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Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

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PubMed2000

Should data and safety monitoring boards share confidential interim data?

Consider the following situation: Two clinical trials are underway, closely related in terms of the interventions being compared and the target populations. In preparing for a planned interim analysis, the statistician for trial 1 finds that the results support a recommendation to stop the trial early. Should the statistician ask the investigators for trial 2 to make interim results of their trial available to the data and safety monitoring board (DSMB) for trial 1? If so, in what form? Would the answers change if the trial 1 results showed a strong but not convincing trend? What is the obligation of the trial 2 investigators to respond to such a request? What role do the two DSMBs have, either in initiating a request or in agreeing to respond to it? In this article, we examine this situation in some detail, having faced it occasionally in our own experience with clinical trials and DSMBs. The chief argument in favor of sharing data is that data from trial 2 are obviously relevant to the question being addressed by trial 1 and therefore ought to be available to those who must interpret the results from that trial. On the other hand, there are several reasons for not sharing interim data. For example, sharing is incompatible with the independence of the trials; the time for synthesizing evidence from both trials is after the two teams of investigators have presented the full analysis and interpretation of their separate trials. For this and other conceptual and practical reasons we conclude that it is better, in most cases, for DSMBs to consider only information that has already been made public in some form.

Clinical Trials as Topic↗
PubMed2006

Health-e-child: an integrated biomedical platform for grid-based paediatric applications.

There is a compelling demand for the integration and exploitation of heterogeneous biomedical information for improved clinical practice, medical research, and personalised healthcare across the EU. The Health-e-Child project aims at developing an integrated healthcare platform for European Paediatrics, providing seamless integration of traditional and emerging sources of biomedical information. The long-term goal of the project is to provide uninhibited access to universal biomedical knowledge repositories for personalised and preventive healthcare, large-scale information-based biomedical research and training, and informed policy making. The project focus will be on individualized disease prevention, screening, early diagnosis, therapy and follow-up of paediatric heart diseases, inflammatory diseases, and brain tumours. The project will build a Grid-enabled European network of leading clinical centres that will share and annotate biomedical data, validate systems clinically, and diffuse clinical excellence across Europe by setting up new technologies, clinical workflows, and standards. This paper outlines the design approach being adopted in Health-e-Child to enable the delivery of an integrated biomedical information platform.

Databases as Topic↗
PubMed1991

"Medical informatics in a medical research facility. An interactive multimedia presentation". Diabetes as a model.

This interactive demonstration provides a model for integrating information in a medical facility. By the use of networking computers, diagnostic data and scientific data are shared between geographically-separated clinical and research units. Data collected in a patient database in the outpatient clinic is sorted on specified qualifying criteria and the resulting subset further analyzed for research studies. To show the process of patient selection from a general database to a diabetes database, and further selection to a subset of diabetes, i.e., Diabetic Neuropathy, the authors used HyperCard. Firstly, HyperCard provided us with a flexible design allowing for both vertical and horizontal progressions. Because we wanted to include an educational component on diabetes and its complications, this flexibility was important. At any point in the demonstration, the viewer is able to access more information nested in several levels. Secondly, we wanted to be able to import a variety of programs that are used to translate diagnostic data into scientific data that is analyzed and prepared for publication in a medical textbook or journal. According to Douglas Adams, author of "Pathways and Relationships", HyperCard occupies the same niche in the evolution of software as human beings do in the evolution of life. "It's the fact that we are unspecialized but infinitely adaptable that has been our success as a species. In the same way, HyperCard is unspecialized but can turn its hand to any kind of task. And if the task is beyond it, HyperCard can use the phone, go for a ride on Excel, or go out and find a powerful graphics tool or sophisticated wordprocessing program!"

Academies and Institutes↗
PubMed1983

Texas Consortium for Physical Therapy Clinical Education. A model for Interinstitutional Consortium arrangements.

This article describes the Texas Consortium for Physical Therapy Clinical Education, which exemplifies one type of collaborative arrangement among universities. Coordination of physical therapy clinical education among five Texas universities is the major function of the Texas Consortium. Although originally developed from a federally funded project (1977-1980), it currently functions with sole financial support from the participating universities. The collaborative efforts of the Texas Consortium have resulted in 1) developing and implementing a common evaluation tool for students' clinical performance; 2) coordinating development of new clinical education centers, development of clinical instructors, and visits to students at clinical education centers; and 3) developing and using a shared computer program for data on clinical education centers. The successful functioning of the Texas Consortium with a resultant decrease in duplication of time, effort, and costs of clinical education demonstrates that this type of arrangement is feasible and beneficial.

Costs and Cost Analysis↗
PubMed1997

Three perspectives on integrated clinical databases.

The dramatic transformation of health care organizations from independent local entities into regional and national integrated health care delivery enterprises has forced a reevaluation of the role of information systems. Until recently, nearly all clinical information systems were acquired to support financial and administrative services within single facilities. When independent facilities merge to form an integrated health system (IHS), they find that their unique computer systems do not allow for the sharing or combining of clinical data. However, new technologies are beginning to enable patient-specific data scattered among many information systems in many different hospitals and ambulatory care settings to be unified into a single database called a clinical data repository. The hope is that comprehensive electronic clinical records can enable IHSs to meet their goals of improving the quality and reducing the cost of health care. As the number of technological impediments to forming integrated clinical information systems rapidly decreases, nontechnologic issues surrounding the sharing of patient information become more prominent. The author focuses on the clinician's, the administrator's, and the patient's unique perspectives on the benefits and possible problems associated with clinical data repositories. He then describes how one IHS, together with an academic medical institution, has begun to grapple with many of these concerns through an effort called Project Spectrum. The goal of the project is the successful implementation of a comprehensive clinical data repository.

Clinical Medicine↗
PubMed1996

Reducing risks in blood transfusion: process and outcome.

The last decade has seen substantial improvements in the provision of safe "infection-free' blood for patients in many countries. This has resulted from the combined effects of better donor education, selection, testing and exclusion processes. The residual risk of infection with HBsAg attributable to laboratory error is less than 0.1/ 100,000 (1/750,000). The risk for HIV remains to be quantified but may approach this figure. With such low risks it will be difficult to provide statistical evidence that further improvements in the process of selection, testing or exclusion will have an impact on reducing risk from either agent. Over the same time, less progress has been made reducing risk to the recipient attributable to problems in the clinical supply process, i.e. getting the right blood, to the right person, at the right place, at the right time. Uniform definitions of terminology defining blood donation characteristics, together with the sharing of performance data are essential if we are to make national and international comparison of the risks that patients face when they receive a transfusion. Equally, the use of agreed definitions, and the sharing of data on the clinical outcomes of transfusion can provide the key to better prescribing based on evidence of actual risks and benefits.

Blood Banks↗
PubMed2003

Outcome, tolerability and compliance of compassionate use interferon and ribavirin for hepatitis C infection in a shared care hospital clinic.

BACKGROUND AND AIMS: To determine response rate, side-effects and compliance in patients with chronic hepatitis C virus (HCV) infection following treatment with interferon-alpha-2b and ribavirin in a 'shared care' hospital clinic. METHODS: Data were collected prospectively on 81 patients treated with combination therapy for chronic HCV infection between 1999 and 2001. All had biochemical and virological evidence of active infection. All patients had undergone liver biopsy except haemophiliac patients. Patients infected with genotype 1 were treated for 12 months. Patients infected with genotypes 2 and 3 were treated for 6 months. Patient care was shared with the referring general practitioner. Intention to treat, end of treatment and sustained virological response (SVR) rates, side-effects and compliance were assessed. RESULTS: Eighty-one patients with chronic HCV infection were treated with combination therapy. The majority of HCV patients were genotype 1 (n = 46; 57%). There were 12 patients (15%) with cirrhosis. SVR rates were: (i) 24% for genotype 1, (ii) 58% for genotype 3 and (iii) 75% for genotype 2. SVR was achieved in three (23%) cirrhotic patients. Compliance with the treatment regimen was 98%. Seven per cent of patients were withdrawn from therapy prematurely because of side-effects. CONCLUSIONS: These 'shared care' clinic results compare well with controlled clinical trials using combination therapy for chronic HCV infection. Outcomes were poorer in genotype 1 patients and in patients with cirrhosis. Compliance with therapy was excellent because of the 'Shared Care Programme' with participation of general practitioners, psychiatrists and hepatitis C nurse practitioners in the management protocol.

Adult↗
PubMed1986

Implementation of a statewide perinatal automated medical network (PAM/NET) for Michigan.

PAM/NET is a computerized data base and conferencing system used by nine neonatal intensive care units in Michigan and Illinois. The system depends on the timesharing resource of a large university mainframe computer. The data base functions are managed by a sophisticated inverted file relational data base management system capable of mass storage and rapid and specific retrieval of individual cases or summary data. Data stored in the system are used to generate admission, discharge and developmental assessment clinic summaries that serve as such for the medical record and as letters to primary physicians. We report here the early experience in the design and dissemination of this database network to the participating hospitals. Conflicting goals of sharing and confidentiality of clinical data are addressed in the design of this system.

Ambulatory Care Facilities↗
PubMed2005

The clinical and genetic associations of anti-cyclic citrullinated peptide antibodies in psoriatic arthritis.

OBJECTIVES: Antibodies recognizing a cyclic citrullinated peptide (anti-CCP) are highly specific for rheumatoid arthritis (RA) but their role in psoriatic arthritis (PsA) remains unclear. The aim of this study was therefore to investigate the prevalence of anti-CCP antibodies in PsA and assess their clinical and genetic associations. METHODS: One hundred and twenty-six patients with PsA, 40 patients with seropositive RA and 40 controls were tested for the presence of anti-CCP antibodies, rheumatoid factor (RF) and the HLA-DRB1 shared epitope. Clinical and radiological data were collected prospectively on all patients and compared between anti-CCP-positive and -negative patients. RESULTS: Seven (5.6%) patients with PsA were positive for anti-CCP antibodies compared with 0% of controls and 97% of patients with seropositive RA. The presence of anti-CCP antibodies in PsA was significantly associated with the HLA-DRB1 shared epitope (P<0.005), erosive disease (P<0.05), number of swollen joints (P<0.02) and DMARD use (P<0.05). CONCLUSIONS: Overall, the increased prevalence of anti-CCP antibodies in this PsA population failed to reach statistical significance. However, when present, they were a marker of disease severity and had RA-linked MHC class II associations. Further studies are needed in a larger population of patients with PsA and appropriate controls to confirm any true association that may be present.

Adult↗
PubMed1994

The standards movement builds momentum.

The success of efforts to build health information networks and to implement computerized patient records will hinge on the development of standards for the electronic format and content of financial and clinical transactions. Without standards, sharing data among disparate systems will be extremely cumbersome, and drawing conclusions based on research will prove difficult. For years, several volunteer groups have been toiling to develop these standards. These efforts are beginning to pay off. This special report summarizes the latest trends in standards development. This series of stories includes an update on efforts to develop standard data sets for financial and administrative transactions; a guide to the jargon of health care electronic data interchange, an overview of efforts to speed the development of standards for computerized records; and a case study of a hospital implementing one set of clinical standards.

Clinical Medicine↗
PubMedDate not supplied

Voices from the wilderness: an interpretive study describing the role and practice of outpost nurses.

OBJECTIVE: Outpost nurses function as primary care providers and in a community health nursing role, providing comprehensive primary health care in Canada's underserved northern communities. Little information exists regarding how outpost nurses meet this expectation. The purpose of this interpretive study was to address the following research questions: 1) How do experienced outpost nurses perceive and enact their role? 2) How are practical knowledge and clinical wisdom revealed in the practice narratives of experienced outpost nurses? METHODS: Purposive sampling was used to recruit the nine experienced outpost nurses who participated by sharing narratives of clinical practice. Data analysis was conducted in accordance with Benner's model of interpretive phenomenology. Paradigm and exemplary cases served to ground the interpretation in the data. RESULTS: Four themes emerged from the data: a) primary care competencies are fundamental to outpost practice, b) nurses evolve into the outpost role by learning community health competencies and adapting to context-specific practice issues, c) experienced outpost nurses build and maintain responsive relationships with communities, and d) experienced outpost nurses become comfortable with the autonomy and responsibility of practice. DISCUSSION: The findings of this study reinforce the complex nature of outpost nursing; it is an anomalous community health nursing role grounded in primary care competency. Interpretation of the data suggests that outpost nurses share practice domains and competencies with nurse practitioners. A better understanding of the outpost nursing role clarifies how nurses might better contribute to improving the health status of northern residents, helping northern communities become healthy communities.

Adult↗
PubMed2004

A web-based federated neuroinformatics model for surgical planning and clinical research applications in epilepsy.

There is an increasing need to efficiently share diverse clinical and image data among different clinics, labs, and departments of a medical center enterprise to facilitate better quality care and more effective clinical research. In this paper, we describe a web-based, federated information model as a viable technical solution with applications in medical refractory epilepsy and other neurological disorders. We describe four such online applications developed in a federated system prototype: surgical planning, image analysis, statistical data analysis, and dynamic extraction, transforming, and loading (ETL) of data from a heterogeneous collection of data sources into an epilepsy multimedia data warehouse (EMDW). The federated information system adopts a three-tiered architecture, consisting of a user-interface layer, an application logic layer, and a data service layer. We implemented two complementary federated information technologies, i.e., XML (eXtensible Markup Language) and CORBA (Common Object Request Broker Architecture), in the prototype to enable multimedia data exchange and brain images transmission. The preliminary results show that the federated prototype system provides a uniform interface, heterogeneous information integration and efficient data sharing for users in our institution who are concerned with the care of patients with epilepsy and who pursue research in this area.

Animals↗
PubMed2026

289th ENMC international workshop: assessing and managing emerging AAV related toxicities after gene therapy for neuromuscular disorders, 26 - 28 September 2025, Hoofddorp, The Netherlands.

Adeno-associated virus (AAV) mediated gene therapies has emerged as a potentially transformative treatment approaches for neuromuscular disorders, with two FDA-approved products now in widespread clinical use: onasemnogene abeparvovec (Zolgensma) for spinal muscular atrophy and delandistrogene moxeparvovec-rokl (Elevidys) for Duchenne Muscular Dystrophy. However, severe and occasionally fatal adverse events affecting vital organs, including the blood, liver, muscle, and heart, have emerged in both clinical trials and real-world post marketing settings. The 289th European NeuroMuscular Centre (ENMC) workshop convened 38 participants from patient advocacy groups, industry, and preclinical and clinical research groups to collaboratively review these toxicities, their underlying mechanisms, and potential mitigation and monitoring strategies. Discussions addressed the clinical spectrum and biological drivers of these events, the respective roles of innate and adaptive immunity, the contribution of specific vector characteristics as well as of the specific disease and recipient. The application of risk stratification and immunosuppressive regimens for prevention, monitoring, and management were considered. Emerging toxicities, including capillary leak syndrome, endothelial and dorsal root ganglia injuries, were reviewed alongside corresponding preclinical data from non-human primates. Participants agreed on the need to harmonize standard operating procedures, clinical guidelines, and data-sharing practices, and endorsed collaborative initiatives to proactively address critical gaps and unresolved key questions through a patient-centered framework.

Adaptive immune response↗
PubMed2003

Insulin-lowering agents in the management of polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS) is a medical condition that has brought multiple specialists together. Gynecologists, endocrinologists, cardiologists, pediatricians, and dermatologists are all concerned with PCOS patients and share research data and design clinical trials to learn more about the syndrome. Insulin resistance is a common feature of PCOS and is more marked in obese women, suggesting that PCOS and obesity have a synergistic effect on the magnitude of the insulin disorder. Hyperinsulinemia associated with insulin resistance has been causally linked to all features of the syndrome, such as hyperandrogenism, reproductive disorders, acne, hirsutism, and metabolic disturbances. Women with PCOS should be evaluated for cardiovascular risk factors, such as lipid profile and blood pressure. Modification of diet and lifestyle should be suggested to those who are obese. Several insulin-lowering agents have been tested in the management of PCOS. In particular, metformin is the only drug currently in widespread clinical use for treatment of PCOS. In a high percentage of patients, treatment with metformin is followed by regularization of menstrual cycle, reduction in hyperandrogenism and in cardiovascular risk factors, and improvement in response to therapies for induction of ovulation.

Female↗
PubMedDate not supplied

What is Health Level 7?

HL7 is a huge undertaking and continues to grow. We talked about certain main themes of the spec that I've found interesting and thought you might too. You can always find additional information-especially from the HL7 website itself at www.hl7.org or www.altisinc.com/ IE/hl7.html. The main thing to remember is that HL7 is a specification for describing, formatting, encoding, and sharing of clinical and administrative data in healthcare. An easy way to remember that is that the 7 in HL7 refers to the Application layer in the OSI model. The next time someone talks about their HL7 software or application, you'll know that they really mean their HL7 compliant software or application. Then be sure to ask them how many composites are in their OBX segments!

Communication↗
PubMed2004

Polycystic ovary syndrome and type 2 diabetes mellitus.

Polycystic ovary syndrome (PCOS) is a medical condition that has brought multiple specialists together. Gynecologists, endocrinologists, cardiologists, pediatricians, and dermatologists are all concerned with PCOS patients and share research data and design clinical trials to learn more about the syndrome. Insulin resistance is a common feature of PCOS and is more marked in obese women, suggesting that PCOS and obesity have a synergistic effect on the magnitude of the insulin disorder. It leads to increased insulin secretion by beta-cells and compensatory hyperinsulinemia. Hyperinsulinemia associated with insulin resistance has been causally linked to all features of the syndrome, such as hyperandrogenism, reproductive disorders, acne, hirsutism and metabolic disturbances. If beta-cell compensatory response declines, relative or absolute insulin insufficiency develops which may lead to glucose intolerance and type 2 diabetes. Moreover, insulin resistance in PCOS may be considered a risk factor for gestational diabetes (GD).

Adult↗
PubMed1996

The challenge of managing laboratory information in a managed care environment.

This article considers some of the major changes that are occurring in pathology and pathology informatics in response to the shift to managed care in the United States. To better understand the relationship between information management in clinical laboratories and managed care, a typology of integrated delivery systems is presented. Following this is a discussion of the evolutionary trajectory for the computer networks that serve these large consolidated healthcare delivery organizations. The most complex of these computer networks is a community health information network. Participation in the planning and deployment of community health information networks will be important for pathologists because information management within pathology will be inexorably integrated into the larger effort by integrated delivery systems to share clinical, financial, and administrative data on a regional basis. Finally, four laboratory information management challenges under managed care are discussed, accompanied by possible approaches to each of them. The challenges presented are (1) organizational integration of departmental information systems such as the laboratory information system; (2) weakening of the best-of-breed approach to laboratory information system selection; (3) the shift away from the centralized laboratory paradigm; and (4) the development of rule-based systems to monitor and control laboratory utilization.

Community Networks↗