CONTEXT:Minimizing bias in randomized controlled trials (RCTs) includes intention-to-treat analyses. Hospice/palliative care RCTs are constrained by high attrition unpredictable when consenting, including withdrawals between randomization and first exposure to the intervention. Such withdrawals may systematically bias findings away from the new intervention being evaluated if they are considered nonresponders. OBJECTIVES:This study aimed to quantify the impact within intention-to-treat principles. METHODS:A theoretical model was developed to assess the impact of withdrawals between randomization and first exposure on study power and effect sizes. Ten reported hospice/palliative care studies had power recalculated accounting for such withdrawal. RESULTS:In the theoretical model, when 5% of withdrawals occurred between randomization and first exposure to the intervention, change in power was demonstrated in binary outcomes (2.0%-2.2%), continuous outcomes (0.8%-2.0%), and time-to-event outcomes (1.6%-2.0%), and odds ratios were changed by 0.06-0.17. Greater power loss was observed with larger effect sizes. Withdrawal rates were 0.9%-10% in the 10 reported RCTs, corresponding to power losses of 0.1%-2.2%. For studies with binary outcomes, withdrawal rates were 0.3%-1.2% changing odds ratios by 0.01-0.22. CONCLUSION:If blinding is maintained and all interventions are available simultaneously, our model suggests that excluding data from withdrawals between randomization and first exposure to the intervention minimizes one bias. This is the safety population as defined by the International Committee on Harmonization. When planning for future trials, minimizing the time between randomization and first exposure to the intervention will minimize the problem. Power should be calculated on people who receive the intervention.

CONTEXT:Breathlessness is associated with depression, but its relationship to anxiety or impaired function is less clear. OBJECTIVES:This study evaluated associations between chronic breathlessness and anxiety, depression, and functional status in the general population. METHODS:This cross-sectional study of consenting adults (18 years and older) used an online survey. Quota sampling (n = 3000) was used reflecting the 2016 national census for sex, age, and place of residence. Other data included Four-Item Patient Health Questionnaire for depression and anxiety, the modified Medical Research Council (mMRC) Breathlessness Scale, and the Australia-modified Karnofsky Performance Scale. Multinomial logistic regression assessed predictors. RESULTS:About 2977 respondents had all relevant scores (female 51.2%; median age 45.0 [range 18-92]). Prevalence of breathlessness (mMRC ≥2) was 2.4%, anxiety 6.0%, depression 2.7%, coexisting anxiety/depression 6.1%, and poorer functional status (Australia-modified Karnofsky Performance Scale ≤60) 1.6%. In multinomial regression, depression, anxiety, and coexisting anxiety/depression were predicted by younger age, longer duration of breathlessness, and poorer functional status. The highest proportions of people with breathlessness were found in the coexisting anxiety/depression group (10.6%) and depression only group (8.8%). Poorest function was in the coexisting anxiety/depression group with 11.6%. The relationship between poorer functional status and coexisting anxiety/depression was significant (odds ratio 0.90; 95% CI 0.89, 0.92). Adjusted odds ratio for breathlessness and depression only was 3.0 (95% CI 1.2, 7.8). CONCLUSION:Clinically important breathlessness (mMRC ≥2) was associated with depression, anxiety, and coexisting anxiety/depression. Poorer function that is associated with psychological morbidity in the general population requires further research.

INTRODUCTION:Delirium is a significant medical complication for hospitalised patients. Up to one-third of delirium episodes are preventable in older inpatients through non-pharmacological strategies that support essential human needs, such as physical and cognitive activity, sleep, hydration, vision and hearing. We hypothesised that a multicomponent intervention similarly may decrease delirium incidence, and/or its duration and severity, in inpatients with advanced cancer. Prior to a phase III trial, we aimed to determine if a multicomponent non-pharmacological delirium prevention intervention is feasible and acceptable for this specific inpatient group. METHODS AND ANALYSIS:The study is a phase II cluster randomised wait-listed controlled trial involving inpatients with advanced cancer at four Australian palliative care inpatient units. Intervention sites will introduce delirium screening, diagnostic assessment and a multicomponent delirium prevention intervention with six domains of care: preserving natural sleep; maintaining optimal vision and hearing; optimising hydration; promoting communication, orientation and cognition; optimising mobility; and promoting family partnership. Interdisciplinary teams will tailor intervention delivery to each site and to patient need. Control sites will first introduce only delirium screening and diagnosis, later implementing the intervention, modified according to initial results. The primary outcome is adherence to the intervention during the first seven days of admission, measured for 40 consecutively admitted eligible patients. Secondary outcomes relate to fidelity and feasibility, acceptability and sustainability of the study intervention, processes and measures in this patient population, using quantitative and qualitative measures. Delirium incidence and severity will be measured to inform power calculations for a future phase III trial. ETHICS AND DISSEMINATION:Ethical approval was obtained for all four sites. Trial r...

BACKGROUND:Advance care planning (ACP) is identified as being an important process for people with dementia. However, its efficacy for improving outcomes relevant for the individual, carers and the health system has yet to be established.AimWe conducted a systematic review with the aims of testing the efficacy of ACP for people with dementia and describing the settings and population in which it has been evaluated. METHODS:A search was completed of electronic databases in August 2016. Articles were included if they described interventions aimed at increasing planning for future care of people with dementia, delivered to the person with dementia, their carers and/or health professionals. RESULTS:Of 4,772 articles returned by searches, 30 met the inclusion criteria, testing interventions in nursing home (n= 16) community (n = 10) and acute care (n = 4) settings. Only 18 interventions directly involved the person with dementia, with the remainder focusing on surrogate decision-makers. In all settings, interventions were found effective in increasing ACP practice. In nursing homes, ACP was found to influence care and increase the concordance between end of life wishes and care provided. Interventions in the community were found to improve patient quality of life but were not shown to influence concordance. CONCLUSION:Future research should focus on ways to involve people with dementia in decision-making through supported means.

© The Author(s) 2019. The concept of moral distress comes from nursing ethics, and was initially defined as ‘…when one knows the right thing to do, but institutional constraints make it nearly impossible to pursue the right course of action’. There is a large body of literature associated with moral distress, yet multiple definitions now exist, significantly limiting its usefulness. We undertook a systematic review of the argument-based bioethics literature on this topic as the basis for a critical appraisal, identifying 55 papers for analysis. We found that moral distress is most frequently framed around individual experiences of distress in relation to local practices and constraints, and understood in terms of power relations and workplace hierarchies. This understanding is directly derived from, and often still seen as specific to, nursing. Frequently the perspective of the morally distressed individual is privileged. Understandings of moral distress have evolved towards an ‘occupational health approach’, with the assumption that moral distress should be measured and prevented. Counter-perspectives were identified, highlighting conceptual problems. Based on our review, we propose a redefinition of moral distress: ‘Ethical unease or disquiet resulting from a situation where a clinician believes they have contributed to avoidable patient or community harm through their involvement in an action, inaction or decision that conflicts with their own values’. This definition is specific enough for research use, anchored in clinicians’ professional responsibilities and concerns about harms to patients, framed relationally rather than hierarchically, and amenable to multiple perspectives on any given morally distressing situation.

The working ages (25-65 years) are a period when most people have significant work, financial, and family responsibilities. A small proportion of working age people will face an expected premature death from cancer or other life-limiting illness. Understanding the impact an expected premature death has on this population is important for informing support. The current study set out to summarize research describing the effects that facing an expected premature death has on employment, financial, and lifestyle of working age people and their families.A systematic review using narrative synthesis approach. Four electronic databases were searched in July 2016 for peer-reviewed, English language studies focusing on the financial, employment, and lifestyle concerns of working age adults living with an advanced life-limiting illness and/or their carers and/or children.Fifteen quantitative and 12 qualitative studies were included. Two-thirds (n = 18) were focused on cancer. All studies identified adverse effects on workforce participation, finances, and lifestyle. Many patients were forced to work less or give up work/retire early because of symptoms and reduced functioning. In addition to treatment costs, patients and families were also faced with child care, travel, and home/car modification costs. Being younger was associated with greater employment and financial burden, whereas having children was associated with lower functional well-being. Changes in family roles were identified as challenging regardless of diagnosis, whereas maintaining normalcy and creating stability was seen as a priority by parents with advanced cancer. This review is limited by the smaller number of studies focussing on the needs of working age people with nonmalignant disease. Significance of results Working age people facing an expected premature death and their families have significant unmet financial, employment, and lifestyle needs. Comparing and contrasting their severity, timing, and p...

A family-focused care approach in palliative
care recognizes the fundamental role of families
in contributing to the care of people with
life-limiting conditions. It is essential that
healthcare providers develop understanding
of families’ needs and the skills to collaborate
effectively with families caring for people at
the end of their lives. This chapter introduces
the concept and components of family-focused
palliative care. It continues with a discussion
of what patients and families perceive to be
the most important aspects of end-of-life care.
This chapter provides information to assist
healthcare providers who work with people
with life-limiting conditions and their families
in providing family-focused care and to
identify gaps and challenges to providing
such care.