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1.  Can Computer-Generated Evidence-Based Care Suggestions Enhance Evidence-Based Management of Asthma and Chronic Obstructive Pulmonary Disease? A Randomized, Controlled Trial 
Health Services Research  2005;40(2):477-498.
Translation of evidence-based guidelines into clinical practice has been inconsistent. We performed a randomized, controlled trial of guideline-based care suggestions delivered to physicians when writing orders on computer workstations.
Study Setting
Inner-city academic general internal medicine practice.
Study Design
Randomized, controlled trial of 246 physicians (25 percent faculty general internists, 75 percent internal medicine residents) and 20 outpatient pharmacists. We enrolled 706 of their primary care patients with asthma or chronic obstructive pulmonary disease. Care suggestions concerning drugs and monitoring were delivered to a random half of the physicians and pharmacists when writing orders or filling prescriptions using computer workstations. A 2 × 2 factorial randomization of practice sessions and pharmacists resulted in four groups of patients: physician intervention, pharmacist intervention, both interventions, and controls.
Data Extraction/Collection Methods
Adherence to the guidelines and clinical activity was assessed using patients' electronic medical records. Health-related quality of life, medication adherence, and satisfaction with care were assessed using telephone questionnaires.
Principal Findings
During their year in the study, patients made an average of five scheduled primary care visits. There were no differences between groups in adherence to the care suggestions, generic or condition-specific quality of life, satisfaction with physicians or pharmacists, medication compliance, emergency department visits, or hospitalizations. Physicians receiving the intervention had significantly higher total health care costs. Physician attitudes toward guidelines were mixed.
Care suggestions shown to physicians and pharmacists on computer workstations had no effect on the delivery or outcomes of care for patients with reactive airways disease.
PMCID: PMC1361152  PMID: 15762903
medical decision making; guidelines; quality improvement
2.  Validation of a common data model for active safety surveillance research 
Systematic analysis of observational medical databases for active safety surveillance is hindered by the variation in data models and coding systems. Data analysts often find robust clinical data models difficult to understand and ill suited to support their analytic approaches. Further, some models do not facilitate the computations required for systematic analysis across many interventions and outcomes for large datasets. Translating the data from these idiosyncratic data models to a common data model (CDM) could facilitate both the analysts' understanding and the suitability for large-scale systematic analysis. In addition to facilitating analysis, a suitable CDM has to faithfully represent the source observational database. Before beginning to use the Observational Medical Outcomes Partnership (OMOP) CDM and a related dictionary of standardized terminologies for a study of large-scale systematic active safety surveillance, the authors validated the model's suitability for this use by example.
Validation by example
To validate the OMOP CDM, the model was instantiated into a relational database, data from 10 different observational healthcare databases were loaded into separate instances, a comprehensive array of analytic methods that operate on the data model was created, and these methods were executed against the databases to measure performance.
There was acceptable representation of the data from 10 observational databases in the OMOP CDM using the standardized terminologies selected, and a range of analytic methods was developed and executed with sufficient performance to be useful for active safety surveillance.
PMCID: PMC3240764  PMID: 22037893
Developing/using computerized provider order entry; Systems to support and improve diagnostic accuracy; other specific EHR applications (results review); medication administration; disease progression and image managem; data exchange; communication and integration across care settings (inter- and intraenterprise); measuring/improving patient safety and reducing medical errors; improving healthcare workflow and process efficiency
3.  Evaluating the Impact of Database Heterogeneity on Observational Study Results 
American Journal of Epidemiology  2013;178(4):645-651.
Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results.
PMCID: PMC3736754  PMID: 23648805
database; heterogeneity; methods; population characteristics; reproducibility of results; surveillance
4.  Bridging Islands of Information to Establish an Integrated Knowledge Base of Drugs and Health Outcomes of Interest 
Drug Safety  2014;37(8):557-567.
The entire drug safety enterprise has a need to search, retrieve, evaluate, and synthesize scientific evidence more efficiently. This discovery and synthesis process would be greatly accelerated through access to a common framework that brings all relevant information sources together within a standardized structure. This presents an opportunity to establish an open-source community effort to develop a global knowledge base, one that brings together and standardizes all available information for all drugs and all health outcomes of interest (HOIs) from all electronic sources pertinent to drug safety. To make this vision a reality, we have established a workgroup within the Observational Health Data Sciences and Informatics (OHDSI, collaborative. The workgroup’s mission is to develop an open-source standardized knowledge base for the effects of medical products and an efficient procedure for maintaining and expanding it. The knowledge base will make it simpler for practitioners to access, retrieve, and synthesize evidence so that they can reach a rigorous and accurate assessment of causal relationships between a given drug and HOI. Development of the knowledge base will proceed with the measureable goal of supporting an efficient and thorough evidence-based assessment of the effects of 1,000 active ingredients across 100 HOIs. This non-trivial task will result in a high-quality and generally applicable drug safety knowledge base. It will also yield a reference standard of drug–HOI pairs that will enable more advanced methodological research that empirically evaluates the performance of drug safety analysis methods.
PMCID: PMC4134480  PMID: 24985530
5.  Enhancing patient safety and quality of care by improving the usability of electronic health record systems: recommendations from AMIA 
In response to mounting evidence that use of electronic medical record systems may cause unintended consequences, and even patient harm, the AMIA Board of Directors convened a Task Force on Usability to examine evidence from the literature and make recommendations. This task force was composed of representatives from both academic settings and vendors of electronic health record (EHR) systems. After a careful review of the literature and of vendor experiences with EHR design and implementation, the task force developed 10 recommendations in four areas: (1) human factors health information technology (IT) research, (2) health IT policy, (3) industry recommendations, and (4) recommendations for the clinician end-user of EHR software. These AMIA recommendations are intended to stimulate informed debate, provide a plan to increase understanding of the impact of usability on the effective use of health IT, and lead to safer and higher quality care with the adoption of useful and usable EHR systems.
PMCID: PMC3715367  PMID: 23355463
Usability; Human Factors; Medical Error; Health Information Technology; Electronic Health Records; Clinical Informatics
6.  Online disease management of diabetes: Engaging and Motivating Patients Online With Enhanced Resources-Diabetes (EMPOWER-D), a randomized controlled trial 
To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes.
Materials and methods
Engaging and Motivating Patients Online With Enhanced Resources for Diabetes was a 12-month parallel randomized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin (A1C) values ≥7.5% from primary care sites sharing an electronic health record. The intervention included: (1) wirelessly uploaded home glucometer readings with graphical feedback; (2) comprehensive patient-specific diabetes summary status report; (3) nutrition and exercise logs; (4) insulin record; (5) online messaging with the patient's health team; (6) nurse care manager and dietitian providing advice and medication management; and (7) personalized text and video educational ‘nuggets’ dispensed electronically by the care team. A1C was the primary outcome variable.
Compared with usual care (UC, n=189), patients in the intervention (INT, n=193) group had significantly reduced A1C at 6 months (−1.32% INT vs −0.66% UC; p<0.001). At 12 months, the differences were not significant (−1.14% INT vs −0.95% UC; p=0.133). In post hoc analysis, significantly more INT patients had improved diabetes control (>0.5% reduction in A1C) than UC patients at 12 months (69.9 (95% CI 63.2 to 76.5) vs 55.4 (95% CI 48.4 to 62.5); p=0.006).
A nurse-led, multidisciplinary health team can manage a population of diabetic patients in an online disease management program. INT patients achieved greater decreases in A1C at 6 months than UC patients, but the differences were not sustained at 12 months. More INT than UC patients achieved improvement in A1C (>0.5% decrease).
Trial registered in clinical #NCT00542204
PMCID: PMC3628059  PMID: 23171659
Diabetes Mellitus Type 2; Disease Management; Personal Health Record; Health Information Technology; Electronic Health Record; Telemedicine
8.  Communities' Readiness for Health Information Exchange: The National Landscape in 2004 
Background: The Secretary of Health and Human Services recently released a report calling for the nation to create a national health information network (NHIN) that would interconnect Regional Health Information Organizations (RHIOs). These RHIOs, which others have called Local or Regional Health Information Infrastructures (LHII), would in turn interconnect local as well as national health information resources. Little data exist about the activities taking place in communities to create LHIIs.
Approach: The authors analyzed data that communities submitted in response to a request for capabilities issued by the Foundation for eHealth as part of their Connecting Communities for Better Health program using descriptive statistics and subjective evaluation.
Impression: The authors analyzed data from 134 responses from communities in 42 states and the District of Columbia. Communities are enthusiastic about moving forward with health information exchange to create LHIIs to improve the efficiency, quality, and safety of care. They have identified significant local sources of investment and plan to use some clinical data standards but not as broadly as was expected. The communities have not yet developed the specific technical approaches or the sustainable business models that will be required. Many communities are interested in creating an LHII and are developing the leadership commitment needed to translate that interest into an operational reality. Clinical information standards can be incorporated into a community's plans as often as they need to be. Communities have to overcome funding issues, develop deeper understanding of the technical and organizational issues, and aggressively share their learning to succeed within their community and to help other communities succeed.
PMCID: PMC551542  PMID: 15561785
9.  Controlled Trial of Direct Physician Order Entry 
Objective: Direct physician order entry (POE) offers many potential benefits, but evidence suggests that POE requires substantially more time than traditional paper-based ordering methods. The Medical Gopher is a well-accepted system for direct POE that has been in use for more than 15 years. The authors hypothesized that physicians using the Gopher would not spend any more time writing orders than physicians using paper-based methods.
Design: A randomized controlled trial of POE using the Medical Gopher system in 11 primary care internal medicine practices.
Measurements: The authors collected detailed time use data using time motion studies of the physicians and surveyed their opinions about the POE system.
Results: The authors found that physicians using the Gopher spent 2.2 min more per patient overall, but when duplicative and administrative tasks were taken into account, physicians were found to have spent only 0.43 min more per patient. With experience, the order entry time fell by 3.73 min per patient. The survey revealed that the physicians believed that the system improved their patient care and wanted the Gopher to continue to be available in their practices.
Conclusions: Little extra time, if any, was required for physicians to use the POE system. With experience in its use, physicians may even save time while enjoying the many benefits of POE.
PMCID: PMC130081  PMID: 11418543
18.  Data for drugs available through low-cost prescription drug programs are available through pharmacy benefit manager and claims data 
Observational data are increasingly being used for pharmacoepidemiological, health services and clinical effectiveness research. Since pharmacies first introduced low-cost prescription programs (LCPP), researchers have worried that data about the medications provided through these programs might not be available in observational data derived from administrative sources, such as payer claims or pharmacy benefit management (PBM) company transactions.
We used data from the Indiana Network for Patient Care to estimate the proportion of patients with type 2 diabetes to whom an oral hypoglycemic agent was dispensed. Based on these estimates, we compared the proportions of patients who received medications from chains that do and do not offer an LCPP, the proportion trend over time based on claims data from a single payer, and to proportions estimated from the Medical Expenditure Panel Survey (MEPS).
We found that the proportion of patients with type 2 diabetes who received oral hypoglycemic medications did not vary based on whether the chain that dispensed the drug offered an LCPP or over time. Additionally, the rates were comparable to those estimated from MEPS.
Researchers can be reassured that data for medications available through LCPPs continue to be available through administrative data sources.
PMCID: PMC3416643  PMID: 22726249
Low-cost prescription program; Oral antihyperglycemic agents; Pharmacy benefit manager; Claims data
19.  A Framework for evaluating the costs, effort, and value of nationwide health information exchange 
The nationwide health information network (NHIN) has been proposed to securely link community and state health information exchange (HIE) entities to create a national, interoperable network for sharing healthcare data in the USA. This paper describes a framework for evaluating the costs, effort, and value of nationwide data exchange as the NHIN moves toward a production state. The paper further presents the results of an initial assessment of the framework by those engaged in HIE activities.
Using a literature review and knowledge gained from active NHIN technology and policy development, the authors constructed a framework for evaluating the costs, effort, and value of data exchange between an HIE entity and the NHIN.
An online survey was used to assess the perceived usefulness of the metrics in the framework among HIE professionals and researchers.
The framework is organized into five broad categories: implementation; technology; policy; data; and value. Each category enumerates a variety of measures and measure types. Survey respondents generally indicated the framework contained useful measures for current and future use in HIE and NHIN evaluation. Answers varied slightly based on a respondent's participation in active development of NHIN components.
The proposed framework supports efforts to measure the costs, effort, and value associated with nationwide data exchange. Collecting longitudinal data along the NHIN's path to production should help with the development of an evidence base that will drive adoption, create value, and stimulate further investment in nationwide data exchange.
PMCID: PMC2995720  PMID: 20442147
Computer communication networks; evaluation studies as topic; medical informatics; United States
20.  Enhancing laboratory report contents to improve outpatient management of test results 
In today's environment, providers are extremely time-constrained. Assembling relevant contextual data to make decisions on laboratory results can take a significant amount of time from the day. The Regenstrief Institute has created a system which leverages data within Indiana Health Information Exchange's (IHIE's) repository, the Indiana Network for Patient Care (INPC), to provide well-organized and contextual information on returning laboratory results to outpatient providers. The system described here uses data extracted from INPC to add historical test results, medication-dispensing events, visit information, and clinical reminders to traditional laboratory result reports. These “Enhanced Laboratory Reports” (ELRs) are seamlessly delivered to outpatient practices connected through IHIE via the DOCS4DOCS clinical messaging service. All practices, including those without electronic medical record systems, can receive ELRs. In this paper, the design and implementation issues in creating this system are discussed, and generally favorable preliminary results of attitudes by providers towards ELRs are reported.
PMCID: PMC2995639  PMID: 20064809
Clinical messaging; health information exchange; Ambulatory Care Information Systems; Clinical Laboratory Information Systems; Integrated Advanced Information Management Systems; Knowledge Bases
21.  Variability in Drug Formularies and Implications in Decision Support 
AMIA Annual Symposium Proceedings  2011;2011:1327-1336.
Formularies are highly variable, which limits physicians ability to prescribe cost effective medications for their patients. In this study we explore the composition of 3,346 formularies in terms of outpatient prescription coverage, medication class coverage, and cost implications. Our analysis revealed that 42% of formularies are duplicative and that the unique formularies contain variability for medications that contribute little in terms of cost or overall use. These results lead us to believe the number and complexities of formularies can be dramatically reduced leading to more intuitive decision support for physicians when writing prescriptions.
PMCID: PMC3243218  PMID: 22195194
22.  All Health Care is Not Local: An Evaluation of the Distribution of Emergency Department Care Delivered in Indiana 
The Emergency Department (ED) delivers a major portion of health care – often with incomplete knowledge about the patient. As such, EDs are particularly likely to benefit from a health information exchange (HIE). The Indiana Public Health Emergency Surveillance System (PHESS) sends real-time registration information for emergency department encounters. Over the three-year study period, we found 2.8 million patients generated 7.4 million ED visits. The average number of visits was 2.6 visits/patient (range 1–385). We found more than 40% of ED visits during the study period were for patients having data at multiple institutions. When examining the network density, we found nearly all EDs share patients with more than 80 other EDs. Our results help clarify future health care policy decisions regarding optimal NHIN architecture and discount the notion that ‘all healthcare is local’.
PMCID: PMC3243262  PMID: 22195094
23.  Race and Medication Adherence and Glycemic Control: Findings from an Operational Health Information Exchange 
AMIA Annual Symposium Proceedings  2011;2011:1649-1657.
The Central Indiana Beacon Community leads efforts for improving adherence to oral hypoglycemic agents (OHA) to achieve improvements in glycemic control for patients with type 2 diabetes. In this study, we explored how OHA adherence affected hemoglobin A1C (HbA1c) level in different racial groups. OHA adherence was measured by 6-month proportion of days covered (PDC). Of 3,976 eligible subjects, 12,874 pairs of 6-month PDC and HbA1c levels were formed between 2002 and 2008. The average HbA1c levels were 7.4% for African-Americans and 6.5% for Whites. The average 6-month PDCs were 40% for African-Americans and 50% for Whites. In mixed effect generalized linear regression analyses, OHA adherence was inversely correlated with HbA1c level for both African-Americans (−0.80, p<0.0001) and Whites (−0.53, p<0.0001). The coefficient was −0.26 (p<0.0001) for the interaction of 6-month PDC and African-Americans. Significant risk factors for OHA non-adherence were race, young age, non-commercial insurance, newly-treated status, and polypharmacy.
PMCID: PMC3243292  PMID: 22195231
24.  Natural language processing to extract follow-up provider information from hospital discharge summaries 
We evaluate the performance of a Natural Language Processing (NLP) application designed to extract follow-up provider information from free-text discharge summaries at two hospitals.
We compare performance by the NLP application, called the Regenstrief EXtracion tool (REX), to performance by three physician reviewers at extracting follow-up provider names, phone/fax numbers and location information. Precision, recall, and F-measures are reported, with 95% CI for pairwise comparisons.
Of 556 summaries with follow-up information, REX performed as follows in precision, recall, F-measure respectively: Provider Name 0.96, 0.92, 0.94; Phone/Fax 0.99, 0.92, 0.96; Location 0.83, 0.82, 0.82. REX was as good as all physician-reviewers in identifying follow-up provider names and phone/fax numbers, and slightly inferior to two physicians at identifying location information. REX took about four seconds (vs. 3–5 minutes for physician-reviewers) to extract follow-up information.
A NLP program had physician-like performance at extracting provider follow-up information from discharge summaries.
PMCID: PMC3041312  PMID: 21347103
25.  Emergency Medical Services: The Frontier in Health Information Exchange 
Emergency medical service (EMS) providers routinely lack even basic access to pre-existing patient information when delivering patient care in the field. Improving access to pre-existing patient information could improve the quality, safety and efficiency of care that they can deliver. EMS providers in Indianapolis use an electronic record to document their care. In order to provide access to pre-existing patient information, we integrated the EMS electronic record into the Indiana Network for Patient Care (INPC) --an operational statewide health information exchange (HIE). Over a six month study period, there were 28,986 911 calls to EMS, with 4,332 (16%) requests for patient data. Of the 58 medics surveyed, a substantial majority felt the information delivered was an important tool for delivering quality patient care.
PMCID: PMC3041358  PMID: 21346973

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