Emergency medicine resident physicians' perceptions of electronic documentation and workflow: a mixed methods study.

OBJECTIVE: To understand emergency department (ED) physicians' use of electronic documentation in order to identify usability and workflow considerations for the design of future ED information system (EDIS) physician documentation modules. METHODS: We invited emergency medicine resident physicians to participate in a mixed methods study using task analysis and qualitative interviews. Participants completed a simulated, standardized patient encounter in a medical simulation center while documenting in the test environment of a currently used EDIS. We recorded the time on task, type and sequence of tasks performed by the participants (including tasks performed in parallel). We then conducted semi-structured interviews with each participant. We analyzed these qualitative data using the constant comparative method to generate themes. RESULTS: Eight resident physicians participated. The simulation session averaged 17 minutes and participants spent 11 minutes on average on tasks that included electronic documentation. Participants performed tasks in parallel, such as history taking and electronic documentation. Five of the 8 participants performed a similar workflow sequence during the first part of the session while the remaining three used different workflows. Three themes characterize electronic documentation: (1) physicians report that location and timing of documentation varies based on patient acuity and workload, (2) physicians report a need for features that support improved efficiency; and (3) physicians like viewing available patient data but struggle with integration of the EDIS with other information sources. CONCLUSION: We confirmed that physicians spend much of their time on documentation (65%) during an ED patient visit. Further, we found that resident physicians did not all use the same workflow and approach even when presented with an identical standardized patient scenario. Future EHR design should consider these varied workflows while trying to optimize efficiency, such as improving integration of clinical data. These findings should be tested quantitatively in a larger, representative study.

Computerised physician order entry-related medication errors: analysis of reported errors and vulnerability testing of current systems.

IMPORTANCE: Medication computerised provider order entry (CPOE) has been shown to decrease errors and is being widely adopted. However, CPOE also has potential for introducing or contributing to errors. OBJECTIVES: The objectives of this study are to (a) analyse medication error reports where CPOE was reported as a 'contributing cause' and (b) develop 'use cases' based on these reports to test vulnerability of current CPOE systems to these errors. METHODS: A review of medication errors reported to United States Pharmacopeia MEDMARX reporting system was made, and a taxonomy was developed for CPOE-related errors. For each error we evaluated what went wrong and why and identified potential prevention strategies and recurring error scenarios. These scenarios were then used to test vulnerability of leading CPOE systems, asking typical users to enter these erroneous orders to assess the degree to which these problematic orders could be entered. RESULTS: Between 2003 and 2010, 1.04 million medication errors were reported to MEDMARX, of which 63 040 were reported as CPOE related. A review of 10 060 CPOE-related cases was used to derive 101 codes describing what went wrong, 67 codes describing reasons why errors occurred, 73 codes describing potential prevention strategies and 21 codes describing recurring error scenarios. Ability to enter these erroneous order scenarios was tested on 13 CPOE systems at 16 sites. Overall, 298 (79.5%) of the erroneous orders were able to be entered including 100 (28.0%) being 'easily' placed, another 101 (28.3%) with only minor workarounds and no warnings. CONCLUSIONS AND RELEVANCE: Medication error reports provide valuable information for understanding CPOE-related errors. Reports were useful for developing taxonomy and identifying recurring errors to which current CPOE systems are vulnerable. Enhanced monitoring, reporting and testing of CPOE systems are important to improve CPOE safety.

Use of an Expedited Review Tool to Screen for Prior Diagnostic Error in Emergency Department Patients.

OBJECTIVE: Missed diagnoses are an important area of care quality resulting in significant morbidity and mortality. Determination of rates and causes has been limited by difficulties in screening, including the effort of manual chart review. We developed and tested a semi- automated review tool to expedite screening for diagnostic errors in an electronic health record (EHR). METHODS: We retrospectively reviewed patients seen in the emergency department (ED) of a teaching hospital over 31 days, using an automated screen to identify those with a prior in-system visit during the 14 days preceding their ED visit. We collected prior and subsequent notes from the institution's EHR for these cases, then populated a specially designed relational database enabling rapid comparison of prior visit records to the sentinel ED visit. Each case was assessed for potential missed or delayed diagnosis, and rated by likelihood as "definite, probable, possible, unlikely or none." RESULTS: A total of 5 066 patient encounters were screened by a clinician using the tool, of which 1 498 (30%) had a clinical encounter within the preceding 14 days. Of these, 37 encounters (2.6% of those reviewed) were "definite" or "probable" missed diagnoses. The rapid review tool took a mean of 1.9 minutes per case for primary review, compared with 11.2 minutes per case for reviews without the automated tool. CONCLUSIONS: Diagnostic errors were present in a significant number of cases presenting to the ED after recent healthcare visits. An innovative review tool enabled a substantially increased efficiency in screening for diagnostic errors.

Relationship between documentation method and quality of chronic disease visit notes.

OBJECTIVE: To assses the relationship between methods of documenting visit notes and note quality for primary care providers (PCPs) and specialists, and to determine the factors that contribute to higher quality notes for two chronic diseases. METHODS: Retrospective chart review of visit notes at two academic medical centers. Two physicians rated the subjective quality of content areas of the note (vital signs, medications, lifestyle, labs, symptoms, assessment & plan), overall quality, and completed the 9 item Physician Documentation Quality Instrument (PDQI-9). We evaluated quality ratings in relation to the primary method of documentation (templates, free-form or dictation) for both PCPs and specialists. A one factor analysis of variance test was used to examine differences in mean quality scores among the methods. RESULTS: A total of 112 physicians, 71 primary care physicians (PCP) and 41 specialists, wrote 240 notes. For specialists, templated notes had the highest overall quality scores (p≤0.001) while for PCPs, there was no statistically significant difference in overall quality score. For PCPs, free form received higher quality ratings on vital signs (p = 0.01), labs (p = 0.002), and lifestyle (p = 0.002) than other methods; templated notes had a higher rating on medications (p≤0.001). For specialists, templated notes received higher ratings on vital signs, labs, lifestyle and medications (p = 0.001). DISCUSSION: There was no significant difference in subjective quality of visit notes written using free-form documentation, dictation or templates for PCPs. The subjective quality rating of templated notes was higher than that of dictated notes for specialists. CONCLUSION: As there is wide variation in physician documentation methods, and no significant difference in note quality between methods, recommending one approach for all physicians may not deliver optimal results.

Screening for Learning and Memory Mutations: A New Approach.

We describe a fully automated, live-in 24/7 test environment, with experimental protocols that measure the accuracy and precision with which mice match the ratio of their expected visit durations to the ratio of the incomes obtained from two hoppers, the progress of instrumental and classical conditioning (trials-to-acquisition), the accuracy and precision of interval timing, the effect of relative probability on the choice of a timed departure target, and the accuracy and precision of memory for the times of day at which food is available. The system is compact; it obviates the handling of the mice during testing; it requires negligible amounts of experimenter/technician time; and it delivers clear and extensive results from 3 protocols within a total of 7-9 days after the mice are placed in the test environment. Only a single 24-hour period is required for the completion of first protocol (the matching protocol), which is strong test of temporal and spatial estimation and memory mechanisms. Thus, the system permits the extensive screening of many mice in a short period of time and in limited space. The software is publicly available.

The progestative effect of the levonorgestrel-releasing intrauterine system--when does it manifest?

The objective of the study was to evaluate, clinically and sonographically, the time required for the progestative effect of the levonorgestrel-releasing intrauterine system (IUS, Mirena) to be manifested. Doppler flow of the cervical branch and spiral artery of the uterine artery, as well as the endometrial width (up to day 10 of the cycle), were evaluated in 36 women carrying levonorgestrel-releasing IUS 1-2 months after insertion of the device compared to 4-6 months after insertion. The rate of intermenstrual bleeding was reduced from 44% during the first 2 months, to only 8% of women after 4-6 months of use. Complete cessation of menstrual bleeding occurred in 5% after 2 months and in 66% after 4-6 months following insertion. While there was no change in the Doppler flow in the cervical branch of the uterine artery between both groups, there was a significant reduction in the subendometrial flow in the spiral artery. This observation was reinforced by the demonstration of significant reduction in endometrial thickness in the following 4 months of use. The present study has demonstrated that the local progestative effect of the levonorgestrel-releasing IUS on the endometrium is already manifested within a period of 3 months and over after insertion.

A human volunteer challenge model using frozen bacteria of the new epidemic serotype, V. cholerae O139 in Thai volunteers.

A total of 35 volunteers were recruited for an IRB-approved inpatient dose-escalation challenge. The goal was to identify a dose that produced an observed cholera attack rate > or =80% and an illness of sufficient severity during the defined study period such that the model would be useful for determining vaccine protection. Volunteers were challenged in groups of 5 with V. cholerae O139 that had been reconstituted immediately before use. Only 2 out of 5 volunteers who received the lowest dose (4.3 x 10(4) cfu) had diarrhea. As the inoculum size increased, the attack rate of diarrhea increased to 3-4 of 5 volunteers. At the highest dose tested, approximately 5 x 10(7) cfu, the attack rate was 73%. We recommend the use of frozen V. Cholera O139 in a human experimental challenge model to assess cholera vaccine efficacy (VE) in a cholera endemic area but with 4 days observation period before initiation of tetracycline to allow assessment of severity.

Improving inpatient antibiotic prescribing: insights from participation in a national collaborative.

BACKGROUND: Increasing rates of antimicrobial resistance and the role antibiotic overuse plays in contributing to this problem have been widely documented and have prompted appeals to change prescribing practices. How to actually achieve such changes represents a major challenge. As part of the Institute for Healthcare Improvement (IHI) Breakthrough Series project Improving Prescribing Practices (IPP), in 1997-1998, Cook County Hospital (Chicago) worked with other institutions that chose antibiotics as their focus in this national collaborative. PRACTICAL SUGGESTIONS: Practical suggestions are offered within six categories--adopting a general approach to improving antibiotic prescribing (marshalling credible evidence, addressing physician concerns and skepticism, and removing barriers to make it easier for prescribers to change); rethinking guidelines (providing syndrome-based guidance, revising national guidelines for local use, defining scenarios in which drug(s) can be safely withheld, offering alternatives, prospectively resolving conflicts over drug of choice and empiric regimens, and defining situations in which immediate treatment is and is not critical); getting the message out and changes implemented (using antibiotic order forms, computer order entry, and infectious disease specialist consultation); building viable linkages to leverage change (bridging disciplines); improving measurement; and promoting nondrug strategies and patients' roles in treating and preventing infection. CONCLUSION: Antimicrobials are unique, being the only class of drug therapy that affects not only the patient to whom it is prescribed but other current and future patients as well. Institutions therefore have a special responsibility to ensure their efficient and judicious use. It is often easier to prescribe antibiotics than to exercise restraint.

Fatal distraction: finance versus vigilance in U.S. hospitals.

Three decades ago, a now classic study on the sale of human blood defied conventional economic wisdom by demonstrating that a marketplace system for blood distribution was less efficient, less safe, and more costly. Emerging data, including the article by Thomas and colleagues in this issue, suggest the same may be true for hospitals. For-profit hospitals in Utah and Colorado had higher preventable adverse event rates than matched nonprofits. The author explores possible explanations, including the role of nursing care. While some claimed that a for-profit marketplace would stimulate efforts for improved quality, evidence is accumulating that report cards and profit-driven competition have failed to deliver on their promises. More promising is a series of not-for-profit initiatives to reduce errors that redirects our attention to patients and their need for better quality care. Rather than allowing competition to lower costs and avoid sick patients to distract us, our energies need to focus on better quality alternatives.

Oral oseltamivir in human experimental influenza B infection.

Oseltamivir is the prodrug of Ro64-0802 (GS4071), a potent and selective inhibitor of influenza A and B virus neuraminidases. Three randomized, double-blind, placebo-controlled, parallel-group studies evaluated oral oseltamivir for early treatment (75 or 150 mg twice daily for 5 days) or prevention (75 mg once or twice daily for 7 days) of experimental influenza B virus infection in healthy susceptible adults. Treatment study A (n=60) demonstrated similar trends to treatment study B (n=117), in which 75 mg doses of oseltamivir introduced 24 h after inoculation reduced median area under curve (AUC) virus titre (oseltamivir, 22.7; placebo, 131.1 log10 TCID50 x h/ml; P=0.002) and duration of viral shedding (oseltamivir, 23.9 h; placebo, 95.8 h; P=0.0005). In prevention study C (n=58), oseltamivir did not reduce infection rates (85 versus 84%) but significantly reduced median AUC virus titre (10.0 versus 66.9 log10 TCID50 x h/ml; P=0.03) and duration of viral shedding (36 versus 84 h; P=0.03) compared with placebo. Oseltamivir was well tolerated. No emergence of drug-resistant variants was detected by testing last-day isolates (n=112) in neuraminidase inhibition assays. These results indicate that oseltamivir has significant antiviral activity in experimental human influenza B virus infection when used for prophylaxis or early treatment.

Clinical activity of pleconaril in an experimentally induced coxsackievirus A21 respiratory infection.

A randomized, double-blind study assessed the efficacy and safety of pleconaril, a novel antiviral drug with broad-spectrum activity against picornaviruses, in the treatment of 33 adults with an experimentally induced viral respiratory infection. Subjects received either pleconaril 200 mg twice daily (initial dose of 400 mg) or placebo for 7 days. Fourteen hours after receiving the initial dose of either pleconaril or placebo, subjects were inoculated intranasally with 100 plaque-forming units of coxsackievirus A21. Results revealed statistically significant reductions in viral shedding in nasal secretions (P<.001), nasal mucus production (P=.004), and total respiratory illness symptom scores (P=.013) in pleconaril-treated as compared with placebo-treated subjects. The most common adverse events were nausea and abdominal pain. These data support the safety and efficacy of pleconaril in decreasing the signs and symptoms and viral shedding associated with a viral respiratory infection.

Randomized, double-blind, placebo-controlled, multicentered trial of the efficacy of a single dose of live oral cholera vaccine CVD 103-HgR in preventing cholera following challenge with Vibrio cholerae O1 El tor inaba three months after vaccination.

CVD 103-HgR is a live oral cholera vaccine strain constructed by deleting 94% of the gene for the enzymatically active A subunit of cholera toxin from classical Inaba Vibrio cholerae O1 569B; the strain also contains a mercury resistance gene as an identifying marker. This vaccine was well tolerated and immunogenic in double-blind, controlled studies and was protective in open-label studies of volunteers challenged with V. cholerae O1. A randomized, double-blind, placebo-controlled, multicenter study of vaccine efficacy was designed to test longer-term protection of CVD 103-HgR against moderate and severe El Tor cholera in U.S. volunteers. A total of 85 volunteers (50 at the University of Maryland and 35 at Children's Hospital Medical Center/University of Cincinnati) were recruited for vaccination and challenge with wild-type V. cholerae El Tor Inaba. Volunteers were randomized in a double-blind manner to receive, with buffer, a single oral dose of either CVD 103-HgR (2 x 10(8) to 8 x 10(8) CFU) or placebo (killed E. coli K-12). About 3 months after immunization, 51 of these volunteers were orally challenged with 10(5) CFU of virulent V. cholerae O1 El Tor Inaba strain N16961, prepared from a standardized frozen inoculum. Ninety-one percent of the vaccinees had a >/=4-fold rise in serum vibriocidal antibodies after vaccination. After challenge, 9 (39%) of the 23 placebo recipients and 1 (4%) of the 28 vaccinees had moderate or severe diarrhea (>/=3-liter diarrheal stool) (P < 0.01; protective efficacy, 91%). A total of 21 (91%) of 23 placebo recipients and 5 (18%) of 28 vaccinees had any diarrhea (P < 0.001; protective efficacy, 80%). Peak stool V. cholerae excretion among placebo recipients was 1.1 x 10(7) CFU/g and among vaccinees was 4.9 x 10(2) CFU/g (P < 0.001). This vaccine could therefore be a safe and effective tool to prevent cholera in travelers.

Validation and characterization of a human volunteer challenge model for cholera by using frozen bacteria of the new Vibrio cholerae epidemic serotype, O139.

Until recently, all epidemic strains of Vibrio cholerae were of the O1 serotype. Current epidemics have also been caused by a new serotype, Vibrio cholerae O139. Although the pathogenesis and clinical features of O139 cholera are similar to those of O1 cholera, immunity to serotype O1 does not confer immunity to serotype O139. Therefore, prior to beginning vaccine efficacy studies, we sought to validate the use of a large standardized frozen inoculum of virulent V. cholerae O139 4260B for use in a human volunteer challenge model. Healthy volunteers (n = 25) were recruited for an Internal Review Board-approved inpatient dose-escalation challenge. Our goal was to identify a dose at which the cholera attack rate and the geometric mean purge were sufficient for determining vaccine efficacy against moderate and severe disease. At a dose of 10(5) CFU, 8 of 10 volunteers experienced purging and had a positive stool culture for V. cholerae. However, at this dose, the geometric mean stool volume of 2,175 g was insufficient by study criteria. At a dose of 10(6) CFU, 14 of 15 volunteers experienced purging, with a geometric mean stool volume of 5,621 g. Disease severity was significantly greater in volunteers with blood group O than those with non-O blood types (10,353 g versus 3,555 g, P < 0.001). Following challenge, all volunteers demonstrated a significant rise in antitoxin antibodies but the serum vibriocidal titer was attenuated compared to that seen after challenge with an O1 strain. This model provides a reproducible illness of sufficient severity for testing the efficacies of new O139 or combined O1-O139 vaccines.

Primary care for the medically underserved: challenges and opportunities.

The medically underserved present unique challenges to primary care practitioners. Sociocultural and financial barriers of the underserved impede access to necessary care; the prevalence and severity of diseases in the underserved population vary from those of the general population; the institution of preventive-care measures can be especially problematic; and the doctor-patient relationship is uncommonly complex. This article reviews current thinking about the causes of unequal health, the effects of unequal health care, and the special opportunities for disease prevention among the socioeconomically disadvantaged people in the US. Sensitivity to these and other issues can enhance primary care practitioners' efforts to improve care of the underserved now, pending future political consensus about universal health insurance.

Safety and immunogenicity of live, attenuated human rotavirus vaccine 89-12.

The safety and immunogenicity of an orally administered live human rotavirus vaccine candidate (89-12), attenuated by 33 passages in monkey kidney cells, were evaluated in placebo-controlled trials in adults, children and infants. This strain was selected because natural infections with 89-12-like rotaviruses provided 100% protection over two years. The initial evaluations in adults, seropositive children and nine infants indicated that the vaccine was safe. Two doses of vaccine (10(5) p.f.u. dose-1) or placebo were then given to 42 infants, aged from 6 to 26 weeks. No significant difference in side effects was seen. Seroconversion was demonstrated in 19 of 20 previously uninfected vaccine recipients, but > or = 4-fold rises in 89-12 neutralizing antibody titers were detected in only seven subjects. Intestinal IgA responses were detected in 15 subjects. This attenuated human rotavirus was safe and immunogenic and should be further evaluated as a vaccine candidate.