this difference helps doctors whose patients are using complementary or alternative therapies to define the boundaries between these therapies and professional medicine and provide appropriate disclosure of risks. Discussing complementary and alternative therapies and how they differ from standard medical care can provide opportunities to explore patients' concerns and improve the therapeutic relationship.