Attitude change and increased confidence with management of chronic breathlessness following a health professional training workshop: a survey evaluation.

BACKGROUND: Clinicians and people living with chronic breathlessness have expressed a need to better understand and manage this symptom. The aim of this study was to evaluate a 3-day health professional training workshop on the practical management of chronic breathlessness. METHODS: Workshop design and delivery were based on current understandings and clinical models of chronic breathlessness management, principles of transformative learning, and included sessions co-designed with people living with breathlessness. Registrants were invited to complete pre and post-workshop surveys. Pre and 1-week post-workshop online questionnaires assessed familiarity and confidence about workshop objectives (0[lowest]-10[highest] visual analogue scale), attitudes and practices regarding chronic breathlessness (agreement with statements on 5-point Likert scales). Post-workshop, participants were asked to describe implementation plans and anticipated barriers. Baseline familiarity and confidence were reported as mean (SD) and change examined with paired t-tests. Pre-post attitudes and practices were summarised by frequency/percentages and change examined non-parametrically (5-point Likert scale responses) or using a McNemar test of change (binary responses). RESULTS: Forty-seven of 55 registrants joined the study; 39 completed both pre and post-workshop questionnaires (35 female; 87% clinicians; median 8 years working with people with chronic breathlessness). Post-workshop, greatest gains in confidence were demonstrated for describing biopsychosocial concepts unpinning chronic breathlessness (mean change confidence = 3.2 points; 95% CI 2.7 to 4.0, p < 0.001). Respondents significantly changed their belief toward agreement that people are able to rate their breathlessness intensity on a scale (60 to 81% agreement) although only a minority strongly agreed with this statement at both time points (pre 11%, post 22%). The largest shift in attitude was toward agreement (z statistic 3.74, p < 0.001, effect size r = 0.6) that a person's experience of breathlessness should be used to guide treatment decisions (from 43 to 73% strong agreement). Participants' belief that cognitive behavioural strategies are effective for relief of breathlessness changed further toward agreement after the workshop (81 to 100%, McNemar test chi- square = 5.14, p = 0.02). CONCLUSION: The focus of this training on biopsychosocial understandings of chronic breathlessness and involvement of people living with this symptom were valued. These features were identified as facilitators of change in fundamental attitudes and preparedness for practice.

Holistic services for people with advanced disease and chronic breathlessness: a systematic review and meta-analysis.

BACKGROUND: Breathlessness is a common, distressing symptom in people with advanced disease and a marker of deterioration. Holistic services that draw on integrated palliative care have been developed for this group. This systematic review aimed to examine the outcomes, experiences and therapeutic components of these services. METHODS: Systematic review searching nine databases to June 2017 for experimental, qualitative and observational studies. Eligibility and quality were independently assessed by two authors. Data on service models, health and cost outcomes were synthesised, using meta-analyses as indicated. Data on recipient experiences were synthesised thematically and integrated at the level of interpretation and reporting. RESULTS: From 3239 records identified, 37 articles were included representing 18 different services. Most services enrolled people with thoracic cancer, involved palliative care staff and comprised 4-6 contacts over 4-6 weeks. Commonly used interventions included breathing techniques, psychological support and relaxation techniques. Meta-analyses demonstrated reductions in Numeric Rating Scale distress due to breathlessness (n=324; mean difference (MD) -2.30, 95% CI -4.43 to -0.16, p=0.03) and Hospital Anxiety and Depression Scale (HADS) depression scores (n=408, MD -1.67, 95% CI -2.52 to -0.81, p<0.001) favouring the intervention. Statistically non-significant effects were observed for Chronic Respiratory Questionnaire (CRQ) mastery (n=259, MD 0.23, 95% CI -0.10 to 0.55, p=0.17) and HADS anxiety scores (n=552, MD -1.59, 95% CI -3.22 to 0.05, p=0.06). Patients and carers valued tailored education, self-management interventions and expert staff providing person-centred, dignified care. However, there was no observable effect on health status or quality of life, and mixed evidence around physical function. CONCLUSION: Holistic services for chronic breathlessness can reduce distress in patients with advanced disease and may improve psychological outcomes of anxiety and depression. Therapeutic components of these services should be shared and integrated into clinical practice. REGISTRATION NUMBER: CRD42017057508.

Airflow relieves chronic breathlessness in people with advanced disease: An exploratory systematic review and meta-analyses.

BACKGROUND: Chronic breathlessness is a neglected symptom of advanced diseases. AIM: To examine the effect of airflow for chronic breathlessness relief. DESIGN: Exploratory systematic review and meta-analysis. DATA SOURCES: Medline, CINAHL, AMED and Cochrane databases were searched (1985-2018) for observational studies or randomised controlled trials of airflow as intervention or comparator. Selection against predefined inclusion criteria, quality appraisal and data extraction was conducted by two independent reviewers with access to a third for unresolved differences. 'Before and after' breathlessness measures from airflow arms were analysed. Meta-analysis was carried out where possible. RESULTS: In all, 16 of 78 studies (n = 929) were included: 11 randomised controlled trials of oxygen versus medical air, 4 randomised controlled trials and 1 fan cohort study. Three meta-analyses were possible: (1) Fan at rest in three studies (n = 111) offered significant benefit for breathlessness intensity (0-100 mm visual analogue scale and 0-10 numerical rating scale), mean difference -11.17 (95% confidence intervals (CI) -16.60 to -5.74), p = 0.06 I2 64%. (2) Medical air via nasal cannulae at rest in two studies (n = 89) improved breathlessness intensity (visual analogue scale), mean difference -12.0 mm, 95% CI -7.4 to -16.6, p < 0.0001 I2 = 0%. (3) Medical airflow during a constant load exercise test before and after rehabilitation (n = 29) in two studies improved breathlessness intensity (modified Borg scale, 0-10), mean difference -2.9, 95% CI -3.2 to -2.7, p < 0.0001 I2 = 0%. CONCLUSION: Airflow appears to offer meaningful relief of chronic breathlessness and should be considered as an adjunct treatment in the management of breathlessness.

Predicting outcomes following holistic breathlessness services: A pooled analysis of individual patient data.

BACKGROUND: Holistic breathlessness services have been developed for people with advanced disease and chronic breathlessness, leading to improved psychological aspects of breathlessness and health. The extent to which patient characteristics influence outcomes is unclear. AIM: To identify patient characteristics predicting outcomes of mastery and distress due to breathlessness following holistic breathlessness services. DESIGN: Secondary analysis of pooled individual patient data from three clinical trials. Our primary analysis assessed predictors of clinically important improvements in Chronic Respiratory Questionnaire mastery scores (+0.5 point), and our secondary analysis predictors of improvements in Numerical Rating Scale distress due to breathlessness (-1 point). Variables significantly related to improvement in univariate models were considered in separate backwards stepwise logistic regression models. PARTICIPANTS: The dataset comprised 259 participants (118 female; mean (standard deviation) age 69.2 (10.6) years) with primary diagnoses of chronic obstructive pulmonary disease (49.8%), cancer (34.7%) and interstitial lung disease (10.4%). RESULTS: Controlling for age, sex and trial, baseline mastery remained the only significant independent predictor of improvement in mastery (odds ratio 0.57, 95% confidence intervals 0.43-0.74; p < 0.001), and baseline distress remained the only significant predictor of improvement in distress (odds ratio 1.64; 95% confidence intervals 1.35-2.03; p < 0.001). Baseline lung function, breathlessness severity, health status, mild anxiety and depression, and diagnosis did not predict outcomes. CONCLUSIONS: Outcomes of mastery and distress following holistic breathlessness services are influenced by baseline scores for these variables, and not by diagnosis, lung function or health status. Stratifying patients by levels of mastery and/or distress due to breathlessness appears appropriate for clinical trials and services.

Approaches to palliative oxygen therapy in chronic obstructive pulmonary disease: a multi-national survey of specialists.

As palliative oxygen therapy (POT) is beneficial only to a minority of patients with chronic breathlessness, it is no longer routinely recommended. This multi-national, online survey of respiratory and palliative medicine specialists, with 440 participants, identified that prescription of POT has decreased over the past decade; however a sizeable proportion of doctors, particularly within palliative care, still support and recommend POT. Further education and research regarding the optimal management of chronic breathlessness are required.

Recommendations for services for people living with chronic breathlessness in advanced disease: Results of a transparent expert consultation.

Chronic breathlessness is highly distressing for people with advanced disease and their informal carers, yet health services for this group remain highly heterogeneous. We aimed to generate evidence-based stakeholder-endorsed recommendations for practice, policy and research concerning services for people with advanced disease and chronic breathlessness. We used transparent expert consultation, comprising modified nominal group technique during a stakeholder workshop, and an online consensus survey. Stakeholders, representing multiple specialities and professions, and patient/carers were invited to participate. Thirty-seven participants attended the stakeholder workshop and generated 34 separate recommendations, rated by 74 online survey respondents. Seven recommendations had strong agreement and high levels of consensus. Stakeholders agreed services should be person-centred and flexible, should cut across multiple disciplines and providers and should prioritize breathlessness management in its own right. They advocated for wide geographical coverage and access to expert care, supported through skills-sharing among professionals. They also recommended recognition of informal carers and their role by clinicians and policymakers. Overall, stakeholders' recommendations reflect the need for improved access to person-centred, multi-professional care and support for carers to provide or access breathlessness management interventions. Future research should test the optimal models of care and educational strategies to meet these recommendations.

Palliative care and management of troublesome symptoms for people with chronic obstructive pulmonary disease.

People with advanced chronic obstructive pulmonary disease (COPD) have distressing physical and psychological symptoms, often have limited understanding of their disease, and infrequently discuss end-of-life issues in routine clinical care. These are strong indicators for expert multidisciplinary palliative care, which incorporates assessment and management of symptoms and concerns, patient and caregiver education, and sensitive communication to elicit preferences for care towards the end of life. The unpredictable course of COPD and the difficulty of predicting survival are barriers to timely referral and receipt of palliative care. Early integration of palliative care with respiratory, primary care, and rehabilitation services, with referral on the basis of the complexity of symptoms and concerns, rather than prognosis, can improve patient and caregiver outcomes. Models of integrated working in COPD could include: services triggered by troublesome symptoms such as refractory breathlessness; short-term palliative care; and, in settings with limited access to palliative care, consultation only in specific circumstances or for the most complex patients.

Attitudes to specialist palliative care and advance care planning in people with COPD: a multi-national survey of palliative and respiratory medicine specialists.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) guidelines recommend early access to palliative care together with optimal, disease-directed therapy for people with advanced disease, however, this occurs infrequently. This study explored the approaches of respiratory and palliative medicine specialists to palliative care and advance care planning (ACP) in advanced COPD. METHODS: An online survey was emailed to all specialists and trainees in respiratory medicine in Australia and New Zealand (ANZ), and to all palliative medicine specialists and trainees in ANZ and the United Kingdom. RESULTS: Five hundred seventy-seven (33.1%) responses were received, with 440 (25.2%) complete questionnaires included from 177 respiratory and 263 palliative medicine doctors. Most respiratory doctors (140, 80.9%) were very or quite comfortable providing a palliative approach themselves to people with COPD. 113 (63.8%) respiratory doctors recommended referring people with advanced COPD to specialist palliative care, mainly for access to: psychosocial and spiritual care (105, 59.3%), carer support (104, 58.5%), and end-of-life care (94, 53.1%). 432 (98.2%) participants recommended initiating ACP discussions. Palliative medicine doctors were more likely to recommend discussing: what palliative care is (p < 0.0001), what death and dying might be like (p < 0.0001) and prognosis (p = 0.004). Themes highlighted in open responses included: inadequate, fragmented models of care, with limited collaboration or support from palliative care services. CONCLUSIONS: While both specialties recognised the significant palliative care and ACP needs of people with advanced COPD, in reality few patients access these elements of care. Formal collaboration and bi-directional support between respiratory and palliative medicine, are required to address these unmet needs.

Differing Approaches to Managing the Chronic Breathlessness Syndrome in Advanced COPD: A Multi-National Survey of Specialists.

This study explored the approaches of respiratory and palliative medicine specialists to managing the chronic breathlessness syndrome in patients with severe chronic obstructive pulmonary disease. A voluntary, online survey was emailed to all specialists and trainees in respiratory medicine in Australia and New Zealand (ANZ), and to all palliative medicine specialists and trainees in ANZ and the United Kingdom (UK). Five hundred and seventy-seven (33.0%) responses were received from 1,749 specialists, with 440 (25.2%) complete questionnaires included from 177 respiratory and 263 palliative medicine doctors. Palliative medicine doctors in ANZ and the UK had similar approaches to managing chronic breathlessness, whereas respiratory and palliative medicine doctors had significantly different approaches (p < 0.0001). Both specialties most commonly recommended a combination of non-pharmacological and pharmacological breathlessness management strategies. Respiratory doctors focussed more on pulmonary rehabilitation, whereas palliative medicine doctors recommended breathing techniques, anxiety management and the handheld fan. Palliative medicine doctors (197 (74.9%)) recommended short acting oral morphine for breathlessness, as compared with 73 (41.2%) respiratory doctors (p < 0.0001). Respiratory doctors cited opioid concerns related to respiratory depression and lack of knowledge. Nineteen (10.7%) respiratory doctors made no specific recommendations for managing chronic breathlessness. Both specialties reported actively managing chronic breathlessness, albeit with differing approaches. Integrated services, which combine the complementary knowledge and approaches of both specialities, may overcome current gaps in care and improve the management of distressing, chronic breathlessness.

Breathlessness services as a new model of support for patients with respiratory disease.

The complexity of breathlessness in advanced disease requires a diversity of measures ideally tailored to the individual patient needs. 'Breathlessness services' have been systematically developed and tested to provide specific interventions and support for patients and their carers. The aim of this article is (1) to identify and describe components of breathlessness services and (2) to describe the clinical model of one specific service in more detail. This article is based on a systematic review evaluating randomized controlled trials (RCTs) and quasi-RCTs which examine the effectiveness of services aiming to improve breathlessness of patients with advanced disease. The Munich Breathlessness Service (MBS) is described in detail as an example of a recently set-up specialist service. Five service models were identified which were tested in six RCTs. Services varied regarding structure and composition with face-to-face meetings, some with additional telephone contacts. Service duration was median 6 weeks (range 2-12 weeks). Involved professions were nurses, various therapists and, in two models, also physicians. The breathing-thinking-functioning model was targeted by various service components. The MBS is run by a multi-professional team mainly with physicians and physiotherapists. Patients are seen weekly over 5-6 weeks with an individualized management plan. Breathlessness services are a new model for patients with advanced disease integrating symptom management and early access to palliative care.

Contributions of a hand-held fan to self-management of chronic breathlessness.

This study explored the benefits of a hand-held fan as perceived by patients with chronic breathlessness and their carers.A secondary multimethod analysis was conducted of interview data collected in three clinical trials. Two researchers independently coded level of benefit qualitatively reported by each patient. Univariate and multivariate statistics were used to explore perceived benefit as a factor of sex, age and diagnosis. Qualitative analysis used an integrative method.133 patients commented on the fan, of whom 72 had a carer. Diagnoses included nonmalignant (n=91, 68.4%) and malignant (n=21, 15.8%) conditions. Of 111 patients who provided codable data, four (3.6%) perceived no benefit, 16 (14.4%) were uncertain, 80 (72.0%) perceived some benefit and 11 (10.0%) perceived very substantial benefit. Multivariate analysis was inconclusive. Benefit was described in terms of shorter recovery time, especially after activity. 10 (7.5%) patients said the fan reduced their need for home oxygen or inhaled ß-agonist medications. Negative perceptions of a few included dislike of the cooling sensation and embarrassment in public.Findings suggest that a hand-held fan is a portable intervention with few disadvantages from which most patients with chronic breathlessness will derive benefit alongside other nonpharmacological and pharmacological strategies. Research is needed to optimise guidance on fan administration.

Use of Salivary Diurnal Cortisol as an Outcome Measure in Randomised Controlled Trials: a Systematic Review.

BACKGROUND: Dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis is associated with diverse adverse health outcomes, making it an important therapeutic target. Measurement of the diurnal rhythm of cortisol secretion provides a window into this system. At present, no guidelines exist for the optimal use of this biomarker within randomised controlled trials (RCTs). PURPOSE: The aim of this study is to describe the ways in which salivary diurnal cortisol has been measured within RCTs of health or behavioural interventions in adults. METHODS: Six electronic databases (up to May 21, 2015) were systematically searched for RCTs which used salivary diurnal cortisol as an outcome measure to evaluate health or behavioural interventions in adults. A narrative synthesis was undertaken of the findings in relation to salivary cortisol methodology and outcomes. RESULTS: From 78 studies that fulfilled the inclusion criteria, 30 included healthy participants (38.5 %), 27 included patients with physical disease (34.6 %) and 21 included patients with psychiatric disease (26.9 %). Psychological therapies were most commonly evaluated (n = 33, 42.3 %). There was substantial heterogeneity across studies in relation to saliva collection protocols and reported cortisol parameters. Only 39 studies (50 %) calculated a rhythm parameter such as the diurnal slope or the cortisol awakening response (CAR). Patterns of change in cortisol parameters were inconsistent both within and across studies and there was low agreement with clinical findings. CONCLUSIONS: Salivary diurnal cortisol is measured inconsistently across RCTs, which is limiting the interpretation of findings within and across studies. This indicates a need for more validation work, along with consensus guidelines.

The importance of the feasibility study: Lessons from a study of the hand-held fan used to relieve dyspnea in people who are breathless at rest.

BACKGROUND: The dyspnea accompanying advanced cardiorespiratory disease is often refractory to palliation. It is disabling, distressing and associated with the diseases most common everywhere in the world. The hand-held fan, used to generate a draught across the face, is a simple, cost-effective, safe, and universally applicable palliative breathlessness intervention, consistently described as valuable in qualitative research. A previous crossover trial confirmed its benefit in patients breathless at rest, but the washout period was uncertain. AIM: To determine the washout period after use of the hand-held fan to inform accurate randomized controlled trial design. DESIGN: An observational methodological study. Breathlessness intensity was measured using 100 mm visual analog scale and numerical rating scale, and "relief of breathlessness" was measured on a 5-point scale. Those benefitting from the fan provided visual analog scale/numerical rating scale scores until (1) scores returned to baseline values or (2) until response had plateaued. The primary outcome measure was the time (in minutes) to reach either component of the primary study endpoint. SETTINGS/PARTICIPANTS: Four in-/out-patient hospice/hospital units; participants had chronic refractory breathlessness using the fan. RESULTS: Overall, 31 patients participated (mean age: 74.8 years; range: 49-98 years, standard deviation = 11.5 years); 64% were males. Approximately, half of the sample experienced benefit of moderate effect size. The relative reduction in breathlessness relative to the mean baseline score for the sample was 27% for the visual analog scale and 19% for the numerical rating scale. CONCLUSION: Feasibility work is essential, even for simple widely employed interventions.

Benzodiazepines for the relief of breathlessness in advanced malignant and non-malignant diseases in adults.

BACKGROUND: This is an updated version of the original Cochrane review published in Issue 1, 2010, on 'Benzodiazepines for the relief of breathlessness in advanced malignant and non-malignant diseases in adults'. Breathlessness is one of the most common symptoms experienced in the advanced stages of malignant and non-malignant disease. Benzodiazepines are widely used for the relief of breathlessness in advanced diseases and are regularly recommended in the literature. At the time of the previously published Cochrane review, there was no evidence for a beneficial effect of benzodiazepines for the relief of breathlessness in people with advanced cancer and chronic obstructive pulmonary disease (COPD). OBJECTIVES: The primary objective of this review was to determine the efficacy of benzodiazepines for the relief of breathlessness in people with advanced disease. Secondary objectives were to determine the efficacy of different benzodiazepines, different doses of benzodiazepines, different routes of application, adverse effects of benzodiazepines, and the efficacy in different disease groups. SEARCH METHODS: This is an update of a review published in 2010. We searched 14 electronic databases up to September 2009 for the original review. We checked the reference lists of all relevant studies, key textbooks, reviews, and websites. For the update, we searched CENTRAL, MEDLINE, and EMBASE and registers of clinical trials for further ongoing or unpublished studies, up to August 2016. We contacted study investigators and experts in the field of palliative care asking for further studies, unpublished data, or study details when necessary. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) assessing the effect of benzodiazepines compared with placebo or active control in relieving breathlessness in people with advanced stages of cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), motor neurone disease (MND), and idiopathic pulmonary fibrosis (IPF). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed identified titles and abstracts. Three review authors independently performed assessment of all potentially relevant studies (full text), data extraction, and assessment of methodological quality. We carried out meta-analysis where appropriate. MAIN RESULTS: Overall, we identified eight studies for inclusion: seven in the previous review and an additional study for this update. We also identified two studies awaiting classification in this update. The studies were small (a maximum number of 101 participants) and comprised data from a total of 214 participants with advanced cancer or COPD, which we analysed. There was only one study of low risk of bias. Most of the studies had an unclear risk of bias due to lack of information on random sequence generation, concealment, and attrition. Analysis of all studies did not show a beneficial effect of benzodiazepines for the relief of breathlessness (the primary outcome) in people with advanced cancer and COPD (8 studies, 214 participants) compared to placebo, midazolam, morphine, or promethazine. Furthermore, we observed no statistically significant effect in the prevention of episodic breathlessness (breakthrough dyspnoea) in people with cancer (after 48 hours: risk ratio of 0.76 (95% CI 0.53 to 1.09; 2 studies, 108 participants)) compared to morphine. Sensitivity analyses demonstrated no statistically significant differences regarding type of benzodiazepine, dose, route and frequency of delivery, duration of treatment, or type of control. Benzodiazepines caused statistically significantly more adverse events, particularly drowsiness and somnolence, when compared to placebo (risk difference 0.74 (95% CI 0.37, 1.11); 3 studies, 38 participants). In contrast, two studies reported that morphine caused more adverse events than midazolam (RD -0.18 (95% CI -0.31, -0.04); 194 participants). AUTHORS' CONCLUSIONS: Since the last version of this review, we have identified one new study for inclusion, but the conclusions remain unchanged. There is no evidence for or against benzodiazepines for the relief of breathlessness in people with advanced cancer and COPD. Benzodiazepines caused more drowsiness as an adverse effect compared to placebo, but less compared to morphine. Benzodiazepines may be considered as a second- or third-line treatment, when opioids and non-pharmacological measures have failed to control breathlessness. There is a need for well-conducted and adequately powered studies.

Managing breathlessness: a palliative care approach.

Breathlessness is an important and common symptom globally, affecting patients with a variety of malignant and non-malignant diseases. It causes considerable suffering to patients and also their families, and is a significant cost to healthcare systems. Optimal management of the symptom should therefore be of interest and importance to a wide range of clinicians. Best practice in the management of breathlessness consists of both non-pharmacological and pharmacological interventions as evidenced by recent randomised controlled trials of multidisciplinary breathlessness support services. As well as providing evidence for integration of early palliative care into respiratory services, these revealed that patient distress due to breathlessness can be significantly reduced and better outcomes can be achieved at lower cost than standard care.

Building consensus for provision of breathlessness rehabilitation for patients with chronic obstructive pulmonary disease and chronic heart failure.

The study aimed to gain consensus on key priorities for developing breathlessness rehabilitation services for patients with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF). Seventy-four invited stakeholders attended a 1-day conference to review the evidence base for exercise-based rehabilitation in COPD and CHF. In addition, 47 recorded their views on a series of statements regarding breathlessness rehabilitation tailored to the needs of both patient groups. A total of 75% of stakeholders supported symptom-based rather than disease-based rehabilitation for breathlessness with 89% believing that such services would be attractive for healthcare commissioners. A total of 87% thought patients with CHF could be exercised using COPD training principles and vice versa. A total of 81% felt community-based exercise training was safe for patients with severe CHF or COPD, but only 23% viewed manual-delivered rehabilitation an effective alternative to supervised exercise training. Although there was strong consensus that exercise training was a core component of rehabilitation in CHF and COPD populations, only 36% thought that this was the 'most important' component, highlighting the need for psychological and other non-exercise interventions for breathlessness. Patients with COPD and CHF face similar problems of breathlessness and disability on a background of multi-morbidity. Existing pulmonary and cardiac rehabilitation services should seek synergies to provide sufficient flexibility to accommodate all patients with COPD and CHF. Development of new services could consider adopting a patient-focused rather than disease-based approach. Exercise training is a core component, but rehabilitation should include other interventions to address dyspnoea, psychological and education needs of patients and needs of carers.

A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease.

BACKGROUND: About 90 % of patients with intra-thoracic malignancy experience breathlessness. Breathing training is helpful, but it is unknown whether repeated sessions are needed. The present study aims to test whether three sessions are better than one for breathlessness in this population. METHODS: This is a multi-centre randomised controlled non-blinded parallel arm trial. Participants were allocated to three sessions or single (1:2 ratio) using central computer-generated block randomisation by an independent Trials Unit and stratified for centre. The setting was respiratory, oncology or palliative care clinics at eight UK centres. Inclusion criteria were people with intrathoracic cancer and refractory breathlessness, expected prognosis ≥3 months, and no prior experience of breathing training. The trial intervention was a complex breathlessness intervention (breathing training, anxiety management, relaxation, pacing, and prioritisation) delivered over three hour-long sessions at weekly intervals, or during a single hour-long session. The main primary outcome was worst breathlessness over the previous 24 hours ('worst'), by numerical rating scale (0 = none; 10 = worst imaginable). Our primary analysis was area under the curve (AUC) 'worst' from baseline to 4 weeks. All analyses were by intention to treat. RESULTS: Between April 2011 and October 2013, 156 consenting participants were randomised (52 three; 104 single). Overall, the 'worst' score reduced from 6.81 (SD, 1.89) to 5.84 (2.39). Primary analysis [n = 124 (79 %)], showed no between-arm difference in the AUC: three sessions 22.86 (7.12) vs single session 22.58 (7.10); P value = 0.83); mean difference 0.2, 95 % CIs (-2.31 to 2.97). Complete case analysis showed a non-significant reduction in QALYs with three sessions (mean difference -0.006, 95 % CIs -0.018 to 0.006). Sensitivity analyses found similar results. The probability of the single session being cost-effective (threshold value of £20,000 per QALY) was over 80 %. CONCLUSIONS: There was no evidence that three sessions conferred additional benefits, including cost-effectiveness, over one. A single session of breathing training seems appropriate and minimises patient burden. TRIAL REGISTRATION: Registry: ISRCTN; TRIAL REGISTRATION NUMBER: ISRCTN49387307; http://www.isrctn.com/ISRCTN49387307 ; registration date: 25/01/2011.

Breathlessness and crises in the context of advanced illness: A comparison between COPD and lung cancer patients.

OBJECTIVE: The objective of this study was to explore and contrast the experience and meaning of breathlessness in patients with chronic obstructive pulmonary disease (COPD) or lung cancer at the end of life. METHOD: We conducted a qualitative study embedded in a longitudinal study using topic-guided in-depth interviews with a purposive sample of patients suffering from breathlessness affecting their daily activities due to advanced (primary or secondary) lung cancer or COPD stage III/IV. All interviews were audiotaped, transcribed verbatim, and analyzed using framework analysis. RESULTS: Ten COPD and eight lung cancer patients were interviewed. Both groups reported similarities in their experience. These included exertion through breathlessness throughout the illness course, losses in their daily activities, and the experience of breathlessness leading to crises. The main difference was the way in which patients adapted to their particular illness experience and the resulting crises over time. While COPD patients more likely sought to get their life with breathlessness under control, speaking of daily living with breathlessness under certain conditions, the participating lung cancer patients often faced the possibility of death and expressed a need for security. SIGNIFICANCE OF RESULTS: Breathlessness leads to crises in patients with advanced disease. Although experiences of patients are similar, reactions and coping mechanisms vary and are more related to the disease and the stage of disease.

Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial.

BACKGROUND: Breathlessness is common in advanced cancer. The Breathlessness Intervention Service (BIS) is a multi-disciplinary complex intervention theoretically underpinned by a palliative care approach, utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease. We sought to establish whether BIS was more effective, and cost-effective, for patients with advanced cancer and their carers than standard care. METHODS: A single-centre Phase III fast-track single-blind mixed-method randomised controlled trial (RCT) of BIS versus standard care was conducted. Participants were randomised to one of two groups (randomly permuted blocks). A total of 67 patients referred to BIS were randomised (intervention arm n = 35; control arm n = 32 received BIS after a two-week wait); 54 completed to the key outcome measurement. The primary outcome measure was a 0 to 10 numerical rating scale for patient distress due to breathlessness at two-weeks. Secondary outcomes were evaluated using the Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Services Receipt Inventory, EQ-5D and topic-guided interviews. RESULTS: BIS reduced patient distress due to breathlessness (primary outcome: -1.29; 95% CI -2.57 to -0.005; P = 0.049) significantly more than the control group; 94% of respondents reported a positive impact (51/53). BIS reduced fear and worry, and increased confidence in managing breathlessness. Patients and carers consistently identified specific and repeatable aspects of the BIS model and interventions that helped. How interventions were delivered was important. BIS legitimised breathlessness and increased knowledge whilst making patients and carers feel 'not alone'. BIS had a 66% likelihood of better outcomes in terms of reduced distress due to breathlessness at lower health/social care costs than standard care (81% with informal care costs included). CONCLUSIONS: BIS appears to be more effective and cost-effective in advanced cancer than standard care. TRIAL REGISTRATION: RCT registration at ClinicalTrials.gov NCT00678405 (May 2008) and Current Controlled Trials ISRCTN04119516 (December 2008).

Increase in Hypofractionated Radiation Therapy Among Patients with Invasive Breast Cancer or Ductal Carcinoma In Situ: Who is Left Behind?

PURPOSE: We aimed to update the trend of hypofractionated whole-breast irradiation (HF-WBI) use over time in the US and examine factors associated with lack of HF-WBI adoption for patients with early-stage invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) undergoing a lumpectomy. METHODS AND MATERIALS: Among patients who underwent a lumpectomy, we identified 928,034 patients with early-stage IBC and 330,964 patients with DCIS in the 2004 to 2020 National Cancer Database. We defined HF-WBI as 2.5-3.33 Gy/fraction to the breast and conventionally fractionated WBI as 1.8-2.0 Gy/fraction. We evaluated the trend of HF-WBI utilization using a generalized linear model with the log link and binomial distribution. Factors associated with HF-WBI utilization were assessed using multivariable logistic regression in patients diagnosed between 2018 and 2020. RESULTS: Among patients with IBC, HF-WBI use has significantly increased from 0.7% in 2004 to 63.9% in 2020. Similarly, HF-WBI usage among patients with DCIS has also increased significantly from 0.4% in 2004 to 56.6% in 2020. Black patients with IBC were less likely than White patients to receive HF-WBI (adjusted odds ratio [AOR] 0.81; 95% CI, 0.77-0.85). Community cancer programs were less likely to administer HF-WBI to patients with IBC (AOR, 0.80; 95% CI, 0.77-0.84) and to those with DCIS (AOR, 0.87; 95% CI, 0.79-0.96) than academic/research programs. Younger age, positive nodes, larger tumor size, low volume programs, and facility location were also associated with lack of HF-WBI adoption in both patient cohorts. CONCLUSIONS: HF-WBI utilization among postlumpectomy patients has significantly increased from 2004 to 2020 and can finally be considered standard of care in the US. We found substantial disparities in adoption within patient and facility subgroups. Reducing disparities in HF-WBI adoption has the potential to further alleviate health care costs while improving patients' quality of life.