Bryant T. Karras

GEM: A Proposal for a More Comprehensive Guideline Document Model Using XML

OBJECTIVE To develop a guideline document model that includes a sufficiently broad set of concepts to be useful throughout the guideline life cycle. DESIGN Current guideline document models are limited in that they reflect the specific orientation of the stakeholder who created them; thus, developers and disseminators often provide few constructs for conceptualizing recommendations, while implementers de-emphasize concepts related to establishing guideline validity. The authors developed the Guideline Elements Model (GEM) using XML to better represent the heterogeneous knowledge contained in practice guidelines. Core constructs were derived from the Institute of Medicines Guideline Appraisal Instrument, the National Guideline Clearinghouse, and the augmented decision table guideline representation. These were supplemented by additional concepts from a literature review. RESULTS The GEM hierarchy includes more than 100 elements. Major concepts relate to a guidelines identity, developer, purpose, intended audience, method of development, target population, knowledge components, testing, and review plan. Knowledge components in guideline documents include recommendations (which in turn comprise conditionals and imperatives), definitions, and algorithms. CONCLUSION GEM is more comprehensive than existing models and is expressively adequate to represent the heterogeneous information contained in guidelines. Use of XML contributes to a flexible, comprehensible, shareable, and reusable knowledge representation that is both readable by human beings and processible by computers.

Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

PURPOSE Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment-Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. PATIENTS AND METHODS This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. RESULTS The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. CONCLUSION The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

Roundtable on bioterrorism detection: information system-based surveillance.

During the 2001 AMIA Annual Symposium, the Anesthesia, Critical Care, and Emergency Medicine Working Group hosted the Roundtable on Bioterrorism Detection. Sixty-four people attended the roundtable discussion, during which several researchers discussed public health surveillance systems designed to enhance early detection of bioterrorism events. These systems make secondary use of existing clinical, laboratory, paramedical, and pharmacy data or facilitate electronic case reporting by clinicians. This paper combines case reports of six existing systems with discussion of some common techniques and approaches. The purpose of the roundtable discussion was to foster communication among researchers and promote progress by 1) sharing information about systems, including origins, current capabilities, stages of deployment, and architectures; 2) sharing lessons learned during the development and implementation of systems; and 3) exploring cooperation projects, including the sharing of software and data. A mailing list server for these ongoing efforts may be found at http://bt.cirg.washington.edu.

Computerized symptom and quality-of-life assessment for patients with cancer part I: development and pilot testing.

PURPOSE/OBJECTIVES To develop and test an innovative computerized symptom and quality-of-life (QOL) assessment for patients with cancer who are evaluated for and treated with radiation therapy. DESIGN Descriptive, longitudinal prototype development and cross-sectional clinical data. SETTING Department of radiation oncology in an urban, academic medical center. SAMPLE 101 outpatients who were evaluated for radiation therapy, able to communicate in English (or through one of many interpreters available at the University of Washington), and competent to understand the study information and give informed consent. Six clinicians caring for the patients in the sample were enrolled. METHODS Iterative prototype development was conducted using a standing focus group of clinicians. The software was developed based on survey markup language and implemented in a wireless, Web-based format. Patient participants completed the computerized assessment prior to consultation with the radiation physician. Graphical output pages with flagged areas of symptom distress or troublesome QOL issues were made available to consulting physicians and nurses. MAIN RESEARCH VARIABLES Pain intensity, symptoms, QOL, and demographics. INSTRUMENTS Computerized versions of a 0 to 10 Pain Intensity Numerical Scale (PINS), Symptom Distress Scale, and Short Form-8. FINDINGS Focus group recommendations included clinician priorities of brevity, flexibility, and simplicity for both input interface and output and that the assessment output contain color graphic display. Patient participants included 45 women and 56 men with a mean age of 52.7 years (SD = 13.8). Fewer than half of the participants (40%) reported using a computer on a regular basis (weekly or daily). Completion time averaged 7.8 minutes (SD = 3.7). Moderate to high levels of distress were reported more often for fatigue, pain, and emotional issues than for other symptoms or concerns. CONCLUSIONS Computerized assessment of cancer symptoms and QOL is technically possible and feasible in an ambulatory cancer clinic. A wireless, Web-based system facilitates access to results and data entry and retrieval. The symptom and QOL profiles of these patients new to radiation therapy were comparable to other samples of outpatients with cancer. IMPLICATIONS FOR NURSING The ability to capture an easily interpreted illustration of a patients symptom and QOL experience in less than 10 minutes is a potentially useful adjunct to traditional face-to-face interviewing. Ultimately, electronic patient-generated data could produce automated red flags directed to the most appropriate clinicians (e.g., nurse, pain specialist, social worker, nutritionist) for further evaluation. Such system enhancement could greatly facilitate oncology nurses coordination role in caring for complex patients with cancer.

Syndromic surveillance using automated collection of computerized discharge diagnoses

The Syndromic Surveillance Information Collection (SSIC) system aims to facilitate early detection of bioterrorism attacks (with such agents as anthrax, brucellosis, plague, Q fever, tularemia, smallpox, viral encephalitides, hemorrhagic fever, botulism toxins, staphylococcal enterotoxin B, etc.) and early detection of naturally occurring disease outbreaks, including large foodborne disease outbreaks, emerging infections, and pandemic influenza. This is accomplished using automated data collection of visit-level discharge diagnoses from heterogeneous clinical information systems, integrating those data into a common XML (Extensible Markup Language) form, and monitoring the results to detect unusual patterns of illness in the population. The system, operational since January 2001, collects, integrates, and displays data from three emergency department and urgent care (ED/UC) departments and nine primary care clinics by automatically mining data from the information systems of those facilities. With continued development, this system will constitute the foundation of a population-based surveillance system that will facilitate targeted investigation of clinical syndromes under surveillance and allow early detection of unusual clusters of illness compatible with bioterrorism or disease outbreaks.

Roundtable on Bioterrorism Detection

During the 2001 AMIA Annual Symposium, the Anesthesia, Critical Care, and Emergency Medicine Working Group hosted the Roundtable on Bioterrorism Detection. Sixty-four people attended the roundtable discussion, during which several researchers discussed public health surveillance systems designed to enhance early detection of bioterrorism events. These systems make secondary use of existing clinical, laboratory, paramedical, and pharmacy data or facilitate electronic case reporting by clinicians. This paper combines case reports of six existing systems with discussion of some common techniques and approaches. The purpose of the roundtable discussion was to foster communication among researchers and promote progress by 1) sharing information about systems, including origins, current capabilities, stages of deployment, and architectures; 2) sharing lessons learned during the development and implementation of systems; and 3) exploring cooperation projects, including the sharing of software and data. A mailing list server for these ongoing efforts may be found at http://bt.cirg.washington.edu.

Reengineering a Database for Clinical Trials Management: Lessons for System Architects

This paper describes the process of enhancing Trial/DB, a database system for clinical studies management. The systems enhancements have been driven by the need to maximize the effectiveness of developer personnel in supporting numerous and diverse users, of study designers in setting up new studies, and of administrators in managing ongoing studies. Trial/DB was originally designed to work over a local area network within a single institution, and basic architectural changes were necessary to make it work over the Internet efficiently as well as securely. Further, as its use spread to diverse communities of users, changes were made to let the processes of study design and project management adapt to the working styles of the principal investigators and administrators for each study. The lessons learned in the process should prove instructive for system architects as well as managers of electronic patient record systems.

Pen-based, mobile decision support in healthcare

The use of computers has become well established throughout the business enterprise; but computer usage within the health care sector has lagged, particularly for automation of interactions between individual clinicians and their patients. A number of factors have contributed to this including difficulties in representing medical knowledge in computer-processible formats, the limited application of standards for data recording and transmission, and problems in human-computer interaction.A major obstacle to the use of computers in medicine has been the stationary nature of desktop computers. Most clinicians are mobile knowledge workers who need access to information across a wide variety of settings: in offices, exam rooms, emergency departments, hospitals, nursing homes and at home. Within each setting, there is concern that a large box on the consultation desk may interfere with communication between clinicians and patients. Moreover, many physicians do not have keyboard skills. Even for those who can type, keyboard data entry---concomitant with interviewing and examination-- is difficult. To overcome these obstacles, our group at the Yale Center for Medical Informatics has developed systems that operate on small, mobile platforms and accept pen-based data entry.We recognized early on that systems would have to be integrated tightly with clinical workflow and provide benefits to offset the inconvenience associated with their use. Clinical workflow refers to the complex interacting tasks performed by clinicians as they go about their daily work and to the corresponding information flows that are generated. A particular interest has been in providing clinical decision support at the point-of-care. We have extracted knowledge from evidence-based clinical practice guidelines and embedded it in mobile, pen-based systems that inform decision making by clinicians.

Development and evaluation of public health informatics at University of Washington.

Public Health Informatics (PHI) education began at the University of Washington (UW) with a Summer Institute in 1995. The Biomedical and Health Informatics graduate program, which is housed in the School of Medicine, is an interdisciplinary, multi-school program. It demonstrates the UWs cooperative efforts in advancing informatics, encompassing the schools of public health, medicine, nursing, dentistry, pharmacy, information and graduate schools in computer science. This article provides an overview of the developmental milestones related to activities in PHI and describes the evaluation strategy and assessment plan for PHI training at the UW (http://phig.washington.edu).

Time-Tradeoff Utilities for Identifying and Evaluating a Minimum Data Set for Time-Critical Biosurveillance

Background. Researchers and policy makers are interested in identifying, implementing, and evaluating a national minimum data set for biosurveillance. However, work remains to be done to establish methods for measuring the value of such data. Purpose. The purpose of this article is to establish and evaluate a method for measuring the utility of biosurveillance data. Method. The authors derive an expected utility model in which the value of data may be determined by trading data relevance for time delay in receiving data. In a sample of 23 disease surveillance practitioners, the authors test if such tradeoffs are sensitive to the types of data elements involved (chief complaint v. emergency department [ED] log of visit) and proportional changes to the time horizon needed for receiving data (24 v. 48 h). In addition, they evaluate the logical error rate: the proportion of responses that scored less relevant data as having higher utility. Results. Utilities of chief complaints were significantly higher than ED log of visit, F(1, 21)= 5.60, P < 0.05, suggesting the method is sensitive. Further utilities did not depend on time horizon used in the exercise, F(1, 21) = 0.00, P = ns. Of 92 time tradeoffs elicited, there were 5 logical errors (i.e., 5% logical error rate). Conclusions. In this article, the authors establish a time-tradeoff exercise for valuing biosurveillance data. Empirically, the method shows initial promise for evaluating a minimum data set for biosurveillance. Future applications of this approach may prove useful in disease surveillance planning and evaluation.