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Biomedical subjects

James K Stoller

Publications and source records attributed to James K Stoller.

At least 55 records · Page 3Linked to original sources
PubMed2003

Augmentation therapy with alpha1-antitrypsin: patterns of use and adverse events.

STUDY OBJECTIVES: To describe patterns of prescribing augmentation therapy, and types and rates of adverse events in the National Heart, Lung, and Blood Institute Registry for Individuals with Severe Deficiency of Alpha(1)-Antitrypsin. DESIGN: Observational cohort study with follow-up visits every 6 to 12 months for up to 7 years. MEASUREMENTS: The rate and dosing frequency with which Registry participants were prescribed to receive augmentation therapy by their managing physicians, and the type and frequency of adverse events, classified in two ways: severity of self-reported symptoms, and actions taken as a consequence of the symptom. RESULTS: Over the course of Registry follow-up, 66% (n = 747) of the participants received augmentation therapy at some time. In keeping with recommendations made in the 1989 American Thoracic Society (ATS) statement, 75% of participants with airflow obstruction at first visit (defined as FEV(1) < 80% predicted) received augmentation therapy within 3 years, though some participants with FEV(1) > or = 80% predicted (14%) also received augmentation therapy. Among those with COPD for whom augmentation therapy was not prescribed, financial constraints were the reported cause in 30%. Observed patterns also varied from approved practice, in that dosing frequencies other than the US Food and Drug Administration-approved, once-weekly regimen were frequently prescribed. The overall rate of reported adverse events was 0.02 per patient-month, with 83% of participants reporting no events. This overall rate was composed of 16% considered mild events, 76% moderate events, and 9% severe events. CONCLUSIONS: We conclude that augmentation therapy was generally well tolerated and, consistent with ATS guidelines, physicians generally did not prescribe augmentation therapy for subjects with FEV(1) > or = 80% predicted. However, the large percentage of subjects with FEV(1) <80% predicted not receiving augmentation therapy and the frequent use of 2- to 3-week or monthly dosing reflects variation of practice from suggested treatment guidelines.

Bronchodilator Agents↗
PubMed2003

Major components of the direct medical costs of alpha1-antitrypsin deficiency.

STUDY OBJECTIVES: To examine the sources of the direct medical costs of alpha(1)-antitrypsin (AAT) deficiency based on survey data from affected individuals. BACKGROUND: Prior research has reported the total cost of AAT deficiency but has not examined the specific components of the direct medical costs of affected individuals. METHODS: In order to detail the sources of the direct medical costs, we sent surveys to 688 respondents of a previous survey. We estimated the costs in three ways, which differed in the method of managing missing values. With method 1, the group mean value of cost per unit of utilization, multiplied by the occurrences of utilization, was used to replace the missing value. Two sensitivity analyses (ie, methods 2 and 3) were conducted to test the robustness of our estimate. With method 2, values of zero were entered for all missing values. With method 3, the missing values were replaced by the group mean value. The Wilcoxon test was used to test the cost differences between patients of different phenotypes. All cost data were expressed in 1998 US dollars. RESULTS AND CONCLUSIONS: Two hundred ninety-two individuals responded to the survey. The annual total health-care costs were high (mean range, $36,471 to $46,114 US dollars; median range, $12,485 to $37,100 US dollars [according to the method for managing missing data]) for AAT deficiency. The total costs for individuals with the PI*ZZ phenotype exceeded those for individuals with a non-PI*ZZ phenotype. The use of IV augmentation therapy accounted for more than half of all direct medical costs for the respondents. Besides the costs for therapy with alpha(1)-proteinase inhibitor (Prolastin; Bayer; West Haven, CT), other major cost sources were prescription drugs other than alpha(1)-proteinase inhibitor, hospitalization, health insurance, and physician visits.

Adult↗
PubMed2003

Long-term outcomes for patients discharged from a long-term hospital-based weaning unit.

BACKGROUND: Because little attention has been given to the long-term outcomes of patients in hospital-based ventilator weaning units, we undertook this assessment of 5-year outcomes of patients discharged from the Respiratory Special Care Unit (ReSCU) of the Cleveland Clinic Hospital. METHODS: The ReSCU consists of six private beds on a pulmonary specialty ward. Features of the unit include noninvasive monitoring with signal output at each bedside and at a central monitoring station. The unit is staffed by nurses with specific pulmonary rehabilitation expertise and has 24-h respiratory therapist supervision. Ongoing prospective data collection in the ReSCU includes monitoring weaning success, demographic features, hospital discharge status, and hospital discharge disposition. Long-term outcomes were ascertained using a review of hospital medical records and direct inquiry to patients and/or family members. RESULTS: Between August 22, 1993, and August 22, 1996, 162 individuals were admitted to the ReSCU, with 7 persons having repeat admissions during separate hospital admissions. Seventeen percent of these persons (n = 27) died during the hospitalization, while 83% were discharged from the index hospitalization (ie, the hospital stay during which the patient was first admitted to the ReSCU). Kaplan-Meier (KM) mortality rate estimates were as follows: 1 month, 11% (95% confidence interval [CI], 6 to 15%); 1 year, 57% (95% CI, 49 to 65%); 2 years, 68% (95% CI, 61 to 75%); 3 years, 73% (95% CI, 66 to 80%); 4 years, 76% (95% CI, 69 to 83%); and 5 years, 81% (95% CI, 75 to 87%). The 5-year KM mortality rate estimates considered by year of ReSCU admission were as follows: 1993, 92% (95% CI, 77 to 100%); 1994, 84% (95% CI, 73 to 95%); 1995, 87% (95% CI, 77 to 96%); and through August 22, 1996, 66% (95% CI, 51 to 81%). CONCLUSIONS: In this population requiring prolonged inpatient ventilatory support, moderately high acute mortality rates are consistent with data from other series. In this analysis of longer-term follow-up rates, the 5-year survival rates are low, with higher mortality rates within the first 2 years and a slower decline in survival thereafter.

Aged↗
PubMed2003

Missed bronchodilator medication treatments in respiratory therapy: frequency and underlying causes.

BACKGROUND: In the context of increasing attention to medical errors, missed therapies have become a subject of focus both for optimizing clinical care and for assuring appropriate institutional performance during external review by accrediting bodies. Because the issue of missed treatments in respiratory therapy has received little attention to date, we undertook to describe the frequency and causes of missed respiratory therapy bronchodilator medication treatments at the Cleveland Clinic Hospital. METHODS: Between August 2000 and August 2001, using a respiratory therapy management information system, we recorded the number of respiratory therapy bronchodilator medication treatments ordered and delivered (via small-volume nebulizer and metered-dose inhaler) and the reason(s) for each missed treatment. RESULTS: Over the 12-month study interval 113,554 bronchodilator medication treatments (74,921 via small-volume nebulizer and 38,633 via metered-dose inhaler) were ordered. Overall, 4,012 medication treatments were missed (3.5% of the total), with variation by month ranging from 2.0% to 5.0%. The commonest reason for failure to administer the ordered bronchodilator treatment was the patient being out of the room at the time of the therapist's visit, which accounted for nearly one third of missed therapies. Next most common was the patient refusing treatment (24.6%), followed by the patient being unavailable because of ongoing activities or therapy (eg, physical therapy or a medical procedure). The least common reason was the respiratory therapist being called away to administer therapy to another patient (1.4%). CONCLUSIONS: Overall, the frequency of missed bronchodilator treatments was relatively low in this series. The next steps include developing strategies to lower the frequency of missed treatments, so as to optimize the allocation of respiratory therapy services, and studying the clinical consequences of missed therapies.

Bronchodilator Agents↗
PubMed2003

Anomalous hepatic venous drainage into the left atrium: an unusual cause of hypoxemia.

A 50-year-old woman with life-long hypoxemia and digital clubbing had a transient ischemic attack at age 47, without identifiable vascular or cardioembolic source. Extensive work-up revealed a 20% anatomic shunt (while breathing 100% oxygen) and evidence of an intrapulmonary shunt (an agitated saline, contrast-enhanced transesophageal echocardiogram showed bubbles in the left atrium and in 3 of the 4 visualized pulmonary veins) but without evidence of the hepatopulmonary syndrome, intrapulmonary arteriovenous malformations, or any intracardiac shunt. She had the congenital anomalies of cleft palate and lip and inferior vena caval interruption with azygos continuation, and anomalous hepatic venous drainage into the left atrium. In keeping with the sparse evidence of 12 previously reported patients with anomalous hepatic-venous-to-left-atrial drainage, the intrapulmonary shunt was believed to result from the diversion of hepatic venous blood from the pulmonary circulation. Surgical correction of the anomalous drainage and restoration of hepatic venous drainage into the right atrium immediately improved oxygenation, and follow-up contrast-enhanced echocardiography 3 months after the surgery showed resolution of the associated intrapulmonary shunt. This case extends the sparse available evidence with this unusual combination of congenital anomalies, reminds clinicians to consider unusual causes of right-to-left shunt and of paradoxical embolization, and invites clarification of the mechanism by which anomalous hepatic venous drainage into the left atrium allows reversible intra-pulmonary right-to-left shunt.

Female↗
PubMed2003

Weekly versus daily changes of in-line suction catheters: impact on rates of ventilator-associated pneumonia and associated costs.

BACKGROUND: An earlier randomized, controlled trial showed that weekly or as-needed (as opposed to daily) changes of in-line suction catheters were associated with substantial cost savings, without a higher rate of ventilator-associated pneumonia (VAP). To examine the impact of decreasing the frequency of in-line suction catheter changes in our medical intensive care unit, we conducted an observational study, comparing the catheter costs and frequency of VAP during (1) a control period, during which in-line suction catheters were changed daily, and (2) a treatment period, during which the catheters were changed every 7 days or sooner if needed, for mechanical failure or soilage. METHODS: All adult patients admitted to our 18-bed medical intensive care unit were evaluated for the 3-month interval 1 year prior to the practice change (May through July 1998) and for the 3 months after implementing the new policy (May through July 1999). To avoid bias related to usual seasonal variation in VAP frequency, we also determined (via medical records) the VAP rate during May through July 1997. The occurrence of VAP was ascertained by an infection control practitioner, using criteria established by the Centers for Disease Control and applied in a standard fashion. The VAP rate was calculated as the mean number of VAPs per 100 ventilator-days for each 3-month interval. Use of ventilators, humidifiers, and non-heated-wire, disposable circuits was uniform during the study, as were policies regarding humidity, temperature settings, and frequency of routine ventilator circuit changes. RESULTS: During the control period 146 patients accounted for 1,075 ventilator-days and there were 2 VAPs (0.19 VAPs per 100 ventilator-days). During the treatment period 143 patients accounted for 1,167 ventilator-days and there were no VAPs. The mean +/- SD duration of in-line suction catheter use during the treatment period was 3.8 +/- 0.8 days, and 51% of the patients had the same catheter in place for > 3 days (range 4-9 days). The actual cost of catheters used during the treatment period was lower than during the control period ($1,330 vs $6,026), predicting annual catheter cost savings of $18,782. CONCLUSIONS: We conclude that (1) a policy of weekly (vs daily) change of in-line suction catheter is associated with substantial cost savings, with no significant increase in the frequency of VAP, and (2) to the extent that these findings confirm the results of prior studies they support a policy of changing in-line suction catheters weekly rather than daily.

Catheterization↗
PubMed2003

Basilar hyperlucency in a patient with emphysema due to hypocomplementemic urticarial vasculitis syndrome.

Disproportionate emphysematous involvement of the lung bases, compared with the apices, sometimes called basilar hyperlucency, is an unusual radiographic pattern that has been reported primarily in patients with alpha-1 antitrypsin deficiency, but also in individuals with emphysema caused by intravenous injection of methylphenidate. We present a patient with emphysema associated with hypocomplementemic urticarial vasculitis syndrome and whose chest radiograph demonstrated basilar hyperlucency. To the extent that basilar hyperlucency has not been well recognized as a feature of hypocomplementemic urticarial vasculitis syndrome, this report extends the spectrum of causes of this unusual radiographic pattern of emphysema.

Complement System Proteins↗
PubMed2003

Key current clinical issues in alpha-1 antitrypsin deficiency.

Alpha-1 antitrypsin deficiency is a common but under-recognized condition on which respiratory therapists can have a large impact. A key recent development is the issuance of an international evidence-based standards document regarding diagnosis and management of individuals with alpha-1 antitrypsin deficiency. This report summarizes that standards document, which recommends more widespread testing for alpha-1 antitrypsin deficiency, in order to extend the benefits of diagnosis to individuals found to have alpha-1 antitrypsin deficiency. An important aspect of the standards document is that evidence regarding the clinical efficacy of intravenous alpha-1 antitrypsin augmentation therapy is reviewed. Though no definitive support from a randomized clinical trial is available, the weight of evidence favors the clinical efficacy of alpha-1 antitrypsin augmentation therapy, at least in individuals with moderate degrees of established airflow obstruction. On that basis the standards document recommends intravenous augmentation therapy in specified clinical circumstances.

Adolescent↗
PubMed2003

Smoking cessation.

Cigarette smoking is the primary cause of chronic obstructive pulmonary disease, and smoking cessation is the most effective means of stopping the progression of chronic obstructive pulmonary disease. Worldwide, approximately a billion people smoke cigarettes and 80% reside in low-income and middle-income countries. Though in the United States there has been a substantial decline in cigarette smoking since 1964, when the Surgeon General's report first reviewed smoking, smoking remains widespread in the United States today (about 23% of the population in 2001). Nicotine is addictive, but there are now effective drugs and behavioral interventions to assist people to overcome the addiction. Available evidence shows that smoking cessation can be helped with counseling, nicotine replacement, and bupropion. Less-studied interventions, including hypnosis, acupuncture, aversive therapy, exercise, lobeline, anxiolytics, mecamylamine, opioid agonists, and silver acetate, have assisted some people in smoking cessation, but none of those interventions has strong research evidence of efficacy. To promote smoking cessation, physicians should discuss with their smoking patients "relevance, risk, rewards, roadblocks, and repetition," and with patients who are willing to attempt to quit, physicians should use the 5-step system of "ask, advise, assess, assist, and arrange." An ideal smoking cessation program is individualized, accounting for the reasons the person smokes, the environment in which smoking occurs, available resources to quit, and individual preferences about how to quit. The clinician should bear in mind that quitting smoking can be very difficult, so it is important to be patient and persistent in developing, implementing, and adjusting each patient's smoking-cessation program. One of the most effective behavioral interventions is advice from a health care professional; it seems not to matter whether the advice is from a doctor, respiratory therapist, nurse, or other clinician, so smoking cessation should be encouraged by multiple clinicians. However, since respiratory therapists interact with smokers frequently, we believe it is particularly important for respiratory therapists to show leadership in implementing smoking cessation.

Adult↗
PubMed2002

Low levels of nitric oxide and carbon monoxide in alpha 1-antitrypsin deficiency.

Quantitations of exhaled nitric oxide (NO) and carbon monoxide (CO) have been proposed as noninvasive markers of airway inflammation. We hypothesized that exhaled CO is increased in individuals with alpha(1)-antitrypsin (AT) deficiency, who have lung inflammation and injury related to oxidative and proteolytic processes. Nineteen individuals with alpha(1)-AT deficiency, 22 healthy controls, and 12 patients with non-alpha(1)-AT-deficient chronic obstructive pulmonary disease (COPD) had NO, CO, CO(2), and O(2) measured in exhaled breath. Individuals with alpha(1)-AT deficiency had lower levels of NO and CO than control or COPD individuals. Alpha(1)-AT-deficient and COPD patients had lower exhaled CO(2) than controls, although only alpha(1)-AT-deficient patients had higher exhaled O(2) than healthy controls. NO was correlated inversely with exhaled O(2) and directly with exhaled CO(2), supporting a role for NO in regulation of gas exchange. Exhaled gases were not significantly related to corticosteroid use or lung function. Demonstration of lower than normal CO and NO levels may be useful as an additional noninvasive method to evaluate alpha(1)-AT deficiency in individuals with a severe, early onset of obstructive lung disease.

Administration, Inhalation↗
PubMed2002

The pulmonologist's perspective regarding the solitary pulmonary nodule.

The pulmonologist's goal in managing a patient with a solitary pulmonary nodule is to distinguish the benign from malignant nodule and, where malignancy is either confirmed or strongly suspected, to expedite resection. By using established clinical features (eg, age, smoking status) and radiographic findings (eg, calcification, growth rate, size), a probability of malignancy can be determined. If necessary, noninvasive or adjuvant invasive testing is used to alter the probability to one that permits observation or demands resection. The proper use of these tests mandates knowledge about their performance characteristics. Decision-analytic approaches, using Bayesian analysis, may assist with the calculation of probability. These models have not consistently outperformed the clinician or adjuvant testing. The use of low-dose computed tomography (CT) scanning as a screening tool has led to the discovery of many small, indeterminate nodules. Management decisions for these nodules are influenced by their low prevalence of malignancy and small size. Future advances will add to our ability to effectively meet our stated goal.

Decision Making↗
PubMed2002

Biochemical efficacy and safety of a new pooled human plasma alpha(1)-antitrypsin, Respitin.

BACKGROUND: Augmentation therapy with pooled human plasma-derived alpha(1)-antitrypsin (AAT) has been shown to have biochemical efficacy in restoring serum AAT levels above the protective threshold. Also, clinical efficacy has been suggested. OBJECTIVE: To evaluate the bioequivalence of a new solvent detergent-treated preparation of pooled human plasma-derived AAT (proposed name Respitin; Alpha Therapeutic Corporation; Los Angeles, CA) to the commercially available preparation (Prolastin; Bayer Corporation; West Haven, CT), we conducted a randomized controlled trial. METHODS: Eligible subjects were adults (> 18 years of age) who had never smoked or were ex-smokers, had severe deficiency of AAT, and had fixed airflow obstruction (ie, postbroncholdilator FEV(1) of 30 to 80% of predicted values and/or diffusing capacity of the lung for carbon monoxide [DLCO] of < 70% of predicted values with evidence of emphysema on a CT scan). Of the 28 subjects recruited, 26 completed the 12-week comparison. Participants were randomized to receive Respitin (60 mg/kg once weekly; 14 subjects) or Prolastin (60 mg/kg once weekly; 14 subjects), and recipients of Prolastin then crossed over to receive Respitin thereafter for the 24-week duration of the study. RESULTS: The primary efficacy criteria were satisfied for equivalence to comparator (ie, the ratio of mean trough serum levels for Respitin/Prolastin at weeks 8 to 11 exceeded the efficacy criterion [0.905; p = 0.0206] as did the slope of the mean trough level over weeks 11 to 23 [-0.003 micromol per week]). In Respitin recipients, the trough serum antineutrophil elastase capacity at week 7 and at weeks 8 to 11 was also equivalent to the comparator, as was the rise in AAT levels in epithelial lining fluid from baseline to week 7. The levels of urinary elastin degradation products showed little appreciable change for > 24 weeks, and no difference between compared groups was shown through week 12. Adverse events were similarly infrequent in compared groups. Finally, neither spirometry measurements nor DLCO showed a significant change through 24 weeks. CONCLUSIONS: We conclude that this new solvent detergent-treated pooled human plasma-derived AAT (Respitin) demonstrates biochemical equivalence to Prolastin and that this new drug is well-tolerated.

Adult↗
PubMed2002

Emphysema in nonsmokers: alpha 1-antitrypsin deficiency and other causes.

Nonsmokers with signs of emphysema at an earlier age than is typical for emphysema deserve a workup for one of the less common causes of emphysema, which include alpha 1-antitrypsin deficiency, connective tissue diseases, hypocomplementemic urticarial vasculitis syndrome, intravenous drug use, human immunodeficiency virus infection, and several rare metabolic disorders.

Age of Onset↗
PubMed2002

Bedside spirometry in a tertiary care hospital: the cleveland clinic experience.

BACKGROUND: In contrast to outpatient, laboratory testing, which is performed by a small, dedicated group of pulmonary function technologists, inpatient, bedside spirometry at the Cleveland Clinic Hospital is performed less frequently and by a larger group of respiratory therapists with broader responsibilities. A 1998 audit of bedside spirometry tests at our hospital showed that American Thoracic Society acceptability and reproducibility criteria were infrequently met (15% of instances). METHODS: To address that shortcoming, we initiated an improvement plan for bedside spirometry that included: (1) A didactic review of American Thoracic Society acceptability and reproducibility criteria that was videotaped and reviewed by all but one of the therapists performing spirometry; (2) limiting the number of operators to a "core group" to allow more tests per therapist; (3) producing printouts of the pulmonary function tests, which allows immediate review of volume-time and flow-volume curves; (4) central review of all tests by a pulmonary function technologist and feedback and constructive suggestions on test quality and reproducibility to operators. After initiating the program we performed a consecutive survey of all inpatient spirometry sessions performed from July 16, 1998, to March 2, 1999. RESULTS: During the survey period, 63.5% of the tests (n = 137) were deemed acceptable, exceeding the low baseline rate of 15% (p < 0.001). Values for forced expiratory volume in the first second were reproducible in 83.9% of sessions. Values for forced vital capacity were reproducible in 80.3% of sessions. CONCLUSION: A quality improvement program for bedside spirometry testing that emphasizes training and routine feedback on test quality can enhance the quality of inpatient spirometry testing.

Clinical Competence↗
PubMed2002

Impact of a radio frequency management information system on the process and timing of providing respiratory care services.

BACKGROUND: Although radio frequency (RF) systems have proliferated and are designed to simplify care delivery in many clinical settings, little information is available on the impact of such RF systems on the delivery of patient care. Having used a hand-held-device-based management information system in our Respiratory Therapy Section for 16 years, we assessed the impact of an RF system on the delivery of respiratory therapy (RT) services. METHODS: A single nursing unit dedicated to pulmonary and ear, nose, and throat care was selected for the RF system trial. Baseline (pre-RF) data were collected over 2 separate 1-month intervals (February 1999 and February 2000). The main outcome measures were (1) the amount of time needed at the beginning of the shift to organize and assign orders for RT services, (2) the time interval between notification of an RT consult order and completion of the RT consult, and (3) the time interval between notification of an RT treatment order and completion of the RT treatment. The activities required for organizing and assigning the orders were manually timed. Starting 6 weeks after therapists were trained to use the RF system, similar data were collected while using the RF system for two 1-month intervals (February and March 2001). RESULTS: The mean +/- SD time interval between receiving an RT consult order and completing the consult was reduced from 7.8 +/- 18.9 h to 2.8 +/- 2.4 h (p = 0.002). The percentage of patients who waited longer than 8 hours between receipt of a consult order and completion of the consult decreased from 18% to 4.7% (p = 0.026). The total time required for organizing and assigning RT work was reduced from 81.6 min to 43.6 min. CONCLUSIONS: The RF system had several advantages over the hand-held-device-based system: (1) shorter interval between the order for and completion of an RT consult, (2) lower percentage of patients for whom the interval between the order and the consult exceeded 8 hours, and (3) less time required to make shift assignments. These results invite assessment of whether accelerated delivery of RT services confers clinical benefits.

Allied Health Personnel↗