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Background: Despite evidence demonstrating the utility of using Person-Centred Outcome Measures within palliative care settings, implementing them into routine practice is challenging. Most research has described barriers to, without explaining the causal mechanisms underpinning, implementation. Implementation theories explain how, why, and in which contexts specific relationships between barriers/enablers might improve implementation effectiveness but have rarely been used in palliative care outcomes research. Aim: To use Normalisation Process Theory to understand and explain the causal mechanisms that underpin successful implementation of Person-Centred Outcome Measures within palliative care. Design: Exploratory qualitative study. Data collected through semi-structured interviews and analysed using a Framework approach. Setting/participants: 63 healthcare professionals, across 11 specialist palliative care services, were purposefully sampled by role, experience, seniority, and settings (inpatient, outpatient/day therapy, home-based/community). Results: Seven main themes were developed, representing the causal mechanisms and relationships underpinning successful implementation of outcome measures into routine practice. Themes were: Subjectivity of measures; Frequency and version of Integrated Palliative care Outcome Scale; Training, education, and peer support; Building and sustaining community engagement; Electronic system readiness; The art of communication; Reinforcing use through demonstrating value. Conclusions: Relationships influencing implementation resided at individual and organisational levels. Addressing these factors is key to driving the implementation of outcome measures into routine practice so that those using palliative care services can benefit from the systematic identification, management, and measurement of their symptoms and concerns. We provide key questions that are essential for those implementing and using outcome measures to consider in order to facilitate the integration of outcome measures into routine palliative care practice.

Background: Opioids are essential medicines. Despite international and national laws permitting availability, opioid access remains inadequate, particularly in South, Southeast, East and Central Asia. Aim: To review evidence of perceptions and experiences of regulatory enablers and barriers to opioid access in South, Southeast, East and Central Asia. Design: Systematic review of post-2000 research according to PRISMA guidelines. Data were subjected to critical interpretive synthesis. International, national and sub-national barriers were organised developing a conceptual framework of opioid availability. Data sources: PsycINFO, Medline, Embase, The Cochrane Library. CINAHL, Complete and ASSIA from 2000 until 20th May 2019. Results: 21/14097 studies included: quantitative n = 15, qualitative n = 3 and mixed-methods n = 3. Four barrier/enabler themes were developed: Legal, regulatory, socio-political; lack of laws explicitly enabling opioid access, restrictive international controls and clinician prescribing concerns. Opioid availability; limited availability, poor policymaker and clinician education regarding opioid benefits, poor continuity of supply. Opioid Accessibility; medicine costs, distance to prescribing centres. Prescribing; extensive bureaucratic barriers, lack of human resources for prescribing. We present a novel framework of a self-perpetuating model of inadequate opioid provision. The Single Convention on Narcotics provides the context of restrictive laws and negative attitudes amongst policymakers. A consequent lack of prescribers and clinicians’ negative attitudes at sub-national levels, results in inadequate access to and use of opioids. Data of inadequate consumption informs annual requirement estimates used by the International Narcotics Control Board to determine future opioid availability. Conclusions: Regulatory and socio-political actions unintentionally limit opioid access. International and national laws explicitly enabling opioid access are required, to assuage concerns, promote training and appropriate prescribing.

BackgroundBreast cancer is the commonest form of cancer among women globally, including in India. The rising incidence in the developing world is thought to be due to increased life expectancy, urbanisation, and adoption of western lifestyles. A recent systematic review found that Indian women living in India or as immigrants in Canada experienced a range of psychological distresses both ameliorated and exacerbated by cultural issues personally, within the family, within their community, and in the context of faith, and only two of the five qualitative studies explored the experience of women with breast cancer living in India. Distress may also affect treatment compliance.AimThe aim of the study was to explore the psychological distresses experienced by Indian women with breast cancer living in Kerala, South India, during and after treatment and to understand better what helped to relieve or increase these distresses.MethodsIn-depth interviews were conducted with 20 consenting women undergoing treatment for breast cancer. Purposive sampling was used to obtain maximum variation in sociodemographic and clinical characteristics. Interviews were verbatim transcribed, translated into English, and back-translated to Malayalam to ensure that the meaning had not been lost. English data were analysed using thematic frame work analysis and synthesised to provide a deeper understanding of the individuals’ experience.ResultsThree major themes emerged from the data. The first major theme was ‘far-reaching psychological distress’. This included anxiety, guilt, anger, and depression in response to the disease and physical side effects of treatment and issues relating to body image, especially hair loss and sexuality. The second major theme was ‘getting on with life’. Women tried to make sense of the disease, by actively seeking information, the role of medical professionals, and their practical adaptations. Many found a new future and a new way to live normal. The third major theme was the ‘support system’ strongly based on family, friends, faith, and the community which affect them positively as well as negatively.ConclusionPsychological concerns related to disease and treatment are common in Indian women with particular emphasis on body image issues associated with hair loss. Family and faith were key support systems for almost all the women, although it could also be the causes of distress.

Context People with acute-on-chronic breathlessness due to cardiorespiratory conditions frequently present to the emergency department (ED) causing burden for the person concerned, their care takers, and emergency services. Objective To understand the reasons for ED presentation for acute-on-chronic breathlessness and how optimal care might avoid presentations. Methods Qualitative in-depth linked interviews were conducted as part of a mixed-methods study. Transcripts of audio-recordings were subjected to thematic analysis. Consenting patients presenting to a single tertiary hospital ED with acute-on-chronic breathlessness able to be interviewed were eligible. Patient-participants (n = 18) were purposively sampled for maximum variation. Patient-participant–nominated carers (n = 9) and clinicians (n = 8) were recruited. Results Theme 1: "The context for the decision to present to the ED" is the experience of acute-on-chronic breathlessness, in which a person faces an existential crisis not knowing where the next breath is coming from, and previous help-seeking experiences. Theme 2 ("Reasons for presentation"): Some were reluctant to seek help until crisis when family carers were often involved in the decision to present. Others had previous poor experiences of help-seeking for breathlessness in the community and turned to the ED by default. Some had supportive primary clinicians and presented to the ED either on their clinician's recommendation or because their clinician was unavailable. Conclusions The decision to present to the ED is made in the context of serious crisis and previous experiences. Discussion of the reason for presentation may enable better management of chronic breathlessness and reduce the need for future emergency presentation.

Background: Chronic obstructive pulmonary disease and lung cancer are both life-limiting diseases that confer burden in the form of symptoms and affect functioning and quality of life. Comparing burden between these diseases is of interest to determine whether people with chronic obstructive pulmonary disease require improved access to Specialist Palliative Care. Access should be based on needs rather than diagnosis or prognosis but is limited for people with chronic obstructive pulmonary disease compared to lung cancer. Aim: The aim of this study was to synthesise research comparing burden from chronic obstructive pulmonary disease and lung cancer to estimate relative need for Specialist Palliative Care. Design: A systematic review was conducted of observational quantitative studies published in English peer-reviewed journals comparing burden from chronic obstructive pulmonary disease and lung cancer (PROSPERO CRD42018108819). No limits were placed on disease stage. Meta-analyses were performed where studies used the same measure; otherwise, synthesis used a narrative approach. Risk of bias was assessed using the Agency for Healthcare Research and Quality tool. Data sources: Electronic databases were searched in September 2019. Results: Of 790 articles returned, 13 were included, reporting 11 studies. Risk of bias was generally moderate. Except for pain, burden tended to be at least as substantial from chronic obstructive pulmonary disease as from lung cancer, with breathlessness and impacts on functioning being significantly worse. Longitudinal studies suggest that people with chronic obstructive pulmonary disease live with burden for longer. Conclusion: Efforts should be made to ensure that access to Specialist Palliative Care is commensurate with chronic obstructive pulmonary disease’s substantial and long-lasting burden. Future research should clarify whether managing burden in chronic obstructive pulmonary disease and lung cancer requires different approaches.

Purpose of review Clinicians who seek to reduce the symptomatic burden of chronic breathlessness by initiating regular low-dose morphine has the choice of immediate or sustained-release formulations - which will be better for this often frail population, and which has the more robust evidence to inform its prescription? Both formulations can be used. Recent findings For chronic breathlessness, three factors consistently favour the use of regular, low-dose, sustained-release morphine over immediate-release formulations: SUMMARY: As the evidence base expands for the symptomatic reduction of chronic breathlessness, pharmacological interventions will play a part. Using the best available evidence underpins patient-centred approaches that seek to predictably maximize the net effect.As such, the weight of evidence in patient-centred clinical care favours the use of regular, low-dose sustained-release morphine for the symptomatic reduction of chronic breathlessness.

Chronic breathlessness is a disabling and distressing condition for which there is a growing evidence base for a range of interventions. Non-pharmacological interventions are the mainstay of management and should be optimised prior to use of opioid medication. Opioids are being implemented variably in practice for chronic breathlessness. This narrative review summarises the evidence defining current opioids for breathlessness best practice and identifies remaining research gaps. There is level 1a evidence to support the use of opioids for breathlessness. The best evidence is for 10–30 mg daily de novo low-dose oral sustained-release morphine in opioid-naïve patients. This should be considered the current standard of care following independent, regulatory scrutiny by one of the world’s therapeutics regulatory bodies. Optimal benefits are seen in steady state; however, there are few published data about longer term benefits or harms. Morphine-related adverse events are common but mostly mild and self-limiting on withdrawal of drug. Early and meticulous management of constipation, nausea and vomiting is needed particularly in the first week of administration. Serious adverse events are no more common than placebo in clinical studies. Observational studies in severe chronic lung disease do not show excess mortality or hospital admission in those taking opioids. We have no long-term data on immune or endocrine function. There are promising data regarding prophylaxis for exertion-related breathlessness, but given the risks associated with transmucosal fentanyl, caution is needed with regard to clinical use pending longer term, robust safety data.

Malnutrition predicts poorer clinical outcomes for people with cancer. Older adults with cancer are a complex, growing population at high risk of weight-losing conditions. A number of malnutrition screening tools exist, however the best screening tool for this group is unknown. The aim was to systematically review the published evidence regarding markers and measures of nutritional status in older adults with cancer (age ≥ 70). A systematic search was performed in Ovid Medline, EMBASE, Web of Science, CINAHL, British Nursing Database and Cochrane CENTRAL; search terms related to malnutrition, cancer, older adults. Titles, abstracts and papers were screened and quality-appraised. Data evaluating ability of markers of nutritional status to predict patient outcomes were subjected to meta-analysis or narrative synthesis. Forty-two studies, describing 15 markers were included. Meta-analysis found decreased food intake was associated with mortality (OR 2.15 [2.03–4.20] p = p = 0.04). PNI markers (albumin, total lymphocyte count) could be seen as markers of inflammation rather than nutrition. There a suggested relationship between very low body mass index (BMI) (2) and clinical outcomes. No tool was identified as appropriate to screen for malnutrition, as distinct from inflammatory causes of weight-loss. Risk of cancer-cachexia and sarcopenia in older adults with cancer limits the tools analysed. Measures of food intake predicted mortality and should be included in clinical enquiry. A screening tool that distinguishes between malnutrition, cachexia and sarcopenia in older adults with cancer is needed.

The relationship between body weight and lung function is complex. Using a dyadic multilevel linear modeling approach, treating body mass index (BMI; weight (kg)/height (m)2) and lung function as paired, within-person outcomes, we tested the hypothesis that persons with more rapid increase in BMI exhibit more rapid decline in lung function, as measured by forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and their ratio (FEV1:FVC). Models included random intercepts and slopes and adjusted for sociodemographic and smoking-related factors. A sample of 9,115 adults with paired measurements of BMI and lung function taken at ≥3 visits were selected from a pooled set of 5 US population-based cohort studies (1983–2018; mean age at baseline = 46 years; median follow-up, 19 years). At age 46 years, average annual rates of change in BMI, FEV1, FVC, and FEV1:FVC ratio were 0.22 kg/m2/year, −25.50 mL/year, −21.99 mL/year, and −0.24%/year, respectively. Persons with steeper BMI increases had faster declines in FEV1 (r = −0.16) and FVC (r = −0.26) and slower declines in FEV1:FVC ratio (r = 0.11) (all P values

Palliative care in Parkinson's disease (PD) has developed significantly in the past five years. The presence of unmet palliative care need, similar to that in malignant conditions, is well established, but may not always be identified by clinicians in everyday practice. To address this, clinicians must be able to rapidly identify, triage, assess and address unmet needs and monitor response to intervention. This is also central to establishing integrated models of care for PD. Systematic evaluation of need can be facilitated by structured assessment tools, and several such tools have now been described for PD. This article reviews the palliative care assessment tools which have been developed for PD, both for patients and also for caregivers. It sets out the psychometric properties of these tools and describes the way in which they may be applied within an overall, systematic assessment of unmet need.

Background: Missing data can introduce bias and reduce the power, precision and generalisability of study findings. Guidelines on how to address missing data are limited in scope and detail, and poorly implemented. Aim: To develop guidelines on how best to (i) reduce, (ii) handle and (iii) report missing data in palliative care clinical trials. Design: Modified nominal group technique. Setting/participants: Patient and public research partners, palliative care clinicians, trialists, methodologists and statisticians attended a 1-day workshop, following which a multi-stakeholder development group drafted the guidelines. Results: Seven main recommendations for reducing missing data, nine for handling missing data and twelve for reporting missing data were developed. The top five recommendations were: (i) train all research staff on missing data, (ii) prepare for missing data at the trial design stage, (iii) address missing data in the statistical analysis plan, (iv) collect the reasons for missing data and (v) report descriptive statistics comparing the baseline characteristics of those with missing and observed data. Reducing missing data, preparing for missing data and understanding the reasons for missing data were greater priorities for stakeholders than how to deal with missing data once they had occurred. Conclusion: Comprehensive guidelines on how to address missing data were developed by stakeholders involved in palliative care trials. Implementation of the guidelines will require endorsement of research funders and research journals.

Background The diagnosis of symptomatic cancer-associated thrombosis often causes distress and alarm for patients, especially for those unaware of the risk, or the signs and symptoms to look out for. There are few data about cancer patients’ experiences of incidentally diagnosed pulmonary embolism (IPE), where lack of warning (recognised signs, symptoms) may cause delayed diagnosis and aggravate distress. Objectives To explore cancer patients’ experience of the diagnosis of and living with incidental pulmonary embolism treated with anticoagulation. Methods A qualitative study using modified grounded theory approach. Semi-structured interviews were conducted as part of a mixed- methods prospective observational survey study of consenting patients with IPE. Data were subjected to thematic analysis. The qualitative findings are presented. Findings Eleven participants were interviewed (mean age 68.3 years, range 38–82 years; various forms of cancer and stages). Three major themes and one cross-cutting theme were generated. Theme (1): IPE is experienced in the context of cancer and concomitant comorbidities. Issues are understood in the shadow of–and often overshadowed by—current serious illness. Theme (2): Being diagnosed with IPE. Misattribution to cancer or other comorbidities caused delay in help-seeking and diagnosis. Theme (3): Coping with anticoagulation. Participants’ incorporated anticoagulation treatment and its effects into their daily routine with acceptance and stoicism. Finally, the cross-cutting theme relates to a lack of information and uncertainty, contributing to distress throughout the experience. Conclusion The diagnosis of IPE was upsetting and unexpected. Expert and timely information was valued by those with IPE. Education called for about the increased risk of cancer-associated thrombosis and the signs and symptoms to be aware of.

Background: The diagnosis of symptomatic cancer-associated thrombosis often causes distress and alarm for patients, especially for those unaware of the risk, or the signs and symptoms to look out for. There are few data about cancer patients’ experiences of incidentally diagnosed pulmonary embolism (IPE), where lack of warning (recognised signs, symptoms) may cause delayed diagnosis and aggravate distress.Objectives: To explore cancer patients’ experience of the diagnosis of and living with incidental pulmonary embolism treated with anticoagulation. Methods: A qualitative study using modified grounded theory approach. Semi-structured interviews were conducted as part of a mixed- methods prospective observational survey study of consenting patients with IPE. Data were subjected to thematic analysis. The qualitative findings are presented. Findings: Eleven participants were interviewed (mean age 68.3 years, range 38-82 years; various forms of cancer and stages). Three major themes and one cross-cutting theme were generated. Theme (1): IPE is experienced in the context of cancer and concomitant comorbidities. Issues are understood in the shadow of – and often overshadowed by - current serious illness. Theme (2): Being diagnosed with IPE. Misattribution to cancer or other comorbidities caused delay in help-seeking and diagnosis. Theme (3): Coping with anticoagulation. Participants’ incorporated anticoagulation treatment and its effects into their daily routine with acceptance and stoicism. Finally, the cross-cutting theme relates to a lack of information and uncertainty, contributing to distress throughout the experienceConclusion: The diagnosis of IPE was upsetting and unexpected. Expert and timely information was valued by those with IPE. Education called for about the increased risk of cancer-associated thrombosis and the signs and symptoms to be aware of.

People with advanced heart failure have supportive and palliative needs requiring systematic assessment.We aimed to assess the validity of the Needs Assessment Tool: Progressive Disease - Heart Failure (NAT:PD-HF).Secondary analysis of routinely collected patient data from a specialist palliative care-heart disease service improvement project. NAT:PD-HF, the Integrated Palliative care Outcome Scale (IPOS), and patient and/or carer-report data were collected. Concurrent validity between NAT:PD-HF items and comparison measures (Kendall's tau; kappa); construct validity via known-group comparisons; predictive utility of NAT:PD-HF for survival (multivariable Cox hazard regression model).Data from 88 patients (50% men; mean age 85; median survival 205 days; 64% left ventricular systolic dysfunction) were analyzed. Prevalence- and bias-adjusted kappa values indicated moderate agreement for physical symptom needs (k: 0.33 for patients, 0.42 for carers). Substantial agreement was observed for patient and/or carer psychological symptoms, and information needs (k ≥ 0.6). NAT:PD-HF distinguished between patients with different survival, comorbidities, functional scores, and palliative Phase of Illness with moderate to high effect sizes. NAT did not predict survival when adjusted for mortality risk score and functional status (2+ needs HR: 1.52, 95% CI: 1.01-1.74).The NAT:PD-HF is a valid tool for clinician assessment of physical, psychosocial, and information patient and/or carer needs.

ObjectiveParkinson’s disease is a progressive, life-limiting disease, which benefits from structured palliative care. Systematic recognition and triage of needs helps facilitate care, allows focused referral to specialist palliative care and aids sustainability of services. Existing palliative care tools for Parkinson’s are patient/caregiver completed and focus on quantification rather than identification of the need. The Needs Assessment Tool: Progressive Disease in Cancer was designed for rapid identification of unmet needs in cancer. We describe adaptation and psychometric testing of the tool for Parkinson’s disease (NAT:Parkinson’s disease).MethodsSet in secondary care, Parkinson’s disease outpatient clinics in the UK, this study included people with Parkinson’s, age >18, including all disease stages. People with atypical Parkinsonian syndromes were excluded. Adaptation was made using systematic review and focus groups. Construct validity was tested in 50 consecutive patients against established patient and caregiver measures, analysed with Kendall’s Tau B. Inter-rater reliability, using video consultations, were calculated in broad range of clinicians involved in Parkinson’s disease care using a weighted kappa; 0–0.2=slight, 0.21–0.40=fair, 0.41–0.60=moderate, 0.61–0.80=substantial and pResultsValidity was substantial for two, moderate for five and fair for four constructs. Inter-rater reliability was substantial for one, moderate for three and fair for six constructs. Two constructs failing to demonstrate fair reliability did show very high percentage agreement.ConclusionFindings support the suitability of the NAT:Parkinson’s disease for everyday clinical use in the identification and triage of unmet palliative need for people with Parkinson’s disease.

Objective:\ud The objective of this study is to explore the specific information and communication needs of men affected by prostate cancer to inform the development of educational materials for clinicians.\ud \ud Methods:\ud This is a qualitative descriptive study. A purposive sampling strategy was used to identify men at different cancer stages and with experience of different treatment regimens. Semistructured interviews (25) were conducted with 19 men and six carers over the phone. Interview data were analysed using a framework approach.\ud \ud Results:\ud Four themes emerged: gaps in the information provided by secondary care doctors and nurses, communication skills needed in effective clinical information provision, a need for individualised information and alternative information sources used to meet unmet needs. Regardless of cancer stage and treatment, men with prostate cancer and their carers found information regarding common and burdensome adverse effects of prostate cancer treatment particularly lacking, and their ongoing and changing information needs often overlooked. They needed information delivered in a compassionate and individually tailored manner, considering content, timing and emotional support within the context of their unique life circumstances.\ud \ud Conclusion:\ud Clinicians often fail to recognise the need for or deliver patient-centred conversations about treatment, managing side effects and prognosis. The findings will be used to develop clinician-facing educational materials.\ud

Background Not being able to work has negative health, social and financial consequences. Persisting breathlessness is prevalent in working-aged people. Is it associated with lower workforce participation? This study, using the South Australian Health Omnibus, aimed to explore associations between paid workforce participation and persisting breathlessness intensity, and economic impacts on income in people of working age. Methods This cross-sectional study conducted face-to-face interviews with a random sample of adults in South Australia (n = 8916). Questions included key demographic data, workforce participation and the presence and intensity of persisting breathlessness. Data from working-aged respondents (20–65 years of age) were standardised to the census for regression analyses. Work was coded to paid full- or part-time work or ‘other’. Persisting breathlessness (more than three of the last six months) used the modified Medical Research Council breathlessness scale (aggregated to 0, 1, 2–4). Opportunity cost valuations compared annual income foregone by persisting breathlessness severity. Results Of people interviewed, 6,608 were working-aged (49.9% male; 67.5% had post-secondary qualifications; 70.9% were in paid full- or part-time work; and 1.7% had mMRC score 2–4). Workforce participation dropped in working aged people with increasing breathlessness: mMRC 0, 70.6%; mMRC 1, 51.7%; mMRC 2–4, 20.3%. In the regression model, people with the most severe breathlessness were much less likely to work (OR 0.14; 95% CI 0.09, 0.22). Annual income foregone by people with persisting breathlessness was AU$10.7 billion (AU$9.1b for full-time and AU$1.6b for part-time work; range AU$5.9b, AU$49.7b). Conclusion Worsening persisting breathlessness is associated with lower workforce participation with direct financial consequences, greatest for older males.

ImportanceChronic 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.ObjectiveTo 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 ParticipantsMulticenter, 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.InterventionsPeople 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 MeasuresThe 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).ResultsAmong 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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT02720822

IntroductionThe battery-operated hand-held fan (‘fan’) is an inexpensive and portable non-pharmacological intervention for chronic breathlessness. Evidence from randomised controlled trials suggests the fan reduces breathlessness intensity and improves physical activity in patients with a range of advanced chronic conditions. Qualitative data from these trials suggests the fan may also reduce anxiety and improve daily functioning for many patients. This study aimed to explore barriers and facilitators to the fan’s implementation in specialist respiratory care as a non-pharmacological intervention for chronic breathlessness in patients with chronic obstructive pulmonary disease (COPD).MethodsA qualitative approach was taken, using focus groups. Participants were clinicians from any discipline working in specialist respiratory care at two hospitals. Questions asked about current fan-related practice and perceptions regarding benefits, harms and mechanisms, and factors influencing its implementation. Analysis used a mixed inductive/deductive approach.ResultsForty-nine participants from nursing (n = 30), medical (n = 13) and allied health (n = 6) disciplines participated across 9 focus groups. The most influential facilitator was a belief that the fan’s benefits outweighed disadvantages. Clinicians’ beliefs about the fan’s mechanisms determined which patient sub-groups they targeted, for example anxious or palliative/end-stage patients. Barriers to implementation included a lack of clarity about whose role it was to implement the fan, what advice to provide patients, and limited access to fans in hospitals. Few clinicians implemented the fan for acute-on-chronic breathlessness or in combination with other interventions.ConclusionImplementation of the fan in specialist respiratory care may require service- and clinician-level interventions to ensure it is routinely recommended as a first-line intervention for chronic breathlessness in patients for whom this symptom is of concern, regardless of COPD stage.

Background: Trials of interventions for delirium in various patient populations report disparate outcomes and measures but little is known about those used in palliative care trials. A core outcome set promotes consistency of outcome selection and measurement. Aim: To inform core outcome set development by examining outcomes, their definitions, measures and time-points in published palliative care studies of delirium prevention or treatment delirium interventions. Design: Prospectively registered systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Data sources: We searched six electronic databases (1980–November 2020) for original studies, three for relevant reviews and the International Clinical Trials Registry Platform for unpublished studies and ongoing trials. We included randomised, quasi-randomised and non-randomised intervention studies of pharmacological and non-pharmacological delirium prevention and/or treatment interventions. Results: From 13/3244 studies (2863 adult participants), we identified 9 delirium-specific and 13 non-delirium specific outcome domains within eight Core Outcome Measures in Effectiveness Trials (COMET) taxonomy categories. There were multiple and varied outcomes and time points in each domain. The commonest delirium specific outcome was delirium severity ( n = 7), commonly using the Memorial Delirium Assessment Scale (6/8 studies, 75%). Four studies reported delirium incidence. Non-delirium specific outcomes included mortality, agitation, adverse events, other symptoms and quality of life. Conclusion: The review identified few delirium interventions with heterogeneity in outcomes, their definition and measurement, highlighting the need for a uniform approach. Findings will inform the next stage to develop consensus for a core outcome set to inform delirium interventional palliative care research.

Breathlessness is prevalent among palliative care patients with intensity likely to increase as death approaches for many people. There are two main patterns of breathlessness—episodic breathlessness and constant breathlessness—and three separate qualities of breathlessness—air hunger, work or effort, and tightness. Chronic breathlessness is defined as disabling breathlessness despite optimal treatment of the underlying pathophysiology. The measurement of breathlessness includes three domains: sensory-perceptual experience, affective distress, and symptom impact. The management of breathlessness includes specific disease management, non-pharmacological interventions, pharmacological therapies, and, in a very small proportion of people, palliative non-invasive ventilation. A full assessment of the widespread effects of chronic breathlessness on the individual including coping style and help-seeking behaviour is important to tailor interventions. Interventions focused on the breathlessness can be based on a ‘Breathing, Thinking, Functioning’ clinical framework. Oral, low-dose morphine in steady state remains the pharmacological treatment with the strongest evidence base.

Evidence-based medicine (EBM) has transformed clinicians’ approach to the practice of medicine. In most disciplines, EBM is the fundamental component of decision-making driving expectations of the care received by patients and families. To improve outcomes, EBM blends science and compassion to provide personalized, effective treatments, and consistent application of interventions. The ever-increasing demand for palliative care will continue unabated due to longer lifespans and a shift in the approach to disease from primarily acute illnesses to predominantly chronic conditions. The adoption of EBM by palliative care providers will advance the knowledge and practice base, elevating its position among other medical disciplines that have adopted EBM as the dominant paradigm. The framework of EBM informs a systematic and manageable approach to the overwhelming amount of available evidence. Patients will benefit from EBM practices when palliative care practitioners provide the most effective and personalized care tailored each patient’s needs, characteristics, and preferences.

Background: In combination with non-pharmacological interventions, opioids may safely reduce chronic breathlessness in patients with severe illness. However, implementation in clinical practice varies. Aim: To synthesise the published literature regarding health professionals’, patients’ and families’ views on the use of opioids for chronic breathlessness, identifying issues which influence implementation in clinical practice. Design: Systematic review and synthesis using the five-stage framework synthesis method. Data sources: Three electronic databases (MEDLINE, Embase via OVID, ASSIA via Proquest) were searched (March 2020) using a predefined search strategy. Studies were also citation chained from key papers. Papers were screened against a priori eligibility criteria. Data were extracted from included studies using the framework synthesis method. Qualitative and quantitative data were synthesised using the pillar process. Included studies were critically appraised using the Mixed-Methods Appraisal Tool. Results: After de-duplication, 843 papers were identified. Following screening, 22 studies were included. Five themes were developed: (i) clinician/patient characteristics, (ii) education/knowledge/experience, (iii) relationship between clinician/family, (iv) clinician/patient fear of opioids and (v) regulatory issues. Conclusions: There are significant barriers and enablers to the use of opioids for the symptomatic reduction of chronic breathlessness based on the knowledge, views and attitudes of clinicians, patients and families. Clinicians’ interactions with patients and their families strongly influences adherence with opioid treatment regimens for chronic breathlessness. Clinicians’, patients’ and families’ knowledge about the delicate balance between benefits and risks is generally poor. Education for all, but particularly clinicians, is likely to be a necessary (but insufficient) factor for improving implementation in practice.

PurposeDespite data showing breathlessness to be more prevalent in older adults, we have little detail about the severity or multidimensional characteristics of breathlessness and other self-reported measures (such as quality of life and other cardiorespiratory-related symptoms) in this group at the population level. We also know little about the relationship between multidimensional breathlessness, other symptoms, comorbidities and future clinical outcomes such as quality of life, hospitalisation and mortality. This paper reports the design and descriptive findings from the first two waves of a longitudinal prospective cohort study in older adults.ParticipantsBetween 2010 and 2011, 1900 men in a region in southern Sweden aged 65 years were invited to attend for VAScular and Chronic Obstructive Lung disease (VASCOL) baseline (Wave 1) assessments which included physiological measurements, blood sampling and a self-report survey of lifestyle and previous medical conditions. In 2019, follow-up postal survey data (Wave 2) were collected with additional self-report measures for breathlessness, other symptoms and quality of life. At each wave, data are cross-linked with nationwide Swedish registry data of diseases, treatment, hospitalisation and cause of death.Findings to date1302/1900 (68%) of invited men participated in Wave 1, which include 56% of all 65-year-old men in the region. 5% reported asthma, 2% chronic obstructive pulmonary disease, 56% hypertension, 10% diabetes and 19% had airflow limitation. The VASCOL cohort had comparable characteristics to those of similarly aged men in Sweden. By 2019, 109/1302 (8.4%) had died. 907/1193 (76%) of the remainder participated in Wave 2. Internal data completeness of 95% or more was achieved for most Wave 2 measures.Future plansA third wave will be conducted within 4 years, and the cohort will be followed through repeated follow-ups planned every fourth year, as well as national registry data of diagnosis, treatments and cause of death.

ObjectivesWe aimed to identify and evaluate: (1) treatment-emergent adverse events (TEAE (worse or new since baseline)) and the subgroup of severe TEAEs in a placebo-controlled 7-day randomised trial of regular, low-dose, sustained-release oral morphine for chronic breathlessness and (2) clinical characteristics associated with TEAE.MethodsSafety analysis of trial data. Adults with chronic breathlessness (modified Medical Research Council breathlessness score ≥2) due to heart or lung disease, or cancer, not on regular opioids were eligible. Symptoms associated with opioids (TEAE of special interest) were systematically sought using Common Terminology Criteria for Adverse Events (CTCAE) grading. Other harms could be reported at any time. The relationship between characteristics and presence of ≥1 TEAE of special interest was explored using univariable logistic regression analyses.Results1449/5624 (26%) Adverse Events from 279 participants were TEAE of which 150/1449 (10%) were severe (CTCAE grades 3–5). 1086/5624 (75%) were events of special interest of which 41/1086 (4%) were severe. Compared with placebo, morphine was not associated with more TEAE or severe TEAE of special interest (TEAE: OR 0.53, 95% CI 0.21 to 1.38, p=0.20; severe TEAE: OR 0.96, 95% CI 0.27 to 3.41, p=0.95) nor with CTCAE severity grade (χ2=4.39, p=0.50). Among the 26/150 (17%) with severe TEAEs, study withdrawal was more common in the morphine arm (18/26 (69%) morphine arm; 8/26 (30%) placebo arm). None of the severe TEAEs was a respiratory harm.ConclusionsSevere morphine-associated toxicity was uncommon and not associated with study arm. Clinical consequences were minor and self-limiting.Trial registration numberACTRN126000806268.

Chronic breathlessness is debilitating and frightening, often resulting in emergency department presentations with acute-on-chronic breathlessness. Self-management is complex, involving 14 components as identified by the Practical Systematic Review in Self-Management Support (PRISMS). Low-intensity educational interventions that support breathlessness self-management through written/visual educational materials, alongside limited health professional support, are available. Our aim was to describe components of low-intensity educational interventions that support and improve self-management for adults with chronic breathlessness and evaluate their efficacy for improving breathlessness-related outcomes. A systematic review was conducted, including RCTs that compared these interventions with usual care in adults with chronic disease. Synthesis took a narrative approach utilizing the PRISMS taxonomy and Template for Intervention Description and Replication (TIDieR) checklist. Of the 1948 articles identified, 7 met criteria reporting 7 RCTs using 6 interventions. Studies utilized 12 out of 14 PRISMS components, the most frequent being training/rehearsal for psychological strategies. Evidence for effectiveness was inconsistent and attempts to identify beneficial components were confounded by intervention complexity and heterogeneity. The optimal content and delivery of low-intensity educational interventions that support self-management to improve chronic breathlessness-related outcomes in adults cannot be defined from current published literature. Future research should incorporate more detailed, standardized reporting to enable comparison and meta-analysis.

Advanced respiratory disease imposes a greater symptom burden than many cancers but not does have comparable recognition of the need for supportive and palliative care or the infrastructure for its systematic delivery. Consequently, many people with advanced respiratory disease (and those closest to them) have a poor quality of life, disabled by chronic breathlessness, fatigue and other symptoms. They are socially isolated by the consequences of long-term illness and are often financially impoverished. The past decade has seen an increasing realisation that care for this group must improve and that symptom management must be prioritised. Clinical guidelines recommend person-centred care, including access to supportive and palliative care as needed, as part of standard medical practice. Advanced lung disease clinics and specialist breathlessness services (pioneered within palliative care) are developing within respiratory medicine services but are provided inconsistently. This review covers the comprehensive assessment of the patient with advanced respiratory disease, the importance of supporting carers and the current best practice in the management of breathlessness, fatigue and cough. It also suggests ways to incorporate person-centred care into the general respiratory clinic, assisted by better liaison with specialist palliative and primary care. Emerging evidence shows that excellent symptom management leads to better clinical outcomes and reduces inappropriate use of emergency medical services. Key points People living with advanced respiratory disease and severe chronic breathlessness (and those closest to them) have a poor quality of life. Chronic breathlessness is a disabling symptom, and acute-on-chronic/episodic breathlessness is frightening to experience and observe. Chronic breathlessness imposes profound physical limitations and psychosocial burdens on those suffering from it or living with someone experiencing it. Fatigue and cough are two other cardinal symptoms of advanced respiratory disease, with very detrimental effects on quality of life. The impact of all these symptoms can be alleviated to a variable extent by a predominantly non-drug complex intervention. Many of the interventions are delivered primarily by allied health or nursing professionals. Doctors, nurses and other health professionals also need to play an active part in promoting quality of life as part of excellent medical care. A person-centred, psychologically informed approach is needed by all clinicians treating patients with advanced respiratory disease. Educational aims To give specialist respiratory clinicians practical clinical tools to help improve the quality of life of their patients with advanced respiratory disease and chronic breathlessness. To outline the evidence base for these interventions with reference to definitive sources. To highlight the importance of person-centred care in people with respiratory disease at all stages of illness., Improving quality of life in people with chronic breathlessness, with a combination of (mostly) non-drug and drug interventions, improves clinical outcomes and reduces patient/carer suffering and futile use of medical services http://bit.ly/30s9ckh

Background: Despite recommendations, people with heart failure have poor access to palliative care. Aim: To identify the evidence in relation to palliative care for people with symptomatic heart failure. Design: Systematic review and narrative synthesis. (PROSPERO CRD42016029911) Data sources: Databases (Medline, Cochrane database, CINAHL, PsycINFO, HMIC, CareSearch Grey Literature), reference lists and citations were searched and experts contacted. Two independent reviewers screened titles and abstracts and retrieved papers against inclusion criteria. Data were extracted from included papers and studies were critically assessed using a risk of bias tool according to design. Results: Thirteen interventional and 10 observational studies were included. Studies were heterogeneous in terms of population, intervention, comparator, outcomes and design rendering combination inappropriate. The evaluation phase studies, with lower risk of bias, using a multi-disciplinary specialist palliative care intervention showed statistically significant benefit for patient-reported outcomes (symptom burden, depression, functional status, quality of life), resource use and costs of care. Benefit was not seen in studies with a single component/discipline intervention or with higher risk of bias. Possible contamination in some studies may have caused under-estimation of effect and missing data may have introduced bias. There was no apparent effect on survival. Conclusion: Overall, the results support the use of multi-disciplinary palliative care in people with advanced heart failure but trials do not identify who would benefit most from specialist palliative referral. There are no sufficiently robust multi-centre evaluation phase trials to provide generalisable findings. Use of common population, intervention and outcomes in future research would allow meta-analysis.

Recruitment challenges to clinical research studies in palliative care settings, particularly in hospices, are well documented. However, a recent study (Hospice Inpatient Deep vein thrombosis Detection (HIDDen) study) performed across five hospices in the UK recruited above target and on time. We describe strategies that aided successful recruitment in this study, and the lessons learnt for improving future studies. A recent review suggested that the ‘Social Marketing Mix Framework’ (SMMF) could help researchers with recruitment strategies in palliative care. We describe the recruiting strategies employed through the Social Marketing Mix lens and consider if it would be a useful framework for future researchers to use at the planning stage. Successful recruitment strategies employed in HIDDen study included: (i) addressing particular study-related factors, (ii) ensuring all patients were screened and offered participation if eligible, (iii) reducing impact on the clinical team through dedicated research nurses at sites, (iv) addressing research team issues with cross-cover between sites, where geographically possible, and (v) regular video conferencing meetings for support and collaborative solving of challenges. Limited pre-existing research infrastructure at most of the recruiting hospices created particular challenges. The SMMF provides a potential structure to help researchers to plan recruitment. However, to fully streamline trial set up and in order for hospice involvement in research to be realised systematically, a centralised approach to governance, organisational culture change whereby hospices embrace research as a legitimate purpose and consistent access to research staff are identified as key strategic elements promoting recruitment to studies in hospices.

Background: Delirium is common, distressing, serious and under-researched in specialist palliative care settings. Objectives: To examine whether people requiring palliative care were included in non-pharmacological delirium intervention studies in inpatient settings, how they were characterised and what their outcomes were. Design: Systematic review (PROSPERO 2017 CRD42017062178). Data sources: Systematic search in March 2017 for non-pharmacological delirium intervention studies in adult inpatients. Database search terms were ‘delirium’, ‘hospitalisation’, ‘inpatient’, ‘palliative care’, ‘hospice’, ‘critical care’ and ‘geriatrics’. Scottish Intercollegiate Guidelines Network methodological checklists guided risk of bias assessment. Results: The 29 included studies were conducted between 1994 and 2015 in diverse settings in 15 countries (9136 participants, mean age = 76.5 years ( SD = 8.1), 56% women). Most studies tested multicomponent interventions ( n = 26) to prevent delirium ( n = 19). Three-quarters of the 29 included studies ( n = 22) excluded various groups of people requiring palliative care; however, inclusion criteria, participant diagnoses, illness severity and mortality indicated their presence in almost all studies ( n = 26). Of these, 21 studies did not characterise participants requiring palliative care or report their specific outcomes (72%), four reported outcomes for older people with frailty, dementia, cancer and comorbidities, and one was explicitly focused on people receiving palliative care. Study heterogeneity and limitations precluded definitive determination of intervention effectiveness and only allowed interpretations of feasibility for people requiring palliative care. Acceptability outcomes (intervention adverse events and patients’ subjective experience) were rarely reported overall. Conclusion: Non-pharmacological delirium interventions have frequently excluded and under-characterised people requiring palliative care and infrequently reported their outcomes.

To explore the role of coping moderators in self-management of breathlessness crises by people with advanced respiratory disease.A secondary analysis of semi-structured interview data.Interviews with patients who had advanced respiratory disease, chronic breathlessness and at least one experience where they considered presenting to Emergency but self-managed instead (a "near miss"). Participants were recruited from New South Wales, Queensland, Victoria, South Australia or Tasmania. Eligible caregivers were those who contributed to Emergency-related decision-making. Interviews were coded inductively and then deductively against the coping moderators social support and dispositional coping style, defined by the Transactional Model of Stress and Coping.Interviews were conducted between October 2015 - April 2016 with 20 patients and three caregivers. Social networks offered emotional and practical support but also had potential for conflict with patients' 'hardy' coping style. Patient hardiness (characterized by a sense of 'commitment' and 'challenge') promoted a proactive approach to self-management but made some patients less willing to accept support. Information-seeking tendencies varied between patients and were sometimes shared with caregivers. An optimistic coping style appeared to be less equivocally beneficial.This study shows that social support and coping style may influence how people self-manage through their breathlessness crises and identified ways coping moderators can facilitate or hinder effective self-management.This study confers insights into how social-support and coping style can be supported and optimized to facilitate breathlessness self-management. Acknowledging coping moderator interactions is beneficial for developing resources and strategies that recognise patient mastery.目的: 探讨应对调节者在晚期呼吸系统疾病患者呼吸困难危机自我管理中的作用。 设计: 半结构化访谈数据的二次分析。 方法: 采访患有晚期呼吸系统疾病、慢性呼吸困难的患者,至少有一次他们考虑过紧急情况下自我管理的经历(“相近差错”)。参与者来自新南威尔士、昆士兰、维多利亚、南澳大利亚或塔斯马尼亚。合格的护理人员是那些参与紧急相关决策的人。 访谈以应激和应对的交互模型为基础,对应对调节者的社会支持和倾向性应对方式进行归纳和演绎编码。 结果: 在2015年10月至2016年4月期间,对20名患者和3名护理人员进行了访谈。社交网络提供了情感和实际支持,但也有可能与患者的“坚强”应对方式发生冲突。患者的意志力(以“承诺”和“挑战”为特征)促进了积极主动的自我管理方法,但使一些患者不愿意接受支持。患者之间的信息寻求倾向各不相同,有时与护理人员分享。乐观的应对方式看来有明显的好处。 结论: 本研究表明,社会支持和应对方式可能影响人们如何通过呼吸困难的危机自我管理,并确定应对调解人可以促进或阻碍有效的自我管理的方式。 影响: 本研究探讨如何支持和优化社会支持和应对方式,以促进呼吸困难的自我管理。认识到应对调节者的相互作用有助于开发认识到患者掌握情况的资源和策略。.

This article focuses on what is meant by the term ‘book’. Here, there is a consideration of how the definition of the book has altered over time as technology has improved and as writers themselves began to have different relationships to the book and industry. It further explores the ways the book itself has altered in format, from printed to digital, with audio editions, and socially in relation to the rise of social media and a new form of author who chooses to write and share their works directly within social platforms. In this context, book must be redefined to incorporate the context of new social technology.

BackgroundParenteral nutrition (PN) and palliative venting gastrostomies (PVG) are two interventions used clinically to manage inoperable malignant bowel obstruction (MBO); however, little is known about their role in clinical and quality-of-life outcomes to inform clinical decision making.AimTo examine the impact of PN and PVG on clinical and quality-of-life outcomes in inoperable MBO.DesignA mixed-methods systematic review and narrative synthesis.Data sourcesThe following databases were searched (from inception to 29 April 2021): MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, Bielefeld Academic Search Engine, Health Technology Assessment and CareSearch for qualitative or quantitative studies of MBO, and PN or PVG. Titles, abstracts and papers were independently screened and quality appraised.ResultsA total of 47 studies representing 3538 participants were included. Current evidence cannot tell us whether these interventions improve MBO survival, but this was a firm belief by patients and clinicians informing their decision. Both interventions appear to allow patients valuable time at home. PVG provides relief from nausea and vomiting. Both interventions improve quality of life but not without significant burdens. Nutritional and performance status may be maintained or improved with PN.ConclusionPN and PVG seem to allow valuable time at home. We found no conclusive evidence to show either intervention prolonged survival, due to the lack of randomised controlled trials that have to date not been performed due to concerns about equipoise. Well-designed studies regarding survival for both interventions are needed.PROSPERO registration numberCRD42020164170.

Background Most health service utilisation studies are of people with specific diagnoses or demographic characteristics, and rarely of specific chronic symptoms. The aim of this study was to establish whether population-level health service utilisation increases in people with chronic breathlessness. Methods A cross-sectional analysis was carried out of the South Australian Health Omnibus Survey 2017, a multi-stage, clustered area, systematic sampling survey of adults where questions are administered face-to-face in respondents’ homes. Self-report of health service utilisation in the previous 3 months (medical consultations, emergency department, hospital admission), chronic breathlessness (severity, duration, modified Medical Research Council (mMRC) breathlessness scale) and demographic data were used to predict self-reported health service utilisation. Results A total of 2898 people were included (49.0% male; median age 48.0 years (IQR 32.0–63.0); 64.1% educated beyond school; 55.4% in work; 73.5% had outpatient contact; 6.3% had a hospital admission in the previous 3 months). Chronic breathlessness (mMRC ≥1) was reported by 8.8% of respondents. In bivariable analyses, people with greater contact with health services were older, and a higher proportion were overweight/obese and had more severe chronic breathlessness. In multivariable analyses, chronic breathlessness and older age were positively associated with outpatient care and inpatient care, and people with chronic breathlessness were hospitalised for longer (incidence rate ratio 2.5; 95% CI 1.4–4.5). Conclusion There is a significant association between worse chronic breathlessness and increased health service utilisation. There is a need for greater understanding of factors that initiate contact with health services., Worsening self-reported severity of chronic breathlessness is strongly associated with increases in general practice and emergency department use and inpatient admissions, after controlling for age, sex, level of education, rurality and body mass index https://bit.ly/3sa9knG

Social media and digital technologies are transforming what and how we read. Books and Social Media considers the way in which readers and writers come together in digital communities to discover and create new works of fiction. This new way of engaging with fiction stretches the boundaries of what has been considered a book in the past by moving beyond the physical or even digitally bound object to the consideration of content, containers, and the ability to share. Using empirical data and up-to-date research methods, Miriam Johnson introduces the ways in which digitally social platforms give rise to a new type of citizen author who chooses to sidestep the industry’s gatekeepers and share their works directly with interested readers on social platforms. Gender and genre, especially, play a key role in developing the communities in which these authors write. The use of surveys, interviews, and data mining brings to the fore issues of gender, genre, community, and power, which highlight the push and pull between these writers and the industry. Questioning what we always thought we knew about what makes a book and traditional publishing channels, this book will be of interest to anyone studying or researching publishing, book history, print cultures, and digital and contemporary literatures.

The publication of the United Kingdom (UK) Standards for Public Involvement (PI) (UK Standards) in research drew a clear line in the sand regarding the importance of utilising the unique experience, skills and expertise that lay people may offer to the development, conduct and dissemination of clinical research. The UK Standards provide a benchmark which researchers should aim to achieve, yet its implementation continues to be a step wise iterative process of change management. A recent evaluation by a regional research group has suggested that our understanding of PI is enhanced through reflection on the UK Standards. We report on the utility of PI in the design, conduct and dissemination of the HIDDen study, a national, multicentre clinical study based across three UK centres.A retrospective review of PI within the HIDDen study was conducted using field notes taken by the lead author from interactions throughout their involvement as a lay representative on the study. Key members of the HIDDen study were interviewed and data analysed to explore adherence to the UK Standards.There was universal support for PI across the study management group with genuine inclusivity of lay members of the committee. All six of the UK Standards were met to varying degrees. The greatest opportunities lay in 'working together' and 'support and learning'. There were challenges meeting 'governance' with evidence of participation in decision making but less evidence of opportunities in management, regulation, leadership.This study concurs with previous research supporting the utility of the Standards in the conduct and evaluation of PI in clinical research. To our knowledge this is the first multi-national study to be evaluated against the UK Standards.The past decade has seen a genuine increase in patient and public involvement (PI) in clinical research, far beyond a symbolic presence on a trial management committee or inclusion on a grant application. The United Kingdom (UK) Standards for Public Involvement provide a useful structure to support PI throughout a study as well as defining a benchmark that can be used to improve the involvement of patients and the public in studies.The importance of reflecting on and reporting on PI in specific studies has been recognised since it contributes to a stepwise change process which will eventually lead to PI becoming normal practice for clinical research. A recent review identified a myriad of frameworks by which PI may be evaluated, risking an inconsistent approach to PI evaluation and consequently slowing down its progression.The Hospice Inpatient Deep vein thrombosis Detection study (HIDDen) was a national multicentre study to explore the prevalence and associated variables of blood clots in patients with advanced cancer when they were admitted to the specialist palliative care unit.In this paper we will be considering the HIDDen research in terms of the UK Standards for Public Involvement.