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.

Openness Personality Trait Associated With Benefit From a Nonpharmacological Breathlessness Intervention in People With Intrathoracic Cancer: An Exploratory Analysis.

CONTEXT: Breathlessness is common in people with lung cancer. Nonpharmacological breathlessness interventions reduce distress because of and increase mastery over breathlessness. OBJECTIVES: Identify patient characteristics associated with response to breathlessness interventions. METHODS: Exploratory secondary trial data analysis. Response defined as a one-point improvement in 0-10 Numerical Rating Scale of worst breathlessness/last 24 hours (response-worst) or a 0.5-point improvement in the Chronic Respiratory Questionnaire (CRQ) mastery (response-mastery) at four weeks. Univariable regression explored relationships with plausible demographic, clinical, and psychological variables followed by multivariable regression for associated (P < 0.05) variables. RESULTS: About 158 participants with intrathoracic cancer (mean age 69.4 [SD 9.35] years; 40% women) were randomized to one or three breathlessness training sessions. About 91 participants had evaluable data for response-worst and 107 for response-mastery. In the univariable analyses, the personality trait openness was associated with response-worst (odds ratio [OR] 1.99 [95% CI 1.08-3.67]; P = 0.028) and response-mastery (OR 1.84 [95% CI 1.04-3.23]; P = 0.035). Higher CRQ-fatigue (OR 0.61 [95% CI 0.41-0.91]; P = 0.015), CRQ-emotion (OR 0.68 [95% CI 0.47-0.96]; P = 0.030), and worse CRQ-mastery (OR 0.61 [95% CI 0.42-0.88]; P = 0.008), and the presence of metastases and fatigue were associated with reduced odds of response-mastery. In the adjusted response-mastery model, only openness remained (OR 1.73 [95% CI 0.95-3.15]; P = 0.072). CONCLUSION: Worse baseline health, worse breathlessness mastery, but not severity, and openness were associated with a better odds of response. Breathlessness services must be easy to access, and patients should be encouraged and supported to attend.

Self-rated health and mortality in patients with chronic heart failure.

AIMS: In patients with chronic heart failure (CHF), there is limited information on self-rated health (SRH). We aimed to examine the distribution of SRH and whether SRH is associated with mortality in patients with stable CHF. METHODS AND RESULTS: We enrolled 100 patients (71 +/- 11 years, 54% men, left ventricular ejection fraction 47 +/- 11%) in a prospective study with 48 months of follow-up. Self-rated health was assessed using a seven-grade descriptive scale: very good, good, quite good, average, quite poor, poor, and very poor. Median SRH was quite poor and the most frequent SRH (31 patients) was average. During an average follow-up of 1005 +/- 507 days, 58 patients died. More patients in the group that rated their health as quite poor or worse died (70% vs. 43%, P = 0.008). In a Cox proportional hazard model, SRH as a seven-grade descriptive scale [hazard ratios (HR) 1.39, 95% CI 1.10-1.74] or as a median value (HR 2.13, 95% CI 1.23-3.69) predicted mortality. The association remained significant after adjustment for patient characteristics and biomarkers (P < 0.05 for both). CONCLUSION: In patients with stable CHF, SRH independently predicts mortality. This suggests that SRH could be used in everyday clinical practice to obtain important prognostic information beyond clinical examination and laboratory work-up.

A comparison of patient and physician-rated New York Heart Association class in a community-based heart failure clinic.

OBJECTIVE: The New York Heart Association (NYHA) classification is recommended for grading symptoms of chronic heart failure and is a powerful prognostic marker. Patient-rated NYHA (Pa-NYHA) and physician-rated NYHA (Dr-NYHA) class have never been compared directly, and it is unknown whether they carry similar prognostic significance. METHODS AND RESULTS: NYHA class was rated independently by a physician and patient in 1752 patients referred with suspected heart failure. Pa-NYHA and Dr-NYHA varied by 1 class in 37.1% cases and by 2 classes in 12.8% cases. Mean Dr-NYHA and Pa-NYHA were higher in women than men (1.98 vs 1.89, P = .016; 2.17 vs 2.02, P = .002) despite less cardiac disease. Dr-NYHA correlated more with 6-minute walk test distance and severity of left ventricular systolic dysfunction than Pa-NYHA (Spearman's rho: -0.53 vs -0.44 and 0.32 vs 0.16). Dr-NYHA better predicted mortality when compared with Pa-NYHA (log-rank: chi(2) = 105 vs 46, both P < .001). CONCLUSION: Patients rate NYHA differently from physicians, and women rate NYHA differently from men. Dr-NYHA relates more strongly to survival and severity of left ventricular systolic dysfunction, suggesting that for physicians the NYHA classification may have become a "heart failure severity score" and not as was intended, purely a measure of a patient's symptoms and functional status.

Recall of lifestyle advice in patients recently hospitalised with heart failure: a EuroHeart Failure Survey analysis.

BACKGROUND: There are limited data on recall and implementation of lifestyle advice in patients with heart failure (HF). AIM: To investigate what advice patients with HF recall being given, and whether they report following the advice they remember. METHODS AND RESULTS: 3261 patients with suspected HF participating in the EuroHeart Failure Survey were interviewed by a health professional 12 weeks after hospital discharge. Patients recalled receiving 46% of pre-specified items of advice and 67% reported that they followed these completely. Both recall (53%) and implementation (71%) was best in patients with left ventricular systolic dysfunction (LVSD). In multivariate analysis, younger age, male sex, patient awareness of the condition and patients reporting that they received a clear explanation of the diagnosis by a health professional, all factors associated with having LVSD, were the strongest predictors of recall. CONCLUSIONS: Recall of and adherence to advice by patients with HF in this large European cross-sectional survey was disappointing. Responsibility for patient education lies with health professionals who should ensure that patients receive and understand advice, and are able to recall and follow it. A greater awareness of the issues surrounding lifestyle advice and more evidence supporting its value could improve patient care.

The influence on cognition of the interaction between the macro-nutrient content of breakfast and glucose tolerance.

Previously it has been found that both missing breakfast and having poorer glucose tolerance were associated with better memory. The present study therefore examined the impact of eight breakfasts, in a factorial design, that contained either high or low levels of carbohydrate, fat or protein. The meals were designed to vary the rate of release of glucose into the blood stream. Memory, reaction times and vigilance were assessed 30, 75 and 120 min following breakfast. Using fasting blood glucose levels as a measure of glucose tolerance, better memory was found to be associated with better glucose tolerance and the consumption of meals that more slowly release glucose into the blood. The effects of the meals on reaction times and vigilance were opposite to those with memory in that higher levels of blood glucose tended to be associated with better performance. It was concluded that individual differences in glucose tolerance interact with the glycaemic load of a meal to influence cognitive functioning.

Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure.

BACKGROUND: Home oxygen therapy (HOT) is commonly used for patients with severe chronic heart failure (CHF) who have intractable breathlessness. There is no trial evidence to support its use. OBJECTIVES: To detect whether or not there was a quality-of-life benefit from HOT given as long-term oxygen therapy (LTOT) for at least 15 hours per day in the home, including overnight hours, compared with best medical therapy (BMT) in patients with severely symptomatic CHF. DESIGN: A pragmatic, two-arm, randomised controlled trial recruiting patients with severe CHF. It included a linked qualitative substudy to assess the views of patients using home oxygen, and a free-standing substudy to assess the haemodynamic effects of acute oxygen administration. SETTING: Heart failure outpatient clinics in hospital or the community, in a range of urban and rural settings. PARTICIPANTS: Patients had to have heart failure from any aetiology, New York Heart Association (NYHA) class III/IV symptoms, at least moderate left ventricular systolic dysfunction, and be receiving maximally tolerated medical management. Patients were excluded if they had had a cardiac resynchronisation therapy device implanted within the past 3 months, chronic obstructive pulmonary disease fulfilling the criteria for LTOT or malignant disease that would impair survival or were using a device or medication that would impede their ability to use LTOT. INTERVENTIONS: Patients received BMT and were randomised (unblinded) to open-label LTOT, prescribed for 15 hours per day including overnight hours, or no oxygen therapy. MAIN OUTCOME MEASURES: The primary end point was quality of life as measured by the Minnesota Living with Heart Failure (MLwHF) questionnaire score at 6 months. Secondary outcomes included assessing the effect of LTOT on patient symptoms and disease severity, and assessing its acceptability to patients and carers. RESULTS: Between April 2012 and February 2014, 114 patients were randomised to receive either LTOT or BMT. The mean age was 72.3 years [standard deviation (SD) 11.3 years] and 70% were male. Ischaemic heart disease was the cause of heart failure in 84%; 95% were in NYHA class III; the mean left ventricular ejection fraction was 27.8%; and the median N-terminal pro-B-type natriuretic hormone was 2203 ng/l. The primary analysis used a covariance pattern mixed model which included patients only if they provided data for all baseline covariates adjusted for in the model and outcome data for at least one post-randomisation time point (n = 102: intervention, n = 51; control, n = 51). There was no difference in the MLwHF questionnaire score at 6 months between the two arms [at baseline the mean score was 54.0 (SD 18.4) for LTOT and 54.0 (SD 17.9) for BMT; at 6 months the mean score was 48.1 (SD 18.5) for LTOT and 49.0 (SD 20.2) for BMT; adjusted mean difference -0.10, 95% confidence interval (CI) -6.88 to 6.69; p = 0.98]. At 3 months, the adjusted mean MLwHF questionnaire score was lower in the LTOT group (-5.47, 95% CI -10.54 to -0.41; p = 0.03) and breathlessness scores improved, although the effect did not persist to 6 months. There was no effect of LTOT on any secondary measure. There was a greater number of deaths in the BMT arm (n = 12 vs. n = 6). Adherence was poor, with only 11% of patients reporting using the oxygen as prescribed. CONCLUSIONS: Although the study was significantly underpowered, HOT prescribed for 15 hours per day and subsequently used for a mean of 5.4 hours per day has no impact on quality of life as measured by the MLwHF questionnaire score at 6 months. Suggestions for future research include (1) a trial of patients with severe heart failure randomised to have emergency oxygen supply in the house, supplied by cylinders rather than an oxygen concentrator, powered to detect a reduction in admissions to hospital, and (2) a study of bed-bound patients with heart failure who are in the last few weeks of life, powered to detect changes in symptom severity. TRIAL REGISTRATION: Current Controlled Trials ISRCTN60260702. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 75. See the NIHR Journals Library website for further project information.

Breakfasts that release glucose at different speeds interact with previous alcohol intake to influence cognition and mood before and after lunch.

Alcohol consumption and the glycemic load (GL) of a meal interact to influence both mood and memory. The authors compared the effects of eating a high GL lunch on mood and memory after consumption of a breakfast high in either rapidly (RAG) or slowly (SAG) available glucose. When less than 4.5 g of alcohol had been drunk the previous evening, the eating of a high RAG meal was associated with better memory later in the morning. In contrast, after more than 4.5 g of alcohol had been drunk the previous evening, the SAG meal resulted in better memory. After lunch, if more than 4.5 g alcohol had been drunk the previous evening, the RAG breakfast, but neither the SAG meal nor fasting, resulted in a more confused feeling.

The delivery rate of dietary carbohydrates affects cognitive performance in both rats and humans.

RATIONALE: Glucose is the main metabolic fuel of the brain. The rate of glucose delivery from food to the bloodstream depends on the nature of carbohydrates in the diet, which can be summarized as the glycaemic index (GI). OBJECTIVES: To assess the benefit of a low versus high GI breakfast on cognitive performances within the following 4 h. METHODS: The influence of the GI of the breakfast on verbal memory of young adults was measured throughout the morning in parallel to the assessment of blood glucose levels. The learning abilities of rats performing an operant-conditioning test 3 h after a breakfast-like meal of various GI was also examined. RESULTS: A low GI rather than high GI diet improved memory in humans, especially in the late morning (150 and 210 min after breakfast). Similarly, rats displayed better learning performance 180 min after they were fed with a low rather than high GI diet. CONCLUSION: Although performances appeared to be only remotely related to blood glucose, our data provide evidence that a low GI breakfast allows better cognitive performances later in the morning.

Carbohydrate, memory, and mood.

From a physiologic perspective, the role of glucose in brain functioning is reviewed and the effect of diet-induced changes in blood glucose on mood and cognition are outlined. Many studies have used a glucose drink or a meal composed almost entirely of carbohydrate as an experimental tool. Because pure sources of carbohydrate will be rarely consumed, the possibility that foods of different glycemic indices will modify mood and memory is briefly considered.

Experiences of air travel in patients with chronic heart failure.

AIM: To conduct a survey in a representative cohort of ambulatory patients with stable, well managed chronic heart failure (CHF) to discover their experiences of air travel. METHODS: An expert panel including a cardiologist, an exercise scientist, and a psychologist developed a series of survey questions designed to elicit CHF patients' experiences of air travel (Appendix 1). The survey questions, information sheets and consent forms were posted out in a self-addressed envelope to 1293 CHF patients. RESULTS: 464 patients (response rate 39%) completed the survey questionnaires. 54% of patients had travelled by air since their heart failure diagnosis. 20% of all patients reported difficulties acquiring travel insurance. 65% of patients who travelled by air experienced no health-related problems. 35% of patients who travelled by air experienced health problems, mainly at the final destination, going through security and on the aircraft. 27% of all patients would not travel by air in the future. 38% of patients would consider flying again if there were more leg room on the aeroplane, if their personal health improved (18%), if they could find cheaper travel insurance (19%), if there were less waiting at the airport (11%), or if there were less walking/fewer stairs to negotiate at the airport (7%). CONCLUSION: For most patients in this sample of stable, well managed CHF, air travel was safe.

The effect of the interaction between glucose tolerance and breakfasts varying in carbohydrate and fibre on mood and cognition.

As a glucose containing drink has been reported to improve memory, and missing breakfast has been reported to adversely influence memory late in the morning, meals designed to differ in their ability to release glucose into the blood stream were contrasted. Using a factorial design, breakfasts containing 15, 30 or 50 g of carbohydrate and 1.5, 6 or 13 g of fibre were compared. The glucose tolerance of participants proved to be an important factor. Those with better tolerance reported better mood. Those eating breakfasts containing greater amounts of carbohydrate reported feeling tired rather than energetic. The amount of carbohydrate did not negatively affect memory in those with better glucose tolerance, however, the consumption of more carbohydrate resulted in more forgetting in those with poorer glucose tolerance. The effect with reactions times differed from memory in that a greater intake of carbohydrate resulted in faster responses later in the morning.

The reproducibility and sensitivity of the 6-min walk test in elderly patients with chronic heart failure.

AIMS: The 6-min walk test (6-MWT) is used to estimate functional capacity. However, in elderly patients with chronic heart failure (CHF): (i) 1 year reproducibility of the 6-MWT; (ii) sensitivity of the 6-MWT to self-perceived changes in symptoms of heart failure; and (iii) implications for patient numbers required for studies using the 6-MWT as an endpoint have not been described. METHODS AND RESULTS: One thousand and seventy-seven patients with CHF, aged>60, with NYHA Class > or =II were recruited. Heart failure symptom assessment was determined using a questionnaire related to aspects of physical function, and patients performed a baseline 6-MWT, with follow-up 1 year later. Seventy-four patients with unchanged symptoms had an unchanged 6-MWT distance, with an overall intraclass correlation coefficient of 0.80 (95% CI=0.69-0.87). Four hundred and twenty-three patients reported an improvement in symptoms during follow-up. There was a negative correlation (r=-0.55; P=0.0001) between Delta symptoms and Delta 6-MWT (i.e. a reduced 6-MWT distance is associated with reduced symptom severity at follow-up). Five hundred and sixteen patients reported worsening symptoms of heart failure, a moderate inverse correlation (r=-0.53; P=0.0001) was displayed between Delta symptoms and Delta 6-MWT. For all patients, irrespective of symptom status, a high inverse correlation (r=-0.75; P=0.0001) was evident. On the basis of the data for patients with unchanged symptoms, it is calculated that to detect an increase in 6-MWT of 50 m, with 90% power, a study size of approximately 120 is required. CONCLUSION: In elderly patients with CHF, the 6-MWT shows satisfactory agreement when repeated 1 year later. Change in 6-MWT distance is sensitive to change in self-perceived symptoms of heart failure.