Coping with critical drug shortages: an ethical approach for allocating scarce resources in hospitals.

The number of critical medication shortages in the United States has reached an unprecedented level, requiring decisions about allocating limited drug supplies. Ad hoc decisions are susceptible to arbitrary judgments, revealing preformed biases for or against groups of people. Health care institutions lack standardized protocols for rationing scarce drugs. We describe the principles on which an ethically justifiable policy of medication allocation during critical shortages was created at our hospital. Based on supportable scientific evidence and with all clinically similar patients treated as similarly deserving of consideration, drugs were distributed according to a hierarchy of clinical need and predicted efficacy. We explain the ethical rationale for the procedures we adopted, how the policy was implemented at a large academic medical center, and more than 1 year of experience with a number of different medications. Our experience has demonstrated the feasibility and utility of formulating a rational and ethically sound policy for scarce resource allocation in an academic teaching hospital that could be used in a variety of health care settings. The method has proven to be reliable, workable, and acceptable to clinicians, staff, and patients.

Development of a collaborative program to provide extracorporeal membrane oxygenation for adults with refractory hypoxemia within the framework of a pandemic.

OBJECTIVE: We report the process used to rapidly develop a collaborative adult respiratory extracorporeal membrane oxygenation program as a response to caring for young adult patients with refractory hypoxemia in the setting of the pH1N1 pandemic. DESIGN: Interdisciplinary response of a complex medical system to a public health crisis. PATIENTS, INTERVENTIONS, MEASUREMENTS, AND MAIN RESULTS: After the successful use of extracorporeal membrane oxygenation in young adults with pH1N1-induced acute respiratory distress syndrome refractory to conventional therapies, an adult venovenous extracorporeal membrane oxygenation program was implemented over an 8-wk period. Implementation of this program involved a number of key steps that were crucial in the development process, including administrative and institutional support, multidisciplinary leadership and collaboration, extensive interdisciplinary educational initiatives, and substantial technical modifications. CONCLUSIONS: In the setting of the pH1N1 influenza pandemic, an adult respiratory extracorporeal membrane oxygenation program was successfully developed to complement an established neonatal-pediatric program. This program expansion integrated all of the necessary components involved in the development process from start to finish and confirms that a healthcare system can respond very quickly and successfully to an urgent healthcare need.

One-year trajectories of care and resource utilization for recipients of prolonged mechanical ventilation: a cohort study.

BACKGROUND: Growing numbers of critically ill patients receive prolonged mechanical ventilation. Little is known about the patterns of care as patients transition from acute care hospitals to postacute care facilities or about the associated resource utilization. OBJECTIVE: To describe 1-year trajectories of care and resource utilization for patients receiving prolonged mechanical ventilation. DESIGN: 1-year prospective cohort study. SETTING: 5 intensive care units at Duke University Medical Center, Durham, North Carolina. PARTICIPANTS: 126 patients receiving prolonged mechanical ventilation (defined as ventilation for >or=4 days with tracheostomy placement or ventilation for >or=21 days without tracheostomy), as well as their 126 surrogates and 54 intensive care unit physicians, enrolled consecutively over 1 year. MEASUREMENTS: Patients and surrogates were interviewed in the hospital, as well as 3 and 12 months after discharge, to determine patient survival, functional status, and facility type and duration of postdischarge care. Physicians were interviewed in the hospital to elicit prognoses. Institutional billing records were used to assign costs for acute care, outpatient care, and interfacility transportation. Medicare claims data were used to assign costs for postacute care. RESULTS: 103 (82%) hospital survivors had 457 separate transitions in postdischarge care location (median, 4 transitions [interquartile range, 3 to 5 transitions]), including 68 patients (67%) who were readmitted at least once. Patients spent an average of 74% (95% CI, 68% to 80%) of all days alive in a hospital or postacute care facility or receiving home health care. At 1 year, 11 patients (9%) had a good outcome (alive with no functional dependency), 33 (26%) had a fair outcome (alive with moderate dependency), and 82 (65%) had a poor outcome (either alive with complete functional dependency [4 patients; 21%] or dead [56 patients; 44%]). Patients with poor outcomes were older, had more comorbid conditions, and were more frequently discharged to a postacute care facility than patients with either fair or good outcomes (P < 0.05 for all). The mean cost per patient was $306,135 (SD, $285,467), and total cohort cost was $38.1 million, for an estimated $3.5 million per independently functioning survivor at 1 year. LIMITATION: The results of this single-center study may not be applicable to other centers. CONCLUSION: Patients receiving prolonged mechanical ventilation have multiple transitions of care, resulting in substantial health care costs and persistent, profound disability. The optimism of surrogate decision makers should be balanced by discussions of these outcomes when considering a course of prolonged life support. PRIMARY FUNDING SOURCE: None.

Rescue therapy in adult and pediatric patients with pH1N1 influenza infection: a tertiary center intensive care unit experience from April to October 2009.

OBJECTIVE: Severe respiratory failure is a well-recognized complication of pH1N1 influenza infection. Limited data regarding the efficacy of rescue therapies, including high-frequency oscillatory ventilation and extracorporeal membrane oxygenation, have been previously reported in the setting of pH1N1 influenza infection in the United States. DESIGN: Retrospective, single-center cohort study. SETTING: Pediatric, cardiac, surgical, and medical intensive care units in a single tertiary care center in the United States. PATIENTS: One hundred twenty-seven consecutive patients with confirmed influenza A infection requiring hospitalization between April 1, 2009, and October 31, 2009. INTERVENTIONS: Electronic medical records were reviewed for demographic and clinical data. MEASUREMENTS AND MAIN RESULTS: The number of intensive care unit admissions appears inversely related to age with 39% of these admissions <20 yrs of age. Median duration of intensive care unit care was 10.0 days (4.0-24.0), and median duration of mechanical ventilation was 8.0 days (0.0-23.5). Rescue therapy (high-frequency oscillatory ventilation or extracorporeal membrane oxygenation) was used in 36% (12 of 33) of intensive care unit patients. The severity of respiratory impairment was determined by Pao²/Fio² ratio and oxygenation index. High-frequency oscillatory ventilation at 24 hrs resulted in improvements in median Pao²/Fio² ratio (71 [58-93] vs. 145 [126-185]; p < .001), oxygenation index (27 [20-30] vs. 18 [12-25]; p = .016), and Fio2 (100 [70-100] vs. 45 [40-55]; p < .001). Extracorporeal membrane oxygenation resulted in anticipated improvement in parameters of oxygenation at both 2 hrs and 24 hrs after initiation of therapy. Despite the severity of oxygenation impairment, overall survival for both rescue therapies was 75% (nine of 12), 80% (four of five) for high-frequency oscillatory ventilation alone, and 71% (five of seven) for high-frequency oscillatory ventilation + extracorporeal membrane oxygenation. CONCLUSION: In critically ill adult and pediatric patients with pH1N1 infection and severe lung injury, the use of high-frequency oscillatory ventilation and extracorporeal membrane oxygenation can result in significant improvements in Pao²/Fio² ratio, oxygenation index, and Fio². However, the impact on mortality is less certain.

Expectations and outcomes of prolonged mechanical ventilation.

OBJECTIVE: To compare prolonged mechanical ventilation decision-makers' expectations for long-term patient outcomes with prospectively observed outcomes and to characterize important elements of the surrogate-physician interaction surrounding prolonged mechanical ventilation provision. Prolonged mechanical ventilation provision is increasing markedly despite poor patient outcomes. Misunderstanding prognosis in the prolonged mechanical ventilation decision-making process could provide an explanation for this phenomenon. DESIGN: Prospective observational cohort study. SETTING: Academic medical center. PATIENTS: A total of 126 patients receiving prolonged mechanical ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Participants were interviewed at the time of tracheostomy placement about their expectations for 1-yr patient survival, functional status, and quality of life. These expectations were then compared with observed 1-yr outcomes measured with validated questionnaires. The 1-yr follow-up was 100%, with the exception of patient death or cognitive inability to complete interviews. At 1 yr, only 11 patients (9%) were alive and independent of major functional status limitations. Most surrogates reported high baseline expectations for 1-yr patient survival (n = 117, 93%), functional status (n = 90, 71%), and quality of life (n = 105, 83%). In contrast, fewer physicians described high expectations for survival (n = 54, 43%), functional status (n = 7, 6%), and quality of life (n = 5, 4%). Surrogate-physician pair concordance in expectations was poor (all kappa = <0.08), as was their accuracy in outcome prediction (range = 23%-44%). Just 33 surrogates (26%) reported that physicians discussed what to expect for patients' likely future survival, general health, and caregiving needs. CONCLUSIONS: One-year patient outcomes for prolonged mechanical ventilation patients were significantly worse than expected by patients' surrogates and physicians. Lack of prognostication about outcomes, discordance between surrogates and physicians about potential outcomes, and surrogates' unreasonably optimistic expectations seem to be potentially modifiable deficiencies in surrogate-physician interactions.

Economic evaluation of propofol and lorazepam for critically ill patients undergoing mechanical ventilation.

OBJECTIVE: The economic implications of sedative choice in the management of patients receiving mechanical ventilation are unclear because of differences in costs and clinical outcomes associated with specific sedatives. Therefore, we aimed to determine the cost-effectiveness of the most commonly used sedatives prescribed for mechanically ventilated critically ill patients. DESIGN, SETTING, AND PATIENTS: Adopting the perspective of a hospital, we developed a probabilistic decision model to determine whether continuous propofol or intermittent lorazepam was associated with greater value when combined with daily awakenings. We also evaluated the comparative value of continuous midazolam in secondary analyses. We assumed that patients were managed in a medical intensive care unit and expected to require ventilation for > or = 48 hrs. Model inputs were derived from primary analysis of randomized controlled trial data, medical literature, Medicare reimbursement rates, pharmacy databases, and institutional data. MAIN RESULTS: We measured cost-effectiveness as costs per mechanical ventilator-free day within the first 28 days after intubation. Our base-case probabilistic analysis demonstrated that propofol dominated lorazepam in 91% of simulations and, on average, was both $6,378 less costly per patient and associated with more than three additional mechanical ventilator-free days. The model did not reveal clinically meaningful differences between propofol and midazolam on costs or measures of effectiveness. CONCLUSION: Propofol has superior value compared with lorazepam when used for sedation among the critically ill who require mechanical ventilation when used in the setting of daily sedative interruption.

Broncholith removal using cryotherapy during flexible bronchoscopy: a case report.

Pulmonary broncholithiasis can cause a management dilemma depending on its location and the possible involvement of vascular structures. Many patients undergo rigid bronchoscopy or surgical interventions for the removal of broncholiths. In this case report, we describe a 38-year-old white man with a history of performing warehouse demolitions who presented with chronic cough, dyspnea on exertion, and recurrent pneumonia. Imaging studies revealed hilar and mediastinal calcifications, as well as a calcification in the right middle lobe bronchus. Flexible bronchoscopy revealed a mobile obstructing calcified mass in the right middle lobe bronchus. Attempts at removing the mass with forceps were unsuccessful. Instead, the mass was removed using cryotherapy with minimal bleeding and complete resolution of the obstruction. Pathologic examination confirmed that the mass was a broncholith, and stains revealed the presence of histoplasma fungal forms. Partially attached broncholiths can be removed safely using flexible bronchoscopy with the aid of cryotherapy.

Evidence for the treatment of patients with pulmonary nodules: when is it lung cancer?: ACCP evidence-based clinical practice guidelines (2nd edition).

BACKGROUND: The solitary pulmonary nodule (SPN) is a frequent incidental finding that may represent primary lung cancer or other malignant or benign lesions. The optimal management of the SPN remains unclear. METHODS: We conducted a systematic literature review to address the following questions: (1) the prevalence of SPN; (2) the prevalence of malignancy in nodules with varying characteristics (size, morphology, and type of opacity); (3) the relationships between growth rates, histology, and other nodule characteristics; and (4) the performance characteristics and complication rates of tests for SPN diagnosis. We searched MEDLINE and other databases and used previous systematic reviews and recent primary studies. RESULTS: Eight large trials of lung cancer screening showed that both the prevalence of at least one nodule (8 to 51%) and the prevalence of malignancy in patients with nodules (1.1 to 12%) varied considerably across studies. The prevalence of malignancy varied by size (0 to 1% for nodules < 5 mm, 6 to 28% for nodules 5 to 10 mm, and 64 to 82% for nodules > 20 mm). Data from six studies of patients with incidental or screening-detected nodules showed that the risk for malignancy was approximately 20 to 30% in nodules with smooth edges; in nodules with irregular, lobulated, or spiculated borders, the rate of malignancy was higher but varied across studies from 33 to 100%. Nodules that were pure ground-glass opacities were more likely to be malignant (59 to 73%) than solid nodules (7 to 9%). The sensitivity of positron emission tomography imaging for identifying a malignant SPN was consistently high (80 to 100%), whereas specificity was lower and more variable across studies (40 to 100%). Dynamic CT with nodule enhancement yielded the most promising sensitivity (sensitivity, 98 to 100%; specificity, 54 to 93%) among imaging tests. In studies of CT-guided needle biopsy, nondiagnostic results were seen approximately 20% of the time, but sensitivity and specificity were excellent when biopsy yielded a specific benign or malignant result. CONCLUSIONS: The prevalence of an SPN and the prevalence of malignancy in patients with an SPN vary widely across studies. The interpretation of these variable prevalence rates should take into consideration not only the nodule characteristics but also the population at risk. Modern imaging tests and CT-guided needle biopsy are highly sensitive for identifying a malignant SPN, but the specificity of imaging tests is variable and often poor.

An economic evaluation of prolonged mechanical ventilation.

OBJECTIVE: Patients who receive prolonged mechanical ventilation have high resource utilization and relatively poor outcomes, especially the elderly, and are increasing in number. The economic implications of prolonged mechanical ventilation provision, however, are uncertain and would be helpful to providers and policymakers. Therefore, we aimed to determine the lifetime societal value of prolonged mechanical ventilation. DESIGN AND PATIENTS: Adopting the perspective of a healthcare payor, we developed a Markov model to determine the cost effectiveness of providing mechanical ventilation for at least 21 days to a 65-yr-old critically ill base-case patient compared with the provision of comfort care resulting in withdrawal of ventilation. Input data were derived from the medical literature, Medicare, and a recent large cohort study of ventilated patients. MEASUREMENTS AND MAIN RESULTS: We determined lifetime costs and survival, quality-adjusted life expectancy, and cost effectiveness as reflected by costs per quality-adjusted life-year gained. Providing prolonged mechanical ventilation to the base-case patient cost "dollars"55,460 per life-year gained and "dollars"82,411 per quality-adjusted life-year gained compared with withdrawal of ventilation. Cost-effectiveness ratios were most sensitive to variation in age, hospital costs, and probability of readmission, although less sensitive to postacute care-facility costs. Specifically, incremental costs per quality-adjusted life-year gained by prolonged mechanical ventilation provision exceeded "dollars"100,000 with age >or=68 and when predicted 1-yr mortality was >50%. CONCLUSIONS: The cost effectiveness of prolonged mechanical ventilation provision varies dramatically based on age and likelihood of poor short- and long-term outcomes. Identifying patients likely to have unfavorable outcomes, lowering intensity of care for appropriate patients, and reducing costly readmissions should be future priorities in improving the value of prolonged mechanical ventilation.

Differences in one-year health outcomes and resource utilization by definition of prolonged mechanical ventilation: a prospective cohort study.

INTRODUCTION: The outcomes of patients ventilated for longer than average are unclear, in part because of the lack of an accepted definition of prolonged mechanical ventilation (PMV). To better understand the implications of PMV provision, we compared one-year health outcomes between two common definitions of PMV as well as between PMV patients and those ventilated for shorter periods of time. METHODS: We conducted a secondary analysis of prospectively collected data from medical and surgical intensive care units at an academic tertiary care medical center. The study included 817 critically ill patients ventilated for > or = 48 hours, 267 (33%) of whom received PMV based on receipt of a tracheostomy and ventilation for > or = 96 hours. A total of 114 (14%) patients met the alternate definition of PMV by being ventilated for > or = 21 days. Survival, functional status, and costs were measured at baseline and at 2, 6, and 12 months after discharge. Of one-year survivors, 71 (17%) were lost to follow up. RESULTS: PMV patients ventilated for > or = 21 days had greater costs ($140,409 versus $143,389) and higher one-year mortality (58% versus 48%) than did PMV patients with tracheostomies who were ventilated for > or = 96 hours. The majority of PMV deaths (58%) occurred after hospital discharge whereas 67% of PMV patients aged 65 years or older had died by one year. At one year PMV patients on average had limitations in two basic and five instrumental elements of functional status that exceeded both their pre-admission status and the one-year disability of those ventilated for < 96 hours. Costs per one-year survivor were $423,596, $266,105, and $165,075 for patients ventilated > or = 21 days, > or = 96 hours with a tracheostomy, and < 96 hours, respectively. CONCLUSION: Contrasting definitions of PMV capture significantly different patient populations, with > or = 21 days of ventilation specifying the most resource-intensive recipients of critical care. PMV patients, particularly the elderly, suffer from a significant burden of costly, chronic critical illness and are at high risk for death throughout the first year after intensive care.

Contraindications and safety of transbronchial lung biopsy via flexible bronchoscopy. A survey of pulmonologists and review of the literature.

BACKGROUND: Transbronchial lung biopsy (TBLB) via flexible bronchoscopy is a common procedure performed by pulmonologists. Limited scientific data exist concerning the risk of this procedure in patients with conditions that may adversely affect the rate of procedural complications. OBJECTIVES: To evaluate the current practice pattern and attitude of pulmonologists toward the performance of TBLB in the presence of high-risk conditions. METHODS: A survey was constructed and distributed at the American College of Chest Physicians annual meeting, held in Philadelphia, USA, in November of 2001. RESULTS: A total of 227 surveys were distributed with a return of 158 (69.6%). Anticoagulation medications are temporarily held prior to TBLB by the majority of our survey respondents (98.7% for intravenous heparin, 90.5% for warfarin, and 87.3% for low-molecular-weight heparin). Medications with effect on platelet function are held by fewer pulmonologists. There is a wide variation in the pulmonologists' perception of the risk of performing TBLB when certain medical conditions coexist: pulmonary hypertension [absolute contraindication (AC), 28.7%; relative contraindication (RC) 58.6%], superior vena cava syndrome (AC 19.6%, RC 51%), mechanical ventilation (AC 17.8%, RC 58.6%) and lung cavity/abscess (AC 7%, RC 44.9%). A significant percentage of pulmonologists (55%) do not regard an elevated serum creatinine at any level as AC to TBLB. Thirty-eight percent of the survey participants administer desmopressin prior to TBLB in uremic patients to prevent excessive bleeding. CONCLUSIONS: Prior to performing bronchoscopic TBLB, the majority of pulmonologists temporarily holds anticoagulation medications. However, there is a lack of agreement in relation to perceived contraindications and safety of TBLB.

Outcome of lung transplant patients admitted to the medical ICU.

INTRODUCTION: Lung transplantation is an acceptable treatment option for end-stage lung disease. Short-term survival has improved, but lung transplant recipients remain at high risk for a variety of complications that can necessitate care in an ICU. Little is known about the epidemiology, clinical outcomes, and risk factors for survival among lung transplant recipients admitted to the ICU. METHODS: All lung transplant recipients at a single institution discharged from the hospital after their transplant and subsequently admitted to the medical ICU (MICU) between March 1, 1999, and February 28, 2001, were included. Patients were followed until death or February 28, 2002. Demographic data collected included transplant type and date, APACHE (acute physiology and chronic health evaluation) III scores, last preadmission and best posttransplant FEV(1) in liters, admitting diagnosis, use of mechanical ventilation, and previous MICU admission. RESULTS: There were 51 patients admitted to the MICU during the study period (73 total admissions). Their demographic data, pretransplant diagnoses, and type of transplant were similar to those of the rest of Duke University Medical Center lung transplant patients. Fifty-three percent (27 of 51 patients) required mechanical ventilation during their first MICU admission. Thirty-seven percent (19 of 51 patients) died during their first MICU admission. Fifty-nine percent (16 of 27 patients) receiving mechanical ventilation died. Patients who died had lower FEV(1) to posttransplant best FEV(1) ratio prior to MICU admission, and also had higher APACHE III scores on MICU admission compared to survivors: FEV(1), 51.3 +/- 21.9% (n = 14) vs 75.5 +/- 20.4% (n = 30) [p = 0.001]; APACHE III score, 77.7 +/- 21.4 (n = 19) vs 60.1 +/- 16.5 (n = 32) [p = 0.002]. Survival rates by Kaplan-Meier analysis at 1 year and 2 years after initial MICU admission were 43.1% and 40.9%, respectively. The longest survivor is currently alive 1,087 days after initial MICU admission. CONCLUSION: Admission to the MICU is common in lung transplant recipients. MICU care, including mechanical ventilation, is associated with a poor prognosis in lung transplant recipients, but is appropriate for selected patients with good allograft function.

Clinical practice guidelines for the maintenance of patient physical safety in the intensive care unit: use of restraining therapies--American College of Critical Care Medicine Task Force 2001-2002.

OBJECTIVE: To develop clinical practice guidelines for the use of restraining therapies to maintain physical and psychological safety of adult and pediatric patients in the intensive care unit. PARTICIPANTS: A multidisciplinary, multispecialty task force of experts in critical care practice was convened from the membership of the American College of Critical Care Medicine (ACCM), the Society of Critical Care Medicine (SCCM), and the American Association of Critical Care Nurses (AACN). EVIDENCE: The task force members reviewed the published literature (MEDLINE articles, textbooks, etc.) and provided expert opinion from which consensus was derived. Relevant published articles were reviewed individually for validity using the Cochrane methodology (http://hiru.mcmaster.ca/cochrane/ or www.cochrane.org). CONSENSUS PROCESS: The task force met as a group and by teleconference to identify the pertinent literature and derive consensus recommendations. Consideration was given to both the weight of scientific information within the literature and expert opinion. Draft documents were composed by a task force steering committee and debated by the task force members until consensus was reached by nominal group process. The task force draft then was reviewed, assessed, and edited by the Board of Regents of the ACCM. After steering committee approval, the draft document was reviewed and approved by the SCCM Council. CONCLUSIONS: The task force developed nine recommendations with regard to the use of physical restraints and pharmacologic therapies to maintain patient safety in the intensive care unit.

Effectiveness of medical resident education in mechanical ventilation.

Specific methods of mechanical ventilation management reduce mortality and lower health care costs. However, in the face of a predicted deficit of intensivists, it is unclear whether residency programs are training internists to provide effective care for patients who require mechanical ventilation. To evaluate these educational outcomes, we administered a validated 19-item case-based test and survey to resident physicians at 31 diverse U.S. internal medicine residency programs nationwide. Of 347 senior residents, 259 (75%) responded. The mean test score was 74% correct (SD, 14%; range, 37 to 100%). Important items representing evidence-based standards of critical care answered incorrectly were as follows: use of appropriate tidal volume in the acute respiratory distress syndrome (48% incorrect), identifying a patient ready for a weaning trial (38% incorrect), and recognizing indication for noninvasive ventilation (27% incorrect). Most accurately identified pneumothorax (86% correct) and increased intrathoracic positive end-expiratory pressure (93% correct). Better scores were associated with "closed" versus "open" intensive care unit organization (76 versus 71% correct, p = 0.001), resident perception of greater versus lesser ventilator knowledge (79 versus 71% correct, p = 0.001), and graduation from a U.S. versus international medical school (75 versus 69% correct, p = 0.033). Although overall training satisfaction correlated strongly with program use of learning objectives (r = 0.89, p < 0.0001), only 46% reported being satisfied with their mechanical ventilation training. We conclude that senior residents may not be gaining essential evidence-based knowledge needed to provide effective care for patients who require mechanical ventilation. Residency programs should emphasize evidence-based learning objectives to guide mechanical ventilation instruction.