Kenneth D. Mandl

Early Experiences with Personal Health Records

Over the past year, several payers, employers, and commercial vendors have announced personal health record projects. Few of these are widely deployed and few are fully integrated into ambulatory or hospital-based electronic record systems. The earliest adopters of personal health records have many lessons learned that can inform these new initiatives. We present three case studies--MyChart at Palo Alto Medical Foundation, PatientSite at Beth Israel Deaconess Medical Center, and Indivo at Childrens Hospital Boston. We describe our implementation challenges from 1999 to 2007 and postulate the evolving challenges we will face over the next five years.

HealthMap: Global Infectious Disease Monitoring through Automated Classification and Visualization of Internet Media Reports

Abstract Objective Unstructured electronic information sources, such as news reports, are proving to be valuable inputs for public health surveillance. However, staying abreast of current disease outbreaks requires scouring a continually growing number of disparate news sources and alert services, resulting in information overload. Our objective is to address this challenge through the HealthMap.org Web application, an automated system for querying, filtering, integrating and visualizing unstructured reports on disease outbreaks. Design This report describes the design principles, software architecture and implementation of HealthMap and discusses key challenges and future plans. Measurements We describe the process by which HealthMap collects and integrates outbreak data from a variety of sources, including news media (e.g., Google News), expert-curated accounts (e.g., ProMED Mail), and validated official alerts. Through the use of text processing algorithms, the system classifies alerts by location and disease and then overlays them on an interactive geographic map. We measure the accuracy of the classification algorithms based on the level of human curation necessary to correct misclassifications, and examine geographic coverage. Results As part of the evaluation of the system, we analyzed 778 reports with HealthMap, representing 87 disease categories and 89 countries. The automated classifier performed with 84% accuracy, demonstrating significant usefulness in managing the large volume of information processed by the system. Accuracy for ProMED alerts is 91% compared to Google News reports at 81%, as ProMED messages follow a more regular structure. Conclusion HealthMap is a useful free and open resource employing text-processing algorithms to identify important disease outbreak information through a user-friendly interface.

Implementing Syndromic Surveillance: A Practical Guide Informed by the Early Experience

Syndromic surveillance refers to methods relying on detection of individual and population health indicators that are discernible before confirmed diagnoses are made. In particular, prior to the laboratory confirmation of an infectious disease, ill persons may exhibit behavioral patterns, symptoms, signs, or laboratory findings that can be tracked through a variety of data sources. Syndromic surveillance systems are being developed locally, regionally, and nationally. The efforts have been largely directed at facilitating the early detection of a covert bioterrorist attack, but the technology may also be useful for general public health, clinical medicine, quality improvement, patient safety, and research. This report, authored by developers and methodologists involved in the design and deployment of the first wave of syndromic surveillance systems, is intended to serve as a guide for informaticians, public health managers, and practitioners who are currently planning deployment of such systems in their regions.

Surveillance Sans Frontières: Internet-Based Emerging Infectious Disease Intelligence and the HealthMap Project

John Brownstein and colleagues discuss HealthMap, an automated real-time system that monitors and disseminates online information about emerging infectious diseases.

Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov

BACKGROUND Clinical trial registries are in widespread use to promote transparency around trials and their results. OBJECTIVE To describe characteristics of drug trials listed in ClinicalTrials.gov and examine whether the funding source of these trials is associated with favorable published outcomes. DESIGN An observational study of safety and efficacy trials for anticholesteremics, antidepressants, antipsychotics, proton-pump inhibitors, and vasodilators conducted between 2000 and 2006. SETTING ClinicalTrials.gov, a Web-based registry of clinical trials launched in 1999. MEASUREMENTS Publications resulting from the trials for the 5 drug categories of interest were identified, and data were abstracted on the trial record and publication, including timing of registration, elements of the study design, funding source, publication date, and study outcomes. Assessments were based on the primary funding categories of industry, government agencies, and nonprofit or nonfederal organizations. RESULTS Among 546 drug trials, 346 (63%) were primarily funded by industry, 74 (14%) by government sources, and 126 (23%) by nonprofit or nonfederal organizations. Trials funded by industry were more likely to be phase 3 or 4 trials (88.7%; P < 0.001 across groups), to use an active comparator in controlled trials (36.8%; P = 0.010 across groups), to be multicenter (89.0%; P < 0.001 across groups), and to enroll more participants (median sample size, 306 participants; P < 0.001 across groups). Overall, 362 (66.3%) trials had published results. Industry-funded trials reported positive outcomes in 85.4% of publications, compared with 50.0% for government-funded trials and 71.9% for nonprofit or nonfederal organization-funded trials (P < 0.001). Trials funded by nonprofit or nonfederal sources with industry contributions were also more likely to report positive outcomes than those without industry funding (85.0% vs. 61.2%; P = 0.013). Rates of trial publication within 24 months of study completion ranged from 32.4% among industry-funded trials to 56.2% among nonprofit or nonfederal organization-funded trials without industry contributions (P = 0.005 across groups). LIMITATIONS The publication status of a trial could not always be confirmed, which could result in misclassification. Additional information on study protocols and comprehensive trial results were not available to further explore underlying factors for the association between funding source and outcome reporting. CONCLUSION In this sample of registered drug trials, those funded by industry were less likely to be published within 2 years of study completion and were more likely to report positive outcomes than were trials funded by other sources. PRIMARY FUNDING SOURCE National Library of Medicine and National Institute of Child Health and Human Development, National Institutes of Health.

Electronic Patient-Physician Communication: Problems and Promise

The introduction of the telephone into medical practice in the last decades of the 19th century was greeted with both celebration and trepidation. Invented in 1876 by Alexander Graham Bell, the telephone was commercially introduced in the late 1870s. It was not until World War I, however, that the telephone became a common utility [1]. Although some physicians heralded the advantages of efficiency and accessibility that the telephone offered, others expressed concerns about being overwhelmed by patients seeking over-the-telephone care, the safety of telephone diagnosis, and problems of privacy. By the mid-1920s, the telephone was fully integrated into physician practice, as it was in broader society. The telephone had become a mandatory medical technology, as central to practice as the stethoscope and sphygmomanometer [2]. We are again on the threshold of a dramatic expansion in communications technology that may have profound effects on the patientphysician relationship and the practice of medicine. We are approaching a critical mass of Internet users that will lead to a wide diffusion of electronic communications within medical practice [3, 4]. The American Medical Informatics Association recently published recommendations to guide computer-based communications between clinicians and patients [5]. Little attention, however, is being paid to the implications of direct electronic linkages between physicians and patients. Unless implemented with substantial forethought, these linkages may disturb delicate balances in the patientphysician relationship, widen social disparities in health outcomes, and create barriers to access. We attempt to identify some of the promise and pitfalls of electronic patientphysician communication before such technology becomes widely distributed. Furthermore, we propose a research agenda to provide data that is useful for careful shaping of the communications infrastructure. The Present State of Electronic Medicine Internet technologies have become useful tools for medical practice. Online, physicians can search the medical literature and find both synoptic and full-text medical journal content [6-10]. Patients have access to medical information, self-help and support groups, and even medical experts [11-13]. The World Wide Web can be used to link patient data across multiple institutions for retrieval by providers at the point of service or by researchers [14, 15]. The Internet also allows visual contact. For example, the National Library of Medicines Telemedicine Initiative enables parents of premature infants to videoconference from home with the neonatal intensive care unit [16]. Although the Internet community has always resisted national and international efforts to regulate its structure or content [17, 18], a motion is under way to impose an organizational structure and monitor the quality of the largely unchecked, unstructured, and unregulated volumes of medical information found on the Web [19-21]. Journals, professional organizations [19, 21, 22], and the federal government [23-27] have proposed monitoring medical information on the Internet and regulating telemedicine technologies. Early federal efforts along these lines include the Congressional Telecommunications Act of 1996 [28] as well as the U.S. Food and Drug Administrations proposed oversight of telemedicine applications and clinical software [22]. Direct electronic communication linkages between physicians and patients are also evolving, although so far these are under considerably less scrutiny. One such linkage is simple e-mail. Approximately 40 000 000 persons in the United States use the Internet [29], and anecdotal reports are emerging of its use for communication between physicians and patients. In university health service settings, in which both patients and physicians tend to have access to e-mail, an initial investigation has demonstrated the potential for widespread acceptance of electronic patientphysician communications by this method [30, 31]. The Promise of E-Mail E-mail can connect physicians with patients, thereby increasing access to care, enhancing patient education, augmenting screening programs, and improving adherence to treatment plans. Barriers to access often arise simply because physicians can be difficult to reach [32]. Unlike telephone conversations, which require both parties to be available at the same time, e-mail, like voice mail, is an asynchronous mode of communication [33, 34], essentially creating continuous access to the health care system. A widening gap is developing between the crucial need for transmitting more information and the relatively few and often brief face-to-face opportunities for communication between physicians and patients. The quality of these personal encounters is further diminished by the need for physicians to address administrative issues, such as referrals, insurance approvals, and rejected claims, during precious contact time. Inadequate communication, now more the rule than the exception, leads to increased stress [35], diminished satisfaction [36, 37], decreased adherence to therapeutic regimens [38, 39], and elevated risk for malpractice claims [40]. Linking patients and physicians through e-mail could increase the involvement of patients in the supervision and documentation of their own health care, processes that may activate patients and contribute to improved health [41-44]. An example of electronic linkages activating patients is CHESS (Comprehensive Health Enhancement Support System), an interactive computer-based system used to support persons with AIDS and HIV infection [45]. Telephone and voice mail technologies have been effective in screening for mental disorders and substance abuse [46, 47]. For example, computer-generated telephone reminders can improve compliance with preschool immunization visits [48]. Standard e-mail or e-mail with an interface allowing structured data entry may allow more effective triage and automation of messaging than voice and video mail do. Whether e-mail between physicians and patients can have advantages for the therapeutic relationship is a question worthy of investigation. We propose a research agenda structured around foreseeable problem areas in electronic patientphysician communication. Potential Pitfalls of E-Mail and the Need for a Research Agenda Inappropriate Use of Communication Tools Health care providers need a framework for choosing the communication mode that is most appropriate for each situation. Certain kinds of communication needs may be satisfied through e-mail. For example, the patient may use e-mail to make an appointment. He or she may request general information, such as a list of low-sodium foods, or specific information, such as a modified insulin dosage based on home monitoring of glucose levels. The physician might initiate e-mail contact to conduct routine guidance and education (for example, to advise a new mother to put her baby to sleep on his back), to remind a patient of an upcoming visit, or to check on a patients progress (for example, in a smoking cessation program). In contrast, the use of e-mail might be contraindicated in some areas, and face-to-face or telephone contact might be required. Use of e-mail by patients for urgent needs could lead to problems not being addressed quickly enough. It might also be inappropriate for physicians to use e-mail to communicate abnormal or confusing test results or to relay bad news. The diagnosis of a new problem requiring a complex and dynamic dialogue might be best handled synchronously. Face-to-face contacts are optimal for making many diagnoses, although elaborate telephone triage systems have been successfully used for this purpose [49]. Preference for the use of e-mail will depend on the context as well as on the individual physician and patient. Just as some physicians now feel more comfortable than others with telephone medicine, so must physicians exercise personal discretion in their use of e-mail. Used properly, e-mail may promote increased contact between physicians and patients. By increasing opportunities for communication before and after visits, e-mail might help optimize the value of personal encounters. Empirical studies, as well as expert consensus panels, are needed to develop general guidelines to direct patients and clinicians to use the contextually appropriate mode of communication. Evidence-based indications and contraindications for e-mail in the medical context must be clearly specified so that e-mail is used appropriately and does not become a barrier to telephone or face-to-face contact. Security and Confidentiality The confidentiality of medical information [50] and the privacy of e-mail are paramount. Patients or physicians who use e-mail in the workplace for medical interchange are not assured of confidentiality and may inadvertently expose sensitive details of illness or social circumstances to an employer. Furthermore, patients who use family e-mail accounts at home may lack privacy from spouses, children, or parents. Medical account addresses could be distinct from other personal or professional ones. Medical e-mail addresses and the messages generated through them should be reliably documented in and linked to the patients medical record. Such linkage can be accomplished in various ways, from simply including a patient identifier to embedding a hypertext link to a Web-enabled medical record [14]. A critical decision will be the selection of a set of national health identifiers, as called for by the Health Portability Act of 1996 [23]. Naive use of broadly disseminated identifiers may be unwise. For example, one proposed identifier, the Social Security number, can easily be used to identify a patient and link his or her health record to other records, such as those in financial and marketing databases [51]. The Computer Science and Telecommunication Board of the National Research Council [52] r

Time series modeling for syndromic surveillance

BackgroundEmergency department (ED) based syndromic surveillance systems identify abnormally high visit rates that may be an early signal of a bioterrorist attack. For example, an anthrax outbreak might first be detectable as an unusual increase in the number of patients reporting to the ED with respiratory symptoms. Reliably identifying these abnormal visit patterns requires a good understanding of the normal patterns of healthcare usage. Unfortunately, systematic methods for determining the expected number of (ED) visits on a particular day have not yet been well established. We present here a generalized methodology for developing models of expected ED visit rates.MethodsUsing time-series methods, we developed robust models of ED utilization for the purpose of defining expected visit rates. The models were based on nearly a decade of historical data at a major metropolitan academic, tertiary care pediatric emergency department. The historical data were fit using trimmed-mean seasonal models, and additional models were fit with autoregressive integrated moving average (ARIMA) residuals to account for recent trends in the data. The detection capabilities of the model were tested with simulated outbreaks.ResultsModels were built both for overall visits and for respiratory-related visits, classified according to the chief complaint recorded at the beginning of each visit. The mean absolute percentage error of the ARIMA models was 9.37% for overall visits and 27.54% for respiratory visits. A simple detection system based on the ARIMA model of overall visits was able to detect 7-day-long simulated outbreaks of 30 visits per day with 100% sensitivity and 97% specificity. Sensitivity decreased with outbreak size, dropping to 94% for outbreaks of 20 visits per day, and 57% for 10 visits per day, all while maintaining a 97% benchmark specificity.ConclusionsTime series methods applied to historical ED utilization data are an important tool for syndromic surveillance. Accurate forecasting of emergency department total utilization as well as the rates of particular syndromes is possible. The multiple models in the system account for both long-term and recent trends, and an integrated alarms strategy combining these two perspectives may provide a more complete picture to public health authorities. The systematic methodology described here can be generalized to other healthcare settings to develop automated surveillance systems capable of detecting anomalies in disease patterns and healthcare utilization.

Empirical Evidence for the Effect of Airline Travel on Inter-Regional Influenza Spread in the United States

Background The influence of air travel on influenza spread has been the subject of numerous investigations using simulation, but very little empirical evidence has been provided. Understanding the role of airline travel in large-scale influenza spread is especially important given the mounting threat of an influenza pandemic. Several recent simulation studies have concluded that air travel restrictions may not have a significant impact on the course of a pandemic. Here, we assess, with empirical data, the role of airline volume on the yearly inter-regional spread of influenza in the United States. Methods and Findings We measured rate of inter-regional spread and timing of influenza in the United States for nine seasons, from 1996 to 2005 using weekly influenza and pneumonia mortality from the Centers for Disease Control and Prevention. Seasonality was characterized by band-pass filtering. We found that domestic airline travel volume in November (mostly surrounding the Thanksgiving holiday) predicts the rate of influenza spread (r 2 = 0.60; p = 0.014). We also found that international airline travel influences the timing of influenza mortality (r 2 = 0.59; p = 0.016). The flight ban in the US after the terrorist attack on September 11, 2001, and the subsequent depression of the air travel market, provided a natural experiment for the evaluation of flight restrictions; the decrease in air travel was associated with a delayed and prolonged influenza season. Conclusions We provide the first empirical evidence for the role of airline travel in long-range dissemination of influenza. Our results suggest an important influence of international air travel on the timing of influenza introduction, as well as an influence of domestic air travel on the rate of inter-regional influenza spread in the US. Pandemic preparedness strategies should account for a possible benefit of airline travel restrictions on influenza spread.

Use of Unstructured Event-Based Reports for Global Infectious Disease Surveillance

Free or low-cost unstructured reports offer an alternative to traditional indicator-based outbreak reporting.

Adverse Drug Events in the Outpatient Setting: An 11-Year National Analysis

Adverse drug events (ADEs) are a common complication of medical care resulting in high morbidity and medical expenditure. Population level estimates of outpatient ADEs are limited. Our objective was to provide national estimates and characterizations of outpatient ADEs and determine risk factors associated with these events.