Severity Of Dyspnea Research Articles

Carotid Artery Disease and Lower Extremities Artery Disease in Patients with Chronic Obstructive Pulmonary Disease.

AIM:To assess the frequency of carotid artery disease (CAD) and lower extremities artery disease (LEAD) in patients with chronic obstructive pulmonary disease (COPD) and their relation to the severity of airflow limitation and the level of C-reactive protein (CRP).METHODS:We performed a cross-sectional study including 60 patients with COPD (52 male, 8 female), aged 40 to 80 years, initially diagnosed according to the actual criteria. Also, 30 subjects in whom COPD was excluded, matched to COPD patients by sex, age, body mass index and smoking status, served as controls. All study subjects completed questionnaire and underwent pulmonary evaluation (dyspnea severity assessment, baseline and post-bronchodilator spirometry, gas analyses, and chest X-ray), angiological evaluation by Doppler ultrasonography and measurement of serum CRP level.RESULTS:We found a statistically significant difference between the frequency of carotid plaques in COPD patients as compared to their frequency in controls (65% vs 30%; P = 0.002). The mean value of intima-media thickness (IMT) in COPD patients with CAD was significantly higher than its mean value in controls (0.8 ± 0.2 vs. 0.7 ± 0.2; P = 0.049). IMT value in COPD patients with CAD was significantly related to the degree of airflow limitation, i.e. to the degree of FEV1 decline (P = 0.000), as well as to the serum CRP level (P = 0.001). We found a statistically significant difference between the frequency of COPD patients with LEAD as compared to the frequency of LEAD in controls (78.3% vs 43.3%; P = 0.001). According to the Fontaine classification, COPD patients with LEAD were categorized in the stages I, IIA and IIB (53.3%, 30% and 16.7%, respectively), whereas all controls with LEAD were categorized in the Fontaine stage I. Among COPD patients with LEAD there was significant association between disease severity and clinical manifestations due to the vascular changes (P = 0.001) and serum CRP level (P = 0.001).CONCLUSION:Our findings suggest higher prevalence and higher severity of vascular changes in COPD patients as compared to their prevalence and severity in non-COPD subjects. Prevalence and severity of vascular changes in COPD patients were significantly related to the severity of airflow limitation and serum CRP levels.

Evaluation of compliance of pulmonary hypertension patients to the treatment with inhaled iloprost (Ventavis): results of prospective, multicenter, non-interventional IVENT study

Evaluation of compliance of pulmonary hypertension patients to the treatment with inhaled iloprost (Ventavis): results of prospective, multicenter, non-interventional IVENT study

Multicenter observational prospective study of nivolumab (Nivo) as 2+ line treatment in advanced refractory NSCLC pts: Clinical and quality of life outcomes.

e20567 Background: We aimed to evaluate clinical and quality of life (QoL) outcomes of Nivo as 2+ line treatment in NSCLC pts within expanded access program and real world practice. Methods: Adult pts with advanced refractory NSCLC were enrolled in 11 centers in RF. All the pts received Nivo 3 mg/kg q2w. Tumor response was assessed using RECIST v. 1.1, adverse events (AEs) – NCI CTCAE v3.0. Patients filled out RAND SF-36 and ESAS-R at baseline, 1, 3, 6 and 12 mos after treatment start. Overall survival (OS) and progression-free survival (PFS) curves were evaluated by the Kaplan-Meyer method and compared by the log-rank test. GEE method was used for QoL analysis; χ2 test – for disease control rate (DCR) comparison. Results: The preliminary analysis was performed in the group of 200 pts with median follow-up 7.4 mos (65% – males; median age – 62 y.o.; ECOG 0-1 – 81%; former/current smokers – 70.5%; non squamous NSCLC – 64%; ≥2 lines of previous treatment – 53%, bone mts – 22%). DCR was revealed in 60.3% pts (108/179 pts, median first evaluation – 2.1 mos); 13 pts died before first response evaluation; 8 pts were not evaluated for response at cut-off. DCR was higher in squamous NSCLC (66%, squamous vs 51%, non squamous; χ2 = 4.0, p = .045). Median OS – 11.5 mos (95%CI 8.3–14.7), median PFS – 4.2 mos (95%CI 3.5–4.9). Patients with poor ECOG (ECOG 2-3 vs 0-1: median OS – 5.6 mos vs 12.4 mos, median PFS – 2.7 vs 4.2 mos) and those with bone mts (with mts vs without mts: median OS – 5.0 vs 12.5 mos, median PFS – 2.8 vs 4.1 mos) had worse survival; log-rank p < 0.05. QoL improved during 6 mos of treatment in more than 50% pts; average increase by 60% of mean Integral QoL Index (IQoLI) at different time-points was observed. Upon GEE, IQoLI improvement during 12 mos was revealed (p < .0001). The severity of fatigue and dyspnea, which had the highest burden at base-line, decreased during 6 mos of treatment in more than 50% and 30% pts, consequently. AEs were registered in 32.7% pts (median of Nivo treatment – 2 mos); among them 17 pts had grades 3-4 AEs; 5 pts – SAEs. Conclusions: Preliminary results of this study support the acceptable efficacy and safety of Nivo in NSCLC pts. Nivo treatment leads to meaningful QoL improvement and decrease of symptom burden in this patient population.

Development and internal validation of a multinomial NTCP model for the severity of acute dyspnea after radiotherapy for lung cancer

Background and purposeDyspnea evolution after radiotherapy for lung cancer is complex with potential symptom deterioration and improvement from baseline. We developed and internally validated a multinomial normal tissue complication probability (NTCP) model predicting dyspnea grade. Materials and methodsPatient-reported dyspnea was collected pre-treatment and during 6 months follow-up for 182 stage I–IV lung cancer patients treated with radical (chemo)radiotherapy. Dyspnea changes (ΔDys) from the baseline grade (Dys0) to the follow-up grade (Dys) were evaluated. A multinomial logistic regression model simultaneously predicting 3 grades of Dys (Dys ≥ 3, Dys = 2 and Dys ≤ 1 (reference level)) was optimized. Reference NTCP models predicting Dys ≥ 2 and Dys ≥ 3 risks irrespective of Dys0 were generated for comparison. Models were shrunken and performance was assessed using optimism-corrected AUC (bootstrapping). ResultsRates of ΔDys ≥ 1 (deterioration) and ΔDys ≤ -1 (improvement) at 6 months were 31.9% and 12.6%. Dys ≥ 3, Dys = 2 and Dys ≤ 1 rates were 13.7%, 20.9% and 65.4%, respectively. The multinomial model (combining the risk factors Dys0 and MLD and the protective factor chemotherapy treatment) predicted Dys ≥ 3, Dys = 2 and Dys ≤ 1 with AUC (95% CI) of 0.72 (0.65–0.75) 0.76 (0.72–0.79) and 0.78 (0.74–0.80), respectively. Reference Dys ≥ 2 and Dys ≥ 3 models showed worse AUC: 0.64 (0.59–0.67) and 0.66 (0.50–0.70), respectively. ConclusionsDyspnea grade could be predicted with high accuracy using a multinomial NTCP model, yielding personalized dyspnea symptom improvement and deterioration risks.

Symptom correlates of dyspnea in advanced cancer patients using the Edmonton Symptom Assessment System.

Dyspnea is frequently experienced in advanced cancer patients and is associated with poor prognosis and functional decline. This study used the Edmonton Symptom Assessment System (ESAS) to characterize the relationship between dyspnea and concurrent symptoms experienced by advanced cancer patients. A prospective database was collected and analyzed to extract patient demographics and ESAS scores. Logistic regression analysis and generalized estimating equations (GEE) identified correlations of other ESAS symptoms in three categories: severity of dyspnea (none, mild, moderate, severe), moderate/severe dyspnea (ESAS ≥ 4), and presence of dyspnea (ESAS ≥ 1), at patients' first visit and over time, respectively. Multivariable analysis revealed drowsiness (p = 0.001), and anxiety (p = 0.01) and appetite loss (p = 0.02) were associated with increased severity of dyspnea at first visit. Over time, tiredness (p = 0.02), drowsiness (p = 0.04), nausea (p = 0.02), and anxiety (p = 0.0006) were more likely to experience increased dyspnea severity. Tiredness (p = 0.0003), depression (p = 0.03), and appetite loss (p = 0.003) were significant for moderate/severe dyspnea at first visit. Over multiple visits, tiredness (p < 0.0001), anxiety (p = 0.0008), and appetite loss (p = 0.0008) had higher probabilities of moderate/severe dyspnea. For the presence of dyspnea at the first visit, anxiety (p = 0.03) and drowsiness (p = 0.002) were significantly correlated with an increased frequency of dyspnea. Over time, anxiety (p < 0.0001) and drowsiness (p < 0.0001) remained significant with the addition of nausea (p = 0.0007). The highly interactive relationship between dyspnea and other common cancer symptoms necessitates the development of comprehensive symptom assessments and utilization of multimodal management approaches that consider concurrent symptoms for improved identification and treatment of dyspnea.

Disparities in Geographic Access to Hospital Outpatient Pulmonary Rehabilitation Programs in the United States

For individuals with COPD, pulmonary rehabilitation (PR) improves outcomes in terms of exercise capacity, severity of dyspnea, and health-related quality of life. However, many US patients with COPD do not use PR services. There has been limited research on geographic access to needed health-care services for individuals who live in rural communities in the United States. This study: (1) examines the geographic distribution of hospital-based outpatient PR programs in the US; and (2) compares the organizational characteristics of hospitals that offer PR programs and those that do not. A multistep process supported the determination of whether a hospital provided PR services and included: program directory data from the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) website and websites for AACVPR state affiliates and other COPD-relevant organizations; searches of hospital websites; e-mails with state contacts and other state organizations; and phone calls with hospital staff and state contacts. The study population included all Medicare-certified short-term acute care general medical and surgical hospitals. Data were collected and analyzed from January to November 2018. Medicare Provider of Service and American Hospital association data were used to compare the characteristics of hospitals with and without PR programs, using descriptive and bivariate statistics. 1,776 US counties do not have a hospital outpatient PR program located in a short-term acute care general medical or surgical hospital in the county, including 697 counties that do not have a hospital. The availability of a hospital outpatient PR program varies significantly by county type, hospital type and Census region. Hospitals located in a noncore county, designated as a Critical Access Hospital, or located in the South and the West were less likely to have an outpatient PR program. Significant geographic disparities exist in access to hospital outpatient PR. Potential strategies for addressing these disparities include: increasing clinician and patient awareness of the potential benefits of PR; offering staff training and incentives to supervise and provide PR services; improving Medicare reimbursement rates for PR services; replicating PR programs that have success serving rural areas; expanding cardiac rehabilitation programs to include PR; and assessing the use of telehealth technologies to provide PR in isolated areas.

Clinical importance of sex differences in dyspnea and its sex related determinants in asthma and COPD patients

PurposeThere is an increasing amount of data regarding the influence of sex on dyspnea perception, however, the influence of sex has not been included in clinical guidelines for asthma and chronic obstructive pulmonary disease (COPD). Materials and methodsThe study included 123 clinically stable subjects. Seventy five patients had COPD, of which 70.6% were men and 29.4% were women. Forty-eight subjects had asthma, comprised of 45.8% and 54.2%, men and women, respectively. Dyspnea was assessed with the use of modified Medical Research Council (mMRC) Visual Analogue Scale VAS, and BORG scale. All patients underwent spirometry with a broncho-reversibility test. ResultsThere were no differences in age for neither asthma patients, 56.5 ± 11.6 and 55.0 ± 12.7 (p = 0.5) for males and females, nor for COPD patients, 66.8 ± 9.0 and 66.8 ± 7.7 (p = 0.7) for males and females, respectively. Asthmatic females had more dyspnea than males when assessed with VAS, 1.85 ± 2.24 and 3.84 ± 2.80 (p = 0.01), for males and females, respectively. When assessed with BORGpre 6-MWT, dyspnea results were 0.86 ± 1.83 and 2.43 ± 2.31 (p = 0.005), for males and females, respectively. In the whole group, apart from FEV1 (for mMRC, VAS, BORGpre) and BMI (BORGpost) the severity of dyspnea was related to female sex when assessed with mMRC (OR=2.83; 95%CI: 1.25–6.42) and VAS (OR = 2.17; 95%CI:1.00–4.73). ConclusionsAlthough more apparent in asthma, it was revealed for the first time, that sex has a strong influence on the magnitude of dyspnea perception, both in asthma and COPD. Therefore, sex related dyspnea sensation should probably be included in clinical assessment and patient treatment.

A lung ultrasound score for early triage of elderly patients with acute dyspnea.

Lung ultrasound has value in diagnosing dyspnea. The main objective of this study was to evaluate the accuracy of a modified lung ultrasound (MLUS) score to predict the severity of acute dyspnea in elderly patients. This was an observational single-centre study including patients over age 64 admitted to the emergency department for acute dyspnea with hypoxia. Participants had an early lung ultrasound performed by a dedicated emergency physician, followed by the usual care by a team blinded to the lung ultrasound results. Patients were allocated by disposition to either a critical care (CC) group (patients who needed admission to the intensive care unit [ICU] and/or who died within 48 h) or a standard care group. Among 137 patients analysed (mean age 79 ± 13 years, 74 [54%] women), 43 (31%) were categorized into the CC group. The time taken to obtain the MLUS was 30 ± 22 min. The area under the receiver operating characteristic curve of the MLUS for predicting the CC group was 0.97 (0.92-0.99; p &lt; 0.01) with a cut-off set strictly above 17 for 93% sensitivity (81-99), 99% specificity (94-100), a positive predictive value of 98% (87-100), a negative predictive value of 97% (91-99), a positive likelihood ratio of 86, a negative likelihood ratio of 0.07, and a diagnostic accuracy of 97% (93-99). In a multivariate analysis, the MLUS was the only independent associated factor for the CC group. An early lung ultrasound score can predict the need for ICU admission and/or death within 48 hours in elderly dyspneic patients.

Effect of rituximab on heart involvement in systemic sclerosis

As of now, there has been a great body of data on the use of rituximab (RTM) in systemic sclerosis (SS), mainly on its positive effect on skin fibrosis and lung injury. However, information is still scarce about the effect of RTM on other organs and systems, namely the heart affected by SS.Objective: to assess the time course of changes in the signs of heart involvement in SS patients one year after initiation of RTM therapy.Subjects and methods. The paper gives data on changes in cardiac disorders in 71 patients with SS one year after the prescription of RTM.Results and discussion. The rate of cardiac rhythm and conduction disorders and diastolic dysfunction was unchanged. At the same time, a significant increase in left ventricular ejection fraction (EF) and a reduction in the severity of dyspnea was achieved, which correlated with improved lung function (a significant rise in forced vital capacity). The results of treatment in three patients with predominant heart involvement associated with SS (coronary heart disease and hypertension were ruled out) were considered in detail. These patients displayed pronounced positive changes as increased EF, less severe cardiac arrhythmias, reduced chronic heart failure, better quality of life, as well as the synchronicity of lower disease activity, less skin induction, improved lung function, and stabilized pulmonary artery systolic pressure.Conclusion. RTM in combination with traditional therapy can be considered as a potentially effective drug for the treatment of heart involvement in SS.

Chronic obstructive pulmonary disease patients electronic register analysis: the effectiveness of patient's dynamic follow up and evaluation of treatment program.

The aim of the study. To estimate the effectiveness of clinical patients register implementation as well as to analyze different treatment and prophylactic programs on chronic obstructive pulmonary disease (COPD) patients' structure. The COPD patient's register consists of 4257 cases. Spirometrical data were evaluated. Dynamic follow was performed on 567 COPD patients. Bronchodilator's therapy was estimated as well as combined inhaled corticosteroid/ long acting β2-agonist medications and vaccination against pneumococcal infection. Computer program "Electronic polyclinic" proposed by the authors of this article is effective in precision of diagnostic decision making in cohort study, dynamic follow up after clinical symptoms, evaluation of instrumental and laboratory results, prophylactics and treatment effectiveness, "clinical patients registers" automatic formation using syndrome or nosological principle, checking the COPD patients in the group of those with bronchial obstruction. Positive effects of long-acting bronchodilator treatment on COPD exacerbation decreasing and more expressed effect of inhaled corticosteroid/ long acting β2-agonists were confirmed. More interesting result was influence of vaccination against pneumococcal infection PCV13 (polyvalent conjugated vaccine) on exacerbation frequency and dyspnea severity.

Clinical impact of body composition phenotypes in patients with COPD: a retrospective analysis.

Abnormal body composition is an independent determinant of COPD outcomes. To date, it is already known that patient stratification into body composition phenotypes are associated with important outcomes, such as exercise capacity and inflammation, but there are no data comparing physical activity and muscle strength among these phenotypes. Thus, the aim of this study was to compare clinical characteristics and physical function in patients with COPD stratified into body composition phenotypes. Two-hundred and seventy stable COPD patients were classified according to the 10th and 90th percentiles of sex-age-BMI-specific reference values for fat-free and fat mass indexes into four groups: Normal body composition (NBC), Obese, Sarcopenic, and Sarcopenic-obese (SO). Patients underwent assessment of exercise capacity, peripheral and respiratory muscle strength, physical activity, dyspnea severity, functional status, and symptoms of anxiety and depression. The prevalence of patients classified as NBC, Obese, Sarcopenic, and SO was 39%, 13%, 21%, or 27%, respectively. SO presented lower 6MWT compared with NBC (P < 0.05). Sarcopenic and SO groups presented worse muscle strength compared with NBC (P < 0.05). Sarcopenic group presented more time in moderate-to-vigorous physical activity compared to all other groups (P < 0.05) and less sedentary time when compared with NBC and obese groups (P < 0.05). There were no differences regarding dyspnea severity, functional status, and symptoms of anxiety and depression (P > 0.16). Sarcopenic and SO groups had, respectively, 7.8 [95% CI: 1.6-37.7] and 9.5 [2.2-41.7] times higher odds to have a 6MWT equal or lower to 350 meters. Body composition phenotypes are associated with physical function in patients with COPD. Sarcopenic-obese patients were the most impaired.

Influence of Particulate Matter during Seasonal Smog on Quality of Life and Lung Function in Patients with Chronic Obstructive Pulmonary Disease

The impact of outdoor air pollution on the quality of life (QoL) of chronic obstructive pulmonary disease (COPD) patients, as measured by the COPD assessment test (CAT) questionnaire, is limited. The aim of this study was to determine the impact of a short-term increase in outdoor particulate matter in which the particles are less than 10 microns in diameter (PM10) during a seasonal smog period on QoL, symptoms, and lung function in COPD patients. This prospective observational study was conducted at Chiang Dao Hospital, Chiang Mai, Thailand between March and August 2016. Measurement of QoL, severity of dyspnea, forced vital capacity (FVC), and forced expiratory volume in the first second (FEV1) were performed at both high and low PM10 periods. Fifty-nine patients met the inclusion criteria for enrollment into the study, with the mean age being 71.5 ± 8.0 years. Total CAT score, but not mMRC score, was statistically higher during the high PM10 period. The two lung function parameters, FVC and FEV1, were significantly lower at the high PM10 compared to the low PM10 period. We concluded that exposure to PM10 during the seasonal smog period resulted in short-term negative impact on the quality of life and lung function in COPD patients.

Assessment of the respiratory muscles strength at various stages of ischemic stroke

To assess the power of RM in patients with IS at different stages of the disease. Power characteristics of RM of 56 patients with IS with different severity of the disease were examined after 2-4, 5-6 and 13-14 months of IS onset. Maximum inspiratory (MIP) and expiratory (MEP) pressures in the oral cavity, maximum rate of pressure development (MRPD) and sniff nasal inspiratory pressure (SNIP) were determined. A decrease in expiratory and inspiratory RM strength was shown in the early and late periods of IS, severity of which was depended on the severity of neurologic disorders. The bronchial obstruction resulted in RM dysfunction. Expiratory muscles weakness only was observed in the remote period while one third of patients had obstructive disorders of breathing. The functional activity of different RM at different IS stages was correlated with the smoking index, forced expiratory volume in the first second, forced vital capacity, skeletal muscles mass and severity of dyspnea, asthenia and disturbances of vital functions. These differences were the most obvious in elderly group of people. RM power examination of IS patients is an important mechanism of early diagnosis and rehabilitation.

Impact of modified pulmonary rehabilitation on morbidity due to chronic obstructive pulmonary disease in rural area

Background: Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease which leads to a significant reduction in the quality of life of patients. Pulmonary rehabilitation (PR) is a multidisciplinary intervention to improve the quality of life of COPD patients. In our study, we have tried to see the effect of modified PR program to improve the quality of life in COPD patients of rural area with limited resources. Objective: The aim of this study was to study the effect of modified PR on the lung functions and quality of life of COPD patients. Materials and Methods: It was an analytical and interventional study where 30 patients of COPD were included. The total duration of study was of 12 weeks which was divided in two phases. The first phase (pharmacotherapy-[PT] Phase) comprises 6 weeks when patients were given only PT as per the Global Initiative for chronic obstructive lung disease guidelines, and subsequent phase (PT plus PR phase) comprises the next 6 weeks when patients were provided PT plus modified PR which included once a week supervised chest physiotherapy at hospital, dietary advice, and psychiatric evaluation followed by the same advice at home and were checked through the telephone weekly. Between the two phases, the severity of dyspnea (COPD assessment test [CAT] score and Modified Medical Research Council [MMRC] grade), quality of life (Saint George questionnaires [SGRQs]), psychological aspects (Patient Health Questionnaire 9 [PHQ9]), and lung functions (spirometry – forced expiratory volume in 1 s [FEV1], forced vital capacity [FVC], and FEV1/FVC) and exercise capacity (6-min walk test [6MWT]) were compared and analyzed. Results: We found a significant improvement after PR in SGRQ (P ≤ 0.001), CAT score (P ≤ 0.001), MMRC grade (P ≤ 0.001), PHQ9 score (P ≤ 0.001), and 6MWT (P ≤ 0.001) but no statistical significant improvement in spirometry parameters. Conclusion: Modified home-based PR program can be an effective therapy to improve quality of life of COPD patients in rural areas with limited resources.

Modern Possibilities of Metabolic Therapy in Improving the Quality of Life in Patients with Postinfarction Cardiosclerosis

95 patients with postinfarction cardiosclerosis and angina pectoris II and III functional classes were examined. The study included patients who refused intervention revascularization. The main group included 48 patients who were added taurine (Dibikor 750 mg / day) to enhance the effect of basic therapy, and the comparison group included 47 patients who received standard therapy and placebo. The duration of treatment was 3 months. The study demonstrated positive effects of taurine that was confirmed by significant improvements in the following indicators: subjective status, indicators of the Seattle questionnaire, echocardiographic parameters, cardiac arrhythmias. There was a decrease in the severity of fatigue by 2 times, a decrease in the intensity of complaints of palpitations by 72.3%, a decrease in the severity of dyspnea by 30.0% and a severity of pain in the heart area by 50%. Indicators of most scales of the Seattle questionnaire in patients of the main group at the end of the study significantly exceeded (p <0.05) the corresponding values in patients of the comparison group. In patients whose treatment was used taurine, a significant improvement in inotropic function was noted (the ejection fraction is significantly higher than in the comparison group, respectively 56.0 ± 1.8 and 53.5 ± 1.1%, p <0,05), the bathmotropic and chronotropic myocardial functions improved, which was shown by a 45% decrease in the number of ventricular extrasystoles, a 57% decrease in the frequency of supraventricular heart rhythm disturbances, a decrease in the incidence rate of ST segment depression (in the main group the number of episodes was significantly lower than p <0,05 than in the comparison group). The use of taurine in the complex treatment of patients with exertional angina, after suffering a myocardial infarction, is safe and not accompanied by side effects. Taurine is advisable to include in the complex treatment of patients with exertional angina pectoris, who have had a myocardial infarction in order to improve the myocardial inotropic function, enhance the antiarrhythmic and lipid-lowering effects of the basic therapy. The recommended dose of Taurine is 750 mg per day as a supplement to standard therapy with a duration of therapy of at least 3 months.

Primary intra-aortic balloon support versus inotropes for decompensated heart failure and low output: a randomised trial.

The haemodynamic effects of primary implantation of an intra-aortic balloon pump (IABP) versus inotropes in decompensated heart failure and low output (DHF-LO), but without an acute coronary syndrome, have not been investigated. We therefore aimed to investigate the effect of primary IABP implantation as compared to inotropes on haemodynamics in DHF-LO with no acute ischaemia. Patients (n=32) with DHF-LO despite IV diuretics were randomised to primary 50 mL IABP or inotropes (INO: enoximone or dobutamine). The primary endpoint was the improvement of organ perfusion assessed by ∆ mixed-venous oxygen saturation (SvO2) at 3 hours; secondary endpoints included ∆ cardiac power output (CPO), NT-proBNP proportional change, cumulative fluid balance and ∆ dyspnoea severity score, all at 48 hours. Data are presented as median (IQR). Patients were 60 (48-69) years old and 72% were male. Baseline SvO2 was 44 (39-53)%. ∆SvO2 was higher in the IABP group (+17 [+9; +24] vs. +5 [+2; +9]%, p<0.05). IABP patients had a higher ∆CPO, a greater relative reduction in NT-proBNP, a more negative cumulative fluid balance, and a greater reduction in dyspnoea severity score. There were no IABP-related serious adverse events (SAEs). Thirty-day mortality was 23% (IABP) vs. 44% (INO). Primary circulatory support by IABP showed a significant increase in improved organ perfusion assessed by SvO2.

Determining the minimal clinically important difference for the PEmbQoL questionnaire, a measure of pulmonary embolism‐specific quality of life

Essentials The minimal clinically important difference (MCID) for PEmbQoL has not yet been determined. We estimated the MCID for PEmbQoL and its subscales via anchor- and distribution-based approaches. Our results indicate that MCID for PEmbQoL appears to be 15 points. Our work enables interpretation of changes or differences in PEmbQoL. SUMMARY: Background Pulmonary embolism (PE) reduces quality of life (QOL). The PEmbQoL questionnaire, a PE-related QOL measure, was recently developed and validated and has been used to quantify disease-specific QOL in clinical studies of patients with PE. However, to date, interpretation of PEmbQoL scores has been limited by a lack of information on the minimal clinically important difference (MCID) of this measure. Objective To determine the MCID for PEmbQoL and its subscales using anchor-based and distribution-based approaches. Methods We analyzed data from the ELOPE Study, a prospective, multicenter cohort study of long-term outcomes after a first episode of acute PE. At baseline and 1, 3, 6 and 12months after PE, we measured generic QOL (SF-36), PE-specific QOL (PEmbQoL) and dyspnea severity (UCSD Shortness of Breath Questionnaire). We used time-varying repeated-measures mixed-effect models to estimate anchor-based MCID and effect sizes to estimate distribution-based MCID. Results Eighty-two patients participated in this sub-study. Their mean age was 49.4years, 60% were male and 84% had PE diagnosed in an outpatient setting. Using both anchor- and distribution-based approaches, the MCID for PEmbQoL appears to be 15 points. Based on this MCID, 42%, 59%, 66% and 75% of patients experienced at least one MCID unit of improvement in PEmbQoL from baseline to 1, 3, 6 and 12months, respectively. Conclusion Our results provide new information on the MCID of PEmbQoL, a PE-specific QOL questionnaire that can be used by researchers and clinicians to measure and interpret changes in PE-specific QOL over time, or as an outcome in clinical trials.

Disease awareness in patients with COPD: measurement and extent.

BackgroundPatient awareness of COPD refers to knowledge and acceptance of the disease and its treatment. Although it is relevant to management and outcomes, the disease awareness of patients is poorly investigated, and no validated questionnaires are currently available. We aimed to develop the novel Disease Awareness in COPD Questionnaire (DACQ), which was validated in relation to demographic and clinical features, in patients participating in the SATisfaction and Adherence to COPD Treatment (SAT) study.MethodsDACQ was developed according to a list of items regarding the patient’s knowledge, acceptance, and perception of COPD as well as of treatment needs. The questionnaire was validated by assessing internal structure and consistency, correlations with other patient-reported outcomes, and stability over time. Furthermore, the extent of disease awareness of patients enrolled in the SAT study was assessed by using DACQ, and correlations with demographic and clinical features were evaluated.ResultsDACQ was composed of four domains. Overall reliability and stability over time were adequate; correlations between DACQ and other tools measuring different constructs (ie, treatment satisfaction, illness perception, impact of COPD symptoms on daily life, and dyspnea severity) were, as expected, more limited. In the enrolled patient sample, a suboptimal level of disease awareness (<70%) was detected, especially in terms of disease acceptance and perception. Disease knowledge was positively associated with COPD severity, while the impact of symptoms on daily life was negatively associated with disease acceptance, awareness of treatment needs, and overall awareness.ConclusionDACQ proved to be a reliable tool to assess awareness in COPD patients. Awareness of COPD patients need to be improved.Clinical trial registrationClinicalTrials.gov ID# NCT02689492.

Exploratory Study Examining A Composite Index Measuring Sarcopenia and Anxiety in COPD – Relationship with Frailty, Disease Severity, Exertional Dyspnea and Quality of Life.

Recent models of palliative care for COPD shifted from care-provision at the end of life, to emphasizing early integration when symptom burden significantly impairs quality of life (QOL). Sarcopenia was recently shown to associate with reduced exercise capacity, functional performance and health status. Similarly, anxiety is related with poorer QOL, more exacerbations, more re-hospitalizations, prolonged length of stay and higher mortality in COPD. We hypothesize that a bi-dimensional index comprising measurement of sarcopenia and anxiety – SARA score, can identify frailer patients with high symptom burden and significantly diminished QoL, for early palliative care. A feasibility study comprising 33 subjects with stage 2-4 COPD are recruited. The SARA scale comprises the SARC-F questionnaire that measures sarcopenia, as well as the anxiety domain of the Hospital Anxiety and Depression Scale (HADS). A composite score derived from the two indices forms the SARA score that ranges 2-6 points. Correlational analyses examined relationships between SARA and markers of frailty (Fried Index, FRAIL questionnaire), exertional dyspnea (eMRCD scale), QoL (Chronic Respiratory Questionnaire, CRQ) and disease severity (CAT score). Univariate analyses were employed to compare the mean score of the above variables between 2 groups (SARA 3 vs SARA <3). Subjects had a mean age of 70. 25 (75.8%) have stage 3 and 4 COPD. SARA score demonstrates moderate correlation with eMRCD, CAT, FRAIL and Fried scores, as well as the fatigue, emotional function and mastery domain of the CRQ (all p<0.05). Additionally, it highly correlated with the depression domain of HADS (HADS-D) (p<0.001). Univariate analyses demonstrate that SARA 3 is significantly associated with greater eMRCD, CAT score, FRAIL, Fried’s index, HADS-D and the three domain of CRQ listed above. Preliminary analysis suggest that the SARA may help identify subjects with greater frailty, more severe disease, higher psychological morbidity and poorer QoL, for early palliative multi-disciplinary interventions.

Cost-effectiveness analysis of umeclidinium bromide/vilanterol 62.5/25 mcg versus tiotropium/olodaterol 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease: a Spanish National Healthcare System perspective

BackgroundA head-to-head study demonstrated the superiority of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg on trough forced expiratory volume in 1 s (FEV1) versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD). This analysis evaluated the cost effectiveness of UMEC/VI versus TIO/OLO from a Spanish National Healthcare System perspective, using data from this study and Spanish literature.MethodsThis analysis was conducted from the perspective of the Spanish National Healthcare System with a 3-year horizon as base case. A disease progression model using a linked risk equation approach was used to estimate disease progression and associated healthcare costs, and quality-adjusted life years (QALYs). The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study was used to develop the statistical risk equations for clinical endpoints, and costs were calculated using a health state approach (by dyspnea severity). Utilities for QALY calculation were estimated using patient baseline characteristics within a regression fit to Spanish observational data. Treatment effect, expressed as change from baseline in FEV1 was obtained from the head-to-head study and used in the model (UMEC/VI minus TIO/OLO difference: + 52 mL [95% confidence interval: 28, 77]). Baseline patient characteristics were sourced from Spanish literature or the head-to-head study if unavailable. A scenario analysis using only the intent-to-treat (ITT) population from the head-to-head study, and sensitivity analyses (including probabilistic sensitivity analyses), were conducted. Direct healthcare costs (2017 Euro) were obtained from Spanish sources and costs and benefits were discounted at 3% per annum.ResultsUMEC/VI was associated with small improvements in QALYs (+ 0.029) over a 3-year time horizon, compared with TIO/OLO, alongside cost savings of €393/patient. The ITT scenario analysis and sensitivity analyses had similar results. All probabilistic simulations resulted in UMEC/VI being less costly and more effective than TIO/OLO.ConclusionUMEC/VI dominated TIO/OLO (more effective and less expensive). These results may aid payers and decision-makers in Spain when making judgements on which long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) treatments can be considered cost effective in Spain.