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Documentation↗
Biomedical subjects
Peter J Embi
Publications and source records attributed to Peter J Embi.
Responding rapidly to FDA drug withdrawals: design and application of a new approach for a consumer health website.
BACKGROUND: Information about drug withdrawals may not reach patients in a timely manner, and this could result in adverse events. Increasingly, the public turns to consumer health websites for health information, but such sites may not update their content for days or weeks following important events like Food and Drug Administration (FDA) drug withdrawal actions. There is no recognized standard for how quickly consumer health websites should respond to such events, and reports addressing this issue are lacking. OBJECTIVE: The objective of this study was to develop and implement an approach to enhance the efficiency with which a consumer health website (NetWellness.org) responds to FDA drug withdrawal actions. METHODS: Evaluation of the current approach used by NetWellness staff to update content affected by FDA action revealed a slow process driven by the goal of performing thorough and comprehensive review and editing. To achieve our desired goal of accurately updating affected content within 24 hours of FDA action, we developed a strategy that included rapid updating of affected Web pages with warning boxes and hyperlinks to the information about the withdrawal. With the next FDA withdrawal event, that of valdecoxib (Bextra) on April 7, 2005, we applied this new approach, observed the time and resource requirements, and monitored the rate at which consumers viewed the updated information to gauge its potential impact. RESULTS: Application of the new approach allowed one person to modify the affected Web pages in less than 1 hour and within 18 hours of the FDA announcement. Using the old strategy, response to a similar event, the withdrawal of rofecoxib (Vioxx) 6 months earlier, had taken over 3 weeks and the efforts of several personnel. Updated valdecoxib content received 188 hits within the first month and 4285 hits within 1 year. CONCLUSIONS: Rapid updating of a consumer health website's content in response to an FDA drug withdrawal event was easily accomplished by applying the approach described. This allowed consumers to view accurate information regarding the withdrawn drug much sooner than would otherwise have been the case. Given that consumers increasingly turn to websites for their health information, adoption of a rapid response standard for important health events like FDA drug withdrawals should be considered by the consumer health informatics community.
Anti-Inflammatory Agents, Non-Steroidal↗
Effect of a clinical trial alert system on physician participation in trial recruitment.
BACKGROUND: Failure to recruit a sufficient number of eligible subjects in a timely manner represents a major impediment to the success of clinical trials. Physician participation is vital to trial recruitment but is often limited. METHODS: After 12 months of traditional recruitment to a clinical trial, we activated our electronic health record (EHR)-based clinical trial alert (CTA) system in selected outpatient clinics of a large, US academic health care system. When a patient's EHR data met selected trial criteria during the subsequent 4-month intervention period, the CTA prompted physician consideration of the patient's eligibility and facilitated secure messaging to the trial's coordinator. Subjects were the 114 physicians practicing at selected EHR-equipped clinics throughout our study. We compared differences in the number of physicians participating in recruitment and their recruitment rates before and after CTA activation. RESULTS: The CTA intervention was associated with significant increases in the number of physicians generating referrals (5 before and 42 after; P < .001) and enrollments (5 before and 11 after; P = .03), a 10-fold increase in those physicians' referral rate (5.7/mo before and 59.5/mo after; rate ratio, 10.44; 95% confidence interval, 7.98-13.68; P<.001), and a doubling of their enrollment rate (2.9/mo before and 6.0/mo after; rate ratio, 2.06; 95% confidence interval, 1.22-3.46; P = .007). CONCLUSIONS: Use of an EHR-based CTA led to significant increases in physicians' participation in and recruitment rates to an ongoing clinical trial. Given the trend toward the EHR implementation in health care centers engaged in clinical research, this approach may represent a much-needed solution to the common problem of inadequate trial recruitment.
Adult↗
Development of an electronic health record-based Clinical Trial Alert system to enhance recruitment at the point of care.
Clinical trials are essential to the progress of medical science. Physician participation in trial recruitment is vital, but most do not participate. Few approaches to improve physician participation in trial recruitment have been described or proven successful. Previously described approaches have largely relied on locally developed technology or been designed for use in specialized settings, thereby limiting their generalizability. We describe the design, operation and initial testing of a new Clinical Trial Alert (CTA) system built upon the existing capabilities of a commercial EHR in use across a large academic healthcare system. Given the trend toward implementation of similarly capable EHRs in institutions engaged in clinical research, this approach should be widely applicable and may represent a solution to the common problem of inadequate clinical trial recruitment. Further study of this system is ongoing.
Clinical Trials as Topic↗
Physician perceptions of an Electronic Health Record-based Clinical Trial Alert system: a survey of study participants.
Physicians play a vital role in the clinical trial recruitment process, but most do not participate. We developed a new Clinical Trial Alert (CTA) system and studied its effect on a cohort of physicians across a health system. Following this study, we surveyed our physician subjects. Their responses offer insights into the CTA's utility, their attitudes toward trial recruitment, and suggest areas for CTA refinement.
Attitude of Health Personnel↗
NetWellness 1995 - 2005: ten years of experience and growth as a non-profit consumer health information and Ask-an-Expert service.
In the 10 years since its inception, NetWellness (NW) has grown from a regional demonstration project to service the health information needs of an international audience. We present data regarding NW's growth, usage statistics, data regarding the contributions of our volunteer faculty, representative feedback of visitors, and future plans for this successful service.
Consumer Behavior↗
Impacts of computerized physician documentation in a teaching hospital: perceptions of faculty and resident physicians.
OBJECTIVE: Computerized physician documentation (CPD) has been implemented throughout the nation's Veterans Affairs Medical Centers (VAMCs) and is likely to increasingly replace handwritten documentation in other institutions. The use of this technology may affect educational and clinical activities, yet little has been reported in this regard. The authors conducted a qualitative study to determine the perceived impacts of CPD among faculty and housestaff in a VAMC. DESIGN: A cross-sectional study was conducted using semistructured interviews with faculty (n = 10) and a group interview with residents (n = 10) at a VAMC teaching hospital. MEASUREMENTS: Content analysis of field notes and taped transcripts were done by two independent reviewers using a grounded theory approach. Findings were validated using member checking and peer debriefing. RESULTS: Four major themes were identified: (1) improved availability of documentation; (2) changes in work processes and communication; (3) alterations in document structure and content; and (4) mistakes, concerns, and decreased confidence in the data. With a few exceptions, subjects felt documentation was more available, with benefits for education and patient care. Other impacts of CPD were largely seen as detrimental to aspects of clinical practice and education, including documentation quality, workflow, professional communication, and patient care. CONCLUSION: CPD is perceived to have substantial positive and negative impacts on clinical and educational activities and environments. Care should be taken when designing, implementing, and using such systems to avoid or minimize any harmful impacts. More research is needed to assess the extent of the impacts identified and to determine the best strategies to effectively deal with them.
Attitude of Health Personnel↗
Use and utility of Web-based residency program information: a survey of residency applicants.
BACKGROUND: The Internet has become essential to the residency application process. In recent years, applicants and residency programs have used the Internet-based tools of the National Residency Matching Program (NRMP, the Match) and the Electronic Residency Application Service (ERAS) to process and manage application and Match information. In addition, many residency programs have moved their recruitment information from printed brochures to Web sites. Despite this change, little is known about how applicants use residency program Web sites and what constitutes optimal residency Web site content, information that is critical to developing and maintaining such sites. OBJECTIVE: To study the use and perceived utility of Web-based residency program information by surveying applicants to an internal medicine program. METHODS: Our sample population was the applicants to the Oregon Health & Science University Internal Medicine Residency Program who were invited for an interview. We solicited participation using the group e-mail feature available through the Electronic Residency Application Service Post-Office application. To minimize the possibility for biased responses, the study was confined to the period between submission of National Residency Matching Program rank-order lists and release of Match results. Applicants could respond using an anonymous Web-based form or by reply to the e-mail solicitation. We tabulated responses, calculated percentages for each, and performed a qualitative analysis of comments. RESULTS: Of the 431 potential participants, 218 responded (51%) during the study period. Ninety-nine percent reported comfort browsing the Web; 52% accessed the Web primarily from home. Sixty-nine percent learned about residency Web sites primarily from residency-specific directories while 19% relied on general directories. Eighty percent found these sites helpful when deciding where to apply, 69% when deciding where to interview, and 36% when deciding how to rank order programs for the Match. Forty-nine percent found sites most useful in deciding where to apply, while 40% found them most useful while preparing for their interviews. Seventy-two percent felt that a "complete" Web site could substitute for a mailed printed brochure. Qualitative analysis identified additional important information needs. CONCLUSIONS: Applicants are turning to residency Web sites for information during critical phases of the application process. Though usually helpful, many of these sites are felt to be incomplete and may not be meeting important applicant information needs. These findings should be useful to those involved in residency recruitment efforts and in counseling applicants.
Attitude to Computers↗
Multifocal varicella-zoster virus vasculopathy without rash.
A 51-year-old woman with CREST syndrome (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia) developed stepwise progressive focal neurological deficits without zoster rash. Multifocal ischemic infarcts were seen on magnetic resonance imaging, and cerebral angiography revealed focal stenosis of arteries affecting the intracranial circulation. A brain biopsy was nondiagnostic. Virological etiology of the disease was verified by the detection of varicella-zoster virus antibody in cerebrospinal fluid and by reduced serum-cerebrospinal fluid varicella-zoster virus IgG ratios (compared with normally high ratios of total IgG and albumin). Treatment with intravenous acyclovir stabilized but did not significantly improve her neurological deficits.
Brain Infarction↗
SmartQuery: context-sensitive links to medical knowledge sources from the electronic patient record.
Physicians have many unmet information needs that arise in the course of patient care. Many clinical questions could potentially be answered by streamlined access to medical literature, textbooks, and clinical guidelines in the context of the electronic medical record. We designed and implemented SmartQuery, a prototype application to provide context-sensitive links from an electronic patient record to relevant medical knowledge sources, then performed a preliminary user evaluation. Our results suggest that such an application may be clinically useful, and provide some insight into problems and priorities for future development.
Expert Systems↗