Estimating the clinical and budgetary impact of using angiotensin receptor neprilysin inhibitor as first line therapy in patients with HFrEF.

AIMS: Recent updates of international treatment guidelines for heart failure with reduced ejection fraction (HFrEF) differ regarding the use of angiotensin receptor neprilysin inhibitor (ARNI) as first-line treatment. The American Heart Association/American College of Cardiology/Heart Failure Society of America (AHA/ACC/HFSA) 2022 guidelines gives ARNI a Class IA recommendation for HFrEF patients while the European Society of Cardiology's guidelines are less clear when ARNI could be considered as first line treatment option in de novo patients. This study aimed to model the clinical and budgetary outcomes of implementing these guidelines, comparing conservative ARNI prescription patterns with less conservative in Sweden and in the United Kingdom. METHODS AND RESULTS: A health economic model was developed to compare different treatment patterns for HFrEF. Incident cohorts were included on an annual basis and followed over 10 years. The model included treatment specific all-cause mortality and hospitalization rates, as well as drug acquisition, monitoring, and hospitalization costs. Increasing the use of ARNI could lead to about 7000-12 300 life years gained and 2600-4600 hospitalizations prevented in Sweden. These health benefits come with an additional cost of 112-195 million euros. Similar results were estimated for the United Kingdom, albeit on a larger population. CONCLUSIONS: Increasing the proportion of patients receiving ARNI instead of angiotensin converting enzyme inhibitors as first-line treatment of HFrEF will lead to a considerable number of additional life years gained and prevented hospitalizations but with additional cost in terms of health care expenditure in Sweden and in the United Kingdom.

Prioritising electrocardiograms for manual review to improve the efficiency of atrial fibrillation screening.

Screening for atrial fibrillation (AF) could reduce the incidence of stroke by identifying undiagnosed AF and prompting anticoagulation. However, screening may involve recording many electrocardiograms (ECGs) from each participant, several of which require manual review which is costly and time-consuming. The aim of this study was to investigate whether the number of ECG reviews could be reduced by using a model to prioritise ECGs for review, whilst still accurately diagnosing AF. A multiple logistic regression model was created to estimate the likelihood of an ECG exhibiting AF based on the mean RR-interval and variability in RR-intervals. It was trained on 1,428 manually labelled ECGs from 144 AF screening programme participants, and evaluated using 11,443 ECGs from 1,521 participants. When using the model to order ECGs for review, the number of reviews for AF participants was reduced by 74% since no further reviews are required after an AF ECG is identified; however, it did not impact the number of reviews in non-AF participants (the vast majority of participants), so the overall number of reviews was reduced by 3% with no missed AF diagnoses. When using the model to also exclude ECGs from review, the overall number of reviews was reduced by 28% with no missed AF diagnoses, and by 53% with only 4% of AF diagnoses missed. In conclusion, the workload can be reduced by using a model to prioritise ECGs for review. Ordering ECGs alone only provides only a moderate reduction in workload. The additional use of a threshold to exclude ECGs from review provides a much greater reduction in workload at the expense of some missed AF diagnoses. Clinical Relevance-This shows the potential benefit of using a model to prioritise electrocardiograms for review in order to reduce the manual workload of AF screening.

Changes in clinical and imaging variables during withdrawal of heart failure therapy in recovered dilated cardiomyopathy.

AIMS: This study aimed to profile the changes in non-invasive clinical, biochemical, and imaging markers during withdrawal of therapy in patients with recovered dilated cardiomyopathy, providing insights into the pathophysiology of relapse. METHODS AND RESULTS: Clinical, biochemical, and imaging data from patients during phased withdrawal of therapy in the randomized or single-arm cross-over phases of TRED-HF were profiled. Clinical variables were measured at each study visit and imaging variables were measured at baseline, 16 weeks, and 6 months. Amongst the 49 patients [35% women, mean age 53.6 years (standard deviation 11.6)] who withdrew therapy, 20 relapsed. Increases in mean heart rate [7.6 beats per minute (95% confidence interval, CI, 4.5, 10.7)], systolic blood pressure [6.6 mmHg (95% CI 2.7, 10.5)], and diastolic blood pressure [5.8 mmHg (95% CI 3.1, 8.5)] were observed within 4-8 weeks of starting to withdraw therapy. A rise in mean left ventricular (LV) mass [5.1 g/m2 (95% CI 2.8, 7.3)] and LV end-diastolic volume [3.9 mL/m2 (95% CI 1.1, 6.7)] and a reduction in mean LV ejection fraction [-4.2 (95% CI -6.6, -1.8)] were seen by 16 weeks, the earliest imaging follow-up. Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) fell immediately after withdrawing beta-blockers and only tended to increase 6 months after beginning therapy withdrawal [mean change in log NT-proBNP at 6 months: 0.2 (95% CI -0.1, 0.4)]. CONCLUSIONS: Changes in plasma NT-proBNP are a late feature of relapse, often months after a reduction in LV function. A rise in heart rate and blood pressure is observed soon after withdrawing therapy in recovered dilated cardiomyopathy, typically accompanied or closely followed by early changes in LV structure and function.

Angiotensin receptor neprilysin inhibition versus individualized RAAS blockade: design and rationale of the PARALLAX trial.

AIMS: Although the effect of the angiotensin receptor blocker neprilysin inhibitor (ARNI) sacubitril/valsartan on heart failure (HF) hospitalizations and cardiovascular death has been evaluated, its effects on functional capacity in patients with HF and ejection fraction (EF) >40% has yet to be determined. In addition, no prior studies have compared sacubitril/valsartan with angiotensin-converting enzyme inhibitor therapy. We sought to compare the effect of ARNI to background-medication-based individualized comparators (BMICs) on N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity [6 min walk distance (6MWD)], symptoms, and quality of life [Kansas City Cardiomyopathy Questionnaire (KCCQ)] in patients with HF and EF >40% in a randomized clinical trial. METHODS: PARALLAX is a prospective, randomized, controlled, double-blind multicentre clinical trial in patients with chronic symptomatic HF with EF >40%, New York Heart Association (NYHA) class II-IV symptoms, elevated natriuretic peptides, and evidence of structural heart disease. Eligible patients are randomized to sacubitril/valsartan vs. BMIC for cardiovascular and related co-morbidities. BMIC includes (i) enalapril, (ii) valsartan, and (iii) placebo depending on the type of medical therapy prior to enrolment. The primary endpoints are the change in plasma NT-proBNP concentration from baseline to 12 weeks and the change from baseline in 6MWD distance at 24 weeks. The secondary endpoints assess quality of life and symptom burden. CONCLUSIONS: PARALLAX will determine if sacubitril/valsartan compared with standard medical therapy for co-morbidities improves NT-proBNP levels, exercise capacity, quality of life, and symptom burden in HF patients with EF >40%.

Temporal Trends in the Incidence of Heart Failure among Patients with Chronic Obstructive Pulmonary Disease and Its Association with Mortality.

Rationale: Heart failure (HF) is a common comorbidity in the chronic obstructive pulmonary disease (COPD) population, but previous research has shown underrecognition.Objectives: The objectives of this study were to determine the incidence of HF in a prevalent COPD cohort and to determine the association of incident HF with short- and long-term mortality of patients with COPD.Methods: Crude incidence of HF in the HF-naive primary care COPD population was calculated for each year from 2006 to 2016 using UK data from the Clinical Practice Research Datalink (CPRD). Patients with COPD were identified using a validated code list and were required to be >35 years old at COPD diagnosis, have a history of smoking, and have documented airflow obstruction. The Office of National Statistics provided mortality data for England. Adjusted mortality rate ratios (aMRRs) from Poisson regression were calculated for patients with COPD and incident HF (COPD-iHF) in 2006, 2011, and 2015, and compared temporally with patients with COPD and without incident HF (COPD-no HF) in those years. Regression was adjusted for age, sex, body mass index, severity of airflow limitation, smoking status, history of cardiovascular disease, and diabetes.Results: We identified 95,987 HF-naive patients with COPD. Crude incidence of HF was steady from 2006 to 2016 (1.18 per 100 person-years; 95% confidence interval [CI], 1.09-1.27). Patients with COPD-iHF experienced greater than threefold increase in 1-year mortality and twofold increase in 5-year and 10-year mortality compared with patients with COPD-no HF, with no change on the basis of year of HF diagnosis. Mortality of patients with COPD-iHF did not improve over time, comparing incident HF in 2011 (1-yr aMRR, 1.26; 95% CI, 0.83-1.90; 5-yr aMRR, 1.26; 95% CI, 0.98-1.61) and 2015 (1-yr aMRR, 1.63; 95% CI, 0.98-2.70) with incident HF in 2006.Conclusions: The incidence of HF in the UK COPD population was stable in the last decade. Survival of patients with COPD and incident HF has not improved over time in England. Bespoke guidelines for the diagnosis and management of HF in the COPD population are needed to improve identification and survival of patients.

Biomarkers in patients with heart failure and central sleep apnoea: findings from the SERVE-HF trial.

AIMS: The Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients with Heart Failure trial investigated the effects of adaptive servo-ventilation (ASV) (vs. control) on outcomes of 1325 patients with heart failure and reduced ejection fraction (HFrEF) and central sleep apnoea (CSA). The primary outcome (a composite of all-cause death or unplanned HF hospitalization) did not differ between the two groups. However, all-cause and cardiovascular (CV) mortality were higher in the ASV group. Circulating biomarkers may help in better ascertain patients' risk, and this is the first study applying a large set of circulating biomarkers in patients with both HFrEF and CSA. METHODS AND RESULTS: Circulating protein-biomarkers (n = 276) ontologically involved in CV pathways, were studied in 749 (57% of the trial population) patients (biomarker substudy), to investigate their association with the study outcomes (primary outcome, CV death and all-cause death). The mean age was 69 ± 10 years, and > 90% were male. The groups (ASV vs. control and biomarker substudy vs. no biomarker) were well balanced. The "best" clinical prognostic model included male sex, systolic blood pressure < 120 mmHg, diabetes, loop diuretic, cardiac device, 6-min walking test distance, and N-terminal pro BNP as the strongest prognosticators. On top of the "best" clinical prognostic model, the biomarkers that significantly improved both the discrimination (c-index) and the net reclassification index (NRI) of the model were soluble suppression of tumorigenicity 2 for the primary outcome; neurogenic locus notch homolog protein 3 (Notch-3) for CV-death and all-cause death; and growth differentiation factor 15 (GDF-15) for all-cause death only. CONCLUSIONS: We studied 276 circulating biomarkers in patients with HFrEF and central sleep apnoea; of these biomarkers, three added significant prognostic information on top of the best clinical model: soluble suppression of tumorigenicity 2 (primary outcome), Notch-3 (CV and all-cause death), and GDF-15 (all-cause death).

Real-world costs of transvenous lead extraction: the challenge for reimbursement.

AIMS: Transvenous lead extraction is challenging, often requiring specialist equipment and prolonged hospital admission. A single tariff or itemized costs may be available for reimbursement. Due to limited data relating to the costs of transvenous extraction, it is unclear whether either form of reimbursement is adequate. We aim to describe accurately the total real-world costs of managing patients undergoing transvenous extraction at a single, large centre. We further aim to consider the additional costs of device reimplantation. METHODS AND RESULTS: At a single UK extraction centre, a retrospective, patient level service line analysis was undertaken, during a complete financial year. Seventy-four patients required transvenous extraction (47 infected and 27 non-infected; 156 leads). Sixty-nine procedures (93%) were performed under general anaesthesia, with a median time in theatre of 95 min [interquartile range (IQR) 71-120]. Specialist extraction tools were required for 130 leads (83%). The median hospitalization duration was 3 days (IQR 1-8). The mean cost of extraction was £9228 (±4099); infected £10 727 (±4178) and non-infected £6619 (±2269). With the additional costs of device reimplantation, the overall mean cost rose to £17 574 (±12 882); infected £22 615 (±13 343) and non-infected £8801 (±5007). At the time of this study, the UK NHS tariff was £2530 for elective and £4764 for non-elective extraction, covering barely half of the real costs. CONCLUSION: We demonstrated a substantial difference between the real-world cost of extraction and the UK NHS tariff. Extracting centres should scrutinize their practice, including the timing of reimplantation.

Heart failure across Asia: Same healthcare burden but differences in organization of care.

A gap in the knowledge on the status of heart failure (HF) in Asia versus other regions led to the creation of a working group of Asian experts from 9 countries or regions (Hong Kong, Indonesia, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam). Each expert sought the best available data from local publications, registries, or clinical practice. The prevalence of HF in Asia was generally similar to global values (1% to 3%), but with some outliers. There were substantial variations in healthcare spending, and the average cost of HF hospitalization varied from 813 US$ in Indonesia to nearly 9000 US$ in South Korea. Comorbidities were frequent, particularly hypertension, diabetes mellitus, and dyslipidemia. Modifiable risk factors such as smoking were alarmingly common in some countries. Asian HF patients spent between 5 and 12.5days in hospital, and 3% to 15% were readmitted for HF by 30days. The pharmacological treatment of Asian patients generally followed international guidelines, including renin-angiotensin-aldosterone system inhibitors (61% to 90%), diuretics (76% to 99%), beta-blockers (32% to 78%), and digoxin (19% to 53%), with some room for improvement in terms of life-saving therapies. Our review supports implementation of a more comprehensive and organized approach to HF care in Asia.

Disparities Between Clinician and Patient Perception of Breakthrough Pain Control.

CONTEXT: There are disparities in the level of symptom severity as perceived by patients and health professionals. There is limited information about patients' and clinicians' global assessment of breakthrough pain control, the need to change analgesics, and change in breakthrough pain over time. OBJECTIVES: To establish whether patients and clinicians independently agree on adequacy of breakthrough pain control, management strategy, and impression of change over time. METHODS: One hundred patients with breakthrough cancer pain were assessed and followed up one week later by a palliative medicine specialist. The patient and clinician independently answered the same questions about the adequacy of the patient's breakthrough pain control and breakthrough pain management. The results were compared with items on the Breakthrough Pain Assessment Tool (BAT). RESULTS: At initial consultation, 35% of patients rated their breakthrough cancer pain as inadequately controlled compared with 72% of clinicians. Breakthrough pain analgesics were changed in 68% of cases. At one-week follow-up consultation, 62% of patients considered their breakthrough cancer pain to be better, and in 57% of cases, the clinicians also categorized the pain this way. CONCLUSION: There are significant differences in global impressions of breakthrough pain between patients and pain clinicians that become less disparate as a therapeutic relationship evolves. Therapeutic decisions were based on clinical rather than patient perceptions.

Randomized trial of combination cytokine and adult autologous bone marrow progenitor cell administration in patients with non-ischaemic dilated cardiomyopathy: the REGENERATE-DCM clinical trial.

AIMS: The REGENERATE-DCM trial is the first phase II randomized, placebo-controlled trial aiming to assess if granulocyte colony-stimulating factor (G-CSF) administration with or without adjunctive intracoronary (IC) delivery of autologous bone marrow-derived cells (BMCs) improves global left ventricular (LV) function in patients with dilated cardiomyopathy (DCM) and significant cardiac dysfunction. METHODS AND RESULTS: Sixty patients with DCM and left ventricular ejection fraction (LVEF) at referral of ≤45%, New York Heart Association (NYHA) classification ≥2 and no secondary cause for the cardiomyopathy were randomized equally into four groups: peripheral placebo (saline), peripheral G-CSF, peripheral G-CSF and IC serum, and peripheral G-CSF and IC BMC. All patients, except the peripheral placebo group, received 5 days of G-CSF. In the IC groups, this was followed by bone marrow harvest and IC infusion of cells or serum on Day 6. The primary endpoint was LVEF change from baseline to 3 months, determined by advanced cardiac imaging. At 3 months, peripheral G-CSF combined with IC BMC therapy was associated with a 5.37% point increase in LVEF (38.30% ± 12.97 from 32.93% ± 16.46 P = 0.0138), which was maintained to 1 year. This was associated with a decrease in NYHA classification, reduced NT-pro BNP, and improved exercise capacity and quality of life. No significant change in LVEF was seen in the remaining treatment groups. CONCLUSION: This is the first randomized, placebo-controlled trial with a novel combination of G-CSF and IC cell therapy that demonstrates an improvement in cardiac function, symptoms, and biochemical parameters in patients with DCM.

Accuracy of a Diagnostic Algorithm to Diagnose Breakthrough Cancer Pain as Compared With Clinical Assessment.

CONTEXT: Breakthrough cancer pain (BTCP) is a heterogeneous condition, and there are no internationally agreed standardized criteria to diagnose it. There are published algorithms to assist with diagnosis, but these differ in content. There are no comparative data to support use. OBJECTIVES: To compare the diagnostic ability of a simple algorithm against a comprehensive clinical assessment to diagnose BTCP and to assess if verbal rating descriptors can adequately discriminate controlled background pain. METHODS: Patients with cancer pain completed a three-step algorithm with a researcher to determine if they had controlled background pain and BTCP. This was followed by a detailed pain consultation with a clinical specialist who was blinded to the algorithm results and determined an independent pain diagnosis. The sensitivity, specificity, and positive and negative predictive values were calculated for the condition of BTCP. Further analysis determined which verbal pain severity descriptors corresponded with the condition of controlled background pain. RESULTS: The algorithm had a sensitivity of 0.54 and a specificity of 0.76 in the identification of BTCP. The positive predictive value was 0.7, and the negative predictive value was 0.62. The sensitivity of a background pain severity rating of mild or less to accurately categorize controlled background pain was 0.69 compared with 0.97 for severity of moderate or less; however, this was balanced by a higher specificity rating for mild or less, 0.78 compared with 0.2. CONCLUSION: The diagnostic breakthrough pain algorithm had a good positive predictive value but limited sensitivity using a cutoff score of "mild" to define controlled background pain. When the cutoff level was changed to moderate, the sensitivity increased, but specificity reduced. A comprehensive clinical assessment remains the preferred method to diagnose BTCP.

Development and validation of the breakthrough pain assessment tool (BAT) in cancer patients.

CONTEXT: The successful management of breakthrough pain depends on a combination of adequate assessment, appropriate (individualized) treatment, and adequate re-assessment. Currently, there is no fully validated clinical assessment tool for breakthrough pain in cancer patients. OBJECTIVES: The aim of this project was to develop and validate a breakthrough pain assessment tool (the BAT) for use in the clinical setting. METHODS: The content of the BAT was determined by reviewing the medical literature, conducting a Delphi process with experts in breakthrough pain and/or pain assessment and conducting semi-structured interviews with cancer patients with breakthrough pain. The tool was then subjected to a series of standard psychometric tests to assess its factor structure, validity (i.e., content validity, construct validity), reliability (i.e., internal consistency, test-retest reliability), and responsiveness to change. RESULTS: The BAT comprised two pages with 14 questions. Factor analysis confirmed the presence of two underlying factors. Psychometric testing confirmed that the tool is valid, reliable, and responsive to change. CONCLUSION: This study provides initial evidence for the validity and reliability of the breakthrough pain assessment tool which may be used to facilitate the management of patients with breakthrough cancer pain in the clinical setting.

Heart failure: preventing disease and death worldwide.

Heart failure is a life-threatening disease and addressing it should be considered a global health priority. At present, approximately 26 million people worldwide are living with heart failure. The outlook for such patients is poor, with survival rates worse than those for bowel, breast or prostate cancer. Furthermore, heart failure places great stresses on patients, caregivers and healthcare systems. Demands on healthcare services, in particular, are predicted to increase dramatically over the next decade as patient numbers rise owing to ageing populations, detrimental lifestyle changes and improved survival of those who go on to develop heart failure as the final stage of another disease. It is time to ease the strain on healthcare systems through clear policy initiatives that prioritize heart failure prevention and champion equity of care for all. Despite the burdens that heart failure imposes on society, awareness of the disease is poor. As a result, many premature deaths occur. This is in spite of the fact that most types of heart failure are preventable and that a healthy lifestyle can reduce risk. Even after heart failure has developed, premature deaths could be prevented if people were taught to recognize the symptoms and seek immediate medical attention. Public awareness campaigns focusing on these messages have great potential to improve outcomes for patients with heart failure and ultimately to save lives. Compliance with clinical practice guidelines is also associated with improved outcomes for patients with heart failure. However, in many countries, there is considerable variation in how closely physicians follow guideline recommendations. To promote equity of care, improvements should be encouraged through the use of hospital performance measures and incentives appropriate to the locality. To this end, policies should promote the research required to establish an evidence base for performance measures that reflect improved outcomes for patients. Continuing research is essential if we are to address unmet needs in caring for patients with heart failure. New therapies are required for patients with types of heart failure for which current treatments relieve symptoms but do not address the disease. More affordable therapies are desperately needed in the economically developing world. International collaborative research focusing on the causes and treatment of heart failure worldwide has the potential to benefit tens of millions of people. Change at the policy level has the power to drive improvements in prevention and care that will save lives. It is time to make a difference across the globe by confronting the problem of heart failure. A CALL TO ACTION: POLICY RECOMMENDATIONS: We urge policymakers at local, national and international levels to collaborate and act on the following recommendations. PROMOTE HEART FAILURE PREVENTION: Support the development and implementation of public awareness programmes about heart failure. These should define heart failure in simple and accessible language, explain how to recognize the symptoms and emphasize that most types of heart failure are preventable.Highlight the need for healthcare professionals across all clinical disciplines to identify patients with illnesses that increase the risk of heart failure and to prescribe preventive medications.Prioritize the elimination of infectious diseases in parts of the world where they still cause heart failure. IMPROVE HEART FAILURE AWARENESS AMONGST HEALTHCARE PROFESSIONALS: Encourage the development and use of heart failure education programmes for all appropriate healthcare professionals. These should aim to improve the prevention, diagnosis, treatment and long-term management of heart failure and raise awareness of clinical practice guidelines. ENSURE EQUITY OF CARE FOR ALL PATIENTS WITH HEART FAILURE: Provide a healthcare system that delivers timely access to diagnostic services and treatment of heart failure, as well as a seamless transition to long-term management.Ensure that the best available and most appropriate care is consistently provided to all patients with heart failure through efficient use of resources. SUPPORT AND EMPOWER PATIENTS AND THEIR CAREGIVERS: Provide resources for the education and practical support of patients with heart failure and their families or other caregivers, empowering them to engage proactively in long-term care. PROMOTE HEART FAILURE RESEARCH: Fund and encourage international collaborative research to improve understanding of the patterns, causes and effects of modern day heart failure and how the disease can be prevented across the globe.Fund and encourage research into new and more affordable therapies and medical devices for all types of heart failure.Fund and encourage research into evidence-based healthcare performance measures that reflect improved clinical outcomes for patients with heart failure.

Reducing heart failure admission rates in England 2004-2011 are not related to changes in primary care quality: national observational study.

AIMS: Heart failure (HF) is an important clinical problem. Expert consensus has defined HF as a primary care-sensitive condition for which the risk of unplanned admissions may be reduced by high quality primary care, but there is little supporting evidence. We analysed time trends in HF admission rates in England and risk and protective factors for admission. METHODS AND RESULTS: We used Hospital Episodes Statistics to produce indirectly standardized HF admission counts by general practice for 2004-2011. Clustered negative binomial regression analysis produced admission risk ratios and assessed the significance of potential explanatory covariates. These included population factors (deprivation; HF, coronary heart disease, and smoking prevalence), primary care resourcing [access; general practitioner (GP) supply], and primary care quality ('Quality and Outcomes Framework' indicator.) There were 327,756 HF admissions of patients registered with 8405 practices over the study period. There was a significant reduction in admissions over time, from 6.96/100,000 in 2004 to 5.60/100,000 in 2010 (P < 0.001). Deprivation and HF prevalence were risk factors for admission. GP supply and access protected against admission. However, these effects were small and did not explain the large and highly significant annual trend in falling admission rates. CONCLUSIONS: The observed fall in admissions over time cannot be explained by the primary care covariates we included. This analysis suggests that the potential for further significant reduction in emergency HF admissions by improving clinical quality of primary care (as currently measured) may be limited. Further work is required to identify the reasons for the reduction in admissions.

Utility of overnight pulse oximetry and heart rate variability analysis to screen for sleep-disordered breathing in chronic heart failure.

BACKGROUND: Sleep-disordered breathing (SDB) is under diagnosed in chronic heart failure (CHF). Screening with simple monitors may increase detection of SDB in a cardiology setting. This study aimed to evaluate the accuracy of heart rate variability analysis and overnight pulse oximetry for diagnosis of SDB in patients with CHF. METHODS: 180 patients with CHF underwent simultaneous polysomnography, ambulatory electrocardiography and wrist-worn overnight pulse oximetry. SDB was defined as an apnoea-hypopnoea index ≥15/h. To identify SDB from the screening tests, the per cent very low frequency increment (%VLFI) component of heart rate variability was measured with a pre-specified cutoff ≥2.23%, and the 3% oxygen desaturation index was measured with a pre-specified cutoff >7.5 desaturations/h. RESULTS: 173 patients with CHF had adequate sleep study data; SDB occurred in 77 (45%) patients. Heart rate variability was measurable in 78 (45%) patients with area under the %VLFI receiver operating characteristic curve of 0.50. At the ≥2.23% cutoff, %VLFI sensitivity was 58% and specificity was 48%. The 3% oxygen desaturation index was measurable in 171 (99%) patients with area under the curve of 0.92. At the pre-specified cutoff of >7.5 desaturations/h, the 3% oxygen desaturation index had a sensitivity of 97%, specificity of 32%, negative likelihood ratio of 0.08 and positive likelihood ratio of 1.42. Diagnostic accuracy was increased using a cutoff of 12.5 desaturations/h, with sensitivity of 93% and specificity of 73%. CONCLUSIONS: The high sensitivity and low negative likelihood ratio of the 3% oxygen desaturation index indicates that pulse oximetry would be of use as a simple screening test to rule out SDB in patients with CHF in a cardiology setting. The %VLFI component of heart rate variability is not suitable for detection of SDB in CHF.

Breakthrough pain: a qualitative study involving patients with advanced cancer.

CONTEXT: Breakthrough cancer pain is associated with a high burden of physical, psychological and social problems in quantitative studies. Individual experiences of living with breakthrough pain have not been studied. OBJECTIVES: This study aims to explore the individual experience of living with breakthrough cancer pain using a qualitative methodology. METHODS: In depth semi-structured interviews were conducted in ten patients with breakthrough cancer pain, and a qualitative content analysis was performed. RESULTS: The overarching themes that emerged were daily living, communication with health care professionals and management of breakthrough pain. CONCLUSIONS: Recognising the impact of breakthrough pain and the issues expressed by patients regarding communication and medication gives the clinician a framework for assessment and intervention.

Patient and staff perspective of a nurse-led support programme for patients waiting for cardiac surgery: participant perspective of a cardiac support programme.

BACKGROUND: A nurse-led support and education programme for patients waiting for coronary artery bypass surgery was evaluated in a randomised controlled trial of 188 patients at a tertiary centre in the UK. AIM: To add a qualitative perspective to the evaluation by exploring patients' experience while taking part in the trial and staff views of the patients' experience and the intervention. METHODS: A purposive sample of 19 patients was interviewed and the transcriptions read to staff during focus groups. They discussed what they learned from the stories and their own experience of the programme. RESULTS: The patients appreciated support from the nurses but felt communication and physical assessment could be improved. The patients varied in their understanding of the programme and their degree of motivation to improve their health. The staff varied in their approach to preparing patients for surgery. External factors influencing the intervention's impact were length of time on the waiting list and the increasing contribution of local rehabilitation services. CONCLUSION: Staff need to improve communication both between themselves and with the patients. Patients appreciate physical and psychological preparation for surgery, but the waiting period is not the optimal time to address their risk factors for coronary disease.

A randomised controlled trial to evaluate a nurse-led programme of support and lifestyle management for patients awaiting cardiac surgery 'Fit for surgery: Fit for life' study.

BACKGROUND: The 'Fit For Surgery' programme was based on previous studies suggesting improvement in risk factors contributing to coronary disease while patients wait for cardiac surgery. AIM: To evaluate our nurse-led programme in a randomised controlled trial with 188 patients. METHODS: Patients listed for coronary artery bypass surgery with at least one poorly controlled risk factor were randomised to standard care or the intervention which provided lifestyle counselling and preparation for surgery at monthly intervals. Primary outcome measurements were anxiety, blood pressure, cholesterol, length of stay and body mass index. Costs of the intervention were also collected. RESULTS: For both groups blood pressure and total cholesterol improved (Blood pressure mm Hg (Control -9.11 (CI -4.89, -13.33); Intervention -13.02 (CI -8.76, -U17.29) both p<0.01); total cholesterol (Control -0.20 (CI -0.03, -0.37) p=0.02, Intervention -0.18 (CI -0.02, -0.34) p=0.03). However there were no significant differences between the groups. Cost minimization analysis showed that the total costs were less in the intervention group due to fewer admissions (total costs pounds 10,754 (3746) v pounds 13,047 (5835), CI -3743, -843; p=0.002). CONCLUSIONS: The nurse-led programme did not appear to reduce risk factors prior to coronary artery bypass surgery. However, the intervention appears to reduce overall healthcare utilization.