Support needs of Australians bereaved during the COVID-19 pandemic: A cross-sectional survey study.

BACKGROUND: COVID-19 disrupted access to bereavement support. The objective of this study was to identify the bereavement supports used by Australians during the COVID-19 pandemic, perceived helpfulness of supports used, prevalence and areas of unmet support need, and characteristics of those with unmet support needs. METHODS: A convenience sample of bereaved adults completed an online questionnaire (April 2021-April 2022) about their bereavement experiences including support use and perceived helpfulness, unmet support needs and mental health. Multiple logistic regression was conducted to determine sociodemographic correlates of unmet needs. Open-ended responses were examined using content analysis to determine key themes. RESULTS: 1,878 bereaved Australians completed the questionnaire. Participants were mostly women (94.9%) living in major cities (68%) and reported the death of a parent (45%), with an average age of 55.1 years (SD = 12.2). The five most used supports were family and friends, self-help resources, general practitioners, psychologists, and internet/online community groups. Notably, each was nominated as most helpful and most unhelpful by participants. Two-thirds (66%) reported specific unmet support needs. Those with unmet needs scored lower on mental health measures. Correlates of unmet needs included being of younger age, being a spouse or parent to the deceased; reporting more impacts from public health measures, and not reporting family and friends as supports. The most frequent unmet need was for social support after the death and during lockdown. CONCLUSIONS: This study demonstrates the complexity of bereavement support needs during a pandemic. Specialised grief therapy needs to be more readily available to the minority of grievers who would benefit from it. A clear recommendation for a bereavement support action plan is to bolster the ability of social networks to provide support in times of loss. The fostering of social support in the wake of bereavement is a major gap that needs to be addressed in practice, policy, and research.

Prevalence, severity and impacts of breathlessness in Indian adults: An exploratory, nationally representative, cross-sectional online survey.

There are no known estimates of the prevalence, severity and impacts from breathlessness in low- and middle-income countries. This study aimed to explore the prevalence, severity, self-attributed underlying conditions and impacts of breathlessness limiting exertion in community-dwelling adults in India. This exploratory, population-based online survey recruited a pre-planned sample of 3,000 adult respondents stratified by age, sex and rurality (quotas as per the 2011 Indian National Census). Measures included: demographics; breathlessness limiting exertion (modified Medical Research [mMRC] scale); health-related quality of life (EQ-5D-5L); and disability (World Health Organisation's Disability Assessment Schedule 2.0 12-item questionnaire [WHODAS-12]). Respondents (n = 3,046) had a mean age of 38 years (SD 15); 57% were male, 59% lived in rural areas and 33% had completed 12th grade. Breathlessness limiting exertion (mMRC ≥1) was reported by 44%, mostly attributed to poor nutrition (28%), lung conditions excluding tuberculosis (17%) or anaemia (13%). Compared to those without breathlessness, a higher proportion of people with breathlessness (mMRC ≥1) reported problems across all EQ-5D-5L dimensions. Most people reporting breathlessness (81%) indicated the symptom had adversely affected their normal activities. Disability scores (WHODAS-12 total and individual domains) increased as breathlessness worsened. To conclude, in India, conservative estimates indicate 626 million people live with breathlessness of whom 52 million people live with severe breathlessness. The symptom is associated with poorer health-related quality of life and marked disability, including reduced ability to perform daily activities.

The associations between social determinants of health, mental health, substance-use and recidivism: a ten-year retrospective cohort analysis of women who completed the connections programme in Australia.

BACKGROUND: Women with substance-use issues are overrepresented in prison. Research on women's recidivism often focuses on offending behaviour rather than the health and social circumstances women are experiencing when reimprisonment occurs. This study examines the relationship between social determinants of health (SDOH), mental health, substance-use and recidivism among women exiting prison with histories of substance-use. METHODS: A retrospective cohort study of women exiting prison who completed the transitional support programme "Connections" between 2008 and 2018. Recidivism was measured up to two years post-release. Women's support needs were measured at baseline (4 weeks pre-release) and follow-up (four weeks post-release). Ongoing needs in relation to well-established SDOH were calculated if: (1) at baseline women were identified as having a re-entry need with housing, employment, finances, education, domestic violence, child-custody and social support and (2) at follow-up women reported still needing help in that area. Women's self-reported substance-use and mental health since release were captured at follow-up. Descriptive statistics were calculated for all measures. Associations between SDOH, mental health, substance-use and recidivism were estimated by multiple logistic regression, adjusting for potential confounders. We also evaluated the mediating effects of mental health on the relationship between SDOH and substance-use. RESULTS: Substance-use was associated with increased odds of recidivism (adjusted odds ratio (AOR) 1.8, 95% confidence interval (CI) 1.1-2.9; p = 0.02). Poor mental health (AOR 2.9, 95% CI 1.9-4.6; p = < 0.01), ongoing social support (AOR 3.0, 95% CI 1.9-5.0; p = < 0.01), child-custody (AOR 1.9, 95% CI 1.0-3.3 p = 0.04), financial (AOR 2.0, 95% CI 1.3-3.2; p = < 0.01) and housing (AOR 1.8, 95% CI 1.1-2.9; p = 0.02) needs were individually associated with increased odds of substance-use. Mediation analysis found mental health fully mediated the effects of ongoing housing (beta efficiency (b) = - 033, standard error (SE) 0.01; p = 0.05), financial (b = 0.15, SE 0.07; p = 0.05), child-custody (b = 0.18, SE 0.01; p = 0.05) and social support (b = 0.36, SE 0.1; p = 0.05) needs onto substance-use, and partially mediated the effects of domestic violence (b = 0.57, SE 0.23; p = 0.05) onto substance-use. CONCLUSION: This study underscores the critical importance of addressing the interplay between SDOH, mental health, substance-use and recidivism. An approach that targets SDOH holds the potential for reducing mental distress and substance-use, and related recidivism.

The COVID-19 Pandemic: Bereavement Experiences Between Hospital and Home Deaths in Palliative Care.

BACKGROUND: Australian COVID-19 public health measures reduced opportunities for people to communicate with healthcare professionals and be present at the death of family members/friends. AIM: To understand if pandemic-specific challenges and public health measures during the COVID-19 pandemic impacted end-of-life and bereavement experiences differently if the death, supported by palliative care, occurred in a hospital or at home. DESIGN: A cross-sectional online survey was completed by bereaved adults during 2020-2022. Analyses compared home and in-patient palliative care deaths and bereavement outcomes. Additional analyses compared health communication outcomes for those identified as persons responsible or next of kin. SETTING/PARTICIPANTS: Of 744 bereaved people; 69% (n = 514) had a death in hospital and 31% (n = 220) at home. RESULTS: The COVID-19 public health measures influenced people's decision to die at home. Compared to hospital deaths, the home death group had higher levels of grief severity and grief-related functional impairment. Only 37% of bereaved people received information about bereavement and support services. 38% of participants who were at least 12 months postdeath scored at a level suggestive of possible prolonged grief disorder. Levels of depression and anxiety between the two groups were not significantly different. CONCLUSIONS: These findings highlight the need for health services to recognize bereavement as fundamental to palliative and health care and provide pre- and post death grief and bereavement care to ensure supports are available particularly for those managing end-of-life at home, and that such supports are in place prior to as well as at the time of the death.

Effects of the Connections program on return-to-custody, mortality and treatment uptake among people with a history of opioid use: Retrospective cohort study in an Australian prison system.

BACKGROUND AND AIMS: Connections is a voluntary health program that facilitates access to opioid agonist treatment (OAT) and social services for people with opioid use exiting prison. This study aimed to measure the effectiveness of Connections in reducing recidivism and improving health outcomes for people with a history of opioid use on leaving prison. DESIGN: Retrospective cohort study with quasi-random allocation to the program. SETTING: Public adult prisons in New South Wales, Australia, 2008-2015. PARTICIPANTS: Adults released from custody with a history of opioid use. Of 5549 eligible releasees, 3973 were allocated to Connections and 1576 to treatment-as-usual. MEASUREMENTS: Outcomes were return-to-custody, all-cause mortality, and OAT participation. FINDINGS: Regression analyses on an intention-to-treat basis, and adjusting for baseline propensity scores, comparing patients allocated to Connections versus treatment-as-usual showed no difference in rates of return-to-custody within 2 years (hazard ratio [HR]: 1.01; 95% confidence interval [CI]: 0.92 -1.12). Patients allocated to the Connections program were more likely to access OAT (odds ratio [OR]: 1.21; 95% CI: 1.06-1.39) and had lower mortality within 28 days of release (0.25% vs. 0.66%; HR: 0.38; 95% CI: 0.14-1.03). Differences in mortality did not persist beyond 28 days. Subgroup analyses showed that allocation to Connections was associated with higher risk of return-to-custody within 28 days for Aboriginal and/or Torres Strait Islander (Indigenous) and female releasees. CONCLUSIONS: The Connections program for people with opioid use exiting prison did not reduce the likelihood of return-to-custody but did facilitate opioid agonist treatment participation on release from prison.

Gabapentin for Pain in Pediatric Palliative Care.

OBJECTIVE: Gabapentin is commonly used to treat pain in children receiving pediatric palliative care. This study describes the real-world use of gabapentin and the associated benefits and adverse effects/events (AEs). METHODS: A prospective, multicenter cohort of standardized data collection after a clinical decision was made to use gabapentin for managing neuropathic or nociplastic pain in children attended on by a pediatric palliative care service. It was conducted across 11 sites in seven countries including hospital, inpatient, and outpatient services. Clinical outcomes were graded using pain scales validated for age and cognitive ability and the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) at baseline, 14 days, 28 days, six weeks and 12 weeks after initiation of gabapentin. Ad-hoc safety reporting continued throughout the study. RESULTS: Data were collected from 127 children with a median age of 4.7 years (IQR 0.1-17.9); 61% had a neurological disorder, 21% advanced cancer and the cohort had a high level of disability (Lansky/Karnofsky performance score 37.1). Gabapentin was prescribed at standard pediatric doses. On average, 76% of children had a reduction in pain and 42% experienced a potential AE. The mean pain score decreased from 6.0 (SD 2.6) at baseline to 3.3 (SD 2.4) at 14 days and 1.8 (SD 1.8) after 12-weeks of gabapentin therapy. Ten percent had increased pain at each time point. AEs did not increase when individual changes over time were accounted for except for somnolence (7%). Serious AEs attributable to gabapentin were possible or probable in 3% of children. CONCLUSIONS: Gabapentin prescribed at standard doses for advanced cancer and severe neurological injury in children under a pediatric palliative care service was associated with generally improved pain intensity at previously described levels of adverse effects.

The impact of regular, low-dose, sustained-release morphine for chronic breathlessness on caregiver burden: An exploratory analysis of the BEAMS trial.

BACKGROUND: Chronic breathlessness adversely impacts people with chronic obstructive pulmonary disease and their caregivers (family and friends), who may, in turn, experience significant burden due to their caregiving role. Sustained-release morphine may reduce chronic breathlessness in some patients, which may have an impact on caregivers' perceived burden. AIM: To explore the impact on caregiver burden of active treatment of people with chronic breathlessness (modified Medical Research Council (mMRC) ⩾ 3) and chronic obstructive pulmonary disease (COPD) with regular, low-dose, sustained-release morphine within a multi-site, double-blind, randomised, placebo-controlled trial. DESIGN: Exploratory analysis of self-reported caregiver burden at baseline and end of week 3 in a randomised, double-blind, placebo-controlled study. Caregiver measures included: demographics and perceived burden (Zarit Burden Interview 12-item short-form questionnaire). Patient measures included: worst breathlessness and FitBitR-measures. SETTING/PARTICIPANTS: All consenting caregivers of trial patient participants in a multi-site study recruiting from palliative care and respiratory services. RESULTS: Caregivers (n = 49; 59% women; median age 68 years [IQR 50-75]) reported median baseline caregiver burden 12 [IQR 5-17], with 53% reporting high burden (⩾13). Eighty-four percent of caregivers reported no change in burden. In people whose worst breathlessness improved, caregiver burden moved in the same direction, though the correlation was not significant (rs = 0.25, p = 0.17). Conversely, caregiver burden worsened as patients' minutes lightly active increased, with the correlation being significant (rs = 0.56, p = 0.04). CONCLUSIONS: Caregivers reported high levels of caregiver burden, but patients' response to treatment in terms of their symptom and function may influence change in caregiver burden over a three-week period.

Subcutaneous ketamine infusion in palliative patients for major depressive disorder (SKIPMDD)-Phase II single-arm open-label feasibility study.

BACKGROUND: Ketamine at subanaesthetic dosages (≤0.5mg/kg) exhibits rapid onset (over hours to days) antidepressant effects against major depressive disorder in people who are otherwise well. However, its safety, tolerability and efficacy are not known for major depressive disorder in people with advanced life-limiting illnesses. OBJECTIVE: To determine the feasibility, safety, tolerability, acceptability and any antidepressant signal/activity to justify and inform a fully powered study of subcutaneous ketamine infusions for major depressive disorder in the palliative setting. METHODS: This was a single arm, open-label, phase II feasibility study (Australian New Zealand Clinical Trial Registry Number-ACTRN12618001586202). We recruited adults (≥ 18-years-old) with advanced life-limiting illnesses referred to four palliative care services in Sydney, Australia, diagnosed with major depressive disorder from any care setting. Participants received weekly subcutaneous ketamine infusion (0.1-0.4mg/kg) over two hours using individual dose-titration design. Outcomes assessed were feasibility, safety, tolerability and antidepressant activity. RESULTS: Out of ninety-nine referrals, ten participants received ketamine and were analysed for responses. Accrual rate was 0.54 participants/month across sites with 50% of treated participants achieving ≥ 50% reduction in baseline Montgomery-Åsberg Depression Rating Scale, meeting feasibility criteria set a priori. There were no clinically relevant harms encountered. CONCLUSIONS: A future definitive trial exploring the effectiveness of subcutaneous infusion of ketamine for major depressive disorder in the palliative care setting may be feasible by addressing identified study barriers. Individual dose-titration of subcutaneous ketamine infusions over two hours from 0.1mg/kg can be well-tolerated and appears to produce transient antidepressant signals over hours to days.

Feasibility of Integrating MEditatioN inTO heaRt Disease (the MENTOR Study): A Phase II Randomized Controlled Trial.

BACKGROUND: Comorbid depression and/or anxiety symptoms occur in 25% of patients attending cardiac rehabilitation (CR) programs and are associated with poorer prognosis. There is a need to evaluate psychological interventions, including meditation, that have potential to improve psychological health in CR programs. AIMS: The aim of this study was to determine the feasibility and acceptability of integrating a meditation intervention into an existing Australian CR program for the reduction of depression and anxiety symptoms. METHODS: This was a mixed-methods feasibility randomized controlled trial. Thirty-one patients with CVD and, at a minimum, mild depression and/or anxiety symptoms were randomized to meditation and standard CR or to standard CR alone. A 16-minute guided group meditation was delivered face-to-face once a week for 6 weeks, with daily self-guided meditation practice between sessions. Feasibility outcomes included screening, recruitment, and retention. Semistructured interviews of patients' (n = 10) and health professionals' (n = 18) perspectives of intervention participation and delivery were undertaken to assess acceptability. Between-group differences in depression, anxiety, stress, self-efficacy for mindfulness, and health status at 6 and 12 weeks were also assessed. RESULTS AND CONCLUSION: Meditation was considered feasible, with 83% (12/15) of the intervention group completing an average of 3.13 (SD, 2.56) out of 6 group meditation sessions and 5.28 (SD, 8.50) self-guided sessions. Meditation was considered acceptable by patients, clinicians, and health managers. Between-group differences in the number of CR sessions completed favored the intervention group in per-protocol analyses (intervention group vs control group, 12 vs 9 sessions; P = .014), which suggests that meditation may be useful to improve patients' adherence to exercise-based CR program.

Phase II, double blind, placebo controlled, multi-site study to evaluate the safety, feasibility and desirability of conducting a phase III study of anamorelin for anorexia in people with small cell lung cancer: A study protocol (LUANA trial).

Anorexia is experienced by most people with lung cancer during the course of their disease and treatment. Anorexia reduces response to chemotherapy and the ability of patients to cope with, and complete their treatment leading to greater morbidity, poorer prognosis and outcomes. Despite the significant importance of cancer-related anorexia, current therapies are limited, have marginal benefits and unwarranted side effects. In this multi-site, randomised, double blind, placebo controlled, phase II trial, participants will be randomly assigned (1:1) to receive once-daily oral dosing of 100mg of anamorelin HCl or matched placebo for 12 weeks. Participants can then opt into an extension phase to receive blinded intervention for another 12 weeks (weeks 13-24) at the same dose and frequency. Adults (≥18 years) with small cell lung cancer (SCLC); newly diagnosed with planned systemic therapy OR with first recurrence of disease following a documented disease-free interval ≥6 months, AND with anorexia (i.e., ≤ 37 points on the 12-item Functional Assessment of Anorexia Cachexia Treatment (FAACT A/CS) scale) will be invited to participate. Primary outcomes are safety, desirability and feasibility outcomes related to participant recruitment, adherence to interventions, and completion of study tools to inform the design of a robust Phase III effectiveness trial. Secondary outcomes are the effects of study interventions on body weight and composition, functional status, nutritional intake, biochemistry, fatigue, harms, survival and quality of life. Primary and secondary efficacy analysis will be conducted at 12 weeks. Additional exploratory efficacy and safety analyses will also be conducted at 24 weeks to collect data over longer treatment duration. The feasibility of economic evaluations in Phase III trial will be assessed, including the indicative costs and benefits of anamorelin for SCLC to the healthcare system and society, the choice of methods for data collection and the future evaluation design. Trial registration. The trial has been registered with the Australian New Zealand Clinical Trials Registry [ACTRN12622000129785] and approved by the South Western Sydney Local Health District Human Research Ethics Committee [2021/ETH11339]. https://clin.larvol.com/trial-detail/ACTRN12622000129785.

Associations in Perceived Health and Persistent Breathlessness: A Cross-Sectional Study.

Background: Persistent breathlessness is debilitating and increases in prevalence with advanced age and at end of life. This study aimed to evaluate any relationship between self-reported global impressions of change (GIC) in perceived health and breathlessness in older men. Design: Cross-sectional study of 73-year-old Swedish men in the VAScular and Chronic Obstructive Lung disease study. A postal survey included items on perceived changes in health and breathlessness (GIC scales) and breathlessness (assessed using the modified Medical Research Council [mMRC] breathlessness scale, Dyspnea-12 and Multidimensional Dyspnea Scale) since age 65. Results: Of 801 respondents, breathlessness (mMRC ≥2) was reported by 17.9%, worsening breathlessness by 29.1%, and worsening perceived health by 51.3%. Worsening breathlessness was strongly correlated with worsening perceived health (Pearson's correlation coefficient of 0.68 [p < 0.001] and Kendall's τ of 0.56 [p < 0.001]) and associated with more limited function (47.2% vs. 29.7%; p < 0.0001) and increased rates of anxiety/depression. Conclusion: The strong correlation between perceived changes in health and persistent breathlessness helps delineate a more comprehensive picture of the challenges faced by older adults living with this disabling symptom.

Health care professionals' experiences of dealing with cancer cachexia.

BACKGROUND: Cancer cachexia (CC) is a debilitating syndrome severely impacting patients' quality of life and survivorship. We aimed to investigate the health care professionals' (HCPs') experiences of dealing with CC. METHODS: Survey questions entailed definitions and guidelines, importance of CC management, clinician confidence and involvement, screening and assessment, interventions, psychosocial and food aspects. The online survey was disseminated through Australian and New Zealand palliative care, oncology, allied health and nursing organisations. Frequencies were reported using descriptive statistics accounting for response rates. Associations were examined between variables using Fisher's exact and Pearson's chi-square tests. RESULTS: Over 90% of the respondents (n = 192) were medical doctors or nurses. Over 85% of the respondents were not aware of any guidelines, with 83% considering ≥ 10% weight loss from baseline indicative of CC. CC management was considered important by 77% of HCPs, and 55% indicated that it was part of their clinical role to assess and treat CC. In contrast, 56% of respondents were not confident about managing CC, and 93% believed formal training in CC would benefit their clinical practice. Although formal screening tools were generally not used (79%), 75% of respondents asked patients about specific symptoms. Antiemetics (80%) and nutritional counselling (86%) were most prescribed or recommended interventions, respectively. CONCLUSION: This study underlines the deficiencies in knowledge and training of CC which has implications for patients' function, well-being and survival. HCP training and a structured approach to CC management is advocated for optimal and continued patient care.

Factors associated with being an older rather than younger unpaid carer of adults with a chronic health condition: Results from a population-based cross-sectional survey in South Australia.

OBJECTIVE: To examine sociodemographic characteristics and caring experiences associated with being an older rather than younger carer of an adult with a chronic health condition. METHODS: The population-based cross-sectional South Australian Health Omnibus survey was administered in 2016. Multiple logistic regression was used to identify sociodemographic characteristics and caring experiences associated with being an older (≥65 years) versus younger (<65 years) carer of one or more adult(s) with a chronic health condition. RESULTS: Of 988 survey respondents who self-identified as carers, 198(20%) were 65 years or over. Characteristics associated with being an older carer included having a partner, having poor physical health, being born outside Australia, have no formal qualification, living in a household of 1-2 people, have an annual household income ≤$60,000, and owning one's home. Carer experiences associated with older carer status included providing ≥40 h of care per week, perceived control over caring, and caring for someone with a neurological condition, whereas caring for someone with a mental illness, reporting poor mental health of their own, and providing personal care were inversely associated. DISCUSSION: Interventions directed at older carers should consider the increased likelihood that they may be investing large amounts of time in caring for someone with a neurological condition, and be culturally and linguistically diverse.

Comparison of six frailty instruments in adults with heart failure: a prospective cohort pilot study.

AIMS: To compare the frailty prevalence and predictive performance of six frailty instruments in adults with heart failure and determine the feasibility of study methods. METHODS AND RESULTS: Prospective cohort pilot study. Adults aged 18 years or older with a confirmed diagnosis of heart failure in Sydney, New South Wales, Australia. The Frailty Phenotype; the Survey of Health, Ageing, and Retirement in Europe Frailty Instrument (SHARE-FI); St Vincent's Frailty instrument; St Vincent's Frailty instrument plus cognition and mood; The Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight (FRAIL) scale; and the Deficit Accumulation Index (DAI) were compared. Multiple logistic regression was used to develop six frailty instrument models to evaluate the association between each frailty instrument and composite all-cause rehospitalization and mortality at 12 months. One hundred and thirty-one patients were included with a mean age of 54 [± 14(SD)]. Frailty prevalence ranged from 33 to 81%. All instruments except one (the FRAIL scale) appeared to signal an increased odds of rehospitalization and/or mortality, yet these results were non-significant. The six frailty instrument models displayed sensitivity between 88-92% and C-statistic values of 0.71-0.73, suggesting satisfactory discrimination. CONCLUSION: The prevalence of frailty varied across six frailty instruments yet was in the higher range despite a 'younger' heart failure cohort. Further research is required to confirm the psychometric properties of these instruments for routine clinical use in an adequately powered and more diverse heart failure cohort.

Effect of Regular, Low-Dose, Extended-release Morphine on Chronic Breathlessness in Chronic Obstructive Pulmonary Disease: The BEAMS Randomized Clinical Trial.

Importance: Chronic breathlessness is common in people with chronic obstructive pulmonary disease (COPD). Regular, low-dose, extended-release morphine may relieve breathlessness, but evidence about its efficacy and dosing is needed. Objective: To determine the effect of different doses of extended-release morphine on worst breathlessness in people with COPD after 1 week of treatment. Design, Setting, and Participants: Multicenter, double-blind, placebo-controlled randomized clinical trial including people with COPD and chronic breathlessness (defined as a modified Medical Research Council score of 3 to 4) conducted at 20 centers in Australia. People were enrolled between September 1, 2016, and November 20, 2019, and followed up through December 26, 2019. Interventions: People were randomized 1:1:1 to 8 mg/d or 16 mg/d of oral extended-release morphine or placebo during week 1. At the start of weeks 2 and 3, people were randomized 1:1 to 8 mg/d of extended-release morphine, which was added to the prior week's dose, or placebo. Main Outcomes and Measures: The primary outcome was change in the intensity of worst breathlessness on a numerical rating scale (score range, 0 [none] to 10 [being worst or most intense]) using the mean score at baseline (from days -3 to -1) to the mean score after week 1 of treatment (from days 5 to 7) in the 8 mg/d and 16 mg/d of extended-release morphine groups vs the placebo group. Secondary outcomes included change in daily step count measured using an actigraphy device from baseline (day -1) to the mean step count from week 3 (from days 19 to 21). Results: Among the 160 people randomized, 156 were included in the primary analyses (median age, 72 years [IQR, 67 to 78 years]; 48% were women) and 138 (88%) completed treatment at week 1 (48 in the 8 mg/d of morphine group, 43 in the 16 mg/d of morphine group, and 47 in the placebo group). The change in the intensity of worst breathlessness at week 1 was not significantly different between the 8 mg/d of morphine group and the placebo group (mean difference, -0.3 [95% CI, -0.9 to 0.4]) or between the 16 mg/d of morphine group and the placebo group (mean difference, -0.3 [95%, CI, -1.0 to 0.4]). At week 3, the secondary outcome of change in mean daily step count was not significantly different between the 8 mg/d of morphine group and the placebo group (mean difference, -1453 [95% CI, -3310 to 405]), between the 16 mg/d of morphine group and the placebo group (mean difference, -1312 [95% CI, -3220 to 596]), between the 24 mg/d of morphine group and the placebo group (mean difference, -692 [95% CI, -2553 to 1170]), or between the 32 mg/d of morphine group and the placebo group (mean difference, -1924 [95% CI, -47 699 to 921]). Conclusions and Relevance: Among people with COPD and severe chronic breathlessness, daily low-dose, extended-release morphine did not significantly reduce the intensity of worst breathlessness after 1 week of treatment. These findings do not support the use of these doses of extended-release morphine to relieve breathlessness. Trial Registration: ClinicalTrials.gov Identifier: NCT02720822.

Cyclizine pharmacovigilance in hospice/palliative care: net effects for nausea or vomiting.

OBJECTIVES: To describe the contemporary real-world use of cyclizine for nausea or vomiting, and the associated benefits and harms. METHODS: This was a prospective, consecutive case series of routine clinical use of cyclizine for nausea or vomiting in palliative care conducted across 19 sites in Australia, Aotearoa/New Zealand and the UK. Clinical outcomes were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events at baseline and 72 hours after initiation of cyclizine. Ad hoc safety reporting continued for 2 weeks. RESULTS: Data were collected from 101 patients between May 2018 and December 2020. Cyclizine was mostly used in combination with another antiemetic. Overall, 79 patients benefited and 32 experienced harm (56 had benefit without harm; 9 had harm without benefit). The most common harms were constipation (13%), somnolence (9%) and confusion (7%), adding to the already high rates of these symptoms at baseline. For the four patients with serious harms (grade ≥3), these were exacerbations of existing symptoms. Nine patients stopped cyclizine at 72 hours and a further 20 patients within 2 weeks. The most common reasons for stopping were lack of benefit and symptom resolution; none stopped because of harms. CONCLUSIONS: When used as described in a palliative care setting, cyclizine benefits about three-quarters of patients, with about one-third experiencing tolerable harms.

The effects of social support on depression and anxiety in the perinatal period: A mixed-methods systematic review.

BACKGROUND: The social support offered to women in the perinatal period can buffer against depression and anxiety. The sources and types of support that reduce maternal levels of depression and anxiety are not well understood. AIMS: To investigate the effects of structural and functional support on depression and anxiety in women in the perinatal period, and to explore the experiences of women around support during the perinatal period. METHOD: A comprehensive search of six electronic databases was undertaken. Relevant studies published from January 2010 to April 2020 were included (PROSPERO reference number: CRD42020194228). Quantitative and qualitative studies were eligible if they reported the effects of, or had themes related to receiving functional or structural support in the perinatal period on women's levels of depression or anxiety. Qualitative data was synthesised using a thematic synthesis method. Quantitative data could not be pooled due to the lack of comparable RCTs or cohort studies and was thus presented in a narrative form. RESULTS: Fifty-one articles (41 quantitative and 10 qualitative studies) were included. Analysis of quantitative studies demonstrated that insufficient support from partner, friends and family was associated with greater risk of symptoms of depression and anxiety. Distance-delivered interventions (via internet or telephone) diminished levels of depression and anxiety. Qualitative data revealed three overarching themes: appreciating all forms of support in the perinatal period, recognising appropriate and inappropriate support from health professionals and services, and having barriers to mobilising functional and structural support. LIMITATIONS: Grey literature was not explored and search strategies only included English, Spanish and Portuguese language articles. The reviewed studies were heterogeneous and for this reason, quantitative assessments were not feasible. CONCLUSION: Support from specific sources such as family members, friends who are also mothers, health professionals, neighbours, supervisors, co-workers and online communities still need to be further investigated. Implications for health professionals involved in the care of women in the perinatal period are discussed.

Paracentesis for cancer-related ascites in palliative care: An international, prospective cohort study.

BACKGROUND: Paracentesis is commonly undertaken in patients with cancer-related ascites. AIM: To systematically investigate the symptomatic benefits and harms experienced by patients with cancer undergoing paracentesis using real-world data in the palliative care setting. DESIGN: Prospective, multisite, observational, consecutive cohort study. Benefits and harms of paracentesis were assessed between 01/07/2018 and 31/02/2021 as part of routine clinical assessments by treating clinicians at four timepoints: (T0) before paracentesis; (T1) once drainage ceased; (T2) 24 h after T1 and (T3) 28 days after T1 or next paracentesis, if sooner. SETTING/PARTICIPANTS: Data were collected from 11 participating sites across five countries (Australia, England, Hong Kong, Malaysia and New Zealand) on 111 patients undergoing paracentesis via a temporary (73%) or indwelling (21%) catheter: 51% male, median age 69 years, Australia-modified Karnofsky Performance Score 50. RESULTS: At T1 (n = 100), symptoms had improved for most patients (81%), specifically abdominal distension (61%), abdominal pain (49%) and nausea (27%), with two-thirds experiencing improvement in ⩾2 symptoms. In the remaining patients, symptoms were unchanged (7%) or worse (12%). At least one harm occurred in 32% of patients, the most common being an ascitic leak (n = 14). By T3, 89% of patients had experienced some benefit and 36% some harm, including four patients who experienced serious harm, one of which was a fatal bowel perforation. CONCLUSION: Most patients obtained rapid benefits from paracentesis. Harms were less frequent and generally mild, but occasionally serious and fatal. Our findings help inform clinician-patient discussions about the potential outcomes of paracentesis in this frail population.