David F. Lobach

Effect of Clinical Decision-Support Systems: A Systematic Review

BACKGROUND Despite increasing emphasis on the role of clinical decision-support systems (CDSSs) for improving care and reducing costs, evidence to support widespread use is lacking. PURPOSE To evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. DATA SOURCES MEDLINE, CINAHL, PsycINFO, and Web of Science through January 2011. STUDY SELECTION Investigators independently screened reports to identify randomized trials published in English of electronic CDSSs that were implemented in clinical settings; used by providers to aid decision making at the point of care; and reported clinical, health care process, workload, relationship-centered, economic, or provider use outcomes. DATA EXTRACTION Investigators extracted data about study design, participant characteristics, interventions, outcomes, and quality. DATA SYNTHESIS 148 randomized, controlled trials were included. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n= 25; odds ratio [OR], 1.42 [95% CI, 1.27 to 1.58]), ordering clinical studies (n= 20; OR, 1.72 [CI, 1.47 to 2.00]), and prescribing therapies (n= 46; OR, 1.57 [CI, 1.35 to 1.82]). Few studies measured potential unintended consequences or adverse effects. LIMITATIONS Studies were heterogeneous in interventions, populations, settings, and outcomes. Publication bias and selective reporting cannot be excluded. CONCLUSION Both commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload, and efficiency outcomes remains sparse. This review expands knowledge in the field by demonstrating the benefits of CDSSs outside of experienced academic centers. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Computerized Decision Support Based on a Clinical Practice Guideline Improves Compliance with Care Standards

PURPOSE Clinical guidelines are designed to assist in the management of specific diseases; however, these guidelines are often neglected in the delivery of care. The purpose of this study was to determine whether clinician use of an clinical practice guideline would increase in response to having, at the patient visit, a decision support system based on a practice guideline that generates a customized management protocol for the individual patient using data from the patients electronic medical record. SUBJECTS AND METHODS In a 6-month controlled trial at a primary care clinic, 58 primary care clinicians were randomized to receive either a special encounter form with the computer-generated guideline recommendations or a standard encounter form. The effect of computer-generated advice on clinician behavior was measured as rate of compliance with guideline recommendations. Data from 30 clinicians were analyzed; data from 28 clinicians were excluded because these clinicians did not meet predefined criteria for minimum exposure to diabetic patient care. RESULTS Availability of patient management recommendations generated by the decision support system resulted in a two-fold increase in clinician compliance with care guidelines for diabetes mellitus (P = 0.01). Median compliance for the group receiving the recommendations was 32.0% versus 15.6% for the control group. CONCLUSION Decision support based on a clinical practice guideline is an effective tool for assisting clinicians in the management of diabetic patients. This decision support system provides a model for how a clinical practice guideline can be integrated into the care process by computer to assist clinicians in managing a specific disease through helping them comply with care standards. Use of decision support systems based on clinical practice guidelines could ultimately improve the quality of medical care.

Computerized Knowledge Management in Diabetes Care

Introduction:Many scientific achievements become part of usual diabetes care only after long delays. The purpose of this article is to identify the impact of automated information interventions on diabetes care and patient outcomes and to enable this knowledge to be incorporated into diabetes care practice. Methods:We conducted systematic electronic and manual searches and identified reports of randomized clinical trials of computer-assisted interventions in diabetes care. Studies were grouped into 3 categories: computerized prompting of diabetes care, utilization of home glucose records in computer-assisted insulin dose adjustment, and computer-assisted diabetes patient education. Results:Among 40 eligible studies, glycated hemoglobin and blood glucose levels were significantly improved in 7 and 6 trials, respectively. Significantly improved guideline compliance was reported in 6 of 8 computerized prompting studies. Three of 4 pocket-sized insulin dosage computers reduced hypoglycemic events and insulin doses. Metaanalysis of studies using home glucose records in insulin dose adjustment documented a mean decrease in glycated hemoglobin of .14 mmol/L (95% confidence interval [CI], 0.11–0.16) and a decrease in blood glucose of .33 mmol/L (95% CI, 0.28–0.39). Several computerized educational programs improved diet and metabolic indicators. Discussion:Computerized knowledge management is becoming a vital component of quality diabetes care. Prompting follow-up procedures, computerized insulin therapy adjustment using home glucose records, remote feedback, and counseling have documented benefits in improving diabetes-related outcomes.

Ontogeny of the human thymus during fetal development

The thymus is a complex, specialized tissue that is essential for the maturation of thymus-derived (T) lymphocytes (reviewed in Refs. 1-3). Studies in avian and murine systems have demonstrated that the nonlymphoid components of the thymic microenvironment (epithelium, fibroblasts, macrophages) play critical roles in normal thymic development (reviewed in Ref. 3). Failure of fusion of endodermal and ectodermal cell layers of the pharynx is thought to be a central lesion in the development of athymic nude mice (4). Others have suggested that the mesoderm-derived component of thymic stroma (fibroblasts and vessels) induces thymic epithelial-cell differentiation and fetal thymic lobulation at the stage of fetal development just prior to lymphoid-cell migration to the thymus (5-7). Moreover, reconstitution of thymic function following bone marrow transplantation in patients with severe combined immunodeficiency disease and thymic dysplasia has given rise to the notion that there is an inductive interaction between bone marrow stem cells and thymic epithelium for normal thymic development to occur (8, 9). Although

A national clinical decision support infrastructure to enable the widespread and consistent practice of genomic and personalized medicine

BackgroundIn recent years, the completion of the Human Genome Project and other rapid advances in genomics have led to increasing anticipation of an era of genomic and personalized medicine, in which an individuals health is optimized through the use of all available patient data, including data on the individuals genome and its downstream products. Genomic and personalized medicine could transform healthcare systems and catalyze significant reductions in morbidity, mortality, and overall healthcare costs.DiscussionCritical to the achievement of more efficient and effective healthcare enabled by genomics is the establishment of a robust, nationwide clinical decision support infrastructure that assists clinicians in their use of genomic assays to guide disease prevention, diagnosis, and therapy. Requisite components of this infrastructure include the standardized representation of genomic and non-genomic patient data across health information systems; centrally managed repositories of computer-processable medical knowledge; and standardized approaches for applying these knowledge resources against patient data to generate and deliver patient-specific care recommendations. Here, we provide recommendations for establishing a national decision support infrastructure for genomic and personalized medicine that fulfills these needs, leverages existing resources, and is aligned with the Roadmap for National Action on Clinical Decision Support commissioned by the U.S. Office of the National Coordinator for Health Information Technology. Critical to the establishment of this infrastructure will be strong leadership and substantial funding from the federal government.SummaryA national clinical decision support infrastructure will be required for reaping the full benefits of genomic and personalized medicine. Essential components of this infrastructure include standards for data representation; centrally managed knowledge repositories; and standardized approaches for leveraging these knowledge repositories to generate patient-specific care recommendations at the point of care.

Proposal for Fulfilling Strategic Objectives of the U.S. Roadmap for National Action on Decision Support through a Service-oriented Architecture Leveraging HL7 Services

Despite their demonstrated effectiveness, clinical decision support (CDS) systems are not widely used within the U.S. The Roadmap for National Action on Clinical Decision Support, published in June 2006 by the American Medical Informatics Association, identifies six strategic objectives for achieving widespread adoption of effective CDS capabilities. In this manuscript, we propose a Service-Oriented Architecture (SOA) for CDS that facilitates achievement of these six objectives. Within the proposed framework, CDS capabilities are implemented through the orchestration of independent software services whose interfaces are being standardized by Health Level 7 and the Object Management Group through their joint Healthcare Services Specification Project (HSSP). Core services within this framework include the HSSP Decision Support Service, the HSSP Common Terminology Service, and the HSSP Retrieve, Locate, and Update Service. Our experiences, and those of others, indicate that the proposed SOA approach to CDS could enable the widespread adoption of effective CDS within the U.S. health care system.

In vitro growth and phenotypic characterization of mesodermal-derived and epithelial components of normal and abnormal human thymus

Long-term in vitro cultures of human thymic tissue were established and phenotypically characterized using monoclonal reagents that define distinct components of the human thymic microenvironment. The epithelial component of the thymus, defined by monoclonal antibodies TE-3, TE-4, BBTECS, and AE1 (anti-keratin) was isolated from the mesodermal component, defined by antibody TE-7, and maintained separately in long-term culture. The epithelial cells were subcultured repeatedly and recovered from storage in liquid nitrogen. The in vitro phenotype of the cultured cells was compared to that of cultured human epidermal cells. A subpopulation of cultured thymic epithelial cells along with a subpopulation of cultured epidermal cells expressed antigens (TE-8, TE-15) characteristic of late stages of keratinized epithelial cell differentiation. Thus, we have established a system whereby components of the human thymic microenvironment can be cultivated in vitro while maintaining the capacity to differentiate. This approach can be used to evaluate the role of components of the thymic microenvironment at various stages of differentiation on developing T lymphocytes. In addition, keratin-containing thymic epithelial cells were successfully cultured from thymuses obtained from patients with myasthenia gravis and thymoma. Cultivation of abnormal thymic epithelium will provide insight into aberrant T lymphocyte-thymic epithelial interaction.

Design of FRESH START: A Randomized Trial of Exercise and Diet among Cancer Survivors.

PURPOSE FRESH START is a randomized controlled trial that will test whether a personally tailored, distance-medicine-based program will increase exercise and fruit and vegetable consumption, and decrease fat intake of individuals recently diagnosed with breast or prostate cancer. METHODS Early-stage breast and prostate cancer cases (N= 530) will be identified within 9 months of diagnosis from hospital cancer registries and large oncologic practices throughout the United States. These individuals will be sent a letter of invitation and screened for eligibility. After a baseline telephone interview, participants will be randomized into one of two arms that receive materials aimed at increasing exercise and fruit and vegetable intake, and decreasing dietary fat: 1). an experimental arm that receives a workbook and a series of six 4-page newsletters delivered every 7 wk and personally tailored on type of cancer, cancer coping style, race, age, self-efficacy, stage of readiness, and barriers and/or progress toward goal behavior (i.e., >or= 30 min of exercise at least 5 d.wk, >or= 5 servings of vegetables and fruit per day, and <or= 30% of calories from fat); or 2). a control arm that receives a series of nontailored health brochures. Follow-up interviews scheduled 1 and 2 yr postbaseline will determine short- and long-term efficacy and the effects of the interventions on other endpoints (quality of life, perceived health, etc.). Factors, such as gender, race, and social support, also will be explored to determine potential interactions with program efficacy. CONCLUSION Given the growing number of cancer survivors, distance-medicine-based interventions addressing multiple behaviors and targeting this high-risk group have the potential to make a positive and broad public health impact.

Comparing the 7-day Physical Activity Recall with a Triaxial Accelerometer for Measuring Time in Exercise

PURPOSE The primary study aim was to evaluate associations of estimated weekly minutes of moderate-to-vigorous-intensity exercise from self-reports of the telephone-administered 7-Day Physical Activity Recall (7-Day PAR) with data captured by the RT3 triaxial accelerometer. METHODS This investigation was undertaken as part of the FRESH START study, a randomized clinical trial that tested an iteratively tailored diet and exercise mailed print intervention among newly diagnosed breast and prostate cancer survivors. A convenience sample of 139 medically eligible subjects living within a 60-mile radius of the study center provided both 7-Day PAR and accelerometer data at enrollment. Ultimately, substudy subjects (n = 115) were found eligible for the FRESH START study and randomized to one of two study treatment arms. Follow-up assessments at year 1 (n = 103) and year 2 (n = 99) provided both the 7-Day PAR and the accelerometer data. RESULTS There was moderate agreement between the 7-Day PAR and the accelerometer with longitudinal serial correlation coefficients of 0.54 (baseline), 0.24 (year 1), and 0.53 (year 2), all P values <0.01, although the accelerometer estimates for weekly time in moderate-to-vigorous physical activity (PA) were much higher than those of the 7-Day PAR at all time points. The two methods were poorly correlated in assessing sensitivity to change from baseline to year 1 (rho = 0.11, P = 0.30). Using mixed models repeated-measures analysis, both methods exhibited similar nonsignificant treatment arm x time interaction P values (7-Day PAR = 0.22, accelerometer = 0.23). CONCLUSIONS The correlations for three serial time points were in agreement with findings of other studies that compared self-reported time in exercise with PA captured by accelerometry. However, these methods capture somewhat different dimensions of PA and provide differing estimates of change over time.

Change in self‐efficacy partially mediates the effects of the FRESH START intervention on cancer survivors' dietary outcomes

Objective: This study examined change in self‐efficacy as a mediator of the effects of a mailed print intervention on the dietary and exercise practices of newly diagnosed breast and prostate cancer survivors.