PubMed Health⌕ Search

Biomedical subjects

Lee A Green

Publications and source records attributed to Lee A Green.

17 recordsLinked to original sources
PubMed2006

An 'Honest Broker' mechanism to maintain privacy for patient care and academic medical research.

PURPOSE: From the Hippocratic Oath to the World Medical Association's Declaration of Geneva, physicians have sworn to protect patients' privacy. However, as systems move to more integrated architectures, protecting this medical data becomes more of a challenge. The increase in complexity of IT environments, the aggregation of data, and the desire of other entities to access this data, often 24 h/day x 7 day/week x 365 day/year, is putting serious strains on our ability to maintain its security. This problem cuts across all electronic record sources from patient care records to academic medical research records. APPROACH: In order to address this issue, we are rethinking the way we store, transmit, process, access, and federate patient data from clinical and research applications. Our groups at the University of Michigan are developing a system called the "Honest Broker" to help manage this problem. The Honest Broker will offload the burden of housing identifiable data elements of protected health information (PHI) (e.g., name and address) as well as manage data transfer between clinical and research systems. Lab results and other non-identifiable data will be stored in separate systems with either a research study ID or clinical ID number. This two-component architecture increases the burden on attackers who now need to compromise two systems, one of which is seriously hardened, in order to match health data with a patient's actual identity. CONCLUSIONS: While no security system is truly intrusion-proof, this architecture provides a high security choke point reducing the likelihood of a breach. By redesigning the method of integrating clinical care and research, we have enabled projects that would be cost prohibitive to conduct otherwise. The scalability of this mechanism is dependant on nature of the heterogenous nature of the clinical systems serving patients.

Biomedical Research↗
PubMed2006

Integrating education into primary care quality and cost improvement at an academic medical center.

INTRODUCTION: In 1996 the University of Michigan Health System created the Guidelines Utilization, Implementation, Development, and Evaluation Studies (GUIDES) unit to improve the quality and cost-effectiveness of primary care for common medical problems. GUIDES's primary functions are to oversee the development of evidence-based, practical clinical guidelines for common medical conditions; measure and provide feedback on physicians' performance; and facilitate systemic changes to support appropriate care. Various methods are used to improve care, including evidence reviews, formal education, informal clinical "opinion leaders," feedback, reminders, and procedure changes. Twenty-four common medical conditions have been addressed through this process. More than 30 measures of clinical performance have been developed and reported. METHODS: This case study describes a systematic, multifaceted program to improve the quality and cost-effectiveness of primary care. RESULTS: Illustrative results for clinical performance are presented for 2 measures of chronic care, 2 measures of preventive care, and 2 measures of acute care. All 6 measures show general improvement in performance across years, with performance near or above the National Committee for Quality Assurance's 90th percentile for Health Plan Employer Data and Information Set measures. DISCUSSION: A systematic approach involving all relevant components of a health system integrates the synthesis of information, education about the information and how to implement it, and addressing operational barriers. Benefits include a curriculum that is shared across faculty, residents, and medical students and more uniform quality of care that faculty model for physicians-in-training.

Academic Medical Centers↗
PubMed2006

Impact of institutional review board practice variation on observational health services research.

OBJECTIVE: To describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics. DESIGN: Explanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data. PRINCIPAL FINDINGS: Approximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site. CONCLUSIONS: Several features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.

Ethics Committees↗
PubMed2005

Hypertension.

For primary care physicians, managing hypertension is a challenging undertaking because it is a good example of the balance be-tween implementing evidence and working with patients' beliefs, ideas, and resources to help them improve their health. In this article the authors review the evidence supporting aggressive recommendations on prevention and treatment of hypertension to decrease cardiovascular, cerebrovascular, and renal disease. They review the public health implications of hypertension, but focus on the challenges clinicians face in working with patients to optimize their health with the financial and personal resources they have available.

Antihypertensive Agents↗
PubMed2003

Management of newly detected atrial fibrillation: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians.

The Joint Panel of the American Academy of Family Physicians and the American College of Physicians, in collaboration with the Johns Hopkins Evidence-based Practice Center, systematically reviewed the available evidence on the management of newly detected atrial fibrillation and developed recommendations for adult patients with first-detected atrial fibrillation. The recommendations do not apply to patients with postoperative or post-myocardial infarction atrial fibrillation, patients with class IV heart failure, patients already taking antiarrhythmic drugs, or patients with valvular disease. The target physician audience is internists and family physicians dedicated to primary care. The recommendations are as follows: RECOMMENDATION 1: Rate control with chronic anticoagulation is the recommended strategy for the majority of patients with atrial fibrillation. Rhythm control has not been shown to be superior to rate control (with chronic anticoagulation) in reducing morbidity and mortality and may be inferior in some patient subgroups to rate control. Rhythm control is appropriate when based on other special considerations, such as patient symptoms, exercise tolerance, and patient preference. Grade: 2A. RECOMMENDATION 2: Patients with atrial fibrillation should receive chronic anticoagulation with adjusted-dose warfarin, unless they are at low risk of stroke or have a specific contraindication to the use of warfarin (thrombocytopenia, recent trauma or surgery, alcoholism). Grade: 1A. RECOMMENDATION 3: For patients with atrial fibrillation, the following drugs are recommended for their demonstrated efficacy in rate control during exercise and while at rest: atenolol, metoprolol, diltiazem, and verapamil (drugs listed alphabetically by class). Digoxin is only effective for rate control at rest and therefore should only be used as a second-line agent for rate control in atrial fibrillation. Grade: 1B. RECOMMENDATION 4: For those patients who elect to undergo acute cardioversion to achieve sinus rhythm in atrial fibrillation, both direct-current cardioversion (Grade: 1C+) and pharmacological conversion (Grade: 2A) are appropriate options. RECOMMENDATION 5: Both transesophageal echocardiography with short-term prior anticoagulation followed by early acute cardioversion (in the absence of intracardiac thrombus) with postcardioversion anticoagulation versus delayed cardioversion with pre- and postanticoagulation are appropriate management strategies for those patients who elect to undergo cardioversion. Grade: 2A. RECOMMENDATION 6: Most patients converted to sinus rhythm from atrial fibrillation should not be placed on rhythm maintenance therapy since the risks outweigh the benefits. In a selected group of patients whose quality of life is compromised by atrial fibrillation, the recommended pharmacologic agents for rhythm maintenance are amiodarone, disopyramide, propafenone, and sotalol (drugs listed in alphabetical order). The choice of agent predominantly depends on specific risk of side effects based on patient characteristics. Grade: 2A.

Adult↗
PubMed2003

Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.

The National High Blood Pressure Education Program presents the complete Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Like its predecessors, the purpose is to provide an evidence-based approach to the prevention and management of hypertension. The key messages of this report are these: in those older than age 50, systolic blood pressure (BP) of greater than 140 mm Hg is a more important cardiovascular disease (CVD) risk factor than diastolic BP; beginning at 115/75 mm Hg, CVD risk doubles for each increment of 20/10 mm Hg; those who are normotensive at 55 years of age will have a 90% lifetime risk of developing hypertension; prehypertensive individuals (systolic BP 120-139 mm Hg or diastolic BP 80-89 mm Hg) require health-promoting lifestyle modifications to prevent the progressive rise in blood pressure and CVD; for uncomplicated hypertension, thiazide diuretic should be used in drug treatment for most, either alone or combined with drugs from other classes; this report delineates specific high-risk conditions that are compelling indications for the use of other antihypertensive drug classes (angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, beta-blockers, calcium channel blockers); two or more antihypertensive medications will be required to achieve goal BP (<140/90 mm Hg, or <130/80 mm Hg) for patients with diabetes and chronic kidney disease; for patients whose BP is more than 20 mm Hg above the systolic BP goal or more than 10 mm Hg above the diastolic BP goal, initiation of therapy using two agents, one of which usually will be a thiazide diuretic, should be considered; regardless of therapy or care, hypertension will be controlled only if patients are motivated to stay on their treatment plan. Positive experiences, trust in the clinician, and empathy improve patient motivation and satisfaction. This report serves as a guide, and the committee continues to recognize that the responsible physician's judgment remains paramount.

Adult↗
PubMed2003

The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report.

"The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure" provides a new guideline for hypertension prevention and management. The following are the key messages(1) In persons older than 50 years, systolic blood pressure (BP) of more than 140 mm Hg is a much more important cardiovascular disease (CVD) risk factor than diastolic BP; (2) The risk of CVD, beginning at 115/75 mm Hg, doubles with each increment of 20/10 mm Hg; individuals who are normotensive at 55 years of age have a 90% lifetime risk for developing hypertension; (3) Individuals with a systolic BP of 120 to 139 mm Hg or a diastolic BP of 80 to 89 mm Hg should be considered as prehypertensive and require health-promoting lifestyle modifications to prevent CVD; (4) Thiazide-type diuretics should be used in drug treatment for most patients with uncomplicated hypertension, either alone or combined with drugs from other classes. Certain high-risk conditions are compelling indications for the initial use of other antihypertensive drug classes (angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, beta-blockers, calcium channel blockers); (5) Most patients with hypertension will require 2 or more antihypertensive medications to achieve goal BP (<140/90 mm Hg, or <130/80 mm Hg for patients with diabetes or chronic kidney disease); (6) If BP is more than 20/10 mm Hg above goal BP, consideration should be given to initiating therapy with 2 agents, 1 of which usually should be a thiazide-type diuretic; and (7) The most effective therapy prescribed by the most careful clinician will control hypertension only if patients are motivated. Motivation improves when patients have positive experiences with and trust in the clinician. Empathy builds trust and is a potent motivator. Finally, in presenting these guidelines, the committee recognizes that the responsible physician's judgment remains paramount.

Adrenergic alpha-Agonists↗
PubMed2002

Validating an instrument for selecting interventions to change physician practice patterns: a Michigan Consortium for Family Practice Research study.

OBJECTIVES: The goal of this study was to develop a psychometric instrument that classified physiciansamprsquo response styles to new information as seekers, receptives, traditionalists, or pragmatists. This classification was based on specific combinations of 3 scales: (a) belief in evidence vs experience as the basis of knowledge, (b) willingness to diverge from common or previous practice, and (c) sensitivity to pragmatic concerns of practice. The instrument will help focus efforts to change practice more accurately. STUDY DESIGN: This was a cross-sectional study of physician responses to a psychometric instrument. Paper-and-pencil survey forms were distributed to 3 waves of physicians, with revision for improved internal consistency at each iteration. POPULATION: Participants were 1393 primary care physicians at continuing education events in the Midwest or at primary care clinic sites in the Veteransamprsquo Health Administration system. OUTCOMES MEASURED: Internal consistency was measured by factor analysis with orthogonal rotation and Cronbachamprsquos alpha. RESULTS: A total of 1287 usable instruments were returned (106, 1120, and 61 in the 3 iterations, respectively), representing approximately three fourths of distributed forms. Final scale internal consistencies were a = 0.79, b = 0.74, and c = 0.68. The patterns of scores on the 3 scales were consistent with the predictions of the theoretical scheme of physician types. The "seeker" type was the rarest, at fewer than 3%. CONCLUSIONS: It is possible to reliably classify physicians into categories that a theoretical framework predicts will respond differently to different interventions for implementing guidelines and translating research findings into practice. The next step is to demonstrate that the classification predicts physician practice behavior.

Adult↗
PubMedDate not supplied

Opening the black box: cognitive strategies in family practice.

PURPOSE: We wanted to describe the cognitive strategies used by family physicians when structuring the decision-making tasks of an outpatient visit. METHODS: This qualitative study used cognitive task analysis, a structured interview method in which a trained interviewer works individually with expert decision makers to capture their stages and elements of information processing. RESULTS: Eighteen family physicians of varying levels of experience participated. Three dominant themes emerged: time pressure, a high degree of variation in task structuring, and varying degrees of task automatization. Based on these data and previous research from the cognitive sciences, we developed a model of novice and expert approaches to decision making in primary care. The model illustrates differences in responses to unexpected opportunity in practice, particularly the expert's use of attentional surplus (reserve capacity to handle problems) vs the novice's choice between taking more time or displacing another task. CONCLUSIONS: Family physicians have specific, highly individualized cognitive task-structuring approaches and show the decision behavior features typical of expert decision makers in other fields. This finding places constraints on and suggests useful approaches for improving practice.

Adult↗
PubMedDate not supplied

Infrastructure requirements for practice-based research networks.

BACKGROUND: The practice-based research network (PBRN) is the basic laboratory for primary care research. Although most PBRNs include some common elements, their infrastructures vary widely. We offer suggestions for developing and supporting infrastructures to enhance PBRN research success. METHODS: Information was compiled based on published articles, the PBRN Resource Center survey of 2003, our PBRN experiences, and discussions with directors and coordinators from other PBRNs. RESULTS: PBRN research ranges from observational studies, through intervention studies, clinical trials, and quality of care research, to large-scale practice change interventions. Basic infrastructure elements such as a membership roster, a board, a director, a coordinator, a news-sharing function, a means of addressing requirements of institutional review boards and the Health Insurance Portability and Accountability Act, and a network meeting must exist to support these initiatives. Desirable elements such as support staff, electronic medical records, multiuser databases, mentoring and development programs, mock study sections, and research training are costly and difficult to sustain through project grant funds. These infrastructure elements must be selected, configured, and sized according to the PBRN's self-defined research mission. Annual infrastructure costs are estimated to range from $69,700 for a basic network to $287,600 for a moderately complex network. CONCLUSIONS: Well-designed and properly supported PBRN infrastructures can support a wide range of research of great direct value to patients and society. Increased and more consistent infrastructure support could generate an explosion of pragmatic, generalizable knowledge about currently understudied populations, settings, and health care problems.

Biomedical Research↗
PubMedDate not supplied

The Michigan Clinical Research Collaboratory: following the NIH Roadmap to the community.

PURPOSE: This case study describes a successful National Institutes of Health (NIH) Roadmap application that has created a new and innovative translational science partnership at the University of Michigan. METHODS: We describe the institution within which the grant application was developed, the role played by the Department of Family Medicine, the role of prior successes in translational and community-based research, the associated infrastructure development, the application development process, and some features of the final project. RESULTS: A partnership among 2 clinical and research centers of excellence at the University of Michigan, 3 practice-based research networks, and a clinical research center was created as the platform to support an NIH Roadmap. The result was a funded 3.3 million dollar, 3-year project supporting the creation of the Michigan Clinical Research Collaboratory (MCRC), a research infrastructure that will support the design, conduct, and dissemination of community-based clinical translation research. The MCRC depends to a considerable degree on the experience, expertise, and infrastructure in community-based translational research of the Department of Family Medicine. CONCLUSIONS: The successful funding of the MCRC grant will support influential translational research programs of high impact and visibility that would not otherwise have occurred. The MCRC grant is an acknowledgment of the important research to be done in the community, the critical nature of infrastructure investment and prior work in competing successfully for such funding, and the personnel and information technology investments required for success. Collaboration between practice-based family medicine investigators and traditional clinical investigators at the University of Michigan has led to successful competition for an NIH Roadmap grant, which has led in turn to greater institutional recognition for the importance and legitimacy of community-based translational research.

Academic Medical Centers↗
PubMedDate not supplied

ClinfoTracker: a generalizable prompting tool for primary care.

BACKGROUND: ClinfoTracker is a prompt and reminder system designed as a platform for the study of the cognitive aspects of prompting in primary care. We examined the impact of ClinfoTracker in three practices and its potential for studying primary care clinicians' use of prompt and reminder systems. METHODS: We studied ClinfoTracker in three practices using an observational design. We measured performance rates of three services during the course of 5 years in one practice and prompt response rates in all three practices for 5 months after implementation. We performed qualitative cognitive task analyses of ClinfoTracker use. RESULTS: Five-year compliance rates increased for fecal occult blood testing (1996-2000, 22.5%, P = .0037; 1997-2000, 23.5%, P = .0024) and type 2 diabetes retinopathy testing (1997-2000, 15.7%, P = .0004; 1998-2000, 16.9%, P = .0001; 1999-2000, 12.4%, P = .0048). ClinfoTracker response rates from the three practices showed significant increases during 5 months (P < .0001). Significant differences seen between practice response rates indicate variable success in ClinfoTracker implementation. Cognitive task analyses performed at site 1 indicate differences in how ClinfoTracker prompts are incorporated into practice. CONCLUSIONS: Improvements in preventive and disease management services after implementation show the potential of ClinfoTracker. Differences in implementation between practice sites and observations of individual clinicians show the promise ClinfoTracker holds for studying clinician use of prompt and reminder systems.

Analysis of Variance↗
PubMedDate not supplied

Translation of research into practice: why we can't "just do it".

Translation of new knowledge into practice proceeds through 3 stages, from awareness through acceptance to adoption. Translational research focuses almost exclusively on the first 2 stages. We argue that improving the disappointing results of translation efforts will require a detailed understanding of how adoption takes place. We summarize research in cognitive science that illustrates how accepted "declarative" knowledge (acquired through lectures, reading, and discussion) differs (even down to its locus in the brain) from adopted "procedural" knowledge that is acted on in clinical practice. We suggest strategies that can capitalize on the cognitive processes by which declarative knowledge is proceduralized, as a means of making translation more effective, including (1) structured case-level feedback, automated or from human consultants, during the declarative stage; (2) practice in context early in the procedural stage; and (3) deliberative practice when procedural knowledge has been formed but is still being refined.

Diffusion of Innovation↗