Pen-based remote data entry system. A pilot clinical trial.

This study assesses the feasibility of pen-based remote data entry and measures the acceptance of such systems by patients and physicians. Three clinical investigators participated in a phase-I/II clinical trial of escalated doses of chemotherapy followed by Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF). The study included 20 patients with testicular cancer who were treated at three university hospitals. The patients' data obtained in this trial were recorded and stored on a pen-based computer system. A total of 798 data points were recorded for each patient using 33 electronic forms resembling the paper forms used during an earlier phase of the study. The data recorded include the past medical history, inclusion/exclusion criteria, disease staging, therapy documentation, laboratory values and side effects. Both physicians and patients were interviewed directly after using the pen-based remote data entry system. Patients accepted that their physician was taking notes on an electronic form rather than on paper. All patients noted that a pen-based system is superior to a desktop computer when used during an interview. For the investigators electronic data entry takes additional effort, but time savings are realized later with less data clearing and increased data quality. These benefits are important for the study sponsor as well. In conclusion, pen-based remote data entry is a feasible new mode of recording clinical data with concrete benefits to both investigators and sponsors.

The design and implementation of a ventilator-management advisor.

VentPlan is an implementation of the architecture developed by the qualitative-quantitative (QQ) research group for combining qualitative and quantitative computation in a ventilator-management advisor (VMA). VentPlan calculates recommended settings for four controls of a ventilator by evaluating the predicted effects of alternative ventilator settings. A belief network converts clinical diagnoses to distributions on physiologic parameters. A mathematical-modeling module applies a patient-specific mathematical model of cardiopulmonary physiology to predict the effects of alternative ventilator settings. A decision-theoretic plan evaluator ranks the predicted effects of alternative ventilator settings according to a multiattribute-value model that specifies physician preferences for ventilator treatments. Our architecture allows VentPlan to interpret quantitative observations in light of the clinical context (such as the clinical diagnosis). We report a retrospective study of the ventilator-setting changes encountered in postoperative patients in a surgical intensive-care unit (ICU). We conclude that the QQ architecture allows VentPlan to apply a patient-specific physiologic model to calculate ventilator settings that are optimal with respect to a decision-theoretic value model describing physician preferences for setting the ventilator.

[Anesthesia-related morbidity and mortality]. / Anästhesiebezogene Morbidität und Mortalität.

Anesthesia-related mortality rate is estimated at 1 death per 10,000 procedures. Four general failures in anesthesia management are responsible for the majority of deaths: difficult intubation, aspiration, insufficient ventilation, and insufficient volume substitution. More than half of all critical incidents are considered preventable--by better patient preparation, better monitoring or increased vigilance. One in ten patients complains of simple complications such as nausea, vomiting, or a sour throat. In addition, 10% of all patients experience intra- or postoperative complications such as arrhythmia, hypo- or hypertension. Several patient-related factors, such as age or the number of coexisting diseases, as well as management factors, such as choice of anesthetic technique or the experience of the anesthesiologist, are important determinants of morbidity and mortality. This review gives a comprehensive summary of recent results in risk-analysis and the study of critical incidents in anesthesia.