M. Michael Shabot

The CRIT Study: Anemia and blood transfusion in the critically ill--current clinical practice in the United States.

ObjectiveTo quantify the incidence of anemia and red blood cell (RBC) transfusion practice in critically ill patients and to examine the relationship of anemia and RBC transfusion to clinical outcomes. DesignProspective, multiple center, observational cohort study of intensive care unit (ICU) patients in the United States. Enrollment period was from August 2000 to April 2001. Patients were enrolled within 48 hrs of ICU admission. Patient follow-up was for 30 days, hospital discharge, or death, whichever occurred first. SettingA total of 284 ICUs (medical, surgical, or medical-surgical) in 213 hospitals participated in the study. PatientsA total of 4,892 patients were enrolled in the study. Measurements and Main ResultsThe mean hemoglobin level at baseline was 11.0 ± 2.4 g/dL. Hemoglobin level decreased throughout the duration of the study. Overall, 44% of patients received one or more RBC units while in the ICU (mean, 4.6 ± 4.9 units). The mean pretransfusion hemoglobin was 8.6 ± 1.7 g/dL. The mean time to first ICU transfusion was 2.3 ± 3.7 days. More RBC transfusions were given in study week 1; however, in subsequent weeks, subjects received one to two RBC units per week while in the ICU. The number of RBC transfusions a patient received during the study was independently associated with longer ICU and hospital lengths of stay and an increase in mortality. Patients who received transfusions also had more total complications and were more likely to experience a complication. Baseline hemoglobin was related to the number of RBC transfusions, but it was not an independent predictor of length of stay or mortality. However, a nadir hemoglobin level of <9 g/dL was a predictor of increased mortality and length of stay. ConclusionsAnemia is common in the critically ill and results in a large number of RBC transfusions. Transfusion practice has changed little during the past decade. The number of RBC units transfused is an independent predictor of worse clinical outcome.

Lessons From “Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System”

We are writing in response to the article “Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System” by Han et al.1 The authors are to be congratulated for their courage in bringing their compelling account of computerized physician order entry (CPOE) implementation problems to the medical literature as they tried to interpret their results concerning mortality. Their article is as much a search for answers as it is a recitation of the shortfalls in their implementation process and computer systems. It is critically important to understand that the types of problems described by Han et al are not limited to their institution. In fact, setbacks and failures in the implementation of clinical information systems (CISs) and CPOE systems are all too common (eg, see refs 2–4). Although it is tempting to focus solely on the role of new technology in the problems highlighted by this example, there are also important lessons to be learned about related organizational and workflow factors that affect the potential for danger associated with CPOE implementation. There are many previous publications about troubled or failed implementations. The account by Han et al is unique in that an adverse change in mortality rate was associated in time with CIS and CPOE implementation. We may question the studys methodology and conclude that causality was not proven, yet the assignment of CPOE to a severity-adjusted odds ratio of 3.71 for patient death simply cannot be ignored. Regardless of what was or was not proven, if only one unnecessary death were caused by the implementation process or CIS and CPOE modules, that is one too many. The question that must be asked is how can intelligent and well-intentioned leaders at all levels of an institution make the kind of implementation … Address correspondence to Dean F. Sittig, PhD, Kaiser Permanente Center for Health Research, 3800 N Interstate Ave, Portland, OR 97227. E-mail: dean.f.sittig{at}kp.org

Aspiration cytology is superior to Tru-Cut needle biopsy in establishing the diagnosis of clinically suspicious breast masses

Eighty-one consecutive patients with breast masses clinically suspicious for malignancy were evaluated prospectively. There were 31 benign lesions and 50 malignancies. Clinical diagnosis was correct in 85% (2.5% false negative, 12.5% false positive). Mammography was diagnostic in 52.8% (31.5% false negative, 15.7% false positive). Needle biopsy was accurate in 78.9% (21.1% false negative, 0% false positive). Aspiration cytology was diagnostic in 96.2% (3.8% false negative, 0% false positive). Statistical comparison of all four tests revealed that aspiration cytology was slightly more accurate than physical examination for all lesions (p = 0.07), but significantly more accurate for benign lesions (p = 0.005). Overall, aspiration cytology was significantly more accurate than mammography (p = 0.000001) and needle biopsy (p = 0.008). Only one minor complication, a superficial infection, occurred with aspiration cytology and needle biopsy. Thin-needle aspiration cytology is a benign procedure that appears to be superior to physical examination, mammography, and needle biopsy in establishing the diagnosis of clinically suspicious breast masses.

Anemia and blood transfusion in trauma patients admitted to the intensive care unit

BACKGROUND Anemia is a common occurrence in the intensive care unit (ICU). Although resuscitation, including the use of blood, is a mainstay of early treatment of trauma victims, the safety and efficacy of red blood cell (RBC) transfusion has come under scrutiny recently. The issue of blood use in critically injured patients requires evaluation. METHODS This was a post hoc analysis of a subset of trauma patients (> or =18 years in age) from a prospective, multicenter, observational, cohort study in the United States. Patients were enrolled within 48 hours after ICU admission and followed for up to 30 days, or until hospital discharge or death. RESULTS Five hundred seventy-six patients from 111 ICUs in 100 hospitals were enrolled between August 2000 and April 2001. At baseline, mean age was 44.1 +/- 20.2 years, 73.6% were men, and mean APACHE II score was 16.9 +/- 8.2. Mean baseline hemoglobin was 11.1 +/- 2.4 g/dL and patients remained anemic throughout the study either with or without transfusion; 55.4% of patients were transfused (mean, 5.8 +/- 5.5 units) during the ICU stay and 43.8% of patients had an ICU length of stay > or = 7 days. Mean pretransfusion hemoglobin was 8.9 +/- 1.8 g/dL. Mean age of RBCs transfused was 20.1 +/- 11.4 days. As compared with the full study population, patients in the trauma subset were more likely to be transfused and received an average of 1 additional unit of blood. CONCLUSION Anemia is common in critically injured trauma patients and persists throughout the duration of critical illness. These patients receive a large number of RBC transfusions during their ICU course with aged blood.

The PDMS as a focal point for distributed patient data

SummaryDistributed data links are essential requirements for a successful patient data management, system (PDMS). These links funnel clinically needed data into bedside ICU workstations. We have constructed four data links which acquire most of the objective data required for direct patient care. Data from bedside monitors is acquired via a standard HP Signal Distribution Network. Urine volumes and core bladder temperatures are acquired over a link to 20 electronic urimeters. Clinical laboratory data is obtained over an HP General Purpose Data Link (GPDL) to a VAX 11/785 laboratory system. Blood gas data is obtained over a second GPDL link to a DEC 11/23 computer. The ICU staff is notified of incoming lab results with bedside video messages. Combined with automated calculations, these data links eliminate thousands of data entry keystrokes daily and allow the PDMS to serve as the focal point for real-time patient care.

Cardiorespiratory monitoring in postoperative patients: I. Prediction of outcome and severity of illness.

An index for prediction of outcome for use as a measure of the severity of illness was developed by a nonparametric multivariate analysis of cardiorespiratory data from 113 critically ill postoperative general surgical patients. This severity (predictive) index was based on a computerized algorithm that compares a given observed value with the frequency distributions of survivors and nonsurvivors. The difference in the mean values of this index for survivors and nonsurvivors was statistically significant (p less than 0.001) during each stage of shock. Sensitivity of the index in prediction of survival ranged from 70-93% depending upon stage, the specificity of the index ranged from 76-92%, and the predictive accuracy ranged from 87-96%. The severity index is used as a process measure to track the course of critically ill patients and to evaluate the efficacy of alternative therapies.

Technology, work, and information flows: lessons from the implementation of a wireless alert pager system

The combination of collaborative work practices and information technology affect the flow of information in clinical settings. The introduction of a new technology into these settings can change not only established work practices but also the information flows. In this paper, we examine the introduction of a wireless alerts pager in a surgical intensive care unit (SICU). Through a qualitative study, we analyze the effects that this new information tool had on both the work practices in the SICU and the information flow in the unit. We describe four challenges that SICU staff members faced with respect to the alerts pagers. We found that the pager provided new routes of information to SICU staff but in doing so disrupted existing work practices and information flows.

Decision support alerts for clinical laboratory and blood gas data.

SummaryWe have designed and implemented a computerized Intensive Care Unit (ICU) decision support alerting system which analyzes all incoming laboratory and blood gas data for critically abnormal values and trends. A computerized patient data management system (HP 78709A PDMS, Hewlett-Packard Co., Waltham, MA) serving 20 Surgical ICU beds is networked to a Clinical Laboratory Information System and a blood gas computer system. The ALERTS subsystem operates on the PDMS as an automatic program triggered by the receipt of fresh laboratory data. Three types of ALERTS are detected: (1) high and low critical values, (2) calculation-adjusted critical values, and (3) critical trends. Once detected, a specific ALERT message is displayed at the bottom of the patient’s bedside PDMS terminal and at the central station.Over an eight month period a total of 1,515 ALERTS were detected from amongst approximately 115,000 laboratory data results transmitted to the Surgical Intensive Care Unit (SICU). Slightly over half of all ALERTS were caused by critical blood gas values. ALERTS were found to be a sensitive indicator of severity of illness: patients with one or more ALERTS suffered an ICU mortality of 9.52%, compared to 0% mortality in patients with no ALERTS. We conclude that automated laboratory data ALERTS represent a valuable decision support tool for the management of high risk ICU patients.

Automatic extraction of intensity-intervention scores from a computerized surgical intensive care unit flowsheet

Systems that objectively score severity of illness and intensity of patient care interventions have been used to guide the appropriate use of intensive care facilities, provide information on nurse staffing ratios, validate subjective classifications of patient illness, and normalize scientific and financial studies for severity of illness. Existing scoring systems require a well-trained observer to perform a thorough chart review to complete manual scoring forms. We have designed a new system in which computerized intensity-intervention scores are automatically extracted from electronic intensive care unit flowsheets, eliminating both manual labor and potential observer variation. In prospective studies, these computerized scores correlated well with manual TISS scores, intensive care unit mortality, intensive care unit length of stay, hospital length of stay, and a subjective classification of patients to graded levels of hospital care. Such automated scores may be used for real-time allocation of health care resources and normalization of prospective studies for severity of illness.

Standardized acquisition of bedside data: the IEEE P1073 medical information bus.

The absence of standards for medical device communications has stymied the acceptance and success of automated clinical data management systems. Even devices with simple RS-232 data output ports require special interfacing hardware and software. Due to the number and variety of medical devices available, each with their own peculiar data output configuration, it has been impractical to interface with most of them. Limited by manual data entry, most computerized patient data management systems have failed to deliver the productivity gains their users expected.The forthcoming IEEE P1073 Medical Information Bus (MIB) Standard promises to correct this situation with a single powerful bedside device interface method. The MIB will provide specifications for all hardware and software necessary for medical data communications. The MIB handles the need for automatic recognition of new devices placed at a bedside, automatic reconfiguration of the network, binding of a device to a particular patients bedside and many other issues unique to the medical data communications environment. The MIB is expected to undergo formal IEEE balloting in 1990 and promises to open a new era in data management for clinical patient care.