Project description:BackgroundRespiratory medicine (RM) and palliative care (PC) physicians' management of chronic breathlessness in advanced chronic obstructive pulmonary disease (COPD), fibrotic interstitial lung disease (fILD) and lung cancer (LC), and the influence of practice guidelines was explored via an online survey.MethodsA voluntary, online survey was distributed to RM and PC physicians via society newsletter mailing lists.Results450 evaluable questionnaires (348 (77%) RM and 102 (23%) PC) were analysed. Significantly more PC physicians indicated routine use (often/always) of opioids across conditions (COPD: 92% vs. 39%, fILD: 83% vs. 36%, LC: 95% vs. 76%; all p < 0.001) and significantly more PC physicians indicated routine use of benzodiazepines for COPD (33% vs. 10%) and fILD (25% vs. 12%) (both p < 0.001). Significantly more RM physicians reported routine use of a breathlessness score (62% vs. 13%, p < 0.001) and prioritised exercise training/rehabilitation for COPD (49% vs. 7%) and fILD (30% vs. 18%) (both p < 0.001). Overall, 40% of all respondents reported reading non-cancer palliative care guidelines (either carefully or looked at them briefly). Respondents who reported reading these guidelines were more likely to: routinely use a breathlessness score (χ2 = 13.8; p < 0.001), use opioids (χ2 = 12.58, p < 0.001) and refer to pulmonary rehabilitation (χ2 = 6.41, p = 0.011) in COPD; use antidepressants (χ2 = 6.25; p = 0.044) and refer to PC (χ2 = 5.83; p = 0.016) in fILD; and use a handheld fan in COPD (χ2 = 8.75, p = 0.003), fILD (χ2 = 4.85, p = 0.028) and LC (χ2 = 5.63; p = 0.018).ConclusionsThese findings suggest a need for improved dissemination and uptake of jointly developed breathlessness management guidelines in order to encourage appropriate use of existing, evidence-based therapies. The lack of opioid use by RM, and continued benzodiazepine use in PC, suggest that a wider range of acceptable therapies need to be developed and trialled.

Project description:BACKGROUND:Breathlessness is the most common and intrusive symptom of advanced non-malignant respiratory and cardiac conditions. 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 in managing their breathlessness. Having published the effectiveness and cost effectiveness of BIS for patients with advanced cancer and their carers, we sought to establish its effectiveness, and cost effectiveness, in advanced non-malignant conditions. METHODS:This was a single-centre Phase III fast-track single-blind mixed method RCT of BIS versus standard care for breathless patients with non-malignant conditions and their carers. Randomisation was to one of two groups (randomly permuted blocks). Eighty-seven patients referred to BIS were randomised (intervention arm n?=?44; control arm n?=?43 received BIS after four-week wait); 79 (91 %) completed to key outcome measurement. The primary outcome measure was 0-10 numeric rating scale for patient distress due to breathlessness at four weeks. Secondary outcome measures were Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Service Receipt Inventory, EQ-5D and topic-guided interviews. RESULTS:Qualitative analyses showed the positive impact of BIS on patients with non-malignant conditions and their carers; quantitative analyses showed a non-significant greater reduction in the primary outcome ('distress due to breathlessness'), when compared to standard care, of -0.24 (95 % CI: -1.30, 0.82). BIS resulted in extra mean costs of £799, reducing to £100 when outliers were excluded; neither difference was statistically significant. The quantitative findings contrasted with those previously reported for patients with cancer and their carers, which showed BIS to be both clinically and cost effective. For patients with non-malignant conditions there was a notable trend of improvement over both trial arms to the key measurement point; participants may have experienced a therapeutic effect from the research interviews, diluting the intervention's impact. CONCLUSIONS:BIS had a statistically non-significant effect for patients with non-malignant conditions, and slightly increased service costs, but had a qualitatively positive impact consistent with findings for advanced cancer. Trials of palliative care interventions should consider multiple, mixed method, primary outcomes and ensure that protocols limit potential contaminating therapeutic effects in study designs. TRIAL REGISTRATION:Current Controlled Trials ISRCTN04119516 (December 2008); ClinicalTrials.gov NCT00678405 (May 2008).

Project description:The London Chest Activities of Daily Living Scale measures the impact of breathlessness on both activity and social functioning. However, the London Chest Activities of Daily Living Scale is not routinely used in patients with advanced disease.To assess the psychometric properties of the London Chest Activities of Daily Living Scale in patients with refractory breathlessness due to advanced disease.A cross-sectional secondary analysis of data from a randomised controlled parallel-group, pragmatic, single-blind fast-track trial (randomised controlled trial) investigating the effectiveness of an integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness, known as the Breathlessness Support Service (NCT01165034). All patients completed the following questionnaires: the London Chest Activities of Daily Living Scale, Chronic Respiratory Questionnaire, the Palliative care Outcome Scale, Palliative care Outcome Scale-symptoms, the Hospital Anxiety and Depression Scale and breathlessness measured on a numerical rating scale. Data quality, scaling assumptions, acceptability, internal consistency and construct validity of the London Chest Activities of Daily Living Scale were determined using standard psychometric approaches.Breathless patients with advanced malignant and non-malignant disease.A total of 88 patients were studied, primary diagnosis included; chronic obstructive pulmonary disease = 53, interstitial lung disease = 17, cancer = 18. Median (range) London Chest Activities of Daily Living Scale total score was 46.5 (14-67). No floor or ceiling effect was observed for the London Chest Activities of Daily Living Scale total score. Internal consistency was good, and Cronbach's alpha for the London Chest Activities of Daily Living Scale total score was 0.90. Construct validity was good with 13 out of 15 a priori hypotheses met.Psychometric analyses suggest that the London Chest Activities of Daily Living Scale is acceptable, reliable and valid in patients with advanced disease and refractory breathlessness.

Project description:IntroductionSELF-BREATHE is a complex, transdiagnostic, supportive, digital breathlessness intervention co-developed with patients. SELF-BREATHE seeks to build capacity and resilience within health services by improving the lives of people with chronic breathlessness using nonpharmacological, self-management approaches. This study aimed to determine whether SELF-BREATHE is feasible to deliver and acceptable to patients living with chronic breathlessness.MethodsA parallel, two-arm, single-blind, single-centre, randomised controlled, mixed-methods feasibility trial with participants allocated to 1) intervention group (SELF-BREATHE) or 2) control group (usual National Health Service (NHS) care). The setting was a large multisite NHS foundation trust in south-east London, UK. The participants were patients living with chronic breathlessness due to advanced malignant or nonmalignant disease(s). Participants were randomly allocated (1:1) to an online, self-guided, breathlessness supportive intervention (SELF-BREATHE) and usual care or usual care alone, over 6 weeks. The a priori progression criteria were ≥30% of eligible patients given an information sheet consented to participate; ≥60% of participants logged on and accessed SELF-BREATHE within 2 weeks; and ≥70% of patients reported the methodology and intervention as acceptable.ResultsBetween January 2021 and January 2022, 52 (47%) out of 110 eligible patients consented and were randomised. Of those randomised to SELF-BREATHE, 19 (73%) out of 26 logged on and used SELF-BREATHE for a mean±sd (range) 9±8 (1-33) times over 6 weeks. 36 (70%) of the 52 randomised participants completed and returned the end-of-study postal questionnaires. SELF-BREATHE users reported it to be acceptable. Post-intervention qualitative interviews demonstrated that SELF-BREATHE was acceptable and valued by users, improving breathlessness during daily life and at points of breathlessness crisis.ConclusionThese data support the feasibility of moving to a fully powered, randomised controlled efficacy trial with minor modifications to minimise missing data (i.e. multiple methods of data collection: face-to-face, telephone, video assessment and by post).

Project description:BackgroundConcurrent use of benzodiazepines in opioid users has been linked to a higher risk of an emergency room visit or inpatient admission for opioid overdose and death from drug overdose. Further research is needed to confirm the findings and analyze contributing risk factors for opioid overdoses in a large commercially insured population.ObjectivesTo estimate the risk of opioid overdose associated with opioid users exposed to various combinations of opioid, benzodiazepine, and non-benzodiazepine sedative-hypnotic therapy. To identify other factors that are associated with increased risk for opioid overdose.DesignRetrospective cohort study.PatientsNew start adult users of opioids, defined as naïve to opioids for 6 months, in Kaiser Permanente California regions from January 2013 through September 2017.Main measuresInpatient or emergency department admissions due to opioid-related overdose.Key resultsA total of 2,241,530 patients were included in this study. Patients exposed to opioids, benzodiazepines, and non-benzodiazepine sedative-hypnotics at any point during their follow-up were 60% more likely to overdose than those who were only exposed to opioids (p < 0.0001). Those exposed to opioids and benzodiazepines were 20% more likely to have an opioid-related overdose than those exposed to opioids only (p < 0.0001). Significant risk factors for opioid overdose included exposure to all three medication classes, higher opioid dosage strengths, elderly age (age ≥ 65 years), history of previous overdose, and substance use disorder.ConclusionsResults from this study demonstrate a significant increase in risk of opioid overdose in patients exposed to combinations of sedative-hypnotics with opioids compared to those only taking opioids. Findings from this study provide evidence that opioids should be avoided in combination with benzodiazepines and non-benzodiazepine sedative-hypnotics, used at the lowest dose possible, and used with caution in the elderly, those with previous history of overdose, and those with substance use disorder at baseline.

Project description:Objectives To evaluate the risk of all cause mortality associated with initiating compared with not initiating benzodiazepines in adults, and to address potential treatment barriers and confounding related to the use of a non-active comparator group.Design Retrospective cohort study.Setting Large de-identified US commercial healthcare database (Optum Clinformatics Datamart).Participants 1:1 high dimensional propensity score matched cohort of benzodiazepine initiators, and randomly selected benzodiazepine non-initiators with a medical visit within 14 days of the start of benzodiazepine treatment (n=1?252?988), between July 2004 and December 2013. To address treatment barriers and confounding, patients were required to have filled one or more prescriptions for any medication in the 90 days and 91-180 days before the index date (ie, the date of starting benzodiazepine treatment for initiators and the date of the selected medical visit for benzodiazepine non-initiators) and the high dimensional propensity score was estimated on the basis of more than 300 covariates.Main outcome measure All cause mortality, determined by linkage with the Social Security Administration Death Master File.Results Over a six month follow-up period, 5061 and 4691 deaths occurred among high dimensional propensity score matched benzodiazepine initiators versus non-initiators (9.3 v 9.4 events per 1000 person years; hazard ratio 1.00, 95% confidence interval 0.96 to 1.04). A 4% (95% confidence interval 1% to 8%) to 9% (2% to 7%) increase in mortality risk was observed associated with the start of benzodiazepine treatment for follow-ups of 12 and 48 months and in subgroups of younger patients and patients initiating short acting agents. In secondary analyses comparing 1:1 high dimensional propensity score matched patients initiating benzodiazepines with an active comparator, ie, patients starting treatment with selective serotonin reuptake inhibitor antidepressants, benzodiazepine use was associated with a 9% (95% confidence interval 3% to 16%) increased risk.Conclusions This large population based cohort study suggests either no increase or at most a minor increase in risk of all cause mortality associated with benzodiazepine initiation. If a detrimental effect exists, it is likely to be much smaller than previously stated and to have uncertain clinical relevance. Residual confounding likely explains at least part of the small increase in mortality risk observed in selected analyses.

Project description: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.

Project description:BackgroundPalliative oxygen therapy is widely used for treatment of dyspnoea in individuals with life-limiting illness who are ineligible for long-term oxygen therapy. We assessed the effectiveness of oxygen compared with room air delivered by nasal cannula for relief of breathlessness in this population of patients.MethodsAdults from outpatient clinics at nine sites in Australia, the USA, and the UK were eligible for enrolment in this double-blind, randomised controlled trial if they had life-limiting illness, refractory dyspnoea, and partial pressure of oxygen in arterial blood (PaO(2)) more than 7.3 kPa. Participants were randomly assigned in a 1:1 ratio by a central computer-generated system to receive oxygen or room air via a concentrator through a nasal cannula at 2 L per min for 7 days. Participants were instructed to use the concentrator for at least 15 h per day. The randomisation sequence was stratified by baseline PaO(2) with balanced blocks of four patients. The primary outcome measure was breathlessness (0-10 numerical rating scale [NRS]), measured twice a day (morning and evening). All randomised patients who completed an assessment were included in the primary analysis for that data point (no data were imputed). This study is registered, numbers NCT00327873 and ISRCTN67448752.Findings239 participants were randomly assigned to treatment (oxygen, n=120; room air, n=119). 112 (93%) patients assigned to receive oxygen and 99 (83%) assigned to receive room air completed all 7 days of assessments. From baseline to day 6, mean morning breathlessness changed by -0.9 points (95% CI -1.3 to -0.5) in patients assigned to receive oxygen and by -0.7 points (-1.2 to -0.2) in patients assigned to receive room air (p=0.504). Mean evening breathlessness changed by -0.3 points (-0.7 to 0.1) in the oxygen group and by -0.5 (-0.9 to -0.1) in the room air group (p=0.554). The frequency of side-effects did not differ between groups. Extreme drowsiness was reported by 12 (10%) of 116 patients assigned to receive oxygen compared with 14 (13%) of 108 patients assigned to receive room air. Two (2%) patients in the oxygen group reported extreme symptoms of nasal irritation compared with seven (6%) in the room air group. One patient reported an extremely troublesome nose bleed (oxygen group).InterpretationSince oxygen delivered by a nasal cannula provides no additional symptomatic benefit for relief of refractory dyspnoea in patients with life-limiting illness compared with room air, less burdensome strategies should be considered after brief assessment of the effect of oxygen therapy on the individual patient.FundingUS National Institutes of Health, Australian National Health and Medical Research Council, Duke Institute for Care at the End of Life, and Doris Duke Charitable Foundation.

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

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