Small airway disease: a riddle wrapped in a mystery inside an enigma.
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Biomedical subjects
Publications and source records attributed to Gene L Colice.
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OBJECTIVES: To discuss the Health Plan Employer Data and Information Set (HEDIS) criteria for measuring performance in asthma care and to review new strategies to improve the quality of asthma care. DATA SOURCES: Expert opinion from a roundtable on National Committee for Quality Assurance HEDIS and asthma care, supplemented with a MEDLINE database search to identify articles published between January 1, 1990, and May 31, 2005, with the following keywords in the title: asthma plus HEDIS, pay for performance, incentive programs, reimbursement, or employee education. STUDY SELECTION: Studies and review articles were selected for their relevance to measuring the quality of asthma care using HEDIS and improving care using newer trends, such as employee education and physician incentive programs. RESULTS: Components of the HEDIS asthma measure have been found to correlate with outcomes, including risk of hospitalization and emergency department visits. However, refinements to the measure may be needed because it may misclassify a portion of patients as having persistent asthma who actually have intermittent asthma according to National Heart, Lung, and Blood Institute criteria. Physician incentive programs are increasingly being explored as a means of improving the quality of care while managing costs. Under current pay-for-performance programs, rewards are issued to providers who demonstrate high-quality care based on the HEDIS asthma measure. CONCLUSIONS: The HEDIS asthma measure remains the most widely used performance tool for evaluating the quality of asthma care. Reimbursement models based on public reporting and pay for performance are expected to be a strong component of future health care payment systems.
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Ciclesonide is the most recently developed inhaled corticosteroid for the treatment of asthma to enter global markets. It has been formulated as an aerosol solution in a metered dose inhaler with hydrofluoralkane. The mass median aerodynamic diameter of aerosolised ciclesonide is 1 - 2 microm, providing excellent lung deposition characteristics. Ciclesonide can undergo reversible esterification in the lungs, possibly allowing once-daily dosing, and is highly protein bound, possibly leading to reduced systemic side effects. Clinical trials suggest that ciclesonide effectively controls asthma and has a favourable safety profile.
Inhaled corticosteroids are effective in controlling airway inflammation. Their anti-inflammatory effect is primarily topical, at the site of deposition in the airways. Consequently, traditional pharmacodynamic and pharmacokinetic concepts, which rely on measuring blood concentrations of drug, have limited applicability for evaluating the efficacy of topically acting inhaled corticosteroids. Important factors affecting efficacy of inhaled corticosteroids are: (i) intrinsic properties of the drugs, particularly their affinity for the corticosteroid receptor; and (ii) the newer pharmacodynamic concept of deposition characteristics of the drug formulation. Small particle formulations, especially those developed in the metered-dose inhaler with the new hydrofluoroalkane propellant, deposit to a much greater extent in the lung and may consequently have improved clinical efficacy. Lipid conjugation of inhaled corticosteroids within the lung may allow prolonged duration of effect, enabling once-daily administration. Pharmacodynamic and pharmacokinetic principles probably do not play a role in describing upper airway adverse effects occurring with inhaled corticosteroids. These are probably also determined by intrinsic properties of the drug and deposition characteristics. However, pharmacodynamic and pharmacokinetic principles seem to be important in addressing systemic safety concerns with inhaled corticosteroids. Those inhaled corticosteroids with a longer serum half-life, especially if they have higher affinity for the corticosteroid receptor, may be associated with greater systemic effects. A new pharmacokinetic concept suggests that increased protein binding within the systemic circulation and high systemic clearance of an inhaled corticosteroid may reduce the risk for systemic effects. These new pharmacodynamic and pharmacokinetic concepts provide a useful framework for identifying the characteristics of an inhaled corticosteroid with an improved benefit-to-risk profile. Increased lung deposition and reduced deposition in the upper airway should result in an inhaled corticosteroid with favorable clinical efficacy and a decreased risk for topical upper airway adverse effects. An inhaled corticosteroid with high plasma protein binding and rapid clearance might pose much less risk for systemic adverse effects than currently available drugs in this class.
With more than $16.1 billion in annual costs, the asthma management system is inadequate and needs revision to improve health and financial outcomes. Solutions may be found in the National Committee for Quality Assurance's guidelines and in such programs as Pay for Performance that financially reward providers for adherence to standards of practice based on Health Plan Employer Data and Information Set measures.
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This prospective study was designed to determine whether incorporating formoterol into a standardized respiratory therapist-directed protocol for administering bronchodilators to hospitalized patients with obstructive airway disease would reduce health care resource use and provide a safety advantage. All patients admitted to Washington Hospital Center with asthma and chronic obstructive pulmonary disease (CODP) are administered bronchodilators under a standardized respiratory therapist-directed protocol. Formoterol was the primary bronchodilator for the intervention period from January through March 2002, with levalbuterol, albuterol, and ipratropium available as needed. Results for the intervention period were compared against two historical control periods. From January through March 2000, the bronchodilators in the protocol were albuterol and ipratropium, and from January through March 2001 levalbuterol, albuterol, and ipratropium were available. Health care resource use was determined by the number of bronchodilator treatments administered per admission. Costs (adjusted to 2002 dollars) for supplies, therapist time, and drugs were calculated for the three time periods. Adverse events related to bronchodilator administration were recorded in a standardized manner for all three time periods. Bronchodilator treatments per admission, respiratory therapist visits per admission, and time spent per admission, and cost per bronchodilator treatment significantly decreased in 2002. Significantly fewer adverse events related to bronchodilator treatments were reported in 2002 than 2000. The addition of formoterol to a respiratory therapist-directed protocol for administering bronchodilators reduced health care resource use and adverse events for patients with asthma and COPD.
BACKGROUND: The endotracheal tube (ETT) cuff-leak test (CLT) has been proposed as a relatively simple, noninvasive method for detecting the presence of laryngeal edema prior to tracheal extubation. OBJECTIVE: To determine the value of the CLT for predicting postextubation stridor (PES) among medical and surgical patients, and to assess the impact of certain variables on the incidence of PES. METHODS: We conducted a prospective, observational study in the intensive care unit at Washington Hospital Center, a 907-bed acute care hospital in Washington DC, with patients who were intubated for > 24 h. As part of respiratory therapy quality assurance, patients intubated for > 24 h are evaluated daily for extubation readiness, and CLT is conducted prior to extubation. The CLT results and the postextubation outcomes were prospectively recorded for 6 months. RESULTS: Of the 462 patients studied, 20 (4.3%) developed PES that required treatment; 7 of those 20 (1.5%) required reintubation. With patients who failed the CLT, defined by an absolute leak volume < or = 110 mL, the positive predictive value for PES was 0.12, the negative predictive value was 0.97, the sensitivity was 0.50, and the specificity was 0.84. Using different definitions for CLT failure did not improve the accuracy of CLT for predicting PES. Patients who had PES were more likely to be female (6.5% vs 2.4%, p = 0.04), to have a longer duration of translaryngeal intubation (6.5 + 4 d vs 4.5 + 4 d, p = 0.02), and to have a larger ratio of ETT size to laryngeal size (49.5 + 6% vs 45.5 + 6%, p = 0.01). CONCLUSIONS: Failing the CLT was not an accurate predictor of PES and should not be used as an indication for either delaying extubation or initiating other specific therapy. Female patients, those whose ratio of ETT size to laryngeal diameter was > 45%, and patients intubated for > 6 d were more likely to develop PES.
BACKGROUND: Community-acquired pneumonia (CAP) is a serious clinical problem, causing hospitalization in about 20% of cases and death in up to 16% of hospitalized patients. Work-loss cost estimates indicate that the treatment of CAP also has a large economic impact. The purpose of this study was to assess the medical and prescription drug (treatment) costs of managing CAP in an employed population. METHOD: The costs of CAP were determined from an administrative claims database covering the years 1996 to 1998 for an employed population and their dependents [65 years of age (100,000 population)]. Treatment costs for managing both inpatient and outpatient cases of CAP were calculated from payments by the health plan. RESULTS: A total of 7,249 episodes of CAP among 6,415 individuals were identified. The hospitalization rate was 19.6%, and the mortality rate for those hospitalized was 9.1%. Patients requiring hospitalization were older and had more comorbid conditions. The mean (+/- SD) treatment cost for an inpatient episode of CAP (including all inpatient and outpatient medical care) was $10,227 +/- 15,342. The costs for inpatients who died during hospitalization (mean cost, $15,822 +/- 26,541) were higher than for episodes in which patients were discharged from the hospital alive (mean cost, $9,595 +/- 13,641). The mean treatment cost for an outpatient episode of CAP was $466 +/- 1,038. CONCLUSIONS: The treatment cost of managing CAP in this employed population was higher than previously estimated. It is estimated that the annual cost of treating CAP in the United States is $12.2 billion.
Asthma is an inflammatory disease of the airways associated with intermittent episodes of bronchospasm. Corticosteroids are the most effective anti-inflammatory class of medication currently available for the treatment of asthma. However, as higher doses of inhaled corticosteroids are used the risks of systemic exposure and side effects will correspondingly increase. Justification of the benefits from higher doses of inhaled corticosteroids can only be made if patients with more severe asthma can be identified. Methods to categorize asthma severity have been introduced in various national asthma management guidelines. Unfortunately, there are substantial conceptual and practical differences among these recommended approaches to asthma severity categorization. Furthermore, these recommended approaches suffer from a focus on features of asthma control, such as symptoms, short-acting beta-agonist use, and lung function rather than actual measures of asthma severity that would encompass markers of airway inflammation. Without the endpoints necessary to assess airway inflammation, current recommendations for asthma severity categorization may lead to systematic under dosing of appropriate anti-inflammatory therapy with subsequent perpetuation of the asthma exacerbation cycle.
Inhaled corticosteroids play a pivotal role in the treatment of asthma. Inhalation permits effective delivery of the corticosteroid in high concentration to target sites within the lung while minimizing systemic exposure. Consequently, the safety profile of inhaled corticosteroids is markedly better than that of oral corticosteroid therapy. However, although it was first thought that direct delivery might eliminate systemic adverse effects, this has not been confirmed by clinical trials and experience. Inhaled corticosteroids are absorbed from the lungs into the systemic circulation, in which they can acutely decrease growth velocity in children, an effect that fortunately appears to be temporary and might have no effect on final adult height. In sufficient dosages, they also produce bone mineral loss leading to osteoporosis and might increase the risk of cataracts, glaucoma, skin atrophy, and vascular changes that increase the risk of ecchymoses. Effective evaluation of the severity and significance of these complications is challenging because highly sensitive tests do not reliably predict clinically significant events, and short-term observations do not predict long-term consequences. Also, compliance wanes with long-term treatment, and susceptibility to a particular adverse event can vary over time, even in the same individual, because of developmental or hormonal changes. This journal supplement will review what has been learned about the safety of inhaled cortico-steroids during the past decade, discussing some of the questions that remain and considering the characteristics of an "ideal" inhaled corticosteroid: one with high local activity in the lung and minimal or no adverse systemic effects.
The preoperative physiologic assessment of a patient being considered for surgical resection of lung cancer must consider the immediate perioperative risks from comorbid cardiopulmonary disease, the long-term risks of pulmonary disability, and the threat to survival due to inadequately treated lung cancer. As with any planned major operation, especially in a population predisposed to atherosclerotic cardiovascular disease by cigarette smoking, a cardiovascular evaluation is an important component in assessing perioperative risks. Measuring the FEV(1) and the diffusing capacity of the lung for carbon monoxide (DLCO) measurements should be viewed as complementary physiologic tests for assessing risk related to pulmonary function. If there is evidence of interstitial lung disease on radiographic studies or undue dyspnea on exertion, even though the FEV(1) may be adequate, a DLCO should be obtained. In patients with abnormalities in FEV(1) or DLCO identified preoperatively, it is essential to estimate the likely postresection pulmonary reserve. The amount of lung function lost in lung cancer resection can be estimated by using either a perfusion scan or the number of segments removed. A predicted postoperative FEV(1) or DLCO < 40% indicates an increased risk for perioperative complications, including death, from lung cancer resection. Exercise testing should be performed in these patients to further define the perioperative risks prior to surgery. Formal cardiopulmonary exercise testing is a sophisticated physiologic testing technique that includes recording the exercise ECG, heart rate response to exercise, minute ventilation, and oxygen uptake per minute, and allows calculation of maximal oxygen consumption (.VO(2)max). Risk for perioperative complications can generally be stratified by .VO(2)max. Patients with preoperative .VO(2)max > 20 mL/kg/min are not at increased risk of complications or death; .VO(2)max< 15 mL/kg/min indicates an increased risk of perioperative complications; and patients with .VO(2)max < 10 mL/kg/min have a very high risk for postoperative complications. Alternative types of exercise testing include stair climbing, the shuttle walk, and the 6-min walk. Although often not performed in a standardized manner, stair climbing can predict .VO(2)max. In general terms, patients who can climb five flights of stairs have O(2)max > 20 mL/kg/min. Conversely, patients who cannot climb one flight of stairs have .VO(2)max < 10 mL/kg/min. Data on the shuttle walk and 6-min walk are limited, but patients who cannot complete 25 shuttles on two occasions will have .VO(2)max < 10 mL/kg/min. Desaturation during an exercise test has been associated with an increased risk for perioperative complications. Lung volume reduction surgery (LVRS) for patients with severe emphysema is a controversial procedure. Some reports document substantial improvements in lung function, exercise capability, and quality of life in highly selected patients with emphysema following LVRS. Case series of patients referred for LVRS indicate that perhaps 3 to 6% of these patients may have coexisting lung cancer. Anecdotal experience from these case series suggest that patients with extremely poor lung function can tolerate combined LVRS and resection of the lung cancer with an acceptable mortality rate and good postoperative outcomes. Combining LVRS and lung cancer resection should probably be limited to those patients with heterogeneous emphysema, particularly emphysema limited to the lobe containing the tumor.
The following two distinctly different issues should be taken into account when planning patient care following curative-intent therapy for lung cancer: adequate follow-up to manage complications related to the curative-intent therapy; and surveillance to detect recurrences of the primary lung cancer and/or development of a new primary lung cancer early enough to allow potentially curative retreatment. Follow-up for complications should be performed by the specialist responsible for the curative-intent therapy and should last 3 to 6 months. Recurrences of the original lung cancer will be more likely during the first 2 years after curative-intent therapy, but there will be an increased lifelong risk of approximately 1 to 2% per year of developing a metachronous, or new primary, lung cancer. A standard surveillance program for these patients is recommended based on periodic visits, with chest-imaging studies and counseling patients on symptom recognition. Whether subgroups of patients with a higher risk of developing a metachronous lung cancer (eg, those patients whose primary lung cancer was radiographically occult or central and those patients surviving for > 2 years after treatment for small cell lung cancer) should have a more intensive surveillance program is presently unclear. The surveillance program should be coordinated by a multidisciplinary tumor board and overseen by the physician who diagnosed and initiated therapy for the original lung cancer. Smoking cessation is recommended for all patients following curative-intent therapy for lung cancer.
A multidisciplinary panel was convened by the American College of Chest Physicians (ACCP) to develop clinical practice guidelines for lung cancer prevention, diagnosis, and treatment. The ACCP Expert Panel on Lung Cancer Guidelines produced 20 guidelines, each related to a distinct set of management decisions. This article describes the approach used to develop the guidelines, including identifying, evaluating, and synthesizing evidence, assessing the strength of evidence pertinent to individual guidelines, and grading guideline recommendations.
This chapter describes the components of the initial evaluation for a patient either suspected or known to have lung cancer. The components of the initial evaluation are based on the recognized manifestations of localized lung cancer, ie, symptoms referable to the primary tumor, intrathoracic spread of lung cancer, and patterns of metastatic dissemination. Features of the history and physical signs may be useful indicators of the extent of disease. A standardized evaluation, relying on symptoms, signs, and routinely available laboratory tests, can serve as a useful screen for metastatic disease. Also described are the common features of the various paraneoplastic syndromes associated with lung cancer.
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Asthma is a distressing disease, affecting up to 8% of the US population and causing considerable morbidity. Effective management of asthma requires accurate categorization of asthma severity and effective methods for monitoring the activity of the disease with treatment. Currently, symptoms, lung function, and requirements for corticosteroid treatment are the most accepted factors used for asthma severity categorization. Measures of airway hyperresponsiveness, particularly the use of methacholine, may provide additional information regarding the duration of asthma. Assessing airway inflammation using either sputum eosinophilia or exhaled nitric oxide levels has added little to clinical methods for determining asthma severity, but may be useful in monitoring the activity of the disease.