Economic Burden Associated With Management of Paradoxical Vocal Fold Motion Disorder.

OBJECTIVES: Paradoxical vocal fold movement (PVFM) is often misdiagnosed as asthma and tends to have a prolonged time to diagnosis. Study aims were to estimate the time from dyspnea onset to PVFM diagnosis, to estimate associated pre- and postdiagnosis direct and indirect healthcare cost, and to compare the cost of postdiagnosis care among patients who did and did not undergo standard-of-care speech therapy. METHODS: Patients diagnosed with PVFM were identified retrospectively. Time from dyspnea symptom onset to diagnosis was measured. Direct costs consisting of office visits, procedures, and prescribed pharmaceuticals before and after diagnosis were calculated. Indirect costs associated with lost wages related to healthcare were also estimated. Costs for patients who initiated versus did not initiate speech therapy and who had successful versus unsuccessful therapy were compared. RESULTS: Among 110 patients, median time from dyspnea onset to PVFM diagnosis was 33 months (interquartile range [IQR] 5-60). Direct and indirect prediagnosis median costs were $8,625 (IQR $1,687-$35,812) and $736 (IQR $421-$1,579) while first year following dyspnea symptom onset median direct and indirect costs were $1,706 (IQR $427-$7,118) and $315 (IQR $131-$631). Median direct and indirect costs of care in the postdiagnosis year were $2,062 (IQR $760-$11,496) and $841 (IQR $631-$1,261). Pharmaceuticals were predominant cost drivers in all time periods. Of those who completed speech therapy, 85% had breathing symptom improvement while incurring significant cost savings compared to those whose symptoms persisted. CONCLUSION: Costs of care leading to diagnosis of PVFM are substantial. More efficient methods of identifying patients with PVFM are essential to reduce prolonged time to diagnosis and associated costs. LEVEL OF EVIDENCE: NA Laryngoscope, 132:142-147, 2022.

Cost-effectiveness of sustained-release morphine for refractory breathlessness in COPD: A randomized clinical trial.

BACKGROUND: Chronic breathlessness is a frequent symptom in advanced Chronic Obstructive Pulmonary Disease (COPD) and has major impact on quality of life, daily activities and healthcare utilization. Morphine is used as palliative treatment of chronic breathlessness. The aim is to analyze cost-effectiveness of regular, low-dose morphine in patients with advanced COPD from a healthcare and societal perspective. METHODS: In a randomized controlled trial, participants with advanced COPD were assigned to 10 mg regular, oral sustained-release morphine or placebo twice daily for four weeks. Quality of life (COPD Assessment Test; CAT), quality-adjusted life years (QALY's; EQ-5D-5L), healthcare costs, productivity, and patient and family costs were collected. Incremental cost-effectivity ratio's (ICERs) using healthcare costs and CAT scores, and incremental cost-utility ratio's (ICURs) using societal costs and QALY's were calculated. RESULTS: Data of 106 of 124 participants were analyzed, of which 50 were in the morphine group (mean [SD] age 65.4 [8.0] years; 58 [55%] male). Both ICER and ICUR indicated dominance for morphine treatment. Sensitivity analyses substantiated these results. From a healthcare perspective, the probability that morphine is cost-effective at a willingness to pay €8000 for an minimal clinically important difference of 2 points increase in CAT score is 63%. From a societal perspective, the probability that morphine is cost-effective at a willingness to pay €20,000 per QALY is 78%. CONCLUSION: Morphine for four weeks is cost-effective regarding the healthcare and the societal perspective. To estimate the long-term costs and effects of morphine treatment, a study of longer follow-up should be performed. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02429050).

Determinants of healthcare utilization and costs in COPD patients: first longitudinal results from the German COPD cohort COSYCONET.

Background: In light of overall increasing healthcare expenditures, it is mandatory to study determinants of future costs in chronic diseases. This study reports the first longitudinal results on healthcare utilization and associated costs from the German chronic obstructive pulmonary disease (COPD) cohort COSYCONET. Material and methods: Based on self-reported data of 1904 patients with COPD who attended the baseline and 18-month follow-up visits, direct costs were calculated for the 12 months preceding both examinations. Direct costs at follow-up were regressed on baseline disease severity and other co-variables to identify determinants of future costs. Change score models were developed to identify predictors of cost increases over 18 months. As possible predictors, models included GOLD grade, age, sex, education, smoking status, body mass index, comorbidity, years since COPD diagnosis, presence of symptoms, and exacerbation history. Results: Inflation-adjusted mean annual direct costs increased by 5% (n.s., €6,739 to €7,091) between the two visits. Annual future costs were significantly higher in baseline GOLD grades 2, 3, and 4 (factors 1.24, 95%-confidence interval [1.07-1.43], 1.27 [1.09-1.48], 1.57 [1.27-1.93]). A history of moderate or severe exacerbations within 12 months, a comorbidity count >3, and the presence of dyspnea and underweight were significant predictors of cost increase (estimates ranging between + €887 and + €3,679, all p<0.05). Conclusions: Higher GOLD grade, comorbidity burden, dyspnea and moderate or severe exacerbations were determinants of elevated future costs and cost increases in COPD. In addition we identified underweight as independent risk factor for an increase in direct healthcare costs over time.

The contribution of symptoms and comorbidities to the economic impact of COPD: an analysis of the German COSYCONET cohort.

Background: Although patients with COPD often have various comorbidities and symptoms, limited data are available on the contribution of these aspects to health care costs. This study analyzes the association of frequent comorbidities and common symptoms with the annual direct and indirect costs of patients with COPD. Methods: Self-reported information on 33 potential comorbidities and symptoms (dyspnea, cough, and sputum) of 2,139 participants from the baseline examination of the German COPD cohort COSYCONET was used. Direct and indirect costs were calculated based on self-reported health care utilization, work absence, and retirement. The association of comorbidities, symptoms, and COPD stage with annual direct/indirect costs was assessed by generalized linear regression models. Additional models analyzed possible interactions between COPD stage, the number of comorbidities, and dyspnea. Results: Unadjusted mean annual direct costs were €7,263 per patient. Other than COPD stage, a high level of dyspnea showed the strongest driving effect on direct costs (+33%). Among the comorbidities, osteoporosis (+38%), psychiatric disorders (+36%), heart disease (+25%), cancer (+24%), and sleep apnea (+21%) were associated with the largest increase in direct costs (p<0.01). A sub-additive interaction between advanced COPD stage and a high number of comorbidities reduced the independent cost-driving effects of these factors. For indirect costs, besides dyspnea (+34%), only psychiatric disorders (+32%) and age (+62% per 10 years) were identified as significant drivers of costs (p<0.04). In the subsequent interaction analysis, a high number of comorbidities was found to be a more crucial factor for increased indirect costs than single comorbidities. Conclusion: Detailed knowledge about comorbidities in COPD is useful not only for clinical purposes but also to identify relevant cost factors and their interactions and to establish a ranking of major cost drivers. This could help in focusing therapeutic efforts on both clinically and economically important comorbidities in COPD.

Clinical and economic burden of dyspnea and other COPD symptoms in a managed care setting.

PURPOSE: The degree to which symptoms such as dyspnea affect patients with COPD is individualized. To address the gap between clinical symptom measures and self-perceived disease burden, we investigated the symptom status of adult patients with COPD and followed with an administrative claims analysis of health care resource utilization and costs. METHODS: This was a hybrid US observational study consisting of a cross-sectional patient survey followed by a retrospective analysis of administrative claims data. The primary COPD symptom measures were the modified Medical Research Council (mMRC) Dyspnea scale and the COPD Assessment Test (CAT). RESULTS: A total of 673 patients completed the survey. Of these, 65% reported mMRC grades 0-1 (low symptomatology) and 35% reported mMRC grades 2-4 (high symptomatology); 25% reported CAT score <10 (low symptomatology) and 75% reported CAT score ≥10 (high symptomatology). More patients with high symptomatology (by either measure) had at least one COPD-related inpatient hospitalization, emergency room visit, physician office visit, or other outpatient services, and filled at least one COPD-related prescription medication vs patients with low symptomatology. COPD-related costs were higher for patients with high symptomatology than patients with low symptomatology. In a multivariate analysis, COPD-related costs were also higher in patients reporting severe symptoms. CONCLUSION: Patients with high COPD symptomatology utilized more health care resources and had higher COPD-related health care costs during the 6-month post-survey period than patients with low symptomatology.

Emergency Health Care Professionals' Understanding of the Costs of Care in the Emergency Department.

BACKGROUND: Efficiency and fiscal responsibility are important to the equal, safe, and effective delivery of care in the emergency department, where all presenting patients must be evaluated for emergent conditions. Health care professionals' understanding of the costs of care is a first step to developing rational approaches for the efficient distribution of the finite resources hospitals and emergency departments have at their disposal to reduce costs to patients and health care systems. OBJECTIVE: To determine emergency department health care professionals' knowledge of the costs to patients of routine care delivered in the emergency department. METHODS: An internet-based survey of currently practicing emergency medicine health care professionals with various levels of training (physicians, residents, physician assistants, and nurse practitioners) was conducted to evaluate their ability to identify the cost of care for 3 common presentations to the emergency department: abdominal pain, dyspnea, and sore throat. RESULTS: Four hundred forty-one emergency medicine health care professionals participated. In the 3 cases presented, correct costs were determined by 43.0%, 32.0%, and 40.1% of participants, respectively. Geographic region was not related to cost determination. Larger institution size was related to greater cost chosen (P=.01). Higher level of training was significantly correlated with perceived understanding of cost (P<.001); however, it was not related to accurate cost assessment in this study. CONCLUSION: Emergency medicine health care professionals have an inadequate understanding of the costs associated with care routinely provided in the emergency department.

Regadenoson versus Dipyridamole: A Comparison of the Frequency of Adverse Events in Patients Undergoing Myocardial Perfusion Imaging.

STUDY OBJECTIVE: To compare the frequency of adverse events in patients undergoing myocardial perfusion imaging (MPI) with either regadenoson or dipyridamole. DESIGN: Single-center, retrospective cohort study. SETTING: Large community teaching hospital. PATIENTS: A total of 568 adults who underwent single-photon emission tomography MPI with either regadenoson (284 patients) or dipyridamole (284 patients) as a vasodilator agent, following an institution conversion from regadenoson to dipyridamole in the MPI protocol on July 15, 2013, for cost-saving purposes. MEASUREMENTS AND MAIN RESULTS: Data were collected from the patients' electronic medical records. The primary endpoint was the composite occurrence of any documented adverse event in each group. Secondary endpoints were individual components of the primary endpoint, reason for termination of the MPI examination (protocol completion or premature end due to an adverse event), use of an interventional agent to an treat adverse event, and cost-related outcomes. A higher proportion of patients in the regadenoson group experienced an adverse event than those who received dipyridamole (84.9% vs 56.7%, p<0.0001). None of the patients in either group required early MPI study termination due to an adverse event. No significant differences were noted between groups regarding use of aminophylline or other interventions to treat adverse events. The overall drug cost savings in the postconversion dipyridamole group was $51,526. CONCLUSION: Dipyridamole was associated with fewer adverse events than regadenoson in patients undergoing MPI. Dipyridamole offers a safe and cost-effective alternative to regadenoson for cardiac imaging studies.

Variations in the cost of formal and informal health care for patients with advanced chronic disease and refractory breathlessness: A cross-sectional secondary analysis.

BACKGROUND: Refractory breathlessness in advanced chronic disease leads to high levels of disability, anxiety and social isolation. These result in high health-resource use, although this is not quantified. AIMS: To measure the cost of care for patients with advanced disease and refractory breathlessness and to identify factors associated with high costs. DESIGN: A cross-sectional secondary analysis of data from a randomised controlled trial. SETTING/PARTICIPANTS: Patients with advanced chronic disease and refractory breathlessness recruited from three National Health Service hospitals and via general practitioners in South London. RESULTS: Of 105 patients recruited, the mean cost of formal care was £3253 (standard deviation £3652) for 3 months. The largest contributions to formal-care cost were hospital admissions (>60%), and palliative care contributed <1%. When informal care was included, the total cost increased by >250% to £11,507 (standard deviation £9911). Increased patient disability resulting from breathlessness was associated with high cost (£629 per unit increase in disability score; p = 0.006). Increased breathlessness on exertion and the presence of an informal carer were also significantly associated with high cost. Patients with chronic obstructive pulmonary disease tended to have higher healthcare costs than other patients. CONCLUSION: Informal carers contribute significantly to the care of patients with advanced disease and refractory breathlessness. Disability resulting from breathlessness is an important clinical cost driver. It is important for policy makers to support and acknowledge the contributions of informal carers. Further research is required to assess the clinical- and cost-effectiveness of palliative care interventions in reducing disability resulting from breathlessness in this patient group.

Birmingham COPD Cohort: a cross-sectional analysis of the factors associated with the likelihood of being in paid employment among people with COPD.

BACKGROUND: Employment rates among those with chronic obstructive pulmonary disease (COPD) are lower than those without COPD, but little is known about the factors that affect COPD patients' ability to work. METHODS: Multivariable analysis of the Birmingham COPD Cohort Study baseline data was used to assess the associations between lifestyle, clinical, and occupational characteristics and likelihood of being in paid employment among working-age COPD patients. RESULTS: In total, 608 of 1,889 COPD participants were of working age, of whom 248 (40.8%) were in work. Older age (60-64 years vs 30-49 years: odds ratio [OR] =0.28; 95% confidence interval [CI] =0.12-0.65), lower educational level (no formal qualification vs degree/higher level: OR =0.43; 95% CI =0.19-0.97), poorer prognostic score (highest vs lowest quartile of modified body mass index, airflow obstruction, dyspnea, and exercise (BODE) score: OR =0.10; 95% CI =0.03-0.33), and history of high occupational exposure to vapors, gases, dusts, or fumes (VGDF; high VGDF vs no VGDF exposure: OR =0.32; 95% CI =0.12-0.85) were associated with a lower probability of being employed. Only the degree of breathlessness of BODE was significantly associated with employment. CONCLUSION: This is the first study to comprehensively assess the characteristics associated with employment in a community sample of people with COPD. Future interventions should focus on managing breathlessness and reducing occupational exposures to VGDF to improve the work capability among those with COPD.

Prevalence and burden of dyspnoea among COPD patients in Japan.

BACKGROUND AND AIMS: Dyspnoea is the most common symptom of chronic obstructive pulmonary disease (COPD) significantly affecting activity, impairing patients' well-being and contributing to the economic burden of COPD. The objective of this study was to estimate the prevalence of dyspnoea and its impact on COPD management costs in Japan. METHODS: A cross-sectional survey was conducted among 82 internal medicine physicians and 85 respiratory specialists representing 420 patients with COPD in Japan. Information was collected on demographic and clinical characteristics, dyspnoea (mMRC scale), and healthcare resource use. Dyspnoea prevalence was estimated among all patients and those on specific COPD treatments. The economic burden was derived from two cohorts based on their level of dyspnoea that were matched by propensity scores balancing their demographic and disease burden characteristics. RESULTS: Moderate-severe dyspnoea (mMRC score ≥ 2) was reported by 37.5% of COPD patients and ranging from 21.5% among patients treated with a mono bronchodilator to 59.8% among patients treated with triple therapy. Descriptive analysis showed that dyspnoeic patients have higher annual costs attributable to consultations (€2999 vs. €1906), medications (€1139 vs. €716), exacerbations (€674 vs. €36), other resources (€1789 vs. €140) and in total (€6348 vs. €2797) (p < 0.0001 for all comparisons) compared to patients with mild or no dyspnoea (mMRC score < 2). The total costs remained significantly higher in a propensity-matched cohort adjusted for severity and cardiovascular comorbidity [€6776.1 vs. €4461.3, p = 0.0236]. CONCLUSION: Moderate-severe dyspnoea is common among consulting COPD patients in Japan and is a significant cost driver for the healthcare system.

The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial.

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

Comparison of healthcare resource utilization and costs in patients hospitalized for acute coronary syndrome managed with percutaneous coronary intervention and receiving prasugrel or ticagrelor.

OBJECTIVE: To compare healthcare resource utilization (HCRU) and healthcare costs in patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI) and treated with prasugrel or ticagrelor. METHODS: Hospital charge master data were used to identify ACS-PCI patients aged ≥ 18 years with ≥ 1 in-hospital claim for prasugrel or ticagrelor between August 1, 2011-April 30, 2013. Treatment groups were propensity matched for baseline and index hospitalization characteristics. HCRU and costs were assessed through 90-days post-discharge. Costs were determined based on hospital-specific cost-to-charge ratios and adjusted to 2013 US dollars. RESULTS: Before matching, ticagrelor patients were older, more-often female, and had increased cardiovascular (CV) and bleeding risks compared with prasugrel patients. Propensity-matched length of index hospital stay (4.7 vs 4.9 days, p = 0.23) and risk for all-cause [30-day: relative risk (RR) = 0.86; 95% CI = 0.73-1.0; 90-day: RR = 0.90; 95% CI = 0.80-1.0, and CV-related (30-day: RR = 0.77; 95% CI = 0.59-1.0; 90-day: RR = 0.89; 95% CI = 0.73-1.1) re-hospitalizations did not significantly differ between prasugrel and ticagrelor, respectively. Compared to ticagrelor, the propensity-matched risk of re-hospitalization for myocardial infarction (MI) (30-day: RR = 0.39; 95% CI = 0.21-0.75; 90-day: RR = 0.53; 95% CI = 0.34-0.81) and an outpatient medical encounter for dyspnea (30-day: RR = 0.49; 95% CI = 0.33-0.74; 90-day: RR = 0.60; 95% CI = 0.46-0.80) were significantly lower for prasugrel patients, with no significant differences in bleeding encounters between groups (30-day: RR = 0.87; 95% CI = 0.54-1.40; 90-day: RR = 1.0; 95% CI = 0.71-1.50). Matched total healthcare costs were not significantly different between groups during the index hospitalization ($36,011 vs $37,247, p = 0.21), 30-days post-discharge ($2007 vs $2522, p = 0.48), 90-days post-discharge ($4564 vs $5242, p = 0.49), and aggregate of the index hospitalization through 90-day follow-up ($40,576 vs $42,494, p = 0.09) timeframes. CONCLUSIONS: Re-hospitalization for MI and outpatient encounters for dyspnea were lower in prasugrel treated than in ticagrelor treated ACS-PCI patients up to 90-days post-index hospitalization discharge, with no difference in bleeding encounters or healthcare costs between the two populations. This data supports the utility of prasugrel in routine clinical practice. These findings should be considered within limitations of observational research.

Relation of dyspnea severity on admission for acute heart failure with outcomes and costs.

Hospitalization for heart failure (HF) is frequently related to dyspnea, yet associations among dyspnea severity, outcomes, and health care costs are unknown. The aim of this study was to describe the characteristics of patients hospitalized for acute HF by dyspnea severity and to examine associations among dyspnea severity, outcomes, and costs. Registry data for patients hospitalized for HF were linked with Medicare claims to evaluate dyspnea and outcomes in patients ≥65 years of age. We classified patients by patient-reported dyspnea severity at admission. Outcomes included length of stay, mortality 30 days after admission, days alive and out of the hospital, readmission, and Medicare payments 30 days after discharge. Of 48,616 patients with acute HF and dyspnea, 4,022 (8.3%) had dyspnea with moderate activity, 19,619 (40.3%) with minimal activity, and 24,975 (51.4%) at rest. Patients with dyspnea with minimal activity or at rest had greater co-morbidities, including renal insufficiency. Greater severity of baseline dyspnea was associated with mortality (moderate activity, 6.3%; minimal activity, 7.6%; at rest, 11.6%) and HF readmission (7.2%, 9.0%, and 9.4%). After multivariate adjustment, dyspnea at rest was associated with greater 30-day mortality and HF readmission, fewer days alive and out of the hospital, longer length of stay, and higher Medicare payments compared with dyspnea with moderate activity. In conclusion, dyspnea at rest on presentation was associated with greater mortality, readmission, length of stay, and health care costs in patients hospitalized with acute HF.

A comparison of methods for converting DCE values onto the full health-dead QALY scale.

BACKGROUND: Preference elicitation techniques such as time trade-off (TTO) and standard gamble (SG) receive criticism for their complexity and difficulties of use. Ordinal techniques such as discrete choice experiment (DCE) are arguably easier to understand but generate values that are not anchored onto the full health-dead 1-0 quality-adjusted life-year (QALY) scale required for use in economic evaluation. METHODS: This article compares existing methods for converting modeled DCE latent values onto the full health-dead QALY scale: 1) anchoring DCE values using dead as valued in the DCE and 2) anchoring DCE values using TTO value for worst state to 2 new methods: 3) mapping DCE values onto TTO and 4) combining DCE and TTO data in a hybrid model. Models are compared using their ability to predict mean TTO health state values. DATA: We use postal DCE data (n = 263) and TTO data (n = 307) collected by interview in a general population valuation study of an asthma condition-specific measure (AQL-5D). RESULTS: New methods 3 and 4 using mapping and hybrid models are better able to predict mean TTO health state values (mean absolute difference [MAD], 0.052-0.084) than the anchor-based methods (MAD, 0.075-0.093) and were better able to predict mean TTO health state values even when using in their estimation a subsample of the available TTO data. CONCLUSIONS: These new mapping and hybrid methods have a potentially useful role for producing values on the QALY scale from data elicited using ordinal techniques such as DCE for use in economic evaluation that makes best use of the desirable properties of each elicitation technique and elicited data. Further research is encouraged.

Association of body mass index with increased cost of care and length of stay for emergency department patients with chest pain and dyspnea.

BACKGROUND: High body mass index (BMI) increases the probability of indeterminate findings on diagnostic studies, length of stay, and cost of care for hospitalized patients. No study has examined the economic and operational impact of BMI in patients with chest complaints presenting to the emergency department (ED). The objective was to measure the association of BMI with the main outcomes of cost of care, length of stay (including time in the ED and time in the wards if admitted), and radiation exposure in patients presenting to the ED with chest pain and dyspnea. METHODS AND RESULTS: This was a prospective, 4-center, outcomes study. Patients were adults with dyspnea and chest pain, nondiagnostic electrocardiograms, and no obvious diagnosis. Patients were followed for the main outcomes for 90 days. Outcomes that were stratified by BMI in 5 categories, underweight, normal weight, overweight, obese, and morbidly obese, were compared using the Kruskall-Wallis rank test, and the independent predictive value of BMI was tested with multivariate regressions. Compared with medical costs for normal weight patients, costs were 22% higher for overweight patients (P=0.077), 28% higher for obese patients (P=0.020), and 41% higher for morbidly obese patients (P=0.015). Morbidly obese patients without computerized tomographic scanning stayed in the hospital 34% longer than normal weight patients (P=0.073), and morbidly obese patients with computerized tomographic scanning stayed in the hospital 44% longer than normal weight patients (P=0.083). BMI was not a significant predictor of radiation exposure. Morbidly obese patients had the highest proportion (87%) of no significant cardiopulmonary diagnosis for 90 days after computerized tomographic pulmonary angiography. CONCLUSIONS: BMI was associated with increases in cost of care and length of hospital stay for patients with chest pain and dyspnea. These results emphasize a need for specific protocols to manage morbidly obese patients presenting to the ED with chest pain and dyspnea. Clinical Trial Registration- http://www.clinicaltrials.gov. Unique identifier: NCT01059500.

Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea.

BACKGROUND: Use of pretest probability can reduce unnecessary testing. We hypothesize that quantitative pretest probability, linked to evidence-based management strategies, can reduce unnecessary radiation exposure and cost in low-risk patients with symptoms suggestive of acute coronary syndrome and pulmonary embolism. METHODS AND RESULTS: This was a prospective, 4-center, randomized controlled trial of decision support effectiveness. Subjects were adults with chest pain and dyspnea, nondiagnostic ECGs, and no obvious diagnosis. The clinician provided data needed to compute pretest probabilities from a Web-based system. Clinicians randomized to the intervention group received the pretest probability estimates for both acute coronary syndrome and pulmonary embolism and suggested clinical actions designed to lower radiation exposure and cost. The control group received nothing. Patients were followed for 90 days. The primary outcome and sample size of 550 was predicated on a significant reduction in the proportion of healthy patients exposed to >5 mSv chest radiation. A total of 550 patients were randomized, and 541 had complete data. The proportion with >5 mSv to the chest and no significant cardiopulmonary diagnosis within 90 days was reduced from 33% to 25% (P=0.038). The intervention group had significantly lower median chest radiation exposure (0.06 versus 0.34 mSv; P=0.037, Mann-Whitney U test) and lower median costs ($934 versus $1275; P=0.018) for medical care. Adverse events occurred in 16% of controls and 11% in the intervention group (P=0.06). CONCLUSIONS: Provision of pretest probability and prescriptive advice reduced radiation exposure and cost of care in low-risk ambulatory patients with symptoms of acute coronary syndrome and pulmonary embolism. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01059500.

Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial.

BACKGROUND: Breathlessness is a common and distressing symptom affecting many patients with advanced disease both from malignant and non-malignant origin. A combination of pharmacological and non-pharmacological measures is necessary to treat this symptom successfully. Breathlessness services in various compositions aim to provide comprehensive care for patients and their carers by a multiprofessional team but their effectiveness and cost-effectiveness have not yet been proven. The Breathlessness Support Service (BSS) is a newly created multiprofessional and interdisciplinary outpatient service at a large university hospital in South East London. The aim of this study is to develop and evaluate the effectiveness and cost effectiveness of this multidisciplinary out-patient BSS for the palliation of breathlessness, in advanced malignant and non-malignant disease. METHODS: The BSS was modelled based on the results of qualitative and quantitative studies, and systematic literature reviews. A randomised controlled fast track trial (RCT) comprising two groups: 1) intervention (immediate access to BSS in addition to standard care); 2) control group (standard best practice and access to BSS after a waiting time of six weeks). Patients are included if suffering from breathlessness on exertion or at rest due to advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), interstitial lung disease (ILD) or motor neurone disease (MND) that is refractory to maximal optimised medical management. Both quantitative and qualitative outcomes are assessed in face to-face interviews at baseline, after 6 and 12 weeks. The primary outcome is patients' improvement of mastery of breathlessness after six weeks assessed on the Chronic Respiratory Disease Questionnaire (CRQ). Secondary outcomes for patients include breathlessness severity, symptom burden, palliative care needs, service use, and respiratory measures (spirometry). For analyses, the primary outcome, mastery of breathlessness after six weeks, will be analysed using ANCOVA. Selection of covariates will depend on baseline differences between the groups. Analyses of secondary outcomes will include patients' symptom burden other than breathlessness, physiological measures (lung function, six minute walk distance), and caregiver burden. DISCUSSION: Breathlessness services aim to meet the needs of patients suffering from this complex and burdensome symptom and their carers. The newly created BSS is different to other current services as it is run in close collaboration of palliative medicine and respiratory medicine to optimise medical care of patients. It also involves professionals from various medical, nursing, physiotherapy, occupational therapy and social work background. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01165034).

B-type natriuretic peptide in the evaluation and management of dyspnoea in primary care.

OBJECTIVES: The rapid and accurate diagnosis of heart failure in primary care is a major unmet clinical need. We evaluated the additional use of B-type natriuretic peptide (BNP) levels. DESIGN: A randomized controlled trial. SETTING: Twenty-nine primary care physicians in Switzerland and Germany coordinated by the University Hospital Basel, Switzerland. SUBJECTS: A total of 323 consecutive patients presenting with dyspnoea. INTERVENTIONS: Assignment in a 1 : 1 ratio to a diagnostic strategy including point-of-care measurement of BNP (n = 163) or standard assessment without BNP (n = 160). The total medical cost at 3 months was the primary end-point. Secondary end-points were diagnostic certainty, time to appropriate therapy, functional capacity, hospitalization and mortality. The final diagnosis was adjudicated by a physician blinded to the BNP levels. RESULTS: Heart failure was the final diagnosis in 34% of patients. The number of hospitalizations, functional status and total medical cost at 3 months [median $1655, interquartile range (IQR), 850-3331 vs. $1541, IQR 859-2827; P = 0.68] were similar in both groups. BNP increased diagnostic certainty as defined by the need for further diagnostic work-up (33% vs. 45%; P = 0.02) and accelerated the initiation of the appropriate treatment (13 days vs. 25 days; P = 0.01). The area under the receiver-operating characteristics curve for BNP to identify heart failure was 0.87 (95% confidence interval, 0.81-0.93). CONCLUSIONS: The use of BNP levels in primary care did not reduce total medical cost, but improved some of the secondary end-points including diagnostic certainty and time to initiation of appropriate treatment.

Impact of dyspnea on medical utilization and affiliated costs in patients with acute coronary syndrome.

BACKGROUND: Current clinical practice guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel or prasugrel for patients with acute coronary syndrome (ACS). Ticagrelor, an experimental antiplatelet therapy, has been shown to be associated with significantly higher rates of dyspnea than clopidogrel in clinical trials. Patients with ACS presenting with dyspnea require additional medical attention to rule out possible heart failure or other serious diagnoses. This study used real-world data to quantify the direct medical costs of dyspnea among patients with a history of ACS. OBJECTIVE: To determine the clinical and economic impact of a dyspnea episode for patients with a history of ACS using commercial and Medicare supplemental claims data. METHODS: Patients with an emergency room (ER) visit with a primary diagnosis of dyspnea (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] diagnosis code, 786.0x) in 2008 or 2009 were identified using Thomson Reuters MarketScan(®) Research Databases. Patients were required to have 6 months of continuous medical enrollment prior to an ER visit and a history of ACS (ie, ≥ 1 inpatient claim, ≥ 1 ER visit, or ≥ 2 outpatient claims, with an ICD-9-CM diagnosis code for ACS [410.xx or 411.1x] in any position on the outpatient claim during either the baseline period or on the index date). An episode of dyspnea was defined as all ER and outpatient services on the day of an ER claim with a primary diagnosis of dyspnea, and any inpatient admissions occurring on the day of or day following the ER visit. Procedure utilization and expenditures were evaluated for the ER visit and associated outpatient services, as well as the proportion of ER visits that led to an inpatient stay. Costs were allowed charges (ie, provider payment plus member cost-share) adjusted to 2009 US constant dollars. RESULTS: A total of 8433 ER visits for dyspnea were identified during 2008 to 2009 from these databases of approximately 74 million beneficiaries. The average cost per dyspnea episode was $6958, of which $1621 were outpatient costs associated with the ER visit (standard deviation, $3269). Along with physician services, assessment of dyspnea often included electrocardiogram (71.3%), chest radiograph (75.9%), and, occasionally, a B-type natriuretic peptide test (14.9%) or chest computed axial tomography scan (12.2%). More than one-fourth (25.8%) of dyspnea ER visits preceded an inpatient stay, with an average cost of $20 693 per patient. CONCLUSIONS: Dyspnea is a significant event associated with high medical resource utilization and hospital costs. Ticagrelor, an experimental antiplatelet agent not yet available on the market, has been shown to be associated with significantly higher rates of dyspnea than clopidogrel in clinical trials. Considering that the increased risk of dyspnea for ticagrelor is well documented, these costs may be important to health plan decision-makers when evaluating costs associated with each antiplatelet therapy.

Study protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease.

BACKGROUND: Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS) seeks to improve the care of breathless patients with advanced disease (regardless of cause) through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments) via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed). This paper presents the protocol for Phase III. METHODS/DESIGN: Phase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks) and one for patients with non-malignant disease (intervention delivered over four weeks). The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol) and one for patients with non-malignant conditions (eight week protocol). Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only). The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10). The trial includes economic evaluation. Analysis will be on an intention to treat basis. DISCUSSION: This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast track methodology and single-blinding. The results will provide evidence of the clinical and cost-effectiveness of the service, informing its longer term development and implementation of the model in other centres nationally and internationally. It adds to methodological developments in palliative care research where complex interventions are common but evidence sparse. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00678405ISRCTN: ISRCTN04119516.