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Arteriovenous grafts (AVGs) are an appropriate option for vascular access in certain hemodialysis patients. Expanded polytetrafluoroethylene (PTFE) has become the dominant material for such grafts, due in part to innovations in graft design and surgical interventions to reduce complications and improve patency rates. Comprehensive evidence syntheses have not been conducted to update AVG performance in an era in which both access choice and PTFE graft functioning may have changed. We conducted a systematic review and meta-analysis summarizing outcomes from recent studies of PTFE AVGs in hemodialysis. A systematic review and meta-analysis of studies evaluated PTFE AVG outcomes and followed PRISMA standards. Literature searches were conducted in multiple databases to identify observational and interventional studies of AVG patency and infection risk. Primary, primary assisted, and secondary patency rates were analyzed at 6, 12, 18, and 24 months post-placement. Kaplan-Meier graft survival plots were digitized to re-create individual patient level data. Patency rates were pooled using a random-effects model. We identified 32 studies meeting our selection criteria that were published from 2004 through 2019. A total of 38 study arms of ePTFE grafts were included, representing 3,381 AVG accesses placed. The mean primary, primary assisted, and secondary patency rates at one year were 41% (95% CI: 35%-47%), 46% (95% CI: 41%-51%), and 70%, (95% CI: 64%-75%), respectively. Mean 24-month patency rates were 28% (95% CI: 22%-33%), 34% (95% CI: 27%-41%), and 54% (95% CI: 47%-61%),respectively. A high degree of heterogeneity across studies was observed. Overall risk of infection was not consistently reported, but among available studies the pooled estimate was 9% per patient-year (95% CI: 6%-12%). This meta-analysis provides an up-to-date estimate of the performance of PTFE AVGs, within the context of improved graft designs and improved interventional techniques.

Background Healthcare providers (HCPs) and patient communication are integral to high-quality oncology care. The patient and HCP perspectives are needed to identify gaps in care and develop communication tools. . Objectives This study aimed to understand patient- and HCP-perceived elements of and gaps in high-quality care to develop novel communication tools to improve care. . Methods Qualitative interviews were conducted among 16 patients with cancer and 10 HCPs in the United States. Trained interviewers elicited patients' and HCPs' concerns, views, and perceived needs for communication tools. A thematic analysis was used to identify four quality of care domains, depicted in a conceptual model, and two draft communication tools were developed to address identified gaps. . Findings No patients reported previously using a communication tool, and gaps in communication regarding treatment aims and education were evident. Two tools were developed to assess patients' life and treatment goals and the importance of ongoing education.

Objective Robust cost estimates of cardiovascular (CV) events are required for assessing health care interventions aimed at reducing the economic burden of major adverse CV events. This review synthesizes international cost estimates of CV events. Methods MEDLINE database was searched electronically for English language studies published during 2007-2012, with cost estimates for CV events of interest - unstable angina, myocardial infarction, heart failure, stroke, and CV revascularization. Included studies provided at least one estimate of patient-level direct costs in adults for any identified country. Information on study characteristics and cost estimates were collected. All costs were adjusted for inflation to 2013 values. Results Across the 114 studies included, the average cost was US $6,466 for unstable angina, $11,664 for acute myocardial infarction, $11,686 for acute heart failure, $11,635 for acute ischemic stroke, $37,611 for coronary artery bypass graft, and $13,501 for percutaneous coronary intervention. The ranges for cost estimates varied widely across countries with US cost estimate being at least twice as high as European Union costs for some conditions. Few studies were found on populations outside the US and European Union. Conclusion This review showed wide variation in the cost of CV events within and across countries, while showcasing the continuing economic burden of CV disease. The variability in costs was primarily attributable to differences in study population, costing methodologies, and reporting differences. Reliable cost estimates for assessing economic value of interventions in CV disease are needed.

This cohort study assesses utilization patterns of continuous renal replacement therapy and attempts to establish evidence-based guidelines to standardize the process flow and to promote meaningful use.

BACKGROUND Increased acuity of skilled nursing facility (SNF) patients challenges the current system of care for these patients. OBJECTIVE Evaluate the impact on 30-day readmissions of a program designed to enhance the care of patients discharged from an acute care facility to SNFs. DESIGN An observational, retrospective cohort analysis of 30-day hospital readmissions for patients discharged to 8 SNFs between January 1, 2014, and June 30, 2015. SETTING A collaboration between a large, acute care hospital in an urban setting, an interdisciplinary clinical team, 124 community physicians, and 8 SNFs. PATIENTS All patients discharged from Cedars-Sinai Medical Center to 8 partner SNFs were eligible for participation. INTERVENTION The Enhanced Care Program (ECP) involved the following 3 interventions in addition to standard care: (1) a team of nurse practitioners participating in the care of SNF patients; (2) a pharmacist-driven medication reconciliation at the time of transfer; and (3) educational in-services for SNF nursing staff. MEASUREMENT Thirty-day readmission rate for ECP patients compared to patients not enrolled in ECP. RESULTS The average unadjusted, 30-day readmission rate for ECP patients over the 18-month study period was 17.2% compared to 23.0% among patients not enrolled in ECP (P < 0.001). After adjustment for sociodemographic and clinical characteristics, ECP patients had 29% lower odds of being readmitted within 30 days (P < 0.001). These effects were robust to stratified analyses, analyses adjusted for clustering, and balancing of covariates using propensity weighting. CONCLUSIONS A coordinated, interdisciplinary team caring for SNF patients can reduce 30-day hospital readmissions.

Introduction Comorbidities are common in patients with chronic obstructive pulmonary disease (COPD), and have a significant impact on health status and prognosis. The PLATINO study provides data on self-reported comorbidities and perceived health status in COPD subjects. Methods PLATINO is a population-based study on COPD prevalence in five Latin American cities. COPD diagnosis was defined by GOLD criteria (FEV1/FVC

Resumen Introduccion La enfermedad pulmonar obstructiva cronica (EPOC) se asocia a comorbilidades que influyen en el estado de salud y en el pronostico de los pacientes. El estudio PLATINO aporta datos sobre comorbilidades autorreportadas y percepcion del estado general de salud (EGS) en la EPOC. Metodos PLATINO es un estudio poblacional, sobre prevalencia de EPOC en 5 ciudades de Latinoamerica. El diagnostico de EPOC se realizo segun el criterio de GOLD (FEV1/FVC Resultados Sobre una poblacion total de 5.314 individuos se realizo diagnostico de EPOC en 759. Las comorbilidades reportadas en orden decreciente fueron: cualquier tipo de enfermedad cardiovascular, hipertension, ulcera peptica, enfermedad cardiaca, diabetes, ACV, asma y cancer de pulmon. Los sujetos con EPOC tuvieron mayor indice de comorbilidad, prevalencia de cancer de pulmon (p Conclusiones En poblacion no seleccionada los individuos con EPOC presentan mas comorbilidades. La edad, el sexo femenino y mayor IMC son los principales factores asociados a comorbilidad en estos pacientes. Independientemente de la condicion de EPOC, un mayor numero de comorbilidades se asocia a peor EGS.

Objectives Biosimilars are increasingly attractive to payers around the globe because of mounting financial pressure. Many Latin American governments are developing abbreviated regulatory pathways for biosimilars. There are limited data regarding how certain regulatory agencies in the region plan to address biosimilar access. This study explores potential opportunities and challenges for biosimilar drugs in Brazil, Mexico, Argentina, Chile, and Venezuela. Methods We conducted targeted literature reviews, followed by key informant interviews, to understand the expected regulatory environment for biosimilars. We also asked questions about the economic, political, and historical factors that could play a role in the extent to which biosimilar-specific pathways have been developed across countries to date, and will continue to evolve in the future. Results Brazil has led the development of biosimilar regulation in Latin America, with two distinct pathways, one for more complex molecules such as monoclonal antibodies and a less rigorous path for simpler molecules such as pegylated interferon and low molecular weight heparin. Other countries have been slower to respond, in part because of the degree of emphasis within each country for the advancement of biosimilar regulatory standards. Signs of relaxed standards akin to those seen in Brazil's "individual development" pathway were found in other countries. Conclusions The example of the two-pathway system coupled with governmental prioritization of local manufacturing capabilities in Brazil should promote increased biosimilar utilization within the country. Assuming that the two-pathway system demonstrates success in Brazil, we hypothesize that other Latin American countries may adapt aspects of this "local" model for developing a regulatory pathway for biosimilars.

Background: Acute bronchodilator responsiveness is an area of discussion in COPD. No information exists regarding this aspect of the disease from an unselected COPD population. We assessed acute bronchodilator responsiveness and factors influencing it in subjects with and without airway obstruction in an epidemiologic sample. Methods: COPD was defined by GOLD criteria (post-bronchodilator FEV1/FVC < 0.70). In this analysis, subjects with pre-bronchodilator FEV1/FVC

Forecast the return on investment (ROI) for advances in biologic therapies in years 2015 and 2030, based upon impact on disease prevalence, morbidity, and mortality for asthma, diabetes, and colorectal cancer. A deterministic, spreadsheet-based, forecasting model was developed based on trends in demographics and disease epidemiology. ‘Return’ was defined as reductions in disease burden (prevalence, morbidity, mortality) translated into monetary terms; ‘investment’ was defined as the incremental costs of biologic therapy advances. Data on disease prevalence, morbidity, mortality, and associated costs were obtained from government survey statistics or published literature. Expected impact of advances in biologic therapies was based on expert opinion. Gains in quality-adjusted life years (QALYs) were valued at $100,000 per QALY. The base case analysis, in which reductions in disease prevalence and mortality predicted by the expert panel are not considered, shows the resulting ROIs remain positive for asthma and diabetes but fall below $1 for colorectal cancer. Analysis involving expert panel predictions indicated positive ROI results for all three diseases at both time points, ranging from $207 for each incremental dollar spent on biologic therapies to treat asthma in 2030, to $4 for each incremental dollar spent on biologic therapies to treat colorectal cancer in 2015. If QALYs are not considered, the resulting ROIs remain positive for all three diseases at both time points. Society may expect substantial returns from investments in innovative biologic therapies. These benefits are most likely to be realized in an environment of appropriate use of new molecules. The potential variance between forecasted (from expert opinion) and actual future health outcomes could be significant. Similarly, the forecasted growth in use of biologic therapies relied upon unvalidated market forecasts.

Background Recurrent exacerbations are common in COPD patients. Limited information exists regarding exacerbation frequency in COPD patients from epidemiologic studies. We examined the frequency of self-reported exacerbations and the factors influencing exacerbation frequency among COPD patients in a population-based study conducted in Latin America. Methods We used a post-bronchodilator FEV 1 /FVC ratio of Results Spirometry was performed in 5,314 subjects. There were 759 subjects with airflow limitation; of these, 18.2% reported ever having had an exacerbation, 7.9% reported having an exacerbation, and 6.2% reported having an exacerbation requiring at least a doctor visit within the past year. The proportion of individuals with an exacerbation significantly increased by Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages, from 4.2% in stage 1 to 28.9% in stages 3 and 4. The self-reported exacerbation rate was 0.58 exacerbations per year. The rate of exacerbations requiring at least a doctor visit and length of stay in hospital due to exacerbations also increased as COPD severity progressed. The factors associated with having an exacerbation in the past year were dyspnea, prior asthma diagnosis, receiving any respiratory therapy, and disease severity of GOLD stages 3 and 4. Conclusions The proportion of individuals with airflow limitation and self-reported exacerbation increases as the disease severity progresses. Dyspnea, prior asthma diagnosis, receiving any respiratory therapy, and more severe obstruction were significantly associated with having an exacerbation in the past year.

Asthma control is recognized as a critical aspect of the evaluation and management of the disease. Here we evaluate and compare existing instruments for measuring asthma control in an attempt to evaluate their clinical utility. Based on a literature review, we identified validated instruments used to assess asthma control in adults. We examined the specific measurement properties and the strengths and weaknesses of each instrument, and evaluated a single instrument, the Asthma Control Questionnaire (ACQ), more closely as an example, evaluating its applicability in the clinical setting. Our review identified five validated instruments designed to measure asthma control: the Asthma Control Questionnaire (ACQ), Asthma Control Scoring System (ACSS), Asthma Control Test (ACT), Asthma Therapy Assessment Questionnaire (ATAQ), and the Lara Asthma Symptom Scale (LASS). None of the instruments covered all relevant control characteristics, but most were aligned with guideline definitions of control. All instruments demonstrated validity and responsiveness, with some measure of reliability. All instruments were short and easily administered, easy to interpret, and all had evidence to support their use in clinical decision making.

Objetivo PLATINO es un estudio de base poblacional para medir la prevalencia de la enfermedad pulmonar obstructiva cronica (EPOC) en Sao Paulo (Brasil), Ciudad de Mexico (Mexico), Montevideo (Uruguay), Santiago de Chile (Chile) y Caracas (Venezuela). El objetivo ha sido describir el tratamiento preventivo y farmacologico en individuos con EPOC y los factores asociados al mismo. Pacientes y metodos Los sujetos elegibles completaron un cuestionario y realizaron una espirometria posbroncodilatador. Resultados De un total de 5.529 individuos con datos autorreferidos sobre tratamiento, se identifico como afectados de EPOC (relacion volumen espiratorio forzado en el primer segundo/capacidad vital forzada Conclusiones La espirometria surge no solo como una herramienta diagnostica, sino como factor asociado al tratamiento, en un contexto dispar de utilizacion de los recursos disponibles en estas 5 ciudades de Latinoamerica.

OBJECTIVE To quantify the adherence of patients to drug therapy for osteoporosis in real-world settings via a systematic review and meta-analysis of observational studies. METHODS The PubMed and Cochrane databases were searched for English-language observational studies published from January 1, 1990, to February 15, 2006, that assessed patient adherence to drug therapy for osteoporosis using the following medical subject headings and keywords: drug therapy, medication adherence, medication persistence, medication possession ratio, patient compliance , and osteoporosis . Studies were stratified into 3 groups: persistence (how long a patient continues therapy), compliance (how correctly, in terms of dose and frequency, a patient takes the medication), and adherence (a combination of persistence and compliance). A random-effects model was used to pool results from the selected studies. RESULTS Twenty-four studies were included in the meta-analysis. The pooled database-derived persistence rate was 52% (95% confidence interval [CI], 44%-59%) for treatment lasting 1 to 6 months, 50% (95% CI, 37%-63%) for treatment lasting 7 to 12 months, 42% (95% CI, 20%-68%) for treatment lasting 13 to 24 months, returning to 52% (95% CI, 45%-58%) for treatment lasting more than 24 months. Pooled adherence rates decreased from 53% (95% CI, 52%-54%) for treatment lasting 1 to 6 months to 43% for treatment lasting 7 to 12 months (95% CI, 38%-49%) or 13 to 24 months (43%; 95% CI, 32%-54%). The pooled refill compliance estimate was 68% (95% CI, 63%-72%) for treatment lasting 7 to 12 months and 68% (95% CI, 67%-69%) for treatment lasting 13 to 24 months. The pooled self-reported compliance rate was 62% (95% CI, 48%-75%) for treatment lasting 1 to 6 months and 66% (95% CI, 45%-81%) for treatment lasting 7 to 12 months. CONCLUSION One-third to half of patients do not take their medication as directed. Nonadherence occurs shortly after treatment initiation. Terms and definitions need to be standardized to permit comparability of technologies designed to improve patient adherence. Prospective trials are needed to assess the relationship between adherence and patient outcomes.

Underdiagnosis of COPD appears to be common, although the degree of underdiagnosis is rarely measured. To document the extent of underdiagnosis in a high risk group of ambulatory patients, we performed spirometry in smokers aged 40 years and over drawn from general practices in two countries. Subjects were recruited from primary care practices in Aberdeen, Scotland, and Denver, Colorado, via random mailing. Current and former smokers aged 40 or older with no prior diagnosis of chronic obstructive respiratory disease (and no respiratory medications within the past year) were enrolled. Participants underwent pre- and post-bronchodilator spirometry. A study diagnosis of COPD was defined as post-bronchodilator FEV1/FVC < 0.70. Spirometric examination was complete in 818 patients, of whom 155 (18.9%) had a study diagnosis of COPD. Using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity criteria, the COPD was mild in 57.4%, moderate in 36.8%, and severe in 5.8%. No patients had very severe disease according to GOLD criteria. Screening of smokers over 40 in general practice may yield 10 — 20% undiagnosed COPD cases, with a substantial proportion of these having moderate to severe disease. Earlier diagnosis through targeted case-finding will allow early, aggressive smoking cessation efforts and may lead to a reduction in the burden of COPD symptoms and a reduced impact of the disease on health-related quality of life in these patients.

Objectives In most primary care settings, spirometric screening of all patients at risk is not practical. In prior work, we developed questionnaires to help identify COPD in two risk groups: (1) persons with a positive smoking history but no history of obstructive lung disease (case finding), and (2) patients with prior evidence of obstructive lung disease (differential diagnosis). For these questionnaires, we now present a scoring system for use in primary care. Methods Scores for individual questions were based on the regression coefficients from logistic regression models using a spirometry-based diagnosis of obstruction as the reference outcome. Receiver operator characteristic analysis was used to determine performance characteristics for each questionnaire. Several simplified scoring systems were developed and tested. Results For both scenarios, we created a scoring system with two cut points intended to place subjects within one of three zones: persons with a high likelihood of having obstruction (high predictive value of a positive test result); persons with a low likelihood of obstruction (high predictive value of a negative test result); and an intermediate zone. Using these scoring systems, we achieved sensitivities of 54 to 82%, specificities of 58 to 88%, positive predictive values of 30 to 78%, and negative predictive values of 71 to 93%. Conclusions These questionnaires can be used to help identify persons likely to have COPD among specific risk groups. The use of a simplified scoring system makes these tools beneficial in the primary care setting. Used in conjunction with spirometry, these tools can help improve the efficiency and accuracy of COPD diagnosis in primary care.

This is the first of the IPCRG Guideline papers. The IPCRG took on the task of producing an integrated guideline for the management of chronic respiratory diseases in primary care. This included some original work aimed at developing questionnaires suitable for improving the diagnosis and recognition of respiratory diseases in the primary care setting. This paper provides the background evidence and rationale for the integrated diagnostic section of the IPCRG Guideline. It focusses on identifying the unique challenges in respiratory disease diagnosis in primary care, the use of epidemiology to build a co-ordinated diagnostic framework, and the development of tools to support guideline implementation.

This Diagnosis paper constitutes the second of the IPCRG Guideline papers on the management of chronic respiratory diseases in primary care. Primary care health professionals are usually the first point of contact for patients who can present a wide range of initial symptoms which may or may not constitute their first presentation of a chronic disease such as asthma, COPD, or rhinitis. This paper is focussed upon the early identification and diagnosis of chronic respiratory diseases in primary care. It uses a symptom-based approach, and includes original questionnaires and diagnostic guides to help the primary care clinician proceed systematically through the diagnostic process.

Background: Symptom-based questionnaires may enhance chronic obstructive pulmonary disease (COPD) screening in primary care. Objectives: We prospectively tested questions to help identify COPD among smokers without prior history of lung disease. Methods: Subjects were recruited via random mailing to primary care practices in Aberdeen, UK, and Denver, Colo., USA. Current and former smokers aged 40 or older with no prior respiratory diagnosis and no respiratory medications in the past year were enrolled. Participants answered questions covering demographics and symptoms and then underwent spirometry with reversibility testing. A study diagnosis of COPD was defined as fixed airway obstruction as measured by postbronchodilator FEV1/FVC Results: 818 subjects completed all investigations and proceeded to analysis. The list of 54 questions yielded 52 items for analysis, which was reduced to 17 items for entry into multivariate regression. Eight items had significant relationships with the study diagnosis of COPD, including age, pack-years, body mass index, weather-affected cough, phlegm without a cold, morning phlegm, wheeze frequency, and history of any allergies. Individual items yielded odds ratios ranging from 0.23 to 12. This questionnaire demonstrated a sensitivity of 80.4 and specificity of 72.0. Conclusions: A simple patient self-administered questionnaire can be used to identify patients with a high likelihood of having COPD, for whom spirometric testing is particularly important. Implementation of this questionnaire could enhance the efficiency and diagnostic accuracy of current screening efforts.

Background: Many patients with obstructive lung disease (OLD) carry an inaccurate diagnostic label. Symptom-based questionnaires could identify persons likely to need spirometry. Objectives: We prospectively tested questions derived from a comprehensive literature review and an international Delphi panel to help identify chronic OLD (COPD) in persons with prior evidence of OLD. Methods: Subjects were recruited via random mailing to primary-care practices in Aberdeen, Scotland, and Denver, Colorado. Persons aged 40 and older reporting any prior diagnosis of OLD or any respiratory medications in the past year were enrolled. Participants answered 54 questions covering demographics and symptoms and underwent spirometry with reversibility testing. A study diagnosis of COPD was defined by fixed airway obstruction as measured by post-bronchodilator FEV1/FVC Results: 597 persons completed all investigations and proceeded to analysis. The list of 54 questions yielded 52 items for analyses, which was reduced to 19 items for entry into a multivariate regression model. Nine items had significant relationships with the study diagnosis of COPD, including increased age, pack-years, worsening cough, breathing-related disability or hospitalization, worsening dyspnea, phlegm quantity, cold going to the chest, and receipt of treatment for breathing. Individual items yielded odds ratios ranging from 0.33 to 20.7. This questionnaire demonstrated a sensitivity of 72.0 and a specificity of 82.7. Conclusions: A short, symptom-based questionnaire identifies persons more likely to have COPD among persons with prior evidence of OLD.

Chronic obstructive pulmonary disease (COPD) is usually described as a disease of cigarette smoking. COPD is rarely considered in persons with no smoking history except in the context of another exposure. Accordingly, the disease has not been well characterized in these "never smokers."We evaluated airway obstruction (defined as forced expiratory volume in 1 second/forced vital capacity0.70) in US adults aged 30 to 80 years interviewed in the Third National Health and Nutrition Examination Survey with valid spirometry who had never smoked. Previously described risk factors were examined for their association with obstruction in bivariate and multivariate analyses.Never smokers represented 42% of the Third National Health and Nutrition Examination Survey population aged 30 to 80 years, with obstruction prevalence of 91 per 1000. Never smokers accounted for 4.56 million cases of obstruction, or 23% of the total burden. Among these obstructed never smokers, 19% reported a prior diagnosis of asthma alone, and 12.5% reported COPD (alone or with asthma), leaving 68.5% with no prior respiratory diagnosis. After adjustment for other factors, higher rates of obstruction were significantly associated with increasing age, male sex, lower body mass index, and a history of allergies.Never smokers represent a significant proportion of airway obstruction in US adults. Only one fifth of obstruction in this group is explained by asthma. COPD may explain much of the remainder, although known risk factors were not explanatory in this dataset. Recommendations that lung health screening programs be limited to smokers should be reconsidered.

Summary Objectives To test questions usable in an ambulatory clinic to identify persons likely to have chronic obstructive pulmonary disease (COPD). Methods Analyses were performed as part of a study to identify patients with likely COPD in the Glenfield UK primary care clinic. Patients age 40 and older were recruited based on one of the following criteria: (1) respiratory medications in previous 2 years; (2) history of smoking or (3) history of asthma with no current medications based on case notes. Consenting patients reported smoking history, symptoms, and personal and family history of respiratory conditions. Spirometry with reversibility was conducted to ATS standards. Analyses were performed on this database to test questions for identifying patients with COPD from a sample of patients with a positive smoking history. Multivariate logistic regression identified the question set that best discriminated COPD from other conditions using receiver operating characteristic curves. The usefulness of a simple scoring system was assessed. Results The study sample included 369 current and former smokers. Patients were diagnosed as: COPD = 62 (16.8%); asthma = 30 (8.1%); or no obstructive lung disease = 277 (75.1%). The best questions for discriminating between persons with and without COPD included items on age, dyspnoea on exertion, and wheeze. This set of questions identified COPD patients with a sensitivity of 77.4–87.1% and specificity of 71.3–76.2%. Conclusions A simple questionnaire can facilitate the diagnosis of COPD in a primary care setting.

Objective: Underdiagnosis of COPD is widespread, at least in part due to underuse of spirometry. Symptom-based questionnaires may be helpful as an adjunct to spirometry. The aim of this study was to determine which types of questions might aid in identifying COPD. Methodology: Questionnaires were identified by literature review and input from a multinational advisory board of primary care providers. Questions were placed into groups and evaluated with respect to their ability to perform in two scenarios: (i) to identify persons with COPD from a general population (Case-finding scenario); and (ii) to distinguish persons with COPD from those with asthma (Differential Diagnosis scenario). Questions were retrospectively validated using the Third National Health and Nutrition Examination Survey data. Potential predictive ability was examined in bivariate and multivariate frameworks. Results: Four published question sets and six additional documents were included. There was agreement in the use of smoking and symptom-based questions, but important differences in the use of demographic, personal history and other information. Most question types had significant bivariate relationships with airway obstruction. In multivariate analysis, age, BMI, smoking status and pack-years, symptoms (cough, phlegm, dyspnoea, wheeze), and prior diagnosis consistent with asthma or COPD all showed significant ability to discriminate between persons with and without obstruction in a general population. Conclusion: Simple self-administered questionnaires can be used to identify persons for whom spirometric testing may be especially appropriate. Development of such questionnaires will require additional study, including prospective validation of items in an appropriate clinical setting and policy recommendations on the use of these tools.

COPD is commonly under-diagnosed, in part because people at risk are unaware of the relevant risk factors and do not recognize related symptoms. Providing this information might permit earlier dise...

Summary Aims: To present an age-stratified approach to the diagnosis of obstructive lung disease based on asthma and COPD guidelines and epidemiology. Methods: Asthma guidelines emphasize the role of the history and physical examination, with pulmonary function used primarily to confirm the diagnosis. COPD guidelines begin with symptoms and risk exposure, presenting spirometry as the primary diagnostic maneuver. Data from the National Health Interview Survey and the Third National Health and Nutrition Examination Survey illustrate relationships in prevalence of asthma and COPD in nationally representative samples. Results: Asthma prevalence in adults declines with age from 5–10% at age 20–40 to 4–8% above age 60. COPD is uncommon in adults under age 40 but increases with age, surpassing asthma in older adults. Conclusions: These trends suggest that asthma screening is most useful in adults up to age 40, after which COPD screening and differential diagnosis are of comparable or greater utility.

Study objectives: To summarize the available data on COPD prevalence and assess reasons for conflicting prevalence estimates in the published literature. Design: We reviewed published studies that (1) estimated COPD prevalence for a population, and (2) clearly described the methods used to obtain the estimates. Results: Thirty-two sources of COPD prevalence rates, representing 17 countries and eight World Health Organization-classified regions, were identified and reviewed. Prevalence estimates were based on spirometry (11 studies), respiratory symptoms (14 studies), patient-reported disease (10 studies), or expert opinion. Reported prevalence ranged from 0.23 to 18.3%. The lowest prevalence rates (0.2 to 2.5%) were based on expert opinion. Sixteen studies had measured rates that could reasonably be extrapolated to an entire region or country. All were for Europe or North America, and most fell between 4% and 10%. Conclusions: There is considerable variation in the reported prevalence of COPD. The overall prevalence in adults appears to lie between 4% and 10% in countries where it has been rigorously measured. Some of the variation attributed to differences in risk exposure or population characteristics may be influenced by the methods and definitions used to measure disease. Spirometry is least influenced by local diagnostic practice, but it is subject to variation based on the lung function parameters selected to define COPD.

Purpose The Transplant Learning Center is a program providing education and support for solid-organ transplant recipients taking cyclosporine (Neoral or Sandimmune). One goal of the program is to improve patients' quality of life, which may be influenced by demographic and biological factors, and in turn influences adherence to prescribed medication regimens. We analyzed the results from the initial survey of enrollees to better understand life satisfaction and to test the validity and reliability of the satisfaction scale used in the program. Method Patients enter the program through self-selection: all enrollees who received a kidney transplant were included in this analysis. Satisfaction was measured using the Life Satisfaction Index, which includes 8 questions about aspects of satisfaction with the patient's life. Associations between the Life Satisfaction Index and demographic factors, comorbid medical conditions, adverse effects of immunosuppressants, and medication compliance were examined. Results All 3676 kidney transplant recipients who completed the initial survey were included. Mean satisfaction scores were highest in persons who were older than 64 years, men, and those who were married. Satsifaction scores were positively correlated with education and income. Mean satisfaction score was significantly lower among persons with medical comorbidities, persons who reported that adverse effects of medications were more frequent, and persons who reported noncompliance with their medication regimen. Conclusion The Life Satisfaction Index is a transplant-specific measure of health-related quality of life that can be used to help detect areas of potential concern in the clinical management of kidney transplant recipients.

Introduction: Previous cross-sectional analyses have identified significant associations between quality of life (QOL), comorbidities and adverse effects in renal transplant recipients. This report examines the longitudinal relationship between adverse effects and QOL, with particular attention to the relative impact of adverse effects associated with immunosuppression. Methods: The Transplant Learning Center (TLC) is a program designed to improve QOL and preserve graft function in transplant recipients. Self-selected enrollees filled out questionnaires at roughly 3-month intervals. Each questionnaire included QOL scales developed for the program. Repeated measures multiple regression analysis was used to examine the relationship between the QOL scales, comorbidities, adverse effects, adjusting for other factors. Results: A total of 4247 TLC enrollees were included in the analysis, with a mean time since transplant of 5.1 yr. Comorbidities and adverse effects were common, with high blood pressure reported by 87% of respondents and unusual hair growth reported by 69.6%. In bivariate analysis, emotional/psychological problems and headaches had the largest impact on QOL. In multivariate analysis, emotional/psychological problems decreased sexual interest or ability, and headache had the largest adverse QOL effect. Conclusions: We have identified QOL issues that have been previously underemphasized in transplant recipients. These findings open new areas of research to further explore and define these issues. They provide new opportunities for interventions to address factors adversely impacting QOL and to develop strategies to improve QOL in these patients. Clinicians should actively solicit information about adverse effects of medications, particularly information about sexual and relationship issues, when evaluating renal recipients. These issues should be taken into account when making therapeutic decisions.

BACKGROUND To the authors' knowledge, no analysis has examined the specific components of drug spending for overall cancer care. The authors' objective was to quantify and characterize trends in outpatient drug expenditures for cancer patients. METHODS The authors retrospectively analyzed pharmacy and outpatient professional claims data from commercial and Medicare health maintenance organization enrollees with a solid tumor diagnosis in 1995 and 1998. Charges were subdivided by type of drug (antineoplastic drugs, chemotherapy adjuncts, supportive drugs, and drugs unrelated to cancer treatment). RESULTS In 1995, 14,663 cancer patients received outpatient drug treatment and 13,829 patients in 1998. Total charges increased from $17.9 million (mean charge of $1218 per patient) to $27.9 million (mean charge of $2003 per patient), an average annual increase of 16%. Antineoplastic therapy constituted the largest component of cancer-related drug costs (67%) and represented 76% of the increase from 1995 to 1998. Most charges were incurred in the professional setting for agents administered by injection. The primary explanation for the increases appeared to be a shift in treatment patterns toward newer, more expensive antineoplastic agents. Supportive therapy represented 17% of the increase in cancer drug costs, followed by chemotherapy adjuncts (7%). Charges for drugs unrelated to cancer therapy increased by 21% per year. CONCLUSIONS Antineoplastic therapy administered in an office or clinic was the single most important cost driver, with newer more expensive agents replacing older, less expensive drugs. Attempts to understand and control outpatient drug cost increases for cancer patients should focus primarily on antineoplastic therapy, especially the appropriate substitution of newer agents for older, less expensive alternatives. Some nonchemotherapy cancer drugs may offer an opportunity to improve quality of life with a relatively small effect on overall cancer drug costs. Cancer 2002;94:1142–50. © 2002 American Cancer Society. DOI 10.1002/cncr.10347

OBJECTIVE: To determine whether multiple mailed patient reminders can produce an increase in the rate of diabetic retinal examinations (DRE) over that seen with a single reminder. RESEARCH DESIGN AND METHODS: All diabetic members > or = 18 years who were enrolled in a large network-based health maintenance organization (HMO) in California from August 1996 to July 1997 were identified using claims and pharmacy databases. Members who had no record of DRE in the HMO's claims database were then randomized into two groups. Both groups received mailed educational materials and a reminder to obtain the examination. Their physician groups also received a letter explaining the program, current guidelines for DRE, and a list of their diabetes patients with their DRE status. The single intervention group received no additional reminders. The multiple intervention group received additional reminders at 3, 6, and 9 months after baseline if they continued with no record of service, as determined from the claims database. RESULTS: The study cohort comprised 19,523 diabetic members, which were randomized into single (n = 9,614) and multiple (n = 9,909) intervention groups. There was an increase in monthly DRE rates after the intervention in August 1996 for both intervention groups. After the second reminder was sent to the multiple intervention group, the percentage of diabetic members receiving DRE was higher than the single intervention group. Rates before and after the third intervention were not significantly different, nor were monthly differences found. There was a significant difference in overall annual DRE rates between the groups (P = 0.023). CONCLUSIONS: Multiple patient reminders are more effective than single reminders in improving DRE rates in a managed care setting. However, the improvement noted was clinically small and appeared only after the second reminder; no incremental improvement was seen with additional reminders. Resources used for multiple reminders aimed at diabetic retinopathy might better be spent on other approaches to reducing complications of diabetes.

The objective of this study was to examine the compliance with the National Asthma Education Program (NAEP) guidelines among asthmatic members of eight health plans (regions) in seven states, as well as the factors related to the compliance. Information was gathered by means of a cross-sectional survey in a managed care environment. The participants were 6703 respondents (ages 14-65) with moderate or severe asthma. The main outcome measures were compliance with the NAEP guidelines on the use of inhaled steroids, inhaled beta2-agonists, peak flow measurement, and allergy evaluations. Among the results of this survey we found that although these health plans are located from the West Coast to the East Coast and the socioeconomic status of their members varied greatly, compliance with the NAEP guidelines was low among asthmatic members across all geographical regions. The major areas of low compliance identified were inappropriate pharmacological therapy, lack of objective measurement of lung function through peak flow meter, and insufficient environmental trigger control. The regression analyses indicated that the effect of the health plan explained little of the variation in compliance across these regions (only 0.3% at maximum). Low compliance was associated with young age, smoking, moderate asthma, being asthmatic for a few years, currently working, and being treated by a generalist rather than a specialist. In conclusion, this study showed that the compliance with the national guidelines for asthma care was consistently low across different geographical regions in the nation. Improvement in care for asthmatics will require greater commitment and involvement by all stakeholders including physicians, patients, health plans, and employers. We suggest a need for a national strategy to disseminate clinical guidelines not only to the medical community but also to patients themselves.

Background: The evolution of American health care into integrated systems of delivery and finance requires a specialized set of population-based skills for physicians. The field of preventive medicine represents one source of this expertise. Specific competencies for the emerging area of managerial medicine have not been well delineated. Methods: Using concept documents from the Residency Review Committee for Preventive Medicine and the American Board of Preventive Medicine, a list of proposed competencies for managerial medicine was identified. Surveys were mailed to medical directors of all members of the American Association of Health Plans and to a random sample of diplomates of the American Board of Preventive Medicine. Respondents were asked to rate the importance of these competencies for a population-oriented clinician manager. Results: Areas rated highly by medical directors included health services research (including outcomes research), quality assurance and improvement, health risk assessment and reduction, programmatic skills, and clinical preventive skills. Responses from preventive medicine specialists were similar, but placed lower emphasis on these skills. Conclusion: Despite its limited response rate, this survey may be useful in the implementation of specialty training in managerial medicine. Residency training programs may choose to emphasize specific content areas that reflect the priorities expressed by physicians actively involved in management.

We evaluated whether a team based outpatient heart failure (HF) program utilizing a clinical pharmacist, serial measurements of brain natriuretic peptide (BNP) and GE Vscan point of care (POC) ultrasound can reduce hospital utilization. The HF program included cardiologists and a specialty trained

The perspective of commercial payers on comparative effectiveness research (CER) has not been well researched. This study aims to describe how US commercial payers use and value CER for formulary decision making in different disease states.We recruited 20 medical and pharmaceutical directors from national and regional plans who are involved in pharmaceutical and therapeutics committees to participate in the study. We conducted in-depth qualitative interviews with the payers and asked them to rate the usefulness of CER study types across various disease states and market conditions. The results were analyzed for thematic content.Our findings indicate that payers are interested in a broad range of CER study types, are unsatisfied with the current state of CER, and would like to partner with research groups to develop research and treatment guidelines to better leverage CER. Payers value CER less so in oncology than in other disease states because of limitations in their ability to manage oncology therapies.To improve formulary design processes and support payers in providing more effective health care, policy makers should consider involving commercial payers in the development of CER as well as in the creation of research and treatment guidelines.

Little information exists regarding the epidemiology of the chronic bronchitis phenotype in unselected chronic obstructive pulmonary disease (COPD) populations. We examined the prevalence of the chronic bronchitis phenotype in COPD and non-COPD subjects from the PLATINO study, and investigated how it is associated with important outcomes. Post-bronchodilator forced expiratory volume in 1 s/forced vital capacity

Boehringer Ingelheim GmbH BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a costly condition that frequently causes permanent work disabilities. Little information exists regarding the impact of COPD on work force participation and the indirect costs of the disease in developing countries.OBJECTIVE: To examine the frequency of paid employment and factors influencing it in a Latin-American population-based study.METHODS: Post-bronchodilator FEV(1)/FVC < 0.70 (forced expiratory volume in 1 s/forced vital capacity) was used to define COPD. Information regarding paid work was assessed by the question 'At any time in the past year, have you worked for payment?'RESULTS: Interviews were conducted with 5571 subjects; 5314 (759 COPD and 4554 non-COPD) subjects underwent spirometry. Among the COPD subjects, 41.8% reported having paid work vs. 57.1% of non-COPD (P < 0.0001). the number of months with paid work was reduced in COPD patients (10.5 +/- 0.17 vs. 10.9 +/- 0.06, P < 0.05). the main factors associated with having paid work in COPD patients were male sex (OR 0.33, 95% CI 0.23-0.47), higher education level (OR 1.05, 95% CI 1.01-1.09) and younger age (OR 0.90, 95% CI 0.88-0.92). COPD was not a significant contributor to employment (OR 0.83, 95% CI 0.69-1.00, P = 0.054) in the entire population.CONCLUSIONS: Although the proportion of persons with paid work is lower in COPD, having COPD appears not to have a significant impact on obtaining paid employment in the overall population of developing countries. Cent Univ Venezuela, Hosp Univ Caracas, Serv Neumonol, Fac Med, Caracas 1030, Venezuela Univ Calif Los Angeles, Sch Publ Hlth, Los Angeles, CA 90024 USA Inst Resp Dis, Mexico City, DF, Mexico Univ Republica, Hosp Maciel, Fac Med, Montevideo, Uruguay Universidade Federal de São Paulo, São Paulo, Brazil Pontificia Univ Catolica Chile, Fac Med, Catedra Neumol, Santiago, Chile Univ Fed Pelotas, Fac Med, Pelotas, RS, Brazil Universidade Federal de São Paulo, EPM, São Paulo, Brazil Web of Science

There is evidence to suggest sex differences exists in chronic obstructive pulmonary disease (COPD) clinical expression. We investigated sex differences in health status perception, dyspnoea and physical activity, and factors that explain these differences using an epidemiological sample of subjects with and without COPD. PLATINO is a cross-sectional, population-based study. We defined COPD as post-bronchodilator forced expiratory volume in 1 s/forced vital capacity ratio

Background: Chronic obstructive pulmonary disease (COPD) is increasing worldwide and thus its associated morbidity and mortality. However, COPD often goes undiagnosed. Objectives: We evaluated the rate of non-diagnosed irreversible airway obstruction (AO) and characterized this patient group. We further assessed the possible effects of conducting targeted spirometry in a population sample in Salzburg, Austria, as part of the Burden of Obstructive Lung Disease (BOLD) study. Methods: 1,258 adults ≧40 years of age completed a questionnaire and performed spirometry before and after bronchodilator therapy (post-BD). Irreversible AO was defined as post-BD FEV1/FVC below the lower limit of normal; we used the FEV1% predicted (pred.) to further grade the disease. Participants without a physician diagnosis of COPD who reported respiratory symptoms and a history of risk factors (ever smoking or occupational risk) were defined as eligible for targeted spirometry. Results: 85.9% (171/199) of the participants with irreversible AO did not report a prior diagnosis of COPD. Non-diagnosed AO was inversely related to severity, age, self-reported prior respiratory diseases and cough as a respiratory symptom. 343 participants were eligible for targeted spirometry and irreversible AO was present in 86 (25.1%) participants. Therefore, targeted spirometry could reduce the underdiagnosis of irreversible AO of any severity by 50.3% (86 of 171). The diagnosis of 1 person with FEV1 Conclusion: Although several factors are associated with non-diagnosed AO, spirometry in individuals with respiratory symptoms and exposure to risk factors could reduce undiagnosed irreversible AO by half.

Recurrent exacerbations are common in COPD patients. Limited information exists regarding exacerbation frequency in COPD patients from epidemiologic studies. We examined the frequency of self-reported exacerbations and the factors influencing exacerbation frequency among COPD patients in a population-based study conducted in Latin America.We used a post-bronchodilator FEV(1)/FVC ratio of0.70 to define COPD. Exacerbation was self-reported and defined by symptoms (deterioration of breathing symptoms that affected usual daily activities or caused missed work).Spirometry was performed in 5,314 subjects. There were 759 subjects with airflow limitation; of these, 18.2% reported ever having had an exacerbation, 7.9% reported having an exacerbation, and 6.2% reported having an exacerbation requiring at least a doctor visit within the past year. The proportion of individuals with an exacerbation significantly increased by Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages, from 4.2% in stage 1 to 28.9% in stages 3 and 4. The self-reported exacerbation rate was 0.58 exacerbations per year. The rate of exacerbations requiring at least a doctor visit and length of stay in hospital due to exacerbations also increased as COPD severity progressed. The factors associated with having an exacerbation in the past year were dyspnea, prior asthma diagnosis, receiving any respiratory therapy, and disease severity of GOLD stages 3 and 4.The proportion of individuals with airflow limitation and self-reported exacerbation increases as the disease severity progresses. Dyspnea, prior asthma diagnosis, receiving any respiratory therapy, and more severe obstruction were significantly associated with having an exacerbation in the past year.

SummaryBackgroundCOPD is a highly prevalent disease but underdiagnosed, undertreated and possibly under-recognized by patients. Limited information exists regarding patients' perception of COPD severity. We compared patients' general health status perception, degree of breathlessness and physical activity limitation with the severity of their respiratory condition measured by airway obstruction, in a population-based sample.MethodsWe used postbronchodilator FEV1/FVC

Background: There is scanty information regarding respiratory medication prescription pattern in Latin America. We examined the use of bronchodilators and corticosteroids in a population-based study conducted in five Latin American cities. Methods: Medication use was derived from questions regarding the use of medication ‘‘to help breathing’’ within the previous 12 months, type of medicine, and frequency of use. To minimize the possibility of overdiagnosis, we used postbronchodilator FEV1/FVCo0.70 plus FEV1o80% as the definition of obstruction. Results: Interviews were completed in 5571 subjects from 6711 eligible individuals, and spirometry was performed in 5314 subjects. There were 360 (6.5%) treated subjects and 5211 not treated. Treated subjects were more likely to be older, women, unemployed, have higher tobacco consumption, higher body mass index, higher FEV1 reversibility and airway obstruction. They were also more likely to report prior spirometry, prior diagnosis of COPD, asthma or tuberculosis, and more respiratory symptoms. Over half of treated subjects had neither obstruction nor FEV1 reversibility, and approximately 30% reported no prior diagnosis of asthma or COPD. Prior respiratory diagnoses and wheezing were more strongly associated with treatment than objective measures of airway obstruction. Conclusions: The use of bronchodilators and/or corticosteroids is common in the general population aged 40 years or older, with over one-half of treated subjects using them without being obstructed.

Objectives There is a lack of agreement on assessing disease activity in patients with RA and determining when the RA treatment should be changed or continued. A panel of rheumatologists was convened to develop guidelines to assess adequacy of disease control, focusing on the use of disease-modifying anti-rheumatic drugs. Methods The Research and Development/University of California in Los Angeles (RAND/UCLA) Appropriateness Method was used to evaluate disease control adequacy. After a literature review, 108 scenarios were developed to simulate situations most likely to be encountered in clinical practice and rated on a 9-point scale by a 10-member expert panel. Results Final appropriateness rankings for the scenarios were as follows: 37% 'appropriate', 48% 'inappropriate', and 16% 'neutral'. The panelists felt that patients with disease control in the 'appropriate' range have adequate control with their current therapy, whereas those in the 'inappropriate' range should be considered for a change in therapy. Those in 'neutral' areas should have their therapy reviewed carefully. The panelists recommended that the clinically active joint count should be considered the most important decision factor. In patients with no clinically active joints, regardless of other factors no change in therapy was felt to be warranted. Patients with five or more active joints should be considered inadequately treated, and in patients with one to four active joints other variables must be considered in the decision to change therapy. Conclusion These preliminary guidelines will assist the clinician in determining when a patient's clinical situation warrants therapy escalation and when continuing the current regimen would be appropriate.