Clinical trial registration: transparency is the watchword.
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Biomedical subjects
Publications and source records attributed to Ida Sim.
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OBJECTIVE: Computer-based clinical decision support systems (CDSSs) vary greatly in design and function. Using a taxonomy that we had previously developed, we describe the characteristics of CDSSs reported in the literature. METHODS: We searched PubMed and the Cochrane Library for randomized controlled trials (RCTs) published in English between 1998 and 2003 that evaluated CDSSs. We coded each CDSS using our taxonomy. RESULTS: 58 studies met our inclusion criteria. The 74 reported CDSSs varied greatly in context of use, knowledge and data sources, nature of decision support offered, information delivery, and workflow impact. Two distinct subsets of CDSSs were seen: patient-directed systems that provided decision support for preventive care or health-related behaviors via mail or phone (38% of systems), and inpatient systems targeting clinicians with online decision support and direct online execution of the recommendations (18%). 84% of the CDSSs required extra staffing for handling CDSS-related input or output. CONCLUSION: Reported CDSSs are heterogeneous along many dimensions. Caution should be taken in generalizing the results of CDSS RCTs to different clinical or workflow settings.
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Randomized controlled trials (RCTs) are one of the least biased sources of clinical research evidence, and are therefore a critical resource for the practice of evidence-based medicine. With over 10,000 new RCTs indexed in Medline each year, knowledge systems are needed to help clinicians translate evidence into practice. Common ontologies for RCTs and other domains would facilitate the development of these knowledge systems. However, no standard method exists for developing domain ontologies. In this paper, we describe a new systematic approach to specifying and evaluating the conceptual content of ontologies. In this method, called competency decomposition, the target task for an ontology is hierarchically decomposed into subtasks and methods, and the ontology content is specified by identifying the domain information required to complete each of the subtasks. We illustrate the use of this competency decomposition approach for the content specification and evaluation of an RCT ontology for evidence-based practice.
PURPOSE: EyePACS is an application for communicating and archiving eye-related patient information, images, and diagnostic data. We studied how users adopted the system in diverse clinical settings. METHODS: 53 clinicians and 142 students uploaded cases over 2.5 years from 6 pilot sites: a university teaching clinic, a university glaucoma clinic, an urban private optometric practice, a rural elderly care facility, a diabetic management program, and an eye hospital in India. RESULTS: EyePACS collected 1,122 cases. Users employed it for informal "curbside" consults in 17% of cases. Other uses of the system were: 1) to replace telephone and fax referrals to a retinal specialist (10%), 2) as part of ocular teleconsultations and diabetic retinopathy screening (31%), 3) for education via digital grand rounds and evaluation of students (32%), and 4) for research (10%). CONCLUSION: EyePACS has been used successfully for consults and education in diverse settings. The resulting database of digital cases serves as a searchable reference for clinicians.
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.
BACKGROUND: There is growing recognition that physician use of electronic medical records (EMRs) is critical for improving quality of care in outpatient settings. METHODS: We inter-viewed EMR physician champions from 20 solo/small group practices to understand different types of EMR users and their EMR-related costs and benefits. RESULTS: Interviewees differed greatly in the EMR-related benefits they generated. These differences were associated with how they used the EMR, and the amount of effort they invested in making changes to complement EMR use. We defined five types of physician EMR users: Viewers, Basic Users, Strivers, Arrivers, and System Changers. The majority of interviewees were Strivers and Arrivers, physicians who have already invested substantial time in numerous process changes that help generate EMR-related benefits. CONCLUSIONS: Incentives and comprehensive support services for facilitating complementary process changes could be important for moving physicians from one user group to another. Additional research is needed to verify this user typology and to further define the relationship between user types and EMR-generated financial and quality benefits.
BACKGROUND: Randomized clinical trials (RCTs) are an important source of evidence for clinical practice, but finding and applying RCT reports to care is time consuming. Publishing RCTs directly into machine-understandable "trial banks" may allow computers to deliver RCT evidence more selectively and effectively to clinicians. METHODS: Authors of eligible RCTs published in JAMA or the Annals of Internal Medicine between January 2002 and July 2003 were invited to co-publish their trial in RCT Bank, an electronic knowledge base containing details of trial design, execution, and summary results. Trial bank staff used Bank-a-Trial, a web-based trial-bank entry tool, to enter information from the manuscript into RCT Bank, obtaining additional information as necessary from the authors. RESULTS: The author participation rate rose from 38% to 76% after the first co-published trial was available as an example. Seven diverse RCTs are now co-published, with 14 in progress. CONCLUSIONS: We have demonstrated proof of concept for co-publishing RCTs with leading journals into a structured knowledge base. Phase II of trial bank publishing will introduce direct author submission to RCT Bank.
BACKGROUND: Substantial gaps often exist between every day practice and best practice as defined by research evidence. We present a framework for defining, analyzing, and quantifying such proof-to-practice gaps. METHOD: An intervention's use can be plotted over time as ideal and actual uptake curves among candidates and noncandidates. Gaps of underuse are deviations from ideal uptake among candidates and can be quantified as underuse NNPs (Number Not Prevented): the number of disease events each year that would have been prevented, but were not, because of underuse among candidates of the intervention. Gaps of overuse are deviations from ideal uptake among non candidates and can be similarly quantified as overuse NNPs. RESULTS: Applying our method to the underuse of beta-blockers at hospital discharge postmyocardial infarction (MI) in the United States demonstrates an annual NNP of 2995 first-year post-MI deaths not prevented (sensitivity analysis range 455-20,409). Our NNP analysis framework highlights challenges to the determination of efficacy and efficiency, the definition of what constitutes proof, rapid recognition of proof when it does occur, the definition of eligible candidates, and the definition of the proportion of candidates treated. CONCLUSION: League tables of NNPs can help policy makers compare the clinical consequences of underuse and overuse of diverse interventions, while the NNP framework provides a systematic approach for describing and analyzing the components of proof-to-practice gaps. Such gap analyses can help organizations direct their resources to reducing gaps of greatest clinical consequence.
BACKGROUND: Computer-based clinical decision support systems (CDSSs) vary greatly in design and function. A taxonomy for classifying CDSS structure and function would help efforts to describe and understand the variety of CDSSs in the literature, and to explore predictors of CDSS effectiveness and generalizability. OBJECTIVE: To define and test a taxonomy for characterizing the contextual, technical, and workflow features of CDSSs. METHODS: We retrieved and analyzed 150 English language articles published between 1975 and 2002 that described computer systems designed to assist physicians and/or patients with clinical decision making. We identified aspects of CDSS structure or function and iterated our taxonomy until additional article reviews did not result in any new descriptors or taxonomic modifications. RESULTS: Our taxonomy comprises 95 descriptors along 24 descriptive axes. These axes are in 5 categories: Context, Knowledge and Data Source, Decision Support, Information Delivery, and Workflow. The axes had an average of 3.96 coded choices each. 75% of the descriptors had an inter-rater agreement kappa of greater than 0.6. CONCLUSIONS: We have defined and tested a comprehensive, multi-faceted taxonomy of CDSSs that shows promising reliability for classifying CDSSs reported in the literature.
The Systematic Review Bank (SysBank) is a structured knowledge base that captures information about the design, execution, and results of systematic reviews of randomized controlled trials (RCTs). The SysBank data model has been adapted from RCT Bank, a knowledge base of randomized trials, and refined using three published systematic reviews. SysBank links directly to the RCT Bank entries of studies included in the systematic review. SysBank builds upon RCT Bank to support computer-assisted evidence-based medicine.
Randomized controlled trials (RCTs) are one of the best sources of evidence for the scientific practice of medicine. However, RCT findings are published only as text articles that are of limited machine understandability. The Trial Bank system captures information about the design, execution, and summary results of RCTs into a structured electronic knowledge base called RCT Bank.
OBJECTIVE: Community physicians in the United States prescribe antibiotics to 80% to 90% of smokers with acute bronchitis. We performed a systematic review of the literature to determine the efficacy of antibiotics for smokers with acute bronchitis. DESIGN: A medline search was done using the keywords bronchitis, cough, and antibiotics to identify English language articles published from January 1966 to September 2001. Randomized, placebo-controlled trials of antibiotics in previously healthy smokers and nonsmokers with acute bronchitis were included. MEASUREMENTS AND MAIN RESULTS: For each study, we abstracted information on design, size, inclusion criteria, patient characteristics, and outcomes. Of 2,029 articles in the original search, 109 relevant articles were retrieved and reviewed. There have been no studies specifically addressing antibiotic use in smokers with acute bronchitis. Nine randomized, placebo-controlled trials of antibiotics have included 774 patients and over 276 smokers. Lack of subgroup reporting for smokers precluded meta-analysis. In 7 trials, smoking status did not predict or alter patients' response to antibiotics. In one trial, trimethoprim/sulfamethoxazole resulted in less-frequent cough overall, but not among smokers. In another trial, erythromycin reduced symptom scores only among nonsmokers while antibiotic-treated smokers had a trend toward higher symptom scores. CONCLUSION: Although no trials have specifically addressed antibiotic use in smokers with acute bronchitis, existing data suggest that any benefit of antibiotics is the same or less for smokers than for nonsmokers.
The poor translation of evidence into practice is a well-known problem. Hopes are high that information technology can help make evidence-based practice feasible for mere mortal physicians. In this paper, we draw upon the methods and perspectives of clinical practice, medical informatics, and health services research to analyze the gap between evidence and action, and to argue that computing systems for bridging this gap should incorporate both informatics and health services research expertise. We discuss 2 illustrative systems--trial banks and a web-based system to develop and disseminate evidence-based guidelines (alchemist)--and conclude with a research and training agenda.