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PubMed2003

Advances in multivariate analysis in pharmaceutical process development.

In the last five years, reports of the application of multivariate methods in pharmaceutical process research and development have burgeoned. Examples range from the widespread adoption of statistical experimental design for screening and process optimization to the implementation of workflows that integrate multivariate characterization, experimental design and the development of quantitative structure-property relationships. Having learned from the application of these techniques in drug discovery and armed with modern high-throughput experimentation platforms, practitioners are discovering the power of experimental design and multivariate methods for shortening process development timelines.

Drug Evaluation, Preclinical↗

PubMed2004

Union-management solutions for preventing workplace injury of older workers.

As the US workforce continues to age, organized labor and management will have to work creatively to redesign jobs, workflow, and work pace to accommodate older workers. Union-management cooperation in developing safety strategies have been largely unsuccessful because of mutual distrust, animosity left over from contract negotiations and administration, the absence of strong labor legislation that promotes shared governance, injury concealment, and world-wide competitive pressures to reduce labor costs at the expense of worker safety. If workplace injury prevention that focuses on cost-effective and efficient workplace modifications for older as well as for all workers is to become reality, then employers and their unions will need to develop solutions to forge new, more expansive approaches to accommodation.

Accidents, Occupational↗

PubMed2004

Computerized clinical decision-support in respiratory care.

Computers were initially used in health care for billing and administrative functions. More recently computers have been used to present clinical information such as laboratory results and pharmacy orders. Many medical informatics researchers believe that the ultimate goal of the "electronic health record" should be to advance computerized clinical decision-support. This report considers the challenges of developing electronic-health-record systems and integrating them into useful computerized decision-support systems and presents a "pyramid of progress" concept that involves 5 steps: (1) to gather electronic health data into a standardized and coded format, (2) to validate the quality of that electronic health data, (3) to optimize presentation of electronic health data and explore computerized decision-support, (4) to develop and share computerized knowledge bases that are based on clinical evidence as well as consensus, and (5) to tailor and to implement the computerized strategies so that they fit into the workflow process of patient care. This report discusses 3 examples of successful computerized clinical decision-support (use of antibiotics, laboratory alerting, and ventilator management) and discusses strategies essential to making computerized clinical decision-support more widely available and useful.

Data Collection↗

PubMed2002

Integrating images into a central medical information system.

Of the information items that must be easily available to the different actors involved in the care process, radiological images are not the least important. While until recently it was not feasible to include these into the medical information system, this situation has changed. Still, emphasis in PACS (Picture Archiving and Communication Systems) is primarily on the technological aspects. In this paper, in contrast, we stress the importance of integration of images into the overall workflow and into the overall medical record. We do so using illustrations from the PACS project of the University Hospitals Leuven. We briefly indicate that tight integration at the user interface level is needed, and that this requires more than standardized communication between subsystems.

Computer Systems↗

PubMed2004

Application of receiver operating characteristics curve (ROC) analysis when definitive and suspect morphologic flags appear in the new Coulter LH 750 analyzer.

Workflow efficiency is important in every laboratory. Manual assessment of white blood cell counts and differentials that have been rejected by an automated analyzer is one of the most time-consuming tasks in the routine hematology laboratory. In this study, receiver operating characteristics (ROC) curve analysis was used for the first time when anomalous distribution and suspect flag alarms appeared in hemograms carried out with the new Beckman Coulter LH 750 analyzer. This article is our second about the LH 750 analyzer published in this journal; we increased the number of cases and describe the novel application of statistical analysis of ROC curves. In processing of specimens from patients with 3% to 6% immature granulocytes (myelocytes + metamyelocytes + bands ), the suspect flag Imm Ne 1 (immature granulocytes) showed 77% diagnostic efficiency with a maximum area under curve (AUC) of 0.71 and a 95% confidence interval (CI) of 0.597 to 0.831 without significant differences between the 3 available levels of alarms in the analyzer (L1, L2, L2). In processing of specimens from patients with >6% immature granulocytes, the Imm Ne 1 flag showed superior diagnostic efficiency of 98% with a maximum AUC of 0.80 and a CI of 0.713 to 0.879. The suspect flag Imm Ne 2 in processing of specimens from patients with >6% of immature granulocytes showed diagnostic efficiency of 92% with a maximum AUC of 0.77 and a CI of 0.665 to 0.871, finding a significant positive difference in level L3 regarding sensitivity in comparison with the other 2 levels of the analyzer (L1, L2). For specimens from patients with >2% blasts, the suspect Blasts alarm showed a diagnostic efficiency of 94%, an AUC of 0.91, and a CI of 0.775 to 1.043; positive differences were observed between the levels L2/L3 and L1. In processing of specimens with variant lymphocytes (large, granular, prolymphocytes, cleaved, chronic lymphocytic leukemia type, and so forth) >10% (x = 14%), the suspect alarm Var Lym (variant lymphocytes) showed a low diagnostic sensitivity of 20% with a maximum AUC of 0.59 and a CI of 0.300 to 0.870 without significant differences between the 3 available levels (L1, L2, L3). However, in processing of specimens presenting values >10% reactive or activated lymphocytes (x = 23%), typical for patients with infectious mononucleosis, the Var Lym flag showed a superior sensitivity of 75% with a diagnostic efficiency of 92% and an AUC of 0.84 with a CI of 0.587 to 1.089. Finally, the laboratory can easily program definitive abnormal morphological flags of distribution (granulocytosis, eosinophilia, monocytosis, and so forth) on the basis of its patient population. In this study we were able to carry out comparisons of AUC and to choose the values for the automated counts in percentage, absolute value, or both. Therefore we were able to define the reliability and impact on the alarm routine to optimize the performance of the user-adjustable definitive alarms for anomalous distribution.

Adult↗

PubMedDate not supplied

Paperless medical records: reinventing the patient experience.

At North Shore Magnetic Imaging Center, the patient paper medical record system was becoming very cumbersome, and it served as a source of frustration for everyone involved: patients, technologists, radiologists, and staff members. The center's mapping of a typical patient experience indicated that, from the initial phone call scheduling an exam to a completed visit (claim processed and payment received), a record could be handled by as many as 20 sets of hands! In June 2002, the center's growth and a concern that patients were losing a one-on-one experience with the medical staff led to an evaluation of workflow processes existing at that time. The evaluation began with a survey of staff members, center management, radiologists, and referring physicians. Their responses indicated 3 common themes: stress, overload, and frustration over systems in place. Comments from the survey were grouped into 3 areas: Continue to Do, Stop Doing, and Start Doing. The Start Doing responses provided solid objectives. The center set out to establish a breakthrough project that included all stakeholders--patients, staff, management, and radiologists. The Reinvention Project had 2 primary goals: move to a paperless environment and increase the level of patient care. The project was divided into internal and external teams. The internal team, called the Reinvention Team, was responsible for the actual hands-on aspects of the process. There were numerous external teams; each had defined roles and specific outcomes for achievement. The external teams' responsibilities included implementing an Internet protocol telephone system; researching voice recognition; restructuring job descriptions, training manuals, and performance evaluations; and conducting a patient-centered focus group.

Hospital Shared Services↗

PubMed2004

Transforming nursing practice: clinical systems and the nursing unit of the future.

The healthcare industry has historically focused information system expenditures on financial systems. Finally, enabling the practice of clinicians through information systems is beginning to be viewed as a strategic initiative for hospitals and health systems. Vendor applications are now better able to support clinician workflow. Infrastructure is better able to support mobile devices, which bring information to the bedside. Implementation of nursing applications provides a unique opportunity to redesign inefficient and redundant documentation, thereby enabling greater efficiency. Healthcare organizations can jump-start nursing automation by setting a finite and clear tactical plan for initiatives to be rolled out within a year in a single location. The single location enables the organization to experience how well the initiatives integrate to support optimal delivery of care. This article explores nursing information technology initiatives planned to be deployed at a 1,000-bed teaching facility through the use of a Nursing Unit of the Future.

Hospitals, Teaching↗

PubMed2004

Computerization of guidelines: a knowledge specification method to convert text to detailed decision tree for electronic implementation.

The initial step for the computerization of guidelines is the knowledge specification from the prose text of guidelines. We describe a method of knowledge specification based on a structured and systematic analysis of text allowing detailed specification of a decision tree. We use decision tables to validate the decision algorithm and decision trees to specify and represent this algorithm, along with elementary messages of recommendation. Edition tools are also necessary to facilitate the process of validation and workflow between expert physicians who will validate the specified knowledge and computer scientist who will encode the specified knowledge in a guide-line model. Applied to eleven different guidelines issued by an official agency, the method allows a quick and valid computerization and integration in a larger decision support system called EsPeR (Personalized Estimate of Risks). The quality of the text guidelines is however still to be developed further. The method used for computerization could help to define a framework usable at the initial step of guideline development in order to produce guidelines ready for electronic implementation.

Decision Making, Computer-Assisted↗

PubMed2004

Child Health Improvement through Computer Automation: the CHICA system.

Clinical guidelines are prevalent but frequently not used. Computer reminder systems can improve adherence to guidelines but have not been widely adopted. We present a computer-based decision support system that combines these elements: 1) pediatric preventive care guidelines encoded in Arden Syntax; 2) a dynamic, scannable paper user interface; and 3) a HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just in time" patient-relevant guidelines to physicians during the clinical encounter and accurately captures structured data from all who interact with the system. The system performs these tasks while remaining sensitive to the workflow constraints of a busy outpatient pediatric practice.

Algorithms↗

PubMed2004

Overcoming information overload: an information system for the primary care physician.

Primary Care Office InSite (PCOI) is a Web-based intranet application that provides ready access to a collection of information useful in primary care. The PCOI Web site was developed by, and is widely used within, the Massachusetts General Hospital (MGH) and its affiliated community practices. Over 1600 users logged 60,000 separate sessions in the past year. The site contains clinical practice guidelines, patient educational material, drug prescription and cost information and referral information, all designed for use during routine patient care activity. A continuing and dynamic collaboration between the users and developers of the system, just-in-time access and a "one-stop portal" to a variety of resources have resulted in a very high approval rating by the users. This paper discusses the important characteristics of the Web site, specific functions that improve the workflow of the practicing clinician, and limitations of the present implementation.

Ambulatory Care Information Systems↗

PubMed2004

Characteristics of outpatient clinical decision support systems: a taxonomic description.

Computer-based clinical decision support systems (CDSSs) have been championed for their potential to improve health-care quality. However, there has been no systematic study of the types of CDSSs that have been developed. In previous work, we developed the CDSS Taxonomy for comprehensively describing the technical, workflow, and contextual characteristics of CDSSs. We now use the CDSS Taxonomy to describe outpatient CDSSs evaluated in randomized controlled trials published between 1998 and 2002. 31 studies comprising 42 CDSS systems were included in our analysis. The majority of systems used rule-based reasoning engines to "push" explicit, individualized recommendations concerning non-urgent decisions to clinicians or patients, but not both. 71% of the systems required someone to manually enter data into the system or to process the system output for use by the target decision maker. The average kappa for coding agreement was > 0.6. Our findings demonstrate that outpatient CDSSs vary greatly in design and function. Many impose a data entry or output-processing burden on clinic staff. More complete reporting of CDSS characteristics is needed in the literature.

Ambulatory Care↗

PubMed2004

Synchronized time-motion study in the emergency department using a handheld computer application.

Emergency departments present a challenging environment for workflow evaluation and measurement of the effect of information system interventions. This paper describes a time-motion data collection tool built as a handheld computer application. The tool allows mobility of the observer and the intuitive inter-face supports rapid selection of tasks and frequent changes in tasks. It also allows documentation of overlapping tasks, a common occurrence in the emergency department. Synchronized data collection across the different providers of care in the emergency department is demonstrated, resulting in a data set from which task/event sequences can be built, documenting the ED care of individual patients. This technique should provide a very useful tool in measuring the effect of process changes in this difficult-to-assess environment, particularly changes in the information system.

Computers, Handheld↗

PubMed2004

Managing the tensions between national standardization vs. regional localization of clinical content and templates.

The deployment of sophisticated software tools and electronic health records offers many new opportunities and challenges to support care delivery. One of the key opportunities is to enhance the quality of care with evidence-based medicine (EBM). One of the key challenges is to embed EBM in tools that directly facilitate the process of documentation and care delivery. Since clinicians typically have the option of using free text for most of their documentation, the tools that provide embedded EBM must be at least as efficient as free text. There are many requirements that must be met in order to effectively embed EBM within clinical content tools and enhance both the usability and the actual use of such tools and clinical content: (1) Facilitate the documentation process; (2) Facilitate the care delivery process, e.g. make order entry faster; (3) Contain recommendations that are highly relevant to the clinical context of an encounter; (4) Aid in the capture of discrete coded data. Support for local variation is often key to meeting these objectives and becomes a central factor in helping clinicians shift from unstructured free text, to the use of these tools, which support the delivery of EBM. This document describes the central tension between the objective of national standardization and delivery of EBM and the need for regional localization of clinical content. This tension must be thoughtfully managed to maximize the quality of care delivery and associated workflow practices. The key elements of legitimate local variation that must be recognized in order to achieve these goals are described in this document, and the key principles for managing the tensions between generalization and localization are identified.

Decision Support Systems, Clinical↗

PubMed2004

An adoption study of a clinical reminder system in ambulatory care using a developmental trajectory approach.

In this study, we assess 41 medical residents' acceptance and adoption of a clinical reminder system for chronic disease and preventive care management in the ambulatory care environment using a novel developmental trajectory approach. This group-based, semi-parametric statistical modeling method identifies distinct groups, following distinct usage trajectories, among those who recorded use of the reminder system within an evaluation period of 10 months. We trace system use within these groups over time using computer-generated logs and user satisfaction surveys. Our preliminary analysis of this small sample of users delineates three categories of users. Feedback from these categories of users is being used to re-engineer the application and adapt it better to their workflow and functionality requirements. Despite the small sample size in this particular study, we conclude that this methodology has considerable promise to provide new insights into system usability and adoption issues that may benefit clinical decision support systems as well as information systems more generally.

Ambulatory Care↗

PubMed2004

[Automatic milking systems--quality assurance of milk for drinking].

German consumers trust the safety and the quality of milk and milk products. Compared with other animal products, e. g. meat and meat products, their confidence is justified in so far as milk and milk products cause only few foodborne diseases in Germany, although 80 percent of all German cows develop at least one case of mastitis per lactation. Due to financial reasons, more and more German dairy farmers are forced to initiate a time-saving rationalization of their workflow. Therefore, automatic milking systems (AMS) are used increasingly, even though the costs of purchase result in a slow pick-up in sales. Moreover, AMS do not comply with legal requirements. Thus, an additional regular, the so called "catalogue of measures", had to be enacted to ensure the hygienic harmlessness of milk produced by AMS. This is the first time, that udder health at individual cow level was related to milk quality beyond merely clinical signs. Together with technical innovations for an improved health monitoring at cow and herd level as well as the implementation of quality assurance programs based on prevention, this improvement offers good prospects to produce not only a hygienically harmless, but also a physiologically composed milk and therefore a qualitatively high-grade milk from healthy cows. Being the vehicle of the most recent improvements in technology, AMS do have the potential to make a crucial contribution to this development.

Animal Husbandry↗

PubMedDate not supplied

PACS sans RIS.

Sutter Gould Medical Foundation (SGMF) is a multi-specialty physician practice located in Modesto, CA, and is an affiliate of Sutter Health. In May 2003, SGMF embarked on the journey to install a picture archiving and communication system (PACS) in the main facility. Unique to the project was bringing the PACS live sans (from the French "without") a radiology information system (RIS) and having the PACS driven by an electronic medical record (EMR). Other challenges were present in terms of interfaces for the dictation system, delivering images to the providers on their desktop, and mimicking the referring providers workflow as much as possible in the digital environment to which they were accustomed in the "paper and film" environment.

California↗

PubMedDate not supplied

Paperless medical records: moving from plan to reality.

In 2002, North Shore Magnetic Imaging Center (NSMIC) decided that a major restructuring of the patient process was necessary to alleviate staff frustration and increase the level of patient care. An aggressive, 16-month timeline was established for the center to develop and implement a paperless environment. The project began by focusing on the center's existing radiology information system (RIS). Research showed that no "canned" system would perform the necessary tasks. The center's vendor, with whom senior management had developed a longstanding and trusting relationship, assured the center that, with the proper programming, the existing RIS could support the new paperless environment. Additional technology components were addressed. The first phase enabled staff to obtain physician orders and outside reports from the fax server. Once the patient medical record was fully electronic, these external documents were no longer printed. The transfer of billing information to the radiologist's billing office was achieved through a Health-Level 7 (HL7) interface between NSMIC's RIS and the information systems utilized by the billing office. Technologists were impacted when wireless personal computer (PC) tablets were implemented. Measuring 8.5" x 11" x 0.5", these tablets enable technologists to gather and record patient information while moving freely throughout the center. Forming the Reinvention Team--an internal team of NSMIC staff that would deal with the project's impact on staff, workflow, and patient care--was done in very deliberate fashion. During the recruitment phase of the project, each prospective team member was required to take 2 specific personality profile tests. The team was comprised of a combination of different personality profiles. A radiologist was later added to the team. Throughout the implementation of new processes at NSMIC, numerous breakdowns were encountered. The breakdowns could be classified into 2 categories: technical andpatient-related. Breakdowns were addressed during the Reinvention Team's weekly meetings. A patient's experience at NSMIC has changed dramatically with the implementation of electronic medical records. More patients are able to complete their exam without experiencing anxiety, or even at time claustrophobia, because they are more at ease. The rate for patients becoming claustrophobic has seen a decrease from 1.9% to 0.99% in the past 12 months.

Diagnostic Imaging↗

PubMed2003

Building support for health information technologies.

Despite the increasing role of information technology in health care, its use still lags behind that occurring in other sectors. Factors contributing to this include the complex health care environment and conflicting political agendas. Building political support for information technology in health care depends on understanding the importance of stakeholders and the environment in which they operate. It is important to involve stakeholders early in the process of implementing new information technology in order to identify needs, barriers, and non-starters. Understanding the historical experience of the community and its past attempts at using information technology is also important. Quality of care issues, nursing shortages, cost control concerns, health insurance costs and coverage rates, institutional solvency, and overwhelming paperwork are current problems in the healthcare environment that can hinder willingness to invest in information technology. Ironically, information technology can also help remedy these problems. Impact on workflow, privacy of personal health information, and system reliability, interoperability, and the ease of updating the system can all have political ramifications with regard to acceptance and implementation of information technology.

Medical Informatics↗