Neurocounseling: Brain-Based Clinical Approaches

ERIC Educational Resources Information Center

Field, Thomas A., Ed.; Jones, Laura K., Ed.; Russell-Chapin, Lori A.

2017-01-01

This text presents current, accessible information on enhancing the counseling process using a brain-based paradigm. Leading experts provide guidelines and insights for becoming a skillful neuroscience-informed counselor, making direct connections between the material covered and clinical practice. In this much-needed resource-the first to address…

Nuclear medicine in clinical urology and nephrology

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tauxe, W.N.; Dubousky, E.V.

This book presents explanations of current procedures involving the kidney with information of the performance of each test, its rationale, and interpretation. The information covers all currently used radiopharmaceuticals, radiation dosimetry, instrumentation, test protocols, and mathematical principles of pathophysiology as they relate to nuclear medicine studies. Information is provided on which radiopharmaceutical, instrument, or computer application to use, and when.

Characteristics of clinical trial websites: information distribution between ClinicalTrials.gov and 13 primary registries in the WHO registry network.

PubMed

Ogino, Daisuke; Takahashi, Kunihiko; Sato, Hajime

2014-11-05

It is well known that information about clinical trials is not easily accessible by the public. In Japan, clinical trial information can be accessed by the general public through online registries; however, many people find these registries difficult to use. To improve current clinical trial registries, we propose that combining them with clinical information phrased in lay terms would be beneficial to other interested professionals such as journalists and clinicians, as well as the general public. Therefore, this study aimed to examine the current pattern of distribution of clinical trial information from the primary World Health Organization (WHO) registries. Based on the results of this assessment, we then aimed to build and evaluate a prototype of the Japan Primary Registries Network (JPRN) portal that would be easily accessible to patients and the public, while still remaining useful for professionals. We assessed a total of 14 primary clinical trial registries listed on the WHO International Clinical Trials Registry Platform between January and February 2013. Website content was accessed and checked against a series of items that looked at usability, communication, design and accessibility of the sites. We excluded registries that were not active or were not on the approved WHO registry list at the time of our assessment. We also examined only the English versions of the websites as native-language registries may offer more functionality or different content than the English version of the same website. All registries examined had a function allowing users to search the registry data and that displayed the related information from the search, including the clinical trial registration data. However, few websites were found to be user-friendly, and there was little integration with social media. We confirmed that there are few websites providing useful clinical trial information to patients and their families. However, information gleaned from some of the more advanced online registries could be used to improve the content and functionality of the JPRN portal.

Implementation of Consolidated HIS: Improving Quality and Efficiency of Healthcare

PubMed Central

Choi, Jinwook; Seo, Jeong-Wook; Chung, Chun Kee; Kim, Kyung-Hwan; Kim, Ju Han; Kim, Jong Hyo; Chie, Eui Kyu; Cho, Hyun-Jai; Goo, Jin Mo; Lee, Hyuk-Joon; Wee, Won Ryang; Nam, Sang Mo; Lim, Mi-Sun; Kim, Young-Ah; Yang, Seung Hoon; Jo, Eun Mi; Hwang, Min-A; Kim, Wan Suk; Lee, Eun Hye; Choi, Su Hi

2010-01-01

Objectives Adoption of hospital information systems offers distinctive advantages in healthcare delivery. First, implementation of consolidated hospital information system in Seoul National University Hospital led to significant improvements in quality of healthcare and efficiency of hospital management. Methods The hospital information system in Seoul National University Hospital consists of component applications: clinical information systems, clinical research support systems, administrative information systems, management information systems, education support systems, and referral systems that operate to generate utmost performance when delivering healthcare services. Results Clinical information systems, which consist of such applications as electronic medical records, picture archiving and communication systems, primarily support clinical activities. Clinical research support system provides valuable resources supporting various aspects of clinical activities, ranging from management of clinical laboratory tests to establishing care-giving procedures. Conclusions Seoul National University Hospital strives to move its hospital information system to a whole new level, which enables customized healthcare service and fulfills individual requirements. The current information strategy is being formulated as an initial step of development, promoting the establishment of next-generation hospital information system. PMID:21818449

Harmonizing clinical terminologies: driving interoperability in healthcare.

PubMed

Hamm, Russell A; Knoop, Sarah E; Schwarz, Peter; Block, Aaron D; Davis, Warren L

2007-01-01

Internationally, there are countless initiatives to build National Healthcare Information Networks (NHIN) that electronically interconnect healthcare organizations by enhancing and integrating current information technology (IT) capabilities. The realization of such NHINs will enable the simple and immediate exchange of appropriate and vital clinical data among participating organizations. In order for institutions to accurately and automatically exchange information, the electronic clinical documents must make use of established clinical codes, such as those of SNOMED-CT, LOINC and ICD-9 CM. However, there does not exist one universally accepted coding scheme that encapsulates all pertinent clinical information for the purposes of patient care, clinical research and population heatlh reporting. In this paper, we propose a combination of methods and standards that target the harmonization of clinical terminologies and encourage sustainable, interoperable infrastructure for healthcare.

The business value and cost-effectiveness of genomic medicine.

PubMed

Crawford, James M; Aspinall, Mara G

2012-05-01

Genomic medicine offers the promise of more effective diagnosis and treatment of human diseases. Genome sequencing early in the course of disease may enable more timely and informed intervention, with reduced healthcare costs and improved long-term outcomes. However, genomic medicine strains current models for demonstrating value, challenging efforts to achieve fair payment for services delivered, both for laboratory diagnostics and for use of molecular information in clinical management. Current models of healthcare reform stipulate that care must be delivered at equal or lower cost, with better patient and population outcomes. To achieve demonstrated value, genomic medicine must overcome many uncertainties: the clinical relevance of genomic variation; potential variation in technical performance and/or computational analysis; management of massive information sets; and must have available clinical interventions that can be informed by genomic analysis, so as to attain more favorable cost management of healthcare delivery and demonstrate improvements in cost-effectiveness.

A survey to explore what information, advice and support community-dwelling people with stroke currently receive to manage instability and falls.

PubMed

Shovlin, Eleanor; Kunkel, Dorit

2017-09-13

To describe and determine the benefits of the information and support services currently offered to people with stroke experiencing instability and falls. A cross-sectional survey study. Two hundred and fifty-six surveys were sent out to community stroke groups in Hampshire and the Isle of Wight, as well as to people with stroke on a patient register. One hundred and twenty-five surveys were returned. A total of 107 participants (86%) reported instability and 62 (50%) had experienced a fall in the preceding year; 29 (28%) had reportedly received information on falls prevention. Forty-four participants (43%) sought help from health professionals following instability and falls; just over half reported that the information they received was useful. One quarter (n = 11) of those seeking help were referred on to falls clinics; all attended and 86% felt attending had been beneficial. However, only one participant was followed up by these clinics. Findings suggest that the majority of people with stroke who have experienced instability and falls did not receive any information and support, with very few referred on to falls clinics. Health professionals play a key role in information provision and facilitating access to falls prevention programs. Further research is required to determine the most effective ways to implement current guidelines to manage instability and falls in this high-risk group. Implications for rehabilitation: Many community-dwelling people with stroke did not receive any information, help or support after experiencing instability and falls. Clinicians must stress that falls are a complication, not an expectation, post-stroke. Information on falls prevention and available support services should be offered to individuals prior to discharge from hospital, in GP practices and in rehabilitation settings. All individuals with stroke seeking health professional help following instability and falls should be referred on to falls clinics for individualized multifactorial assessment and intervention to comply with current guidelines.

Stem Cell Basics

MedlinePlus

... Tips Info Center Research Topics Federal Policy Glossary Stem Cell Information General Information Clinical Trials Funding Information Current ... Basics » Stem Cell Basics I. Back to top Stem Cell Basics I. Introduction: What are stem cells, and ...

A Conceptual Model of the Information Requirements of Nursing Organizations

PubMed Central

Miller, Emmy

1989-01-01

Three related issues play a role in the identification of the information requirements of nursing organizations. These issues are the current state of computer systems in health care organizations, the lack of a well-defined data set for nursing, and the absence of models representing data and information relevant to clinical and administrative nursing practice. This paper will examine current methods of data collection, processing, and storage in clinical and administrative nursing practice for the purpose of identifying the information requirements of nursing organizations. To satisfy these information requirements, database technology can be used; however, a model for database design is needed that reflects the conceptual framework of nursing and the professional concerns of nurses. A conceptual model of the types of data necessary to produce the desired information will be presented and the relationships among data will be delineated.

A specialized information center. The clinical neurology information center.

PubMed Central

Friedlander, W J

1978-01-01

The history, philosophy, and methodology of a unique specialized medical information center are reported. The Clinical Neurology Information Center is an educational information service (giving its audience information which can be the basis for formulating their own questions) rather than an instructional information service (giving information in reply to questions). Clinical, as well as basic neuroscience, information is culled by professional neurologists from 855 medical periodicals. The essence of each article is summarized in a single sentence ("terse conclusions") or a bibliographic reference only is given; this material is published every two weeks in the Concise Clinical Neurology Review (CCNR). The format of the CCNR is such that the reader should be able to scan a very large amount of current literature by investing only twenty to thirty minutes every two weeks. The values of this system as well as some of its problems are discussed. PMID:354706

A review of clinical decision making: models and current research.

PubMed

Banning, Maggi

2008-01-01

The aim of this paper was to review the current literature clinical decision-making models and the educational application of models to clinical practice. This was achieved by exploring the function and related research of the three available models of clinical decision making: information-processing model, the intuitive-humanist model and the clinical decision-making model. Clinical decision making is a unique process that involves the interplay between knowledge of pre-existing pathological conditions, explicit patient information, nursing care and experiential learning. Historically, two models of clinical decision making are recognized from the literature; the information-processing model and the intuitive-humanist model. The usefulness and application of both models has been examined in relation the provision of nursing care and care related outcomes. More recently a third model of clinical decision making has been proposed. This new multidimensional model contains elements of the information-processing model but also examines patient specific elements that are necessary for cue and pattern recognition. Literature review. Evaluation of the literature generated from MEDLINE, CINAHL, OVID, PUBMED and EBESCO systems and the Internet from 1980 to November 2005. The characteristics of the three models of decision making were identified and the related research discussed. Three approaches to clinical decision making were identified, each having its own attributes and uses. The most recent addition to the clinical decision making is a theoretical, multidimensional model which was developed through an evaluation of current literature and the assessment of a limited number of research studies that focused on the clinical decision-making skills of inexperienced nurses in pseudoclinical settings. The components of this model and the relative merits to clinical practice are discussed. It is proposed that clinical decision making improves as the nurse gains experience of nursing patients within a specific speciality and with experience, nurses gain a sense of saliency in relation to decision making. Experienced nurses may use all three forms of clinical decision making both independently and concurrently to solve nursing-related problems. It is suggested that O'Neill's clinical decision-making model could be tested by educators and experienced nurses to assess the efficacy of this hybrid approach to decision making.

Current and Emerging Technology Approaches in Genomics

PubMed Central

Conley, Yvette P.; Biesecker, Leslie G.; Gonsalves, Stephen; Merkle, Carrie J.; Kirk, Maggie; Aouizerat, Bradley E.

2013-01-01

Purpose To introduce current and emerging approaches that are being utilized in the field of genomics so the reader can conceptually evaluate the literature and appreciate how these approaches are advancing our understanding of health-related issues. Organizing Construct Each approach is described and includes information related to how it is advancing research, its potential clinical utility, exemplars of current uses, challenges related to technologies used for these approaches, and when appropriate information related to understanding the evidence base for clinical utilization of each approach is provided. Web-based resources are included for the reader who would like more in-depth information and to provide opportunity to stay up to date with these approaches and their utility. Conclusions The chosen approaches– genome sequencing, genome-wide association studies, epigenomics, and gene expression– are extremely valuable approaches for collecting research data to help us better understand the pathophysiology of a variety of health-related conditions, but they are also gaining in utility for clinical assessment and testing purposes. Clinical Relevance Our increased understanding of the molecular underpinnings of disease will assist with better development of screening tests, diagnostic tests, tests that allow us to prognosticate, tests that allow for individualized treatments, and tests to facilitate post-treatment surveillance. PMID:23294727

Use of health information technology by children's hospitals in the United States.

PubMed

Menachemi, Nir; Brooks, Robert G; Schwalenstocker, Ellen; Simpson, Lisa

2009-01-01

The purpose of this study was to examine the adoption of health information technology by children's hospitals and to document barriers and priorities as they relate to health information technology adoption. Primary data of interest were obtained through the use of a survey instrument distributed to the chief information officers of 199 children's hospitals in the United States. Data were collected on current and future use of a variety of clinical health information technology and telemedicine applications, organizational priorities, barriers to use of health information technology, and hospital and chief information officer characteristics. Among the 109 responding hospitals (55%), common clinical applications included clinical scheduling (86.2%), transcription (85.3%), and pharmacy (81.9%) and laboratory (80.7%) information. Electronic health records (48.6%), computerized order entry (40.4%), and clinical decision support systems (35.8%) were less common. The most common barriers to health information technology adoption were vendors' inability to deliver products or services to satisfaction (85.4%), lack of staffing resources (82.3%), and difficulty in achieving end-user acceptance (80.2%). The most frequent priority for hospitals was to implement technology to reduce medical errors or to promote safety (72.5%). This first national look at health information technology use by children's hospitals demonstrates the progress in health information technology adoption, current barriers, and priorities for these institutions. In addition, the findings can serve as important benchmarks for future study in this area.

Evaluation of LOINC for Representing Constitutional Cytogenetic Test Result Reports

PubMed Central

Heras, Yan Z.; Mitchell, Joyce A.; Williams, Marc S.; Brothman, Arthur R.; Huff, Stanley M.

2009-01-01

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future. PMID:20351857

Evaluation of LOINC for representing constitutional cytogenetic test result reports.

PubMed

Heras, Yan Z; Mitchell, Joyce A; Williams, Marc S; Brothman, Arthur R; Huff, Stanley M

2009-11-14

Genetic testing is becoming increasingly important to medical practice. Integrating genetics and genomics data into electronic medical records is crucial in translating genetic discoveries into improved patient care. Information technology, especially Clinical Decision Support Systems, holds great potential to help clinical professionals take full advantage of genomic advances in their daily medical practice. However, issues relating to standard terminology and information models for exchanging genetic testing results remain relatively unexplored. This study evaluates whether the current LOINC standard is adequate to represent constitutional cytogenetic test result reports using sample result reports from ARUP Laboratories. The results demonstrate that current standard terminology is insufficient to support the needs of coding cytogenetic test results. The terminology infrastructure must be developed before clinical information systems will be able to handle the high volumes of genetic data expected in the near future.

Informatics in clinical research in oncology: current state, challenges, and a future perspective.

PubMed

Chahal, Amar P S

2011-01-01

The informatics landscape of clinical trials in oncology has changed significantly in the last 10 years. The current state of the infrastructure for clinical trial management, execution, and data management is reviewed. The systems, their functionality, the users, and the standards available to researchers are discussed from the perspective of the oncologist-researcher. Challenges in complexity and in the processing of information are outlined. These challenges include the lack of communication and information-interchange between systems, the lack of simplified standards, and the lack of implementation and adherence to the standards that are available. The clinical toxicology criteria from the National Cancer Institute (CTCAE) are cited as a successful standard in oncology, and HTTP on the Internet is referenced for its simplicity. Differences in the management of information standards between industries are discussed. Possible future advances in oncology clinical research informatics are addressed. These advances include strategic policy review of standards and the implementation of actions to make standards free, ubiquitous, simple, and easily interpretable; the need to change from a local data-capture- or transaction-driven model to a large-scale data-interpretation model that provides higher value to the oncologist and the patient; and the need for information technology investment in a readily available digital educational model for clinical research in oncology that is customizable for individual studies. These new approaches, with changes in information delivery to mobile platforms, will set the stage for the next decade in clinical research informatics.

Patients' attitudes and preferences about participation and recruitment strategies in clinical trials.

PubMed

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S; Loehrer, Laura L; Wahner-Roedler, Dietlind L

2009-03-01

To assess attitudes of patients about participation in clinical trials. This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results.

Patients' Attitudes and Preferences About Participation and Recruitment Strategies in Clinical Trials

PubMed Central

Sood, Amit; Prasad, Kavita; Chhatwani, Laveena; Shinozaki, Eri; Cha, Stephen S.; Loehrer, Laura L.; Wahner-Roedler, Dietlind L.

2009-01-01

OBJECTIVE: To assess attitudes of patients about participation in clinical trials. PATIENTS AND METHODS: This is a self-report survey of 400 patients who underwent general medical evaluations between September and November 2006 at a tertiary care academic medical center in Rochester, MN. We measured knowledge of access to clinical trials, attitudes toward participation, recruitment preferences, and beliefs about research integrity. RESULTS: Of 485 consecutive patients, 400 (82%) completed the survey. Previous participation in clinical trials was reported by 112 patients (28%). Most were unaware of online information about clinical trials (330 [82%]), were satisfied with their current knowledge (233 [58%]), expected their treating physician to inform them about current trials (304 [76%]), and showed equal interest in participating in conventional or complementary intervention trials (174 [44%]). Of the 400 respondents, 321 (80%) found it appropriate to be contacted by mail and 253 (63%) by telephone regarding study participation. Most patients (364 [91%]) wanted to be informed about research findings or else would not participate in future clinical trials (272 [68%]). The most frequently expected compensation was free parking (234 [58%]). Most thought that their safety (373 [93%]) and privacy (376 [94%]) would be guarded. CONCLUSION: Patients are interested in participating in clinical trials but commonly lack adequate information. If patients received more information (through their treating physicians), enrollment might improve. This single-site study has limited generalizability. Future studies involving a diverse group of patients from a broader geographic distribution will help provide more definitive results. PMID:19252111

Elaboration and formalization of current scientific knowledge of risks and preventive measures illustrated by colorectal cancer.

PubMed

Giorgi, R; Gouvernet, J; Dufour, J; Degoulet, P; Laugier, R; Quilichini, F; Fieschi, M

2001-01-01

Present the method used to elaborate and formalize current scientific knowledge to provide physicians with tools available on the Internet, that enable them to evaluate individual patient risk, give personalized preventive recommendations or early screening measures. The approach suggested in this article is in line with medical procedures based on levels of evidence (Evidence-based Medicine). A cyclical process for developing recommendations allows us to quickly incorporate current scientific information. At each phase, the analysis is reevaluated by experts in the field collaborating on the project. The information is formalized through the use of levels of evidence and grades of recommendations. GLIF model is used to implement recommendations for clinical practice guidelines. The most current scientific evidence incorporated in a cyclical process includes several steps: critical analysis according to the Evidence-based Medicine method; identification of predictive factors; setting-up risk levels; identification of prevention measures; elaboration of personalized recommendation. The information technology implementation of the clinical practice guideline enables physicians to quickly obtain personalized information for their patients. Cases of colorectal prevention illustrate our approach. Integration of current scientific knowledge is an important process. The delay between the moment new information arrives and the moment the practitioner applies it, is thus reduced.

Obsessive-compulsive disorder and related disorders: a comprehensive survey

PubMed Central

Fornaro, Michele; Gabrielli, Filippo; Albano, Claudio; Fornaro, Stefania; Rizzato, Salvatore; Mattei, Chiara; Solano, Paola; Vinciguerra, Valentina; Fornaro, Pantaleo

2009-01-01

Our aim was to present a comprehensive, updated survey on obsessive-compulsive disorder (OCD) and obsessive-compulsive related disorders (OCRDs) and their clinical management via literature review, critical analysis and synthesis. Information on OCD and OCRD current nosography, clinical phenomenology and etiology, may lead to a better comprehension of their management. Clinicians should become familiar with the broad spectrum of OCD disorders, since it is a pivotal issue in current clinical psychiatry. PMID:19450269

"Just-in-time" clinical information.

PubMed

Chueh, H; Barnett, G O

1997-06-01

The just-in-time (JIT) model originated in the manufacturing industry as a way to manage parts inventories process so that specific components could be made available at the appropriate times (that is, "just in time"). This JIT model can be applied to the management of clinical information inventories, so that clinicians can have more immediate access to the most current and relevant information at the time they most need it--when making clinical care decisions. The authors discuss traditional modes of managing clinical information, and then describe how a new, JIT model may be developed and implemented. They describe three modes of clinician-information interactions that a JIT model might employ, the scope of information that may be made available in a JIT model (global information or local, case-specific information), and the challenges posed by the implementation of such an information-access model. Finally, they discuss how JIT information access may change how physicians practice medicine, various ways JIT information may be delivered, and concerns about the trustworthiness of electronically published and accessed information resources.

Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia.

PubMed

Teipel, Stefan; König, Alexandra; Hoey, Jesse; Kaye, Jeff; Krüger, Frank; Robillard, Julie M; Kirste, Thomas; Babiloni, Claudio

2018-06-21

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials. Copyright © 2018. Published by Elsevier Inc.

Nursing in the information age: status quo and future of ICT use in German hospitals.

PubMed

Hübner, Ursula; Sellemann, Björn

2004-01-01

Hospital information systems (HIS) should give support to nurses in their clinical and managerial duties. Though there are statistical data on the current use of HIS systems we know only little about the numbers of nursing modules implemented. We therefore conducted a nationwide survey in Germany (n = 2182) on the current state and future plans of HIS modules including nursing applications (response rate of 27.6 %). The findings show that management applications (84 % accounting) are still more frequent than clinical applications, in particular clinical patient record systems (19 %). What applied for HIS modules in general held also true for nursing on a lower level. Whereas 51 % of the hospitals had rostering systems in place only 6 % used care planning software. Priorities and plans for the future reveal no change in the rank order of systems. We argue that in order for clinical documentation and planning systems to catch up they must be immediately rewarding for the clinicians in their daily need for information

Clinician preferences for verbal communication compared to EHR documentation in the ICU

PubMed Central

Collins, S.A.; Bakken, S.; Vawdrey, D.K.; Coiera, E.; Currie, L

2011-01-01

Background Effective communication is essential to safe and efficient patient care. Additionally, many health information technology (HIT) developments, innovations, and standards aim to implement processes to improve data quality and integrity of electronic health records (EHR) for the purpose of clinical information exchange and communication. Objective We aimed to understand the current patterns and perceptions of communication of common goals in the ICU using the distributed cognition and clinical communication space theoretical frameworks. Methods We conducted a focus group and 5 interviews with ICU clinicians and observed 59.5 hours of interdisciplinary ICU morning rounds. Results Clinicians used an EHR system, which included electronic documentation and computerized provider order entry (CPOE), and paper artifacts for documentation; yet, preferred the verbal communication space as a method of information exchange because they perceived that the documentation was often not updated or efficient for information retrieval. These perceptions that the EHR is a “shift behind” may lead to a further reliance on verbal information exchange, which is a valuable clinical communication activity, yet, is subject to information loss. Conclusions Electronic documentation tools that, in real time, capture information that is currently verbally communicated may increase the effectiveness of communication. PMID:23616870

The Broader Autism Phenotype and Friendships in Non-Clinical Dyads

ERIC Educational Resources Information Center

Wainer, Allison L.; Block, Nicole; Donnellan, M. Brent; Ingersoll, Brooke

2013-01-01

The broader autism phenotype (BAP) is a set of subclinical traits qualitatively similar to those observed in autism spectrum disorders. The current study sought to elucidate the association between self- and informant-reports of the BAP and friendships, in a non-clinical sample of college student dyads. Self-informant agreement of the BAP and…

Asan medical information system for healthcare quality improvement.

PubMed

Ryu, Hyeon Jeong; Kim, Woo Sung; Lee, Jae Ho; Min, Sung Woo; Kim, Sun Ja; Lee, Yong Su; Lee, Young Ha; Nam, Sang Woo; Eo, Gi Seung; Seo, Sook Gyoung; Nam, Mi Hyun

2010-09-01

This purpose of this paper is to introduce the status of the Asan Medical Center (AMC) medical information system with respect to healthcare quality improvement. Asan Medical Information System (AMIS) is projected to become a completely electronic and digital information hospital. AMIS has played a role in improving the health care quality based on the following measures: safety, effectiveness, patient-centeredness, timeliness, efficiency, privacy, and security. AMIS CONSISTED OF SEVERAL DISTINCTIVE SYSTEMS: order communication system, electronic medical record, picture archiving communication system, clinical research information system, data warehouse, enterprise resource planning, IT service management system, and disaster recovery system. The most distinctive features of AMIS were the high alert-medication recognition & management system, the integrated and severity stratified alert system, the integrated patient monitoring system, the perioperative diabetic care monitoring and support system, and the clinical indicator management system. AMIS provides IT services for AMC, 7 affiliated hospitals and over 5,000 partners clinics, and was developed to improve healthcare services. The current challenge of AMIS is standard and interoperability. A global health IT strategy is needed to get through the current challenges and to provide new services as needed.

The History and Current Status of Low Vision Services in Scandinavian Countries

ERIC Educational Resources Information Center

Gustafsson, Jorgen; Inde, Krister

2009-01-01

To increase understanding of the breadth and depth of services that are currently being provided by the various low vision clinics in Scandinavia, the authors sent questionnaires to the 69 clinics asking for information on the total number of staff members employed in full-time positions and the number of staff members by profession (optometrists;…

The impact of health information technology on collaborative chronic care management.

PubMed

Marchibroda, Janet M

2008-03-01

Chronic disease is a growing problem in the United States. More than 125 million Americans had at least 1 chronic care condition in 2000, and this number is expected to grow to 157 million by the year 2020.1 Some of the challenges associated with current chronic care management approaches can be addressed through the use of health information technology (IT) and health information exchange. To review the current challenges of chronic care management and explore how health IT and health information exchange efforts at the national, state, and local levels can be leveraged to address some of these challenges. Efforts to effectively manage chronic care have been hampered by a number of factors, including a fragmented health care system and the need for more coordination across the health care setting; the lack of interoperable clinical information systems, which would help provide readily available, comprehensive information about the patient to those who deliver care, those who manage care, and those who receive care, and finally, the current predominantly fee-for-service reimbursement system that rewards volume and fragmentation, and does not effectively align incentives with the goals of chronic care management. The introduction of health IT, including electronic health records and health information exchange, holds great promise for addressing many of the barriers to effective chronic care management, by providing important clinical information about the patient when it is needed, and where it is needed, in a timely, secure fashion. Having information from the care delivery process readily available through health IT and health information exchange at the national, state, and local levels supports key components of the chronic care management process, including those related to measurement, clinical decision support, collaboration and coordination, and consumer activation. Those engaged in chronic care management should seek to leverage health IT and health information exchange initiatives particularly at the local levels. Community-based initiatives have built social capital and trust across multiple stakeholders; enabled access to clinical data derived from the care delivery process that only resides locally; and in many cases aligned incentives around the mobilization of clinical information across care settings. All of these elements are critical to the long-term success of chronic care management. While there is good research regarding interdisciplinary care models, more research is still needed to identify policies, practices, and strategies for facilitating and building cooperation among those engaged in chronic care management, and those engaged in multi-stakeholder efforts involved in the exchange of clinical health information electronically.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

Clinical information transfer and data capture in the acute myocardial infarction pathway: an observational study.

PubMed

Kesavan, Sujatha; Kelay, Tanika; Collins, Ruth E; Cox, Benita; Bello, Fernando; Kneebone, Roger L; Sevdalis, Nick

2013-10-01

Acute myocardial infarctions (MIs) or heart attacks are the result of a complete or an incomplete occlusion of the lumen of the coronary artery with a thrombus. Prompt diagnosis and early coronary intervention results in maximum myocardial salvage, hence time to treat is of the essence. Adequate, accurate and complete information is vital during the early stages of admission of an MI patient and can impact significantly on the quality and safety of patient care. This study aimed to record how clinical information between different clinical teams during the journey of a patient in the MI care pathway is captured and to review the flow of information within this care pathway. A prospective, descriptive, structured observational study to assess (i) current clinical information systems (CIS) utilization and (ii) real-time information availability within an acute cardiac care setting was carried out. Completeness and availability of patient information capture across four key stages of the MI care pathway were assessed prospectively. Thirteen separate information systems were utilized during the four phases of the MI pathway. Observations revealed fragmented CIS utilization, with users accessing an average of six systems to gain a complete set of patient information. Data capture was found to vary between each pathway stage and in both patient cohort risk groupings. The highest level of information completeness (100%) was observed only in the discharge stage of the MI care pathway. The lowest level of information completeness (58%) was observed in the admission stage. The study highlights fragmentation, CIS duplication, and discrepancies in the current clinical information capture and data transfer across the MI care pathway in an acute cardiac care setting. The development of an integrated and user-friendly electronic data capture and transfer system would reduce duplication and would facilitate efficient and complete information provision at the point of care. © 2012 John Wiley & Sons Ltd.

Healing Magazine, 2002.

ERIC Educational Resources Information Center

DiBiase, Miriam H., Ed.

2002-01-01

This newly designed volume of "Healing Magazine" features practical, clinical information aimed at sharing current work in children's mental health. The first issue shares information on guiding children through times of trauma, particularly after the events of September 11th. Two articles provide information on debriefing after trauma…

Using information technology to improve the quality and efficiency of clinical trial research in academic medical centers.

PubMed

Hardison, C D; Schnetzer, T

1999-01-01

In the area of clinical trial research, academic medical centers (AMCs) need to create additional capacity and improve performance on vital indicators to attract more studies, as they are currently losing their share to stand-alone research sites. Through the utilization of information technology, AMCs will be in a better position to fend off the competitive threats to their clinical research dollars. Most AMCs are in an enviable position to leverage the value of information technology because of the existing people, processes, and technologies that probably already exist throughout the AMC. The challenge, then, is to deploy these resources in a different manner to support clinical trial research.

Handling Big Data in Modern Healthcare.

PubMed

Aziz, Hassan A

2016-11-01

The constant growth of medical knowledge and the increases in specialization in clinical practice have created a significant need to share and access patient information with speed and efficiency. However, current technology is centered on processing data, rather than gathering information. To realize the potential of modern technology in improving patient health, merely collecting and storing data are insufficient: one must convert these data into information and knowledge. In this article, I present an overview of 2 recent advances in technology and their assimilation into the practice of medicine, in the attempt to make clinical data meaningful and then to learn from aggregated clinical data. We address the emergence of clinical data warehouses (CDWs) and health information exchanges (HIEs), as features of the Health Information Technology for Economic and Clinical Health (HITECH) Act. This act, enacted in the United States as part of the American Recovery and Reinvestment Act of 2009, was signed into law on February 17, 2009, to promote the adoption and meaningful use of health information technology. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Autonomy and Privacy in Clinical Laboratory Science Policy and Practice.

PubMed

Leibach, Elizabeth Kenimer

2014-01-01

Rapid advancements in diagnostic technologies coupled with growth in testing options and choices mandate the development of evidence-based testing algorithms linked to the care paths of the major chronic diseases and health challenges encountered most frequently. As care paths are evaluated, patient/consumers become partners in healthcare delivery. Clinical laboratory scientists find themselves firmly embedded in both quality improvement and clinical research with an urgent need to translate clinical laboratory information into knowledge required by practitioners and patient/consumers alike. To implement this patient-centered care approach in clinical laboratory science, practitioners must understand their roles in (1) protecting patient/consumer autonomy in the healthcare informed consent process and (2) assuring patient/consumer privacy and confidentiality while blending quality improvement study findings with protected health information. A literature review, describing the current ethical environment, supports a consultative role for clinical laboratory scientists in the clinical decision-making process and suggests guidance for policy and practice regarding the principle of autonomy and its associated operational characteristics: informed consent and privacy.

Impact of Placement Type on the Development of Clinical Competency in Speech-Language Pathology Students

ERIC Educational Resources Information Center

Sheepway, Lyndal; Lincoln, Michelle; McAllister, Sue

2014-01-01

Background: Speech-language pathology students gain experience and clinical competency through clinical education placements. However, currently little empirical information exists regarding how competency develops. Existing research about the effectiveness of placement types and models in developing competency is generally descriptive and based…

Quality of referral: What information should be included in a request for diagnostic imaging when a patient is referred to a clinical radiologist?

PubMed

G Pitman, Alexander

2017-06-01

Referral to a clinical radiologist is the prime means of communication between the referrer and the radiologist. Current Australian and New Zealand government regulations do not prescribe what clinical information should be included in a referral. This work presents a qualitative compilation of clinical radiologist opinion, relevant professional recommendations, governmental regulatory positions and prior work on diagnostic error to synthesise recommendations on what clinical information should be included in a referral. Recommended requirements on what clinical information should be included in a referral to a clinical radiologist are as follows: an unambiguous referral; identity of the patient; identity of the referrer; and sufficient clinical detail to justify performance of the diagnostic imaging examination and to confirm appropriate choice of the examination and modality. Recommended guideline on the content of clinical detail clarifies when the information provided in a referral meets these requirements. High-quality information provided in a referral allows the clinical radiologist to ensure that exposure of patients to medical radiation is justified. It also minimises the incidence of perceptual and interpretational diagnostic error. Recommended requirements and guideline on the clinical detail to be provided in a referral to a clinical radiologist have been formulated for professional debate and adoption. © 2017 The Royal Australian and New Zealand College of Radiologists.

Redesign of a computerized clinical reminder for colorectal cancer screening: a human-computer interaction evaluation

PubMed Central

2011-01-01

Background Based on barriers to the use of computerized clinical decision support (CDS) learned in an earlier field study, we prototyped design enhancements to the Veterans Health Administration's (VHA's) colorectal cancer (CRC) screening clinical reminder to compare against the VHA's current CRC reminder. Methods In a controlled simulation experiment, 12 primary care providers (PCPs) used prototypes of the current and redesigned CRC screening reminder in a within-subject comparison. Quantitative measurements were based on a usability survey, workload assessment instrument, and workflow integration survey. We also collected qualitative data on both designs. Results Design enhancements to the VHA's existing CRC screening clinical reminder positively impacted aspects of usability and workflow integration but not workload. The qualitative analysis revealed broad support across participants for the design enhancements with specific suggestions for improving the reminder further. Conclusions This study demonstrates the value of a human-computer interaction evaluation in informing the redesign of information tools to foster uptake, integration into workflow, and use in clinical practice. PMID:22126324

Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine.

PubMed

Castaneda, Christian; Nalley, Kip; Mannion, Ciaran; Bhattacharyya, Pritish; Blake, Patrick; Pecora, Andrew; Goy, Andre; Suh, K Stephen

2015-01-01

As research laboratories and clinics collaborate to achieve precision medicine, both communities are required to understand mandated electronic health/medical record (EHR/EMR) initiatives that will be fully implemented in all clinics in the United States by 2015. Stakeholders will need to evaluate current record keeping practices and optimize and standardize methodologies to capture nearly all information in digital format. Collaborative efforts from academic and industry sectors are crucial to achieving higher efficacy in patient care while minimizing costs. Currently existing digitized data and information are present in multiple formats and are largely unstructured. In the absence of a universally accepted management system, departments and institutions continue to generate silos of information. As a result, invaluable and newly discovered knowledge is difficult to access. To accelerate biomedical research and reduce healthcare costs, clinical and bioinformatics systems must employ common data elements to create structured annotation forms enabling laboratories and clinics to capture sharable data in real time. Conversion of these datasets to knowable information should be a routine institutionalized process. New scientific knowledge and clinical discoveries can be shared via integrated knowledge environments defined by flexible data models and extensive use of standards, ontologies, vocabularies, and thesauri. In the clinical setting, aggregated knowledge must be displayed in user-friendly formats so that physicians, non-technical laboratory personnel, nurses, data/research coordinators, and end-users can enter data, access information, and understand the output. The effort to connect astronomical numbers of data points, including '-omics'-based molecular data, individual genome sequences, experimental data, patient clinical phenotypes, and follow-up data is a monumental task. Roadblocks to this vision of integration and interoperability include ethical, legal, and logistical concerns. Ensuring data security and protection of patient rights while simultaneously facilitating standardization is paramount to maintaining public support. The capabilities of supercomputing need to be applied strategically. A standardized, methodological implementation must be applied to developed artificial intelligence systems with the ability to integrate data and information into clinically relevant knowledge. Ultimately, the integration of bioinformatics and clinical data in a clinical decision support system promises precision medicine and cost effective and personalized patient care.

Graphical Presentation of Patient-Treatment Interaction Elucidated by Continuous Biomarkers. Current Practice and Scope for Improvement.

PubMed

Shen, Yu-Ming; Le, Lien D; Wilson, Rory; Mansmann, Ulrich

2017-01-09

Biomarkers providing evidence for patient-treatment interaction are key in the development and practice of personalized medicine. Knowledge that a patient with a specific feature - as demonstrated through a biomarker - would have an advantage under a given treatment vs. a competing treatment can aid immensely in medical decision-making. Statistical strategies to establish evidence of continuous biomarkers are complex and their formal results are thus not easy to communicate. Good graphical representations would help to translate such findings for use in the clinical community. Although general guidelines on how to present figures in clinical reports are available, there remains little guidance for figures elucidating the role of continuous biomarkers in patient-treatment interaction (CBPTI). To combat the current lack of comprehensive reviews or adequate guides on graphical presentation within this topic, our study proposes presentation principles for CBPTI plots. In order to understand current practice, we review the development of CBPTI methodology and how CBPTI plots are currently used in clinical research. The quality of a CBPTI plot is determined by how well the presentation provides key information for clinical decision-making. Several criteria for a good CBPTI plot are proposed, including general principles of visual display, use of units presenting absolute outcome measures, appropriate quantification of statistical uncertainty, correct display of benchmarks, and informative content for answering clinical questions especially on the quantitative advantage for an individual patient with regard to a specific treatment. We examined the development of CBPTI methodology from the years 2000 - 2014, and reviewed how CBPTI plots were currently used in clinical research in six major clinical journals from 2013 - 2014 using the principle of theoretical saturation. Each CBPTI plot found was assessed for appropriateness of its presentation and clinical utility. In our review, a total of seven methodological papers and five clinical reports used CBPTI plots which we categorized into four types: those that distinguish the outcome effect for each treatment group; those that show the outcome differences between treatment groups (by either partitioning all individuals into subpopulations or modelling the functional form of the interaction); those that evaluate the proportion of population impact of the biomarker; and those that show the classification accuracy of the biomarker. The current practice of utilizing CBPTI plots in clinical reports suffers from methodological shortcomings: the lack of presentation of statistical uncertainty, the outcome measure scaled by relative unit instead of absolute unit, incorrect use of benchmarks, and being non-informative in answering clinical questions. There is considerable scope for improvement in the graphical representation of CBPTI in clinical reports. The current challenge is to develop instruments for high-quality graphical plots which not only convey quantitative concepts to readers with limited statistical knowledge, but also facilitate medical decision-making.

[Clinical Tests Testing New Therapies for Stargardt Disease].

PubMed

Kousal, B; Ďuďáková, Ľ; Hlavatá, L; Lišková, P

2016-02-01

To provide information on currently ongoing clinical trials for Stargardt disease. We have searched the clinical trial register (www.clinicaltrials.gov) for the keyword "Stargardt" and list active ongoing studies. There are currently eight registered clinical trials enrolling patients with Stargardt disease; all in phase I or II aiming at four mechanisms of action: inhibition of the production of vitamin A toxic dimers, gene therapy restoring wild type transcription of the ABCA4 gene, neuroprotection preventing retinal cells from oxidative damage, and replacement of the damaged retinal pigment epithelium using stem cell therapy. The basic prerequisite for enrolment in the vast majority of clinical trials is confirmation of the clinical diagnosis by mutational analysis. The wide variety of therapies that are registered as clinical trials for Stargardt disease significantly raises the possibility that effective treatments will be available in the near future for this currently incurable condition and that molecular genetic testing should be increasingly considered. Stargardt disease, clinical trial, ABCA4, mutation.

Improving Injury Prevention Through Health Information Technology

PubMed Central

Haegerich, Tamara M.; Sugerman, David E.; Annest, Joseph L.; Klevens, Joanne; Baldwin, Grant T.

2015-01-01

Health information technology is an emerging area of focus in clinical medicine with the potential to improve injury and violence prevention practice. With injuries being the leading cause of death for Americans aged 1–44 years, greater implementation of evidence-based preventive services, referral to community resources, and real-time surveillance of emerging threats is needed. Through a review of the literature and capturing of current practice in the field, this paper showcases how health information technology applied to injury and violence prevention can lead to strengthened clinical preventive services, more rigorous measurement of clinical outcomes, and improved injury surveillance, potentially resulting in health improvement. PMID:25441230

A Survey on Clinical Research Training Status and Needs in Public Hospitals from Shenzhen

ERIC Educational Resources Information Center

Ji, Ping; Wang, Haibo; Zhang, Chao; Liu, Min; Zhou, Liping; Xiao, Ping; Wang, Yanfang; Wu, Yangfeng

2017-01-01

Objective: To obtain information on the current clinical research training status and evaluate the training needs comprehensively for medical staff in hospitals. Methods: This survey was initiated and conducted by the Health and Family Planning Commission of Shenzhen in conjunction with the Peking University Clinical Research Institute (Shenzhen)…

[Comparison between administrative and clinical databases in the evaluation of cardiac surgery performance].

PubMed

Rosato, Stefano; D'Errigo, Paola; Badoni, Gabriella; Fusco, Danilo; Perucci, Carlo A; Seccareccia, Fulvia

2008-08-01

The availability of two contemporary sources of information about coronary artery bypass graft (CABG) interventions, allowed 1) to verify the feasibility of performing outcome evaluation studies using administrative data sources, and 2) to compare hospital performance obtainable using the CABG Project clinical database with hospital performance derived from the use of current administrative data. Interventions recorded in the CABG Project were linked to the hospital discharge record (HDR) administrative database. Only the linked records were considered for subsequent analyses (46% of the total CABG Project). A new selected population "clinical card-HDR" was then defined. Two independent risk-adjustment models were applied, each of them using information derived from one of the two different sources. Then, HDR information was supplemented with some patient preoperative conditions from the CABG clinical database. The two models were compared in terms of their adaptability to data. Hospital performances identified by the two different models and significantly different from the mean was compared. In only 4 of the 13 hospitals considered for analysis, the results obtained using the HDR model did not completely overlap with those obtained by the CABG model. When comparing statistical parameters of the HDR model and the HDR model + patient preoperative conditions, the latter showed the best adaptability to data. In this "clinical card-HDR" population, hospital performance assessment obtained using information from the clinical database is similar to that derived from the use of current administrative data. However, when risk-adjustment models built on administrative databases are supplemented with a few clinical variables, their statistical parameters improve and hospital performance assessment becomes more accurate.

The potential role for a pharmacist in a multidisciplinary general practitioner super clinic.

PubMed

Bajorek, Beata; LeMay, Kate; Gunn, Kate; Armour, Carol

2015-01-01

The Australian government's General Practitioner (GP) super clinics programme aims to provide well-integrated, multidisciplinary, patient-centred care for people with chronic disease. However, there is no research into the current role of pharmacists in this setting. To explore the perspectives of GP super clinic staff on current and potential (future) pharmacist-led services provided in this setting. Individual interviews (facilitated using a semi-structured interview guide and thematically analysed) were conducted with purposively sampled staff of a GP super clinic in a semirural location in the state of New South Wales, until theme saturation. Participating staff included (n=9): three GPs, one pharmacist, one nurse, one business manager, and three reception staff. Three themes emerged conveying perspectives on: working relationships between staff; a pharmacist's current role; and potential future roles for a pharmacist. All clinic staff actively engaged the pharmacist in their "team approach". Currently established roles for home medicines reviews (HMRs) and drug information were well supported, but needed to be expanded, for example, with formalised case conferences between GPs, pharmacists, and other staff. New roles needed be explored in auditing medication use, optimising medication records, specialised drug information, dispensing, and prescribing. Although GPs had differing views about opportunities for pharmacists' prescribing in this setting, they saw several benefits to this service, such as reducing the time pressure on GPs to enable more effective consultations. Results suggest a pharmacist's services can potentially be better used within the multidisciplinary super clinic model of care to address current gaps within the semi-rural practice setting. Any future role for the pharmacist could be addressed as part of a formalised, strategic approach to creating an integrated healthcare team, with attention to funding and government legislation.

Information management to enable personalized medicine: stakeholder roles in building clinical decision support.

PubMed

Downing, Gregory J; Boyle, Scott N; Brinner, Kristin M; Osheroff, Jerome A

2009-10-08

Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized decision-making, a comparison of current and future applications of clinical decision support to enable individualized medical treatment plans is presented. If clinical decision support tools are to impact outcomes in a clear and positive manner, their development and deployment must therefore consider the needs of the providers, including specific practice needs, information workflow, and practice environment.

Information management to enable personalized medicine: stakeholder roles in building clinical decision support

PubMed Central

2009-01-01

Background Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Discussion Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. Summary This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized decision-making, a comparison of current and future applications of clinical decision support to enable individualized medical treatment plans is presented. If clinical decision support tools are to impact outcomes in a clear and positive manner, their development and deployment must therefore consider the needs of the providers, including specific practice needs, information workflow, and practice environment. PMID:19814826

The Current Studies of Education for a Traditional and Complementary Medicine in Malaysia

PubMed Central

Kim, Yun Jin

2017-01-01

The aim of this study is to understand the current tradition and complementary medicine (T&CM) education in Malaysia. We referred to literature regarding to traditional medicine education in Malaysia, and collected the information via website or interview with faculty of T&CM in universities/colleges and Division of T&CM, Ministry of Health, Malaysia. T&CM education in Malaysia has been following China’s T&CM systems for 50 years. Currently, Division of T&CM, Ministry of Health; and Ministry of Higher Education has approved 11 institutions to offer T&CM education. Students may major in Chinese herbal medicine, acupuncture, or other T&CM subjects. Generally, clinical training programs in China, Taiwan, or Australia include substantial proportion of clinical training. We report on the general information of T&CM education in Malaysia. This result would be the first-stage information for the establishment of a strategy regarding the enhancement of T&CM education in Malaysia. PMID:28853309

Transforming Medical Assessment: Integrating Uncertainty Into the Evaluation of Clinical Reasoning in Medical Education.

PubMed

Cooke, Suzette; Lemay, Jean-Francois

2017-06-01

In an age where practicing physicians have access to an overwhelming volume of clinical information and are faced with increasingly complex medical decisions, the ability to execute sound clinical reasoning is essential to optimal patient care. The authors propose two concepts that are philosophically paramount to the future assessment of clinical reasoning in medicine: assessment in the context of "uncertainty" (when, despite all of the information that is available, there is still significant doubt as to the best diagnosis, investigation, or treatment), and acknowledging that it is entirely possible (and reasonable) to have more than "one correct answer." The purpose of this article is to highlight key elements related to these two core concepts and discuss genuine barriers that currently exist on the pathway to creating such assessments. These include acknowledging situations of uncertainty, creating clear frameworks that define progressive levels of clinical reasoning skills, providing validity evidence to increase the defensibility of such assessments, considering the comparative feasibility with other forms of assessment, and developing strategies to evaluate the impact of these assessment methods on future learning and practice. The authors recommend that concerted efforts be directed toward these key areas to help advance the field of clinical reasoning assessment, improve the clinical care decisions made by current and future physicians, and have positive outcomes for patients. It is anticipated that these and subsequent efforts will aid in reaching the goal of making future assessment in medical education more representative of current-day clinical reasoning and decision making.

Laboratory Information Systems in Molecular Diagnostics: Why Molecular Diagnostics Data are Different.

PubMed

Lee, Roy E; Henricks, Walter H; Sirintrapun, Sahussapont J

2016-03-01

Molecular diagnostic testing presents new challenges to information management that are yet to be sufficiently addressed by currently available information systems for the molecular laboratory. These challenges relate to unique aspects of molecular genetic testing: molecular test ordering, informed consent issues, diverse specimen types that encompass the full breadth of specimens handled by traditional anatomic and clinical pathology information systems, data structures and data elements specific to molecular testing, varied testing workflows and protocols, diverse instrument outputs, unique needs and requirements of molecular test reporting, and nuances related to the dissemination of molecular pathology test reports. By satisfactorily addressing these needs in molecular test data management, a laboratory information system designed for the unique needs of molecular diagnostics presents a compelling reason to migrate away from the current paper and spreadsheet information management that many molecular laboratories currently use. This paper reviews the issues and challenges of information management in the molecular diagnostics laboratory.

Use of historical control data for assessing treatment effects in clinical trials.

PubMed

Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

2014-01-01

Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study's control arm. There is obvious appeal in using (i.e., 'borrowing') this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of 'dynamic' (versus 'static') borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. Copyright © 2013 John Wiley & Sons, Ltd.

Use of historical control data for assessing treatment effects in clinical trials

PubMed Central

Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G.; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

2014-01-01

Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study’s control arm. There is obvious appeal in using (i.e., ‘borrowing’) this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of ‘dynamic’ (versus ‘static’) borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. PMID:23913901

Management of the infant with respiratory syncytial virus.

PubMed

Corey, M A; Clore, E R

1991-04-01

This article examines updated clinical information concerning respiratory syncytial virus (RSV) infection including epidemiology, pathology, clinical manifestations, diagnosis, treatment, nosocomial infection, and prognosis. Also presented is current information on ribavirin therapy, its side effects, and precautions. Research related to the most effective isolation methodology is discussed, as well as nursing diagnoses based on Gordon's Functional Health Patterns and interventions for the infant hospitalized with RSV bronchiolitis and/or pneumonia.

The SMile Card: a computerised data card for multiple sclerosis patients. SMile Card Scientific Board.

PubMed

Mancardi, G L; Uccelli, M M; Sonnati, M; Comi, G; Milanese, C; De Vincentiis, A; Battaglia, M A

2000-04-01

The SMile Card was developed as a means for computerising clinical information for the purpose of transferability, accessibility, standardisation and compilation of a national database of demographic and clinical information about multiple sclerosis (MS) patients. In many European countries, centres for MS are organised independently from one another making collaboration, consultation and patient referral complicated. Only the more highly advanced clinical centres, generally located in large urban areas, have had the possibility to utilise technical possibilities for improving the organisation of patient clinical and research information, although independently from other centres. The information system, developed utilising the Visual Basic language for Microsoft Windows 95, stores information via a 'smart card' in a database which is initiated and updated utilising a microprocessor, located at each neurological clinic. The SMile Card, currently being tested in Italy, permits patients to carry with them all relevant medical information without limitations. Neurologists are able to access and update, via the microprocessor, the patient's entire medical history and MS-related information, including the complete neurological examination and laboratory test results. The SMile Card provides MS patients and neurologists with a complete computerised archive of clinical information which is accessible throughout the country. In addition, data from the SMile Card system can be exported to other database programs.

Beyond Information Retrieval—Medical Question Answering

PubMed Central

Lee, Minsuk; Cimino, James; Zhu, Hai Ran; Sable, Carl; Shanker, Vijay; Ely, John; Yu, Hong

2006-01-01

Physicians have many questions when caring for patients, and frequently need to seek answers for their questions. Information retrieval systems (e.g., PubMed) typically return a list of documents in response to a user’s query. Frequently the number of returned documents is large and makes physicians’ information seeking “practical only ‘after hours’ and not in the clinical settings”. Question answering techniques are based on automatically analyzing thousands of electronic documents to generate short-text answers in response to clinical questions that are posed by physicians. The authors address physicians’ information needs and described the design, implementation, and evaluation of the medical question answering system (MedQA). Although our long term goal is to enable MedQA to answer all types of medical questions, currently, we currently implement MedQA to integrate information retrieval, extraction, and summarization techniques to automatically generate paragraph-level text for definitional questions (i.e., “What is X?”). MedQA can be accessed at http://www.dbmi.columbia.edu/~yuh9001/research/MedQA.html. PMID:17238385

HIV Disease: Current Concepts.

ERIC Educational Resources Information Center

Keeling, Richard P.

1993-01-01

Describes human immunodeficiency virus (HIV), newly characterized human retrovirus which causes chronic, progressive, immune deficiency disease, the most severe phase of which is Acquired Immune Deficiency Syndrome (AIDS). Reviews most important current epidemiologic, clinical, and virologic information about HIV and HIV disease and provides…

The performance implications of pharmacy information system at the university teaching hospitals of Shiraz, Iran: Cluster approach

PubMed Central

Bayati, Saeede; Bastani, Peivand; Sagheb, Zahra Mahmoodzade; Jamalabadi, Sara; Samadbeik, Mahnaz

2017-01-01

Pharmacy information system (PIS) is becoming vital in assisting pharmacists to do their responsibilities. The aim of this study was to identify the current PIS implications in teaching hospitals affiliated with Shiraz University of Medical Science. This cross-sectional study was conducted in teaching hospitals affiliated with Shiraz University of Medical Science over the year 2016. Data were collected by observing the PIS as well as interviewing its users based on the researcher-made checklist. The checklist was prepared based on reviewing the Persian and English literature and its content validity was approved by the experts. To determine the reliability of the checklist, inter-rater reliability was used. Data were analyzed using SPSS16, and hospitals were clustered using SK-means method. In this study, the least conformity to the standards was shown in smart clinical features (4.54%), pharmaceutical companies' relationship (32.6%), and optimization of drug therapy (34.6%). In contrast, the highest conformity to the standards was shown in reporting capabilities (77.3%) and entry information and input (70.4%). Medication stock checking and optimization of drug therapy were effective features that have made a distinction between hospitals and lead to 95% variance between clusters. Based on the results, the current PIS design pays less attention to clinical features. Besides, clinical information for pharmacists and outside organization relationship were not provided by the current system. Thus, emphasis should be placed on the implementation of corrective actions to eliminate the current system's deficiencies. PMID:29184843

Personalized health care and health information technology policy: an exploratory analysis.

PubMed

Wald, Jonathan S; Shapiro, Michael

2013-01-01

Personalized healthcare (PHC) is envisioned to enhance clinical practice decision-making using new genome-driven knowledge that tailors diagnosis, treatment, and prevention to the individual patient. In 2012, we conducted a focused environmental scan and informal interviews with fifteen experts to anticipate how PHC might impact health Information Technology (IT) policy in the United States. Findings indicatedthat PHC has a variable impact on current clinical practice, creates complex questions for providers, patients, and policy-makers, and will require a robust health IT infrastructure with advanced data architecture, clinical decision support, provider workflow tools, and re-use of clinical data for research. A number of health IT challenge areas were identified, along with five policy areas including: interoperable clinical decision support, standards for patient values and preferences, patient engagement, data transparency, and robust privacy and security.

Designing healthcare information technology to catalyse change in clinical care.

PubMed

Lester, William T; Zai, Adrian H; Grant, Richard W; Chueh, Henry C

2008-01-01

The gap between best practice and actual patient care continues to be a pervasive problem in our healthcare system. Efforts to improve on this knowledge-performance gap have included computerised disease management programs designed to improve guideline adherence. However, current computerised reminder and decision support interventions directed at changing physician behaviour have had only a limited and variable effect on clinical outcomes. Further, immediate pay-for-performance financial pressures on institutions have created an environment where disease management systems are often created under duress, appended to existing clinical systems and poorly integrated into the existing workflow, potentially limiting their real-world effectiveness. The authors present a review of disease management as well as a conceptual framework to guide the development of more effective health information technology (HIT) tools for translating clinical information into clinical action.

Framework for a clinical information system.

PubMed

Van de Velde, R

2000-01-01

The current status of our work towards the design and implementation of a reference architecture for a Clinical Information System is presented. This architecture has been developed and implemented based on components following a strong underlying conceptual and technological model. Common Object Request Broker and n-tier technology featuring centralised and departmental clinical information systems as the back-end store for all clinical data are used. Servers located in the 'middle' tier apply the clinical (business) model and application rules to communicate with so-called 'thin client' workstations. The main characteristics are the focus on modelling and reuse of both data and business logic as there is a shift away from data and functional modelling towards object modelling. Scalability as well as adaptability to constantly changing requirements via component driven computing are the main reasons for that approach.

The application and value of information sources in clinical practice: an examination of the perspective of naturopaths.

PubMed

Steel, Amie; Adams, Jon

2011-06-01

The approach of evidence-based medicine (EBM), providing a paradigm to validate information sources and a process for critiquing their value, is an important platform for guiding practice. Researchers have explored the application and value of information sources in clinical practice with regard to a range of health professions; however, naturopathic practice has been overlooked. An exploratory study of naturopaths' perspectives of the application and value of information sources has been undertaken. Semi-structured interviews with 12 naturopaths in current clinical practice, concerning the information sources used in clinical practice and their perceptions of these sources. Thematic analysis identified differences in the application of the variety of information sources used, depending upon the perceived validity. Internet databases were viewed as highly valid. Textbooks, formal education and interpersonal interactions were judged based upon a variety of factors, whilst validation of general internet sites and manufacturers information was required prior to use. The findings of this study will provide preliminary aid to those responsible for supporting naturopaths' information use and access. In particular, it may assist publishers, medical librarians and professional associations in developing strategies to expand the clinically useful information sources available to naturopaths. © 2011 The authors. Health Information and Libraries Journal © 2011 Health Libraries Group.

Clinical benchmarking enabled by the digital health record.

PubMed

Ricciardi, T N; Masarie, F E; Middleton, B

2001-01-01

Office-based physicians are often ill equipped to report aggregate information about their patients and practice of medicine, since their practices have relied upon paper records for the management of clinical information. Physicians who do not have access to large-scale information technology support can now benefit from low-cost clinical documentation and reporting tools. We developed a hosted clinical data mart for users of a web-enabled charting tool, targeting the solo or small group practice. The system uses secure Java Server Pages with a dashboard-like menu to provide point-and-click access to simple reports such as case mix, medications, utilization, productivity, and patient demographics in its first release. The system automatically normalizes user-entered clinical terms to enhance the quality of structured data. Individual providers benefit from rapid patient identification for disease management, quality of care self-assessments, drug recalls, and compliance with clinical guidelines. The system provides knowledge integration by linking to trusted sources of online medical information in context. Information derived from the clinical record is clinically more accurate than billing data. Provider self-assessment and benchmarking empowers physicians, who may resent "being profiled" by external entities. In contrast to large-scale data warehouse projects, the current system delivers immediate value to individual physicians who choose an electronic clinical documentation tool.

Improving detection of psychiatric disturbances in Parkinson's disease: the role of informants.

PubMed

Hirsch, Elaina S; Adler, Geri; Amspoker, Amber B; Williams, James R; Marsh, Laura

2013-01-01

Under-recognition of psychiatric disturbances in patients with Parkinson's disease (PD) contributes to greater overall morbidity. Little is known about the value of collateral psychiatric history, obtained using standardized assessments with informants, for increasing recognition of PD-related psychiatric illness. To examine the extent to which informants provide critical information that enabled psychiatrists to establish psychiatric diagnoses in patients with PD. Individuals with PD (n = 223) and an informant were interviewed separately regarding the PD patient's psychiatric history and current status. A six-psychiatrist panel rated the extent to which informant data was required to establish the final consensus best-estimate current psychiatric diagnoses. Informants rated as "Crucial" or "Significantly Informative" comprised a "Critical Informant" (CI) subgroup; remaining informants were classified as the "Non-Critical Informant" (NCI) subgroup. Of the informants, 71 (31.4%) were "critical" for determining a psychiatric diagnosis. Without a CI, 81.3% of those with impulse control disorders and 43.8% of those with anxiety disorders would not have been diagnosed. Male PD patients and those with less severe motor deficits were also more likely to require a CI. Informants aid in the identification of psychiatric diagnoses, especially impulse control and anxiety disorders. This has implications for clinical practice and conduction of clinical trials.

Information disclosure in clinical informed consent: “reasonable” patient’s perception of norm in high-context communication culture

PubMed Central

2014-01-01

Background The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures. Methods We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues. Results Respondents’ mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee’s name). Overall, items related to benefits and post-procedure’s issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). Conclusions 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure’s issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a “reasonable” patient’s standard is to be met. PMID:24406055

Information disclosure in clinical informed consent: "reasonable" patient's perception of norm in high-context communication culture.

PubMed

Hammami, Muhammad M; Al-Jawarneh, Yussuf; Hammami, Muhammad B; Al Qadire, Mohammad

2014-01-10

The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients' norm perception of information disclosure in other cultures. We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners' details, benefits, risks, complications' management, available alternatives, procedure's description, and post-procedure's issues. Respondents' mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee's name). Overall, items related to benefits and post-procedure's issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure's name) to 13.9% (lead practitioner's training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009). 1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure's issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a "reasonable" patient's standard is to be met.

Advances in arterial spin labelling MRI methods for measuring perfusion and collateral flow.

PubMed

van Osch, Matthias Jp; Teeuwisse, Wouter M; Chen, Zhensen; Suzuki, Yuriko; Helle, Michael; Schmid, Sophie

2017-01-01

With the publication in 2015 of the consensus statement by the perfusion study group of the International Society for Magnetic Resonance in Medicine (ISMRM) and the EU-COST action 'ASL in dementia' on the implementation of arterial spin labelling MRI (ASL) in a clinical setting, the development of ASL can be considered to have become mature and ready for clinical prime-time. In this review article new developments and remaining issues will be discussed, especially focusing on quantification of ASL as well as on new technological developments of ASL for perfusion imaging and flow territory mapping. Uncertainty of the achieved labelling efficiency in pseudo-continuous ASL (pCASL) as well as the presence of arterial transit time artefacts, can be considered the main remaining challenges for the use of quantitative cerebral blood flow (CBF) values. New developments in ASL centre around time-efficient acquisition of dynamic ASL-images by means of time-encoded pCASL and diversification of information content, for example by combined 4D-angiography with perfusion imaging. Current vessel-encoded and super-selective pCASL-methodology have developed into easily applied flow-territory mapping methods providing relevant clinical information with highly similar information content as digital subtraction angiography (DSA), the current clinical standard. Both approaches seem therefore to be ready for clinical use.

A booklet on participants' rights to improve consent for clinical research: a randomized trial.

PubMed

Benatar, Jocelyne R; Mortimer, John; Stretton, Matthew; Stewart, Ralph A H

2012-01-01

Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants' rights. A booklet designed to provide information on participants' rights which used simple language was developed to replace this information in current ICF's Readability of each component of ICF's and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant's rights was assessed by questionnaire. Information related to participants' rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials.

A Booklet on Participants’ Rights to Improve Consent for Clinical Research: A Randomized Trial

PubMed Central

Benatar, Jocelyne R.; Mortimer, John; Stretton, Matthew; Stewart, Ralph A. H.

2012-01-01

Objective Information on the rights of subjects in clinical trials has become increasingly complex and difficult to understand. This study evaluates whether a simple booklet which is relevant to all research studies improves the understanding of rights needed for subjects to provide informed consent. Methods 21 currently used informed consent forms (ICF) from international clinical trials were separated into information related to the specific research study, and general information on participants’ rights. A booklet designed to provide information on participants’ rights which used simple language was developed to replace this information in current ICF’s Readability of each component of ICF’s and the booklet was then assessed using the Flesch-Kincaid Reading ease score (FK). To further evaluate the booklet 282 hospital inpatients were randomised to one of three ways to present research information; a standard ICF, the booklet combined with a short ICF, or the booklet combined with a simplified ICF. Comprehension of information related to the research proposal and to participant’s rights was assessed by questionnaire. Results Information related to participants’ rights contributed an average of 44% of the words in standard ICFs, and was harder to read than information describing the clinical trial (FK 25 versus (vs.) 41 respectively, p = 0.0003). The booklet reduced the number of words and improved FK from 25 to 42. The simplified ICF had a slightly higher FK score than the standard ICF (50 vs. 42). Comprehension assessed in inpatients was better for the booklet and short ICF 62%, (95% confidence interval (CI) 56 to 67) correct, or simplified ICF 62% (CI 58 to 68) correct compared to 52%, (CI 47 to 57) correct for the standard ICF, p = 0.009. This was due to better understanding of questions on rights (62% vs. 49% correct, p = 0.0008). Comprehension of study related information was similar for the simplified and standard ICF (60% vs. 64% correct, p = 0.68). Conclusions A booklet provides a simple consistent approach to providing information on participant rights which is relevant to all research studies, and improves comprehension of patients who typically participate in clinical trials. PMID:23094034

The ideal laboratory information system.

PubMed

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

World Workshop on Oral Medicine VI: Utilization of Oral Medicine-specific software for support of clinical care, research, and education: current status and strategy for broader implementation.

PubMed

Brailo, Vlaho; Firriolo, Francis John; Tanaka, Takako Imai; Varoni, Elena; Sykes, Rosemary; McCullough, Michael; Hua, Hong; Sklavounou, Alexandra; Jensen, Siri Beier; Lockhart, Peter B; Mattsson, Ulf; Jontell, Mats

2015-08-01

To assess the current scope and status of Oral Medicine-specific software (OMSS) utilized to support clinical care, research, and education in Oral Medicine and to propose a strategy for broader implementation of OMSS within the global Oral Medicine community. An invitation letter explaining the objectives was sent to the global Oral Medicine community. Respondents were interviewed to obtain information about different aspects of OMSS functionality. Ten OMSS tools were identified. Four were being used for clinical care, one was being used for research, two were being used for education, and three were multipurpose. Clinical software was being utilized as databases developed to integrate of different type of clinical information. Research software was designed to facilitate multicenter research. Educational software represented interactive, case-orientated technology designed for clinical training in Oral Medicine. Easy access to patient data was the most commonly reported advantage. Difficulty of use and poor integration with other software was the most commonly reported disadvantage. The OMSS presented in this paper demonstrate how information technology (IT) can have an impact on the quality of patient care, research, and education in the field of Oral Medicine. A strategy for broader implementation of OMSS is proposed. Copyright © 2015 Elsevier Inc. All rights reserved.

A KPI framework for process-based benchmarking of hospital information systems.

PubMed

Jahn, Franziska; Winter, Alfred

2011-01-01

Benchmarking is a major topic for monitoring, directing and elucidating the performance of hospital information systems (HIS). Current approaches neglect the outcome of the processes that are supported by the HIS and their contribution to the hospital's strategic goals. We suggest to benchmark HIS based on clinical documentation processes and their outcome. A framework consisting of a general process model and outcome criteria for clinical documentation processes is introduced.

Machine Translation-Supported Cross-Language Information Retrieval for a Consumer Health Resource

PubMed Central

Rosemblat, Graciela; Gemoets, Darren; Browne, Allen C.; Tse, Tony

2003-01-01

The U.S. National Institutes of Health, through its National Library of Medicine, developed ClinicalTrials.gov to provide the public with easy access to information on clinical trials on a wide range of conditions or diseases. Only English language information retrieval is currently supported. Given the growing number of Spanish speakers in the U.S. and their increasing use of the Web, we anticipate a significant increase in Spanish-speaking users. This study compares the effectiveness of two common cross-language information retrieval methods using machine translation, query translation versus document translation, using a subset of genuine user queries from ClinicalTrials.gov. Preliminary results conducted with the ClinicalTrials.gov search engine show that in our environment, query translation is statistically significantly better than document translation. We discuss possible reasons for this result and we conclude with suggestions for future work. PMID:14728236

A model-driven approach for representing clinical archetypes for Semantic Web environments.

PubMed

Martínez-Costa, Catalina; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás; Maldonado, José Alberto

2009-02-01

The life-long clinical information of any person supported by electronic means configures his Electronic Health Record (EHR). This information is usually distributed among several independent and heterogeneous systems that may be syntactically or semantically incompatible. There are currently different standards for representing and exchanging EHR information among different systems. In advanced EHR approaches, clinical information is represented by means of archetypes. Most of these approaches use the Archetype Definition Language (ADL) to specify archetypes. However, ADL has some drawbacks when attempting to perform semantic activities in Semantic Web environments. In this work, Semantic Web technologies are used to specify clinical archetypes for advanced EHR architectures. The advantages of using the Ontology Web Language (OWL) instead of ADL are described and discussed in this work. Moreover, a solution combining Semantic Web and Model-driven Engineering technologies is proposed to transform ADL into OWL for the CEN EN13606 EHR architecture.

Assessing subject privacy and data confidentiality in an emerging region for clinical trials: United Arab Emirates.

PubMed

Nair, Satish Chandrasekhar; Ibrahim, Halah

2015-01-01

Pharmaceutical sponsored clinical trials, formerly conducted predominantly in the United States and Europe, have expanded to emerging regions, including the Middle East. Our study explores factors influencing clinical trial privacy and confidentiality in the United Arab Emirates. Factors including concept familiarity, informed consent compliance, data access, and preservation, were analyzed to assess current practices in the Arab world. As the UAE is an emerging region for clinical trials, there is a growing need for regulations related to data confidentiality and subject privacy. Informational and decisional privacy should be viewed within the realms of Arab culture and religious background.

United States National Library of Medicine Drug Information Portal.

PubMed

Hochstein, Colette; Goshorn, Jeanne; Chang, Florence

2009-01-01

The Drug Information Portal is a free Web resource from the National Library of Medicine (NLM) that provides a user-friendly gateway to current information for more than 15,000 drugs. The site guides users to related resources of NLM, the National Institutes of Health (NIH), and other government agencies. Current drug-related information regarding consumer health, clinical trials, AIDS, MeSH pharmacological actions, MEDLINE/PubMed biomedical literature, and physical properties and structure is easily retrieved by searching on a drug name. A varied selection of focused topics in medicine and drugs is also available from displayed subject headings. This column provides background information about the Drug Information Portal, as well as search basics.

Factors Influencing Successful Use of Information Retrieval Systems by Nurse Practitioner Students

PubMed Central

Rose, Linda; Crabtree, Katherine; Hersh, William

1998-01-01

This study examined whether a relationship exists between selected Nurse Practitioner students' attributes and successful information retrieval as demonstrated by correctly answering clinical questions using an information retrieval system (Medline). One predictor variable, attitude toward current computer technology, was significantly correlated (r =0.43, p ≤ .05) with successful literature searching.

Argumentation and evidence.

PubMed

Upshur, R E G; Colak, Errol

2003-01-01

This essay explores the role of informal logic and its application in the context of current debates regarding evidence-based medicine. This aim is achieved through a discussion of the goals and objectives of evidence-based medicine and a review of the criticisms raised against evidence-based medicine. The contributions to informal logic by Stephen Toulmin and Douglas Walton are explicated and their relevance for evidence-based medicine is discussed in relation to a common clinical scenario: hypertension management. This essay concludes with a discussion on the relationship between clinical reasoning, rationality, and evidence. It is argued that informal logic has the virtue of bringing explicitness to the role of evidence in clinical reasoning, and brings sensitivity to understanding the role of dialogical context in the need for evidence in clinical decision making.

Clinical recommendations of cardiac magnetic resonance, Part II: inflammatory and congenital heart disease, cardiomyopathies and cardiac tumors: a position paper of the working group 'Applicazioni della Risonanza Magnetica' of the Italian Society of Cardiology.

PubMed

Pontone, Gianluca; Di Bella, Gianluca; Silvia, Castelletti; Maestrini, Viviana; Festa, Pierluigi; Ait-Ali, Lamia; Masci, Pier Giorgio; Monti, Lorenzo; di Giovine, Gabriella; De Lazzari, Manuel; Cipriani, Alberto; Guaricci, Andrea I; Dellegrottaglie, Santo; Pepe, Alessia; Marra, Martina Perazzolo; Aquaro, Giovanni D

2017-04-01

The current document was developed by the working group on the 'application of cardiac magnetic resonance' of the Italian Society of Cardiology to provide a perspective on the current state of technical advances and clinical cardiac magnetic resonance applications and to inform cardiologists how to implement their clinical and diagnostic pathway with the introduction of this technique in the clinical practice. Appropriateness criteria were defined using a score system: score 1-3 = inappropriate (test is not generally acceptable and is not a reasonable approach for the indication), score 4-6 = uncertain (test may be generally acceptable and may be a reasonable approach for the indication but more research and/or patient information is needed to classify the indication definitively) and score 7-9 = appropriate (test is generally acceptable and is a reasonable approach for the indication).

Undertaking an information-needs analysis of the emergency-care physician to inform the role of the clinical librarian: a Greek perspective.

PubMed

Lappa, E

2005-06-01

The primary focus of this pilot study was to gain a better understanding of the information needs of emergency-care clinicians. The secondary focus was to compare the traditional current practice of information provision within other emergency departments in Greek hospitals, with the new model of clinical librarianship (CL). Clinical staff in the emergency department deal with a variety of cases, they have no time to visit the library, but need information instantly in their place of work. Clinical decision making in the emergency department setting frequently requires the clinician to obtain additional sources of information and clinical librarians may facilitate this. The present study focused on two professional groups: medical librarians (group A) and clinicians (consultants, senior registrars, registrars, nurses (group B), working in the emergency departments of two Greek hospitals. The study was organized through a questionnaire survey and some in-depth interviews. This study showed that, for 100% of the clinicians in daily practice, the main information needs arise while treating patients, and that information would help in making patient-care decisions. Clinicians made little use of hospital libraries because they are usually under tremendous time pressure. The main outcome of the study was the use of a clinical librarian as an information provider. Clinical librarians supply information to assist decisions, based on this model. This extends the librarian's role in evidence-based medicine, giving much stronger attention to the relevant evidence in clinical practice. Nowadays, health services are facing organizational change. The introduction of new technology, and rapid growth of medical knowledge creates a demand for new ways of providing information. Clinical librarian programmes may deliver patients specific information in a timely manner. The mission of the clinical librarian is to facilitate access to quality information which is necessary for improving health, and to act as an informationist in the emergency department.

Capturing Essential Information to Achieve Safe Interoperability

PubMed Central

Weininger, Sandy; Jaffe, Michael B.; Rausch, Tracy; Goldman, Julian M.

2016-01-01

In this article we describe the role of “clinical scenario” information to assure the safety of interoperable systems, as well as the system’s ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets (MDIDSa) and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a “Patient-controlled analgesia safety interlock” are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a Learning Health System to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™, is described. PMID:27387840

The Need for Data-Informed Clinical Supervision in Substance Use Disorder Treatment

PubMed Central

Ramsey, Alex T.; Baumann, Ana; Silver Wolf, David Patterson; Yan, Yan; Cooper, Ben; Proctor, Enola

2017-01-01

Background Effective clinical supervision is necessary for high-quality care in community-based substance use disorder treatment settings, yet little is known about current supervision practices. Some evidence suggests that supervisors and counselors differ in their experiences of clinical supervision; however, the impact of this misalignment on supervision quality is unclear. Clinical information monitoring systems may support supervision in substance use disorder treatment, but the potential use of these tools must first be explored. Aims First, this study examines the extent to which misaligned supervisor-counselor perceptions impact supervision satisfaction and emphasis on evidence-based treatments. This study also reports on formative work to develop a supervision-based clinical dashboard, an electronic information monitoring system and data visualization tool providing real-time clinical information to engage supervisors and counselors in a coordinated and data-informed manner, help align supervisor-counselor perceptions about supervision, and improve supervision effectiveness. Methods Clinical supervisors and frontline counselors (N=165) from five Midwestern agencies providing substance abuse services completed an online survey using Research Electronic Data Capture (REDCap) software, yielding a 75% response rate. Valid quantitative measures of supervision effectiveness were assessed, along with qualitative perceptions of a supervision-based clinical dashboard. Results Through within-dyad analyses, misalignment between supervisor and counselor perceptions of supervision practices was negatively associated with satisfaction of supervision and reported frequency of discussing several important clinical supervision topics, including evidence-based treatments and client rapport. Participants indicated the most useful clinical dashboard functions and reported important benefits and challenges to using the proposed tool. Discussion Clinical supervision tends to be largely an informal and unstructured process in substance abuse treatment, which may compromise the quality of care. Clinical dashboards may be a well-targeted approach to facilitate data-informed clinical supervision in community-based treatment agencies. PMID:28166480

Capturing Essential Information to Achieve Safe Interoperability.

PubMed

Weininger, Sandy; Jaffe, Michael B; Rausch, Tracy; Goldman, Julian M

2017-01-01

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.

An assessment of the information-seeking abilities and needs of practicing speech-language pathologists

PubMed Central

Nail-Chiwetalu, Barbara; Bernstein Ratner, Nan

2007-01-01

Objectives: This study assessed the information-seeking practices and needs of speech-language pathologists (SLPs). Improved understanding of these needs can inform librarians and educators to better prepare students in principles and methods of evidence-based practice (EBP) and, through continuing education (CE), promote the integration of EBP into clinical practice of SLPs. Methods: A 16-question survey was mailed to 1,000 certified speech-language pathologists in the United States. Results: Two hundred and eight usable surveys were returned for a response rate of 21%. For clinical questions, SLPs most often consulted with a colleague, participated in CE activities, and searched the open Internet. Few respondents relied on scholarly journal articles for assistance with clinical cases. The most prominent barriers to finding appropriate information were time and knowledge of where and how to find relevant information. Few reported having information literacy instruction by a librarian. Discussion: If EBP is to become a viable practice in clinical decision making, there appears to be a tremendous need for information literacy instruction in the university curriculum, as well as through CE activities for currently practicing SLPs. Given respondents' reported lack of time and limited access to full-text journals containing evidence relevant to clinical practice, the field of speech-language pathology will need to generate readily accessible clinical summaries of research evidence through meta-analyses, systematic reviews, and clinical practice guidelines. PMID:17443251

Versatile clinical information system design for emergency departments.

PubMed

Amouh, Teh; Gemo, Monica; Macq, Benoît; Vanderdonckt, Jean; El Gariani, Abdul Wahed; Reynaert, Marc S; Stamatakis, Lambert; Thys, Frédéric

2005-06-01

Compared to other hospital units, the emergency department presents some distinguishing characteristics of its own. Emergency health-care delivery is a collaborative process involving the contribution of several individuals who accomplish their tasks while working autonomously under pressure and sometimes with limited resources. Effective computerization of the emergency department information system presents a real challenge due to the complexity of the scenario. Current computerized support suffers from several problems, including inadequate data models, clumsy user interfaces, and poor integration with other clinical information systems. To tackle such complexity, we propose an approach combining three points of view, namely the transactions (in and out of the department), the (mono and multi) user interfaces and data management. Unlike current systems, we pay particular attention to the user-friendliness and versatility of our system. This means that intuitive user interfaces have been conceived and specific software modeling methodologies have been applied to provide our system with the flexibility and adaptability necessary for the individual and group coordinated tasks. Our approach has been implemented by prototyping a web-based, multiplatform, multiuser, and versatile clinical information system built upon multitier software architecture, using the Java programming language.

Why do we do as we do? Factors influencing clinical reasoning and decision-making among physiotherapists in an acute setting.

PubMed

Holdar, Ulrika; Wallin, Lars; Heiwe, Susanne

2013-12-01

Despite the current movement for health-care to become more informed by evidence, knowledge on effective implementation of evidence-based practice is scarce. To improve research application among physiotherapists, the process of implementation and clinical reasoning needs to be scrutinized. The aim of this study was to identify various experiences of factors that influence the physiotherapist's clinical reasoning in specialist care. A phenomenographic approach was chosen. Eleven physiotherapists at two acute care hospitals in nn. Data was obtained by observations and interviews. Phenomenographic data analysis identified various experiences of clinical decision-making. The Ethical Review Board of the nn approved the study. The observations and the interviews enabled identification of various experiences that influenced clinical decision-making. The physiotherapists' clinical reasoning was perceived to be constrained by contextual factors. The physiotherapists collected current information on the patient by using written and verbal information exchange and used this to generate an inner picture of the patient. By creating hypotheses that were accepted or rejected, they made decisions in advance of their interventions. The decisions were influenced by the individual characteristics of the physiotherapist, his/her knowledge and patient perceptions. Clinical reasoning is a complex and constantly evolving process. Contextual factors such as economy and politics are not easily changed, but factors such as the patient and the physiotherapist as a person are more tangible. Copyright © 2013 John Wiley & Sons, Ltd.

Detailed clinical models: representing knowledge, data and semantics in healthcare information technology.

PubMed

Goossen, William T F

2014-07-01

This paper will present an overview of the developmental effort in harmonizing clinical knowledge modeling using the Detailed Clinical Models (DCMs), and will explain how it can contribute to the preservation of Electronic Health Records (EHR) data. Clinical knowledge modeling is vital for the management and preservation of EHR and data. Such modeling provides common data elements and terminology binding with the intention of capturing and managing clinical information over time and location independent from technology. Any EHR data exchange without an agreed clinical knowledge modeling will potentially result in loss of information. Many attempts exist from the past to model clinical knowledge for the benefits of semantic interoperability using standardized data representation and common terminologies. The objective of each project is similar with respect to consistent representation of clinical data, using standardized terminologies, and an overall logical approach. However, the conceptual, logical, and the technical expressions are quite different in one clinical knowledge modeling approach versus another. There currently are synergies under the Clinical Information Modeling Initiative (CIMI) in order to create a harmonized reference model for clinical knowledge models. The goal for the CIMI is to create a reference model and formalisms based on for instance the DCM (ISO/TS 13972), among other work. A global repository of DCMs may potentially be established in the future.

Equine pituitary pars intermedia dysfunction: current understanding and recommendations from the Australian and New Zealand Equine Endocrine Group.

PubMed

Secombe, C J; Bailey, S R; de Laat, M A; Hughes, K J; Stewart, A S; Sonis, J M; Tan, Rhh

2018-06-03

The purpose of this article is to provide a review of the current knowledge and opinions about the epidemiology, clinical findings (including sequelae), diagnosis, treatment and monitoring of equine pituitary pars intermedia dysfunction, particularly in the Australian context. This information and the recommendations provided will assist practitioners in making informed decisions regarding the diagnosis and management of this disorder. © 2018 Australian Veterinary Association.

Clinimetrics: the science of clinical measurements.

PubMed

Fava, G A; Tomba, E; Sonino, N

2012-01-01

'Clinimetrics' is the term introduced by Alvan R. Feinstein in the early 1980s to indicate a domain concerned with indexes, rating scales and other expressions that are used to describe or measure symptoms, physical signs and other clinical phenomena. Clinimetrics has a set of rules that govern the structure of indexes, the choice of component variables, the evaluation of consistency, validity and responsiveness. This review illustrates how clinimetrics may help expanding the narrow range of information that is currently used in clinical science. It will focus on characteristics and types of clinimetric indexes and their current use. The clinimetric perspective provides an intellectual home for clinical judgment, whose implementation is likely to improve outcomes both in clinical research and practice. © 2011 Blackwell Publishing Ltd.

Clinical handover of patients arriving by ambulance to the emergency department - a literature review.

PubMed

Bost, Nerolie; Crilly, Julia; Wallis, Marianne; Patterson, Elizabeth; Chaboyer, Wendy

2010-10-01

To provide a critical review of research on clinical handover between the ambulance service and emergency department (ED) in hospitals. Data base and hand searches were conducted using the keywords ambulance, handover, handoff, emergency department, emergency room, ER, communication, and clinical handover. Data were extracted, summarised and critically assessed to provide evidence of current clinical handover processes. From 252 documents, eight studies fitted the inclusion criteria of clinical handover and the ambulance to ED patient transfer. Three themes were identified in the review: (1) important information may be missed during clinical handover; (2) structured handovers that include both written and verbal components may improve information exchange; (3) multidisciplinary education about the clinical handover process may encourage teamwork, a shared common language and a framework for minimum patient information to be transferred from the ambulance service to the hospital ED. Knowledge gaps exist concerning handover information, consequences of poor handover, transfer of responsibility, staff perception of handovers, staff training and evaluation of recommended strategies to improve clinical handover. Evidence of strategies being implemented and further research is required to examine the ongoing effects of implementing the strategies. Copyright © 2009 Elsevier Ltd. All rights reserved.

Clinical utility of the MMPI-2-RF SUI items and scale in a forensic inpatient setting: Association with interview self-report and future suicidal behaviors.

PubMed

Glassmire, David M; Tarescavage, Anthony M; Burchett, Danielle; Martinez, Jennifer; Gomez, Anthony

2016-11-01

In this study, we examined whether the 5 Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2008/2011) Suicidal/Death Ideation (SUI) items (93, 120, 164, 251, and 334) would provide incremental suicide-risk assessment information after accounting for information garnered from clinical interview questions. Among 229 forensic inpatients (146 men, 83 women) who were administered the MMPI-2-RF, 34.9% endorsed at least 1 SUI item. We found that patients who endorsed SUI items on the MMPI-2-RF concurrently denied conceptually related suicide-risk information during the clinical interview. For instance, 8% of the sample endorsed Item 93 (indicating recent suicidal ideation), yet denied current suicidal ideation upon interview. Conversely, only 2.2% of the sample endorsed current suicidal ideation during the interview, yet denied recent suicidal ideation on Item 93. The SUI scale, as well as the MMPI-2-RF Demoralization (RCd) and Low Positive Emotions (RC2) scales, correlated significantly and meaningfully with conceptually related suicide-risk information from the interview, including history of suicide attempts, history of suicidal ideation, current suicidal ideation, and months since last suicide attempt. We also found that the SUI scale added incremental variance (after accounting for information garnered from the interview and after accounting for scores on RCd and RC2) to predictions of future suicidal behavior within 1 year of testing. Relative risk ratios indicated that both SUI-item endorsement and the presence of interview-reported risk information significantly and meaningfully increased the risk of suicidal behavior in the year following testing, particularly when endorsement of suicidal ideation occurred for both methods of self-report. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The feasibility of using natural language processing to extract clinical information from breast pathology reports.

PubMed

Buckley, Julliette M; Coopey, Suzanne B; Sharko, John; Polubriaginof, Fernanda; Drohan, Brian; Belli, Ahmet K; Kim, Elizabeth M H; Garber, Judy E; Smith, Barbara L; Gadd, Michele A; Specht, Michelle C; Roche, Constance A; Gudewicz, Thomas M; Hughes, Kevin S

2012-01-01

The opportunity to integrate clinical decision support systems into clinical practice is limited due to the lack of structured, machine readable data in the current format of the electronic health record. Natural language processing has been designed to convert free text into machine readable data. The aim of the current study was to ascertain the feasibility of using natural language processing to extract clinical information from >76,000 breast pathology reports. APPROACH AND PROCEDURE: Breast pathology reports from three institutions were analyzed using natural language processing software (Clearforest, Waltham, MA) to extract information on a variety of pathologic diagnoses of interest. Data tables were created from the extracted information according to date of surgery, side of surgery, and medical record number. The variety of ways in which each diagnosis could be represented was recorded, as a means of demonstrating the complexity of machine interpretation of free text. There was widespread variation in how pathologists reported common pathologic diagnoses. We report, for example, 124 ways of saying invasive ductal carcinoma and 95 ways of saying invasive lobular carcinoma. There were >4000 ways of saying invasive ductal carcinoma was not present. Natural language processor sensitivity and specificity were 99.1% and 96.5% when compared to expert human coders. We have demonstrated how a large body of free text medical information such as seen in breast pathology reports, can be converted to a machine readable format using natural language processing, and described the inherent complexities of the task.

Factors shaping effective utilization of health information technology in urban safety-net clinics.

PubMed

George, Sheba; Garth, Belinda; Fish, Allison; Baker, Richard

2013-09-01

Urban safety-net clinics are considered prime targets for the adoption of health information technology innovations; however, little is known about their utilization in such safety-net settings. Current scholarship provides limited guidance on the implementation of health information technology into safety-net settings as it typically assumes that adopting institutions have sufficient basic resources. This study addresses this gap by exploring the unique challenges urban resource-poor safety-net clinics must consider when adopting and utilizing health information technology. In-depth interviews (N = 15) were used with key stakeholders (clinic chief executive officers, medical directors, nursing directors, chief financial officers, and information technology directors) from staff at four clinics to explore (a) nonhealth information technology-related clinic needs, (b) how health information technology may provide solutions, and (c) perceptions of and experiences with health information technology. Participants identified several challenges, some of which appear amenable to health information technology solutions. Also identified were requirements for effective utilization of health information technology including physical infrastructural improvements, funding for equipment/training, creation of user groups to share health information technology knowledge/experiences, and specially tailored electronic billing guidelines. We found that despite the potential benefit that can be derived from health information technologies, the unplanned and uninformed introduction of these tools into these settings might actually create more problems than are solved. From these data, we were able to identify a set of factors that should be considered when integrating health information technology into the existing workflows of low-resourced urban safety-net clinics in order to maximize their utilization and enhance the quality of health care in such settings.

The clinical trial landscape in oncology and connectivity of somatic mutational profiles to targeted therapies.

PubMed

Patterson, Sara E; Liu, Rangjiao; Statz, Cara M; Durkin, Daniel; Lakshminarayana, Anuradha; Mockus, Susan M

2016-01-16

Precision medicine in oncology relies on rapid associations between patient-specific variations and targeted therapeutic efficacy. Due to the advancement of genomic analysis, a vast literature characterizing cancer-associated molecular aberrations and relative therapeutic relevance has been published. However, data are not uniformly reported or readily available, and accessing relevant information in a clinically acceptable time-frame is a daunting proposition, hampering connections between patients and appropriate therapeutic options. One important therapeutic avenue for oncology patients is through clinical trials. Accordingly, a global view into the availability of targeted clinical trials would provide insight into strengths and weaknesses and potentially enable research focus. However, data regarding the landscape of clinical trials in oncology is not readily available, and as a result, a comprehensive understanding of clinical trial availability is difficult. To support clinical decision-making, we have developed a data loader and mapper that connects sequence information from oncology patients to data stored in an in-house database, the JAX Clinical Knowledgebase (JAX-CKB), which can be queried readily to access comprehensive data for clinical reporting via customized reporting queries. JAX-CKB functions as a repository to house expertly curated clinically relevant data surrounding our 358-gene panel, the JAX Cancer Treatment Profile (JAX CTP), and supports annotation of functional significance of molecular variants. Through queries of data housed in JAX-CKB, we have analyzed the landscape of clinical trials relevant to our 358-gene targeted sequencing panel to evaluate strengths and weaknesses in current molecular targeting in oncology. Through this analysis, we have identified patient indications, molecular aberrations, and targeted therapy classes that have strong or weak representation in clinical trials. Here, we describe the development and disseminate system methods for associating patient genomic sequence data with clinically relevant information, facilitating interpretation and providing a mechanism for informing therapeutic decision-making. Additionally, through customized queries, we have the capability to rapidly analyze the landscape of targeted therapies in clinical trials, enabling a unique view into current therapeutic availability in oncology.

The effects of serotonin manipulations on emotional information processing and mood.

PubMed

Merens, Wendelien; Willem Van der Does, A J; Spinhoven, Philip

2007-11-01

Serotonin is implicated in both mood and cognition. It has recently been shown that antidepressant treatment has immediate effects on emotional information processing, which is much faster than any clinically significant effects. This review aims to investigate whether the effects on emotional information processing are reliable, and whether these effects are related to eventual clinical outcome. Treatment-efficiency may be greatly improved if early changes in emotional information processing are found to predict clinical outcome following antidepressant treatment. Review of studies investigating the short-term effects of serotonin manipulations (including medication) on the processing of emotional information, using PubMed and PsycInfo databases. Twenty-five studies were identified. Serotonin manipulations were found to affect attentional bias, facial emotion recognition, emotional memory, dysfunctional attitudes and decision making. The sequential link between changes in emotional processing and mood remains to be further investigated. The number of studies on serotonin manipulations and emotional information processing in currently depressed subjects is small. No studies yet have directly tested the link between emotional information processing and clinical outcome during the course of antidepressant treatment. Serotonin function is related to several aspects of emotional information processing, but it is unknown whether these changes predict or have any relationship with clinical outcome. Suggestions for future research are provided.

The current status of cone beam computed tomography imaging in orthodontics

PubMed Central

Kapila, S; Conley, R S; Harrell, W E

2011-01-01

Cone beam CT (CBCT) has become an increasingly important source of three dimensional (3D) volumetric data in clinical orthodontics since its introduction into dentistry in 1998. The purpose of this manuscript is to highlight the current understanding of, and evidence for, the clinical use of CBCT in orthodontics, and to review the findings to answer clinically relevant questions. Currently available information from studies using CBCT can be organized into five broad categories: 1, the assessment of CBCT technology; 2, its use in craniofacial morphometric analyses; 3, incidental and missed findings; 4, analysis of treatment outcomes; and 5, efficacy of CBCT in diagnosis and treatment planning. The findings in these topical areas are summarized, followed by current indications and protocols for the use of CBCT in specific cases. Despite the increasing popularity of CBCT in orthodontics, and its advantages over routine radiography in specific cases, the effects of information derived from these images in altering diagnosis and treatment decisions has not been demonstrated in several types of cases. It has therefore been recommended that CBCT be used in select cases in which conventional radiography cannot supply satisfactory diagnostic information; these include cleft palate patients, assessment of unerupted tooth position, supernumerary teeth, identification of root resorption and for planning orthognathic surgery. The need to image other types of cases should be made on a case-by-case basis following an assessment of benefits vs risks of scanning in these situations. PMID:21159912

Clinical research in the United States at a crossroads: proposal for a novel public-private partnership to establish a national clinical research enterprise.

PubMed

Crowley, William F; Sherwood, Louis; Salber, Patricia; Scheinberg, David; Slavkin, Hal; Tilson, Hugh; Reece, E Albert; Catanese, Veronica; Johnson, Stephen B; Dobs, Adrian; Genel, Myron; Korn, Allan; Reame, Nancy; Bonow, Robert; Grebb, Jack; Rimoin, David

2004-03-03

The clinical research infrastructure of the United States is currently at a critical crossroads. To leverage the enormous biomedical research gains made in the past century efficiently, a drastic need exists to reengineer this system into a coordinated, safe, and more efficient and effective enterprise. To accomplish this task, clinical research must be transformed from its current state as a cottage industry to an enterprise-wide health care pipeline whose function is to bring the novel research from both government and private entities to the US public. We propose the establishment of a unique public-private partnership termed the National Clinical Research Enterprise (NCRE). Its agenda should consist of informed public participation, supportive information technologies, a skilled workforce, and adequate funding in clinical research. Devoting only 0.25% of the budgets from all health care stakeholders to support the NCRE would permit adequate funding to build the infrastructure required to address these problems in an enterprise fashion. All participants in the US health care delivery system must come together to focus on system-wide improvements that will benefit the public.

Definition of variables required for comprehensive description of drug dosage and clinical pharmacokinetics.

PubMed

Medem, Anna V; Seidling, Hanna M; Eichler, Hans-Georg; Kaltschmidt, Jens; Metzner, Michael; Hubert, Carina M; Czock, David; Haefeli, Walter E

2017-05-01

Electronic clinical decision support systems (CDSS) require drug information that can be processed by computers. The goal of this project was to determine and evaluate a compilation of variables that comprehensively capture the information contained in the summary of product characteristic (SmPC) and unequivocally describe the drug, its dosage options, and clinical pharmacokinetics. An expert panel defined and structured a set of variables and drafted a guideline to extract and enter information on dosage and clinical pharmacokinetics from textual SmPCs as published by the European Medicines Agency (EMA). The set of variables was iteratively revised and evaluated by data extraction and variable allocation of roughly 7% of all centrally approved drugs. The information contained in the SmPC was allocated to three information clusters consisting of 260 variables. The cluster "drug characterization" specifies the nature of the drug. The cluster "dosage" provides information on approved drug dosages and defines corresponding specific conditions. The cluster "clinical pharmacokinetics" includes pharmacokinetic parameters of relevance for dosing in clinical practice. A first evaluation demonstrated that, despite the complexity of the current free text SmPCs, dosage and pharmacokinetic information can be reliably extracted from the SmPCs and comprehensively described by a limited set of variables. By proposing a compilation of variables well describing drug dosage and clinical pharmacokinetics, the project represents a step forward towards the development of a comprehensive database system serving as information source for sophisticated CDSS.

Patients' perspectives and experiences concerning barriers to accessing information about bilateral prophylactic mastectomy.

PubMed

Glassey, Rachael; O'Connor, Moira; Ives, Angela; Saunders, Christobel; kConFab Investigators; O'Sullivan, Sarah; Hardcastle, Sarah J

2018-05-11

To explore the barriers and experiences of accessing information for women who have received genetic risk assessment/testing results for breast cancer (BC) and are considering a bilateral prophylactic mastectomy (BPM) and, exploring participants' preferences concerning information and support needs. A qualitative retrospective study guided by interpretative phenomenological analysis was utilised. Semi-structured interviews were conducted with forty-six women who were either considering BPM or had already undergone the surgery. Three themes identified barriers to accessing information; difficulties accessing information, inconsistent information and clinical focus/medicalized information. A fourth theme - preferences of information and support needs, identified three subthemes; these were, psychological support, clearly defined processes and photos of mastectomies/reconstruction surgeries. Barriers to accessing information appeared to be widespread. A lack of integrated services contributed to inconsistent information, and medicalized terminology/clinical focus of consultations further complicated understanding. Preferences for information include clearly defined processes, so women know the pathways after confirmation of familial BC risk. Clinical implications include a multidisciplinary team approach, and a protocol that reflects current practice. Copyright © 2018 Elsevier Ltd. All rights reserved.

Advance Care Planning Documentation in Electronic Health Records: Current Challenges and Recommendations for Change.

PubMed

Lamas, Daniela; Panariello, Natalie; Henrich, Natalie; Hammes, Bernard; Hanson, Laura C; Meier, Diane E; Guinn, Nancy; Corrigan, Janet; Hubber, Sean; Luetke-Stahlman, Hannah; Block, Susan

2018-04-01

To develop a set of clinically relevant recommendations to improve the state of advance care planning (ACP) documentation in the electronic health record (EHR). Advance care planning (ACP) is a key process that supports goal-concordant care. For preferences to be honored, clinicians must be able to reliably record, find, and use ACP documentation. However, there are no standards to guide ACP documentation in the electronic health record (EHR). We interviewed 21 key informants to understand the strengths and weaknesses of EHR documentation systems for ACP and identify best practices. We analyzed these interviews using a qualitative content analysis approach and subsequently developed a preliminary set of recommendations. These recommendations were vetted and refined in a second round of input from a national panel of content experts. Informants identified six themes regarding current inadequacies in documentation and accessibility of ACP information and opportunities for improvement. We offer a set of concise, clinically relevant recommendations, informed by expert opinion, to improve the state of ACP documentation in the EHR.

Therapeutic options for HER-2 positive breast cancer: Perspectives and future directions

PubMed Central

Recondo, Gonzalo Jr; Dìaz Canton, Enrique; de la Vega, Màximo; Greco, Martin; Recondo, Gonzalo Sr; Valsecchi, Matias E

2014-01-01

During the last 15 years we have witnessed an unprecedented expansion in the drugs developed to target human epidermal growth factor receptor-2 (HER-2) positive breast cancer. Trastuzumab, pertuzumab, ado-trastuzumab emtansine and lapatinib are currently food and drug administration (FDA)-approved for the treatment of breast cancer patients with HER-2 over-expressed. However, given the amount of information gathered from years of uninterrupted clinical research, it is essential to have periodic updates that succinctly recapitulate what we have learnt over these last years and help us to apply that information in our daily practice. This review will pursue that objective. We will summarize the most relevant and updated information related to the state of the art management of HER-2 positive breast cancer in all the clinical scenarios including the adjuvant, neoadjuvant and metastatic settings. But we will also critically appraise that literature in order to highlight some key clinical concepts that should not be overlooked. Lastly, this review will also point out some of the most promising strategies that are currently being tested and may soon become available. PMID:25114858

Visualizing and Validating Metadata Traceability within the CDISC Standards.

PubMed

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information.

What can Natural Language Processing do for Clinical Decision Support?

PubMed Central

Demner-Fushman, Dina; Chapman, Wendy W.; McDonald, Clement J.

2009-01-01

Computerized Clinical Decision Support (CDS) aims to aid decision making of health care providers and the public by providing easily accessible health-related information at the point and time it is needed. Natural Language Processing (NLP) is instrumental in using free-text information to drive CDS, representing clinical knowledge and CDS interventions in standardized formats, and leveraging clinical narrative. The early innovative NLP research of clinical narrative was followed by a period of stable research conducted at the major clinical centers and a shift of mainstream interest to biomedical NLP. This review primarily focuses on the recently renewed interest in development of fundamental NLP methods and advances in the NLP systems for CDS. The current solutions to challenges posed by distinct sublanguages, intended user groups, and support goals are discussed. PMID:19683066

Visualizing and Validating Metadata Traceability within the CDISC Standards

PubMed Central

Hume, Sam; Sarnikar, Surendra; Becnel, Lauren; Bennett, Dorine

2017-01-01

The Food & Drug Administration has begun requiring that electronic submissions of regulated clinical studies utilize the Clinical Data Information Standards Consortium data standards. Within regulated clinical research, traceability is a requirement and indicates that the analysis results can be traced back to the original source data. Current solutions for clinical research data traceability are limited in terms of querying, validation and visualization capabilities. This paper describes (1) the development of metadata models to support computable traceability and traceability visualizations that are compatible with industry data standards for the regulated clinical research domain, (2) adaptation of graph traversal algorithms to make them capable of identifying traceability gaps and validating traceability across the clinical research data lifecycle, and (3) development of a traceability query capability for retrieval and visualization of traceability information. PMID:28815125

Measuring Workload Demand of Informatics Systems with the Clinical Case Demand Index

PubMed Central

Iyengar, M. Sriram; Rogith, Deevakar; Florez-Arango, Jose F

2017-01-01

Introduction: The increasing use of Health Information Technology (HIT) can add substantially to workload on clinical providers. Current methods for assessing workload do not take into account the nature of clinical cases and the use of HIT tools while solving them. Methods: The Clinical Case Demand Index (CCDI), consisting of a summary score and visual representation, was developed to meet this need. Consistency with current perceived workload measures was evaluated in a Randomized Control Trial of a mobile health system. Results: CCDI is significantly correlated with existing workload measures and inversely related to provider performance. Discussion: CCDI combines subjective and objective characteristics of clinical cases along with cognitive and clinical dimensions. Applications include evaluation of HIT tools, clinician scheduling, medical education. Conclusion: CCDI supports comparative effectiveness research of HIT tools. In addition, CCDI could have numerous applications including training, clinical trials, design of clinical workflows, and others. PMID:29854166

Designing a Clinical Dashboard to Fill Information Gaps in the Emergency Department

PubMed Central

Swartz, Jordan L.; Cimino, James J.; Fred, Matthew R.; Green, Robert A.; Vawdrey, David K.

2014-01-01

Data fragmentation within electronic health records causes gaps in the information readily available to clinicians. We investigated the information needs of emergency medicine clinicians in order to design an electronic dashboard to fill information gaps in the emergency department. An online survey was distributed to all emergency medicine physicians at a large, urban academic medical center. The survey response rate was 48% (52/109). The clinical information items reported to be most helpful while caring for patients in the emergency department were vital signs, electrocardiogram (ECG) reports, previous discharge summaries, and previous lab results. Brief structured interviews were also conducted with 18 clinicians during their shifts in the emergency department. From the interviews, three themes emerged: 1) difficulty accessing vital signs, 2) difficulty accessing point-of-care tests, and 3) difficulty comparing the current ECG with the previous ECG. An emergency medicine clinical dashboard was developed to address these difficulties. PMID:25954420

Designing a clinical dashboard to fill information gaps in the emergency department.

PubMed

Swartz, Jordan L; Cimino, James J; Fred, Matthew R; Green, Robert A; Vawdrey, David K

2014-01-01

Data fragmentation within electronic health records causes gaps in the information readily available to clinicians. We investigated the information needs of emergency medicine clinicians in order to design an electronic dashboard to fill information gaps in the emergency department. An online survey was distributed to all emergency medicine physicians at a large, urban academic medical center. The survey response rate was 48% (52/109). The clinical information items reported to be most helpful while caring for patients in the emergency department were vital signs, electrocardiogram (ECG) reports, previous discharge summaries, and previous lab results. Brief structured interviews were also conducted with 18 clinicians during their shifts in the emergency department. From the interviews, three themes emerged: 1) difficulty accessing vital signs, 2) difficulty accessing point-of-care tests, and 3) difficulty comparing the current ECG with the previous ECG. An emergency medicine clinical dashboard was developed to address these difficulties.

76 FR 31339 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-31

... extension of the currently approved tool for the collection of ambulatory care clinical performance measure...: Medicare Demonstration Ambulatory Care Quality Measure Performance Assessment Tool (``PAT''); Use: This... based system. This system will also provide a platform for developing tools to collect clinical quality...

Text mining of cancer-related information: review of current status and future directions.

PubMed

Spasić, Irena; Livsey, Jacqueline; Keane, John A; Nenadić, Goran

2014-09-01

This paper reviews the research literature on text mining (TM) with the aim to find out (1) which cancer domains have been the subject of TM efforts, (2) which knowledge resources can support TM of cancer-related information and (3) to what extent systems that rely on knowledge and computational methods can convert text data into useful clinical information. These questions were used to determine the current state of the art in this particular strand of TM and suggest future directions in TM development to support cancer research. A review of the research on TM of cancer-related information was carried out. A literature search was conducted on the Medline database as well as IEEE Xplore and ACM digital libraries to address the interdisciplinary nature of such research. The search results were supplemented with the literature identified through Google Scholar. A range of studies have proven the feasibility of TM for extracting structured information from clinical narratives such as those found in pathology or radiology reports. In this article, we provide a critical overview of the current state of the art for TM related to cancer. The review highlighted a strong bias towards symbolic methods, e.g. named entity recognition (NER) based on dictionary lookup and information extraction (IE) relying on pattern matching. The F-measure of NER ranges between 80% and 90%, while that of IE for simple tasks is in the high 90s. To further improve the performance, TM approaches need to deal effectively with idiosyncrasies of the clinical sublanguage such as non-standard abbreviations as well as a high degree of spelling and grammatical errors. This requires a shift from rule-based methods to machine learning following the success of similar trends in biological applications of TM. Machine learning approaches require large training datasets, but clinical narratives are not readily available for TM research due to privacy and confidentiality concerns. This issue remains the main bottleneck for progress in this area. In addition, there is a need for a comprehensive cancer ontology that would enable semantic representation of textual information found in narrative reports. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Atomoxetine pharmacogenetics: associations with pharmacokinetics, treatment response and tolerability.

PubMed

Brown, Jacob T; Bishop, Jeffrey R

2015-01-01

Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder and is predominantly metabolized by the CYP2D6 enzyme. Differences in pharmacokinetic parameters as well as clinical treatment outcomes across CYP2D6 genotype groups have resulted in dosing recommendations within the product label, but clinical studies supporting the use of genotype guided dosing are currently lacking. Furthermore, pharmacokinetic and clinical studies have primarily focused on extensive as compared with poor metabolizers, with little information known about other metabolizer categories as well as genes involved in the pharmacodynamics of atomoxetine. This review describes the pharmacogenetic associations with atomoxetine pharmacokinetics, treatment response and tolerability with considerations for the clinical utility of this information.

Multidisciplinary Modelling of Symptoms and Signs with Archetypes and SNOMED-CT for Clinical Decision Support.

PubMed

Marco-Ruiz, Luis; Maldonado, J Alberto; Karlsen, Randi; Bellika, Johan G

2015-01-01

Clinical Decision Support Systems (CDSS) help to improve health care and reduce costs. However, the lack of knowledge management and modelling hampers their maintenance and reuse. Current EHR standards and terminologies can allow the semantic representation of the data and knowledge of CDSS systems boosting their interoperability, reuse and maintenance. This paper presents the modelling process of respiratory conditions' symptoms and signs by a multidisciplinary team of clinicians and information architects with the help of openEHR, SNOMED and clinical information modelling tools for a CDSS. The information model of the CDSS was defined by means of an archetype and the knowledge model was implemented by means of an SNOMED-CT based ontology.

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs.

PubMed

Tapuria, Archana; Kalra, Dipak; Kobayashi, Shinji

2013-12-01

The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes.

Evidence-based use of electronic clinical tracking systems in advanced practice registered nurse education: an integrative review.

PubMed

Branstetter, M Laurie; Smith, Lynette S; Brooks, Andrea F

2014-07-01

Over the past decade, the federal government has mandated healthcare providers to incorporate electronic health records into practice by 2015. This technological update in healthcare documentation has generated a need for advanced practice RN programs to incorporate information technology into education. The National Organization of Nurse Practitioner Faculties created core competencies to guide program standards for advanced practice RN education. One core competency is Technology and Information Literacy. Educational programs are moving toward the utilization of electronic clinical tracking systems to capture students' clinical encounter data. The purpose of this integrative review was to evaluate current research on advanced practice RN students' documentation of clinical encounters utilizing electronic clinical tracking systems to meet advanced practice RN curriculum outcome goals in information technology as defined by the National Organization of Nurse Practitioner Faculties. The state of the science depicts student' and faculty attitudes, preferences, opinions, and data collections of students' clinical encounters. Although electronic clinical tracking systems were utilized to track students' clinical encounters, these systems have not been evaluated for meeting information technology core competency standards. Educational programs are utilizing electronic clinical tracking systems with limited evidence-based literature evaluating the ability of these systems to meet the core competencies in advanced practice RN programs.

Incarcerated and Court-Involved Adolescents: Counseling an At-Risk Population.

ERIC Educational Resources Information Center

Granello, Paul F.; Hanna, Fred J.

2003-01-01

Discusses background information related to the current state of the juvenile justice system in the United States. Reviews current research regarding juvenile delinquency and outline a series of clinical techniques. Closes by providing a developmental framework for enhancing the understanding of and guiding treatment for this difficult population.…

Use of videos to support teaching and learning of clinical skills in nursing education: A review.

PubMed

Forbes, Helen; Oprescu, Florin I; Downer, Terri; Phillips, Nicole M; McTier, Lauren; Lord, Bill; Barr, Nigel; Alla, Kristel; Bright, Peter; Dayton, Jeanne; Simbag, Vilma; Visser, Irene

2016-07-01

Information and communications technology is influencing the delivery of education in tertiary institutions. In particular, the increased use of videos for teaching and learning clinical skills in nursing may be a promising direction to pursue, yet we need to better document the current research in this area of inquiry. The aim of this paper was to explore and document the current areas of research into the use of videos to support teaching and learning of clinical skills in nursing education. The four main areas of current and future research are effectiveness, efficiency, usage, and quality of videos as teaching and learning materials. While there is a clear need for additional research in the area, the use of videos seems to be a promising, relevant, and increasingly used instructional strategy that could enhance the quality of clinical skills education. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of current and future information technologies on the health care workforce.

PubMed

Masys, Daniel R

2002-01-01

Information technologies have the potential to affect the types and distribution of jobs in the health care workforce. Against a background of an explosively growing body of knowledge in the health sciences, current models of clinical decision making by autonomous practitioners, relying upon their memory and personal experience, will be inadequate for effective twenty-first-century health care delivery. The growth of consumerism and the proliferation of Internet-accessible sources of health-related information will modify the traditional roles of provider and patient and will provide opportunities for new kinds of employment in health-related professions.

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

PubMed Central

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice. PMID:28182155

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. This is an observational study with prospective recruitment (May 2014-May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses. This information has to be accounted for by health managers to define corrective strategies and maximize good clinical practice.

Lung function imaging methods in Cystic Fibrosis pulmonary disease.

PubMed

Kołodziej, Magdalena; de Veer, Michael J; Cholewa, Marian; Egan, Gary F; Thompson, Bruce R

2017-05-17

Monitoring of pulmonary physiology is fundamental to the clinical management of patients with Cystic Fibrosis. The current standard clinical practise uses spirometry to assess lung function which delivers a clinically relevant functional readout of total lung function, however does not supply any visible or localised information. High Resolution Computed Tomography (HRCT) is a well-established current 'gold standard' method for monitoring lung anatomical changes in Cystic Fibrosis patients. HRCT provides excellent morphological information, however, the X-ray radiation dose can become significant if multiple scans are required to monitor chronic diseases such as cystic fibrosis. X-ray phase-contrast imaging is another emerging X-ray based methodology for Cystic Fibrosis lung assessment which provides dynamic morphological and functional information, albeit with even higher X-ray doses than HRCT. Magnetic Resonance Imaging (MRI) is a non-ionising radiation imaging method that is garnering growing interest among researchers and clinicians working with Cystic Fibrosis patients. Recent advances in MRI have opened up the possibilities to observe lung function in real time to potentially allow sensitive and accurate assessment of disease progression. The use of hyperpolarized gas or non-contrast enhanced MRI can be tailored to clinical needs. While MRI offers significant promise it still suffers from poor spatial resolution and the development of an objective scoring system especially for ventilation assessment.

Rationale and methods of the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA).

PubMed

Rodríguez-Artalejo, Fernando; Guallar, Eliseo; Borghi, Claudio; Dallongeville, Jean; De Backer, Guy; Halcox, Julian P; Hernández-Vecino, Ramón; Jiménez, Francisco Javier; Massó-González, Elvira L; Perk, Joep; Steg, Philippe Gabriel; Banegas, José R

2010-06-30

The EURIKA study aims to assess the status of primary prevention of cardiovascular disease (CVD) across Europe. Specifically, it will determine the degree of control of cardiovascular risk factors in current clinical practice in relation to the European guidelines on cardiovascular prevention. It will also assess physicians' knowledge and attitudes about CVD prevention as well as the barriers impeding effective risk factor management in clinical practice. Cross-sectional study conducted simultaneously in 12 countries across Europe. The study has two components: firstly at the physician level, assessing eight hundred and nine primary care and specialist physicians with a daily practice in CVD prevention. A physician specific questionnaire captures information regarding physician demographics, practice settings, cardiovascular prevention beliefs and management. Secondly at the patient level, including 7641 patients aged 50 years or older, free of clinical CVD and with at least one classical risk factor, enrolled by the participating physicians. A patient-specific questionnaire captures information from clinical records and patient interview regarding sociodemographic data, CVD risk factors, and current medications. Finally, each patient provides a fasting blood sample, which is sent to a central laboratory for measuring serum lipids, apolipoproteins, hemoglobin-A1c, and inflammatory biomarkers. Primary prevention of CVD is an extremely important clinical issue, with preventable circulatory diseases remaining the leading cause of major disease burden. The EURIKA study will provide key information to assess effectiveness of and attitudes toward primary prevention of CVD in Europe. A transnational study creates opportunities for benchmarking good clinical practice across countries and improving outcomes. (ClinicalTrials.gov number, NCT00882336).

The Food and Drug Administration and pragmatic clinical trials of marketed medical products

PubMed Central

Anderson, Monique L; Griffin, Joseph; Goldkind, Sara F; Zeitler, Emily P; Wing, Liz; Al-Khatib, Sana M; Sherman, Rachel E

2015-01-01

Pragmatic clinical trials (PCTs) can help answer questions of comparative effectiveness for interventions routinely used in medical practice. PCTs may examine outcomes of one or more marketed medical products, and they are heterogeneous in design and risk. The Food and Drug Administration (FDA) is charged with protecting the rights, safety, and welfare of individuals enrolled in clinical investigations, as well as assuring the integrity upon which approval of medical products are made. The FDA has broad jurisdiction over drugs and medical devices (whether or not they are approved for marketing), and as such, clinical investigations of these products are subject to applicable FDA regulations. While many PCTs will meet the criteria for an exemption from the requirements for an investigational new drug application (IND) or investigational device exemption (IDE), in general all clinical investigations of medical products that fall under FDA jurisdiction must adhere to regulations for informed consent and review by an institutional review board (IRB). We are concerned that current FDA requirements for obtaining individual informed consent may deter or delay the conduct of PCTs intended to develop reliable evidence of comparative safety and effectiveness of approved medical products that are regulated by the FDA. Under current regulations, there are no described mechanisms to alter or waive informed consent to make it less burdensome or more practicable for low-risk PCTs. We recommend that the FDA establish a risk-based approach to obtaining informed consent in PCTs that would facilitate the conduct of PCTs without compromising the protection of enrolled individuals or the integrity of the resulting data. PMID:26374684

Depth of Information Processing and Memory for Medical Facts.

ERIC Educational Resources Information Center

Slade, Peter D.; Onion, Carl W. R.

1995-01-01

The current emphasis in medical education is on engaging learners in deep processing of information to achieve better understanding of the subject matter. Traditional approaches aimed for memorization of medical facts; however, a good memory for medical facts is still essential in clinical practice. This study demonstrates that deep information…

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

PubMed

Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

2013-01-26

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market.

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

PubMed Central

2013-01-01

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. PMID:23351881

Clinical decision guidelines for NHS cosmetic surgery: analysis of current limitations and recommendations for future development.

PubMed

Cook, S A; Rosser, R; Meah, S; James, M I; Salmon, P

2003-07-01

Because of increasing demand for publicly funded elective cosmetic surgery, clinical decision guidelines have been developed to select those patients who should receive it. The aims of this study were to identify: the main characteristics of such guidelines; whether and how they influence clinical decision making; and ways in which they should be improved. UK health authorities were asked for their current guidelines for elective cosmetic surgery and, in a single plastic surgery unit, we examined the impact of its guidelines by observing consultations and interviewing surgeons and managers. Of 115 authorities approached, 32 reported using guidelines and provided sufficient information for analysis. Guidelines mostly concerned arbitrary sets of cosmetic procedures and lacked reference to an evidence base. They allowed surgery for specified anatomical, functional or symptomatic reasons, but these indications varied between guidelines. Most guidelines also permitted surgery 'exceptionally' for psychological reasons. The guidelines that were studied in detail did not appreciably influence surgeons' decisions, which reflected criteria that were not cited in the guidelines, including cost of the procedure and whether patients sought restoration or improvement of their appearance. Decision guidelines in this area have several limitations. Future guidelines should: include all cosmetic procedures; be informed by a broad range of evidence; and, arguably, include several nonclinical criteria that currently inform surgeons' decision-making.

[Inpatient treatment in the addicted patient].

PubMed

Capece, José

2010-01-01

We review the patient hospitalization criteria for Substance Abuse Disorder, taking into account current controversies and the weight of the evidence in the investigation in relation to clinical efficacy and effectiveness. We raise the parameters that mark the 24.455 law on the basic treatment plan from the current data in Argentina, which are inpatient detoxification and residential rehabilitation. We identify the need for detoxification and comprehensive for dual patients rehabilitation centers as peremptory. Criteria are defined according to international validation. We discuss the advantages and disadvantages of hospitalization. Finally, we conclude in the need for a system where devices appropriate epidemiological needs, and that the clinical handle current information.

Supercontinuum ultra-high resolution line-field OCT; experimental spectrograph comparison and comparison with current clinical OCT systems by the imaging of a human cornea

NASA Astrophysics Data System (ADS)

Lawman, Samuel; Romano, Vito; Madden, Peter W.; Mason, Sharon; Williams, Bryan M.; Zheng, Yalin; Shen, Yao-Chun

2018-03-01

Ultra high axial resolution (UHR) was demonstrated early in the development of optical coherence tomography (OCT), but has not yet reached clinical practice. We present the combination of supercontinuum light source and line field (LF-) OCT as a technical and economical route to get UHR-OCT into clinic and other OCT application areas. We directly compare images of a human donor cornea taken with low and high resolution current generation clinical OCT systems with UHR-LF-OCT. These images highlight the massive information increase of UHR-OCT. Application to pharmaceutical pellets, and the functionality and imaging performance of different imaging spectrograph choices for LF- OCT are also demonstrated.

Addressing Low Literacy and Health Literacy in Clinical Oncology Practice

PubMed Central

Garcia, Sofia F.; Hahn, Elizabeth A.; Jacobs, Elizabeth A.

2011-01-01

Low functional literacy and low health literacy continue to be under-recognized and are associated with poorer patient health outcomes. Health literacy is a dynamic state influenced by how well a healthcare system delivers information and services that match patients’ abilities, needs and preferences. Oncology care poses considerable health literacy demands on patients who are expected to process high stakes information about complex multidisciplinary treatment over lengths of time. Much of the information provided to patients in clinical care and research is beyond their literacy levels. In this paper, we provide an overview of currently available guidelines and resources to improve how the needs of patients with diverse literacy skills are met by cancer care providers and clinics. We present recommendations for health literacy assessment in clinical practice and ways to enhance the usability of health information and services by improving written materials and verbal communication, incorporating multimedia and culturally appropriate approaches, and promoting health literacy in cancer care settings. The paper also includes a list of additional resources that can be used to develop and implement health literacy initiatives in cancer care clinics. PMID:20464884

The CTSA Consortium's Catalog of Assets for Translational and Clinical Health Research (CATCHR)

PubMed Central

Mapes, Brandy; Basford, Melissa; Zufelt, Anneliese; Wehbe, Firas; Harris, Paul; Alcorn, Michael; Allen, David; Arnim, Margaret; Autry, Susan; Briggs, Michael S.; Carnegie, Andrea; Chavis‐Keeling, Deborah; De La Pena, Carlos; Dworschak, Doris; Earnest, Julie; Grieb, Terri; Guess, Marilyn; Hafer, Nathaniel; Johnson, Tesheia; Kasper, Amanda; Kopp, Janice; Lockie, Timothy; Lombardo, Vincetta; McHale, Leslie; Minogue, Andrea; Nunnally, Beth; O'Quinn, Deanna; Peck, Kelly; Pemberton, Kieran; Perry, Cheryl; Petrie, Ginny; Pontello, Andria; Posner, Rachel; Rehman, Bushra; Roth, Deborah; Sacksteder, Paulette; Scahill, Samantha; Schieri, Lorri; Simpson, Rosemary; Skinner, Anne; Toussant, Kim; Turner, Alicia; Van der Put, Elaine; Wasser, June; Webb, Chris D.; Williams, Maija; Wiseman, Lori; Yasko, Laurel; Pulley, Jill

2014-01-01

Abstract The 61 CTSA Consortium sites are home to valuable programs and infrastructure supporting translational science and all are charged with ensuring that such investments translate quickly to improved clinical care. Catalog of Assets for Translational and Clinical Health Research (CATCHR) is the Consortium's effort to collect and make available information on programs and resources to maximize efficiency and facilitate collaborations. By capturing information on a broad range of assets supporting the entire clinical and translational research spectrum, CATCHR aims to provide the necessary infrastructure and processes to establish and maintain an open‐access, searchable database of consortium resources to support multisite clinical and translational research studies. Data are collected using rigorous, defined methods, with the resulting information made visible through an integrated, searchable Web‐based tool. Additional easy‐to‐use Web tools assist resource owners in validating and updating resource information over time. In this paper, we discuss the design and scope of the project, data collection methods, current results, and future plans for development and sustainability. With increasing pressure on research programs to avoid redundancy, CATCHR aims to make available information on programs and core facilities to maximize efficient use of resources. PMID:24456567

78 FR 36782 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... relationships between the clinical time spent by physicians and the time that is currently part of the fee... clinical time and fee-schedule time values for surveyed services; (ii) how consistent the relationships are across services and across specialties; (iii) whether the relationships vary across physicians in...

Clinically Significant Change to Establish Benchmarks in Residential Drug and Alcohol Treatment Services

ERIC Educational Resources Information Center

Billingham, Daniel D.; Kelly, Peter J.; Deane, Frank P.; Crowe, Trevor P.; Buckingham, Mark S.; Craig, Fiona L.

2012-01-01

There is increasing emphasis on the use routine outcome assessment measures to inform quality assurance initiatives. The calculation of reliable and clinically significant change indices is one strategy that organizations could use to develop both internal and externally focused benchmarking processes. The current study aimed to develop reliable…

76 FR 53683 - Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-29

... risk-based approach to the oversight of clinical investigations. It does not create or confer any... a range of approaches to monitoring. FDA currently has OMB approval for the information collection... Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or...

Directions in Marriage and Family Therapy, 1994.

ERIC Educational Resources Information Center

Cermele, Debra E., Ed.

1994-01-01

In an effort to help practitioners deal with the great volume of current literature in the field of marriage and family therapy, this compilation attempts to present clinically relevant material in a user-friendly format. Topics selected for inclusion are believed to be up-to-date, informative, and clinically meaningful--as well as theoretically…

Directions in Marriage and Family Therapy: Volume 1.

ERIC Educational Resources Information Center

Directions in Marriage and Family Therapy, 1993

1993-01-01

In an effort to help practitioners deal with the great volume of current literature in the field of marriage and family therapy, this compilation attempts to present clinically relevant material in a user-friendly format. Topics selected for inclusion are believed to be up-to-date, informative, and clinically meaningful--as well as theoretically…

Does My Program Really Make a Difference? Program Evaluation Utilizing Aggregate Single-Subject Data

ERIC Educational Resources Information Center

Burns, Catherine E.

2015-01-01

In the current climate of increasing fiscal and clinical accountability, information is required about overall program effectiveness using clinical data. These requests present a challenge for programs utilizing single-subject data due to the use of highly individualized behavior plans and behavioral monitoring. Subsequently, the diversity of the…

Building a Bridge or Digging a Pipeline? Clinical Data Mining in Evidence-Informed Knowledge Building

ERIC Educational Resources Information Center

Epstein, Irwin

2015-01-01

Challenging the "bridge metaphor" theme of this conference, this article contends that current practice-research integration strategies are more like research-to-practice "pipelines." The purpose of this article is to demonstrate the potential of clinical data-mining studies conducted by practitioners, practitioner-oriented PhD…

How to perform a critical appraisal of diagnostic tests: 7 steps.

PubMed

Chughtai, Aamer; Kelly, Aine Marie; Cronin, Paul

2015-06-01

The critically appraised topic (CAT) is a format in evidence-based practice for sharing information. A CAT is a standardized way of summarizing the most current research evidence focused on a pertinent clinical question. Its aim is to provide both a critique of the most up-to-date retrieved research and an indication of the clinical relevance of results. A clinical question is initially generated following a patient encounter, which leads to and directs a literature search to answer the clinical question. Studies obtained from the literature search are assigned a level of evidence. This allows the most valid and relevant articles to be selected and to be critically appraised. The results are summarized, and this information is translated into clinically useful procedures and processes.

Open Source Clinical NLP - More than Any Single System.

PubMed

Masanz, James; Pakhomov, Serguei V; Xu, Hua; Wu, Stephen T; Chute, Christopher G; Liu, Hongfang

2014-01-01

The number of Natural Language Processing (NLP) tools and systems for processing clinical free-text has grown as interest and processing capability have surged. Unfortunately any two systems typically cannot simply interoperate, even when both are built upon a framework designed to facilitate the creation of pluggable components. We present two ongoing activities promoting open source clinical NLP. The Open Health Natural Language Processing (OHNLP) Consortium was originally founded to foster a collaborative community around clinical NLP, releasing UIMA-based open source software. OHNLP's mission currently includes maintaining a catalog of clinical NLP software and providing interfaces to simplify the interaction of NLP systems. Meanwhile, Apache cTAKES aims to integrate best-of-breed annotators, providing a world-class NLP system for accessing clinical information within free-text. These two activities are complementary. OHNLP promotes open source clinical NLP activities in the research community and Apache cTAKES bridges research to the health information technology (HIT) practice.

Improving the Quality of Informed Consent in Clinical Research with Information Technology.

PubMed

Taber, Celia; Warren, Jim; Day, Karen

2016-01-01

The clinical research industry has yet to fully embrace information technology (IT) for informed consent purposes, even though it is used indispensably in our everyday lives and in other areas of clinical research and healthcare. This paper presents findings of a meta-narrative literature review to discuss the potential for IT to improve the quality of clinical research informed consent. The review reveals three main rationales for including IT in research consent. First, in the current context consent documents frequently fail to be effective decision aids for patients, and the lack of patient centricity in the process. Second, social media provides opportunities for patients to consult with a broader community during research consent to seek broader support, and potential to participate in creating a more patient centric process. Third, multimedia tools provide opportunities for improved patient education, engagement and decision making during research consent. IT offers opportunities to achieve more meaningful research consent, but more research is needed to create an evidence base, policies and economic analyses on the return on investment of using IT in the process.

Evolution of a Patient Information Management System in a Local Area Network Environment at Loyola University of Chicago Medical Center

PubMed Central

Price, Ronald N; Chandrasekhar, Arcot J; Tamirisa, Balaji

1990-01-01

The Department of Medicine at Loyola University Medical Center (LUMC) of Chicago has implemented a local area network (LAN) based Patient Information Management System (PIMS) as part of its integrated departmental database management system. PIMS consists of related database applications encompassing demographic information, current medications, problem lists, clinical data, prior events, and on-line procedure results. Integration into the existing departmental database system permits PIMS to capture and manipulate data in other departmental applications. Standardization of clinical data is accomplished through three data tables that verify diagnosis codes, procedures codes and a standardized set of clinical data elements. The modularity of the system, coupled with standardized data formats, allowed the development of a Patient Information Protocol System (PIPS). PIPS, a userdefinable protocol processor, provides physicians with individualized data entry or review screens customized for their specific research protocols or practice habits. Physician feedback indicates that the PIMS/PIPS combination enhances their ability to collect and review specific patient information by filtering large amount of clinical data.

Translating genomic information into clinical medicine: lung cancer as a paradigm.

PubMed

Levy, Mia A; Lovly, Christine M; Pao, William

2012-11-01

We are currently in an era of rapidly expanding knowledge about the genetic landscape and architectural blueprints of various cancers. These discoveries have led to a new taxonomy of malignant diseases based upon clinically relevant molecular alterations in addition to histology or tissue of origin. The new molecularly based classification holds the promise of rational rather than empiric approaches for the treatment of cancer patients. However, the accelerated pace of discovery and the expanding number of targeted anti-cancer therapies present a significant challenge for healthcare practitioners to remain informed and up-to-date on how to apply cutting-edge discoveries into daily clinical practice. In this Perspective, we use lung cancer as a paradigm to discuss challenges related to translating genomic information into the clinic, and we present one approach we took at Vanderbilt-Ingram Cancer Center to address these challenges.

Running Memory for Clinical Handoffs: A Look at Active and Passive Processing.

PubMed

Anderson-Montoya, Brittany L; Scerbo, Mark W; Ramirez, Dana E; Hubbard, Thomas W

2017-05-01

The goal of the present study was to examine the effects of domain-relevant expertise on running memory and the ability to process handoffs of information. In addition, the role of active or passive processing was examined. Currently, there is little research that addresses how individuals with different levels of expertise process information in running memory when the information is needed to perform a real-world task. Three groups of participants differing in their level of clinical expertise (novice, intermediate, and expert) performed an abstract running memory span task and two tasks resembling real-world activities, a clinical handoff task and an air traffic control (ATC) handoff task. For all tasks, list length and the amount of information to be recalled were manipulated. Regarding processing strategy, all participants used passive processing for the running memory span and ATC tasks. The novices also used passive processing for the clinical task. The experts, however, appeared to use more active processing, and the intermediates fell in between. Overall, the results indicated that individuals with clinical expertise and a developed mental model rely more on active processing of incoming information for the clinical task while individuals with little or no knowledge rely on passive processing. The results have implications about how training should be developed to aid less experienced personnel identify what information should be included in a handoff and what should not.

SANDS: A Service-Oriented Architecture for Clinical Decision Support in a National Health Information Network

PubMed Central

Wright, Adam; Sittig, Dean F.

2008-01-01

In this paper we describe and evaluate a new distributed architecture for clinical decision support called SANDS (Service-oriented Architecture for NHIN Decision Support), which leverages current health information exchange efforts and is based on the principles of a service-oriented architecture. The architecture allows disparate clinical information systems and clinical decision support systems to be seamlessly integrated over a network according to a set of interfaces and protocols described in this paper. The architecture described is fully defined and developed, and six use cases have been developed and tested using a prototype electronic health record which links to one of the existing prototype National Health Information Networks (NHIN): drug interaction checking, syndromic surveillance, diagnostic decision support, inappropriate prescribing in older adults, information at the point of care and a simple personal health record. Some of these use cases utilize existing decision support systems, which are either commercially or freely available at present, and developed outside of the SANDS project, while other use cases are based on decision support systems developed specifically for the project. Open source code for many of these components is available, and an open source reference parser is also available for comparison and testing of other clinical information systems and clinical decision support systems that wish to implement the SANDS architecture. PMID:18434256

Using the diffusion of innovations theory to assess socio-technical factors in planning the implementation of an electronic health record alert across multiple primary care clinics.

PubMed

Lin, Ching-Pin; Guirguis-Blake, Janelle; Keppel, Gina A; Dobie, Sharon; Osborn, Justin; Cole, Allison M; Baldwin, Laura-Mae

2016-04-15

Adverse drug events (ADEs) are a leading cause of death in the United States. Patients with stage 3 and 4 chronic kidney disease (CKD) are at particular risk because many medications are cleared by the kidneys. Alerts in the electronic health record (EHR) about drug appropriateness and dosing at the time of prescription have been shown to reduce ADEs for patients with stage 3 and 4 CKD in inpatient settings, but more research is needed about the implementation and effectiveness of such alerts in outpatient settings.  To explore factors that might inform the implementation of an electronic drug-disease alert for patients with CKD in primary care clinics, using Rogers' diffusion of innovations theory as an analytic framework. Interviews were conducted with key informants in four diverse clinics using various EHR systems. Interviews were audio recorded and transcribed. results Although all clinics had a current method for calculating glomerular filtration rate (GFR), clinics were heterogeneous with regard to current electronic decision support practices, quality improvement resources, and organizational culture and structure. Understanding variation in organizational culture and infrastructure across primary care clinics is important in planning implementation of an intervention to reduce ADEs among patients with CKD.

A computer-based information system for epilepsy and electroencephalography.

PubMed

Finnerup, N B; Fuglsang-Frederiksen, A; Røssel, P; Jennum, P

1999-08-01

This paper describes a standardised computer-based information system for electroencephalography (EEG) focusing on epilepsy. The system was developed using a prototyping approach. It is based on international recommendations for EEG examination, interpretation and terminology, international guidelines for epidemiological studies on epilepsy and classification of epileptic seizures and syndromes and international classification of diseases. It is divided into: (1) clinical information and epilepsy relevant data; and (2) EEG data, which is hierarchically structured including description and interpretation of EEG. Data is coded but is supplemented with unrestricted text. The resulting patient database can be integrated with other clinical databases and with the patient record system and may facilitate clinical and epidemiological research and development of standards and guidelines for EEG description and interpretation. The system is currently used for teleconsultation between Gentofte and Lisbon.

Through the eyes of the Informationist: Identifying information needs of the Breast Imaging Service at a tertiary medical center specializing in cancer.

PubMed

DeRosa, Antonio P; Gibson, Donna S; Morris, Elizabeth A

2017-09-01

The information services offered by Embedded Librarians over the years have led to the more modern-and domain knowledge-specific-role of the Informationist. A 10-point questionnaire was developed and used to interview 12 attending physicians and three fellows chosen at random. The participants are either on the research track (n = 3) or the clinical track (n = 9). A two-part schematic was also created to capture more detailed feedback about the information needs and information-seeking behavior of clinicians regarding patient care (clinical) and research activities. Bibliographic management tool use and time-related factors were also captured in the interviews and written schematics. The role of the Informationist is an emerging, yet valuable one to assigned clinical groups. Clinician's knowledge-base, current awareness, productivity, and evidence-based care can be improved by use of Informationist services.

An approach for the semantic interoperability of ISO EN 13606 and OpenEHR archetypes.

PubMed

Martínez-Costa, Catalina; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás

2010-10-01

The communication between health information systems of hospitals and primary care organizations is currently an important challenge to improve the quality of clinical practice and patient safety. However, clinical information is usually distributed among several independent systems that may be syntactically or semantically incompatible. This fact prevents healthcare professionals from accessing clinical information of patients in an understandable and normalized way. In this work, we address the semantic interoperability of two EHR standards: OpenEHR and ISO EN 13606. Both standards follow the dual model approach which distinguishes information and knowledge, this being represented through archetypes. The solution presented here is capable of transforming OpenEHR archetypes into ISO EN 13606 and vice versa by combining Semantic Web and Model-driven Engineering technologies. The resulting software implementation has been tested using publicly available collections of archetypes for both standards.

Contribution of Clinical Archetypes, and the Challenges, towards Achieving Semantic Interoperability for EHRs

PubMed Central

Kalra, Dipak; Kobayashi, Shinji

2013-01-01

Objectives The objective is to introduce 'clinical archetype' which is a formal and agreed way of representing clinical information to ensure interoperability across and within Electronic Health Records (EHRs). The paper also aims at presenting the challenges building quality labeled clinical archetypes and the challenges towards achieving semantic interoperability between EHRs. Methods Twenty years of international research, various European healthcare informatics projects and the pioneering work of the openEHR Foundation have led to the following results. Results The requirements for EHR information architectures have been consolidated within ISO 18308 and adopted within the ISO 13606 EHR interoperability standard. However, a generic EHR architecture cannot ensure that the clinical meaning of information from heterogeneous sources can be reliably interpreted by receiving systems and services. Therefore, clinical models called 'clinical archetypes' are required to formalize the representation of clinical information within the EHR. Part 2 of ISO 13606 defines how archetypes should be formally represented. The current challenge is to grow clinical communities to build a library of clinical archetypes and to identify how evidence of best practice and multi-professional clinical consensus should best be combined to define archetypes at the optimal level of granularity and specificity and quality label them for wide adoption. Standardizing clinical terms within EHRs using clinical terminology like Systematized Nomenclature of Medicine Clinical Terms is also a challenge. Conclusions Clinical archetypes would play an important role in achieving semantic interoperability within EHRs. Attempts are being made in exploring the design and adoption challenges for clinical archetypes. PMID:24523993

SANDS: a service-oriented architecture for clinical decision support in a National Health Information Network.

PubMed

Wright, Adam; Sittig, Dean F

2008-12-01

In this paper, we describe and evaluate a new distributed architecture for clinical decision support called SANDS (Service-oriented Architecture for NHIN Decision Support), which leverages current health information exchange efforts and is based on the principles of a service-oriented architecture. The architecture allows disparate clinical information systems and clinical decision support systems to be seamlessly integrated over a network according to a set of interfaces and protocols described in this paper. The architecture described is fully defined and developed, and six use cases have been developed and tested using a prototype electronic health record which links to one of the existing prototype National Health Information Networks (NHIN): drug interaction checking, syndromic surveillance, diagnostic decision support, inappropriate prescribing in older adults, information at the point of care and a simple personal health record. Some of these use cases utilize existing decision support systems, which are either commercially or freely available at present, and developed outside of the SANDS project, while other use cases are based on decision support systems developed specifically for the project. Open source code for many of these components is available, and an open source reference parser is also available for comparison and testing of other clinical information systems and clinical decision support systems that wish to implement the SANDS architecture. The SANDS architecture for decision support has several significant advantages over other architectures for clinical decision support. The most salient of these are:

Patient-derived Xenograft (PDX) Models In Basic and Translational Breast Cancer Research

PubMed Central

Dobrolecki, Lacey E.; Airhart, Susie D.; Alferez, Denis G.; Aparicio, Samuel; Behbod, Fariba; Bentires-Alj, Mohamed; Brisken, Cathrin; Bult, Carol J.; Cai, Shirong; Clarke, Robert B.; Dowst, Heidi; Ellis, Matthew J.; Gonzalez-Suarez, Eva; Iggo, Richard D.; Kabos, Peter; Li, Shunqiang; Lindeman, Geoffrey J.; Marangoni, Elisabetta; McCoy, Aaron; Meric-Bernstam, Funda; Piwnica-Worms, Helen; Poupon, Marie-France; Reis-Filho, Jorge; Sartorius, Carol A.; Scabia, Valentina; Sflomos, George; Tu, Yizheng; Vaillant, François; Visvader, Jane E.; Welm, Alana; Wicha, Max S.

2017-01-01

Patient-derived xenograft (PDX) models of a growing spectrum of cancers are rapidly supplanting long-established traditional cell lines as preferred models for conducting basic and translational pre-clinical research. In breast cancer, to complement the now curated collection of approximately 45 long-established human breast cancer cell lines, a newly formed consortium of academic laboratories, currently from Europe, Australia, and North America, herein summarizes data on over 500 stably transplantable PDX models representing all three clinical subtypes of breast cancer (ER+, HER2+, and “Triple-negative” (TNBC)). Many of these models are well-characterized with respect to genomic, transcriptomic, and proteomic features, metastatic behavior, and treatment response to a variety of standard-of-care and experimental therapeutics. These stably transplantable PDX lines are generally available for dissemination to laboratories conducting translational research, and contact information for each collection is provided. This review summarizes current experiences related to PDX generation across participating groups, efforts to develop data standards for annotation and dissemination of patient clinical information that does not compromise patient privacy, efforts to develop complementary data standards for annotation of PDX characteristics and biology, and progress toward “credentialing” of PDX models as surrogates to represent individual patients for use in pre-clinical and co-clinical translational research. In addition, this review highlights important unresolved questions, as well as current limitations, that have hampered more efficient generation of PDX lines and more rapid adoption of PDX use in translational breast cancer research. PMID:28025748

Integrating DXplain into a clinical information system using the World Wide Web.

PubMed

Elhanan, G; Socratous, S A; Cimino, J J

1996-01-01

The World Wide Web(WWW) offers a cross-platform environment and standard protocols that enable integration of various applications available on the Internet. The authors use the Web to facilitate interaction between their Web-based Clinical Information System and a decision-support system-DXplain, at the Massachusetts General Hospital-using local architecture and Common Gateway Interface programs. The current application translates patients laboratory test results into DXplain's terms to generate diagnostic hypotheses. Two different access methods are utilized for this model; Hypertext Transfer Protocol (HTTP) and TCP/IP function calls. While clinical aspects cannot be evaluated as yet, the model demonstrates the potential of Web-based applications for interaction and integration and how local architecture, with a controlled vocabulary server, can further facilitate such integration. This model serves to demonstrate some of the limitations of the current WWW technology and identifies issues such as control over Web resources and their utilization and liability issues as possible obstacles for further integration.

A comparative analysis of the dissemination of best practice measures for key populations.

PubMed

Lundy, Jennifer; Santangelo, Jennifer; Rogers, Patrick; Kuehn, Lynn; Christensen, Sharon; Bournique, Judy; Mekhjian, Hagop; Kamal, Jyoti

2008-11-06

In collaboration with the department of Quality and Operations Improvement, Clinical Applications and the Information Warehouse, we have leveraged available Information Warehouse data to build a Best Practice Compliance Measurement Dashboard. This tool combines information from our operating room charting system, our order entry system and coding information from the patient billing and management system to provide 'previous day', data on a patients current course of treatment.

Where to find information about drugs

PubMed Central

Day, Richard O; Snowden, Leone

2016-01-01

SUMMARY Good medicines information is critical to medical practice. Choose high-quality, pre-appraised sources first and make sure they are current. Select the information that is most relevant to the needs of your particular patient. Take the time to become familiar with the features of the resources you use. Australian Medicines Handbook, Therapeutic Guidelines, Australian Prescriber and NPS MedicineWise cover most routine clinical practice needs. PMID:27346917

Multimethod, Multi-Informant Agreement, and Positive Predictive Value in the Identification of Child Anxiety Disorders Using the SCAS and ADIS-C

ERIC Educational Resources Information Center

Brown-Jacobsen, Amy M.; Wallace, Dustin P.; Whiteside, Stephen P. H.

2011-01-01

The current study sought to provide practical information for the clinical use of child and parent reports of child anxiety symptoms by investigating agreement between parent, child, and clinician as well as the predictive value of this information. Examining 88 anxious children and their parents, the study compared agreement by correlating parent…

An Architecture for Integrated Regional Health Telematics Networks

DTIC Science & Technology

2001-10-25

that enables informed citizens to have an impact on the healthcare system and to be more concerned and care for their own health . The current...resource, educational, integrated electronic health record (I- EHR ), and added value services [2]. These classes of telematic services are applica...cally distributed clinical information systems . 5) Finally, added-value services (e.g. image processing, information indexing, data pre-fetching

"There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

PubMed

Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

2012-01-01

We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

AACR precision medicine series: Highlights of the integrating clinical genomics and cancer therapy meeting.

PubMed

Maggi, Elaine; Montagna, Cristina

2015-12-01

The American Association for Cancer Research (AACR) Precision Medicine Series "Integrating Clinical Genomics and Cancer Therapy" took place June 13-16, 2015 in Salt Lake City, Utah. The conference was co-chaired by Charles L. Sawyers form Memorial Sloan Kettering Cancer Center in New York, Elaine R. Mardis form Washington University School of Medicine in St. Louis, and Arul M. Chinnaiyan from University of Michigan in Ann Arbor. About 500 clinicians, basic science investigators, bioinformaticians, and postdoctoral fellows joined together to discuss the current state of Clinical Genomics and the advances and challenges of integrating Next Generation Sequencing (NGS) technologies into clinical practice. The plenary sessions and panel discussions covered current platforms and sequencing approaches adopted for NGS assays of cancer genome at several national and international institutions, different approaches used to map and classify targetable sequence variants, and how information acquired with the sequencing of the cancer genome is used to guide treatment options. While challenges still exist from a technological perspective, it emerged that there exists considerable need for the development of tools to aid the identification of the therapy most suitable based on the mutational profile of the somatic cancer genome. The process to match patients to ongoing clinical trials is still complex. In addition, the need for centralized data repositories, preferably linked to well annotated clinical records, that aid sharing of sequencing information is central to begin understanding the contribution of variants of unknown significance to tumor etiology and response to therapy. Here we summarize the highlights of this stimulating four-day conference with a major emphasis on the open problems that the clinical genomics community is currently facing and the tools most needed for advancing this field. Copyright © 2015. Published by Elsevier B.V. All rights reserved.

Use of an Information Retrieval Service in an Obstetrics/Gynecology Residency Program.

ERIC Educational Resources Information Center

And Others; Gunning, John E.

1980-01-01

A program that uses the clinical librarian as a member of the patient care team has been developed by an obstetrics and gynecology department of a university medical center to keep faculty and hospital house staff knowledgeable about current developments and research. Program objectives, methodology, costs, evaluation, and information utilization…

76 FR 40933 - Agency Information Collection Activities: Extension of a Currently Approved Collection Semi...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-12

... grants to law school legal clinics, legal aid or legal services programs, domestic violence victims..., Office on Violence Against Women (OVW) will be submitting the following information collection request to... collection, please Cathy Poston, Office on Violence Against Women, at 202-514-5430 or the DOJ Desk Officer at...

The Handbook of Psychiatric Drug Therapy for Children and Adolescents.

ERIC Educational Resources Information Center

Theesen, Karen A.

A compilation of literature and clinical wisdom, this handbook provides the reader with current information on the safety and efficacy of the psychotropic agents in the pediatric population. It lists information on the pharmacokinetics, adverse effects, dosing, and suggested monitoring guidelines for children and adolescents. The guide may also be…

75 FR 34148 - Intent To Request Renewal From OMB of One Current Public Collection of Information; Office of Law...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-16

.../ Federal Air Marshal are required to complete regarding their mental health history. DATES: Send your..., Communications Branch, Business Management Office, Office of Information Technology, TSA-11, Transportation... evaluation determining that they do not have an established medical history or clinical diagnosis of...

75 FR 73111 - Submission for OMB Review; Comment Request; Customer and Other Partners Satisfaction Surveys

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... request displays a currently valid OMB control number. Proposed Collection: Title: Generic Clearance for... Control Number: 0925-0458). Need and Use of Information Collection: The information collected in these... Center customers and other partners with Clinical Center services; (2) to assist with the design of...

When Trust Is Not Enough: A Serial Mediation Model Explaining the Effect of Race Identity, eHealth Information Efficacy, and Information Behavior on Intention to Participate in Clinical Research.

PubMed

Strekalova, Yulia A

2018-02-01

Black participants remain significantly underrepresented in clinical research. Mistrust in medical researchers has been named a key barrier to the successful enrollment of minority study participants. However, trust is a social-interactional construct, and its effects on behavior are complex. This study hypothesized that intention to participate in clinical research is mediated by trust in medical researchers, eHealth literacy, and information seeking behavior. The data were collected through an online survey ( N = 340) and analyzed to identify serial mediation. The model showed insignificant direct effect of race identity on behavioral intention, c' = -0.19, t(335) = -1.22, p = .22, but a significant total effect, c = -0.44, t(335) = -2.59, p < .01. The indirect effect of race identity on behavioral intention was also significant. The positive effect of trust in medical researchers on decisions to participate in clinical research can be amplified by stronger eHealth literacy and active information seeking, which can be supported through focused strategic health education and communication interventions. A focus on the development of information literacy that could provide prospective minority research volunteers with skills for informed decision making should be explored as an option for increasing mindful, informed participation in clinical research among currently underrepresented racial and ethnic groups.

Ethical clinical translation of stem cell interventions for neurologic disease.

PubMed

Cote, David J; Bredenoord, Annelien L; Smith, Timothy R; Ammirati, Mario; Brennum, Jannick; Mendez, Ivar; Ammar, Ahmed S; Balak, Naci; Bolles, Gene; Esene, Ignatius Ngene; Mathiesen, Tiit; Broekman, Marike L

2017-01-17

The application of stem cell transplants in clinical practice has increased in frequency in recent years. Many of the stem cell transplants in neurologic diseases, including stroke, Parkinson disease, spinal cord injury, and demyelinating diseases, are unproven-they have not been tested in prospective, controlled clinical trials and have not become accepted therapies. Stem cell transplant procedures currently being carried out have therapeutic aims, but are frequently experimental and unregulated, and could potentially put patients at risk. In some cases, patients undergoing such operations are not included in a clinical trial, and do not provide genuinely informed consent. For these reasons and others, some current stem cell interventions for neurologic diseases are ethically dubious and could jeopardize progress in the field. We provide discussion points for the evaluation of new stem cell interventions for neurologic disease, based primarily on the new Guidelines for Stem Cell Research and Clinical Translation released by the International Society for Stem Cell Research in May 2016. Important considerations in the ethical translation of stem cells to clinical practice include regulatory oversight, conflicts of interest, data sharing, the nature of investigation (e.g., within vs outside of a clinical trial), informed consent, risk-benefit ratios, the therapeutic misconception, and patient vulnerability. To help guide the translation of stem cells from the laboratory into the neurosurgical clinic in an ethically sound manner, we present an ethical discussion of these major issues at stake in the field of stem cell clinical research for neurologic disease. © 2016 American Academy of Neurology.

Clinical usefulness of library and information services in Japan: The detailed use and value of information in clinical settings.

PubMed

Sakai, Yukiko; Sato, Yoko; Sato, Masae; Watanabe, Makiko

2018-01-01

Considering that there is a lack of evidence regarding the contribution of library and information services to evidence-based medicine in actual clinical practice in Japan, the purpose of the study is to explore the current status of use and value of library and information services in clinical settings to examine the usefulness of information in implementing evidence-based medicine (EBM) into practice. A Web-based survey was conducted at seven sites (hospitals with 300-1,200 beds) and interviews conducted at five sites to investigate information behavior among health professionals (physicians, residents, and nurses) in 2016, replicating the Value Study carried out in the United States in 2010 and 2011. Using a critical incident technique, respondents answered questions about their information topics, information resources used, search location, access points, and evaluation of the information. Analysis from 598 valid responses (275 physicians, 55 residents, and 268 nurses) revealed the characteristics of information use and recognition of the value of information. Physicians and residents showed their information needs regarding clinical care using PubMed (80.4%, 65.5%), Ichushi-Web (61.8%, 63.6%), and UpToDate (40.4%, 65.5%). While physicians rely more on electronic journals (37.8%), residents use more hybrid resources including Japanese print books (38.2%) and online books (30.9% for Japanese, 32.7% for English) to confirm their knowledge. Nurses need more information close to patients and explore a wider variety of information resources such as Japanese print books (60.4%), Ichushi -Web (40.3%), Japanese online books (20.5%), and websites of academic organizations (19.0%). Although the overall recognition of the value of information was relatively modest, concrete changes in clinical practice were found in some areas. Environments with insufficient information and availability of electronic resources should be improved to increase the use of library and information services for implementing EBM.

"People like numbers": a descriptive study of cognitive assessment methods in clinical practice for Aboriginal Australians in the Northern Territory.

PubMed

Dingwall, Kylie M; Pinkerton, Jennifer; Lindeman, Melissa A

2013-01-31

Achieving culturally fair assessments of cognitive functioning for Aboriginal people is difficult due to a scarcity of appropriately validated tools for use with this group. As a result, some Aboriginal people with cognitive impairments may lack fair and equitable access to services. The objective of this study was to examine current clinical practice in the Northern Territory regarding cognitive assessment for Aboriginal people thereby providing some guidance for clinicians new to this practice setting. Qualitative enquiry was used to describe practice context, reasons for assessment, and current practices in assessing cognition for Aboriginal Australians. Semi-structured interviews were conducted with 22 clinicians working with Aboriginal clients in central and northern Australia. Results pertaining to assessment methods are reported. A range of standardised tests were utilised with little consistency across clinical practice. Nevertheless, it was recognised that such tests bear severe limitations, requiring some modification and significant caution in their interpretation. Clinicians relied heavily on informal assessment or observations, contextual information and clinical judgement. Cognitive tests developed specifically for Aboriginal people are urgently needed. In the absence of appropriate, validated tests, clinicians have relied on and modified a range of standardised and informal assessments, whilst recognising the severe limitations of these. Past clinical training has not prepared clinicians adequately for assessing Aboriginal clients, and experience and clinical judgment were considered crucial for fair interpretation of test scores. Interpretation guidelines may assist inexperienced clinicians to consider whether they are achieving fair assessments of cognition for Aboriginal clients.

Echocardiographic strain and strain-rate imaging: a new tool to study regional myocardial function.

PubMed

D'hooge, Jan; Bijnens, Bart; Thoen, Jan; Van de Werf, Frans; Sutherland, George R; Suetens, Paul

2002-09-01

Ultrasonic imaging is the noninvasive clinical imaging modality of choice for diagnosing heart disease. At present, two-dimensional ultrasonic grayscale images provide a relatively cheap, fast, bedside method to study the morphology of the heart. Several methods have been proposed to assess myocardial function. These have been based on either grayscale or motion (velocity) information measured in real-time. However, the quantitative assessment of regional myocardial function remains an important goal in clinical cardiology. To do this, ultrasonic strain and strain-rate imaging have been introduced. In the clinical setting, these techniques currently only allow one component of the true three-dimensional deformation to be measured. Clinical, multidimensional strain (rate) information can currently thus only be obtained by combining data acquired using different transducer positions. Nevertheless, given the appropriate postprocessing, the clinical value of these techniques has already been shown. Moreover, multidimensional strain and strain-rate estimation of the heart in vivo by means of a single ultrasound acquisition has been shown to be feasible. In this paper, the new techniques of ultrasonic strain rate and strain imaging of the heart are reviewed in terms of definitions, data acquisition, strain-rate estimation, postprocessing, and parameter extraction. Their clinical validation and relevance will be discussed using clinical examples on relevant cardiac pathology. Based on these examples, suggestions are made for future developments of these techniques.

Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials

PubMed Central

Federer, Callie; Yoo, Minjae

2016-01-01

Abstract Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov (https://clinicaltrials.gov/), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov. Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs. PMID:27631620

Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.

PubMed

Federer, Callie; Yoo, Minjae; Tan, Aik Choon

2016-12-01

Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov ( https://clinicaltrials.gov/ ), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov . Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs.

Validity of the WISC-IV Spanish for a Clinically Referred Sample of Hispanic Children

ERIC Educational Resources Information Center

San Miguel Montes, Liza E.; Allen, Daniel N.; Puente, Antonio E.; Neblina, Cris

2010-01-01

The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included…

Insider's Guide to Graduate Programs in Clinical and Counseling Psychology. 2006/2007 Edition

ERIC Educational Resources Information Center

Mayne, Tracy J.; Norcross, John C.; Sayette, Michael A.

2006-01-01

Now in its 2006-2007 edition, this perennial bestseller is the resource students count on for the most current information on applying to doctoral programs in clinical or counseling psychology. The Insider's Guide presents up-to-date facts on 300 accredited programs in the United States and Canada. Each program's profile includes admissions…

Hierarchical Commensurate and Power Prior Models for Adaptive Incorporation of Historical Information in Clinical Trials

PubMed Central

Hobbs, Brian P.; Carlin, Bradley P.; Mandrekar, Sumithra J.; Sargent, Daniel J.

2011-01-01

Summary Bayesian clinical trial designs offer the possibility of a substantially reduced sample size, increased statistical power, and reductions in cost and ethical hazard. However when prior and current information conflict, Bayesian methods can lead to higher than expected Type I error, as well as the possibility of a costlier and lengthier trial. This motivates an investigation of the feasibility of hierarchical Bayesian methods for incorporating historical data that are adaptively robust to prior information that reveals itself to be inconsistent with the accumulating experimental data. In this paper, we present several models that allow for the commensurability of the information in the historical and current data to determine how much historical information is used. A primary tool is elaborating the traditional power prior approach based upon a measure of commensurability for Gaussian data. We compare the frequentist performance of several methods using simulations, and close with an example of a colon cancer trial that illustrates a linear models extension of our adaptive borrowing approach. Our proposed methods produce more precise estimates of the model parameters, in particular conferring statistical significance to the observed reduction in tumor size for the experimental regimen as compared to the control regimen. PMID:21361892

Pharmacogenomic Testing for Neuropsychiatric Drugs: Current Status of Drug Labeling, Guidelines for Using Genetic Information, and Test Options

PubMed Central

Drozda, Katarzyna; Müller, Daniel J.; Bishop, Jeffrey R.

2014-01-01

Advancements in pharmacogenomics have introduced an increasing number of opportunities to bring personalized medicine into clinical practice. Understanding how and when to use this technology to help guide pharmacotherapy used to treat neuropsychiatric conditions remains a challenge for many clinicians. Currently, guidelines exist to assist clinicians in the use of genetic information for drug selection and/or dosing for the tricyclic antidepressants, carbamazepine, and phenytoin. Additional language in the product labeling suggests that genetic information may also be useful for assessing the starting and target doses, as well as drug interaction potential, for a number of other medications used to treat psychiatric and neurological conditions. In this review, we outline the current status of pharmacogenomic testing for neuropsychiatric drugs as it pertains to information contained in drug labeling, consensus guidelines, and test panels, as well as considerations related to obtaining tests for patients. PMID:24523097

Enhancing adult learning in clinical supervision.

PubMed

Goldman, Stuart

2011-01-01

For decades, across almost every training site, clinical supervision has been considered "central to the development of skills" in psychiatry. The crucial supervisor/supervisee relationship has been described extensively in the literature, most often framed as a clinical apprenticeship of the novice to the master craftsman. This approach fails to directly incorporate adult-learning theory (ALT), despite a clear literature supporting its superiority. In this article, the author describes the basic principles of ALT, reviewing the limitations of current supervisory practice from the ALT perspective. He then describes system insights gleaned from elements of the manufacturing process and integrates them into a model that enhances ALT-informed approaches to clinical supervision that can be utilized in all settings. Although there are clear benefits of ALT and the proposed "pull" manufacturing management-informed approaches to supervision, there are several anticipated areas of likely resistance: the issues of time for the collaborative goal-setting, monitoring progress, and revising the educational plan. Much of this is already a factor in the current, labor-intensive patterns of individual supervision, and, in practice, even the formal monthly review has, in almost all cases, taken appreciably less than half of a supervisory hour. Any possible increases in time or effort would be more than compensated for by the inherent efficiency of resident-specific teaching and learning. Current supervisory practices can be revised to include principles of ALT and "pull" manufacturing systems that can enhance resident education.

Technology Readiness of Early Career Nurse Trainees: Utilization of the Technology Readiness Index (TRI).

PubMed

Odlum, Michelle

2016-01-01

Health Information Technology (HIT) adoption by clinicians, including nurses, will lead to reduction in healthcare costs and clinical errors and improve health outcomes. Understanding the importance of technology adoption, the current study utilized the Technology Readiness Index to explore technology perceptions of nursing students. Our analysis identifies factors that may influence perceptions of technology, including decreased optimism for students with clinical experience and increased discomfort of US born students. Our study provides insight to inform training programs to further meet the increasing demands of skilled nursing staff.

[Clinical assessment of drug safety].

PubMed

Imbs, J-L; Welsch, M

2007-09-01

The environment of drug safety is changing. In addition to the current system of pharmacovigilance based on spontaneous report of adverse events, clinical data observed in a given patient with a given symptom is taken into consideration and compared with information coming from pharmacovigilance data bases, which is then analyzed for causality by the experts of both the promotor and the public network. Such information is integrated into a risk management strategy, defined together by the French drug agency (Afssaps) and the marketing authorization holder. This strategy includes a pharmacovigilance plan and, if possible, a risk minimisation plan.

HIV Surveillance Among Pregnant Women Attending Antenatal Clinics: Evolution and Current Direction

PubMed Central

Garcia Calleja, Jesus M; Marsh, Kimberly; Zaidi, Irum; Murrill, Christopher; Swaminathan, Mahesh

2017-01-01

Since the late 1980s, human immunodeficiency virus (HIV) sentinel serosurveillance among pregnant women attending select antenatal clinics (ANCs) based on unlinked anonymous testing (UAT) has provided invaluable information for tracking HIV prevalence and trends and informing global and national HIV models in most countries with generalized HIV epidemics. However, increased coverage of HIV testing, prevention of mother-to-child transmission (PMTCT), and antiretroviral therapy has heightened ethical concerns about UAT. PMTCT programs now routinely collect demographic and HIV testing information from the same pregnant women as serosurveillance and therefore present an alternative to UAT-based ANC serosurveillance. This paper reports on the evolution and current direction of the global approach to HIV surveillance among pregnant women attending ANCs, including the transition away from traditional UAT-based serosurveillance and toward new guidance from the World Health Organization and the Joint United Nations Programme on HIV/AIDS on the implementation of surveillance among pregnant women attending ANCs based on routine PMTCT program data. PMID:29208587

Sustainable HIV treatment in Africa through viral-load-informed differentiated care.

PubMed

Phillips, Andrew; Shroufi, Amir; Vojnov, Lara; Cohn, Jennifer; Roberts, Teri; Ellman, Tom; Bonner, Kimberly; Rousseau, Christine; Garnett, Geoff; Cambiano, Valentina; Nakagawa, Fumiyo; Ford, Deborah; Bansi-Matharu, Loveleen; Miners, Alec; Lundgren, Jens D; Eaton, Jeffrey W; Parkes-Ratanshi, Rosalind; Katz, Zachary; Maman, David; Ford, Nathan; Vitoria, Marco; Doherty, Meg; Dowdy, David; Nichols, Brooke; Murtagh, Maurine; Wareham, Meghan; Palamountain, Kara M; Chakanyuka Musanhu, Christine; Stevens, Wendy; Katzenstein, David; Ciaranello, Andrea; Barnabas, Ruanne; Braithwaite, R Scott; Bendavid, Eran; Nathoo, Kusum J; van de Vijver, David; Wilson, David P; Holmes, Charles; Bershteyn, Anna; Walker, Simon; Raizes, Elliot; Jani, Ilesh; Nelson, Lisa J; Peeling, Rosanna; Terris-Prestholt, Fern; Murungu, Joseph; Mutasa-Apollo, Tsitsi; Hallett, Timothy B; Revill, Paul

2015-12-03

There are inefficiencies in current approaches to monitoring patients on antiretroviral therapy in sub-Saharan Africa. Patients typically attend clinics every 1 to 3 months for clinical assessment. The clinic costs are comparable with the costs of the drugs themselves and CD4 counts are measured every 6 months, but patients are rarely switched to second-line therapies. To ensure sustainability of treatment programmes, a transition to more cost-effective delivery of antiretroviral therapy is needed. In contrast to the CD4 count, measurement of the level of HIV RNA in plasma (the viral load) provides a direct measure of the current treatment effect. Viral-load-informed differentiated care is a means of tailoring care so that those with suppressed viral load visit the clinic less frequently and attention is focussed on those with unsuppressed viral load to promote adherence and timely switching to a second-line regimen. The most feasible approach to measuring viral load in many countries is to collect dried blood spot samples for testing in regional laboratories; however, there have been concerns over the sensitivity and specificity of this approach to define treatment failure and the delay in returning results to the clinic. We use modelling to synthesize evidence and evaluate the cost-effectiveness of viral-load-informed differentiated care, accounting for limitations of dried blood sample testing. We find that viral-load-informed differentiated care using dried blood sample testing is cost-effective and is a recommended strategy for patient monitoring, although further empirical evidence as the approach is rolled out would be of value. We also explore the potential benefits of point-of-care viral load tests that may become available in the future.

[Security Management in Clinical Laboratory Departments and Facilities: Current Status and Issues].

PubMed

Ishida, Haku; Nakamura, Junji; Yoshida, Hiroshi; Koike, Masaru; Inoue, Yuji

2014-11-01

We conducted a questionnaire survey regarding the current activities for protecting patients' privacy and the security of information systems (IS) related to the clinical laboratory departments of university hospitals, certified training facilities for clinical laboratories, and general hospitals in Yamaguchi Prefecture. The response rate was 47% from 215 medical institutions, including three commercial clinical laboratory centers. The results showed that there were some differences in management activities among facilities with respect to continuing education, the documentation or regulation of operational management for paper records, electronic information, remaining samples, genetic testing, and laboratory information for secondary use. They were suggested to be caused by differences in functions between university and general hospitals, differences in the scale of hospitals, or whether or not hospitals have received accreditation or ISO 15189. Regarding the IS, although the majority of facilities had sufficiently employed the access control to IS, there was some room for improvement in the management of special cases such as VIPs and patients with HIV infection. Furthermore, there were issues regarding the login method for computers shared by multiple staff, the showing of the names of personnel in charge of reports, and the risks associated with direct connections to systems and the Internet and the use of portable media such as USB memory sticks. These results indicated that further efforts are necessary for each facility to continue self-assessment and make improvements.

Ceramics in Restorative and Prosthetic DENTISTRY1

NASA Astrophysics Data System (ADS)

Kelly, J. Robert

1997-08-01

This review is intended to provide the ceramic engineer with information about the history and current use of ceramics in dentistry, contemporary research topics, and potential research agenda. Background material includes intra-oral design considerations, descriptions of ceramic dental components, and the origin, composition, and microstructure of current dental ceramics. Attention is paid to efforts involving net-shape processing, machining as a forming method, and the analysis of clinical failure. A rationale is presented for the further development of all-ceramic restorative systems. Current research topics receiving attention include microstructure/processing/property relationships, clinical failure mechanisms and in vitro testing, wear damage and wear testing, surface treatments, and microstructural modifications. The status of the field is critically reviewed with an eye toward future work. Significant improvements seem possible in the clinical use of ceramics based on engineering solutions derived from the study of clinically failed restorations, on the incorporation of higher levels of "biomimicry" in new systems, and on the synergistic developments in dental cements and adhesive dentin bonding.

Clinical worthlessness of genetic prediction of common forms of diabetes mellitus and related chronic complications: A position statement of the Italian Society of Diabetology.

PubMed

Buzzetti, R; Prudente, S; Copetti, M; Dauriz, M; Zampetti, S; Garofolo, M; Penno, G; Trischitta, V

2017-02-01

We are currently facing several attempts aimed at marketing genetic data for predicting multifactorial diseases, among which diabetes mellitus is one of the more prevalent. The present document primarily aims at providing to practicing physicians a summary of available data regarding the role of genetic information in predicting diabetes and its chronic complications. Firstly, general information about characteristics and performance of risk prediction tools will be presented in order to help clinicians to get acquainted with basic methodological information related to the subject at issue. Then, as far as type 1 diabetes is concerned, available data indicate that genetic information and counseling may be useful only in families with many affected individuals. However, since no disease prevention is possible, the utility of predicting this form of diabetes is at question. In the case of type 2 diabetes, available data really question the utility of adding genetic information on top of well performing, easy available and inexpensive non-genetic markers. Finally, the possibility of using the few available genetic data on diabetic complications for improving our ability to predict them will also be presented and discussed. For cardiovascular complication, the addition of genetic information to models based on clinical features does not translate in a substantial improvement in risk discrimination. For all other diabetic complications genetic information are currently very poor and cannot, therefore, be used for improving risk stratification. In all, nowadays the use of genetic testing for predicting diabetes and its chronic complications is definitively of little value in clinical practice. Copyright © 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Concepts for NASA longitudinal health studies

NASA Technical Reports Server (NTRS)

Nicogossian, A. E.; Pool, S. L.; Leach, C. S.; Moseley, E.; Rambaut, P. C.

1983-01-01

Clinical data collected from a 15-year study of the homogenous group of pre-Shuttle astronauts have revealed no significant long-term effects from spaceflight. The current hypothesis suggests that repeated exposures to the space environment in the Shuttle era will similarly have no long-term health effects. However, a much more heterogenous group of astronauts and non-astronaut scientists will fly in Shuttle, and data on this group's adaptation to the space environment and readaptation to earth are currently sparse. In addition, very little information is available concerning the short- and long-term medical consequences of long duration exposure to space and subsequent readaptation to the earth environment. In this paper, retrospective clinical information on astronauts is reviewed and concepts for conducting epidemiological studies examining long-term health effects of spaceflight on humans, including associated occupational risks factors, are presented.

Who decides and what are people willing-to-pay for whole genome sequencing information?

PubMed Central

Marshall, DA; Gonzalez, JM; Johnson, FR; MacDonald, KV; Pugh, A; Douglas, MP; Phillips, KA

2016-01-01

PURPOSE Whole genome sequencing (WGS) can be used as a powerful diagnostic tool which could also be used for screening but may generate anxiety, unnecessary testing and overtreatment. Current guidelines suggest reporting clinically actionable secondary findings when diagnostic testing is performed. We estimated preferences for receiving WGS results. METHODS A US nationally representative survey (n=410 adults) was used to rank preferences for who decides (expert panel, your doctor, you) which WGS results are reported. We estimated the value of information about variants with varying levels of clinical usefulness using willingness-to-pay contingent valuation questions. RESULTS 43% preferred to decide themselves what information is included in the WGS report. 38% (95% CI:33–43%) would not pay for actionable variants, and 3% (95% CI:1–5%) would pay more than $1000. 55% (95% CI:50–60%) would not pay for variants in which medical treatment is currently unclear, and 7% (95% CI:5–9%) would pay more than $400. CONCLUSION Most people prefer to decide what WGS results are reported. Despite valuing actionable information more, some respondents perceive that genetic information could negatively impact them. Preference heterogeneity for WGS information should be considered in the development of policies, particularly to integrate patient preferences with personalized medicine and shared decision making. PMID:27253734

A clinical database management system for improved integration of the Veterans Affairs Hospital Information System.

PubMed

Andrews, R D; Beauchamp, C

1989-12-01

The Department of Veterans Affairs (VA) Decentralized Hospital Computer Program (DHCP) contains data modules derived from separate ancillary services (e.g., Lab, Pharmacy and Radiology). It is currently difficult to integrate information between the modules. A prototype is being developed aimed at integrating ancillary data by storing clinical data oriented to the patient so that there is easy interaction of data from multiple services. A set of program utilities provides for user-defined functions of decision support, queries, and reports. Information can be used to monitor quality of care by providing feedback in the form of reports, and reminders. Initial testing has indicated the prototype's design and implementation are feasible (in terms of space requirements, speed, and ease of use) in outpatient and inpatient settings. The design, development, and clinical use of this prototype are described.

Can physicians recognize their own patients in de-identified notes?

PubMed

Meystre, Stéphane; Shen, Shuying; Hofmann, Deborah; Gundlapalli, Adi

2014-01-01

The adoption of Electronic Health Records is growing at a fast pace, and this growth results in very large quantities of patient clinical information becoming available in electronic format, with tremendous potentials, but also equally growing concern for patient confidentiality breaches. De-identification of patient information has been proposed as a solution to both facilitate secondary uses of clinical information, and protect patient information confidentiality. Automated approaches based on Natural Language Processing have been implemented and evaluated, allowing for much faster text de-identification than manual approaches. A U.S. Veterans Affairs clinical text de-identification project focused on investigating the current state of the art of automatic clinical text de-identification, on developing a best-of-breed de-identification application for clinical documents, and on evaluating its impact on subsequent text uses and the risk for re-identification. To evaluate this risk, we de-identified discharge summaries from 86 patients using our 'best-of-breed' text de-identification application with resynthesis of the identifiers detected. We then asked physicians working in the ward the patients were hospitalized in if they could recognize these patients when reading the de-identified documents. Each document was examined by at least one resident and one attending physician, and with 4.65% of the documents, physicians thought they recognized the patient because of specific clinical information, but after verification, none was correctly re-identified.

[Is the structure of surgical clinics in Germany changing? A current investigation into the structure of surgical clinics in the Federal Republic of Germany].

PubMed

Lob, G; Lob, T; Bauer, H; Niethard, F; Polonius, J; Siebert, H

2009-04-01

Medical developments have led to extensive specialization in the field of surgery. This has already been reflected for many years in altered structure and organization forms of surgical clinics. Indispensable quality standards, statutory general conditions, increasing competition in service providers and health insurance with transparency of the service procedure all intensify this trend. The aim of this investigation was, therefore, to determine how far this differentiation of service supply in the field of surgery is also reflected in the area and in surgical departments and clinics of basic and routine supply. To achieve this, all available published information on the structure and organization of surgical clinics in the Federal Republic of Germany was classified according to current departmentalization into "undivided" or general/visceral surgery facilities compared to orthopedic/trauma surgery departments.

Wise Additions Bridge the Gap between Social Psychology and Clinical Practice: Cognitive-Behavioral Therapy as an Exemplar

PubMed Central

Folk, Johanna B.; Disabato, David J.; Goodman, Fallon R.; Carter, Sarah P.; DiMauro, Jennifer C.; Riskind, John H.

2017-01-01

Progress in clinical science, theory, and practice requires the integration of advances from multiple fields of psychology, but much integration remains to be done. The current article seeks to address the specific gap that exists between basic social psychological theories and the implementation of related therapeutic techniques. We propose several “wise additions,” based upon the principles outlined by Walton (2014), intended to bridge current social psychological research with clinical psychological therapeutic practice using cognitive behavioral therapy as an example. We consider how recent advances in social psychological theories can inform the development and implementation of wise additions in clinical case conceptualization and interventions. We specifically focus on self and identity, self-affirmation, transference, social identity, and embodied cognition, five dominant areas of interest in the field that have clear clinical applications. PMID:28919701

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture

PubMed Central

2014-01-01

Background Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Discussion Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients. There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Summary Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner. PMID:24495473

Contemporary issues concerning informed consent in Japan based on a review of court decisions and characteristics of Japanese culture.

PubMed

Masaki, Sakiko; Ishimoto, Hiroko; Asai, Atsushi

2014-02-04

Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture. Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient's best interest, and doing no harm in decision-making for patients.There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features. Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.

Connecting the Nation: Classrooms, Libraries, and Health Care Organizations in the Information Age. Update 1995.

ERIC Educational Resources Information Center

Gonzalez, Emilio

Connecting every classroom, library, hospital, and clinic in the United States to the National Information Infrastructure (NII) is a priority for the Clinton Administration. This document provides a status report on this initiative by drawing from current data regarding Internet connectivity, a benchmark for NII access. Chapter 1 of the report…

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group

PubMed Central

Bleiberg, H.; Decoster, G.; de Gramont, A.; Rougier, P.; Sobrero, A.; Benson, A.; Chibaudel, B.; Douillard, J. Y.; Eng, C.; Fuchs, C.; Fujii, M.; Labianca, R.; Larsen, A. K.; Mitchell, E.; Schmoll, H. J.; Sprumont, D.; Zalcberg, J.

2017-01-01

Background In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results A simplified form of informed consent with the leading part of 1200–1800 words containing all of the key information necessary to meet ethical and regulatory requirements and ‘relevant supportive information appendix’ of 2000–3000 words is provided. Conclusions This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. PMID:28453700

Pediatric post-marketing safety systems in North America: assessment of the current status.

PubMed

McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

2015-08-01

It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

Low emotion-oriented coping and informal help-seeking behaviour as major predictive factors for improvement in major depression at 5-year follow-up in the adult community.

PubMed

Rodgers, S; Vandeleur, C L; Strippoli, M-P F; Castelao, E; Tesic, A; Glaus, J; Lasserre, A M; Müller, M; Rössler, W; Ajdacic-Gross, V; Preisig, M

2017-09-01

Given the broad range of biopsychosocial difficulties resulting from major depressive disorder (MDD), reliable evidence for predictors of improved mental health is essential, particularly from unbiased prospective community samples. Consequently, a broad spectrum of potential clinical and non-clinical predictors of improved mental health, defined as an absence of current major depressive episode (MDE) at follow-up, were examined over a 5-year period in an adult community sample. The longitudinal population-based PsyCoLaus study from the city of Lausanne, Switzerland, was used. Subjects having a lifetime MDD with a current MDE at baseline assessment were selected, resulting in a subsample of 210 subjects. Logistic regressions were applied to the data. Coping styles were the most important predictive factors in the present study. More specifically, low emotion-oriented coping and informal help-seeking behaviour at baseline were associated with the absence of an MDD diagnosis at follow-up. Surprisingly, neither formal help-seeking behaviour, nor psychopharmacological treatment, nor childhood adversities, nor depression subtypes turned out to be relevant predictors in the current study. The paramount role of coping styles as predictors of improvement in depression found in the present study might be a valuable target for resource-oriented therapeutic models. On the one hand, the positive impact of low emotion-oriented coping highlights the utility of clinical interventions interrupting excessive mental ruminations during MDE. On the other hand, the importance of informal social networks raises questions regarding how to enlarge the personal network of affected subjects and on how to best support informal caregivers.

A survey to identify the clinical coding and classification systems currently in use across Europe.

PubMed

de Lusignan, S; Minmagh, C; Kennedy, J; Zeimet, M; Bommezijn, H; Bryant, J

2001-01-01

This is a survey to identify what clinical coding systems are currently in use across the European Union, and the states seeking membership to it. We sought to identify what systems are currently used and to what extent they were subject to local adaptation. Clinical coding should facilitate identifying key medical events in a computerised medical record, and aggregating information across groups of records. The emerging new driver is as the enabler of the life-long computerised medical record. A prerequisite for this level of functionality is the transfer of information between different computer systems. This transfer can be facilitated either by working on the interoperability problems between disparate systems or by harmonising the underlying data. This paper examines the extent to which the latter has occurred across Europe. Literature and Internet search. Requests for information via electronic mail to pan-European mailing lists of health informatics professionals. Coding systems are now a de facto part of health information systems across Europe. There are relatively few coding systems in existence across Europe. ICD9 and ICD 10, ICPC and Read were the most established. However the local adaptation of these classification systems either on a by country or by computer software manufacturer basis; significantly reduces the ability for the meaning coded with patients computer records to be easily transferred from one medical record system to another. There is no longer any debate as to whether a coding or classification system should be used. Convergence of different classifications systems should be encouraged. Countries and computer manufacturers within the EU should be encouraged to stop making local modifications to coding and classification systems, as this practice risks significantly slowing progress towards easy transfer of records between computer systems.

Sustainable HIV Treatment in Africa through Viral Load-Informed Differentiated Care

PubMed Central

Phillips, Andrew; Shroufi, Amir; Vojnov, Lara; Cohn, Jennifer; Roberts, Teri; Ellman, Tom; Bonner, Kimberly; Rousseau, Christine; Garnett, Geoff; Cambiano, Valentina; Nakagawa, Fumiyo; Ford, Deborah; Bansi-Matharu, Loveleen; Miners, Alec; Lundgren, Jens; Eaton, Jeff; Parkes-Ratanshi, Rosalind; Katz, Zachary; Maman, David; Ford, Nathan; Vitoria, Marco; Doherty, Meg; Dowdy, David; Nichols, Brooke; Murtagh, Maurine; Wareham, Meghan; Palamountain, Kara; Musanhu, Christine Chiedza; Stevens, Wendy; Katzenstein, David; Ciaranello, Andrea; Barnabas, Ruanne; Braithwaite, Scott; Bendavid, Eran; Nathoo, Kusum J; van de Vijver, David; Wilson, David; Holmes, Charles; Bershteyn, Anna; Walker, Simon; Raizes, Elliot; Jani, Ilesh; Nelson, Lisa; Peeling, Rosanna; Terris-Prestholt, Fern; Murungu, Joseph; Mutasa-Apollo, Tsitsi; Hallett, Timothy; Revill, Paul

2016-01-01

There are inefficiencies in current approaches to monitoring patients on antiretroviral therapy (ART) in sub-Saharan Africa. Patients typically attend clinics every 1–3 months for clinical assessment, with clinic costs being comparable with costs of drugs themselves, CD4 counts are measured every 6 months, yet patients are rarely switched to second-line therapies. To ensure sustainability of treatment programmes a transition to more cost-effective ART deliver is needed. In contrast to the CD4 count, measurement of the level of HIV RNA in plasma (“viral load”) provides a direct measure of current treatment effect. Viral load informed differentiated care is a means of tailoring care whereby those with suppressed viral load have less frequent clinical visits and attention is paid to those with unsuppressed viral load to promote adherence and timely switching to a second-line regimen. The most feasible approach in many countries to measure viral load is by collecting dried blood spot (DBS) samples for testing in regional laboratories, although there have been concerns over the sensitivity/specificity of DBS to define treatment failure and the delay in receiving results. We use modelling to synthesize available evidence and evaluate the cost-effectiveness of viral load-informed differentiated care, account for limitations of DBS. We find that viral load-informed differentiated care using DBS is expected to be cost-effective and is recommended as the strategy for patient monitoring, although further empirical evidence as the approach is rolled out would be of value. We also explore the potential benefits of future availability of point-of-care (POC) viral load tests. PMID:26633768

Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers

PubMed Central

Calvert, Melanie; Kyte, Derek; Duffy, Helen; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; Ives, Jonathan; Draper, Heather; Brundage, Michael; Blazeby, Jane; King, Madeleine

2014-01-01

Background Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers. Methods and Findings We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency. Conclusions PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care. PMID:25333995

A Semantic Web-based System for Managing Clinical Archetypes.

PubMed

Fernandez-Breis, Jesualdo Tomas; Menarguez-Tortosa, Marcos; Martinez-Costa, Catalina; Fernandez-Breis, Eneko; Herrero-Sempere, Jose; Moner, David; Sanchez, Jesus; Valencia-Garcia, Rafael; Robles, Montserrat

2008-01-01

Archetypes facilitate the sharing of clinical knowledge and therefore are a basic tool for achieving interoperability between healthcare information systems. In this paper, a Semantic Web System for Managing Archetypes is presented. This system allows for the semantic annotation of archetypes, as well for performing semantic searches. The current system is capable of working with both ISO13606 and OpenEHR archetypes.

“There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

PubMed Central

Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak

2012-01-01

Background We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Materials and Methods Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Results Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. Conclusions There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined. PMID:22937106

Health economics in drug development: efficient research to inform healthcare funding decisions.

PubMed

Hall, Peter S; McCabe, Christopher; Brown, Julia M; Cameron, David A

2010-10-01

In order to decide whether a new treatment should be used in patients, a robust estimate of efficacy and toxicity is no longer sufficient. As a result of increasing healthcare costs across the globe healthcare payers and providers now seek estimates of cost-effectiveness as well. Most trials currently being designed still only consider the need for prospective efficacy and toxicity data during the development life-cycle of a new intervention. Hence the cost-effectiveness estimates are inevitably less precise than the clinical data on which they are based. Methods based on decision theory are being developed by health economists that can contribute to the design of clinical trials in such a way that they can more effectively lead to better informed drug funding decisions on the basis of cost-effectiveness in addition to clinical outcomes. There is an opportunity to apply these techniques prospectively in the design of future clinical trials. This article describes the problems encountered by those responsible for drug reimbursement decisions as a consequence of the current drug development pathway. The potential for decision theoretic methods to help overcome these problems is introduced and potential obstacles in implementation are highlighted. Copyright © 2010 Elsevier Ltd. All rights reserved.

Clinical trials needed to evaluate compression therapy in breast cancer related lymphedema (BCRL). Proposals from an expert group.

PubMed

Partsch, H; Stout, N; Forner-Cordero, I; Flour, M; Moffatt, C; Szuba, A; Milic, D; Szolnoky, G; Brorson, H; Abel, M; Schuren, J; Schingale, F; Vignes, S; Piller, N; Döller, W

2010-10-01

A mainstay of lymphedema management involves the use of compression therapy. Compression therapy application is variable at different levels of disease severity. Evidence is scant to direct clinicians in best practice regarding compression therapy use. Further, compression clinical trials are fragmented and poorly extrapolable to the greater population. An ideal construct for conducting clinical trials in regards to compression therapy will promote parallel global initiatives based on a standard research agenda. The purpose of this article is to review current evidence in practice regarding compression therapy for BCRL management and based on this evidence, offer an expert consensus recommendation for a research agenda and prescriptive trials. Recommendations herein focus solely on compression interventions. This document represents the proceedings of a session organized by the International Compression Club (ICC) in June 2009 in Ponzano (Veneto, Italy). The purpose of the meeting was to enable a group of experts to discuss the existing evidence for compression treatment in breast cancer related lymphedema (BCRL) concentrating on areas where randomized controlled trials (RCTs) are lacking. The current body of research suggests efficacy of compression interventions in the treatment and management of lymphedema. However, studies to date have failed to adequately address various forms of compression therapy and their optimal application in BCRL. We offer recommendations for standardized compression research trials for prophylaxis of arm lymphedema and for the management of chronic BCRL. Suggestions are also made regarding; inclusion and exclusion criteria, measurement methodology and additional variables of interest for researchers to capture. This document should inform future research trials in compression therapy and serve as a guide to clinical researchers, industry researchers and lymphologists regarding the strengths, weaknesses and shortcomings of the current literature. By providing this construct for research trials, the authors aim to support evidence-based therapy interventions, promote a cohesive, standardized and informative body of literature to enhance clinical outcomes, improve the quality of future research trials, inform industry innovation and guide policy related to BCRL.

A retrospective investigation of the clinical management of patients attending an out of hours dental clinic in Merseyside under the new NHS dental contract.

PubMed

Tulip, D E; Palmer, N O A

2008-12-20

To investigate the clinical management of patients attending for emergency dental treatment. A retrospective analysis of clinical record cards. Information was collected from patient record cards concerning the patient's reason for attendance and their management at an emergency dental clinic in South Sefton, Liverpool. Over a nine month period, 1,718 patients attended the clinic; 1,472 record cards were analysed. Over 80% of the patients attending the out of hours (OOH) clinic had pain associated with a localised dental infection or dental abscess. Where a diagnosis was recorded, only 67% of patients received appropriate treatment. Over 50% of patients received antibiotics alone with no other definitive treatment provided. The principal antibiotic prescribed for both adult and child patients was amoxicillin. The current study has highlighted that GDPs working within the OOH services are not adhering to current clinical and best practice guidelines with respect to patient examination, diagnosis, management, in particular the correct prescribing of antibiotics for dental infections, and clinical record keeping.

Defining and reconstructing clinical processes based on IHE and BPMN 2.0.

PubMed

Strasser, Melanie; Pfeifer, Franz; Helm, Emmanuel; Schuler, Andreas; Altmann, Josef

2011-01-01

This paper describes the current status and the results of our process management system for defining and reconstructing clinical care processes, which contributes to compare, analyze and evaluate clinical processes and further to identify high cost tasks or stays. The system is founded on IHE, which guarantees standardized interfaces and interoperability between clinical information systems. At the heart of the system there is BPMN, a modeling notation and specification language, which allows the definition and execution of clinical processes. The system provides functionality to define healthcare information system independent clinical core processes and to execute the processes in a workflow engine. Furthermore, the reconstruction of clinical processes is done by evaluating an IHE audit log database, which records patient movements within a health care facility. The main goal of the system is to assist hospital operators and clinical process managers to detect discrepancies between defined and actual clinical processes and as well to identify main causes of high medical costs. Beyond that, the system can potentially contribute to reconstruct and improve clinical processes and enhance cost control and patient care quality.

A window on disease pathogenesis and potential therapeutic strategies: molecular imaging for arthritis

PubMed Central

2011-01-01

Novel molecular imaging techniques are at the forefront of both preclinical and clinical imaging strategies. They have significant potential to offer visualisation and quantification of molecular and cellular changes in health and disease. This will help to shed light on pathobiology and underlying disease processes and provide further information about the mechanisms of action of novel therapeutic strategies. This review explores currently available molecular imaging techniques that are available for preclinical studies with a focus on optical imaging techniques and discusses how current and future advances will enable translation into the clinic for patients with arthritis. PMID:21345267

Molecular testing for cystic fibrosis carrier status practice guidelines: recommendations of the National Society of Genetic Counselors.

PubMed

Langfelder-Schwind, Elinor; Karczeski, Barbara; Strecker, Michelle N; Redman, Joy; Sugarman, Elaine A; Zaleski, Christina; Brown, Trisha; Keiles, Steven; Powers, Amy; Ghate, Sumheda; Darrah, Rebecca

2014-02-01

To provide practice recommendations for genetic counselors whose clients are considering cystic fibrosis (CF) carrier testing or seeking information regarding CF molecular test results. The goals of these recommendations are to: 1) Provide updated information about the natural history, diagnosis, and treatment of CF and related conditions. 2) Supplement genetic counselors' knowledge and understanding of the available carrier screening and diagnostic testing options. 3) Describe the current state of genotype/phenotype correlations for CFTR mutations and an approach to interpreting both novel and previously described variants. 4) Provide a framework for genetic counselors to assist clients' decision-making regarding CF carrier testing, prenatal diagnosis, and pregnancy management. Disclaimer The practice guidelines of the National Society of Genetic Counselors (NSGC) are developed by members of the NSGC to assist genetic counselors and other health care providers in making decisions about appropriate management of genetic concerns; including access to and/or delivery of services. Each practice guideline focuses on a clinical or practice-based issue, and is the result of a review and analysis of current professional literature believed to be reliable. As such, information and recommendations within the NSGC practice guidelines reflect the current scientific and clinical knowledge at the time of publication, are only current as of their publication date, and are subject to change without notice as advances emerge.In addition, variations in practice, which take into account the needs of the individual patient and the resources and limitations unique to the institution or type of practice, may warrant approaches, treatments and/or procedures that differ from the recommendations outlined in this guideline. Therefore, these recommendations should not be construed as dictating an exclusive course of management, nor does the use of such recommendations guarantee a particular outcome. Genetic counseling practice guidelines are never intended to displace a health care provider's best medical judgment based on the clinical circumstances of a particular patient or patient population.Practice guidelines are published by NSGC for educational and informational purposes only, and NSGC does not "approve" or "endorse" any specific methods, practices, or sources of information.

Open Source Clinical NLP – More than Any Single System

PubMed Central

Masanz, James; Pakhomov, Serguei V.; Xu, Hua; Wu, Stephen T.; Chute, Christopher G.; Liu, Hongfang

2014-01-01

The number of Natural Language Processing (NLP) tools and systems for processing clinical free-text has grown as interest and processing capability have surged. Unfortunately any two systems typically cannot simply interoperate, even when both are built upon a framework designed to facilitate the creation of pluggable components. We present two ongoing activities promoting open source clinical NLP. The Open Health Natural Language Processing (OHNLP) Consortium was originally founded to foster a collaborative community around clinical NLP, releasing UIMA-based open source software. OHNLP’s mission currently includes maintaining a catalog of clinical NLP software and providing interfaces to simplify the interaction of NLP systems. Meanwhile, Apache cTAKES aims to integrate best-of-breed annotators, providing a world-class NLP system for accessing clinical information within free-text. These two activities are complementary. OHNLP promotes open source clinical NLP activities in the research community and Apache cTAKES bridges research to the health information technology (HIT) practice. PMID:25954581

State of affairs in use of steroids in diffuse intrinsic pontine glioma: an international survey and a review of the literature.

PubMed

Veldhuijzen van Zanten, Sophie E M; Cruz, Ofelia; Kaspers, Gertjan J L; Hargrave, Darren R; van Vuurden, Dannis G

2016-07-01

Children diagnosed with diffuse intrinsic pontine glioma (DIPG) face a dismal prognosis, with severe neurologic deterioration and inevitable death at a median of 9 months from diagnosis. Steroids are widely prescribed as supportive or palliative treatment although they are known to cause severe side effects that may reduce the quality of life. This study aims to review the current knowledge on, and use of, steroids in DIPG patients. A global questionnaire-study among health care professionals was performed to ascertain information on the current (multi-)institutional and (multi-)national use of steroids, the availability of clinical guidelines, and the need for improvements in prescribing steroids to DIPG patients. In addition, an extensive literature search was performed to review studies investigating steroids in pediatric brain tumor patients. From 150 responding health care professionals, only 7 % had clinical guidelines. The use of steroids was heterogeneous and over 85 % of respondents reported serious side effects. Fourteen articles, with low level of evidence, described the use of steroids in pediatric brain tumor patients. Clinical trials investigating optimal dose or regimen were lacking. This study is a first inventory of the availability of evidence-based information and clinical guidelines, and the current attitude towards the use of steroids in DIPG patients. To date, the risk-benefit ratio of steroids in this disease is yet to be determined. We emphasize the need for clinical trials resulting in guidelines on steroids, and possibly alternative drugs, to optimize the quality of care and quality of life of DIPG patients.

Implications of pharmacogenomics for drug development and clinical practice.

PubMed

Ginsburg, Geoffrey S; Konstance, Richard P; Allsbrook, Jennifer S; Schulman, Kevin A

2005-11-14

Pharmacogenomics is likely to be among the first clinical applications of the Human Genome Project and is certain to have an enormous impact on the clinical practice of medicine. Herein, we discuss the potential implications of pharmacogenomics on the drug development process, including drug safety, productivity, market segmentation, market expansion, differentiation, and personalized health care. We also review 3 challenges facing the translation of pharmacogenomics into clinical practice: dependence on information technology, limited health care financing, and the scientific uncertainty surrounding validation of specific applications of the technology. To our knowledge, there is currently no formal agenda to promote and cultivate innovation, to develop progressive information technology, or to obtain the financing that would be required to advance the use of pharmacogenomic technologies in patient care. Although the potential of these technologies is driving change in the development of clinical sciences, it remains to be seen which health care systems level needs will be addressed.

[Some current threats to confidentiality in medicine].

PubMed

Echeverría B, Carlos; Goic G, Alejandro; Herrera C, Carolina; Quintana V, Carlos; Rojas O, Alberto; Ruiz-Esquide, Gonzalo; Salinas R, Rodrigo; Serani M, Alejandro; Taboada R, Paulina; Vacarezza Y, Ricardo

2015-03-01

Social, technical and legal conditions of the current practice of medicine make it necessary to insist on certain actions and circumstances that may jeopardize the confidentiality of information, offered by patients to their health providers. Therefore, some effects of the current Chilean law are analyzed in this respect, regarding access to data from the clinical record of a patient. Also, the risks of putting certain data on social networking sites are analyzed, as well as some of its effects on clinical practice. The reasons because of mandatory reporting of diseases, meaning danger to public health, is allowed, are mentioned. We also discuss the difficulties involved in managing the results of preventative health screenings and its knowledge by third parties, as well as some possible violations of personal privacy, regarding dissemination of some people health information and its further mention or figuration in mass media. We conclude that it is a must for both physicians and other health team members, to safeguard confidentiality of data to which they have had access, as well as the need to know the relevant law, in order to respect human dignity of patients, each one as a person. We address the attention to the possibility that, practicing in a different way, it could endanger the reliability of clinical records, also impairing the quality of people's health care.

[Local communalization of clinical records between the municipal community hospital and local medical institutes by using information technology].

PubMed

Iijima, Shohei; Shinoki, Keiji; Ibata, Takeshi; Nakashita, Chisako; Doi, Seiko; Hidaka, Kumi; Hata, Akiko; Matsuoka, Mio; Waguchi, Hideko; Mito, Saori; Komuro, Ryutaro

2012-12-01

We introduced the electronic health record system in 2002. We produced a community medical network system to consolidate all medical treatment information from the local institute in 2010. Here, we report on the present status of this system that has been in use for the previous 2 years. We obtained a private server, set up a virtual private network(VPN)in our hospital, and installed dedicated terminals to issue an electronic certificate in 50 local institutions. The local institute applies for patient agreement in the community hospital(hospital designation style). They are then entitled to access the information of the designated patient via this local network server for one year. They can access each original medical record, sorted on the basis of the medical attendant and the chief physician; a summary of hospital stay; records of medication prescription; and the results of clinical examinations. Currently, there are approximately 80 new registrations and accesses per month. Information is provided in real time allowing up to date information, helping prescribe the medical treatment at the local institute. However, this information sharing system is read-only, and there is no cooperative clinical pass system. Therefore, this system has a limit to meet the demand for cooperation with the local clinics.

Leveraging Big Data in Pediatric Development Programs: Proceedings From the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.

PubMed

Mulugeta, Lily Yeruk; Yao, Lynne; Mould, Diane; Jacobs, Brian; Florian, Jeffrey; Smith, Brian; Sinha, Vikram; Barrett, Jeffrey S

2018-01-10

This article discusses the use of big data in pediatric drug development. The article covers key topics discussed at the ACCP annual meeting symposium in 2016 including the extent to which big data or real-world data can inform clinical trial design and substitute for efficacy and safety data typically obtained in clinical trials. The current states of use, opportunities, and challenges with the use of big data in future pediatric drug development are discussed. © 2018 American Society for Clinical Pharmacology and Therapeutics.

Chemotherapy-induced damage to ovary: mechanisms and clinical impact.

PubMed

Bedoschi, Giuliano; Navarro, Paula Andrea; Oktay, Kutluk

2016-10-01

Cancer is a major public health problem around the world. Currently, about 5% of women diagnosed with cancer are of reproductive age. These young survivors may face compromised fertility. The effects of chemotherapeutic agents on ovarian reserve and its clinical consequences are generally inferred from a variety of surrogate markers of ovarian reserve, all aiming to provide prognostic information on fertility or the likelihood of success of infertility treatment. Until recently, the mechanisms that are responsible for chemotherapy-induced ovarian damage were not fully elucidated. The understanding of these mechanisms may lead to targeted treatments to preserve fertility. In this manuscript, we will review the current knowledge on the mechanism of ovarian damage and clinical impact of chemotherapy agents on fertility.

Aerosol Therapy for Obstructive Lung Diseases

PubMed Central

2011-01-01

Inhaled aerosol therapies are the mainstay of treatment of obstructive lung diseases. Aerosol devices deliver drugs rapidly and directly into the airways, allowing high local drug concentrations while limiting systemic toxicity. While numerous clinical trials, literature reviews, and expert panel guidelines inform the choice of inhalational drugs, deciding which aerosol device (ie, metered-dose inhaler, nebulizer, or dry powder inhaler) best suits a given patient and clinical setting can seem arbitrary and confusing. Similar confusion regarding Current Procedural Terminology (CPT) coding for administration of aerosol therapies can lead to lost revenue from underbilling and wasted administrative effort handling denied claims. This article reviews the aerosol devices currently available, discusses their relative merits in various clinical settings, and summarizes appropriate CPT coding for aerosol therapy. PMID:21896522

Percussion use and training: a survey of music therapy clinicians.

PubMed

Scheffel, Stephanie; Matney, Bill

2014-01-01

Percussion instruments are commonly used in music therapy practice; however, the body of published literature regarding music therapy-related percussion training and practice is limited. The purpose of our survey study was to describe: (a) clinician perspectives of their academic percussion training; (b) use of percussion testing during academic training; (c) clinician perspectives on relevance, adequacy, and importance of academic percussion training; (d) clinician perspectives of their nonacademic percussion training; and (e) current use of percussion in clinical practice. Through comparisons of these parameters, we sought to provide information that may inform future percussion use and training. Participants were selected using an email list from the Certification Board for Music Therapists. Board-certified music therapists (MT-BC) were provided with a researcher-created survey about academic percussion training, nonacademic percussion training, and use of percussion in clinical practice. Survey response rate was 14.4% (611/4234). We used demographic data to address potential nonresponse error and ensure population representation for region of residence and region of academic training. Results revealed concerns about perceived adequacy of percussion training received during music therapy education (14.6% reported receiving no academic percussion training; 40.6% reported training was not adequate), and absence of percussion-specific proficiency exams. Of the training received, 62.8% indicated that training was relevant; however, a majority (76.5%) recommended current music therapy students receive more percussion training on instruments and skills most relevant to clinical practice. Comparisons between academic training, perceived needs in academic training, and clinical usage may inform future training and clinical competency. We provide suggestions for developing future training, as well as for furthering clinical implementation and research. © the American Music Therapy Association 2014. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Current pregnancy among women with spinal cord injury: findings from the US national spinal cord injury database.

PubMed

Iezzoni, L I; Chen, Y; McLain, A B J

2015-11-01

Cross-sectional study. To examine the prevalence of pregnancy and associations with sociodemographic and clinical factors among women with spinal cord injury (SCI). US National Spinal Cord Injury Database, an SCI registry that interviews participants 1, 5 and then every 5 years post injury. Data include SCI clinical details, functional impairments, participation measures, depressive symptoms and life satisfaction. Women aged 18-49 are asked about hospitalizations in the last year relating to pregnancy or its complications. Data represent 1907 women, who completed 3054 interviews. We used generalized estimating equations to examine bivariable associations between pregnancy and clinical and psychosocial variables and to perform multivariable regressions predicting pregnancy. Across all women, 2.0% reported pregnancy during the prior 12 months. This annual prevalence differed significantly by the years elapsed since injury; the highest rate occurred 15 years post injury (3.7%). Bivariable analyses found that younger age at injury was significantly associated with current pregnancy (P<0.0001). Compared with nonpregnant women, those reporting current pregnancy were significantly more likely to be married or partnered, have sport-related SCI, have higher motor scores and have more positive psychosocial status scores. Multivariable analyses found significant associations between current pregnancy and age, marital status, motor score and mobility and occupation scale scores. Current pregnancy rates among reproductive-aged women with SCI are similar to rates of other US women with chronic mobility impairments. More information is needed about pregnancy experiences and outcomes to inform both women with SCI seeking childbearing and clinicians providing their care.

[Current situation and development trend of Chinese medicine information research].

PubMed

Dong, Yan; Cui, Meng

2013-04-01

Literature resource service was the main service that Chinese medicine (CM) information offered. But in recent years users have started to request the health information knowledge service. The CM information researches and application service mainly included: (1) the need of strength studies on theory, application of technology, information retrieval, and information standard development; (2) Information studies need to support clinical decision making, new drug research; (3) Quick response based on the network monitoring and support to emergency countermeasures. CM information researches have the following treads: (1) developing the theory system structure of CM information; (2) studying the methodology system of CM information; (3) knowledge discovery and knowledge innovation.

A survey of deans and ADEA activities on dental licensure issues.

PubMed

Ranney, Richard R; Haden, N Karl; Weaver, Richard W; Valachovic, Richard W

2003-10-01

A written survey on issues in clinical testing for licensure was sent to the deans of all dental schools in the United States. Response rate was 89 percent. Results indicate that administrative leaders of the country's dental schools think that third-party evaluation of graduates is appropriate, but they do not have confidence in current clinical tests for licensure. More than nine out of ten respondents indicated that change was needed in current testing procedures, and 82 percent thought the tests as currently conducted were not valid for decision purposes. Regional differences existed among the responses, with the least dissatisfaction occurring in the West. The highest-rated and most frequently mentioned reasons for dissatisfaction with clinical tests were the involvement of patients (human subjects) as currently done. Most respondents favored a national level for licensure tests, although the majority also approved of the recently enacted New York law that permits completion of a postgraduate year in an accredited program to substitute for clinical testing. Respondents indicated a belief that a national database on academic measures as compared to outcomes on clinical licensure tests would be useful, with overall grade point average or class rank as the favored academic measure. Informed by the recommendations of its representatives to the AADE-ADEA Innovative Testing and Educational Methodologies Committee and results of the survey of deans, ADEA is pursuing steps to foster change in the clinical licensure process.

Current facts on pacemaker electromagnetic interference and their application to clinical care

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sager, D.P.

1987-03-01

The development of the sensing demand cardiac pacemaker brought with it the problem of interference as a result of extraneous electric current and electromagnetic fields. This problem still deserves consideration, not only because harmful disruption of pacemaker function, while infrequent, can occur but also because myths and misunderstandings have flourished on the subject. Misinformation has often led to needless patient anxiety and unnecessary restrictions in activities of daily living. Similarly, when health care practitioners are misinformed about pacemaker interference, potentially hazardous situations can occur in the clinical environment. This article is a review of current information on the sources andmore » effects of electromagnetic interference (EMI) on pacemakers and includes a discussion of their application to patient care.« less

Information systems: the key to evidence-based health practice.

PubMed Central

Rodrigues, R. J.

2000-01-01

Increasing prominence is being given to the use of best current evidence in clinical practice and health services and programme management decision-making. The role of information in evidence-based practice (EBP) is discussed, together with questions of how advanced information systems and technology (IS&T) can contribute to the establishment of a broader perspective for EBP. The author examines the development, validation and use of a variety of sources of evidence and knowledge that go beyond the well-established paradigm of research, clinical trials, and systematic literature review. Opportunities and challenges in the implementation and use of IS&T and knowledge management tools are examined for six application areas: reference databases, contextual data, clinical data repositories, administrative data repositories, decision support software, and Internet-based interactive health information and communication. Computerized and telecommunications applications that support EBP follow a hierarchy in which systems, tasks and complexity range from reference retrieval and the processing of relatively routine transactions, to complex "data mining" and rule-driven decision support systems. PMID:11143195

A Window Into Clinical Next-Generation Sequencing-Based Oncology Testing Practices.

PubMed

Nagarajan, Rakesh; Bartley, Angela N; Bridge, Julia A; Jennings, Lawrence J; Kamel-Reid, Suzanne; Kim, Annette; Lazar, Alexander J; Lindeman, Neal I; Moncur, Joel; Rai, Alex J; Routbort, Mark J; Vasalos, Patricia; Merker, Jason D

2017-12-01

- Detection of acquired variants in cancer is a paradigm of precision medicine, yet little has been reported about clinical laboratory practices across a broad range of laboratories. - To use College of American Pathologists proficiency testing survey results to report on the results from surveys on next-generation sequencing-based oncology testing practices. - College of American Pathologists proficiency testing survey results from more than 250 laboratories currently performing molecular oncology testing were used to determine laboratory trends in next-generation sequencing-based oncology testing. - These presented data provide key information about the number of laboratories that currently offer or are planning to offer next-generation sequencing-based oncology testing. Furthermore, we present data from 60 laboratories performing next-generation sequencing-based oncology testing regarding specimen requirements and assay characteristics. The findings indicate that most laboratories are performing tumor-only targeted sequencing to detect single-nucleotide variants and small insertions and deletions, using desktop sequencers and predesigned commercial kits. Despite these trends, a diversity of approaches to testing exists. - This information should be useful to further inform a variety of topics, including national discussions involving clinical laboratory quality systems, regulation and oversight of next-generation sequencing-based oncology testing, and precision oncology efforts in a data-driven manner.

Glenohumeral osteoarthritis: overview, therapy, and rehabilitation.

PubMed

Macías-Hernández, Salvador Israel; Morones-Alba, Juan Daniel; Miranda-Duarte, Antonio; Coronado-Zarco, Roberto; Soria-Bastida, María de Los Angeles; Nava-Bringas, Tania; Cruz-Medina, Eva; Olascoaga-Gómez, Andrea; Tallabs-Almazan, Laura Verónica; Palencia, Chanell

2017-08-01

Glenohumeral osteoarthritis (GHOA) is a common cause of pain and functional disability of the shoulder. Despite the limited evidence, there are several options for the treatment of this pathology. The aim of this article is to provide current information on the characteristics of the disease and the pathophysiology, evidence based on medical and surgical treatments with emphasis on the rehabilitation process. It was performed with an extensive literature review, mainly clinical practice guidelines, randomized controlled trials, reviews, focusing on the rehabilitation management. There are few clinical practice guidelines that address GHOA as a pathology with unique characteristics. Evidence based treatment recommendations are mostly supported by low-quality evidence and experts' opinions, with few high levels of evidence studies guiding treatment decisions. Despite the lack of good quality evidence, rehabilitation programs have proven to be efficient and reliable, and this revision provides information and recommendations in this field. Implication of Rehabilitation Glenohumeral osteoarthritis is a common cause of pain and functional disability of the shoulder There are few clinical practice guidelines that address Glenohumeral Osteoarthritis as a pathology with unique characteristics, and recommendations for rehabilitation and therapeutic exercise are poor The paper provides current information on the characteristics of the disease, its rehabilitation process, and could be of interest for rehabilitation professionals to direct their practices in this field.

Psychopharmacological and Other Treatments in Preschool Children with Attention-Deficit/Hyperactivity Disorder: Current Evidence and Practice

PubMed Central

Arnold, L. Eugene; Anthony, Bruno J.

2008-01-01

Abstract Objective This article reviews rational approaches to treating attention-deficit/hyperactivity disorder (ADHD) in preschool children, including pharmacological and nonpharmacological treatments. Implications for clinical practice are discussed. Data Sources We searched MEDLINE, PsychINFO, Cumulative Index to Nursing & Allied Health, Educational Resources Information Center, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effects for relevant literature published in English from 1967 to 2007 on preschool ADHD. We also reviewed the references cited in identified reports. Study Selection Studies were reviewed if the sample included at least some children younger than 6 years of age or attending kindergarten, the study participants had a diagnosis of ADHD or equivalent symptoms, received intervention aimed at ADHD symptoms, and included a relevant outcome measure. Data Extraction Studies were reviewed for type of intervention and outcome relevant to ADHD and were rated for the level of evidence for adequacy of the data to inform clinical practice. Conclusions The current level of evidence for adequacy of empirical data to inform clinical practice for short-term treatment of ADHD in preschool children is Level A for methylphenidate and Level B for parent behavior training, child training, and additive-free elimination diet. PMID:18844482

Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis

PubMed Central

Thariani, Rahber; Henry, Norah Lynn; Ramsey, Scott D; Blough, David K; Barlow, Bill; Gralow, Julie R; Veenstra, David L

2014-01-01

Background Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. Aim To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II–III breast cancer survivors. Materials & methods We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3–6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. Results The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30–60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. Conclusion Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation. PMID:24236631

Information needs of residents during inpatient and outpatient rotations: identifying effective personal digital assistant applications.

PubMed

Barrett, James R; Strayer, Scott M; Schubart, Jane R

2003-01-01

Last year, we reported (2002 AMIA Proceedings, p 971) on how medical school residents report on their use of personal digital assistants (PDA) or hand held devices. We first surveyed 88 residents in six residency programs representing both generalist and specialist practices (Family Medicine, Internal Medicine, Neurology, Pediatrics, Radiology, and Surgery. Following our survey, we contacted some of these same residents for follow-up advantages and disadvantages of specific software applications, and what information residents would like to have on their PDAs. Our survey and interview results included several specific advantages and disadvantages of PDA usage by residents. Advantages included: (1) many residents readily adapted the personal organizers (calendars. address books, to-do lists) to help keep track of their clinical tasks, and keeping in touch with patients, (2) commercial medical references (such as ePocrates) are used most by the surveyed residents to answer immediate medical questions. Perceived drawbacks include: (1) calculators and patient trackers that were not clearly able to be tailored to residents' needs, e.g., to limit and modify types of calculations to just those actually used, (2) physical size (both too small a display size, and too bulky overall), and (3) several residents mentioned a concern of becoming too dependent on one source of information, a source that was viewed as being too easy to lose or break. Three broad patterns emerged. First, residents in all seven of our surveyed practices use PDAs and most surveyed residents use them on a daily basis; we conclude that PDAs are being widely used across the spectrum of generalist to specialty practices, regardless of whether a residency program specifically encourages PDA usage. Second, security and HIPAA compliance issues need to be addressed, in part by resident education about archiving PDA files. Lastly, PDAs may become even more widely used if clinical data specific to an individual resident can easily and securely be maintained on PDAs. Design of Current Studies Our current study builds on the above perceived needs: we will follow residents during portions of a clinical day. Preliminary observations in three clinical areas (Medical Intensive Care Unit (MICU), General Medicine Outpatient, and Family Medicine Outpatient) confirm the conclusions of our previous study. PDAs are used for: (1) medical references (e.g., five minute clinical consult, Infotriever) (2) pharmaceutical information (such as ePocrates), and (3) professional organization (calendar, address book). Our intention in this new study is to identify the overall flow of information and how PDAs might improve the information flow in clinical settings. We choose to observe residents in both inpatient and outpatient clinics. We anticipate that PDAs will have different uses in these two settings; preliminary observations in one outpatient clinic (Family Medicine) suggests that PDAs are used during the doctor - patient interaction, specifically to suggest the importance of smoking cessation. Preliminary observations in an inpatient clinical setting (the MICU) suggest that PDAs are primarily used outside of patient rooms, e.g. to make medical calculations and to obtain diagnostic procedures. We plan to observe residents during various parts of their days in order to develop a detailed understanding of what information sources (e.g., consultations, computer reports, paper charts) are available at different times and which sources are frequently used. This information will help us develop a pocket-sized, paper-based checksheet that the residents carry with them. The checksheet will help us identify which information sources are used, at various times and frequencies. Interviews with the residents using these checksheets should provide additional details of how utility of the resource, disadvantages of the resource, etc. Specific Goals The goals of our current study include: (1) direct observations of residents PDA usage to determine how this compares to our previous results (above), ts (above), (2) determine if PDA usage varies between outpatient and inpatient clinics, (3) determine how different information sources are used in these clinics. Our long range goal includes considering how PDAs might improve the information gathering processes by identifying useful PDA applications, along with user interfaces residents find intuitive.

Commercial landscape of noninvasive prenatal testing in the United States.

PubMed

Agarwal, Ashwin; Sayres, Lauren C; Cho, Mildred K; Cook-Deegan, Robert; Chandrasekharan, Subhashini

2013-06-01

Cell-free fetal DNA-based noninvasive prenatal testing (NIPT) could significantly change the paradigm of prenatal testing and screening. Intellectual property (IP) and commercialization promise to be important components of the emerging debate about clinical implementation of these technologies. We have assembled information about types of testing, prices, turnaround times, and reimbursement of recently launched commercial tests in the United States from the trade press, news articles, and scientific, legal, and business publications. We also describe the patenting and licensing landscape of technologies underlying these tests and ongoing patent litigation in the United States. Finally, we discuss how IP issues may affect clinical translation of NIPT and their potential implications for stakeholders. Fetal medicine professionals (clinicians and researchers), genetic counselors, insurers, regulators, test developers, and patients may be able to use this information to make informed decisions about clinical implementation of current and emerging noninvasive prenatal tests. © 2013 John Wiley & Sons, Ltd.

Commercial Landscape of noninvasive prenatal testing in the United States

PubMed Central

Agarwal, Ashwin; Sayres, Lauren C.; Cho, Mildred K.; Cook-Deegan, Robert; Chandrasekharan, Subhashini

2014-01-01

Cell-free fetal DNA-based noninvasive prenatal testing (NIPT) could significantly change the paradigm of prenatal testing and screening. Intellectual property (IP) and commercialization promise to be important components of the emerging debate about clinical implementation of these technologies. We have assembled information about types of testing, prices, turnaround times and reimbursement of recently launched commercial tests in the United States from the trade press, news articles, and scientific, legal, and business publications. We also describe the patenting and licensing landscape of technologies underlying these tests and ongoing patent litigation in the United States. Finally, we discuss how IP issues may affect clinical translation of NIPT and their potential implications for stakeholders. Fetal medicine professionals (clinicians and researchers), genetic counselors, insurers, regulators, test developers and patients may be able to use this information to make informed decisions about clinical implementation of current and emerging noninvasive prenatal tests. PMID:23686656

Data Sources for Estimating Environment-Related Diseases

PubMed Central

Walker, Bailus

1984-01-01

Relating current morbidity and mortality to environmental and occupational factors requires information on parameters of environmental exposure for practitioners of medicine and other health scientists. A fundamental source of that information is the exposure history recorded in hospitals, clinics, and other points of entry to the health care system. The qualitative and quantitative aspects of this issue are reviewed. PMID:6716500

Barriers to implementing evidence-based clinical guidelines: A survey of early adopters

PubMed Central

Spallek, Heiko; Song, Mei; Polk, Deborah E; Bekhuis, Tanja; Frantsve-Hawley, Julie; Aravamudhan, Krishna

2010-01-01

Objective The purpose of this study is to identify barriers that early-adopting dentists perceive as common and challenging when implementing recommendations from evidence-based (EB) clinical guidelines. Method This is a cross-sectional study. Dentists who attended the 2008 Evidence-based Dentistry Champion Conference were eligible for inclusion. Forty-three dentists (34%) responded to a 22-item questionnaire administered online. Two investigators independently coded and categorized responses to open-ended items. Descriptive statistics were computed to assess the frequency of barriers and perceived challenges. Results The most common barriers to implementation are difficulty in changing current practice model, resistance and criticism from colleagues, and lack of trust in evidence or research. Barriers perceived as serious problems have to do with lack of up-to-date evidence, lack of clear answers to clinical questions, and contradictory information in the scientific literature. Conclusions Knowledge of barriers will help improve translation of biomedical research for dentists. Information in guidelines needs to be current, clear, and simplified for use at chairside; dentists’ fears need to be addressed. PMID:21093800

Computerized physician order entry from a chief information officer perspective.

PubMed

Cotter, Carole M

2004-12-01

Designing and implementing a computerized physician order entry system in the critical care units of a large urban hospital system is an enormous undertaking. With their significant potential to improve health care and significantly reduce errors, the time for computerized physician order entry or physician order management systems is past due. Careful integrated planning is the key to success, requiring multidisciplinary teams at all levels of clinical and administrative management to work together. Articulated from the viewpoint of the Chief Information Officer of Lifespan, a not-for-profit hospital system in Rhode Island, the vision and strategy preceding the information technology plan, understanding the system's current state, the gap analysis between current and future state, and finally, building and implementing the information technology plan are described.

Applications of Minicomputers to Library and Related Problems. Papers Presented at the 1974 Clinic on Library Applications of Data Processing, April 28-May 1, 1974.

ERIC Educational Resources Information Center

Lancaster, F. Wilfrid, Ed.

More than 100 representatives from various types of libraries attended a clinic on the current and future applications of minicomputers in library operations. Among the library-related problems considered were: (1) circulation and control, (2) cataloging, (3) education and training, (4) information retrieval, (5) acquisitions, and (6) serials…

Perceived Academic Performance, Self-Esteem and Locus of Control as Indicators of Need for Assessment of Adolescent Suicide Risk: Implications for Teachers

ERIC Educational Resources Information Center

Martin, Graham; Richardson, Angela S.; Bergen, Helen A.; Roeger, Leigh; Allison, Stephen

2005-01-01

Introduction: There is currently a need for research into indicators that could be used by non-clinical professionals working with young people, to inform the need for referral for further clinical assessment of those at risk of suicide. Method: Participants of this repeated measures longitudinal study, were 2603, 2485, and 2246 school students…

Evaluation of Smartphone Applications for Cardiopulmonary Resuscitation Training in South Korea

PubMed Central

Cho, Yongtak; Song, Yeongtak; Lim, Tae Ho; Kang, Hyunggoo

2016-01-01

Objective. There are many smartphone-based applications (apps) for cardiopulmonary resuscitation (CPR) training. We investigated the conformity and the learnability/usability of these apps for CPR training and real-life supports. Methods. We conducted a mixed-method, sequential explanatory study to assess CPR training apps downloaded on two apps stores in South Korea. Apps were collected with inclusion criteria as follows, Korean-language instruction, training features, and emergency supports for real-life incidents, and analyzed with two tests; 15 medical experts evaluated the apps' contents according to current Basic Life Support guidelines in conformity test, and 15 nonmedical individuals examined the apps using System Usability Scale (SUS) in the learnability/usability test. Results. Out of 79 selected apps, five apps were included and analyzed. For conformity (ICC, 0.95, p < 0.001), means of all apps were greater than 12 of 20 points, indicating that they were well designed according to current guidelines. Three of the five apps yielded acceptable level (greater than 68 of 100 points) for learnability/usability. Conclusion. All the included apps followed current BLS guidelines and a majority offered acceptable learnability/usability for layperson. Current and developmental smartphone-based CPR training apps should include accurate CPR information and be easy to use for laypersons that are potential rescuers in real-life incidents. For Clinical Trials. This is a clinical trial, registered at the Clinical Research Information Service (CRIS, cris.nih.go.kr), number KCT0001840. PMID:27668257

Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey.

PubMed

Kyte, Derek; Ives, Jonathan; Draper, Heather; Calvert, Melanie

2016-01-01

Assessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal 'PRO alerts': psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management we conducted a national survey of personnel involved in clinical trials with a PRO endpoint. We conducted a national cross-sectional survey of 767 UK-based research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials using PROs. Respondents were self-selected volunteers from a non-randomised sample of eligible individuals recruited via 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Questions centred on the proportion of trial personnel encountering alerts, how staff responded to PRO alerts and whether current guidance was deemed sufficient to support research personnel. We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. 20% of research nurses did not view completed PRO questionnaires and were not in a position to discover alerts, 39-50% of the remaining respondent group participants reported encountering PRO alerts. Of these, 83% of research nurses and 54% of data managers/trial coordinators reported taking action to assist the trial participant, but less than half were able to record the intervention in the trial documentation. Research personnel reported current PRO alert guidance/training was insufficient. Research personnel are intermittently exposed to PRO alerts. Some intervene to help trial participants, but are not able to record this intervention in the trial documentation, risking co-intervention bias. Other staff do not check PRO information during the trial, meaning alerts may remain undiscovered, or do not respond to alerts if they are inadvertently encountered; both of which may impact on patient safety. Guidance is needed to support PRO alert management that protects the interests of trial participants whilst avoiding potential bias.

WE-E-18C-01: Multi-Energy CT: Current Status and Recent Innovations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pelc, N; McCollough, C; Yu, L

2014-06-15

Conventional computed tomography (CT) uses a single polychromatic x-ray spectrum and energy integrating detectors, and produces images whose contrast depends on the effective attenuation coefficient of the broad spectrum beam. This can introduce errors from beam hardening and does not produce the optimal contrast-to-noise ratio. In addition, multiple materials can have the same effective attenuation coefficient, causing different materials to be indistinguishable in conventional CT images. If transmission measurements at two or more energies are obtained, even with polychromatic beams, more specific information about the object can be obtained. If the object does not contain materials with k-edges in themore » spectrum, the x-ray attenuation can be well-approximated by a linear combination of two processes (photoelectric absorption and Compton scattering) or, equivalently, two basis materials. For such cases, two spectral measurements suffice, although additional measurements can provide higher precision. If K-edge materials are present, additional spectral measurements can allow these materials to be isolated. Current commercial implementations use varied approaches, including two sources operating a different kVp, one source whose kVp is rapidly switched in a single scan, and a dual layer detector that can provide spectral information in every reading. Processing of the spectral information can be performed in the raw data domain or in the image domain. The process of calculating the amount of the two basis functions implicitly corrects for beam hardening and therefore can lead to improvements in quantitative accuracy. Information can be extracted to provide material specific information beyond that of conventional CT. This additional information has been shown to be important in several clinical applications, and can also lead to more efficient clinical protocols. Recent innovations in x-ray sources, detectors, and systems have made multi-energy CT much more practical and improved its performance. In addition, this is a very active area of research and further improvements are expected through further technological improvements. Learning Objectives: Basic principles of multi-energy CT Current implementations of mutli-energy CT Data and image analysis methods in multi-energy CT Current clinical applications of dual energy CT5. recent innovations and anticipated advances in multi-energy CT.« less

Cardiac ion channel modulation by the hypoglycaemic agent rosiglitazone.

PubMed

Hancox, J C

2011-06-01

The hypoglycaemic thiazolidinedione rosiglitazone is used clinically in the treatment of type 2 diabetes. However, in 2010, information relating to rosiglitazone-associated increased cardiovascular risk led the European Medicines Agency to recommend suspension of marketing authorizations for rosiglitazone-containing anti-diabetes drugs, while the US Food and Drug Administration recommended significant restriction on the agent's use. Two timely studies in this issue of the British Journal of Phrarmacology provide new information regarding modification of cardiac cellular electrophysiology by rosiglitazone. Szentandrássy et al. demonstrate canine ventricular action potential modification and concentration-dependent suppression of L-type Ca current and of transient outward and rapid delayed rectifier K currents. Jeong et al. demonstrate concentration-dependent inhibition of recombinant K(v) 4.3 channels, providing mechanistic insight into the likely molecular basis of transient outward K current inhibition by the compound. Further studies using diabetic models would be of value to determine whether, in a diabetic setting, rosiglitazone modification of these channels could affect the risk of arrhythmia at clinically relevant drug concentrations. © 2011 The Author. British Journal of Pharmacology © 2011 The British Pharmacological Society.

Prescription Tablets in the Digital Age: A Cross-Sectional Study Exploring Patient and Physician Attitudes Toward the Use of Tablets for Clinic-Based Personalized Health Care Information Exchange

PubMed Central

Palakodeti, Sandeep; Kvedar, Joseph C; Jethwani, Kamal

2015-01-01

Background To reduce the cost of health care while increasing efficiency and quality, health systems are seeking innovative means to engage and empower patients. Improved use of information technology and electronic health record (EHR) infrastructure is essential, and required for “meaningful use” as mandated by the federal government. Providing personalized health information using tablets at the point of care could enhance the clinical experience and enable efficient collection of patient reported outcome measures to guide clinical decision making. Objective The aim of this study is to explore patient and provider attitudes and interest in a proposed clinic-based tablet system for personal health information exchange. To provide a context to understand patients’ use of tablets during their clinic visit, we also examine patients’ current activities and time spent in the waiting room, and their use of health information resources. Methods Surveys were administered to 84 patients in the waiting room of a community health center affiliated with Massachusetts General Hospital (MGH) in Boston, MA. This survey included a vignette and illustration describing a proposed tablet-based system in which the patient, upon sign in at the clinic, receives a tablet loaded with personalized information tailored to their specific medical conditions and preferences. Patients were queried about their interest in such a system in comparison to traditional forms of patient education as well as their current health information seeking behaviors and activities and time spent in the waiting room. Interviews with five MGH-affiliated health care providers were conducted to assess their opinions regarding the proposed tablet system. Results The majority (>60%) of patients were “very” or “extremely” interested in the proposed tablet system and thought it would improve their knowledge about their medical condition (60%), assist them in making healthy choices (57%), and help them to feel more comfortable talking with their provider (55%). Patients thought the system would be more motivating, informative, and engaging than traditional printed health education materials. The tablet system was not considered more effective than face-to-face interaction with providers, though 44% thought it would improve their relationship with their physician. Overall, 91% of respondents were willing to learn how to use a tablet and 75% reported being “very” or “extremely” confident they could use one. Four of the five providers believed that the proposed tablet system would improve clinical workflow and patient education. Patients and providers were concerned about privacy and security of data collected using the tablets. Conclusions Both patients and providers were highly amenable to integrating tablets into the clinical experience, and tablets may be useful in improving patients’ health knowledge, the collection of patient reported outcome measures, and improved patient-provider communication. Further research into operationalizing such systems and their validation is necessary before integration into standard clinical practice. PMID:26481906

Prescription Tablets in the Digital Age: A Cross-Sectional Study Exploring Patient and Physician Attitudes Toward the Use of Tablets for Clinic-Based Personalized Health Care Information Exchange.

PubMed

Patel, Vishal; Hale, Timothy M; Palakodeti, Sandeep; Kvedar, Joseph C; Jethwani, Kamal

2015-10-19

To reduce the cost of health care while increasing efficiency and quality, health systems are seeking innovative means to engage and empower patients. Improved use of information technology and electronic health record (EHR) infrastructure is essential, and required for "meaningful use" as mandated by the federal government. Providing personalized health information using tablets at the point of care could enhance the clinical experience and enable efficient collection of patient reported outcome measures to guide clinical decision making. The aim of this study is to explore patient and provider attitudes and interest in a proposed clinic-based tablet system for personal health information exchange. To provide a context to understand patients' use of tablets during their clinic visit, we also examine patients' current activities and time spent in the waiting room, and their use of health information resources. Surveys were administered to 84 patients in the waiting room of a community health center affiliated with Massachusetts General Hospital (MGH) in Boston, MA. This survey included a vignette and illustration describing a proposed tablet-based system in which the patient, upon sign in at the clinic, receives a tablet loaded with personalized information tailored to their specific medical conditions and preferences. Patients were queried about their interest in such a system in comparison to traditional forms of patient education as well as their current health information seeking behaviors and activities and time spent in the waiting room. Interviews with five MGH-affiliated health care providers were conducted to assess their opinions regarding the proposed tablet system. The majority (>60%) of patients were "very" or "extremely" interested in the proposed tablet system and thought it would improve their knowledge about their medical condition (60%), assist them in making healthy choices (57%), and help them to feel more comfortable talking with their provider (55%). Patients thought the system would be more motivating, informative, and engaging than traditional printed health education materials. The tablet system was not considered more effective than face-to-face interaction with providers, though 44% thought it would improve their relationship with their physician. Overall, 91% of respondents were willing to learn how to use a tablet and 75% reported being "very" or "extremely" confident they could use one. Four of the five providers believed that the proposed tablet system would improve clinical workflow and patient education. Patients and providers were concerned about privacy and security of data collected using the tablets. Both patients and providers were highly amenable to integrating tablets into the clinical experience, and tablets may be useful in improving patients' health knowledge, the collection of patient reported outcome measures, and improved patient-provider communication. Further research into operationalizing such systems and their validation is necessary before integration into standard clinical practice.

How do Medical Radiation Science educators keep up with the [clinical] Joneses?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Giles, Eileen

Medical radiation science (MRS) disciplines include medical imaging, radiation therapy and nuclear medicine. These allied health fields are technology driven and evolving rapidly with regard to imaging and treatment techniques within the clinical environment. This research aims to identify the activities academics are currently participating in to maintain clinical currency and offer strategies to support academics to connect with an ever-changing clinical environment. A cross-sectional designed survey was sampled across the nine Australian universities where MRS programmes are offered. The survey targeted academic teaching staff that were working in MRS programmes at the time of distribution (n ≈ 90). Enablersmore » and barriers to maintaining clinical currency as well as support to participate in continuing professional development were rated by the respondents. Descriptive statistics were used to analyse quantitative data, and free-text comment responses were collated and themed. There were 38 responses to the survey (42%) and all three disciplines were represented. Responses highlighted activities valued by academics as contributing to their knowledge of current practice and as resources to inform their teaching. Positive elements included participating in clinical work and research, attending clinical sites and training days and attending scientific meetings. Common barriers identified by academics in this area were time constraints, workload allocation and employer/financial support. This research has identified that Australian MRS academics participate in a broad range of activities to inform their teaching and maintain knowledge of contemporary clinical practice. A connection with the clinical world is valued highly by academics, however, access and support to maintain that link is often a difficulty and as a result for MRS teaching staff keeping up with the clinical [MRS] Joneses is often a challenge.« less

A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

PubMed

Bleiberg, H; Decoster, G; de Gramont, A; Rougier, P; Sobrero, A; Benson, A; Chibaudel, B; Douillard, J Y; Eng, C; Fuchs, C; Fujii, M; Labianca, R; Larsen, A K; Mitchell, E; Schmoll, H J; Sprumont, D; Zalcberg, J

2017-05-01

In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Smartphone use in dermatology for clinical photography and consultation: Current practice and the law.

PubMed

Abbott, Lisa M; Magnusson, Roger S; Gibbs, Emma; Smith, Saxon D

2018-05-01

Smartphones are rapidly changing the way doctors capture and communicate clinical information, particularly in highly visual specialties such as dermatology. An understanding of how and why smartphones are currently used in clinical practice is critical in order to evaluate professional and legal risks, and to formulate policies that enable safe use of mobile technologies for the maximal benefit of practitioners and patients. Australian dermatologists and dermatology trainees were surveyed on their current practices relating to clinical smartphone use. Of the 105 respondents, 101 provided useable results. The data show clinical smartphone use is common and frequent, with more than 50% of respondents sending and receiving images on their smartphones at least weekly. Clinical photographs were usually sent via multimedia message or email and were commonly stored on smartphones (46%). Security measures adopted to protect data were limited. There was inadequate documentation of consent for transmission of photographs and advice provided. Only 22% of respondents were aware of clear policies in their workplace regarding smartphone use, and a majority desired further education on digital image management. Given the frequency of use and the degree of importance placed on the ability to send and receive clinical images, clinical smartphone use will persist and will likely increase over time. Current practices are insufficient to comply with professional and legal obligations, and increase practitioners' vulnerability to civil and disciplinary proceedings. Further education, realistic policies and adequate software resources are critical to ensure protection of patients, practitioners and the reputation of the dermatological profession. © 2017 The Australasian College of Dermatologists.

The challenges of emerging HISs in bridging the communication gaps among physicians and nurses in China: an interview study.

PubMed

Wen, Dong; Zhang, Xingting; Wan, Jie; Fu, Jing; Lei, Jianbo

2017-06-12

To explore the current situation, existing problems and possible causes of said problems with regards to physician-nurse communication under an environment of increasingly widespread usage of Hospital Information Systems and to seek out new potential strategies in information technology to improve physician-nurse communication. Semi-structured interviews were conducted with 20 physicians and nurses in five leading tertiary grade A hospitals in Beijing, China (two physicians and two nurses in each hospital). The interviews primarily included three aspects comprising the current situation and problems of clinical physician-nurse communication, the application and problems of Hospital Information Systems, and assessments on the improvement of physician-nurse communication through the usage of information technology. The inductive conventional content analysis approach was employed. (1) Physicians and nurses are generally quite satisfied with the current situation of communication. However, the information needs of nurses are prone to being overlooked, and the communication methods are primarily synchronous communication such as face-to-face and phone communication. (2) Hospital Information Systems are gradually being used for physician-nurse communication; in the meantime, physicians and nurses face challenges with regards to the improvement of physician-nurse communication through the usage of information technology. Challenges differ based on the different stages of using the system and the different levels of understanding of physicians and nurses towards information technology. Their dissatisfaction mainly deals with system errors and the level of convenience in using the system. (3) In-depth interviews found that in general, physicians and nurses have a strong interest and trust in improving physician-nurse communication through appropriate information technology, e.g., communication methods such as information reminders for physicians and nurses through mobile devices and instant voice-to-text conversion methods. There are objective risks in physician-nurse communication in Chinese hospitals, and clinical information systems lack solutions to the relevant problems. Developing a dedicated, mobile, quick and convenient module for physician-nurse communication within existing hospital information system with automatic reminders for important information that segregates between synchronous and asynchronous communication according to the different types of information could help improve physician-nurse communication.

Biotechnology Computing: Information Science for the Era of Molecular Medicine.

ERIC Educational Resources Information Center

Masys, Daniel R.

1989-01-01

The evolution from classical genetics to biotechnology, an area of research involving key macromolecules in living cells, is chronicled and the current state of biotechnology is described, noting related advances in computing and clinical medicine. (MSE)

Genetics of non-conventional lipoprotein fractions

USDA-ARS?s Scientific Manuscript database

Lipoprotein subclass measures associate with cardiometabolic disease risk. Currently the information that lipoproteins convey on disease risk over that of traditional demographic and lipid measures is minimal, and so their use is clinics is limited. However, lipoprotein subclass perturbations repres...

Health information technology adoption in New Zealand optometric practices.

PubMed

Heidarian, Ahmadali; Mason, David

2013-11-01

Health information technology (HIT) has the potential to fundamentally change the practice of optometry and the relationship between optometrists and patients and to improve clinical outcomes. This paper aims to provide data on how health information technology is currently being used in New Zealand optometric practices. Also this paper aims to explore the potential benefits and barriers to the future adoption of health information technology in New Zealand. One hundred and six New Zealand optometrists were surveyed about their current use of health information technology and about potential benefits and barriers. In addition, 12 semi-structured interviews were carried out with leaders of health information technology in New Zealand optometry. The areas of interest were the current and intended use of HIT, the potential benefits of and barriers to using HIT in optometric offices and the level of investment in health information technology. Nearly all optometrists (98.7 per cent) in New Zealand use computers in their practices and 93.4 per cent of them use a computer in their consulting room. The most commonly used clinical assessment technology in optometric practices in New Zealand was automated perimeter (97.1 per cent), followed by a digital fundus/retinal camera (82.6 per cent) and automated lensometer (62.9 per cent). The pachymeter is the technology that most respondents intended to purchase in the next one to five years (42.6 per cent), followed by a scanning laser ophthalmoscope (36.8 per cent) and corneal topographer (32.9 per cent). The main benefits of using health information technology in optometric practices were improving patient perceptions of ‘state of the art’ practice and providing patients with information and digital images to explain the results of assessment. Barriers to the adoption of HIT included the need for frequent technology upgrades, cost, lack of time for implementation, and training. New Zealand optometrists are using HIT broadly in their practices and expect HIT use to increase over time.

What are people willing to pay for whole-genome sequencing information, and who decides what they receive?

PubMed

Marshall, Deborah A; Gonzalez, Juan Marcos; Johnson, F Reed; MacDonald, Karen V; Pugh, Amy; Douglas, Michael P; Phillips, Kathryn A

2016-12-01

Whole-genome sequencing (WGS) can be used as a powerful diagnostic tool as well as for screening, but it may lead to anxiety, unnecessary testing, and overtreatment. Current guidelines suggest reporting clinically actionable secondary findings when diagnostic testing is performed. We examined preferences for receiving WGS results. A US nationally representative survey (n = 410 adults) was used to rank preferences for who decides (an expert panel, your doctor, you) which WGS results are reported. We estimated the value of information about variants with varying levels of clinical usefulness by using willingness to pay contingent valuation questions. The results were as follows: 43% preferred to decide themselves what information is included in the WGS report. 38% (95% confidence interval (CI): 33-43%) would not pay for actionable variants, and 3% (95% CI: 1-5%) would pay more than $1,000. 55% (95% CI: 50-60%) would not pay for variants for which medical treatment is currently unclear, and 7% (95% CI: 5-9%) would pay more than $400. Most people prefer to decide what WGS results are reported. Despite valuing actionable information more, some respondents perceive that genetic information could negatively impact them. Preference heterogeneity for WGS information should be considered in the development of policies, particularly to integrate patient preferences with personalized medicine and shared decision making.Genet Med 18 12, 1295-1302.

A machine learning based approach to identify protected health information in Chinese clinical text.

PubMed

Du, Liting; Xia, Chenxi; Deng, Zhaohua; Lu, Gary; Xia, Shuxu; Ma, Jingdong

2018-08-01

With the increasing application of electronic health records (EHRs) in the world, protecting private information in clinical text has drawn extensive attention from healthcare providers to researchers. De-identification, the process of identifying and removing protected health information (PHI) from clinical text, has been central to the discourse on medical privacy since 2006. While de-identification is becoming the global norm for handling medical records, there is a paucity of studies on its application on Chinese clinical text. Without efficient and effective privacy protection algorithms in place, the use of indispensable clinical information would be confined. We aimed to (i) describe the current process for PHI in China, (ii) propose a machine learning based approach to identify PHI in Chinese clinical text, and (iii) validate the effectiveness of the machine learning algorithm for de-identification in Chinese clinical text. Based on 14,719 discharge summaries from regional health centers in Ya'an City, Sichuan province, China, we built a conditional random fields (CRF) model to identify PHI in clinical text, and then used the regular expressions to optimize the recognition results of the PHI categories with fewer samples. We constructed a Chinese clinical text corpus with PHI tags through substantial manual annotation, wherein the descriptive statistics of PHI manifested its wide range and diverse categories. The evaluation showed with a high F-measure of 0.9878 that our CRF-based model had a good performance for identifying PHI in Chinese clinical text. The rapid adoption of EHR in the health sector has created an urgent need for tools that can parse patient specific information from Chinese clinical text. Our application of CRF algorithms for de-identification has shown the potential to meet this need by offering a highly accurate and flexible solution to analyzing Chinese clinical text. Copyright © 2018 Elsevier B.V. All rights reserved.

Pharmacogenetics in Cardiovascular Medicine

PubMed Central

Tuteja, Sony; Limdi, Nita

2017-01-01

Purpose of review Pharmacogenetics is an important component of precision medicine. Even within the genomic era, several challenges lie ahead in the road towards clinical implementation of pharmacogenetics in the clinic. This review will summarize the current state of knowledge regarding pharmacogenetics of cardiovascular drugs, focusing on those with the most evidence supporting clinical implementation- clopidogrel, warfarin and simvastatin. Recent findings There is limited translation of pharmacogenetics into clinical practice primarily due to the absence of outcomes data from prospective, randomized, genotype-directed clinical trials. There are several ongoing randomized controlled trials that will provide some answers as to the clinical utility of genotype-directed strategies. Several academic medical centers have pushed towards clinical implementation where the clinical validity data are strong. Their experiences will inform operational requirements of a clinical pharmacogenetics testing including the timing of testing, incorporation of test results into the electronic health record, reimbursement and ethical issues. Summary Pharmacogenetics of clopidogrel, warfarin and simvastatin are three examples where pharmacogenetics testing may provide added clinical value. Continued accumulation of evidence surrounding clinical utility of pharmacogenetics markers is imperative as this will inform reimbursement policy and drive adoption of pharamcogenetics into routine care. PMID:29057167

Optimization-based reconstruction for reduction of CBCT artifact in IGRT

NASA Astrophysics Data System (ADS)

Xia, Dan; Zhang, Zheng; Paysan, Pascal; Seghers, Dieter; Brehm, Marcus; Munro, Peter; Sidky, Emil Y.; Pelizzari, Charles; Pan, Xiaochuan

2016-04-01

Kilo-voltage cone-beam computed tomography (CBCT) plays an important role in image guided radiation therapy (IGRT) by providing 3D spatial information of tumor potentially useful for optimizing treatment planning. In current IGRT CBCT system, reconstructed images obtained with analytic algorithms, such as FDK algorithm and its variants, may contain artifacts. In an attempt to compensate for the artifacts, we investigate optimization-based reconstruction algorithms such as the ASD-POCS algorithm for potentially reducing arti- facts in IGRT CBCT images. In this study, using data acquired with a physical phantom and a patient subject, we demonstrate that the ASD-POCS reconstruction can significantly reduce artifacts observed in clinical re- constructions. Moreover, patient images reconstructed by use of the ASD-POCS algorithm indicate a contrast level of soft-tissue improved over that of the clinical reconstruction. We have also performed reconstructions from sparse-view data, and observe that, for current clinical imaging conditions, ASD-POCS reconstructions from data collected at one half of the current clinical projection views appear to show image quality, in terms of spatial and soft-tissue-contrast resolution, higher than that of the corresponding clinical reconstructions.

Current State of Dental Education: Executive Summary.

PubMed

Formicola, Allan J

2017-08-01

This executive summary for Section 1 of the "Advancing Dental Education in the 21 st Century" project provides a composite picture of information from 12 background articles on the current state of dental education in the United States. The summary includes the following topics: the current status of the dental curriculum, the implications of student debt and dental school finances, the expansion of enrollment, student diversity, pre- and postdoctoral education, safety net status of dental school clinics, and trends in faculty.

A high-throughput colorimetric assay for glucose detection based on glucose oxidase-catalyzed enlargement of gold nanoparticles

NASA Astrophysics Data System (ADS)

Xiong, Yanmei; Zhang, Yuyan; Rong, Pengfei; Yang, Jie; Wang, Wei; Liu, Dingbin

2015-09-01

We developed a simple high-throughput colorimetric assay to detect glucose based on the glucose oxidase (GOx)-catalysed enlargement of gold nanoparticles (AuNPs). Compared with the currently available glucose kit method, the AuNP-based assay provides higher clinical sensitivity at lower cost, indicating its great potential to be a powerful tool for clinical screening of glucose.We developed a simple high-throughput colorimetric assay to detect glucose based on the glucose oxidase (GOx)-catalysed enlargement of gold nanoparticles (AuNPs). Compared with the currently available glucose kit method, the AuNP-based assay provides higher clinical sensitivity at lower cost, indicating its great potential to be a powerful tool for clinical screening of glucose. Electronic supplementary information (ESI) available: Experimental section and additional figures. See DOI: 10.1039/c5nr03758a

The contribution of hospital library information services to clinical care: a study in eight hospitals.

PubMed Central

King, D N

1987-01-01

Hospital health sciences libraries represent, for the vast majority of health professionals, the most accessible source for library information and services. Most health professionals do not have available the specialized services of a clinical medical librarian, and rely instead upon general information services for their case-related information needs. The ability of the hospital library to meet these needs and the impact of the information on quality patient care have not been previously examined. A study was conducted in eight hospitals in the Chicago area as a quality assurance project. A total of 176 physicians, nurses, and other health professionals requested information from their hospital libraries related to a current case or clinical situation. They then assessed the quality of information received, its cognitive value, its contribution to patient care, and its impact on case management. Nearly two-thirds of the respondents asserted that they would definitely or probably handle their cases differently as a result of the information provided by the library. Almost all rated the libraries' performance and response highly. An overview of the context and purpose of the study, its methods, selected results, limitations, and conclusions are presented here, as is a review of selected earlier research. PMID:3450340

Personal genome testing: Test characteristics to clarify the discourse on ethical, legal and societal issues

PubMed Central

2011-01-01

Background As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must evolve to encompass these differences. One important development is the rise of personal genome testing on the basis of genetic profiling: the testing of multiple genetic variants simultaneously for the prediction of common multifactorial diseases. Currently, an increasing number of companies are offering personal genome tests directly to consumers and are spurring ELSI-discussions, which stand in need of clarification. This paper presents a systematic approach to the ELSI-evaluation of personal genome testing for multifactorial diseases along the lines of its test characteristics. Discussion This paper addresses four test characteristics of personal genome testing: its being a non-targeted type of testing, its high analytical validity, low clinical validity and problematic clinical utility. These characteristics raise their own specific ELSI, for example: non-targeted genetic profiling poses serious problems for information provision and informed consent. Questions about the quantity and quality of the necessary information, as well as about moral responsibilities with regard to the provision of information are therefore becoming central themes within ELSI-discussions of personal genome testing. Further, the current low level of clinical validity of genetic profiles raises questions concerning societal risks and regulatory requirements, whereas simultaneously it causes traditional ELSI-issues of clinical genetics, such as psychological and health risks, discrimination, and stigmatization, to lose part of their relevance. Also, classic notions of clinical utility are challenged by the newer notion of 'personal utility.' Summary Consideration of test characteristics is essential to any valuable discourse on the ELSI of personal genome testing for multifactorial diseases. Four key characteristics of the test - targeted/non-targeted testing, analytical validity, clinical validity and clinical utility - together determine the applicability and the relevance of ELSI to specific tests. The paper identifies and discusses four areas of interest for the ELSI-debate on personal genome testing: informational problems, risks, regulatory issues, and the notion of personal utility. PMID:21672210

Innovative Solutions for Clinical Trial Follow-up: Adding Value from Nationally Held UK Data.

PubMed

Appleyard, S E; Gilbert, D C

2017-12-01

Clinical trials provide the data that underpin evidence-based oncological practice. Over and above their primary outcome measures, collected and analysed by the clinical trials unit, trials provide an opportunity to generate a wide range of additional information over a prolonged period of time. Nationally held data have potential to facilitate longer term follow-up and explore associated toxicities and downstream consequences and in the UK include data from secondary care, including hospital episode statistics, national chemotherapy and radiotherapy datasets and primary care records. Specific to use in oncological practice, the National Cancer Data Repository contains linked data from a variety of sources for patients with a diagnosis of cancer, both cancer and non-cancer related. The challenge of using these data in clinical trials relates to the need to extract identifiable patient data, with the associated ethical and legal issues. The data access processes are time consuming and require evidence of information governance compliance. This overview article reviews the current data available, the current and potential uses both within and outside clinical trials and the challenges encountered in the process of acquiring data. We focus specifically on the use of nationally held data for non-cancer outcomes, including toxicity and associated conditions. Copyright © 2017 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

A systematic review on pharmacogenetics in cardiovascular disease: is it ready for clinical application?

PubMed

Verschuren, Jeffrey J W; Trompet, Stella; Wessels, Judith A M; Guchelaar, Henk-Jan; de Maat, Moniek P M; Simoons, Maarten L; Jukema, J Wouter

2012-01-01

Pharmacogenetics is the search for heritable genetic polymorphisms that influence responses to drug therapy. The most important application of pharmacogenetics is to guide choosing agents with the greatest potential of efficacy and smallest risk of adverse drug reactions. Many studies focusing on drug-gene interactions have been published in recent years, some of which led to adaptation of FDA recommendations, indicating that we are on the verge of the clinical application of genetic information in drug therapy. This systematic review provides a comprehensive overview of the current knowledge on pharmacogenetics of all major drug classes currently used in the treatment of cardiovascular diseases.

[Problem list in computer-based patient records].

PubMed

Ludwig, C A

1997-01-14

Computer-based clinical information systems are capable of effectively processing even large amounts of patient-related data. However, physicians depend on rapid access to summarized, clearly laid out data on the computer screen to inform themselves about a patient's current clinical situation. In introducing a clinical workplace system, we therefore transformed the problem list-which for decades has been successfully used in clinical information management-into an electronic equivalent and integrated it into the medical record. The table contains a concise overview of diagnoses and problems as well as related findings. Graphical information can also be integrated into the table, and an additional space is provided for a summary of planned examinations or interventions. The digital form of the problem list makes it possible to use the entire list or selected text elements for generating medical documents. Diagnostic terms for medical reports are transferred automatically to corresponding documents. Computer technology has an immense potential for the further development of problem list concepts. With multimedia applications sound and images will be included in the problem list. For hyperlink purpose the problem list could become a central information board and table of contents of the medical record, thus serving as the starting point for database searches and supporting the user in navigating through the medical record.

Novel therapeutic strategies in myelodysplastic syndromes: do molecular genetics help?

PubMed

Chung, Stephen S

2016-03-01

Many studies over the past decade have together identified genes that are recurrently mutated in the myelodysplastic syndromes (MDS). We will summarize how this information has informed our understanding of disease pathogenesis and behavior, with an emphasis on how this information may inform therapeutic strategies. Genomic sequencing techniques have allowed for the identification of many recurrently mutated genes in MDS, with the most common mutations being found in epigenetic modifiers and components of the splicing machinery. Although many mutations are associated with clinical outcomes and disease phenotypes, at the current time they add relatively little to already robust clinical prognostic algorithms. However, as molecular genetic data are accumulated in larger numbers of patients, it is likely that the clinical significance of co-occurring mutations and less common mutations will come to light. Finally, mutated genes may identify biologically distinct subgroups of MDS that may benefit from novel therapies, and a subset of these genes may themselves serve as therapeutic targets. Advances in our knowledge of the molecular genetics of MDS have significantly improved our understanding of disease biology and promise to improve tools for clinical decision-making and identify new therapies for patients.

Clinical professional governance for detailed clinical models.

PubMed

Goossen, William; Goossen-Baremans, Anneke

2013-01-01

This chapter describes the need for Detailed Clinical Models for contemporary Electronic Health Systems, data exchange and data reuse. It starts with an explanation of the components related to Detailed Clinical Models with a brief summary of knowledge representation, including terminologies representing clinic relevant "things" in the real world, and information models that abstract these in order to let computers process data about these things. Next, Detailed Clinical Models are defined and their purpose is described. It builds on existing developments around the world and accumulates in current work to create a technical specification at the level of the International Standards Organization. The core components of properly expressed Detailed Clinical Models are illustrated, including clinical knowledge and context, data element specification, code bindings to terminologies and meta-information about authors, versioning among others. Detailed Clinical Models to date are heavily based on user requirements and specify the conceptual and logical levels of modelling. It is not precise enough for specific implementations, which requires an additional step. However, this allows Detailed Clinical Models to serve as specifications for many different kinds of implementations. Examples of Detailed Clinical Models are presented both in text and in Unified Modelling Language. Detailed Clinical Models can be positioned in health information architectures, where they serve at the most detailed granular level. The chapter ends with examples of projects that create and deploy Detailed Clinical Models. All have in common that they can often reuse materials from earlier projects, and that strict governance of these models is essential to use them safely in health care information and communication technology. Clinical validation is one point of such governance, and model testing another. The Plan Do Check Act cycle can be applied for governance of Detailed Clinical Models. Finally, collections of clinical models do require a repository in which they can be stored, searched, and maintained. Governance of Detailed Clinical Models is required at local, national, and international levels.

Free and open source enabling technologies for patient-centric, guideline-based clinical decision support: a survey.

PubMed

Leong, T Y; Kaiser, K; Miksch, S

2007-01-01

Guideline-based clinical decision support is an emerging paradigm to help reduce error, lower cost, and improve quality in evidence-based medicine. The free and open source (FOS) approach is a promising alternative for delivering cost-effective information technology (IT) solutions in health care. In this paper, we survey the current FOS enabling technologies for patient-centric, guideline-based care, and discuss the current trends and future directions of their role in clinical decision support. We searched PubMed, major biomedical informatics websites, and the web in general for papers and links related to FOS health care IT systems. We also relied on our background and knowledge for specific subtopics. We focused on the functionalities of guideline modeling tools, and briefly examined the supporting technologies for terminology, data exchange and electronic health record (EHR) standards. To effectively support patient-centric, guideline-based care, the computerized guidelines and protocols need to be integrated with existing clinical information systems or EHRs. Technologies that enable such integration should be accessible, interoperable, and scalable. A plethora of FOS tools and techniques for supporting different knowledge management and quality assurance tasks involved are available. Many challenges, however, remain in their implementation. There are active and growing trends of deploying FOS enabling technologies for integrating clinical guidelines, protocols, and pathways into the main care processes. The continuing development and maturation of such technologies are likely to make increasingly significant contributions to patient-centric, guideline-based clinical decision support.

The effects of mild and severe traumatic brain injury on speed of information processing as measured by the computerized tests of information processing (CTIP).

PubMed

Tombaugh, Tom N; Rees, Laura; Stormer, Peter; Harrison, Allyson G; Smith, Andra

2007-01-01

In spite of the fact that reaction time (RT) measures are sensitive to the effects of traumatic brain injury (TBI), few RT procedures have been developed for use in standard clinical evaluations. The computerized test of information processing (CTIP) [Tombaugh, T. N., & Rees, L. (2000). Manual for the computerized tests of information processing (CTIP). Ottawa, Ont.: Carleton University] was designed to measure the degree to which TBI decreases the speed at which information is processed. The CTIP consists of three computerized programs that progressively increase the amount of information that is processed. Results of the current study demonstrated that RT increased as the difficulty of the CTIP tests increased (known as the complexity effect), and as severity of injury increased (from mild to severe TBI). The current study also demonstrated the importance of selecting a non-biased measure of variability. Overall, findings suggest that the CTIP is an easy to administer and sensitive measure of information processing speed.

Incorporating Pharmacogenomics into Health Information Technology, Electronic Health Record and Decision Support System: An Overview.

PubMed

Alanazi, Abdullah

2017-02-01

As the adoption of information technology in healthcare is rising, the potentiality of moving Pharmacogenomics from benchside to bedside is aggravated. This paper reviews the current status of Pharmacogenomics (PGx) information and the attempts for incorporating them into the Electronic Health Record (EHR) system through Decision Support Systems (DSSs). Rigorous review strategies of PGx information and providing context-relevant recommendations in form of action plan- dose adjustment, lab tests rather than just information- would be ideal for making clinical recommendations out of PGx information. Lastly, realistic projections of what pharmacogenomics can provide is another important aspect in incorporating Pharmacogenomics into health information technology.

The laboratory-clinician team: a professional call to action to improve communication and collaboration for optimal patient care in chromosomal microarray testing.

PubMed

Wain, Karen E; Riggs, Erin; Hanson, Karen; Savage, Melissa; Riethmaier, Darlene; Muirhead, Andrea; Mitchell, Elyse; Packard, Bethanny Smith; Faucett, W Andrew

2012-10-01

The International Standards for Cytogenomic Arrays (ISCA) Consortium is a worldwide collaborative effort dedicated to optimizing patient care by improving the quality of chromosomal microarray testing. The primary effort of the ISCA Consortium has been the development of a database of copy number variants (CNVs) identified during the course of clinical microarray testing. This database is a powerful resource for clinicians, laboratories, and researchers, and can be utilized for a variety of applications, such as facilitating standardized interpretations of certain CNVs across laboratories or providing phenotypic information for counseling purposes when published data is sparse. A recognized limitation to the clinical utility of this database, however, is the quality of clinical information available for each patient. Clinical genetic counselors are uniquely suited to facilitate the communication of this information to the laboratory by virtue of their existing clinical responsibilities, case management skills, and appreciation of the evolving nature of scientific knowledge. We intend to highlight the critical role that genetic counselors play in ensuring optimal patient care through contributing to the clinical utility of the ISCA Consortium's database, as well as the quality of individual patient microarray reports provided by contributing laboratories. Current tools, paper and electronic forms, created to maximize this collaboration are shared. In addition to making a professional commitment to providing complete clinical information, genetic counselors are invited to become ISCA members and to become involved in the discussions and initiatives within the Consortium.

XML syntax for clinical laboratory procedure manuals.

PubMed

Saadawi, Gilan; Harrison, James H

2003-01-01

We have developed a document type description (DTD) in Extensable Markup Language (XML) for clinical laboratory procedures. Our XML syntax can adequately structure a variety of procedure types across different laboratories and is compatible with current procedure standards. The combination of this format with an XML content management system and appropriate style sheets will allow efficient procedure maintenance, distributed access, customized display and effective searching across a large body of test information.

[Information technologies in clinical cytology (a lecture)].

PubMed

Shabalova, I P; Dzhangirova, T V; Kasoian, K T

2010-07-01

The lecture is devoted to the urgent problem that is to increase the quality of cytological diagnosis, by diminishing the subjectivism factor via introduction of up-to-date computer information technologies into a cytologist's practice. Its main lines from the standardization of cytological specimen preparation to the registration of a cytologist's opinion and the assessment of the specialist's work quality at the laboratories that successfully use the capacities of the current information systems are described. Information technology capabilities to improve the interpretation of the cellular composition of cytological specimens are detailed.

Genetic Testing as a New Standard for Clinical Diagnosis of Color Vision Deficiencies.

PubMed

Davidoff, Candice; Neitz, Maureen; Neitz, Jay

2016-09-01

The genetics underlying inherited color vision deficiencies is well understood: causative mutations change the copy number or sequence of the long (L), middle (M), or short (S) wavelength sensitive cone opsin genes. This study evaluated the potential of opsin gene analyses for use in clinical diagnosis of color vision defects. We tested 1872 human subjects using direct sequencing of opsin genes and a novel genetic assay that characterizes single nucleotide polymorphisms (SNPs) using the MassArray system. Of the subjects, 1074 also were given standard psychophysical color vision tests for a direct comparison with current clinical methods. Protan and deutan deficiencies were classified correctly in all subjects identified by MassArray as having red-green defects. Estimates of defect severity based on SNPs that control photopigment spectral tuning correlated with estimates derived from Nagel anomaloscopy. The MassArray assay provides genetic information that can be useful in the diagnosis of inherited color vision deficiency including presence versus absence, type, and severity, and it provides information to patients about the underlying pathobiology of their disease. The MassArray assay provides a method that directly analyzes the molecular substrates of color vision that could be used in combination with, or as an alternative to current clinical diagnosis of color defects.

The relationship between lifestyle factors and clinical symptoms of bipolar disorder patients in a Chinese population.

PubMed

Huang, Jia; Yuan, Cheng Mei; Xu, Xian Rong; Wang, Yong; Hong, Wu; Wang, Zuo Wei; Su, You Song; Hu, Ying Yan; Cao, Lan; Wang, Yu; Chen, Jun; Fang, Yi Ru

2018-05-06

There is evidence that bipolar disorder (BD) patients with an unhealthy lifestyle have a worse course of illness. This study was designed to examine the extent to which lifestyle could influence the severity of clinical symptoms associated with BD. A total of 113 BD patients were recruited in this study. The lifestyle information including data on dietary patterns, physical activity, and sleep quality were collected using a self-rated questionnaire. The results showed that the consumption of whole grain, seafood, and dairy products were significantly negatively correlated with the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score. The consumption of sugar, soft drinks, and alcohol as well as being a current smoker were positively correlated with the severity of clinical symptoms. Multiple linear regression and binary logistic regression analyses demonstrated an independent negative correlation between both whole grain and dairy product consumption with the HAMD-17 score. The results from the current study suggested that lifestyle factors, especially dietary patterns, might be associated with clinical symptoms of BD. The association between the consumption of specific foods and severity of depressive symptoms may offer some useful information and further understanding of the role of lifestyle factors in the development of BD. Copyright © 2018. Published by Elsevier B.V.

Genetic Testing as a New Standard for Clinical Diagnosis of Color Vision Deficiencies

PubMed Central

Davidoff, Candice; Neitz, Maureen; Neitz, Jay

2016-01-01

Purpose The genetics underlying inherited color vision deficiencies is well understood: causative mutations change the copy number or sequence of the long (L), middle (M), or short (S) wavelength sensitive cone opsin genes. This study evaluated the potential of opsin gene analyses for use in clinical diagnosis of color vision defects. Methods We tested 1872 human subjects using direct sequencing of opsin genes and a novel genetic assay that characterizes single nucleotide polymorphisms (SNPs) using the MassArray system. Of the subjects, 1074 also were given standard psychophysical color vision tests for a direct comparison with current clinical methods. Results Protan and deutan deficiencies were classified correctly in all subjects identified by MassArray as having red–green defects. Estimates of defect severity based on SNPs that control photopigment spectral tuning correlated with estimates derived from Nagel anomaloscopy. Conclusions The MassArray assay provides genetic information that can be useful in the diagnosis of inherited color vision deficiency including presence versus absence, type, and severity, and it provides information to patients about the underlying pathobiology of their disease. Translational Relevance The MassArray assay provides a method that directly analyzes the molecular substrates of color vision that could be used in combination with, or as an alternative to current clinical diagnosis of color defects. PMID:27622081

Mexican registry of pulmonary hypertension: REMEHIP.

PubMed

Sandoval Zarate, Julio; Jerjes-Sanchez, Carlos; Ramirez-Rivera, Alicia; Zamudio, Tomas Pulido; Gutierrez-Fajardo, Pedro; Elizalde Gonzalez, Jose; Leon, Mario Seoane Garcia De; Gamez, Miguel Beltran; Abril, Francisco Moreno Hoyos; Michel, Rodolfo Parra; Aguilar, Humberto Garcia

REMEHIP is a prospective, multicentre registry on pulmonary hypertension. The main objective will be to identify the clinical profile, medical care, therapeutic trends and outcomes in adult and pediatric Mexican patients with well-characterized pulmonary hypertension. REMEHIP a multicenter registry began in 2015 with a planned recruitment time of 12 months and a 4-year follow-up. The study population will comprise a longitudinal cohort study, collecting data on patients with prevalent and incident pulmonary hypertension. Will be included patients of age >2 years and diagnosis of pulmonary hypertension by right heart catheterization within Group 1 and Group 4 of the World Health Organization classification. The structure, data collection and data analysis will be based on quality current recommendations for registries. The protocol has been approved by institutional ethics committees in all participant centers. All patients will sign an informed consent form. Currently in Mexico, there is a need of observational registries that include patients with treatment in the everyday clinical practice so the data could be validated and additional information could be obtained versus the one from the clinical trials. In this way, REMEHIP emerges as a link among randomized clinical trials developed by experts and previous Mexican experience. Copyright © 2016 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. All rights reserved.

Integrating functional genomics to accelerate mechanistic personalized medicine.

PubMed

Tyner, Jeffrey W

2017-03-01

The advent of deep sequencing technologies has resulted in the deciphering of tremendous amounts of genetic information. These data have led to major discoveries, and many anecdotes now exist of individual patients whose clinical outcomes have benefited from novel, genetically guided therapeutic strategies. However, the majority of genetic events in cancer are currently undrugged, leading to a biological gap between understanding of tumor genetic etiology and translation to improved clinical approaches. Functional screening has made tremendous strides in recent years with the development of new experimental approaches to studying ex vivo and in vivo drug sensitivity. Numerous discoveries and anecdotes also exist for translation of functional screening into novel clinical strategies; however, the current clinical application of functional screening remains largely confined to small clinical trials at specific academic centers. The intersection between genomic and functional approaches represents an ideal modality to accelerate our understanding of drug sensitivities as they relate to specific genetic events and further understand the full mechanisms underlying drug sensitivity patterns.

HIS-based Kaplan-Meier plots--a single source approach for documenting and reusing routine survival information.

PubMed

Breil, Bernhard; Semjonow, Axel; Müller-Tidow, Carsten; Fritz, Fleur; Dugas, Martin

2011-02-16

Survival or outcome information is important for clinical routine as well as for clinical research and should be collected completely, timely and precisely. This information is relevant for multiple usages including quality control, clinical trials, observational studies and epidemiological registries. However, the local hospital information system (HIS) does not support this documentation and therefore this data has to generated by paper based or spreadsheet methods which can result in redundantly documented data. Therefore we investigated, whether integrating the follow-up documentation of different departments in the HIS and reusing it for survival analysis can enable the physician to obtain survival curves in a timely manner and to avoid redundant documentation. We analysed the current follow-up process of oncological patients in two departments (urology, haematology) with respect to different documentation forms. We developed a concept for comprehensive survival documentation based on a generic data model and implemented a follow-up form within the HIS of the University Hospital Muenster which is suitable for a secondary use of these data. We designed a query to extract the relevant data from the HIS and implemented Kaplan-Meier plots based on these data. To re-use this data sufficient data quality is needed. We measured completeness of forms with respect to all tumour cases in the clinic and completeness of documented items per form as incomplete information can bias results of the survival analysis. Based on the form analysis we discovered differences and concordances between both departments. We identified 52 attributes from which 13 were common (e.g. procedures and diagnosis dates) and were used for the generic data model. The electronic follow-up form was integrated in the clinical workflow. Survival data was also retrospectively entered in order to perform survival and quality analyses on a comprehensive data set. Physicians are now able to generate timely Kaplan-Meier plots on current data. We analysed 1029 follow-up forms of 965 patients with survival information between 1992 and 2010. Completeness of forms was 60.2%, completeness of items ranges between 94.3% and 98.5%. Median overall survival time was 16.4 years; median event-free survival time was 7.7 years. It is feasible to integrate survival information into routine HIS documentation such that Kaplan-Meier plots can be generated directly and in a timely manner.

Learning about an Undiagosed Condition in an Adult

MedlinePlus

... of the public with current information on clinical research studies. For example, the study entitled "Studies of Children with Metabolic and Other Genetic Diseases" evaluates individuals of all ages (despite its title) with known or suspected genetic diseases. You can ...

DEVELOPING BIOMARKERS FOR MYCOTOXIN EXPOSURE AND EFFECT

USDA-ARS?s Scientific Manuscript database

The purpose of this presentation is to briefly summarize the toxicology and current state of biomarker development for commercially important mycotoxins with a focus on their potential usefulness in farm animals. Combining information about known exposure, clinical indicators and biomarkers will pro...

Connecting Medical Records: An Evaluation of Benefits and Challenges for Primary Care Practices.

PubMed

Compeau, Deborah Ruth; Terry, Amanda

2017-06-30

Implementation of systems to support health information sharing has lagged other areas of healthcare IT, yet offers a strong possibility for benefit.  Clinical acceptance is a key limiting factor in health IT adoption. To assess the benefits and challenges experienced by clinicians using a custom-developed health information exchange system, and to show how perceptions of benefits and challenges influence perceptions of productivity and care-related outcomes. We used a mixed methods design with two phases. First, we conducted interviews with stakeholders who were familiar with the health information exchange system to inform the development of a measure of benefits and challenges of the use of this system. Second, using this measure we conducted a survey of current and former users of the health information exchange system using a modified Dillman method. 105 current and former users completed the survey. The results showed information quality, ease of completing tasks and clinical process improvement as key benefits that reduced workload and improved patient care.  Challenges related to system reliability, quality of reports and service quality increased workload and decreased impact on care, though the effect of the challenges was smaller than that of the benefits.  Even very limited health information exchange capabilities can improve outcomes for primary care users.  Improving perceptions of benefits may be even more important the removing challenges to use, though it is likely that a threshold of quality must be achieved for this to be true.

Current Pregnancy Among Women with Spinal Cord Injury: Findings from the U.S. National Spinal Cord Injury Database

PubMed Central

Iezzoni, Lisa I.; Chen, Yuying; McLain, Aime B. Jackson

2015-01-01

Study design Cross-sectional study Objective To examine prevalence of pregnancy and associations with sociodemographic and clinical factors among women with spinal cord injury (SCI) Setting U.S. National Spinal Cord Injury Database, an SCI registry that interviews participants 1, 5, and then every 5 years post-injury. Data include SCI clinical details, functional impairments, participation measures, depressive symptoms, and life satisfaction. Women ages 18-49 are asked about hospitalizations in the last year relating to pregnancy or its complications. Data represent 1,907 women, who completed 3,054 interviews. Methods We used generalized estimating equations to examine bivariable associations between pregnancy and clinical and psychosocial variables and to perform multivariable regressions predicting pregnancy. Results Across all women, 2.0% reported pregnancy during the prior 12 months. This annual prevalence differed significantly by years elapsed since injury; the highest rate occurred 15 years post-injury (3.7%). Bivariable analyses found that younger age at injury was significantly associated with current pregnancy (P < 0.0001). Compared with nonpregnant women, those reporting current pregancy were significantly more likely to be married or partnered, have sport-related SCI, have higher motor scores, and have more positive psychosocial status scores. Multivariable analyses found significant associations between current pregnancy and age, marital status, motor score, and mobility and occupation scale scores. Conclusions Current pregnancy rates among reproductive-aged women with SCI are similar to rates of other U.S. women with chronic mobility impairments. More information is needed about pregnancy experiences and outcomes to inform both women with SCI seeking childbearing and clinicians providing their care. PMID:25987000

Reversible Nerve Conduction Block Using Kilohertz Frequency Alternating Current

PubMed Central

Kilgore, Kevin L.; Bhadra, Niloy

2013-01-01

Objectives The features and clinical applications of balanced-charge kilohertz frequency alternating currents (KHFAC) are reviewed. Preclinical studies of KHFAC block have demonstrated that it can produce an extremely rapid and reversible block of nerve conduction. Recent systematic analysis and experimentation utilizing KHFAC block has resulted in a significant increase in interest in KHFAC block, both scientifically and clinically. Materials and Methods We review the history and characteristics of KHFAC block, the methods used to investigate this type of block, the experimental evaluation of block, and the electrical parameters and electrode designs needed to achieve successful block. We then analyze the existing clinical applications of high frequency currents, comparing the early results with the known features of KHFAC block. Results Although many features of KHFAC block have been characterized, there is still much that is unknown regarding the response of neural structures to rapidly fluctuating electrical fields. The clinical reports to date do not provide sufficient information to properly evaluate the mechanisms that result in successful or unsuccessful treatment. Conclusions KHFAC nerve block has significant potential as a means of controlling nerve activity for the purpose of treating disease. However, early clinical studies in the use of high frequency currents for the treatment of pain have not been designed to elucidate mechanisms or allow direct comparisons to preclinical data. We strongly encourage the careful reporting of the parameters utilized in these clinical studies, as well as the development of outcome measures that could illuminate the mechanisms of this modality. PMID:23924075

Development of clinical practice guidelines.

PubMed

Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

2014-01-01

Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

Federating Clinical Data from Six Pediatric Hospitals: Process and Initial Results from the PHIS+ Consortium

PubMed Central

Narus, Scott P.; Srivastava, Rajendu; Gouripeddi, Ramkiran; Livne, Oren E.; Mo, Peter; Bickel, Jonathan P.; de Regt, David; Hales, Joseph W.; Kirkendall, Eric; Stepanek, Richard L.; Toth, Jamie; Keren, Ron

2011-01-01

Integrating clinical data with administrative data across disparate electronic medical record systems will help improve the internal and external validity of comparative effectiveness research. The Pediatric Health Information System (PHIS) currently collects administrative information from 43 pediatric hospital members of the Child Health Corporation of America (CHCA). Members of the Pediatric Research in Inpatient Settings (PRIS) network have partnered with CHCA and the University of Utah Biomedical Informatics Core to create an enhanced version of PHIS that includes clinical data. A specialized version of a data federation architecture from the University of Utah (“FURTHeR”) is being developed to integrate the clinical data from the member hospitals into a common repository (“PHIS+”) that is joined with the existing administrative data. We report here on our process for the first phase of federating lab data, and present initial results. PMID:22195159

In Vivo Imaging and Monitoring of Transplanted Stem Cells: Clinical Applications

PubMed Central

Rodriguez-Porcel, Martin

2010-01-01

Regenerative medicine using stem cells has appeared as a potential therapeutic alternative for coronary artery disease, and stem cell clinical studies are currently on their way. However, initial results of these studies have provided mixed information, in part because of the inability to correlate organ functional information with the presence/absence of transplanted stem cells. Recent advances in molecular biology and imaging have allowed the successful noninvasive monitoring of transplanted stem cells in the living subject. In this article, different imaging strategies (direct labeling, indirect labeling with reporter genes) to study the viability and biology of stem cells are discussed. In addition, the limitations of each approach and imaging modality (eg, single photon emission computed tomography, positron emission tomography, and MRI) and their requirements for clinical use are addressed. Use of these strategies will be critical as the different regenerative therapies are being tested for clinical use. PMID:20425184

Information needs of Botswana health care workers and perceptions of wikipedia.

PubMed

Park, Elizabeth; Masupe, Tiny; Joseph, Joseph; Ho-Foster, Ari; Chavez, Afton; Jammalamadugu, Swetha; Marek, Andrew; Arumala, Ruth; Ketshogileng, Dineo; Littman-Quinn, Ryan; Kovarik, Carrie

2016-11-01

Since the UN Human Rights Council's recognition on the subject in 2011, the right to access the Internet and information is now considered one of the most basic human rights of global citizens [1,2]. Despite this, an information gap between developed and resource-limited countries remains, and there is scant research on actual information needs of workers themselves. The Republic of Botswana represents a fertile ground to address existing gaps in research, policy, and practice, due to its demonstrated gap in access to information and specialists among rural health care workers (HCWs), burgeoning mHealth capacity, and a timely offer from Orange Telecommunications to access Wikipedia for free on mobile platforms for Botswana subscribers. In this study, we sought to identify clinical information needs of HCWs of Botswana and their perception of Wikipedia as a clinical tool. Twenty-eight facilitated focus groups, consisting of 113 HCWs of various cadres based at district hospitals, clinics, and health posts around Botswana, were employed. Transcription and thematic analysis were performed for those groups. Access to the Internet is limited at most facilities. Most HCWs placed high importance upon using Botswana Ministry of Health (MoH) resources for obtaining credible clinical information. However, the clinical applicability of these materials was limited due to discrepancies amongst sources, potentially outdated information, and poor optimization for time-sensitive circumstances. As a result, HCWs faced challenges, such as loss of patient trust and compromises in patient care. Potential solutions posed by HCWs to address these issues included: multifaceted improvements in Internet infrastructure, access to up-to-date information, transfer of knowledge from MoH to HCW, and improving content and applicability of currently available information. Topics of clinical information needs were broad and encompassed: HIV, TB (Tuberculosis), OB/GYN (Obstetrics and Gynecology), and Pediatrics. HCW attitudes towards Wikipedia were variable; some trusted Wikipedia as a reliable point of care information resource whereas others thought that its use should be restricted and monitored by the MoH. There is a demonstrated need for accessible, reliable, and up-to-date information to aid clinical practice in Botswana. Attitudes towards Wikipedia as an open information resource tool are at best, split. Therefore, future studies are necessary to determine the accuracy, currency, and relevancy of Wikipedia articles on the health topics identified by health care workers as areas of information need. More broadly speaking, future efforts should be dedicated to configure a quality-controlled, readily accessible mobile platform based clinical information application tool fitting for Botswana. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

PubMed

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

Building clinical and organizational resilience to reconcile safety threats, tensions and trade-offs: insights from theory and evidence.

PubMed

Jeffs, Lianne; Tregunno, Deborah; MacMillan, Kathleen; Espin, Sherry

2009-01-01

Healthcare delivery settings are complex adaptive and tightly coupled, interrelated systems. Within the larger healthcare system, a key subsystem is the "clinical microsystem" level. It is at this level that clinicians are faced with high levels of uncertainty in their daily work - uncertainty that impacts the quality and safety of care that patients receive. The first aim of this paper is to enhance healthcare leaders' understanding of what is currently known about safety threats and strategies to manage the inherent tensions and trade-offs that occur in everyday practice. The second aim is to inform strategies that build clinical and organizational resilience through a multi-level framework derived from the collective theoretical and empirical work. Together, this information can strengthen safety practices throughout healthcare organizations.

Technological Advances in Nursing Care Delivery.

PubMed

Sullivan, Debra Henline

2015-12-01

Technology is rapidly changing the way nurses deliver patient care. The Health Information Technology for Economic and Clinical Health Act of 2009 encourages health care providers to implement electronic health records for meaningful use of patient information. This development has opened the door to many technologies that use this information to streamline patient care. This article explores current and new technologies that nurses will be working with either now or in the near future. Copyright © 2015 Elsevier Inc. All rights reserved.

Quality Primary Care and Family Planning Services for LGBT Clients: A Comprehensive Review of Clinical Guidelines.

PubMed

Klein, David A; Malcolm, Nikita M; Berry-Bibee, Erin N; Paradise, Scott L; Coulter, Jessica S; Keglovitz Baker, Kristin; Schvey, Natasha A; Rollison, Julia M; Frederiksen, Brittni N

2018-04-01

LGBT clients have unique healthcare needs but experience a wide range of quality in the care that they receive. This study provides a summary of clinical guideline recommendations related to the provision of primary care and family planning services for LGBT clients. In addition, we identify gaps in current guidelines, and inform future recommendations and guidance for clinical practice and research. PubMed, Cochrane, and Agency for Healthcare Research and Quality electronic bibliographic databases, and relevant professional organizations' websites, were searched to identify clinical guidelines related to the provision of primary care and family planning services for LGBT clients. Information obtained from a technical expert panel was used to inform the review. Clinical guidelines meeting the inclusion criteria were assessed to determine their alignment with Institute of Medicine (IOM) standards for the development of clinical practice guidelines and content relevant to the identified themes. The search parameters identified 2,006 clinical practice guidelines. Seventeen clinical guidelines met the inclusion criteria. Two of the guidelines met all eight IOM criteria. However, many recommendations were consistent regarding provision of services to LGBT clients within the following themes: clinic environment, provider cultural sensitivity and awareness, communication, confidentiality, coordination of care, general clinical principles, mental health considerations, and reproductive health. Guidelines for the primary and family planning care of LGBT clients are evolving. The themes identified in this review may guide professional organizations during guideline development, clinicians when providing care, and researchers conducting LGBT-related studies.

A semantic-web oriented representation of the clinical element model for secondary use of electronic health records data.

PubMed

Tao, Cui; Jiang, Guoqian; Oniki, Thomas A; Freimuth, Robert R; Zhu, Qian; Sharma, Deepak; Pathak, Jyotishman; Huff, Stanley M; Chute, Christopher G

2013-05-01

The clinical element model (CEM) is an information model designed for representing clinical information in electronic health records (EHR) systems across organizations. The current representation of CEMs does not support formal semantic definitions and therefore it is not possible to perform reasoning and consistency checking on derived models. This paper introduces our efforts to represent the CEM specification using the Web Ontology Language (OWL). The CEM-OWL representation connects the CEM content with the Semantic Web environment, which provides authoring, reasoning, and querying tools. This work may also facilitate the harmonization of the CEMs with domain knowledge represented in terminology models as well as other clinical information models such as the openEHR archetype model. We have created the CEM-OWL meta ontology based on the CEM specification. A convertor has been implemented in Java to automatically translate detailed CEMs from XML to OWL. A panel evaluation has been conducted, and the results show that the OWL modeling can faithfully represent the CEM specification and represent patient data.

A semantic-web oriented representation of the clinical element model for secondary use of electronic health records data

PubMed Central

Tao, Cui; Jiang, Guoqian; Oniki, Thomas A; Freimuth, Robert R; Zhu, Qian; Sharma, Deepak; Pathak, Jyotishman; Huff, Stanley M; Chute, Christopher G

2013-01-01

The clinical element model (CEM) is an information model designed for representing clinical information in electronic health records (EHR) systems across organizations. The current representation of CEMs does not support formal semantic definitions and therefore it is not possible to perform reasoning and consistency checking on derived models. This paper introduces our efforts to represent the CEM specification using the Web Ontology Language (OWL). The CEM-OWL representation connects the CEM content with the Semantic Web environment, which provides authoring, reasoning, and querying tools. This work may also facilitate the harmonization of the CEMs with domain knowledge represented in terminology models as well as other clinical information models such as the openEHR archetype model. We have created the CEM-OWL meta ontology based on the CEM specification. A convertor has been implemented in Java to automatically translate detailed CEMs from XML to OWL. A panel evaluation has been conducted, and the results show that the OWL modeling can faithfully represent the CEM specification and represent patient data. PMID:23268487

Physician Information Needs and Electronic Health Records (EHRs): Time to Reengineer the Clinic Note.

PubMed

Koopman, Richelle J; Steege, Linsey M Barker; Moore, Joi L; Clarke, Martina A; Canfield, Shannon M; Kim, Min S; Belden, Jeffery L

2015-01-01

Primary care physicians face cognitive overload daily, perhaps exacerbated by the form of electronic health record documentation. We examined physician information needs to prepare for clinic visits, focusing on past clinic progress notes. This study used cognitive task analysis with 16 primary care physicians in the scenario of preparing for office visits. Physicians reviewed simulated acute and chronic care visit notes. We collected field notes and document highlighting and review, and we audio-recorded cognitive interview while on task, with subsequent thematic qualitative analysis. Member checks included the presentation of findings to the interviewed physicians and their faculty peers. The Assessment and Plan section was most important and usually reviewed first. The History of the Present Illness section could provide supporting information, especially if in narrative form. Physicians expressed frustration with the Review of Systems section, lamenting that the forces driving note construction did not match their information needs. Repetition of information contained in other parts of the chart (eg, medication lists) was identified as a source of note clutter. A workflow that included a patient summary dashboard made some elements of past notes redundant and therefore a source of clutter. Current ambulatory progress notes present more information to the physician than necessary and in an antiquated format. It is time to reengineer the clinic progress note to match the workflow and information needs of its primary consumer. © Copyright 2015 by the American Board of Family Medicine.

Understanding chemotherapy treatment pathways of advanced colorectal cancer patients to inform an economic evaluation in the United Kingdom

PubMed Central

Shabaruddin, F H; Elliott, R A; Valle, J W; Newman, W G; Payne, K

2010-01-01

Background: Accurate description of current practice within advanced colorectal cancer (CRC) specialties were needed to inform an economic evaluation of the UGT1A1 pharmacogenetic test for irinotecan in the United Kingdom. Methods: The study was based on a literature review and elicitation of expert opinion. The expert panel comprised 44 consultant oncologists in NHS Hospital Trusts across England. Results: Ten first-line, 10 second-line and 12 third-line chemotherapy regimens were reported, reflecting wide variations in treatment pathways. Predominant pathways emerged with: first-line treatment with oxaliplatin-based regimens, second-line treatment with irinotecan-based regimens and third-line treatment with mitomycin-based regimens. Experts estimated the frequency of febrile neutropaenia 8.4% (95% CI: 6.7–10.0), septic neutropaenia 4.7% (95% CI: 3.4–6.0) and severe diarrhoea 13.1% (95% CI: 10.8–15.5). Approaches for the clinical management of neutropaenia within the NHS were described. Conclusions: This study identified wide variations in the clinical management of advanced CRC patients. Descriptions of current treatment pathways are necessary for economic evaluations. Variations in clinical practice must be reflected in the model to ensure the findings from an economic evaluation of UGT1A1 testing are sufficient to inform policy regarding the cost-effective use of NHS resources. PMID:20661248

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

PubMed

Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

2011-12-01

New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

PubMed Central

Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

2013-01-01

New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

Implementing EHRs: An Exploratory Study to Examine Current Practices in Migrating Physician Practice

PubMed Central

Dolezel, Diane; Moczygemba, Jackie

2015-01-01

Implementation of electronic health record (EHR) systems in physician practices is challenging and complex. In the past, physicians had little incentive to move from paper-based records. With the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, Medicare and Medicaid incentive payments are now available for physicians who implement EHRs for meaningful use. The Office of the National Coordinator for Health Information Technology (ONC) has ample detail on clinical data needed for meaningful use in order to assess the quality of patient care. Details are lacking, however, on how much clinical data, if any, should be transferred from the old paper records during an EHR implementation project. The purpose of this exploratory study was to investigate and document the elements of longitudinal clinical data that are essential for inclusion in the EHR of physicians in a clinical practice setting, as reported by the office managers of the physicians in the study group. PMID:26807077

Healthcare information technology and medical-surgical nurses: the emergence of a new care partnership.

PubMed

Moore, An'Nita; Fisher, Kathleen

2012-03-01

Healthcare information technology in US hospitals and ambulatory care centers continues to expand, and nurses are expected to effectively and efficiently utilize this technology. Researchers suggest that clinical information systems have expanded the realm of nursing to integrate technology as an element as important in nursing practice as the patient or population being served. This study sought to explore how medical surgical nurses make use of healthcare information technology in their current clinical practice and to examine the influence of healthcare information technology on nurses' clinical decision making. A total of eight medical surgical nurses participated in the study, four novice and four experienced. A conventional content analysis was utilized that allowed for a thematic interpretation of participant data. Five themes emerged: (1) healthcare information technology as a care coordination partner, (2) healthcare information technology as a change agent in the care delivery environment, (3) healthcare information technology-unable to meet all the needs, of all the people, all the time, (4) curiosity about healthcare information technology-what other bells and whistles exist, and (5) Big Brother is watching. The results of this study indicate that a new care partnership has emerged as the provision of nursing care is no longer supplied by a single practitioner but rather by a paired team, consisting of nurses and technology, working collaboratively in an interdependent relationship to achieve established goals.

Perceived mHealth barriers and benefits for home-based HIV testing and counseling and other care: Qualitative findings from health officials, community health workers, and persons living with HIV in South Africa

PubMed Central

van Heerden, Alastair; Harris, Danielle M.; van Rooyen, Heidi; Barnabas, Ruanne V.; Ramanathan, Nithya; Ngcobo, Nkosinathi; Mpiyakhe, Zukiswa; Comulada, W. Scott

2017-01-01

mHealth has been proposed to address inefficiencies in the current South African healthcare system, including home-based HIV testing and counseling (HTC) programs. Yet wide-scale adoption of mHealth has not occurred. Even as infrastructure barriers decrease, a need to better understand perceived adoption barriers by stakeholders remains. We conducted focus group discussions (FGD) in South Africa in 2016 with 10 home-based HTC field staff, 12 community health workers (CHWs) and 10 persons living with HIV (PLH). Key informant (KI) interviews were conducted with five health officials. Perceptions about current home-based HTC practices, future mHealth systems and the use of biometrics for patient identification were discussed, recorded and transcribed for qualitative analysis. Themes were based on a conceptual model for perceived mHealth service quality. Stakeholders brought up a lack of communication in sharing patient health information between clinics, between clinics and CHWs, and between clinics and patients as major barriers to care that mHealth can address. CHWs need better patient information from clinics in terms of physical location and health status to plan visitation routes and address patient needs. CHWs perceive that communication barriers create distrust towards them by clinic staff. PLH want automated appointment and medication reminders. KI see mHealth as a way to improve health information transfer to government officials to better allocate healthcare resources. Stakeholders are also optimistic about the ability for biometrics to improve patient identification but disagreed as to which biometrics would be acceptable, especially in older patients. All stakeholders provided useful information towards the development of mHealth systems. Hospitals are adopting patient-centered approaches that solicit feedback from patients and incorporate them into decision-making processes. A similar approach is needed in the development of mHealth systems. Further, such systems are critical to the successful extension of the health system from health facilities into people’s homes. PMID:28475904

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study.

PubMed

Martin-Lujan, Francisco; Piñol-Moreso, Josep L I; Martin-Vergara, Nuria; Basora-Gallisa, Josep; Pascual-Palacios, Irene; Sagarra-Alamo, Ramon; Llopis, Estefania Aparicio; Basora-Gallisa, Maria T; Pedret-Llaberia, Roser

2011-11-11

There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Multicentre randomized clinical trial with an intervention and a control group. 12 primary care centres in the province of Tarragona (Spain). 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Smoking cessation at 12 months. Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. ClinicalTrial.gov, number NCT01194596.

Perceived mHealth barriers and benefits for home-based HIV testing and counseling and other care: Qualitative findings from health officials, community health workers, and persons living with HIV in South Africa.

PubMed

van Heerden, Alastair; Harris, Danielle M; van Rooyen, Heidi; Barnabas, Ruanne V; Ramanathan, Nithya; Ngcobo, Nkosinathi; Mpiyakhe, Zukiswa; Comulada, W Scott

2017-06-01

mHealth has been proposed to address inefficiencies in the current South African healthcare system, including home-based HIV testing and counseling (HTC) programs. Yet wide-scale adoption of mHealth has not occurred. Even as infrastructure barriers decrease, a need to better understand perceived adoption barriers by stakeholders remains. We conducted focus group discussions (FGD) in South Africa in 2016 with 10 home-based HTC field staff, 12 community health workers (CHWs) and 10 persons living with HIV (PLH). Key informant (KI) interviews were conducted with five health officials. Perceptions about current home-based HTC practices, future mHealth systems and the use of biometrics for patient identification were discussed, recorded and transcribed for qualitative analysis. Themes were based on a conceptual model for perceived mHealth service quality. Stakeholders brought up a lack of communication in sharing patient health information between clinics, between clinics and CHWs, and between clinics and patients as major barriers to care that mHealth can address. CHWs need better patient information from clinics in terms of physical location and health status to plan visitation routes and address patient needs. CHWs perceive that communication barriers create distrust towards them by clinic staff. PLH want automated appointment and medication reminders. KI see mHealth as a way to improve health information transfer to government officials to better allocate healthcare resources. Stakeholders are also optimistic about the ability for biometrics to improve patient identification but disagreed as to which biometrics would be acceptable, especially in older patients. All stakeholders provided useful information towards the development of mHealth systems. Hospitals are adopting patient-centered approaches that solicit feedback from patients and incorporate them into decision-making processes. A similar approach is needed in the development of mHealth systems. Further, such systems are critical to the successful extension of the health system from health facilities into people's homes. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effectiveness of a structured motivational intervention including smoking cessation advice and spirometry information in the primary care setting: the ESPITAP study

PubMed Central

2011-01-01

Background There is current controversy about the efficacy of smoking cessation interventions that are based on information obtained by spirometry. The objective of this study is to evaluate the effectiveness in the primary care setting of structured motivational intervention to achieve smoking cessation, compared with usual clinical practice. Methods Design Multicentre randomized clinical trial with an intervention and a control group. Setting 12 primary care centres in the province of Tarragona (Spain). Subjects of study 600 current smokers aged between 35 and 70 years with a cumulative habit of more than 10 packs of cigarettes per year, attended in primary care for any reason and who did not meet any of the exclusion criteria for the study, randomly assigned to structured intervention or standard clinical attention. Intervention Usual advice to quit smoking by a general practitioner as well as a 20-minute personalized visit to provide detailed information about spirometry results, during which FEV1, FVC, FEF 25-75% and PEF measurements were discussed and interpreted in terms of theoretical values. Additional information included the lung age index (defined as the average age of a non-smoker with the same FEV1 as the study participant), comparing this with the chronological age to illustrate the pulmonary deterioration that results from smoking. Measurements Spirometry during the initial visit. Structured interview questionnaire administered at the primary care centre at the initial visit and at 12-month follow-up. Telephone follow-up interview at 6 months. At 12-month follow-up, expired CO was measured in patients who claimed to have quit smoking. Main variables Smoking cessation at 12 months. Analysis Data will be analyzed on the basis of "intention to treat" and the unit of analysis will be the individual smoker. Expected results Among active smokers treated in primary care we anticipate significantly higher smoking cessation in the intervention group than in the control group. Discussion Application of a motivational intervention based on structured information about spirometry results, improved abstinence rates among smokers seen in actual clinical practice conditions in primary care. Trial registration ClinicalTrial.gov, number NCT01194596. PMID:22078490

FEAR OF PAST ABUSIVE PARTNER(S) IMPACTS CURRENT POSTTRAUMATIC STRESS AMONG WOMEN EXPERIENCING PARTNER VIOLENCE

PubMed Central

Jaquier, Véronique; Sullivan, Tami P.

2014-01-01

This study examines the impact of fear of past abusive partner(s) on posttraumatic stress among 212 community-recruited women currently exposed to intimate partner violence (IPV). The path analysis model tested explained 60% of the variation in IPV-related posttraumatic stress. Findings revealed that fear of past abusive partner(s) was uniquely associated with the severity of current posttraumatic stress symptoms over and above the impact of current IPV or childhood abuse and neglect. Future research should continue examining women's subjective emotional experience of past and current victimization so as to further inform both clinical practice and intervention planning. PMID:24590514

Ethical issues in neonatal and pediatric clinical trials.

PubMed

Laventhal, Naomi; Tarini, Beth A; Lantos, John

2012-10-01

Children have been identified as uniquely vulnerable clinical research subjects since the early 1970s. This article reviews the historical underpinnings of this designation, the current regulatory framework for pediatric and neonatal research, and common problems in pediatric research oversight. It also presents 3 areas of pediatric and neonatal research (genomic screening, healthy children donating stem cells, and therapeutic hypothermia for neonates with hypoxic-ischemic encephalopathy) that highlight contemporary challenges in pediatric research ethics, including balancing risk and benefit, informed consent and assent, and clinical equipoise. Copyright © 2012 Elsevier Inc. All rights reserved.

The Problem of the Psychopharmacologist

ERIC Educational Resources Information Center

Kontos, Nicholas; Querques, John; Freudenreich, Oliver

2006-01-01

Objective: The psychopharmacologist designation currently pervades and heavily influences the practice, perception, and teaching of clinical psychiatry. The authors hope to make a case and provide the raw material for informed discussion of this role during psychiatric residency training. Method: A definition for the psychopharmacologist is…

A Critique of the Diagnostic Construct Schizophrenia

ERIC Educational Resources Information Center

Wong, Stephen E.

2014-01-01

This article examines problems in the clinical utility of the diagnosis of schizophrenia including reliance on questionable data, arbitrary criteria and categorization, inadequate precision for assessment and treatment evaluation, and omission of information on causal current and historical environmental factors. Some alternatives to the…

The evolution of pediatric critical care nursing: past, present, and future.

PubMed

Foglia, Dorothy C; Milonovich, Lisa M

2011-06-01

Although current nursing literature is overflowing with information related to the history of nursing in general, and even pediatric nursing, very little is published about PICU nursing. The evolution of pediatric critical care nursing is presented based on a historical context, the current state, and future projections. More specifically, this treatise focuses on the environment, the patient and family, and of course, the PICU nurse. Concluding remarks provide an insight into how health care reforms and how the use of clinical information technology will affect the role of the pediatric critical care nurse in the future. Copyright © 2011 Elsevier Inc. All rights reserved.

Identifying design considerations for a shared decision aid for use at the point of outpatient clinical care: An ethnographic study at an inner city clinic.

PubMed

Hajizadeh, Negin; Perez Figueroa, Rafael E; Uhler, Lauren M; Chiou, Erin; Perchonok, Jennifer E; Montague, Enid

2013-03-06

Computerized decision aids could facilitate shared decision-making at the point of outpatient clinical care. The objective of this study was to investigate whether a computerized shared decision aid would be feasible to implement in an inner-city clinic by evaluating the current practices in shared decision-making, clinicians' use of computers, patient and clinicians' attitudes and beliefs toward computerized decision aids, and the influence of time on shared decision-making. Qualitative data analysis of observations and semi-structured interviews with patients and clinicians at an inner-city outpatient clinic. The findings provided an exploratory look at the prevalence of shared decision-making and attitudes about health information technology and decision aids. A prominent barrier to clinicians engaging in shared decision-making was a lack of perceived patient understanding of medical information. Some patients preferred their clinicians make recommendations for them rather than engage in formal shared decision-making. Health information technology was an integral part of the clinic visit and welcomed by most clinicians and patients. Some patients expressed the desire to engage with health information technology such as viewing their medical information on the computer screen with their clinicians. All participants were receptive to the idea of a decision aid integrated within the clinic visit although some clinicians were concerned about the accuracy of prognostic estimates for complex medical problems. We identified several important considerations for the design and implementation of a computerized decision aid including opportunities to: bridge clinician-patient communication about medical information while taking into account individual patients' decision-making preferences, complement expert clinician judgment with prognostic estimates, take advantage of patient waiting times, and make tasks involved during the clinic visit more efficient. These findings should be incorporated into the design and implementation of a computerized shared decision aid at an inner-city hospital.

Global shortage of neonatal and paediatric antibiotic trials: rapid review

PubMed Central

Thompson, Georgina; Barker, Charlotte I; Folgori, Laura; Bielicki, Julia A; Bradley, John S; Lutsar, Irja; Sharland, Mike

2017-01-01

Objectives There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. Methods Studies were identified using key word searches of the ClinicalTrials.gov registry and were manually filtered using prespecified inclusion/exclusion criteria. Results 76 registered open CTs of antibiotics in children were identified globally; 23 (30%) were recruiting newborns (only 8 (11%) included preterm neonates), 52 (68%) infants and toddlers, 58 (76%) children and 54 (71%) adolescents. The majority of registered trials were late phase (10 (15%) phase 3 and 23 (35%) phase 4/pharmacovigilance). Two-thirds were sponsored by non-profit organisations, compared with pharmaceutical companies (50 (66%) vs 26 (34%), respectively). A greater proportion of non-profit funded trials were efficacy-based strategic trials (n=34, 68%), in comparison with industry-led trials, which were most often focused on safety or pharmacokinetic data (n=17, 65%). Only 2 of the 37 antibiotics listed on the May 2016 Pew Charitable Trusts antibiotic development pipeline, currently being studied in adults, appear to be currently recruiting in open paediatric CTs. Conclusions This review highlights that very few paediatric antibiotic CTs are being conducted globally, especially in neonates. There is a striking disparity noted between antibiotic drug development programmes in adults and children. PMID:29030411

Integrating Social Determinants of Health into Primary Care Clinical and Informational Workflow during Care Transitions

PubMed Central

Hewner, Sharon; Casucci, Sabrina; Sullivan, Suzanne; Mistretta, Francine; Xue, Yuqing; Johnson, Barbara; Pratt, Rebekah; Lin, Li; Fox, Chester

2017-01-01

Context: Care continuity during transitions between the hospital and home requires reliable communication between providers and settings and an understanding of social determinants that influence recovery. Case Description: The coordinating transitions intervention uses real time alerts, delivered directly to the primary care practice for complex chronically ill patients discharged from an acute care setting, to facilitate nurse care coordinator led telephone outreach. The intervention incorporates claims-based risk stratification to prioritize patients for follow-up and an assessment of social determinants of health using the Patient-centered Assessment Method (PCAM). Results from transitional care are stored and transmitted to qualified healthcare providers across the continuum. Findings: Reliance on tools that incorporated interoperability standards facilitated exchange of health information between the hospital and primary care. The PCAM was incorporated into both the clinical and informational workflow through the collaboration of clinical, industry, and academic partners. Health outcomes improved at the study practice over their baseline and in comparison with control practices and the regional Medicaid population. Major Themes: Current research supports the potential impact of systems approaches to care coordination in improving utilization value after discharge. The project demonstrated that flexibility in developing the informational and clinical workflow was critical in developing a solution that improved continuity during transitions. There is additional work needed in developing managerial continuity across settings such as shared comprehensive care plans. Conclusions: New clinical and informational workflows which incorporate social determinant of health data into standard practice transformed clinical practice and improved outcomes for patients.

Calculating when elective abdominal aortic aneurysm repair improves survival for individual patients: development of the Aneurysm Repair Decision Aid and economic evaluation.

PubMed

Grant, Stuart W; Sperrin, Matthew; Carlson, Eric; Chinai, Natasha; Ntais, Dionysios; Hamilton, Matthew; Dunn, Graham; Buchan, Iain; Davies, Linda; McCollum, Charles N

2015-04-01

Abdominal aortic aneurysm (AAA) repair aims to prevent premature death from AAA rupture. Elective repair is currently recommended when AAA diameter reaches 5.5 cm (men) and 5.0 cm (women). Applying population-based indications may not be appropriate for individual patient decisions, as the optimal indication is likely to differ between patients based on age and comorbidities. To develop an Aneurysm Repair Decision Aid (ARDA) to indicate when elective AAA repair optimises survival for individual patients and to assess the cost-effectiveness and associated uncertainty of elective repair at the aneurysm diameter recommended by the ARDA compared with current practice. The UK Vascular Governance North West and National Vascular Database provided individual patient data to develop predictive models for perioperative mortality and survival. Data from published literature were used to model AAA growth and risk of rupture. The cost-effectiveness analysis used data from published literature and from local and national databases. A combination of systematic review methods and clinical registries were used to provide data to populate models and inform the structure of the ARDA. Discrete event simulation (DES) was used to model the patient journey from diagnosis to death and synthesised data were used to estimate patient outcomes and costs for elective repair at alternative aneurysm diameters. Eight patient clinical scenarios (vignettes) were used as exemplars. The DES structure was validated by clinical and statistical experts. The economic evaluation estimated costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) from the NHS, social care provider and patient perspective over a lifetime horizon. Cost-effectiveness acceptability analyses and probabilistic sensitivity analyses explored uncertainty in the data and the value for money of ARDA-based decisions. The ARDA outcome measures include perioperative mortality risk, annual risk of rupture, 1-, 5- and 10-year survival, postoperative long-term survival, median life expectancy and predicted time to current threshold for aneurysm repair. The primary economic measure was the ICER using the QALY as the measure of health benefit. The analysis demonstrated it is feasible to build and run a complex clinical decision aid using DES. The model results support current guidelines for most vignettes but suggest that earlier repair may be effective in younger, fitter patients and ongoing surveillance may be effective in elderly patients with comorbidities. The model adds information to support decisions for patients with aneurysms outside current indications. The economic evaluation suggests that using the ARDA compared with current guidelines could be cost-effective but there is a high level of uncertainty. Lack of high-quality long-term data to populate all sections of the model meant that there is high uncertainty about the long-term clinical and economic consequences of repair. Modelling assumptions were necessary and the developed survival models require external validation. The ARDA provides detailed information on the potential consequences of AAA repair or a decision not to repair that may be helpful to vascular surgeons and their patients in reaching informed decisions. Further research is required to reduce uncertainty about key data, including reintervention following AAA repair, and assess the acceptability and feasibility of the ARDA for use in routine clinical practice. The National Institute for Health Research Health Technology Assessment programme.

[Clinical research evolution. In parallel with the current changes in welfare expectations and information technology incorporation, study designs and data collection and analysis are quickly changing as well].

PubMed

Tavazzi, Luigi

2015-10-01

The development of both technology, biological, and clinical knowledge leads to remarkable changes of scientific research methodology, including the clinical research. Major changes deal with the pragmatic approach of trial designs, an explosive diffusion of observational research which is becoming a usual component of clinical practice, and an active modelling of new research design. Moreover, a new healthcare landscape could be generated from the information technology routinely used to collect clinical data in huge databases, the management and the analytic methodology of big data, and the development of biological sensors compatible with the daily life delivering signals remotely forwardable to central databases. Precision medicine and individualized medicine seem to be the big novelties of the coming years, guiding to a shared pattern of patient/physician relationship. In healthcare, a huge business related mainly, but not exclusively, to the implementation of information technology is growing. This development will favor radical changes in the health systems, also reshaping the clinical activity. A new governance of the research strategies is needed and the application of the results should be based on shared ethical foundations. This new evolving profile of medical research and practice is discussed in this paper.

Fundamentals of functional imaging II: emerging MR techniques and new methods of analysis.

PubMed

Luna, A; Martín Noguerol, T; Mata, L Alcalá

2018-05-01

Current multiparameter MRI protocols integrate structural, physiological, and metabolic information about cancer. Emerging techniques such as arterial spin-labeling (ASL), blood oxygen level dependent (BOLD), MR elastography, chemical exchange saturation transfer (CEST), and hyperpolarization provide new information and will likely be integrated into daily clinical practice in the near future. Furthermore, there is great interest in the study of tumor heterogeneity as a prognostic factor and in relation to resistance to treatment, and this interest is leading to the application of new methods of analysis of multiparametric protocols. In parallel, new oncologic biomarkers that integrate the information from MR with clinical, laboratory, genetic, and histologic findings are being developed, thanks to the application of big data and artificial intelligence. This review analyzes different emerging MR techniques that are able to evaluate the physiological, metabolic, and mechanical characteristics of cancer, as well as the main clinical applications of these techniques. In addition, it summarizes the most novel methods of analysis of functional radiologic information in oncology. Copyright © 2018 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.

Current Status of Pediatric Labeling in China and the near Future Efforts Needed for the Country

PubMed Central

Li, Zhiping; Wang, Yi; Wu, Dan; Gao, Xuan; Wang, Zhiyun

2014-01-01

Background: Children are recognized as “therapeutic orphan” in many parts of the world, one expression of this is the lack of adequate pediatric labeling information. Some research studies have been done to investigate the pediatric labeling condition in the U.S. and other countries, but no national studies had been carried out in China. This survey was conducted aiming to inquire the current situation of pediatric labeling in China. Methods: We investigated 6020 child-applied medicines from 15 representative Chinese hospitals, and analyzed the information according to the dosage forms, therapeutic category, and label information integrity. Results: Among all these medicines, only 238 (3.95%) are pediatric products, the rest are adult formulations with an extended use in children. The major pediatric formulations were injection (45.95%), tablet (23.69%), and capsule (4.93%), respectively. Alimentary tract/metabolism medicine (24.70%) and infections medicines (20.60%) had the most species. In prescription drugs, only 210 of 5187 (4%) medicines had adequate pediatric labeling information. The main cause of this deficiency was lack of evidence derived from pediatric clinical trials. Conclusion: The dilemma of “therapeutic orphan” requires significant attention. Inadequate labeling information and lack of pediatric clinical trials were two prominent issues in China. It calls for more efforts from pharmaceutical industries, regulatory agencies, and legislature in China to collaborate and find solution to improve the situation. PMID:24724075

Information Literacy for Users at the National Medical Library of Cuba: Cochrane Library Course for the Search of Best Evidence for Clinical Decisions

ERIC Educational Resources Information Center

Santana Arroyo, Sonia; del Carmen Gonzalez Rivero, Maria

2012-01-01

The National Medical Library of Cuba is currently developing an information literacy program to train users in the use of biomedical databases. This paper describes the experience with the course "Cochrane Library: Evidence-Based Medicine," which aims to teach users how to make the best use of this database, as well as the evidence-based…

[The Explore of the Security Strategy Model in Hospital Mobile Clinic New Mode].

PubMed

Li, Ke; Xia, Yong; Wang, Wei

2016-03-01

The paper elaborates and analyzes the current status of mobile hospital information security, then puts forward a security new model of the mobile treatment, then its architecture and solutions is elaborated. The use of this model makes the overall security level of hospital information to be further improved and enhanced, it has a positive signifi cance to promote the overal hospital management level.

New Unintended Adverse Consequences of Electronic Health Records

PubMed Central

Wright, A.; Ash, J.; Singh, H.

2016-01-01

Summary Although the health information technology industry has made considerable progress in the design, development, implementation, and use of electronic health records (EHRs), the lofty expectations of the early pioneers have not been met. In 2006, the Provider Order Entry Team at Oregon Health & Science University described a set of unintended adverse consequences (UACs), or unpredictable, emergent problems associated with computer-based provider order entry implementation, use, and maintenance. Many of these originally identified UACs have not been completely addressed or alleviated, some have evolved over time, and some new ones have emerged as EHRs became more widely available. The rapid increase in the adoption of EHRs, coupled with the changes in the types and attitudes of clinical users, has led to several new UACs, specifically: complete clinical information unavailable at the point of care; lack of innovations to improve system usability leading to frustrating user experiences; inadvertent disclosure of large amounts of patient-specific information; increased focus on computer-based quality measurement negatively affecting clinical workflows and patient-provider interactions; information overload from marginally useful computer-generated data; and a decline in the development and use of internally-developed EHRs. While each of these new UACs poses significant challenges to EHR developers and users alike, they also offer many opportunities. The challenge for clinical informatics researchers is to continue to refine our current systems while exploring new methods of overcoming these challenges and developing innovations to improve EHR interoperability, usability, security, functionality, clinical quality measurement, and information summarization and display. PMID:27830226

Smartphone Applications for the Clinical Oncologist in UK Practice.

PubMed

Rozati, Hamoun; Shah, Sonya Pratik; Shah, Neha

2015-06-01

A number of medical smartphone applications have been developed to assist clinical oncology specialists. Concerns have arisen that the information provided may not be under sufficient scrutiny. This study aims to analyse the current applications available for clinical oncologists in the UK. Applications aimed specifically at physician clinical oncologists were searched for on the major smartphone operating systems: Apple iOS; Google Android; Microsoft Windows OS; and Blackberry OS. All applications were installed and analysed. The applications were scrutinised to assess the following information: cost; whether the information included was referenced; when the information was last updated; and whether they made any reference to UK guidelines. A novel rating score based on these criteria was applied to each application. Fifty applications were identified: 24 for Apple's iOS; 23 for Google's Android; 2 for Blackberry OS; and 1 for Windows OS. The categories of applications available were: drug reference; journal reference; learning; clinical calculators; decision support; guidelines; and dictionaries. Journal reference and guideline applications scored highly on our rating system. Drug reference application costs were prohibitive. Learning tools were poorly referenced and not up-to-date. Smartphones provide easy access to information. There are numerous applications devoted to oncology physicians, many of which are free and contain referenced, up-to-date data. The cost and quality of drug reference and learning applications have significant scope for improvement. A regulatory body is needed to ensure the presence of peer-reviewed, validated applications to ensure their reliability.

Preliminary Development of an Informational Media Use Measure for Patients with Implanted Defibrillators: Toward a Model of Social-Ecological Assessment of Patient Education and Support.

PubMed

Knoepke, Christopher E; Matlock, Daniel D

2017-11-01

Social work interventions in health care, particularly those that involve working with people being treated for chronic and life-threatening conditions, frequently involve efforts to educate patients about their disease, treatment options, safety planning, medical adherence, and other associated issues. Despite an intuitive notion that patients access information about all of these issues through a variety of media-both inside and outside the clinical encounter, created by professionals and by others-there currently exists no validated means of assessing patients' use of these forms of information. To address this gap, authors first created candidate item measures with input from both physicians and a small group of diverse patients who currently have an implantable cardioverter defibrillator (ICD), a sophisticated cardiac device for which a trajectory model of social work intervention was recently outlined. Authors then surveyed a group of 205 individuals who have these devices, assessing their use of various media to learn about ICDs. They then conducted factor and item analysis to refine and remove poorly performing items while delineating forms of media use by type. The resultant preliminary measure of informational media use can be further refined and adapted for use with any clinical population. © 2017 National Association of Social Workers.

Replacing Smartphones With Mini Tablet Technology: An Evaluation.

PubMed

Maneval, Rhonda; Mechtel, Marci

Handheld technology allows students to access point-of-care resources throughout the clinical experience. To assess the viability of replacing student smartphones with tablets, an evaluation project was undertaken. Overall, students were equally dissatisfied with the 2 types of tablets that were evaluated. Students saw the potential usefulness of tablets to manage clinical assignments, interact with the learning management system, and communicate with faculty, but not for retrieving information currently accessible on their phones.

Extending the surrogacy analogy: applying the advance directive model to biobanks.

PubMed

Solomon, Stephanie; Mongoven, Ann

2015-01-01

Biobank donors and biobank governance face a conceptual challenge akin to clinical patients and their designated surrogate decision-makers, the necessity of making decisions and policies now that must be implemented under future unknown circumstances. We propose that biobanks take advantage of this parallel to learn lessons from the historical trajectory of advance directives and develop models analogous to current 'best practice' advance directives such as Values Histories and TheFive Wishes. We suggest how such models could improve biobanks' engagement both with communities and with individual donors by being more honest about the limits of current disclosure and eliciting information to ensure the protection of donor interests more robustly through time than current 'informed consent' processes in biobanking. © 2014 S. Karger AG, Basel.

Cost effective Internet access and video conferencing for a community cancer network.

PubMed Central

London, J. W.; Morton, D. E.; Marinucci, D.; Catalano, R.; Comis, R. L.

1995-01-01

Utilizing the ubiquitous personal computer as a platform, and Integrated Services Digital Network (ISDN) communications, cost effective medical information access and consultation can be provided for physicians at geographically remote sites. Two modes of access are provided: information retrieval via the Internet, and medical consultation video conferencing. Internet access provides general medical information such as current treatment options, literature citations, and active clinical trials. During video consultations, radiographic and pathology images, and medical text reports (e.g., history and physical, pathology, radiology, clinical laboratory reports), may be viewed and simultaneously annotated by either video conference participant. Both information access modes have been employed by physicians at community hospitals which are members of the Jefferson Cancer Network, and oncologists at Thomas Jefferson University Hospital. This project has demonstrated the potential cost effectiveness and benefits of this technology. Images Figure 1 Figure 2 Figure 3 PMID:8563397

Digital technology and clinical decision making in depression treatment: Current findings and future opportunities.

PubMed

Hallgren, Kevin A; Bauer, Amy M; Atkins, David C

2017-06-01

Clinical decision making encompasses a broad set of processes that contribute to the effectiveness of depression treatments. There is emerging interest in using digital technologies to support effective and efficient clinical decision making. In this paper, we provide "snapshots" of research and current directions on ways that digital technologies can support clinical decision making in depression treatment. Practical facets of clinical decision making are reviewed, then research, design, and implementation opportunities where technology can potentially enhance clinical decision making are outlined. Discussions of these opportunities are organized around three established movements designed to enhance clinical decision making for depression treatment, including measurement-based care, integrated care, and personalized medicine. Research, design, and implementation efforts may support clinical decision making for depression by (1) improving tools to incorporate depression symptom data into existing electronic health record systems, (2) enhancing measurement of treatment fidelity and treatment processes, (3) harnessing smartphone and biosensor data to inform clinical decision making, (4) enhancing tools that support communication and care coordination between patients and providers and within provider teams, and (5) leveraging treatment and outcome data from electronic health record systems to support personalized depression treatment. The current climate of rapid changes in both healthcare and digital technologies facilitates an urgent need for research, design, and implementation of digital technologies that explicitly support clinical decision making. Ensuring that such tools are efficient, effective, and usable in frontline treatment settings will be essential for their success and will require engagement of stakeholders from multiple domains. © 2017 Wiley Periodicals, Inc.

Information and image integration: project spectrum

NASA Astrophysics Data System (ADS)

Blaine, G. James; Jost, R. Gilbert; Martin, Lori; Weiss, David A.; Lehmann, Ron; Fritz, Kevin

1998-07-01

The BJC Health System (BJC) and the Washington University School of Medicine (WUSM) formed a technology alliance with industry collaborators to develop and implement an integrated, advanced clinical information system. The industry collaborators include IBM, Kodak, SBC and Motorola. The activity, called Project Spectrum, provides an integrated clinical repository for the multiple hospital facilities of the BJC. The BJC System consists of 12 acute care hospitals serving over one million patients in Missouri and Illinois. An interface engine manages transactions from each of the hospital information systems, lab systems and radiology information systems. Data is normalized to provide a consistent view for the primary care physician. Access to the clinical repository is supported by web-based server/browser technology which delivers patient data to the physician's desktop. An HL7 based messaging system coordinates the acquisition and management of radiological image data and sends image keys to the clinical data repository. Access to the clinical chart browser currently provides radiology reports, laboratory data, vital signs and transcribed medical reports. A chart metaphor provides tabs for the selection of the clinical record for review. Activation of the radiology tab facilitates a standardized view of radiology reports and provides an icon used to initiate retrieval of available radiology images. The selection of the image icon spawns an image browser plug-in and utilizes the image key from the clinical repository to access the image server for the requested image data. The Spectrum system is collecting clinical data from five hospital systems and imaging data from two hospitals. Domain specific radiology imaging systems support the acquisition and primary interpretation of radiology exams. The spectrum clinical workstations are deployed to over 200 sites utilizing local area networks and ISDN connectivity.

Gait Analysis Using Wearable Sensors

PubMed Central

Tao, Weijun; Liu, Tao; Zheng, Rencheng; Feng, Hutian

2012-01-01

Gait analysis using wearable sensors is an inexpensive, convenient, and efficient manner of providing useful information for multiple health-related applications. As a clinical tool applied in the rehabilitation and diagnosis of medical conditions and sport activities, gait analysis using wearable sensors shows great prospects. The current paper reviews available wearable sensors and ambulatory gait analysis methods based on the various wearable sensors. After an introduction of the gait phases, the principles and features of wearable sensors used in gait analysis are provided. The gait analysis methods based on wearable sensors is divided into gait kinematics, gait kinetics, and electromyography. Studies on the current methods are reviewed, and applications in sports, rehabilitation, and clinical diagnosis are summarized separately. With the development of sensor technology and the analysis method, gait analysis using wearable sensors is expected to play an increasingly important role in clinical applications. PMID:22438763

Clinical application of high throughput molecular screening techniques for pharmacogenomics

PubMed Central

Wiita, Arun P; Schrijver, Iris

2011-01-01

Genetic analysis is one of the fastest-growing areas of clinical diagnostics. Fortunately, as our knowledge of clinically relevant genetic variants rapidly expands, so does our ability to detect these variants in patient samples. Increasing demand for genetic information may necessitate the use of high throughput diagnostic methods as part of clinically validated testing. Here we provide a general overview of our current and near-future abilities to perform large-scale genetic testing in the clinical laboratory. First we review in detail molecular methods used for high throughput mutation detection, including techniques able to monitor thousands of genetic variants for a single patient or to genotype a single genetic variant for thousands of patients simultaneously. These methods are analyzed in the context of pharmacogenomic testing in the clinical laboratories, with a focus on tests that are currently validated as well as those that hold strong promise for widespread clinical application in the near future. We further discuss the unique economic and clinical challenges posed by pharmacogenomic markers. Our ability to detect genetic variants frequently outstrips our ability to accurately interpret them in a clinical context, carrying implications both for test development and introduction into patient management algorithms. These complexities must be taken into account prior to the introduction of any pharmacogenomic biomarker into routine clinical testing. PMID:23226057

Step Up-Not On-The Step 2 Clinical Skills Exam: Directors of Clinical Skills Courses (DOCS) Oppose Ending Step 2 CS.

PubMed

Ecker, David J; Milan, Felise B; Cassese, Todd; Farnan, Jeanne M; Madigosky, Wendy S; Massie, F Stanford; Mendez, Paul; Obadia, Sharon; Ovitsh, Robin K; Silvestri, Ronald; Uchida, Toshiko; Daniel, Michelle

2018-05-01

Recently, a student-initiated movement to end the United States Medical Licensing Examination Step 2 Clinical Skills and the Comprehensive Osteopathic Medical Licensing Examination Level 2-Performance Evaluation has gained momentum. These are the only national licensing examinations designed to assess clinical skills competence in the stepwise process through which physicians gain licensure and certification. Therefore, the movement to end these examinations and the ensuing debate merit careful consideration. The authors, elected representatives of the Directors of Clinical Skills Courses, an organization comprising clinical skills educators in the United States and beyond, believe abolishing the national clinical skills examinations would have a major negative impact on the clinical skills training of medical students, and that forfeiting a national clinical skills competency standard has the potential to diminish the quality of care provided to patients. In this Perspective, the authors offer important additional background information, outline key concerns regarding the consequences of ending these national clinical skills examinations, and provide recommendations for moving forward: reducing the costs for students, exploring alternatives, increasing the value and transparency of the current examinations, recognizing and enhancing the strengths of the current examinations, and engaging in a national dialogue about the issue.

Perception matters for clinical perfectionism and social anxiety.

PubMed

Levinson, Cheri A; Rodebaugh, Thomas L; Shumaker, Erik A; Menatti, Andrew R; Weeks, Justin W; White, Emily K; Heimberg, Richard G; Warren, Cortney S; Blanco, Carlos; Schneier, Franklin; Liebowitz, Michael R

2015-01-01

Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N=602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N=180), and by using a variance decomposition model of self- and informant-report of perfectionism (N=134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants' perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Evolving Classification of Pulmonary Hypertension.

PubMed

Foshat, Michelle; Boroumand, Nahal

2017-05-01

- An explosion of information on pulmonary hypertension has occurred during the past few decades. The perception of this disease has shifted from purely clinical to incorporate new knowledge of the underlying pathology. This transfer has occurred in light of advancements in pathophysiology, histology, and molecular medical diagnostics. - To update readers about the evolving understanding of the etiology and pathogenesis of pulmonary hypertension and to demonstrate how pathology has shaped the current classification. - Information presented at the 5 World Symposia on pulmonary hypertension held since 1973, with the last meeting occurring in 2013, was used in this review. - Pulmonary hypertension represents a heterogeneous group of disorders that are differentiated based on differences in clinical, hemodynamic, and histopathologic features. Early concepts of pulmonary hypertension were largely influenced by pharmacotherapy, hemodynamic function, and clinical presentation of the disease. The initial nomenclature for pulmonary hypertension segregated the clinical classifications from pathologic subtypes. Major restructuring of this disease classification occurred between the first and second symposia, which was the first to unite clinical and pathologic information in the categorization scheme. Additional changes were introduced in subsequent meetings, particularly between the third and fourth World Symposia meetings, when additional pathophysiologic information was gained. Discoveries in molecular diagnostics significantly progressed the understanding of idiopathic pulmonary arterial hypertension. Continued advancements in imaging modalities, mechanistic pathogenicity, and molecular biomarkers will enable physicians to define pulmonary hypertension phenotypes based on the pathobiology and allow for treatment customization.

Health Information Technology: Meaningful Use and Next Steps to Improving Electronic Facilitation of Medication Adherence.

PubMed

Bosworth, Hayden B; Zullig, Leah L; Mendys, Phil; Ho, Michael; Trygstad, Troy; Granger, Christopher; Oakes, Megan M; Granger, Bradi B

2016-03-15

The use of health information technology (HIT) may improve medication adherence, but challenges for implementation remain. The aim of this paper is to review the current state of HIT as it relates to medication adherence programs, acknowledge the potential barriers in light of current legislation, and provide recommendations to improve ongoing medication adherence strategies through the use of HIT. We describe four potential HIT barriers that may impact interoperability and subsequent medication adherence. Legislation in the United States has incentivized the use of HIT to facilitate and enhance medication adherence. The Health Information Technology for Economic and Clinical Health (HITECH) was recently adopted and establishes federal standards for the so-called "meaningful use" of certified electronic health record (EHR) technology that can directly impact medication adherence. The four persistent HIT barriers to medication adherence include (1) underdevelopment of data reciprocity across clinical, community, and home settings, limiting the capture of data necessary for clinical care; (2) inconsistent data definitions and lack of harmonization of patient-focused data standards, making existing data difficult to use for patient-centered outcomes research; (3) inability to effectively use the national drug code information from the various electronic health record and claims datasets for adherence purposes; and (4) lack of data capture for medication management interventions, such as medication management therapy (MTM) in the EHR. Potential recommendations to address these issues are discussed. To make meaningful, high quality data accessible, and subsequently improve medication adherence, these challenges will need to be addressed to fully reach the potential of HIT in impacting one of our largest public health issues.

Desiderata for a Computer-Assisted Audit Tool for Clinical Data Source Verification Audits

PubMed Central

Duda, Stephany N.; Wehbe, Firas H.; Gadd, Cynthia S.

2013-01-01

Clinical data auditing often requires validating the contents of clinical research databases against source documents available in health care settings. Currently available data audit software, however, does not provide features necessary to compare the contents of such databases to source data in paper medical records. This work enumerates the primary weaknesses of using paper forms for clinical data audits and identifies the shortcomings of existing data audit software, as informed by the experiences of an audit team evaluating data quality for an international research consortium. The authors propose a set of attributes to guide the development of a computer-assisted clinical data audit tool to simplify and standardize the audit process. PMID:20841814

Phage therapy.

PubMed

Housby, John N; Mann, Nicholas H

2009-06-01

There is a renaissance of interest in the antimicrobial potential of phages as more pathogens become multiply antibiotic resistant. Phage therapy is not a new concept, and it is important to ask why it is not part of the current repertoire of western medicine despite the fact that it has been continuously and extensively used in Eastern Europe for almost a century. Answering this question successfully will, largely, determine whether phage therapy can gain the credibility needed to overcome the scientific, financial and regulatory hurdles facing its adoption in mainstream clinical practice. Despite a paucity of such information from human studies, pharmacokinetic data and clinical outcomes from animal studies are currently providing convincing evidence for the safety and efficacy of phage therapy.

Wound care in the wilderness: is there evidence for honey?

PubMed

Stewart, James Austin; McGrane, Owen Lane; Wedmore, Ian S

2014-03-01

Honey is one of the most ancient remedies for wound care. Current research has shown promising results for its use in wound care. This review is intended to inform readers of the physiological properties of honey and the evidence that exists to support its clinical use. When compared with evidence for current wound treatment, honey has proven to be a safe, effective, and sometimes superior treatment for various wounds. There are currently US Food and Drug Administration-approved medical-grade honey products available in the United States. Although there have been no clinical trials exploring the use of honey in wilderness environments, it may be a safe, improvisational wound treatment. More robust studies are needed for definitive conclusions of its efficacy and safety. Published by Wilderness Medical Society on behalf of Wilderness Medical Society.

Understanding Financial Statements in Clinical Practice: A Primer.

PubMed

Makanji, Heeren S; Jenis, Louis G

2017-05-01

The purpose of this article is to describe the different types of financial statements and the information they contain regarding the current and long-term financial health of a business practice. These statements are essential to guiding strategic decision making for physicians and executives.

Healing Magazine, Volume 8, 2003.

ERIC Educational Resources Information Center

2003

This volume of "Healing Magazine" features practical, clinical information aimed at sharing current work in children's mental health. The first issue contains articles on intervention for self-injurious behavior, providing school-based grief groups, effectively using time-out as a parenting tool, and KidsPeace's suicide prevention…

Continuing Education in the Professions. Current Information Sources, No. 24.

ERIC Educational Resources Information Center

Syracuse Univ., NY. ERIC Clearinghouse on Adult Education.

Beginning with bibliographies, surveys, and other general works, this 225-item annotated bibliography on professional continuing education covers the following areas: engineering and technical education; chemistry and clinical psychology; medicine and health (including psychiatry); inservice education and retraining for lawyers, law enforcement…

ADAP: A Divorce Assessment Proposal.

ERIC Educational Resources Information Center

Ferreiro, Beverly Webster; And Others

1986-01-01

Proposed guidelines for mental health clinicians in assessing clients' divorce-related concerns. Current empirical information on factors affecting individual and family adjustment after divorce is organized into a practical format for clinical application. Details a comprehensive assessment that will help the clinician to understand the client's…

Wife Abuse and the Wife Abuser: Review and Recommendations.

ERIC Educational Resources Information Center

Carden, Ann D.

1994-01-01

Reviews clinical, theoretical, and empirical literature on wife abuse/abusers. Presents historical and contextual information, overview of domestic violence, prevalence data, and descriptions of evolution and current status of public and professional awareness and response. Proposes integrative model for understanding etiologic, dynamic, and…

Are Genetic Tests for Atherosclerosis Ready for Routine Clinical Use?

PubMed

Paynter, Nina P; Ridker, Paul M; Chasman, Daniel I

2016-02-19

In this review, we lay out 3 areas currently being evaluated for incorporation of genetic information into clinical practice related to atherosclerosis. The first, familial hypercholesterolemia, is the clearest case for utility of genetic testing in diagnosis and potentially guiding treatment. Already in use for confirmatory testing of familial hypercholesterolemia and for cascade screening of relatives, genetic testing is likely to expand to help establish diagnoses and facilitate research related to most effective therapies, including new agents, such as PCSK9 inhibitors. The second area, adding genetic information to cardiovascular risk prediction for primary prevention, is not currently recommended. Although identification of additional variants may add substantially to prediction in the future, combining known variants has not yet demonstrated sufficient improvement in prediction for incorporation into commonly used risk scores. The third area, pharmacogenetics, has utility for some therapies today. Future utility for pharmacogenetics will wax or wane depending on the nature of available drugs and therapeutic strategies. © 2016 American Heart Association, Inc.

Self-etching adhesives: review of adhesion to tooth structure part II.

PubMed

Strydom, C

2005-02-01

Self-etching adhesives are steadily increasing in popularity among dental practitioners with their easy handling technique and their promise of no post-op sensitivity. As with any new bonding material, in vitro and in vivo investigations are required to assess the clinical efficacy of these systems. The current literature was reviewed to provide information on these systems, including the influence of their acidity and permeability on the quality of the bond, the role of water in long-term degradation of the bond in in vivo and in vitro studies, and the clinical efficacy of the self-etching adhesives in clinical research studies. Published abstracts, reviews, laboratory reports and clinical research papers in the dental literature. Very little information is available on self-etching systems pertaining to the long-term in vitro and in vivo durability of their bond and their medium- to long-term clinical outcome. Although post-op sensitivity seems to be something of the past, short-term clinical studies show that some self-etching adhesives do not perform as well as total-etch systems.

Clinical 3D printing: A protected health information (PHI) and compliance perspective.

PubMed

Feldman, Henry; Kamali, Parisa; Lin, Samuel J; Halamka, John D

2018-07-01

Advanced manufacturing techniques such as 3-dimensional (3D) printing, while mature in other industries, are starting to become more commonplace in clinical care. Clinicians are producing physical objects based on patient clinical data for use in planning care and educating patients, all of which should be managed like any other healthcare system data, except it exists in the "real" world. There are currently no provisions in the Health Insurance Portability and Accountability Act (HIPAA) either in its original 1996 form or in more recent updates that address the nature of physical representations of clinical data. We submit that if we define the source data as protected health information (PHI), then the objects 3D printed from that data need to be treated as both (PHI), and if used clinically, part of the clinical record, and propose some basic guidelines for quality and privacy like all documentation until regulatory frameworks can catch up to this technology. Many of the mechanisms designed in the paper and film chart era will work well with 3D printed patient data. Copyright © 2018 Elsevier B.V. All rights reserved.

Hemorrhage Control for Major Traumatic Vascular Injuries

DTIC Science & Technology

2017-10-01

subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number. PLEASE DO...aims: 1) Determine current practice patterns for the treatment of patients with NCTH among 4 clinical sites using a retrospective study design (Phase...competency, and training issues for catheter-based hemorrhage control (Phase 1b); 3) Conduct a prospective 4-site observational study to test the hypothesis

RECONCEPTUALIZING CONSENT FOR DIRECT-TO-CONSUMER HEALTH SERVICES.

PubMed

Spector-Bagdady, Kayte

2015-01-01

The market for direct-to-consumer (DTC) health services continues to grow rapidly with former patients converting to customers for the opportunity to purchase varied diagnostic tests without the involvement of their clinician. For the first time a DTC genetic testing company is advertising health-related reports "that meet [Food and Drug Administration] standards for being clinically and scientifically valid." Ethicists and regulatory agencies alike have recognized the need for a more informed transaction in the DTC context, but how should we classify a commercial transaction for something normally protected by a duty of care? How can we assure informed agreements in an industry with terms and conditions as varied as the services performed? The doctrine of "informed consent" began as an ethical construct building on the promise of beneficence in the clinical relationship and elevating the principle of autonomy--but in the DTC context should we hold providers to legal standards of informed consent and associated medical malpractice liability, or contractual obligations where consumers would seek remedy for breach? This Article analyzes the fine balance that must be struck in an industry where companies are selling services for entertainment or non-medical purposes that possess the capacity to produce serious and disquieting medical information. It begins by reviewing current standards of consent in the clinical setting from both a legal and ethical perspective and then lays forth current standards for DTC consent using two currently controversial case studies: that of keepsake fetal ultrasound and genetic testing. DTC keepsake ultrasound and genetic testing providers attempt to de-medicalize the devices used for these procedures from their intended medical uses to non-medical uses. But while keepsake ultrasound is marketed as "intended for entertainment purposes only," it can provide medical information as an incidental finding. 23andMe currently purports to be the only DTC genetics service that "includes" reports that meet FDA qualifications, despite disclaimers of intent to "provide medical advice." The attempted de-medicalization of these devices, therefore, has not been fully transformative, and DTC providers should have more robust ethical and legal duties than the average goods and services seller. This Article delineates these responsibilities, beginning with ethical duties surrounding marketing, entering into, and providing DTC services. It then turns to the legal paradigms necessary to enable, or at least allow for, DTC providers to meet these ethical obligations. While it argues that contractual, as opposed to fiduciary, requirements are most appropriate and that waivers of liability will likely be upheld, it also advocates for a heightened expectation of disclosure during contracting.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pituitary disorders as a predictor of apathy and executive dysfunction in adult survivors of childhood brain tumors.

PubMed

Fox, Michelle E; King, Tricia Z

2016-11-01

The relationship between apathy and endocrine dysfunction, both frequent outcomes of neurological insult, has not yet been investigated in brain tumor survivors. The present study aimed to assess the relationship between pituitary disorders and apathy and other facets of executive function in long-term adult survivors of childhood brain tumors and to differentiate between apathy and depression in this population. Seventy-six adult survivors of childhood brain tumors at least 5 years past diagnosis participated. An informant completed the Frontal Systems Behavior Scale (FrSBe), and 75 of the 76 participants completed a Structured Clinical Interview for the DSM-IV-TR (SCID). Information on neuroendocrine dysfunction was obtained through medical chart review. Clinically significant levels of apathy on the FrSBe were identified in 41% of survivors. Pituitary dysfunction significantly explained 9% of the variance in apathy scores and affected whether an individual presented with clinical levels of apathy. Pituitary dysfunction predicted higher levels of executive dysfunction but did not impact whether a participant reached clinical levels of executive dysfunction. A past major depressive episode (MDE) significantly predicted current apathy but showed no relationship with pituitary disorders. Radiation treatment predicted pituitary dysfunction but not the differences in apathy or executive functions. Apathy and executive dysfunction in survivors of childhood brain tumors are strongly predicted by pituitary dysfunction, and individuals with pituitary dysfunction are more likely to present with clinical levels of apathy as adults. Clinical levels of apathy may present absent of current depression, and pituitary dysfunction impacts apathy uniquely. © 2016 Wiley Periodicals, Inc.

Development of a relational database to capture and merge clinical history with the quantitative results of radionuclide renography.

PubMed

Folks, Russell D; Savir-Baruch, Bital; Garcia, Ernest V; Verdes, Liudmila; Taylor, Andrew T

2012-12-01

Our objective was to design and implement a clinical history database capable of linking to our database of quantitative results from (99m)Tc-mercaptoacetyltriglycine (MAG3) renal scans and export a data summary for physicians or our software decision support system. For database development, we used a commercial program. Additional software was developed in Interactive Data Language. MAG3 studies were processed using an in-house enhancement of a commercial program. The relational database has 3 parts: a list of all renal scans (the RENAL database), a set of patients with quantitative processing results (the Q2 database), and a subset of patients from Q2 containing clinical data manually transcribed from the hospital information system (the CLINICAL database). To test interobserver variability, a second physician transcriber reviewed 50 randomly selected patients in the hospital information system and tabulated 2 clinical data items: hydronephrosis and presence of a current stent. The CLINICAL database was developed in stages and contains 342 fields comprising demographic information, clinical history, and findings from up to 11 radiologic procedures. A scripted algorithm is used to reliably match records present in both Q2 and CLINICAL. An Interactive Data Language program then combines data from the 2 databases into an XML (extensible markup language) file for use by the decision support system. A text file is constructed and saved for review by physicians. RENAL contains 2,222 records, Q2 contains 456 records, and CLINICAL contains 152 records. The interobserver variability testing found a 95% match between the 2 observers for presence or absence of ureteral stent (κ = 0.52), a 75% match for hydronephrosis based on narrative summaries of hospitalizations and clinical visits (κ = 0.41), and a 92% match for hydronephrosis based on the imaging report (κ = 0.84). We have developed a relational database system to integrate the quantitative results of MAG3 image processing with clinical records obtained from the hospital information system. We also have developed a methodology for formatting clinical history for review by physicians and export to a decision support system. We identified several pitfalls, including the fact that important textual information extracted from the hospital information system by knowledgeable transcribers can show substantial interobserver variation, particularly when record retrieval is based on the narrative clinical records.

The Oral Microbiome Bank of China.

PubMed

Xian, Peng; Xuedong, Zhou; Xin, Xu; Yuqing, Li; Yan, Li; Jiyao, Li; Xiaoquan, Su; Shi, Huang; Jian, Xu; Ga, Liao

2018-05-03

The human microbiome project (HMP) promoted further understanding of human oral microbes. However, research on the human oral microbiota has not made as much progress as research on the gut microbiota. Currently, the causal relationship between the oral microbiota and oral diseases remains unclear, and little is known about the link between the oral microbiota and human systemic diseases. To further understand the contribution of the oral microbiota in oral diseases and systemic diseases, a Human Oral Microbiome Database (HOMD) was established in the US. The HOMD includes 619 taxa in 13 phyla, and most of the microorganisms are from American populations. Due to individual differences in the microbiome, the HOMD does not reflect the Chinese oral microbial status. Herein, we established a new oral microbiome database-the Oral Microbiome Bank of China (OMBC, http://www.sklod.org/ombc ). Currently, the OMBC includes information on 289 bacterial strains and 720 clinical samples from the Chinese population, along with lab and clinical information. The OMBC is the first curated description of a Chinese-associated microbiome; it provides tools for use in investigating the role of the oral microbiome in health and diseases, and will give the community abundant data and strain information for future oral microbial studies.

The Healthnet project: extending online information resources to end users in rural hospitals.

PubMed

Holtum, E; Zollo, S A

1998-10-01

The importance of easily available, high quality, and current biomedical literature within the clinical enterprise is now widely documented and accepted. Access to this information has been shown to have a direct bearing on diagnosis, choices of tests, choices of drugs, and length of hospital stay. However, many health professionals do not have adequate access to current health information, particularly those practicing in rural, isolated, or underserved hospitals. Thanks to a three-year telemedicine award from the National Library of Medicine, The University of Iowa (UI) has developed a high-speed, point-to-point telecommunications network to deliver clinical and educational applications to ten community-based Iowa hospitals. One of the services offered over the network allows health professionals from the site hospitals to access online health databases and order articles via an online document delivery service. Installation, training, and troubleshooting support are provided to the remote sites by UI project staff. To date, 1,339 health professionals from the ten networked hospitals have registered to use the Healthnet program. Despite the friendly interface on the computer workstations installed at the sites, training emerged as the key issue in maximizing health professional utilization of these programs.

The Healthnet project: extending online information resources to end users in rural hospitals.

PubMed Central

Holtum, E; Zollo, S A

1998-01-01

The importance of easily available, high quality, and current biomedical literature within the clinical enterprise is now widely documented and accepted. Access to this information has been shown to have a direct bearing on diagnosis, choices of tests, choices of drugs, and length of hospital stay. However, many health professionals do not have adequate access to current health information, particularly those practicing in rural, isolated, or underserved hospitals. Thanks to a three-year telemedicine award from the National Library of Medicine, The University of Iowa (UI) has developed a high-speed, point-to-point telecommunications network to deliver clinical and educational applications to ten community-based Iowa hospitals. One of the services offered over the network allows health professionals from the site hospitals to access online health databases and order articles via an online document delivery service. Installation, training, and troubleshooting support are provided to the remote sites by UI project staff. To date, 1,339 health professionals from the ten networked hospitals have registered to use the Healthnet program. Despite the friendly interface on the computer workstations installed at the sites, training emerged as the key issue in maximizing health professional utilization of these programs. PMID:9803302

HIV Surveillance Among Pregnant Women Attending Antenatal Clinics: Evolution and Current Direction.

PubMed

Dee, Jacob; Garcia Calleja, Jesus M; Marsh, Kimberly; Zaidi, Irum; Murrill, Christopher; Swaminathan, Mahesh

2017-12-05

Since the late 1980s, human immunodeficiency virus (HIV) sentinel serosurveillance among pregnant women attending select antenatal clinics (ANCs) based on unlinked anonymous testing (UAT) has provided invaluable information for tracking HIV prevalence and trends and informing global and national HIV models in most countries with generalized HIV epidemics. However, increased coverage of HIV testing, prevention of mother-to-child transmission (PMTCT), and antiretroviral therapy has heightened ethical concerns about UAT. PMTCT programs now routinely collect demographic and HIV testing information from the same pregnant women as serosurveillance and therefore present an alternative to UAT-based ANC serosurveillance. This paper reports on the evolution and current direction of the global approach to HIV surveillance among pregnant women attending ANCs, including the transition away from traditional UAT-based serosurveillance and toward new guidance from the World Health Organization and the Joint United Nations Programme on HIV/AIDS on the implementation of surveillance among pregnant women attending ANCs based on routine PMTCT program data. ©Jacob Dee, Jesus M Garcia Calleja, Kimberly Marsh, Irum Zaidi, Christopher Murrill, Mahesh Swaminathan. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 05.12.2017.

Physicians' Current Practices and Opportunities for DNA Banking of Dying Patients With Cancer

PubMed Central

Quillin, John M.; Bodurtha, Joann N.; Siminoff, Laura A.; Smith, Thomas J.

2011-01-01

Purpose: The availability of genetic tests for cancer susceptibility is increasing. Current tests, however, have limited clinical sensitivity. Even when clinically valid tests are available, the genetic counseling and informed consent process might not be feasible for dying patients with cancer. DNA banking preserves the opportunity for future research or clinical testing and may provide critical opportunities for surviving relatives. This study explored the current practices and potential for DNA banking for cancer susceptibility among oncologists specializing in palliative care. Methods: Palliative care oncologists actively providing clinical care for dying patients with cancer were recruited for an online survey. Descriptive statistics for DNA banking practices, perceived qualification to recommend banking, and potential predictors were assessed. Results: Data were collected from 49 physicians (37% recruitment rate). Eighty percent reported assessing at least some patients for genetic cancer susceptibility in the past 12 months. No participants reported banking DNA for patients in the past 12 months. Only 5% reported feeling at least somewhat qualified to order DNA banking. A Web-based risk assessment tool and genetic counselor on staff were perceived as the most helpful potential resources. Conclusion: Despite its potential, DNA banking is not being used by palliative care oncologists. PMID:21886501

The use of health status questionnaires in the management of chronic obstructive pulmonary disease patients in clinical practice.

PubMed

van der Molen, Thys; Diamant, Zuzana; Kocks, Jan Willem H; Tsiligianni, Ioanna G

2014-08-01

Current guidelines recommend chronic obstructive pulmonary disease (COPD) management based on symptoms or health status assessment and lung function parameters. However, COPD is a complex and heterogeneous disease that needs an individualized approach for proper disease management. A structured consultation including health status assessment tools, such as the Clinical COPD Questionnaire and the COPD Assessment Test should improve the quality of the consultation, providing more information than symptoms alone. Both questionnaires are designed to provide the clinician information enabling a more personalized disease approach and subsequent management. Although both Clinical COPD Questionnaire and COPD Assessment Test have good discriminate properties, their use as prognostic markers of severity and their ability to modify disease management has not yet been fully established. New studies are needed to further determine their value on several disease outcomes.

[A Questionnaire Survey on Cooperation between Community Pharmacies and Hospitals in Outpatient Chemotherapy-Comparison of Roles of Pharmacists in Community Pharmacy and Hospitals].

PubMed

Ishibashi, Masaaki; Ishii, Masakazu; Nagano, Miku; Kiuchi, Yuji; Iwamoto, Sanju

2018-01-01

　Previous reports suggested that sharing outpatient information during chemotherapy is very important for managing pharmaceutical usage between community pharmacies and hospitals. We herein examined using a questionnaire survey whether pharmaceutical management for outpatient chemotherapy is desired by community and hospital pharmacists. The response rates were 44.3% (133/300) for pharmacists in community pharmacies and 53.7% (161/300) for pharmacists in hospitals. Prescriptions for outpatients during chemotherapy were issued at 88.2% of the hospitals. Currently, 28.9% of hospital pharmacists rarely provide pharmaceutical care, such as patient guidance and adverse effect monitoring, for outpatients receiving oral chemotherapy. Furthermore, whereas 93.7% of hospital pharmacists conducted prescription audits based on the chemotherapy regimen, audits were only performed by 14.8% of community pharmacists. Thus, outpatients, particularly those on oral regimens, were unable to receive safe pharmaceutical care during chemotherapy. Community pharmacists suggested that hospital pharmacists should use "medication notebooks" and disclose prescription information when providing clinical information to community pharmacists. They also suggested sending clinical information to hospital pharmacists by fax. On the other hand, hospital pharmacists suggested the use of "medication notebooks" and electronic medical records when providing clinical information to community pharmacists. In addition, they suggested for community pharmacists to use electronic medical records when providing clinical information to hospital pharmacists. As there may be differences in opinion between community and hospital pharmacists, mutual preliminary communication is important for successful outpatient chemotherapy.

Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: an ACTTION systematic review

PubMed Central

Smith, Shannon M.; Paillard, Florence; McKeown, Andrew; Burke, Laurie B.; Edwards, Robert R.; Katz, Nathaniel P.; Papadopoulos, Elektra J.; Rappaport, Bob A.; Slagle, Ashley; Strain, Eric C.; Wasan, Ajay D.; Turk, Dennis C.; Dworkin, Robert H.

2017-01-01

Measurement of inappropriate medication use events (e.g., abuse, misuse) in clinical trials is important in characterizing a medication’s abuse potential. However, no “gold standard” assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (i.e., content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and non-opioid prescription medications to identify any that meet U.S. and European regulatory agencies’ rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the lifespan rather than current use, including items that did not directly assess inappropriate use (e.g., questions about anger), or failing to capture information pertinent to inappropriate use events (e.g., intention, route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, non-standardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. PMID:25660826

Current State of Information Technologies for the Clinical Research Enterprise across Academic Medical Centers

PubMed Central

Murphy, Shawn N.; Dubey, Anil; Embi, Peter J.; Harris, Paul A.; Richter, Brent G.; Turisco, Fran; Weber, Griffin M.; Tcheng, James E.; Keogh, Diane

2012-01-01

Abstract Information technology (IT) to support clinical research has steadily grown over the past 10 years. Many new applications at the enterprise level are available to assist with the numerous tasks necessary in performing clinical research. However, it is not clear how rapidly this technology is being adopted or whether it is making an impact upon how clinical research is being performed. The Clinical Research Forum’s IT Roundtable performed a survey of 17 representative academic medical centers (AMCs) to understand the adoption rate and implementation strategies within this field. The results were compared with similar surveys from 4 and 6 years ago. We found the adoption rate for four prominent areas of IT‐supported clinical research had increased remarkably, specifically regulatory compliance, electronic data capture for clinical trials, data repositories for secondary use of clinical data, and infrastructure for supporting collaboration. Adoption of other areas of clinical research IT was more irregular with wider differences between AMCs. These differences appeared to be partially due to a set of openly available applications that have emerged to occupy an important place in the landscape of clinical research enterprise‐level support at AMC’s. Clin Trans Sci 2012; Volume #: 1–4 PMID:22686207

Translating research findings of chronic kidney disease management to clinical practice: Challenges and opportunities.

PubMed

Stevens, Lesley Ann; Levin, Adeera

2004-01-01

Chronic Kidney disease (CKD) has been identified as a public health epidemic, fueled in part by improved outcomes of both diabetic and cardiac patient populations, as well as by the increasing recognition that it is possible to identify CKD at earlier stages. The estimated 8 to 10 million Americans that have CKD, with its concomitant morbidity and mortality, have the potential to overwhelm the current system of specialty practice medicine and health care resources. How can clinicians, clinician scientists, and health care administrators translate research findings into clinical practice in an effective manner to improve the care of this burgeoning patient group? The challenge of translating research into clinical care requires identification of that which we do and do not know, communication of knowledge between those who do and do not know, and efficient collection of information for systematic evaluation. This article will describe the challenges of translating current research findings into clinical practice. There is a need to identify the complexity of CKD disease processes and issues associated with delivery of care and to describe the difficulties in the dissemination of new knowledge to physicians. Because of the propensity of CKD to affect identifiable groups of patients, we will discuss the potential challenges of these strategies given the racial, ethnic, and cultural diversity in North America. A potential solution to these challenges is a new paradigm of "process-based medicine" that integrates clinical and basic science research findings with multidisciplinary and shared care models of health care delivery. In this context, attention to advances in information technology, the cognitive processes that underlie physician learning, and the findings of outcome research may ensure true integration of clinical research and clinical practice.

Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review.

PubMed

Smith, Shannon M; Paillard, Florence; McKeown, Andrew; Burke, Laurie B; Edwards, Robert R; Katz, Nathaniel P; Papadopoulos, Elektra J; Rappaport, Bob A; Slagle, Ashley; Strain, Eric C; Wasan, Ajay D; Turk, Dennis C; Dworkin, Robert H

2015-05-01

Measurement of inappropriate medication use events (eg, abuse or misuse) in clinical trials is important in characterizing a medication's abuse potential. However, no gold standard assessment of inappropriate use events in clinical trials has been identified. In this systematic review, we examine the measurement properties (ie, content validity, cross-sectional reliability and construct validity, longitudinal construct validity, ability to detect change, and responder definitions) of instruments assessing inappropriate use of opioid and nonopioid prescription medications to identify any that meet U.S. and European regulatory agencies' rigorous standards for outcome measures in clinical trials. Sixteen published instruments were identified, most of which were not designed for the selected concept of interest and context of use. For this reason, many instruments were found to lack adequate content validity (or documentation of content validity) to evaluate current inappropriate medication use events; for example, evaluating inappropriate use across the life span rather than current use, including items that did not directly assess inappropriate use (eg, questions about anger), or failing to capture information pertinent to inappropriate use events (eg, intention and route of administration). In addition, the psychometric data across all instruments were generally limited in scope. A further limitation is the heterogeneous, nonstandardized use of inappropriate medication use terminology. These observations suggest that available instruments are not well suited for assessing current inappropriate medication use within the specific context of clinical trials. Further effort is needed to develop reliable and valid instruments to measure current inappropriate medication use events in clinical trials. This systematic review evaluates the measurement properties of inappropriate medication use (eg, abuse or misuse) instruments to determine whether any meet regulatory standards for clinical trial outcome measures to assess abuse potential. Copyright © 2015 American Pain Society. All rights reserved.

Can corneal pannus with trachomatous inflammation--follicular be used in combination as an improved specific clinical sign for current ocular Chlamydia trachomatis infection?

PubMed

Derrick, Tamsyn; Holland, Martin J; Cassama, Eunice; Markham-David, Rod; Nabicassa, Meno; Marks, Michael; Bailey, Robin L; Last, Anna R

2016-01-27

Trachoma is a blinding disease caused by conjunctival infection with Chlamydia trachomatis (Ct). Mass drug administration (MDA) for trachoma control is administered based on the population prevalence of the clinical sign of trachomatis inflammation - follicular (TF). However, the prevalence of TF is often much higher than the prevalence of Ct infection. The addition of a clinical sign specific for current ocular Ct infection to TF could save resources by preventing unnecessary additional rounds of MDA. Study participants were aged between 1-9 years and resided on 7 islands of the Bijagos Archipelago, Guinea Bissau. Clinical grades for trachoma and corneal pannus and ocular swab samples were taken from 80 children with TF and from 81 matched controls without clinical evidence of trachoma. Ct infection testing was performed using droplet digital PCR. New pannus was significantly associated with Ct infection after adjustment for TF (P = 0.009, OR = 3.65 (1.4-9.8)). Amongst individuals with TF, individuals with new pannus had significantly more Ct infection than individuals with none or old pannus (75.0% vs 45.5%, Chi(2) P = 0.01). TF and new pannus together provide a highly specific (91.7%), but a poorly sensitive (51.9%) clinical diagnostic test for Ct infection. As we move towards trachoma elimination it may be desirable to use a combined clinical sign (new pannus in addition to TF) that is highly specific for current ocular Ct infection. This would allow national health systems to obtain a more accurate estimate of Ct population prevalence to inform further need for MDA without the expense of Ct molecular diagnostics, which are currently unaffordable in programmatic contexts.

Drug Information Services Today: Current Role and Future Perspectives in Rational Drug Therapy.

PubMed

Amundstuen Reppe, Linda; Spigset, Olav; Schjøtt, Jan

2016-02-01

Polypharmacy and complex drug treatment regimens are becoming increasingly common, which may lead to adverse drug reactions, drug interactions, medication nonadherence, and increasing costs and thus challenge the rational use of drugs. At the same time, the accessibility of drug information increases, and health care professionals may have limited opportunities and capabilities to search and critically evaluate drug information. Clinicians have reported difficulties in searching the best evidence and translating study findings into clinically meaningful information applicable to specific patients. Consequently, it remains a challenge to ensure the rational use of drugs in the years to come. Drug information centers (DICs) have been established to promote the rational use of drugs. One of the most important tasks of DICs is the question and answer services for health care professionals posing drug-related questions. DICs staffed by pharmacists and clinical pharmacologists hold expertise in searching for drug information and critical evaluation of the literature. The uniqueness in this service lies not only in the identification and interpretation of the scientific literature but also in the adaptation of the findings into specific clinical situations and the discussion of possible solutions with the enquirer. Thus, DICs could provide valuable decision support to the clinic. Taking into account the increasing number of possible drug-related questions that will arise today and in the future, the DICs will remain highly relevant in the years to come. However, the DICs must follow the developments in health information technology to disseminate relevant, unbiased drug information to old and new users of the service. Moreover, the DICs are important tools to counterbalance the drug information published by the pharmaceutical industry. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

A case study evaluation of a Critical Care Information System adoption using the socio-technical and fit approach.

PubMed

Yusof, Maryati Mohd

2015-07-01

Clinical information systems have long been used in intensive care units but reports on their adoption and benefits are limited. This study evaluated a Critical Care Information System implementation. A case study summative evaluation was conducted, employing observation, interview, and document analysis in operating theatres and 16-bed adult intensive care units in a 400-bed Malaysian tertiary referral centre from the perspectives of users (nurses and physicians), management, and information technology staff. System implementation, factors influencing adoption, fit between these factors, and the impact of the Critical Care Information System were evaluated after eight months of operation. Positive influences on system adoption were associated with technical factors, including system ease of use, usefulness, and information relevancy; human factors, particularly user attitude; and organisational factors, namely clinical process-technology alignment and champions. Organisational factors such as planning, project management, training, technology support, turnover rate, clinical workload, and communication were barriers to system implementation and use. Recommendations to improve the current system problems were discussed. Most nursing staff positively perceived the system's reduction of documentation and data access time, giving them more time with patients. System acceptance varied among doctors. System use also had positive impacts on timesaving, data quality, and clinical workflow. Critical Care Information Systems is crucial and has great potentials in enhancing and delivering critical care. However, the case study findings showed that the system faced complex challenges and was underutilised despite its potential. The role of socio-technical factors and their fit in realizing the potential of Critical Care Information Systems requires continuous, in-depth evaluation and stakeholder understanding and acknowledgement. The comprehensive and specific evaluation measures of the Human-Organisation-Technology Fit framework can flexibly evaluate Critical Care Information Systems. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Big data in pharmacy practice: current use, challenges, and the future.

PubMed

Ma, Carolyn; Smith, Helen Wong; Chu, Cherie; Juarez, Deborah T

2015-01-01

Pharmacy informatics is defined as the use and integration of data, information, knowledge, technology, and automation in the medication-use process for the purpose of improving health outcomes. The term "big data" has been coined and is often defined in three V's: volume, velocity, and variety. This paper describes three major areas in which pharmacy utilizes big data, including: 1) informed decision making (clinical pathways and clinical practice guidelines); 2) improved care delivery in health care settings such as hospitals and community pharmacy practice settings; and 3) quality performance measurement for the Centers for Medicare and Medicaid and medication management activities such as tracking medication adherence and medication reconciliation.

Big data in pharmacy practice: current use, challenges, and the future

PubMed Central

Ma, Carolyn; Smith, Helen Wong; Chu, Cherie; Juarez, Deborah T

2015-01-01

Pharmacy informatics is defined as the use and integration of data, information, knowledge, technology, and automation in the medication-use process for the purpose of improving health outcomes. The term “big data” has been coined and is often defined in three V’s: volume, velocity, and variety. This paper describes three major areas in which pharmacy utilizes big data, including: 1) informed decision making (clinical pathways and clinical practice guidelines); 2) improved care delivery in health care settings such as hospitals and community pharmacy practice settings; and 3) quality performance measurement for the Centers for Medicare and Medicaid and medication management activities such as tracking medication adherence and medication reconciliation. PMID:29354523

Different usage of the same oncology information system in two hospitals in Sydney--lessons go beyond the initial introduction.

PubMed

Yu, Ping; Gandhidasan, Senthilkumar; Miller, Alexis A

2010-06-01

The experience of clinicians at two public hospitals in Sydney, Australia, with the introduction and use of an oncology information system (OIS) was examined to extract lessons to guide the introduction of clinical information systems in public hospitals. Semi-structured interviews were conducted with 12 of 15 radiation oncologists employed at the two hospitals. The personnel involved in the decision making process for the introduction of the system were contacted and their decision making process revisited. The transcribed data were analyzed using NVIVO software. Themes emerged included implementation strategies and practices, the radiation oncologists' current use and satisfaction with the OIS, project management and the impact of the OIS on clinical practice. The hospitals had contrasting experiences in their introduction and use of the OIS. Hospital A used the OIS in all aspects of clinical documentation. Its implementation was associated with strong advocacy by the Head of Department, input by a designated project manager, and use and development of the system by all staff, with timely training and support. With no vision of developing a paperless information system, Hospital B used the OIS only for booking and patient tracking. A departmental policy that data entry for the OIS was centrally undertaken by administrative staff distanced clinicians from the system. All the clinicians considered that the OIS should continuously evolve to meet changing clinical needs and departmental quality improvement initiatives. This case study indicates that critical factors for the successful introduction of clinical information systems into hospital environment were an initial clear vision to be paperless, strong clinical leadership and management at the departmental level, committed project management, and involvement of all staff, with appropriate training. Clinician engagement is essential for post-adoption evolution of clinical information systems. Copyright 2010 Elsevier Ireland Ltd. All rights reserved.

Clinical pharmacology in Russia-historical development and current state.

PubMed

Zagorodnikova Goryachkina, Ksenia; Burbello, Aleksandra; Sychev, Dmitry; Frolov, Maxim; Kukes, Vladimir; Petrov, Vladimir

2015-02-01

Clinical pharmacology in Russia has long history and is currently active, but rather unrecognized internationally. It is governmentally approved as a teaching/scientific specialty since 1983 and as a medical specialty since 1997. Courses of clinical pharmacology are included in the undergraduate curricula in the 5th and/or 6th year of education at all medical schools in the Russian Federation. Postgraduate education includes initial specialization in internal medicine with further residency in clinical pharmacology. Governmental legislation recommends that every healthcare institution has either a department or a single position of clinical pharmacologist. Major routine duties include information about and monitoring of medication use, consultations in difficult clinical situations, pharmacogenetic counseling, therapeutic drug monitoring, pharmacovigilance, and participation in drug and therapeutics (formulary) committees. There are official experts in clinical pharmacology in Russia responsible for coordinating relevant legislative issues. The chief expert clinical pharmacologist represents the discipline directly at the Ministry of Health. Research in clinical pharmacology in Russia is extensive and variable, but only some of it is published internationally. Russia is a participant of international societies of clinical pharmacology and therapeutics and collaboration is actively ongoing. There are still certain problems related to the development of the discipline in Russia-some healthcare institutions do not see the need for clinical pharmacology. However, the number of clinical pharmacologists in Russia is increasing as well as their role in physicians' education, national healthcare, and research.

Addressing Trauma in Substance Abuse Treatment

ERIC Educational Resources Information Center

Giordano, Amanda L.; Prosek, Elizabeth A.; Stamman, Julia; Callahan, Molly M.; Loseu, Sahar; Bevly, Cynthia M.; Cross, Kaitlin; Woehler, Elliott S.; Calzada, Richard-Michael R.; Chadwell, Katie

2016-01-01

Trauma is prevalent among clients with substance abuse issues, yet addictions counselors' training in trauma approaches is limited. The purpose of the current article is to provide pertinent information regarding trauma treatment including the use of assessments, empirically supported clinical approaches, self-help groups and the risk of vicarious…

42 CFR 494.170 - Condition: Medical records.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Condition: Medical records. 494.170 Section 494.170... Administration § 494.170 Condition: Medical records. The dialysis facility must maintain complete, accurate, and...: Completion of patient records and centralization of clinical information. (1) Current medical records and...

42 CFR 494.170 - Condition: Medical records.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Condition: Medical records. 494.170 Section 494.170... Administration § 494.170 Condition: Medical records. The dialysis facility must maintain complete, accurate, and...: Completion of patient records and centralization of clinical information. (1) Current medical records and...

42 CFR 494.170 - Condition: Medical records.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Condition: Medical records. 494.170 Section 494.170... Administration § 494.170 Condition: Medical records. The dialysis facility must maintain complete, accurate, and...: Completion of patient records and centralization of clinical information. (1) Current medical records and...

Current development of podophyllotoxins.

PubMed

Canetta, R; Hilgard, P; Florentine, S; Bedogni, P; Lenaz, L

1982-01-01

The unique biological properties and therapeutic efficacy of the podophyllotoxin derivatives, Vumon (VM26, teniposide) and Vepesid (VP16-213, etoposide), are stimulating the interest of both laboratory and clinical researchers. Investigations on new pharmaceutical formulations, pharmacokinetics and metabolism are providing more appropriate information in drug administration; experimental chemotherapy indicates that, among others, cytosine arabinoside and cisplatin are highly synergistic with podophyllotoxins; single agent and combination treatment clinical trials are defining the respective role of Vumon and Vepesid in cancer chemotherapy.

The Arden Syntax standard for clinical decision support: experiences and directions.

PubMed

Samwald, Matthias; Fehre, Karsten; de Bruin, Jeroen; Adlassnig, Klaus-Peter

2012-08-01

Arden Syntax is a widely recognized standard for representing clinical and scientific knowledge in an executable format. It has a history that reaches back until 1989 and is currently maintained by the Health Level 7 (HL7) organization. We created a production-ready development environment, compiler, rule engine and application server for Arden Syntax. Over the course of several years, we have applied this Arden - Syntax - based CDS system in a wide variety of clinical problem domains, such as hepatitis serology interpretation, monitoring of nosocomial infections or the prediction of metastatic events in melanoma patients. We found the Arden Syntax standard to be very suitable for the practical implementation of CDS systems. Among the advantages of Arden Syntax are its status as an actively developed HL7 standard, the readability of the syntax, and various syntactic features such as flexible list handling. A major challenge we encountered was the technical integration of our CDS systems in existing, heterogeneous health information systems. To address this issue, we are currently working on incorporating the HL7 standard GELLO, which provides a standardized interface and query language for accessing data in health information systems. We hope that these planned extensions of the Arden Syntax might eventually help in realizing the vision of a global, interoperable and shared library of clinical decision support knowledge. Copyright © 2012 Elsevier Inc. All rights reserved.

2018 AAHA Diabetes Management Guidelines for Dogs and Cats.

PubMed

Behrend, Ellen; Holford, Amy; Lathan, Patty; Rucinsky, Renee; Schulman, Rhonda

Diabetes mellitus (DM) is a common disease encountered in canine and feline medicine. The 2018 AAHA Diabetes Management Guidelines for Dogs and Cats revise and update earlier guidelines published in 2010. The 2018 guidelines retain much of the information in the earlier guidelines that continues to be applicable in clinical practice, along with new information that represents current expert opinion on controlling DM. An essential aspect of successful DM management is to ensure that the owner of a diabetic dog or cat is capable of administering insulin, recognizing the clinical signs of inadequately managed DM, and monitoring blood glucose levels at home, although this is ideal but not mandatory; all topics that are reviewed in the guidelines. Insulin therapy is the mainstay of treatment for clinical DM. The guidelines provide recommendations for using each insulin formulation currently available for use in dogs and cats, the choice of which is generally based on efficacy and duration of effect in the respective species. Also discussed are non-insulin therapeutic medications and dietary management. These treatment modalities, along with insulin therapy, give the practitioner an assortment of options for decreasing the clinical signs of DM while avoiding hypoglycemia, the two conditions that represent the definition of a controlled diabetic. The guidelines review identifying and monitoring patients at risk for developing DM, which are important for avoiding unnecessary insulin therapy in patients with transient hyperglycemia or mildly elevated blood glucose.

May spa therapy be a valid opportunity to treat hand osteoarthritis? A review of clinical trials and mechanisms of action

NASA Astrophysics Data System (ADS)

Fortunati, Nicola Angelo; Fioravanti, Antonella; Seri, Gina; Cinelli, Simone; Tenti, Sara

2016-01-01

Osteoarthritis (OA) is the most common form of arthritis and its current treatment includes non-pharmacological and pharmacological modalities. Spa therapy represents a popular treatment for many rheumatic diseases. The aim of this review was to summarize the currently available information on clinical effects and mechanisms of action of spa therapy in OA of the hand. We conducted a search of the literature to extract articles describing randomized clinical trials (RCTs) in hand OA published in the period 1952-2015. We identified three assessable articles reporting RCTs on spa therapy in hand OA. Data from these clinical trials support a beneficial effect of spa therapy on pain, function and quality of life in hand OA. Spa therapy seems to have a role in the treatment of hand OA. However, additional RCTs are necessary to clarify the mechanisms of action and the effects of the application of thermal treatments.

Marketed nonsteroidal anti-inflammatory agents, antihypertensives, and human immunodeficiency virus protease inhibitors: as-yet-unused weapons of the oncologists’ arsenal

PubMed Central

Papanagnou, Panagiota; Baltopoulos, Panagiotis; Tsironi, Maria

2015-01-01

Experimental data indicate that several pharmacological agents that have long been used for the management of various diseases unrelated to cancer exhibit profound in vitro and in vivo anticancer activity. This is of major clinical importance, since it would possibly aid in reassessing the therapeutic use of currently used agents for which clinicians already have experience. Further, this would obviate the time-consuming process required for the development and the approval of novel antineoplastic drugs. Herein, both pre-clinical and clinical data concerning the antineoplastic function of distinct commercially available pharmacological agents that are not currently used in the field of oncology, ie, nonsteroidal anti-inflammatory drugs, antihypertensive agents, and anti-human immunodeficiency virus agents inhibiting viral protease, are reviewed. The aim is to provide integrated information regarding not only the molecular basis of the antitumor function of these agents but also the applicability of the reevaluation of their therapeutic range in the clinical setting. PMID:26056460

The assessment and treatment of prosodic disorders and neurological theories of prosody.

PubMed

Diehl, Joshua J; Paul, Rhea

2009-08-01

In this article, we comment on specific aspects of Peppé (Peppé, 2009). In particular, we address the assessment and treatment of prosody in clinical settings and discuss current theory on neurological models of prosody. We argue that in order for prosodic assessment instruments and treatment programs to be clinical effective, we need assessment instruments that: (1) have a representative normative comparison sample and strong psychometric properties; (2) are based on empirical information regarding the typical sequence of prosodic acquisition and are sensitive to developmental change; (3) meaningfully subcategorize various aspects of prosody; (4) use tasks that have ecological validity; and (5) have clinical properties, such as length and ease of administration, that allow them to become part of standard language assessment batteries. In addition, we argue that current theories of prosody processing in the brain are moving toward network models that involve multiple brain areas and are crucially dependent on cortical communication. The implications of these observations for future research and clinical practice are outlined.

Current Treatment Strategies for Intracranial Aneurysms: An Overview

PubMed Central

Lin, Hao; Summers, Richard; Yang, Mingmin; Cousins, Brian G.

2017-01-01

Intracranial aneurysm is a leading cause of stroke. Its treatment has evolved over the past 2 decades. This review summarizes the treatment strategies for intracranial aneurysms from 3 different perspectives: open surgery approach, transluminal treatment approach, and new technologies being used or trialed. We introduce most of the available treatment techniques in detail, including contralateral clipping, wrapping and clipping, double catheters assisting coiling and waffle-cone technique, and so on. Data from major trials such as Analysis of Treatment by Endovascular approach of Non-ruptured Aneurysms (ATENA), Internal Subarachnoid Trial (ISAT), Clinical and Anatomical Results in the Treatment of Ruptured Intracranial Aneurysms (CLARITY), and Barrow Ruptured Aneurysm Trial (BRAT) as well as information from other clinical reports and local experience are reviewed to suggest a clinical pathway for treating different types of intracranial aneurysms. It will be a valuable supplement to the current existing guidelines. We hope it could help assisting real-time decision-making in clinical practices and also encourage advancements in managing the disease. PMID:28355880

Registry Assessment of Peripheral Interventional Devices (RAPID)　- Registry Assessment of Peripheral Interventional Devices Core Data Elements.

PubMed

Jones, W Schuyler; Krucoff, Mitchell W; Morales, Pablo; Wilgus, Rebecca W; Heath, Anne H; Williams, Mary F; Tcheng, James E; Marinac-Dabic, J Danica; Malone, Misti L; Reed, Terrie L; Fukaya, Rie; Lookstein, Robert; Handa, Nobuhiro; Aronow, Herbert D; Bertges, Daniel J; Jaff, Michael R; Tsai, Thomas T; Smale, Joshua A; Zaugg, Margo J; Thatcher, Robert J; Cronenwett, Jack L; Nc, Durham; Md, Silver Spring; Japan, Tokyo; Ny, New York; Ri, Providence; Vt, Burlington; Mass, Newton; Colo, Denver; Ariz, Tempe; Calif, Santa Clara; Minn, Minneapolis; Nh, Lebanon

2018-01-25

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.Methods and Results:Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Clinical decision making and the expected value of information.

PubMed

Willan, Andrew R

2007-01-01

The results of the HOPE study, a randomized clinical trial, provide strong evidence that 1) ramipril prevents the composite outcome of cardiovascular death, myocardial infarction or stroke in patients who are at high risk of a cardiovascular event and 2) ramipril is cost-effective at a threshold willingness-to-pay of $10,000 to prevent an event of the composite outcome. In this report the concept of the expected value of information is used to determine if the information provided by the HOPE study is sufficient for decision making in the US and Canada. and results Using the cost-effectiveness data from a clinical trial, or from a meta-analysis of several trials, one can determine, based on the number of future patients that would benefit from the health technology under investigation, the expected value of sample information (EVSI) of a future trial as a function of proposed sample size. If the EVSI exceeds the cost for any particular sample size then the current information is insufficient for decision making and a future trial is indicated. If, on the other hand, there is no sample size for which the EVSI exceeds the cost, then there is sufficient information for decision making and no future trial is required. Using the data from the HOPE study these concepts are applied for various assumptions regarding the fixed and variable cost of a future trial and the number of patients who would benefit from ramipril. Expected value of information methods provide a decision-analytic alternative to the standard likelihood methods for assessing the evidence provided by cost-effectiveness data from randomized clinical trials.

Electronic information and clinical decision support for prescribing: state of play in Australian general practice

PubMed Central

Robertson, Jane; Moxey, Annette J; Newby, David A; Gillies, Malcolm B; Williamson, Margaret; Pearson, Sallie-Anne

2011-01-01

Background. Investments in eHealth worldwide have been mirrored in Australia, with >90% of general practices computerized. Recent eHealth incentives promote the use of up to date electronic information sources relevant to general practice with flexibility in mode of access. Objective. To determine GPs’ access to and use of electronic information sources and computerized clinical decision support systems (CDSSs) for prescribing. Methods. Semi-structured interviews were conducted with 18 experienced GPs and nine GP trainees in New South Wales, Australia in 2008. A thematic analysis of interview transcripts was undertaken. Results. Information needs varied with clinical experience, and people resources (specialists, GP peers and supervisors for trainees) were often preferred over written formats. Experienced GPs used a small number of electronic resources and accessed them infrequently. Familiarity from training and early clinical practice and easy access were dominant influences on resource use. Practice time constraints meant relevant information needed to be readily accessible during consultations, requiring integration or direct access from prescribing software. Quality of electronic resource content was assumed and cost a barrier for some GPs. Conclusions. The current Australian practice incentives do not prescribe which information resources GPs should use. Without integration into practice computing systems, uptake and routine use seem unlikely. CDSS developments must recognize the time pressures of practice, preference for integration and cost concerns. Minimum standards are required to ensure that high-quality information resources are integrated and regularly updated. Without standards, the anticipated benefits of computerization on patient safety and health outcomes will be uncertain. PMID:21109619

Utility of routine data sources for feedback on the quality of cancer care: an assessment based on clinical practice guidelines.

PubMed

Coory, Michael; Thompson, Bridie; Baade, Peter; Fritschi, Lin

2009-05-27

Not all cancer patients receive state-of-the-art care and providing regular feedback to clinicians might reduce this problem. The purpose of this study was to assess the utility of various data sources in providing feedback on the quality of cancer care. Published clinical practice guidelines were used to obtain a list of processes-of-care of interest to clinicians. These were assigned to one of four data categories according to their availability and the marginal cost of using them for feedback. Only 8 (3%) of 243 processes-of-care could be measured using population-based registry or administrative inpatient data (lowest cost). A further 119 (49%) could be measured using a core clinical registry, which contains information on important prognostic factors (e.g., clinical stage, physiological reserve, hormone-receptor status). Another 88 (36%) required an expanded clinical registry or medical record review; mainly because they concerned long-term management of disease progression (recurrences and metastases) and 28 (11.5%) required patient interview or audio-taping of consultations because they involved information sharing between clinician and patient. The advantages of population-based cancer registries and administrative inpatient data are wide coverage and low cost. The disadvantage is that they currently contain information on only a few processes-of-care. In most jurisdictions, clinical cancer registries, which can be used to report on many more processes-of-care, do not cover smaller hospitals. If we are to provide feedback about all patients, not just those in larger academic hospitals with the most developed data systems, then we need to develop sustainable population-based data systems that capture information on prognostic factors at the time of initial diagnosis and information on management of disease progression.

Benefits of dietary fiber in clinical nutrition.

PubMed

Klosterbuer, Abby; Roughead, Zamzam Fariba; Slavin, Joanne

2011-10-01

Dietary fiber is widely recognized as an important part of a healthy diet and is a common addition to enteral nutrition (EN) formulas. Fiber sources differ in characteristics such as solubility, fermentability, and viscosity, and it is now well known that different types of fiber exert varying physiological effects in the body. Clinical studies suggest fiber can exert a wide range of benefits in areas such as bowel function, gut health, immunity, blood glucose control, and serum lipid levels. Although early clinical nutrition products contained fiber from a single source, it is now thought that blends of fiber from multiple sources more closely resemble a regular diet and may provide a greater range of benefits for the patient. Current recommendations support the use of dietary fiber in clinical nutrition when no contraindications exist, but little information exists about which types and combinations of fibers provide the relevant benefit in certain patient populations. This article summarizes the different types of fiber commonly added to EN products and reviews the current literature on the use of fiber blends in clinical nutrition.

Who uses multivitamins? A cross-sectional study in the Physicians' Health Study.

PubMed

Rautiainen, Susanne; Wang, Lu; Gaziano, J Michael; Sesso, Howard D

2014-06-01

The aim of this study was to examine the prevalence of self-reported multivitamin use in the Physicians' Health Study (PHS) cohort and its association with various lifestyle, clinical, and dietary factors to improve our understanding of who tends to use multivitamins. Among 18,040 middle-aged and older men, information on lifestyle and clinical factors was collected from a baseline enrollment questionnaire, and supplement use and dietary factors were assessed through a food-frequency questionnaire. Four categories of multivitamin use were considered: (1) no supplement use, (2) use of multivitamins only, (3) use of multivitamins with other individual vitamin/mineral supplements, and (4) use of other supplements only. We used logistic regression to calculate multivariate odds ratios and 95% confidence intervals of taking multivitamin supplements for various lifestyle, clinical and dietary factors. Overall, 36% of men reported current multivitamin use. Men who were older, current smokers, and currently using aspirin were 143, 43, and 74% more likely to use multivitamins only. Men having a history of hypercholesterolemia were 16% more likely to use multivitamins only. A 14, 24, and 26% greater likelihood of using multivitamins was also observed among men consuming more fruits and vegetables, whole grains, and tea, respectively. Similar associations were observed for the likelihood of using multivitamins with other supplements; however, men with higher physical activity, history of cancer, hypertension, higher consumption of nuts, and lower consumption of red meat and coffee were also more likely to use multivitamins with other supplements (all P < 0.05). Self-reported multivitamin use associated with lifestyle, clinical and dietary factors may be an indicator of healthy behaviors. These results provide important information for the interpretation of the recent findings from the PHS II trial and consideration of results from observational studies of multivitamin use and chronic disease.

Accounting for costs, QALYs, and capacity constraints: using discrete-event simulation to evaluate alternative service delivery and organizational scenarios for hospital-based glaucoma services.

PubMed

Crane, Glenis J; Kymes, Steven M; Hiller, Janet E; Casson, Robert; Martin, Adam; Karnon, Jonathan D

2013-11-01

Decision-analytic models are routinely used as a framework for cost-effectiveness analyses of health care services and technologies; however, these models mostly ignore resource constraints. In this study, we use a discrete-event simulation model to inform a cost-effectiveness analysis of alternative options for the organization and delivery of clinical services in the ophthalmology department of a public hospital. The model is novel, given that it represents both disease outcomes and resource constraints in a routine clinical setting. A 5-year discrete-event simulation model representing glaucoma patient services at the Royal Adelaide Hospital (RAH) was implemented and calibrated to patient-level data. The data were sourced from routinely collected waiting and appointment lists, patient record data, and the published literature. Patient-level costs and quality-adjusted life years were estimated for a range of alternative scenarios, including combinations of alternate follow-up times, booking cycles, and treatment pathways. The model shows that a) extending booking cycle length from 4 to 6 months, b) extending follow-up visit times by 2 to 3 months, and c) using laser in preference to medication are more cost-effective than current practice at the RAH eye clinic. The current simulation model provides a useful tool for informing improvements in the organization and delivery of glaucoma services at a local level (e.g., within a hospital), on the basis of expected effects on costs and health outcomes while accounting for current capacity constraints. Our model may be adapted to represent glaucoma services at other hospitals, whereas the general modeling approach could be applied to many other clinical service areas.

MMP Inhibitors: Past, present and future.

PubMed

Cathcart, Jillian M; Cao, Jian

2015-06-01

  Development of inhibitors of matrix metalloproteinases (MMPs) has been fraught with challenges. Early compounds largely failed due to poor selectivity and bioavailability. Dose-limiting side effects, off-target interactions, and improperly designed clinical trials significantly impeded clinical success. As information becomes available and technology evolves, tools to combat these obstacles have been developed. Improved methods for high throughput screening and drug design have led to identification of compounds exhibiting high potency, binding affinity, and favorable pharmacokinetic profiles. Current research into MMP inhibitors employs innovative approaches for drug delivery methods and allosteric inhibitors. Such innovation is key for development of clinically successful compounds.

Found in translation: Integrating laboratory and clinical oncology research

PubMed Central

Wagner, H

2008-01-01

Translational research in medicine aims to inform the clinic and the laboratory with the results of each other’s work, and to bring promising and validated new therapies into clinical application. While laudable in intent, this is complicated in practice and the current state of translational research in cancer shows both striking success stories and examples of the numerous potential obstacles as well as opportunities for delays and errors in translation. This paper reviews the premises, promises, and problems of translational research with a focus on radiation oncology and suggests opportunities for improvements in future research design. PMID:21611010

The Italian cross-sectional survey of the management of bone metastasis: ZeTa study

PubMed Central

Santini, Daniele; Bertoldo, Francesco; Dell'Aquila, Emanuela; Cecchini, Isabella; Fregosi, Stefania; Bortolussi, Paolo

2012-01-01

Background Several studies have emphasized the importance of the maintenance of bone health in a comprehensive cancer care. However, no survey about approach to bone metastasis care is currently available. The ZeTa study provides a picture of the Italian oncologists' therapeutics habits in this area, in a real clinical-practice scenario. Design This study was based on online questionnaire-based interviews to Italian oncologists that included 145 questions. The aim was to collect information on the treatment of bone metastasis, the current use of bisphosphonates, the awareness of guidelines and the concerns about ONJ, the use of vitamin D supplementation. Results 445 oncologists were contacted, 283 agreed to participate. The results show that the current management of bone metastasis is still sub-optimal, as the recommendations from current clinical guidelines are not completely followed by all specialists. Conclusions This survey highlights the urgent need to improve management of bone metastasis in cancer patients. PMID:26909253

Single-cell proteomics: potential implications for cancer diagnostics.

PubMed

Gavasso, Sonia; Gullaksen, Stein-Erik; Skavland, Jørn; Gjertsen, Bjørn T

2016-01-01

Single-cell proteomics in cancer is evolving and promises to provide more accurate diagnoses based on detailed molecular features of cells within tumors. This review focuses on technologies that allow for collection of complex data from single cells, but also highlights methods that are adaptable to routine cancer diagnostics. Current diagnostics rely on histopathological analysis, complemented by mutational detection and clinical imaging. Though crucial, the information gained is often not directly transferable to defined therapeutic strategies, and predicting therapy response in a patient is difficult. In cancer, cellular states revealed through perturbed intracellular signaling pathways can identify functional mutations recurrent in cancer subsets. Single-cell proteomics remains to be validated in clinical trials where serial samples before and during treatment can reveal excessive clonal evolution and therapy failure; its use in clinical trials is anticipated to ignite a diagnostic revolution that will better align diagnostics with the current biological understanding of cancer.

Noonan syndrome: clinical features, diagnosis, and management guidelines.

PubMed

Romano, Alicia A; Allanson, Judith E; Dahlgren, Jovanna; Gelb, Bruce D; Hall, Bryan; Pierpont, Mary Ella; Roberts, Amy E; Robinson, Wanda; Takemoto, Clifford M; Noonan, Jacqueline A

2010-10-01

Noonan syndrome (NS) is a common, clinically and genetically heterogeneous condition characterized by distinctive facial features, short stature, chest deformity, congenital heart disease, and other comorbidities. Gene mutations identified in individuals with the NS phenotype are involved in the Ras/MAPK (mitogen-activated protein kinase) signal transduction pathway and currently explain ∼61% of NS cases. Thus, NS frequently remains a clinical diagnosis. Because of the variability in presentation and the need for multidisciplinary care, it is essential that the condition be identified and managed comprehensively. The Noonan Syndrome Support Group (NSSG) is a nonprofit organization committed to providing support, current information, and understanding to those affected by NS. The NSSG convened a conference of health care providers, all involved in various aspects of NS, to develop these guidelines for use by pediatricians in the diagnosis and management of individuals with NS and to provide updated genetic findings.

Global shortage of neonatal and paediatric antibiotic trials: rapid review.

PubMed

Thompson, Georgina; Barker, Charlotte I; Folgori, Laura; Bielicki, Julia A; Bradley, John S; Lutsar, Irja; Sharland, Mike

2017-10-13

There have been few clinical trials (CTs) on antibiotics that inform neonatal and paediatric drug labelling. The rate of unlicensed and off-label prescribing in paediatrics remains high. It is unclear whether the current neonatal and paediatric antibiotic research pipeline is adequate to inform optimal drug dosing. Using the ClinicalTrials.gov registry, this review aims to establish the current global status of antibiotic CTs in children up to 18 years of age. Studies were identified using key word searches of the ClinicalTrials.gov registry and were manually filtered using prespecified inclusion/exclusion criteria. 76 registered open CTs of antibiotics in children were identified globally; 23 (30%) were recruiting newborns (only 8 (11%) included preterm neonates), 52 (68%) infants and toddlers, 58 (76%) children and 54 (71%) adolescents. The majority of registered trials were late phase (10 (15%) phase 3 and 23 (35%) phase 4/pharmacovigilance). Two-thirds were sponsored by non-profit organisations, compared with pharmaceutical companies (50 (66%) vs 26 (34%), respectively). A greater proportion of non-profit funded trials were efficacy-based strategic trials (n=34, 68%), in comparison with industry-led trials, which were most often focused on safety or pharmacokinetic data (n=17, 65%). Only 2 of the 37 antibiotics listed on the May 2016 Pew Charitable Trusts antibiotic development pipeline, currently being studied in adults, appear to be currently recruiting in open paediatric CTs. This review highlights that very few paediatric antibiotic CTs are being conducted globally, especially in neonates. There is a striking disparity noted between antibiotic drug development programmes in adults and children. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Gastrointestinal ostomies and sexual outcomes: a comparison of colorectal cancer patients by ostomy status.

PubMed

Reese, J B; Finan, P H; Haythornthwaite, J A; Kadan, M; Regan, K R; Herman, J M; Efron, J; Diaz, L A; Azad, N S

2014-02-01

Research examining effects of ostomy use on sexual outcomes is limited. Patients with colorectal cancer were compared on sexual outcomes and body image based on ostomy status (never, past, and current ostomy). Differences in depression were also examined. Patients were prospectively recruited during clinic visits and by tumor registry mailings. Patients with colorectal cancer (N = 141; 18 past ostomy; 25 current ostomy; and 98 no ostomy history) completed surveys assessing sexual outcomes (medical impact on sexual function, Female Sexual Function Index, International Index of Erectile Function), body image distress (Body Image Scale), and depressive symptoms (Center for Epidemiologic Studies Depression Scale-Short Form). Clinical information was obtained through patient validated self-report measures and medical records. Most participants reported sexual function in the dysfunctional range using established cut-off scores. In analyses adjusting for demographic and medical covariates and depression, significant group differences were found for ostomy status on impact on sexual function (p < .001), female sexual function (p = .01), and body image (p < .001). The current and past ostomy groups reported worse impact on sexual function than those who never had an ostomy (p < .001); similar differences were found for female sexual function. The current ostomy group reported worse body image distress than those who never had an ostomy (p < .001). No differences were found across the groups for depressive symptoms (p = .33) or male sexual or erectile function (p values ≥ .59). Colorectal cancer treatment puts patients at risk for sexual difficulties and some difficulties may be more pronounced for patients with ostomies as part of their treatment. Clinical information and support should be offered.

Gastrointestinal ostomies and sexual outcomes: a comparison of colorectal cancer patients by ostomy status

PubMed Central

Finan, P. H.; Haythornthwaite, J. A.; Kadan, M.; Regan, K. R.; Herman, J. M.; Efron, J.; Diaz, L. A.; Azad, N. S.

2014-01-01

Purpose Research examining effects of ostomy use on sexual outcomes is limited. Patients with colorectal cancer were compared on sexual outcomes and body image based on ostomy status (never, past, and current ostomy). Differences in depression were also examined. Methods Patients were prospectively recruited during clinic visits and by tumor registry mailings. Patients with colorectal cancer (N = 141; 18 past ostomy; 25 current ostomy; and 98 no ostomy history) completed surveys assessing sexual outcomes (medical impact on sexual function, Female Sexual Function Index, International Index of Erectile Function), body image distress (Body Image Scale), and depressive symptoms (Center for Epidemiologic Studies Depression Scale—Short Form). Clinical information was obtained through patient validated self-report measures and medical records. Results Most participants reported sexual function in the dysfunctional range using established cut-off scores. In analyses adjusting for demographic and medical covariates and depression, significant group differences were found for ostomy status on impact on sexual function (p <.001), female sexual function (p =.01), and body image (p <.001). The current and past ostomy groups reported worse impact on sexual function than those who never had an ostomy (p <.001); similar differences were found for female sexual function. The current ostomy group reported worse body image distress than those who never had an ostomy (p <.001). No differences were found across the groups for depressive symptoms (p =.33) or male sexual or erectile function (p values≥.59). Conclusions Colorectal cancer treatment puts patients at risk for sexual difficulties and some difficulties may be more pronounced for patients with ostomies as part of their treatment. Clinical information and support should be offered. PMID:24091721

Clinical Audits in Outpatient Clinics for Chronic Obstructive Pulmonary Disease: Methodological Considerations and Workflow.

PubMed

López-Campos, Jose Luis; Abad Arranz, María; Calero Acuña, Carmen; Romero Valero, Fernando; Ayerbe García, Ruth; Hidalgo Molina, Antonio; Aguilar Pérez-Grovas, Ricardo Ismael; García Gil, Francisco; Casas Maldonado, Francisco; Caballero Ballesteros, Laura; Sánchez Palop, María; Pérez-Tejero, Dolores; Segado, Alejandro; Calvo Bonachera, Jose; Hernández Sierra, Bárbara; Doménech, Adolfo; Arroyo Varela, Macarena; González Vargas, Francisco; Cruz Rueda, Juan Jose

2015-01-01

Previous clinical audits for chronic obstructive pulmonary disease (COPD) have provided valuable information on the clinical care delivered to patients admitted to medical wards because of COPD exacerbations. However, clinical audits of COPD in an outpatient setting are scarce and no methodological guidelines are currently available. Based on our previous experience, herein we describe a clinical audit for COPD patients in specialized outpatient clinics with the overall goal of establishing a potential methodological workflow. A pilot clinical audit of COPD patients referred to respiratory outpatient clinics in the region of Andalusia, Spain (over 8 million inhabitants), was performed. The audit took place between October 2013 and September 2014, and 10 centers (20% of all public hospitals) were invited to participate. Cases with an established diagnosis of COPD based on risk factors, clinical symptoms, and a post-bronchodilator FEV1/FVC ratio of less than 0.70 were deemed eligible. The usefulness of formally scheduled regular follow-up visits was assessed. Two different databases (resources and clinical database) were constructed. Assessments were planned over a year divided by 4 three-month periods, with the goal of determining seasonal-related changes. Exacerbations and survival served as the main endpoints. This paper describes a methodological framework for conducting a clinical audit of COPD patients in an outpatient setting. Results from such audits can guide health information systems development and implementation in real-world settings.

The future of drug discovery: enabling technologies for enhancing lead characterization and profiling therapeutic potential.

PubMed

Janero, David R

2014-08-01

Technology often serves as a handmaiden and catalyst of invention. The discovery of safe, effective medications depends critically upon experimental approaches capable of providing high-impact information on the biological effects of drug candidates early in the discovery pipeline. This information can enable reliable lead identification, pharmacological compound differentiation and successful translation of research output into clinically useful therapeutics. The shallow preclinical profiling of candidate compounds promulgates a minimalistic understanding of their biological effects and undermines the level of value creation necessary for finding quality leads worth moving forward within the development pipeline with efficiency and prognostic reliability sufficient to help remediate the current pharma-industry productivity drought. Three specific technologies discussed herein, in addition to experimental areas intimately associated with contemporary drug discovery, appear to hold particular promise for strengthening the preclinical valuation of drug candidates by deepening lead characterization. These are: i) hydrogen-deuterium exchange mass spectrometry for characterizing structural and ligand-interaction dynamics of disease-relevant proteins; ii) activity-based chemoproteomics for profiling the functional diversity of mammalian proteomes; and iii) nuclease-mediated precision gene editing for developing more translatable cellular and in vivo models of human diseases. When applied in an informed manner congruent with the clinical understanding of disease processes, technologies such as these that span levels of biological organization can serve as valuable enablers of drug discovery and potentially contribute to reducing the current, unacceptably high rates of compound clinical failure.

Perception Matters for Clinical Perfectionism and Social Anxiety

PubMed Central

Levinson, Cheri A.; Rodebaugh, Thomas L.; Shumaker, Erik A.; Menatti, Andrew R.; Weeks, Justin W.; White, Emily K.; Heimberg, Richard G.; Warren, Cortney S.; Blanco, Carlos; Schneier, Franklin; Liebowitz, Michael R.

2014-01-01

Despite research documenting a relationship between social anxiety and perfectionism, very little research has examined the relationship between social anxiety and clinical perfectionism, defined as the combination of high personal standards and high maladaptive perfectionistic evaluative concern. In the current studies we examined whether clinical perfectionism predicted social anxiety in a large sample of undergraduates (N = 602), in a clinical sample of participants diagnosed with social anxiety disorder (SAD; N = 180), and by using a variance decomposition model of self-and informant-report of perfectionism (N = 134). Using self-report, we found that an interaction of personal standards and evaluative concern predicted both social interaction anxiety and fear of scrutiny, but not in the theorized direction. Specifically, we found that self-report of low standards and high evaluative concern was associated with the highest levels of social anxiety, suggesting that when individuals with SAD hold low expectations for themselves combined with high concerns about evaluation, social anxiety symptoms may increase. Alternatively, when an informants’ perspective was considered, and more consistent with the original theory, we found that the interaction of informant-only report of personal standards and shared-report (between both primary participant and informant) of concern over mistakes was associated with self-reported social anxiety, such that high concern over mistakes and high personal standards predicted the highest levels of social anxiety. Theoretical, clinical, and measurement implications for clinical perfectionism are discussed. PMID:25486087

A characterization of clinical questions asked by rehabilitation therapists.

PubMed

Kloda, Lorie Andrea; Bartlett, Joan C

2014-04-01

This study explored the information needs of rehabilitation therapists (occupational therapists, physical therapists, and speech-language pathologists) working with patients who have had strokes in order to characterize their clinical questions, defined as their formalized information needs arising in the context of everyday clinical practice. The researchers took a constructivist, interpretive approach, in which fifteen rehabilitation therapists working in various settings were recruited. Data were gathered using diaries, followed by diary-guided interviews, and thematically analyzed using template analysis. Rehabilitation therapists' clinical questions were characterized as having one or more of twelve foci and containing one or more of eight possible structural elements. Findings demonstrate that the evidence-based practice framework currently applied for questions relating to rehabilitation is inadequate for representing rehabilitation therapists' clinical questions. A new framework that is more comprehensive and descriptive is proposed. Librarians working with students and clinicians in rehabilitation can employ knowledge of the twelve foci and the question structure for rehabilitation to guide the reference interview. Instruction on question formulation in evidence-based practice can employ the revised structure for rehabilitation, offering students and clinicians an alternative to the traditional patient, intervention, comparison, outcome (PICO) structure. Information products, including bibliographic databases and synopsis services, can tailor their interfaces according to question foci and prompt users to enter search terms corresponding to any of the eight possible elements found in rehabilitation therapists' clinical questions.

Can informed consent to research be adapted to risk?

PubMed

Bromwich, Danielle; Rid, Annette

2015-07-01

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the concern that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorisation. In this paper, we show how the standard view of informed consent--consent as autonomous authorisation--can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Student attitudes towards clinical teaching resources in complementary medicine: a focus group examination of Australian naturopathic medicine students.

PubMed

Wardle, Jonathan Lee; Sarris, Jerome

2014-06-01

Complementary medicine is forming an increasingly large part of health care in developed countries and is increasingly being formally taught in tertiary academic settings. An exploratory study of naturopathic student perceptions of, use of and attitudes towards teaching resources in naturopathic clinical training and education. Focus groups were conducted with current and recent students of 4-year naturopathic degree programmes in Brisbane and Sydney to ascertain how they interact with clinical teaching materials, and their perceptions and attitudes towards teaching materials in naturopathic education. Naturopathic students have a complex and critical relationship with their learning materials. Although naturopathic practice is often defined by traditional evidence, students want information that both supports and is critical of traditional naturopathic practices, and focuses heavily on evidence-based medicine. Students remain largely ambivalent about new teaching technologies and would prefer that these develop organically as an evolution from printed materials, rather than depart from dramatically and radically from these previously established materials. Findings from this study will assist publishers, librarians and academics develop clinical information sources that appropriately meet student expectations and support their learning requirements. © 2014 The authors. Health Information and Libraries Journal © 2014 Health Libraries Group.

The Consequences of Insufficient Sleep for Adolescents: Links Between Sleep and Emotional Regulation.

ERIC Educational Resources Information Center

Dahl, Ronald E.

1999-01-01

Reviews current scientific and clinical information regarding consequences of insufficient sleep in adolescents, including sleepiness; tiredness; changes in mood, attention, and behavior; emotional and behavior problems' effects on sleep patterns; and bidirectional effects. Lifestyle forces are pushing teens' sleep/arousal balance in the wrong…

A Method for Selection of Appropriate Assistive Technology for Computer Access

ERIC Educational Resources Information Center

Jenko, Mojca

2010-01-01

Assistive technologies (ATs) for computer access enable people with disabilities to be included in the information society. Current methods for assessment and selection of the most appropriate AT for each individual are nonstandardized, lengthy, subjective, and require substantial clinical experience of a multidisciplinary team. This manuscript…

Providing Early Intervention Services to Diverse Populations: Are Speech-Language Pathologists Prepared?

ERIC Educational Resources Information Center

Caesar, Lena G.

2013-01-01

This study used a survey approach to investigate the current state of speech-language preservice academic and clinical preparation for providing early intervention (EI) services to culturally and linguistically diverse (CLD) populations. Information was obtained from speech-language pathologists (SLPs) employed in EI settings regarding their…

Are Physicians and Patients in Agreement? Exploring Dyadic Concordance

ERIC Educational Resources Information Center

Coran, Justin J.; Koropeckyj-Cox, Tanya; Arnold, Christa L.

2013-01-01

Dyadic concordance in physician-patient interactions can be defined as the extent of agreement between physicians and patients in their perceptions of the clinical encounter. The current research specifically examined two types of concordance: informational concordance--the extent of agreement in physician and patient responses regarding patient…

Tourette Syndrome: A Training Day for Teachers.

ERIC Educational Resources Information Center

Chowdhury, Uttom; Christie, Deborah

2002-01-01

This article describes a Tourette syndrome training day for teachers facilitated by members of the Tic Disorders Clinic at Great Ormond Street Hospital in England. The day provided a mix of information giving and discussion of current practice. Outcomes of the day are related to professional knowledge and experience. (Contains references.) (CR)

Beyond the DSM-IV: Assumptions, Alternatives, and Alterations

ERIC Educational Resources Information Center

Lopez, Shane J.; Edwards, Lisa M.; Pedrotti, Jennifer Teramoto; Prosser, Ellie C.; LaRue, Stephanie; Spalitto, Susan Vehige; Ulven, Jon C.

2006-01-01

Current diagnostic processes reflect the limitations and utility of the framework of the "Diagnostic and Statistical Manual of Mental Disorders" (4th ed.; DSM-IV; American Psychiatric Association, 1994). Clinical information in the DSM-IV's 5-axis system almost exclusively focuses on weaknesses and pathology and is summarized in a flawed…

An Analysis of the Effectiveness of University Counselling Services

ERIC Educational Resources Information Center

Murray, Aja L.; McKenzie, Karen; Murray, Kara R.; Richelieu, Marc

2016-01-01

It is important to demonstrate replicable evidence of the effectiveness of counselling procedures. The study aimed to contribute to the currently limited evidence base examining the effectiveness of university student counselling in the UK. Information on therapeutic outcome [based on Clinical Outcomes in Routine Evaluation-Outcome Measure…

Cardiac Electrophysiology: Normal and Ischemic Ionic Currents and the ECG

ERIC Educational Resources Information Center

Klabunde, Richard E.

2017-01-01

Basic cardiac electrophysiology is foundational to understanding normal cardiac function in terms of rate and rhythm and initiation of cardiac muscle contraction. The primary clinical tool for assessing cardiac electrical events is the electrocardiogram (ECG), which provides global and regional information on rate, rhythm, and electrical…

Stakeholders' Qualitative Perspectives of Effective Telepractice Pedagogy in Speech-Language Pathology

ERIC Educational Resources Information Center

Overby, Megan S.

2018-01-01

Background: Academic programmes in speech-language pathology are increasingly providing telehealth/telepractice clinical education to students. Despite this growth, there is little information describing effective ways to teach it. Aims: The current exploratory study analyzed the perceptions of speech-language pathology/therapy (SLP/SLT) faculty,…

The Ontario printed educational message (OPEM) trial to narrow the evidence-practice gap with respect to prescribing practices of general and family physicians: a cluster randomized controlled trial, targeting the care of individuals with diabetes and hypertension in Ontario, Canada

PubMed Central

Zwarenstein, Merrick; Hux, Janet E; Kelsall, Diane; Paterson, Michael; Grimshaw, Jeremy; Davis, Dave; Laupacis, Andreas; Evans, Michael; Austin, Peter C; Slaughter, Pamela M; Shiller, Susan K; Croxford, Ruth; Tu, Karen

2007-01-01

Background There are gaps between what family practitioners do in clinical practice and the evidence-based ideal. The most commonly used strategy to narrow these gaps is the printed educational message (PEM); however, the attributes of successful printed educational messages and their overall effectiveness in changing physician practice are not clear. The current endeavor aims to determine whether such messages change prescribing quality in primary care practice, and whether these effects differ with the format of the message. Methods/design The design is a large, simple, factorial, unblinded cluster-randomized controlled trial. PEMs will be distributed with informed, a quarterly evidence-based synopsis of current clinical information produced by the Institute for Clinical Evaluative Sciences, Toronto, Canada, and will be sent to all eligible general and family practitioners in Ontario. There will be three replicates of the trial, with three different educational messages, each aimed at narrowing a specific evidence-practice gap as follows: 1) angiotensin-converting enzyme inhibitors, hypertension treatment, and cholesterol lowering agents for diabetes; 2) retinal screening for diabetes; and 3) diuretics for hypertension. For each of the three replicates there will be three intervention groups. The first group will receive informed with an attached postcard-sized, short, directive "outsert." The second intervention group will receive informed with a two-page explanatory "insert" on the same topic. The third intervention group will receive informed, with both the above-mentioned outsert and insert. The control group will receive informed only, without either an outsert or insert. Routinely collected physician billing, prescription, and hospital data found in Ontario's administrative databases will be used to monitor pre-defined prescribing changes relevant and specific to each replicate, following delivery of the educational messages. Multi-level modeling will be used to study patterns in physician-prescribing quality over four quarters, before and after each of the three interventions. Subgroup analyses will be performed to assess the association between the characteristics of the physician's place of practice and target behaviours. A further analysis of the immediate and delayed impacts of the PEMs will be performed using time-series analysis and interventional, auto-regressive, integrated moving average modeling. Trial registration number Current controlled trial ISRCTN72772651. PMID:18039361

Shared decision-making – transferring research into practice: the Analytic Hierarchy Process (AHP)

PubMed Central

Dolan, James G.

2008-01-01

Objective To illustrate how the Analytic Hierarchy Process (AHP) can be used to promote shared decision-making and enhance clinician-patient communication. Methods Tutorial review. Results The AHP promotes shared decision making by creating a framework that is used to define the decision, summarize the information available, prioritize information needs, elicit preferences and values, and foster meaningful communication among decision stakeholders. Conclusions The AHP and related multi-criteria methods have the potential for improving the quality of clinical decisions and overcoming current barriers to implementing shared decision making in busy clinical settings. Further research is needed to determine the best way to implement these tools and to determine their effectiveness. Practice Implications Many clinical decisions involve preference-based trade-offs between competing risks and benefits. The AHP is a well-developed method that provides a practical approach for improving patient-provider communication, clinical decision-making, and the quality of patient care in these situations. PMID:18760559

Sexual health in Spanish postmenopausal women presenting at outpatient clinics.

PubMed

Cornellana, M J; Harvey, X; Carballo, A; Khartchenko, E; Llaneza, P; Palacios, S; Mendoza, N

2017-04-01

One of the most common complaints among postmenopausal women is a change in sexual drive. The aim of this study was to assess the current state of sexual health in Spanish postmenopausal women who present at outpatient gynecology clinics. In this multicenter, observational, cross-sectional, questionnaire-based study, a survey was conducted that included 3026 Spanish postmenopausal women in a routine clinical setting in outpatient gynecology clinics at public and private institutions throughout Spain. We used the Women's Sexual Function questionnaire, which has been validated in Spain. In the multivariate analysis, we found that the best indicators of sexual health in postmenopausal women were a higher education (p < 0.001), working or previously worked (p < 0.001), a stable partner (p < 0.001), living in an urban area (p < 0.01), healthy habits and received information about menopause (p < 0.001). These results indicate that it is important to provide health education and information about menopause and the complaints associated with this period in a woman's life.

Reflective action assessment with a prospective clinical problem solving tool in the context of rehabilitation medicine: an illustrative case study.

PubMed

Kellett, David; Mpofu, Elias; Madden, Richard

2013-06-01

This study describes a case formulation approach applying a prospective ICF derived clinical tool to assess rehabilitation needs for a community dwelling stroke survivor with care from an outpatient rehabilitation medicine clinic. Case history data on the person were assessed for rehabilitation management planning using a prospective tool to interlink current with projected future functional status in everyday settings. Implicit assessment with reflective action informed decision points at each stage of the rehabilitation process. As a result of reflective action using the prospective tool, rehabilitation management led to significant changes in client participation after limitations to mobility and self care were mapped to the living conditions of the stroke survivor. The context sensitive rehabilitative plan resulted in higher subjective health-related quality of life in the stroke survivor and significant other and enhanced their capacity for participation. Reflective action informed assessment applying ICF concepts to clinical problem solving resulted in positive gains in health-related quality of life in a stroke survivor.

Clinical nursing informatics. Developing tools for knowledge workers.

PubMed

Ozbolt, J G; Graves, J R

1993-06-01

Current research in clinical nursing informatics is proceeding along three important dimensions: (1) identifying and defining nursing's language and structuring its data; (2) understanding clinical judgment and how computer-based systems can facilitate and not replace it; and (3) discovering how well-designed systems can transform nursing practice. A number of efforts are underway to find and use language that accurately represents nursing and that can be incorporated into computer-based information systems. These efforts add to understanding nursing problems, interventions, and outcomes, and provide the elements for databases from which nursing's costs and effectiveness can be studied. Research on clinical judgment focuses on how nurses (perhaps with different levels of expertise) assess patient needs, set goals, and plan and deliver care, as well as how computer-based systems can be developed to aid these cognitive processes. Finally, investigators are studying not only how computers can help nurses with the mechanics and logistics of processing information but also and more importantly how access to informatics tools changes nursing care.

A new CAD approach for improving efficacy of cancer screening

NASA Astrophysics Data System (ADS)

Zheng, Bin; Qian, Wei; Li, Lihua; Pu, Jiantao; Kang, Yan; Lure, Fleming; Tan, Maxine; Qiu, Yuchen

2015-03-01

Since performance and clinical utility of current computer-aided detection (CAD) schemes of detecting and classifying soft tissue lesions (e.g., breast masses and lung nodules) is not satisfactory, many researchers in CAD field call for new CAD research ideas and approaches. The purpose of presenting this opinion paper is to share our vision and stimulate more discussions of how to overcome or compensate the limitation of current lesion-detection based CAD schemes in the CAD research community. Since based on our observation that analyzing global image information plays an important role in radiologists' decision making, we hypothesized that using the targeted quantitative image features computed from global images could also provide highly discriminatory power, which are supplementary to the lesion-based information. To test our hypothesis, we recently performed a number of independent studies. Based on our published preliminary study results, we demonstrated that global mammographic image features and background parenchymal enhancement of breast MR images carried useful information to (1) predict near-term breast cancer risk based on negative screening mammograms, (2) distinguish between true- and false-positive recalls in mammography screening examinations, and (3) classify between malignant and benign breast MR examinations. The global case-based CAD scheme only warns a risk level of the cases without cueing a large number of false-positive lesions. It can also be applied to guide lesion-based CAD cueing to reduce false-positives but enhance clinically relevant true-positive cueing. However, before such a new CAD approach is clinically acceptable, more work is needed to optimize not only the scheme performance but also how to integrate with lesion-based CAD schemes in the clinical practice.

Teledermatology. Current status and future directions.

PubMed

Whited, J D

2001-01-01

Teledermatology is becoming an increasingly common means of delivering dermatologic healthcare worldwide and will almost certainly play a greater role in the future. The type of technology used distinguishes the 2 modes of teledermatology consultation. The store and forward technique uses still digital images generated by a digital camera. Consultations of this type are considered asynchronous since the images are obtained, sent, and reviewed at different times. In contrast, real-time interactive consultations are synchronous. Patients and clinicians interact in real-time through an audio-video communication link. Each modality has its advantages and disadvantages, and studies appear in the literature that assess both technologies. Although diagnostic reliability (precision) assessments for teledermatology are subject to limitations, existing information indicates that both store and forward and real-time interactive technology result in reliable diagnostic outcomes when compared with clinic-based evaluations. Less information regarding diagnostic accuracy is available; however, one evaluation that used store and forward technology found comparable diagnostic accuracy between teledermatology consultations and clinic-based examinations. Currently, little information is available regarding cost effectiveness and patient outcomes. Existing evidence, while inconclusive, suggests that teledermatology may be more costly than traditional clinic-based care, especially when using real-time interactive technology. Teledermatology has been shown to have utility as a triage mechanism for determining the urgency or need for a clinic-based consultation. Overall, patients appear to accept teledermatology and are satisfied with it as a means of obtaining healthcare. Clinicians have also generally reported positive experiences with teledermatology. Future studies that focus on cost effectiveness, patient outcomes, and patient and clinician satisfaction will help further define the potential of teledermatology as a means of dermatologic healthcare delivery.

A knowledge engineering framework towards clinical support for adverse drug event prevention: the PSIP approach.

PubMed

Koutkias, Vassilis; Stalidis, George; Chouvarda, Ioanna; Lazou, Katerina; Kilintzis, Vassilis; Maglaveras, Nicos

2009-01-01

Adverse Drug Events (ADEs) are currently considered as a major public health issue, endangering patients' safety and causing significant healthcare costs. Several research efforts are currently concentrating on the reduction of preventable ADEs by employing Information Technology (IT) solutions, which aim to provide healthcare professionals and patients with relevant knowledge and decision support tools. In this context, we present a knowledge engineering approach towards the construction of a Knowledge-based System (KBS) regarded as the core part of a CDSS (Clinical Decision Support System) for ADE prevention, all developed in the context of the EU-funded research project PSIP (Patient Safety through Intelligent Procedures in Medication). In the current paper, we present the knowledge sources considered in PSIP and the implications they pose to knowledge engineering, the methodological approach followed, as well as the components defining the knowledge engineering framework based on relevant state-of-the-art technologies and representation formalisms.

BoB, a best-of-breed automated text de-identification system for VHA clinical documents.

PubMed

Ferrández, Oscar; South, Brett R; Shen, Shuying; Friedlin, F Jeffrey; Samore, Matthew H; Meystre, Stéphane M

2013-01-01

De-identification allows faster and more collaborative clinical research while protecting patient confidentiality. Clinical narrative de-identification is a tedious process that can be alleviated by automated natural language processing methods. The goal of this research is the development of an automated text de-identification system for Veterans Health Administration (VHA) clinical documents. We devised a novel stepwise hybrid approach designed to improve the current strategies used for text de-identification. The proposed system is based on a previous study on the best de-identification methods for VHA documents. This best-of-breed automated clinical text de-identification system (aka BoB) tackles the problem as two separate tasks: (1) maximize patient confidentiality by redacting as much protected health information (PHI) as possible; and (2) leave de-identified documents in a usable state preserving as much clinical information as possible. We evaluated BoB with a manually annotated corpus of a variety of VHA clinical notes, as well as with the 2006 i2b2 de-identification challenge corpus. We present evaluations at the instance- and token-level, with detailed results for BoB's main components. Moreover, an existing text de-identification system was also included in our evaluation. BoB's design efficiently takes advantage of the methods implemented in its pipeline, resulting in high sensitivity values (especially for sensitive PHI categories) and a limited number of false positives. Our system successfully addressed VHA clinical document de-identification, and its hybrid stepwise design demonstrates robustness and efficiency, prioritizing patient confidentiality while leaving most clinical information intact.

Examining the functionality of the DeLone and McLean information system success model as a framework for synthesis in nursing information and communication technology research.

PubMed

Booth, Richard G

2012-06-01

In this review, studies examining information and communication technology used by nurses in clinical practice were examined. Overall, a total of 39 studies were assessed spanning a time period from 1995 to 2008. The impacts of the various health information and communication technology evaluated by individual studies were synthesized using the DeLone and McLean's six-dimensional framework for evaluating information systems success (ie, System Quality, Information Quality, Service Quality, Use, User Satisfaction, and Net Benefits). Overall, the majority of researchers reported results related to the overall Net Benefits (positive, negative, and indifferent) of the health information and communication technology used by nurses. Attitudes and user satisfaction with technology were also commonly measured attributes. The current iteration of DeLone and McLean model is effective at synthesizing basic elements of health information and communication technology use by nurses. Regardless, the current model lacks the sociotechnical sensitivity to capture deeper nurse-technology relationalities. Limitations and recommendations are provided for researchers considering using the DeLone and McLean model for evaluating health information and communication technology used by nurses.

Evolving therapies for the management of chronic and acute decompensated heart failure.

PubMed

Cook, Jennifer C; Tran, Richard H; Patterson, J Herbert; Rodgers, Jo E

2016-11-01

The pharmacology, clinical efficacy, and safety profiles of evolving therapies for the management of chronic heart failure (HF) and acute decompensated heart failure (ADHF) are described. HF confers a significant financial burden despite the widespread use of traditional guideline-directed medical therapies such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, β-blockers, and aldosterone receptor antagonists, and the rates of HF-related mortality and hospitalization have remained unacceptably high. In response to a demand for novel pharmacologic agents, several therapeutic compounds have recently gained approval or are currently under review by the Food and Drug Administration. Sacubitril-valsartan has demonstrated benefit in reducing cardiovascular mortality and HF-related hospitalizations in clinical trials, while ivabradine and ferric carboxymaltose have proven efficacious in reducing HF-related hospitalizations. Lastly, the role of serelaxin in ADHF is currently under investigation in an ongoing Phase III study. While large, outcome-driven clinical trials are fundamental in informing the clinical application of these therapeutic agents, careful patient selection is imperative to ensuring similar outcomes postmarketing. In addition, optimization of current guideline-directed medical therapy remains essential as new therapies emerge and are incorporated into guideline recommendations. Additional therapeutic agents currently undergoing investigation include bucindolol hydrochloride, cimaglermin alfa, nitroxyl, omecamtiv mecarbil, TRV027, and ularitide. Clinical practitioners should remain abreast of emerging literature so that new therapeutic entities are optimally applied and positive patient outcomes are achieved. Recently introduced agents for the treatment of patients with HF include sacubitril-valsartan, ivabradine, and ferric carboxymaltose. Additional agents worthy of attention include serelaxin and other therapies currently under investigation. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

A Delphic consensus assessment: imaging and biomarkers in gastroenteropancreatic neuroendocrine tumor disease management.

PubMed

Oberg, Kjell; Krenning, Eric; Sundin, Anders; Bodei, Lisa; Kidd, Mark; Tesselaar, Margot; Ambrosini, Valentina; Baum, Richard P; Kulke, Matthew; Pavel, Marianne; Cwikla, Jaroslaw; Drozdov, Ignat; Falconi, Massimo; Fazio, Nicola; Frilling, Andrea; Jensen, Robert; Koopmans, Klaus; Korse, Tiny; Kwekkeboom, Dik; Maecke, Helmut; Paganelli, Giovanni; Salazar, Ramon; Severi, Stefano; Strosberg, Jonathan; Prasad, Vikas; Scarpa, Aldo; Grossman, Ashley; Walenkamp, Annemeik; Cives, Mauro; Virgolini, Irene; Kjaer, Andreas; Modlin, Irvin M

2016-09-01

The complexity of the clinical management of neuroendocrine neoplasia (NEN) is exacerbated by limitations in imaging modalities and a paucity of clinically useful biomarkers. Limitations in currently available imaging modalities reflect difficulties in measuring an intrinsically indolent disease, resolution inadequacies and inter-/intra-facility device variability and that RECIST (Response Evaluation Criteria in Solid Tumors) criteria are not optimal for NEN. Limitations of currently used biomarkers are that they are secretory biomarkers (chromogranin A, serotonin, neuron-specific enolase and pancreastatin); monoanalyte measurements; and lack sensitivity, specificity and predictive capacity. None of them meet the NIH metrics for clinical usage. A multinational, multidisciplinary Delphi consensus meeting of NEN experts (n = 33) assessed current imaging strategies and biomarkers in NEN management. Consensus (>75%) was achieved for 78% of the 142 questions. The panel concluded that morphological imaging has a diagnostic value. However, both imaging and current single-analyte biomarkers exhibit substantial limitations in measuring the disease status and predicting the therapeutic efficacy. RECIST remains suboptimal as a metric. A critical unmet need is the development of a clinico-biological tool to provide enhanced information regarding precise disease status and treatment response. The group considered that circulating RNA was better than current general NEN biomarkers and preliminary clinical data were considered promising. It was resolved that circulating multianalyte mRNA (NETest) had clinical utility in both diagnosis and monitoring disease status and therapeutic efficacy. Overall, it was concluded that a combination of tumor spatial and functional imaging with circulating transcripts (mRNA) would represent the future strategy for real-time monitoring of disease progress and therapeutic efficacy. © 2016 The authors.

Management of Hypoparathyroidism: Summary Statement and Guidelines.

PubMed

Brandi, Maria Luisa; Bilezikian, John P; Shoback, Dolores; Bouillon, Roger; Clarke, Bart L; Thakker, Rajesh V; Khan, Aliya A; Potts, John T

2016-06-01

Hypoparathyroidism is a rare disorder characterized by hypocalcemia and absent or deficient PTH. This report presents a summary of current information about epidemiology, presentation, diagnosis, clinical features, and management and proposes guidelines to help clinicians diagnose, evaluate, and manage this disorder. Participants in the First International Conference on the Management of Hypoparathyroidism represented a worldwide constituency with acknowledged interest and expertise in key basic, translational, and clinical aspects of hypoparathyroidism. Three Workshop Panels were constituted to address questions for presentation and discussion at the Conference held in Florence, Italy, May 7-9, 2015. At that time, a series of presentations were made, followed by in-depth discussions in an open forum. Each Workshop Panel also met in closed sessions to formulate the three evidence-based reports that accompany this summary statement. An Expert Panel then considered this information, developed summaries, guidelines, and a research agenda that constitutes this summary statement. Preceding the conference, each Workshop Panel conducted an extensive literature search as noted in the individual manuscripts accompanying this report. All presentations were based upon the best peer-reviewed information taking into account the historical and current literature. This report represents the Expert Panel's synthesis of the conference material placed in a context designed to be relevant to clinicians and those engaged in cutting-edge studies of hypoparathyroidism. This document not only provides a summary of our current knowledge but also places recent advances in its management into a context that should enhance future advances in our understanding of hypoparathyroidism.

Outcome-centered antiepileptic therapy: Rate, rhythm and relief.: Implementing AAN Epilepsy Quality Measures in clinical practice.

PubMed

D'Cruz, O'Neill

2015-12-01

Clinicians who manage patients with epilepsy are expected to assess the relevance of clinical trial results to their practice, integrate new treatments into the care algorithm, and implement epilepsy quality measures, with the overall goal of improving patient outcomes. A disease-based clinical framework that helps with choice and combinations of interventions facilitates provision of efficient, cost-effective, and high-quality care. This article addresses the current conceptual framework that informs clinical evaluation of epilepsy, explores gaps between development of treatment options, quality measures and clinical goals, and proposes an outcome-centered approach that bridges these gaps with the aim of improving patient and population-level clinical outcomes in epilepsy. Copyright © 2015 The Author. Published by Elsevier Inc. All rights reserved.

Sexuality and physical intimacy in long-term care.

PubMed

Lichtenberg, Peter A

2014-01-01

Sexuality and sexual needs in older adults remains a neglected area of clinical intervention, particularly so in long-term care settings. Because older adults in medical rehabilitation and long-term care beds present with significant frailties, and often significant neurocognitive disorders, it makes it difficult for occupational therapists and other staff to evaluate the capacity of an older adult resident to participate in sexual relationships. The current paper reviews the current literature on sexuality and aging, examines some of the clinical practices and guidelines regarding sexual expression in long-term care, and presents two case examples. A semistructured interview and decision tree is presented to assist therapists in making careful and informed decisions and thereby balancing the needs for protection with the needs for autonomy.

'I still have no idea why this patient was here': An exploration of the difficulties GP trainees experience when gathering information.

PubMed

Giroldi, Esther; Veldhuijzen, Wemke; de Leve, Tijme; van der Weijden, Trudy; Bueving, Herman; van der Vleuten, Cees

2015-07-01

Collecting information during patient encounters is essential for the delivery of patient-centered care. To obtain insight into areas that require more attention in medical communication training, this study explores what difficulties GP trainees encounter when gathering information. In this phenomenological study, we observed a morning clinic of 15 GP trainees. To explore trainees' experiences with information-gathering, we held brief interviews after every consultation and a lengthier interview directly after the morning clinic. The resulting data were analyzed using template analysis. From trainees' reflections, we distilled five difficulties that trainees experience when gathering information: (1) Goal conflicts; (2) Ineffectiveness of trained communication skills in specific situations; (3) Trainees' distress hampers open communication; (4) Untrustworthy information; (5) Tunnel vision. Information-gathering is difficult for GP trainees. Current generic communication skills training does not seem to support trainees sufficiently to handle effectively the challenges they encounter during consultations. Medical communication training needs to support trainees in handling their goal-conflicts and feelings that hamper information-gathering, while also providing them with communication strategies adapted to handling specific challenging situations. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Using a genetic test result in the care of family members: how does the duty of confidentiality apply?

PubMed

Parker, Michael; Lucassen, Anneke

2018-04-27

The use of genetic and genomic testing is becoming more widespread in healthcare and more inherited explanations for family history of diseases or conditions are being uncovered. Currently, relevant genetic information is not always used in the care of family members who might benefit from it, because of health professionals' fears of inappropriately breaching another family member's confidence. Such examples are likely to increase as testing possibilities expand. Here we present the case for use of familial information in the care and treatment of family members. We argue that whilst a clinical diagnosis in person A is confidential, the discovery of a familial factor that led to this diagnosis should be available for use in depersonalised form by health professionals to inform the testing and clinical care of other family members. The possibility of such use should be made clear in clinical practice at the time of initial testing, but should not require consent from the person in whom the familial factor was first identified. We call for further debate on these questions in the wake of high profile non-disclosure of genetic information cases, and forthcoming Data Protection legislation changes.

The various aspects of genetic and epigenetic toxicology: testing methods and clinical applications.

PubMed

Ren, Ning; Atyah, Manar; Chen, Wan-Yong; Zhou, Chen-Hao

2017-05-22

Genotoxicity refers to the ability of harmful substances to damage genetic information in cells. Being exposed to chemical and biological agents can result in genomic instabilities and/or epigenetic alterations, which translate into a variety of diseases, cancer included. This concise review discusses, from both a genetic and epigenetic point of view, the current detection methods of different agents' genotoxicity, along with their basic and clinical relation to human cancer, chemotherapy, germ cells and stem cells.

Targeting ALK: Precision Medicine Takes On Drug Resistance

PubMed Central

Lin, Jessica J.; Riely, Gregory J.; Shaw, Alice T.

2017-01-01

Anaplastic lymphoma kinase (ALK) is a validated molecular target in several ALK-rearranged malignancies, including non-small-cell lung cancer (NSCLC). However, the clinical benefit of targeting ALK using tyrosine kinase inhibitors (TKIs) is almost universally limited by the emergence of drug resistance. Diverse mechanisms of resistance to ALK TKIs have now been discovered, and these basic mechanisms are informing the development of novel therapeutic strategies to overcome resistance in the clinic. In this Review, we summarize the current successes and challenges of targeting ALK. PMID:28122866

AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.

PubMed

2017-01-01

Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients, health economists, academia, and others. The multistakeholder group represented the key professionals and entities affected by the federal laws and FDA regulations that restrict the sharing of preapproval information and the collective credibility necessary for proposing this new communication process. Forum participants primarily focused on 6 items of discussion: (1) creating and defining new terms for how biopharmaceutical manufacturers may provide clinical and economic information 12-18 months before FDA approval; (2) defining the clinical and scientific standards that this information should meet; (3) determining which entities should have access to this information and the value to each; (4) the format and process by which this information should be disseminated; (5) developing definitions for existing terms referenced in current laws, regulations, or guidance documents that would need to be modernized to align with the identified new term; and (6) providing safeguards to prevent this information from reaching unintended entities. Forum participants selected "preapproval information exchange" (PIE) as the correct term to describe this proposed new communication process and to be inclusive of data from pivotal phase III clinical trials, pharmaco-economic data, and patient-reported outcomes, as well as other relevant items, including anticipated indications, place in therapy, and routes of administration. Stakeholders agreed that PIE should be truthful, non-misleading, and include a broad range of information to meet the needs of population health decision makers and health care technology evolution. Recipients of PIE would be limited to population health decision makers who need this information for coverage decisions. The format and process for PIE disseminated should allow for a bidirectional exchange between manufacturers and population health decision makers but should not be proscribed in legislation. Furthermore, new legislative language may be beneficial, since PIE is a novel category of information. New legislation could provide a safe harbor and clarity that PIE does not violate preapproval promotion and the Federal Food, Drug, and Cosmetic Act and its regulations. The AMCP Partnership Forum on Enabling the Exchange of Clinical and Economic Data Pre-FDA Approval and the development of this proceedings document were supported by AbbVie, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Celgene, Intarcia Therapeutics, Eli Lilly and Company, GlaxoSmithKline, Merck, National Pharmaceutical Council, Novo Nordisk, Pfizer, Pharmaceutical Research and Manufacturers of America, Precision for Value, Sanofi, Takeda Pharmaceuticals, U.S.A., and Xcenda. All sponsors participated in the forum and in revising and approving the manuscript.

Use and perceptions of information among family physicians: sources considered accessible, relevant, and reliable.

PubMed

Kosteniuk, Julie G; Morgan, Debra G; D'Arcy, Carl K

2013-01-01

The research determined (1) the information sources that family physicians (FPs) most commonly use to update their general medical knowledge and to make specific clinical decisions, and (2) the information sources FPs found to be most physically accessible, intellectually accessible (easy to understand), reliable (trustworthy), and relevant to their needs. A cross-sectional postal survey of 792 FPs and locum tenens, in full-time or part-time medical practice, currently practicing or on leave of absence in the Canadian province of Saskatchewan was conducted during the period of January to April 2008. Of 666 eligible physicians, 331 completed and returned surveys, resulting in a response rate of 49.7% (331/666). Medical textbooks and colleagues in the main patient care setting were the top 2 sources for the purpose of making specific clinical decisions. Medical textbooks were most frequently considered by FPs to be reliable (trustworthy), and colleagues in the main patient care setting were most physically accessible (easy to access). When making specific clinical decisions, FPs were most likely to use information from sources that they considered to be reliable and generally physically accessible, suggesting that FPs can best be supported by facilitating easy and convenient access to high-quality information.

Use and perceptions of information among family physicians: sources considered accessible, relevant, and reliable

PubMed Central

Kosteniuk, Julie G.; Morgan, Debra G.; D'Arcy, Carl K.

2013-01-01

Objectives: The research determined (1) the information sources that family physicians (FPs) most commonly use to update their general medical knowledge and to make specific clinical decisions, and (2) the information sources FPs found to be most physically accessible, intellectually accessible (easy to understand), reliable (trustworthy), and relevant to their needs. Methods: A cross-sectional postal survey of 792 FPs and locum tenens, in full-time or part-time medical practice, currently practicing or on leave of absence in the Canadian province of Saskatchewan was conducted during the period of January to April 2008. Results: Of 666 eligible physicians, 331 completed and returned surveys, resulting in a response rate of 49.7% (331/666). Medical textbooks and colleagues in the main patient care setting were the top 2 sources for the purpose of making specific clinical decisions. Medical textbooks were most frequently considered by FPs to be reliable (trustworthy), and colleagues in the main patient care setting were most physically accessible (easy to access). Conclusions: When making specific clinical decisions, FPs were most likely to use information from sources that they considered to be reliable and generally physically accessible, suggesting that FPs can best be supported by facilitating easy and convenient access to high-quality information. PMID:23405045

Evaluating health information technology: provider satisfaction with an HIV-specific, electronic clinical management and reporting system.

PubMed

Magnus, Manya; Herwehe, Jane; Andrews, Laura; Gibson, Laura; Daigrepont, Nathan; De Leon, Jordana M; Hyslop, Newton E; Styron, Steven; Wilcox, Ronald; Kaiser, Michael; Butler, Michael K

2009-02-01

Health information technology (HIT) offers the potential to improve care for persons living with HIV. Provider satisfaction with HIT is essential to realize benefits, yet its evaluation presents challenges. An HIV-specific, electronic clinical management and reporting system was implemented in Louisiana's eight HIV clinics, serving over 7500. A serial cross-sectional survey was administered at three points between April 2002 and July 2005; qualitative methods were used to augment quantitative. Multivariable methods were used to characterize provider satisfaction. The majority of the sample (n = 196; T1 = 105; T2 = 46; T3 = 45) was female (80.0%), between ages of 25 and 50 years (68.3%), frequent providers at that clinic (53.7% more than 4 days per week), and had been at the same clinic for a year or more (85.0%). Improvements in satisfaction were observed in patient tracking ( p < 0.05), distribution of educational materials ( p < 0.04), and belief that electronic systems improve care ( p < 0.05). Provider self-reports of time to complete critical functions decreased for all tasks, two significantly so. Time (in minutes) to find current CD4 count decreased at each time point (mean 3.9 [standard deviation {SD} 5.8], 2.9 [2.3], 2.1 [2.6], p>0.05), current viral load decreased at each time point (mean 4.0 [SD 5.6], 2.9 [2.5], 1.8 [2.6], p = 0.08], current antiretroviral status decreased at each time point (mean 3.9 [SD 4.7], 2.9 [3.7], 1.5 [1.1], p < 0.04), history of antiretroviral use decreased at each time point (mean 15.1 [SD 21.9], 6.0 [5.4], 5.4 [7.2], p < 0.04]. Time savings were realized, averaging 16.1 minutes per visit ( p < 0.04). Providers were satisfied with HIT in multiple domains, and significant time savings were realized.

Resident physicians as human information systems: sources yet seekers

PubMed Central

Bass, Ellen J; DeVoge, Justin Michael; Waggoner-Fountain, Linda A; Borowitz, Stephen M

2013-01-01

Objective To characterize question types that residents received on overnight shifts and what information sources were used to answer them. Materials and Methods Across 30 overnight shifts, questions asked of on-call senior residents, question askers’ roles, and residents’ responses were documented. External sources were noted. Results 158 of 397 questions (39.8%) related to the plan of care, 53 (13.4%) to medical knowledge, 48 (12.1%) to taskwork knowledge, and 44 (11.1%) to the current condition of patients. For 351 (88.4%) questions residents provided specific, direct answers or visited the patient. For 16 of these, residents modeled or completed the task. For 216 questions, residents used previous knowledge or their own clinical judgment. Residents solicited external information sources for 118 questions and only a single source for 77 (65.3%) of them. For the 118, most questions concerned either the plan of care or the patient's current condition and were asked by interns and nurses (those with direct patient care responsibilities). Discussion Resident physicians serve as an information system and they often specifically answer the question using previous knowledge or their own clinical judgment, suggesting that askers are contacting an appropriately knowledgeable person. However, they do need to access patient information such as the plan of care. They also serve an educator role and answer many knowledge-related questions. Conclusions As synchronous verbal communications continue to be important pathways for information flow, informaticians need to consider the relationship between such communications and workflow in the development of healthcare support tools. PMID:23268485

Participants’ perceptions and understanding of a malaria clinical trial in Bangladesh

PubMed Central

2014-01-01

Background Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects’ understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. Methods In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Results Of 16 participants, the vast majority (81%) were illiterate. All subjects had a ‘therapeutic misconception’ i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients’ perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants’ satisfaction with treatment and nursing care. Conclusion There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings. PMID:24893933

Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

PubMed

Das, Debashish; Cheah, Phaik Yeong; Akter, Fateha; Paul, Dulal; Islam, Akhterul; Sayeed, Abdullah A; Samad, Rasheda; Rahman, Ridwanur; Hossain, Amir; Dondorp, Arjen; Day, Nicholas P; White, Nicholas J; Hasan, Mahtabuddin; Ghose, Aniruddha; Ashley, Elizabeth A; Faiz, Abul

2014-06-04

Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care. There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.

How Researchers Define Vulnerable Populations in HIV/AIDS Clinical Trials

PubMed Central

Lo, Bernard; Strauss, Ronald P.; Eron, Joseph; Gifford, Allen L.

2010-01-01

In this study, we interviewed researchers, asking them to define vulnerable populations in HIV/AIDS clinical trials, and provide feedback on the federal regulations for three vulnerable populations. Interview data informed a conceptual framework, and were content analyzed to identify acceptability or disagreement with the regulations. Beginning with several characteristics of vulnerable enrollees identified by researchers, the conceptual framework illustrates possible scenarios of how enrollees could be considered vulnerable in clinical research. Content analysis identified barriers affecting HIV/AIDS researchers’ ability to conduct clinical trials with pregnant women, prisoners, and children, for which the regulations specify additional protections. This study challenges current thinking about federal regulations’ group-based approach to defining vulnerable populations. PMID:20721614

Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect.

PubMed

Mintzes, Barbara; Lexchin, Joel; Quintano, Ancella Santos

2015-01-01

Although selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive. Authors' personal files, key documents from Food and Drug Administration and European Medicines Agency and focussed searches of PubMed. Existing sources of information provide an incomplete overview of scientific research. Persistent arguments about commercial confidentiality and the potential difficulties in de-identifying raw data can block important progress. Current industry efforts are voluntary and only partially satisfy the need for complete data. Requirements for trial registration are increasing. Important regulatory changes in particular in Europe have the potential to result in the release of more information. Documenting the effects of prospective trial registration and requirements for proactive clinical trial publication on healthcare decisions, public health and rational resource allocation. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Time to rethink the role of the library in educating doctors: driving information literacy in the clinical environment.

PubMed

Simons, Mary R; Morgan, Michael Kerin; Davidson, Andrew Stewart

2012-10-01

Can information literacy (IL) be embedded into the curriculum and clinical environment to facilitate patient care and lifelong learning? The Australian School of Advanced Medicine (ASAM) provides competence-based programs incorporating patient-centred care and lifelong learning. ASAM librarians use outcomes-based educational theory to embed and assess IL into ASAM's educational and clinical environments. A competence-based IL program was developed where learning outcomes were linked to current patients and assessed with checklists. Weekly case presentations included clinicians' literature search strategies, results, and conclusions. Librarians provided support to clinicians' literature searches and assessed their presentations using a checklist. Outcome data showed clinicians' searching skills improved over time; however, advanced MEDLINE searching remained challenging for some. Recommendations are provided. IL learning that takes place in context using measurable outcomes is more meaningful, is enduring, and likely contributes to patient care. Competence-based assessment drives learning in this environment.

Biomarker-guided translation of brain imaging into disease pathway models

PubMed Central

Younesi, Erfan; Hofmann-Apitius, Martin

2013-01-01

The advent of state-of-the-art brain imaging technologies in recent years and the ability of such technologies to provide high-resolution information at both structural and functional levels has spawned large efforts to introduce novel non-invasive imaging biomarkers for early prediction and diagnosis of brain disorders; however, their utility in both clinic and drug development at their best resolution remains limited to visualizing and monitoring disease progression. Given the fact that efficient translation of valuable information embedded in brain scans into clinical application is of paramount scientific and public health importance, a strategy is needed to bridge the current gap between imaging and molecular biology, particularly in neurodegenerative diseases. As an attempt to address this issue, we present a novel computational method to link readouts of imaging biomarkers to their underlying molecular pathways with the aim of guiding clinical diagnosis, prognosis and even target identification in drug discovery for Alzheimer's disease. PMID:24287435

Enabling Genomic-Phenomic Association Discovery without Sacrificing Anonymity

PubMed Central

Heatherly, Raymond D.; Loukides, Grigorios; Denny, Joshua C.; Haines, Jonathan L.; Roden, Dan M.; Malin, Bradley A.

2013-01-01

Health information technologies facilitate the collection of massive quantities of patient-level data. A growing body of research demonstrates that such information can support novel, large-scale biomedical investigations at a fraction of the cost of traditional prospective studies. While healthcare organizations are being encouraged to share these data in a de-identified form, there is hesitation over concerns that it will allow corresponding patients to be re-identified. Currently proposed technologies to anonymize clinical data may make unrealistic assumptions with respect to the capabilities of a recipient to ascertain a patients identity. We show that more pragmatic assumptions enable the design of anonymization algorithms that permit the dissemination of detailed clinical profiles with provable guarantees of protection. We demonstrate this strategy with a dataset of over one million medical records and show that 192 genotype-phenotype associations can be discovered with fidelity equivalent to non-anonymized clinical data. PMID:23405076

[Consumer involvement in the Disease Management Guideline for Asthma--a background report].

PubMed

Senger, Sylvia; Lelgemann, Monika; Kopp, Ina

2006-01-01

In the past clinical guidelines were mainly developed by experts and in everyday clinical practice almost exclusively used by clinical experts, while issues that were relevant from the patients' (consumers') point of view tended to be neglected. But then, the majority of patient information has not been perceptibly connected to clinical guidelines. Connecting the development of clinical guidelines with the development of patient information publications would make good sense for both products, though. On the one hand, evidence-based treatment guidelines could be made available to the actual target group of the clinical care process--i.e. the patients or consumers--and on the other hand, patient experiences and competencies (social evidence) might inform the production of guidelines. Such a procedure demands the cooperation of clinical experts and patients. So far there are no generally accepted methods in Germany for the practical implementation of consumer involvement on both the organizational and content level with the aim of involving patients in the development process of guidelines as well as the production of the respective patient information versions. Such a methodology shall be established as part of the National Program for Disease Management Guidelines. For the first time in this program, patient involvement is being exercised within the scope of the National Disease Management Guideline for Asthma (NDM Asthma). Here, patients are involved in the NDM development process by providing the opportunity to comment on the consented guideline draft and to participate in the translation of the NDM Asthma into a patient version. The present paper is a background report describing the current state of work and indicating consequences for some future developments.

Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred

PubMed Central

2014-01-01

Background Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes. Methods We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”. Results Respondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure patient understand” statements (p < 0.001 and p = 0.002, respectively), which were ranked 1–3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both). Conclusions 1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients’ self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill’s individual autonomy model may be suitable for most patients. PMID:24406020

Evaluating the effects of cognitive support on psychiatric clinical comprehension.

PubMed

Dalai, Venkata V; Khalid, Sana; Gottipati, Dinesh; Kannampallil, Thomas; John, Vineeth; Blatter, Brett; Patel, Vimla L; Cohen, Trevor

2014-10-01

Clinicians' attention is a precious resource, which in the current healthcare practice is consumed by the cognitive demands arising from complex patient conditions, information overload, time pressure, and the need to aggregate and synthesize information from disparate sources. The ability to organize information in ways that facilitate the generation of effective diagnostic solutions is a distinguishing characteristic of expert physicians, suggesting that automated systems that organize clinical information in a similar manner may augment physicians' decision-making capabilities. In this paper, we describe the design and evaluation of a theoretically driven cognitive support system (CSS) that assists psychiatrists in their interpretation of clinical cases. The system highlights, and provides the means to navigate to, text that is organized in accordance with a set of diagnostically and therapeutically meaningful higher-level concepts. To evaluate the interface, 16 psychiatry residents interpreted two clinical case scenarios, with and without the CSS. Think-aloud protocols captured during their interpretation of the cases were transcribed and analyzed qualitatively. In addition, the frequency and relative position of content related to key higher-level concepts in a verbal summary of the case were evaluated. In addition the transcripts from both groups were compared to an expert derived reference standard using latent semantic analysis (LSA). Qualitative analysis showed that users of the system better attended to specific clinically important aspects of both cases when these were highlighted by the system, and revealed ways in which the system mediates hypotheses generation and evaluation. Analysis of the summary data showed differences in emphasis with and without the system. The LSA analysis suggested users of the system were more "expert-like" in their emphasis, and that cognitive support was more effective in the more complex case. Cognitive support impacts upon clinical comprehension. This appears to be largely helpful, but may also lead to neglect of information (such as the psychosocial history) that the system does not highlight. The results have implications for the design of CSSs for clinical narratives including the role of information organization and textual embellishments for more efficient clinical case presentation and comprehension. Copyright © 2014 Elsevier B.V. All rights reserved.

Evaluating the effects of cognitive support on psychiatric clinical comprehension

PubMed Central

Dalai, Venkata V.; Khalid, Sana; Gottipati, Dinesh; Kannampallil, Thomas; John, Vineeth; Blatter, Brett; Patel, Vimla L.; Cohen, Trevor

2014-01-01

Objective Clinicians’ attention is a precious resource, which in the current healthcare practice is consumed by the cognitive demands arising from complex patient conditions, information overload, time pressure, and the need to aggregate and synthesize information from disparate sources. The ability to organize information in ways that facilitate the generation of effective diagnostic solutions is a distinguishing characteristic of expert physicians, suggesting that automated systems that organize clinical information in a similar manner may augment physicians’ decision-making capabilities. In this paper, we describe the design and evaluation of a theoretically driven cognitive support system (CSS) that assists psychiatrists in their interpretation of clinical cases. The system highlights, and provides the means to navigate to, text that is organized in accordance with a set of diagnostically and therapeutically meaningful higher-level concepts. Methods and Materials To evaluate the interface, 16 psychiatry residents interpreted two clinical case scenarios, with and without the CSS. Think-aloud protocols captured during their interpretation of the cases were transcribed and analyzed qualitatively. In addition, the frequency and relative position of content related to key higher-level concepts in a verbal summary of the case were evaluated. In addition the transcripts from both groups were compared to an expert derived reference standard using latent semantic analysis (LSA). Results Qualitative analysis showed that users of the system better attended to specific clinically important aspects of both cases when these were highlighted by the system, and revealed ways in which the system mediates hypotheses generation and evaluation. Analysis of the summary data showed differences in emphasis with and without the system. The LSA analysis suggested users of the system were more “expert-like” in their emphasis, and that cognitive support was more effective in the more complex case. Conclusions Cognitive support impacts upon clinical comprehension. This appears to be largely helpful, but may also lead to neglect of information (such as the psychosocial history) that the system does not highlight. The results have implications for the design of CSSs for clinical narratives including the role of information organization and textual embellishments for more efficient clinical case presentation and comprehension. PMID:25179216

Rivaroxaban real-world evidence: Validating safety and effectiveness in clinical practice.

PubMed

Beyer-Westendorf, Jan; Camm, A John; Coleman, Craig I; Tamayo, Sally

2016-09-28

Randomised controlled trials (RCTs) are considered the gold standard of clinical research as they use rigorous methodologies, detailed protocols, pre-specified statistical analyses and well-defined patient cohorts. However, RCTs do not take into account the complexity of real-world clinical decision-making. To tackle this, real-world data are being increasingly used to evaluate the long-term safety and effectiveness of a given therapy in routine clinical practice and in patients who may not be represented in RCTs, addressing key clinical questions that may remain. Real-world evidence plays a substantial role in supporting the use of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) in clinical practice. By providing data on patient profiles and the use of anticoagulation therapies in routine clinical practice, real-world evidence expands the current awareness of NOACs, helping to ensure that clinicians are well-informed on their use to implement patient-tailored clinical decisions. There are various issues with current anticoagulation strategies, including under- or overtreatment and frequent monitoring with VKAs. Real-world studies have demonstrated that NOAC use is increasing (Dresden NOAC registry and Global Anticoagulant Registry in the FIELD-AF [GARFIELD-AF]), as well as reaffirming the safety and effectiveness of rivaroxaban previously observed in RCTs (XArelto on preveNtion of sTroke and non-central nervoUS system systemic embolism in patients with non-valvular atrial fibrillation [XANTUS] and IMS Disease Analyzer). This article will describe the latest updates in real-world evidence across a variety of methodologies, such as non-interventional studies (NIS), registries and database analyses studies. It is anticipated that these studies will provide valuable clinical insights into the management of thromboembolism, and enhance the current knowledge on anticoagulant use and outcomes for patients.

Clinical guideline on bone conduction implants.

PubMed

Lavilla Martín de Valmaseda, María José; Cavalle Garrido, Laura; Huarte Irujo, Alicia; Núñez Batalla, Faustino; Manrique Rodriguez, Manuel; Ramos Macías, Ángel; de Paula Vernetta, Carlos; Gil-Carcedo Sañudo, Elisa; Lassaleta, Luis; Sánchez-Cuadrado, Isabel; Espinosa Sánchez, Juan Manuel; Batuecas Caletrio, Ángel; Cenjor Español, Carlos

2018-04-13

During the last decade there have been multiple and relevant advances in conduction and mixed hearing loss treatment. These advances and the appearance of new devices have extended the indications for bone-conduction implants. The Scientific Committee of Audiology of the Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello SEORL-CCC (Spanish Society of Otolaryngology and Head and Neck Surgery), together with the Otology and Otoneurology Committees, have undertaken a review of the current state of bone-conduction devices with updated information, to provide a clinical guideline on bone-conduction implants for otorhinolaryngology specialists, health professionals, health authorities and society in general. This clinical guideline on bone-conduction implants contains information on the following: 1) Definition and description of bone-conduction devices; 2) Current and upcoming indications for bone conduction devices: Magnetic resonance compatibility; 3) Organization requirements for a bone-conduction implant programme. The purpose of this guideline is to describe the different bone-conduction implants, their characteristics and their indications, and to provide coordinated instructions for all the above-mentioned agents for decision making within their specific work areas. Copyright © 2018 Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. Publicado por Elsevier España, S.L.U. All rights reserved.

Clinical practice guidelines in complementary and alternative medicine. An analysis of opportunities and obstacles. Practice and Policy Guidelines Panel, National Institutes of Health Office of Alternative Medicine.

PubMed

1997-01-01

An estimated 1 of 3 Americans uses some form of complementary and alternative medicine (CAM), such as acupuncture, homeopathy, or herbal medicine. In 1995, the National Institutes of Health Office of Alternative Medicine convened an expert panel to examine the role of clinical practice guidelines in CAM. The panel concluded that CAM practices currently are unsuitable for the development of evidence-based practice guidelines, in part because of the lack of relevant outcomes data from well-designed clinical trials. Moreover, the notions of standardization and appropriateness, inherent in guideline development, face challenging methodologic problems when applied to CAM, which considers many different treatment practices appropriate and encourages highly individualized care. Due to different belief systems and divergent theories about the nature of health and illness, CAM disciplines have fundamental differences in how they define target conditions, causes of disease, interventions, and outcome measures of effectiveness. These differences are even more striking when compared with those used by Western medicine. The panel made a series of recommendations on strategies to strengthen the evidence base for future guideline development in CAM and to meet better the current information needs of clinicians, patients, and guideline developers who seek information about CAM treatments.

Should the chiropractic profession embrace the doctrine of informed consent?

PubMed Central

Lehman, James J.; Conwell, Timothy D.; Sherman, Paul R.

2008-01-01

Abstract This commentary provides a narrative review of the literature focusing on the use of a health care informed consent process in the United States. This article reviews the current positions of the World Medical Association, American Medical Association, American Chiropractic Association, Wisconsin and New Jersey State Courts, US Federal Government Office of Health Policy and Clinical Outcomes, and 1 college of chiropractic regarding the doctrine of informed consent. The authors recommend that the chiropractic profession embrace the doctrine of informed consent and promulgate it as a standard of care. The implementation of this doctrine by chiropractic physicians promotes and improves the safety of chiropractic interventions. PMID:19646372

Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

PubMed

Izadi, Morteza; Fazel, Mozhgan; Nasiri-Vanashi, Taha; Saadat, Seyed Hasan; Taheri, Saeed

2012-05-01

Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

Public Health Information Systems: Priorities and Practices for Successful Deployments.

PubMed

Pearce, Martin

2016-01-01

A fast paced workshop designed for senior public health decision makers and clinical leaders implementing information systems to support delivery of public health programs. The tutorial will introduce public health information systems and provide best practices for implementing solutions related to immunization, communicable disease case management and outbreak management. Using a combination of formats, the tutorial will: • Highlight key functionality of public health information systems. • Review global crises currently exposing gaps and deficiencies in public health information. • Examine governance, planning, and implementation priorities. • Highlight considerations supporting implementations nationally and in special populations. • Provide real, actionable lessons learned to take away and apply in the real world.

The effects of black pepper on the intestinal absorption and hepatic metabolism of drugs.

PubMed

Han, Hyo-Kyung

2011-06-01

There is currently a need for a better understanding of the mechanisms of food-drug interaction as well as the clinical implication to maximize the effectiveness and applicability of black pepper or its active component, piperine, as a bioavailability enhancer in the clinical arena. This review deals with the effects of black pepper and piperine on drug metabolizing enzymes as well as on intestinal drug absorption. The review provides the reader with a comprehensive update on the potential mechanisms and pharmacokinetic interactions of black pepper and piperine with co-administered medicines. The article also provides a comprehensive update on the current known issues with black pepper and piperine. The information provided is used to assess the clinical significance of black pepper and piperine and optimize their effectiveness as a bioavailability enhancer. For black pepper or piperine to be widely applicable in current medical practice, as a combination therapy, the clinical significance of food-drug interactions caused by concurrent use of black pepper or piperine should be carefully assessed with consideration for many compounding factors affecting the clinical outcome of pharmacokinetic interactions (e.g., dose, dosing regimen, genetic variation and species). Furthermore, the effective formulation strategy for the optimization of the pharmacokinetic characteristics of dietary components is crucial to improve their in vivo performance and ultimately maximize their effectiveness as a bioavailability enhancer.

The kidney as a new target for antidiabetic drugs: SGLT2 inhibitors.

PubMed

Cangoz, S; Chang, Y-Y; Chempakaseril, S J; Guduru, R C; Huynh, L M; John, J S; John, S T; Joseph, M E; Judge, R; Kimmey, R; Kudratov, K; Lee, P J; Madhani, I C; Shim, P J; Singh, S; Singh, S; Ruchalski, C; Raffa, R B

2013-10-01

A novel class of antidiabetic drugs - SGLT2 (Na(+) /glucose cotransporter type 2) inhibitors - target renal reabsorption of glucose and promote normal glucose levels, independent of insulin production or its action at receptors. We review this new mechanistic approach and the reported efficacy and safety of clinical testing of lead compounds. Information was obtained from various bibliographic sources, including PubMed and others, on the basic science and the clinical trials of SGLT2 inhibitors. The information was then summarized and evaluated from the perspective of contribution to a fuller understanding of the potential and current status of the lead clinical candidates. Diabetes mellitus is a spectrum of disorders that involves inadequate insulin function resulting in adverse health sequelae due to acute and chronic hyperglycaemia. Current antidiabetic pharmacotherapy primarily addresses either insulin production at the pancreatic β-cells or insulin action at insulin receptors. These drugs have less than full clinical effectiveness and sometimes therapy-limiting adverse effects. The third major component of glucose balance, namely elimination, has not been a significant therapeutic target to date. SGLT2 inhibitors are a novel approach. A sufficient number of clinical trials have been conducted on sufficiently chemically diverse SGLT2 inhibitors to reasonably conclude that they have efficacy (HbA1c reductions of 0·4-1%), and thus far, the majority of adverse effects have been mild and transitory or treatable, with the caveat of possible association with increased risk of breast cancer in women and bladder cancer in men. © 2013 John Wiley & Sons Ltd.

The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC).

PubMed

Fernandes, G S; Sternberg, C; Lopes, G; Chammas, R; Gifoni, M A C; Gil, R A; Araujo, D V

2018-01-11

A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.

An object-oriented design for automated navigation of semantic networks inside a medical data dictionary.

PubMed

Ruan, W; Bürkle, T; Dudeck, J

2000-01-01

In this paper we present a data dictionary server for the automated navigation of information sources. The underlying knowledge is represented within a medical data dictionary. The mapping between medical terms and information sources is based on a semantic network. The key aspect of implementing the dictionary server is how to represent the semantic network in a way that is easier to navigate and to operate, i.e. how to abstract the semantic network and to represent it in memory for various operations. This paper describes an object-oriented design based on Java that represents the semantic network in terms of a group of objects. A node and its relationships to its neighbors are encapsulated in one object. Based on such a representation model, several operations have been implemented. They comprise the extraction of parts of the semantic network which can be reached from a given node as well as finding all paths between a start node and a predefined destination node. This solution is independent of any given layout of the semantic structure. Therefore the module, called Giessen Data Dictionary Server can act independent of a specific clinical information system. The dictionary server will be used to present clinical information, e.g. treatment guidelines or drug information sources to the clinician in an appropriate working context. The server is invoked from clinical documentation applications which contain an infobutton. Automated navigation will guide the user to all the information relevant to her/his topic, which is currently available inside our closed clinical network.

[Clinical Handling of Patients with Dissociative Disorders].

PubMed

Okano, Kenichiro

2015-01-01

This paper discusses the way informed psychiatrists are expected to handle dissociative patients in clinical situations, with a specific focus on dissociative identity disorders and dissociative fugue. On the initial interview with dissociative patients, information on their history of trauma and any nascent dissociative symptoms in their childhood should be carefully obtained. Their level of stress in their current life should also be assessed in order to understand their symptomatology, as well as to predict their future clinical course. A psychoeducational approach is crucial; it might be helpful to give information on dissociative disorder to these patients as well as their family members in order to promote their adherence to treatment. Regarding the symptomatology of dissociative disorders, detailed symptoms and the general clinical course are presented. It was stressed that dissociative identity disorder and dissociative fugue, the most high-profile dissociative disorders, are essentially different in their etiology and clinical presentation. Dissociative disorders are often confused with and misdiagnosed as psychotic disorders, such as schizophrenia. Other conditions considered in terms of the differential diagnosis include borderline personality disorder as well as temporal lobe epilepsy. Lastly, the therapeutic approach to dissociative identity disorder is discussed. Each dissociative identity should be understood as potentially representing some traumatically stressful event in the past. The therapist should be careful not to excessively promote the creation or elaboration of any dissociative identities. Three stages are proposed in the individual psychotherapeutic process. In the initial stage, a secure environment and stabilization of symptoms should be sought. The second stage consists of aiding the "host" personality to make use of other more adaptive coping skills in their life. The third stage involves coaching as well as continuous awareness of their comorbid psychiatric conditions. Lastly, factors preventing the patients' smooth recovery process are mentioned. They include their contact with past and current aggressors, chronic and ongoing stress within the family, including abuse and violence, and comorbid conditions such as depression and chronic medical conditions.

Quality of human-computer interaction - results of a national usability survey of hospital-IT in Germany

PubMed Central

2011-01-01

Background Due to the increasing functionality of medical information systems, it is hard to imagine day to day work in hospitals without IT support. Therefore, the design of dialogues between humans and information systems is one of the most important issues to be addressed in health care. This survey presents an analysis of the current quality level of human-computer interaction of healthcare-IT in German hospitals, focused on the users' point of view. Methods To evaluate the usability of clinical-IT according to the design principles of EN ISO 9241-10 the IsoMetrics Inventory, an assessment tool, was used. The focus of this paper has been put on suitability for task, training effort and conformity with user expectations, differentiated by information systems. Effectiveness has been evaluated with the focus on interoperability and functionality of different IT systems. Results 4521 persons from 371 hospitals visited the start page of the study, while 1003 persons from 158 hospitals completed the questionnaire. The results show relevant variations between different information systems. Conclusions Specialised information systems with defined functionality received better assessments than clinical information systems in general. This could be attributed to the improved customisation of these specialised systems for specific working environments. The results can be used as reference data for evaluation and benchmarking of human computer engineering in clinical health IT context for future studies. PMID:22070880

Quantifying Short-Term Dynamics of Parkinson’s Disease Using Self-Reported Symptom Data From an Internet Social Network

PubMed Central

Wicks, Paul; Vaughan, Timothy; Pentland, Alex

2013-01-01

Background Parkinson’s disease (PD) is an incurable neurological disease with approximately 0.3% prevalence. The hallmark symptom is gradual movement deterioration. Current scientific consensus about disease progression holds that symptoms will worsen smoothly over time unless treated. Accurate information about symptom dynamics is of critical importance to patients, caregivers, and the scientific community for the design of new treatments, clinical decision making, and individual disease management. Long-term studies characterize the typical time course of the disease as an early linear progression gradually reaching a plateau in later stages. However, symptom dynamics over durations of days to weeks remains unquantified. Currently, there is a scarcity of objective clinical information about symptom dynamics at intervals shorter than 3 months stretching over several years, but Internet-based patient self-report platforms may change this. Objective To assess the clinical value of online self-reported PD symptom data recorded by users of the health-focused Internet social research platform PatientsLikeMe (PLM), in which patients quantify their symptoms on a regular basis on a subset of the Unified Parkinson’s Disease Ratings Scale (UPDRS). By analyzing this data, we aim for a scientific window on the nature of symptom dynamics for assessment intervals shorter than 3 months over durations of several years. Methods Online self-reported data was validated against the gold standard Parkinson’s Disease Data and Organizing Center (PD-DOC) database, containing clinical symptom data at intervals greater than 3 months. The data were compared visually using quantile-quantile plots, and numerically using the Kolmogorov-Smirnov test. By using a simple piecewise linear trend estimation algorithm, the PLM data was smoothed to separate random fluctuations from continuous symptom dynamics. Subtracting the trends from the original data revealed random fluctuations in symptom severity. The average magnitude of fluctuations versus time since diagnosis was modeled by using a gamma generalized linear model. Results Distributions of ages at diagnosis and UPDRS in the PLM and PD-DOC databases were broadly consistent. The PLM patients were systematically younger than the PD-DOC patients and showed increased symptom severity in the PD off state. The average fluctuation in symptoms (UPDRS Parts I and II) was 2.6 points at the time of diagnosis, rising to 5.9 points 16 years after diagnosis. This fluctuation exceeds the estimated minimal and moderate clinically important differences, respectively. Not all patients conformed to the current clinical picture of gradual, smooth changes: many patients had regimes where symptom severity varied in an unpredictable manner, or underwent large rapid changes in an otherwise more stable progression. Conclusions This information about short-term PD symptom dynamics contributes new scientific understanding about the disease progression, currently very costly to obtain without self-administered Internet-based reporting. This understanding should have implications for the optimization of clinical trials into new treatments and for the choice of treatment decision timescales. PMID:23343503

Quantifying short-term dynamics of Parkinson's disease using self-reported symptom data from an Internet social network.

PubMed

Little, Max; Wicks, Paul; Vaughan, Timothy; Pentland, Alex

2013-01-24

Parkinson's disease (PD) is an incurable neurological disease with approximately 0.3% prevalence. The hallmark symptom is gradual movement deterioration. Current scientific consensus about disease progression holds that symptoms will worsen smoothly over time unless treated. Accurate information about symptom dynamics is of critical importance to patients, caregivers, and the scientific community for the design of new treatments, clinical decision making, and individual disease management. Long-term studies characterize the typical time course of the disease as an early linear progression gradually reaching a plateau in later stages. However, symptom dynamics over durations of days to weeks remains unquantified. Currently, there is a scarcity of objective clinical information about symptom dynamics at intervals shorter than 3 months stretching over several years, but Internet-based patient self-report platforms may change this. To assess the clinical value of online self-reported PD symptom data recorded by users of the health-focused Internet social research platform PatientsLikeMe (PLM), in which patients quantify their symptoms on a regular basis on a subset of the Unified Parkinson's Disease Ratings Scale (UPDRS). By analyzing this data, we aim for a scientific window on the nature of symptom dynamics for assessment intervals shorter than 3 months over durations of several years. Online self-reported data was validated against the gold standard Parkinson's Disease Data and Organizing Center (PD-DOC) database, containing clinical symptom data at intervals greater than 3 months. The data were compared visually using quantile-quantile plots, and numerically using the Kolmogorov-Smirnov test. By using a simple piecewise linear trend estimation algorithm, the PLM data was smoothed to separate random fluctuations from continuous symptom dynamics. Subtracting the trends from the original data revealed random fluctuations in symptom severity. The average magnitude of fluctuations versus time since diagnosis was modeled by using a gamma generalized linear model. Distributions of ages at diagnosis and UPDRS in the PLM and PD-DOC databases were broadly consistent. The PLM patients were systematically younger than the PD-DOC patients and showed increased symptom severity in the PD off state. The average fluctuation in symptoms (UPDRS Parts I and II) was 2.6 points at the time of diagnosis, rising to 5.9 points 16 years after diagnosis. This fluctuation exceeds the estimated minimal and moderate clinically important differences, respectively. Not all patients conformed to the current clinical picture of gradual, smooth changes: many patients had regimes where symptom severity varied in an unpredictable manner, or underwent large rapid changes in an otherwise more stable progression. This information about short-term PD symptom dynamics contributes new scientific understanding about the disease progression, currently very costly to obtain without self-administered Internet-based reporting. This understanding should have implications for the optimization of clinical trials into new treatments and for the choice of treatment decision timescales.

Evaluation of drug interaction microcomputer software: Dambro's Drug Interactions.

PubMed

Poirier, T I; Giudici, R A

1990-01-01

Dambro's Drug Interactions was evaluated using general and specific criteria. The installation process, ease of learning and use were rated excellent. The user documentation and quality of the technical support were good. The scope of coverage, clinical documentation, frequency of updates, and overall clinical performance were fair. The primary advantages of the program are the quick searching and detection of drug interactions, and the attempt to provide useful interaction data, i.e., significance and reference. The disadvantages are the lack of current drug interaction information, outdated references, lack of evaluative drug interaction information, and the inability to save or print patient profiles. The program is not a good value for the pharmacist but has limited use as a quick screening tool.

An environmental scan of weight assessment and management practices in paediatric spina bifida clinics across Canada.

PubMed

McPherson, Amy C; Leo, Jennifer; Church, Paige; Lyons, Julia; Chen, Lorry; Swift, Judy

2014-01-01

Childhood obesity is a global health concern, but children with spina bifida in particular have unique interacting risk factors for increased weight. To identify and explore current clinical practices around weight assessment and management in pediatric spina bifida clinics. An online, self-report survey of healthcare professionals (HCPs) was conducted in all pediatric spina bifida clinics across Canada (15 clinics). Summary and descriptive statistics were calculated and descriptive thematic analysis was performed on free text responses. 52 responses across all 15 clinics indicated that weight and height were assessed and recorded most of the time using a wide variety of methods, although some HCPs questioned their suitability for children with spina bifida. Weight and height information was not routinely communicated to patients and their families and HCPS identified considerable barriers to discussing weight-related information in consultations. Despite weight and height reportedly being measured regularly, HCPs expressed concern over the lack of appropriate assessment and classification tools. Communication across multi-disciplinary team members is required to ensure that children with weight-related issues do not inadvertently get overlooked. Specific skill training around weight-related issues and optimizing consultation time should be explored further for HCPs working with this population.

Data governance requirements for distributed clinical research networks: triangulating perspectives of diverse stakeholders

PubMed Central

Kim, Katherine K; Browe, Dennis K; Logan, Holly C; Holm, Roberta; Hack, Lori; Ohno-Machado, Lucila

2014-01-01

There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research. PMID:24302285

Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention--convened meeting.

PubMed

Broussard, Cheryl S; Frey, Meghan T; Hernandez-Diaz, Sonia; Greene, Michael F; Chambers, Christina D; Sahin, Leyla; Collins Sharp, Beth A; Honein, Margaret A

2014-09-01

To address information gaps that limit informed clinical decisions on medication use in pregnancy, the Centers for Disease Control and Prevention (CDC) solicited expert input on a draft prototype outlining a systematic approach to evaluating the quality and strength of existing evidence for associated risks. The draft prototype outlined a process for the systematic review of available evidence and deliberations by a panel of experts to inform clinical decision making for managing health conditions in pregnancy. At an expert meeting convened by the CDC in January 2013, participants divided into working groups discussed decision points within the prototype. This report summarizes their discussions of best practices for formulating an expert review process, developing evidence summaries and treatment guidance, and disseminating information. There is clear recognition of current knowledge gaps and a strong collaboration of federal partners, academic experts, and professional organizations willing to work together toward safer medication use during pregnancy. Published by Elsevier Inc.

Developing a systematic approach to safer medication use during pregnancy: summary of a Centers for Disease Control and Prevention—convened meeting

PubMed Central

Broussard, Cheryl S.; Frey, Meghan T.; Hernandez-Diaz, Sonia; Greene, Michael F.; Chambers, Christina D.; Sahin, Leyla; Collins Sharp, Beth A.; Honein, Margaret A.

2015-01-01

To address information gaps that limit informed clinical decisions on medication use in pregnancy, the Centers for Disease Control and Prevention (CDC) solicited expert input on a draft prototype outlining a systematic approach to evaluating the quality and strength of existing evidence for associated risks. The draft prototype outlined a process for the systematic review of available evidence and deliberations by a panel of experts to inform clinical decision making for managing health conditions in pregnancy. At an expert meeting convened by the CDC in January 2013, participants divided into working groups discussed decision points within the prototype. This report summarizes their discussions of best practices for formulating an expert review process, developing evidence summaries and treatment guidance, and disseminating information. There is clear recognition of current knowledge gaps and a strong collaboration of federal partners, academic experts, and professional organizations willing to work together toward safer medication use during pregnancy. PMID:24881821

SYN-PEDS: SYNtactical Pediatric Evaluation and Diagnostic System

PubMed Central

Witten, Matthew; Maloney, David

1980-01-01

SYN-PEDS is a multimodular system which is designed to be an inhome interactive access to a neonatal and pediatric diagnostic information database. This system is designed to assist a parent in assessing his child's condition, as well as in determining whether or not the child needs immediate medical attention. This system is not designed to replace the pediatrician but rather, it is designed as a preventative and health maintenance information system which has the unusually nice side benefit if helping to reduce medical system costs by cutting down on the number of unnecessary visits to private and local clinics as well as private physicians. The current version of SYN-PEDS is composed of of four operative modules: CRITICAL, TREAT, CLINFO, and DIAGNOSE/SYMPTM. These four modules allow the parent/user to interact with the SYN-PEDS system in various modes. As an example, CLINFO is the module which provides clinical information on a variety of subjects. This module is for a parent who wishes information on a particular subject of interest.

Complex Psychiatric Comorbidity of Treatment-Seeking Youth With Autism Spectrum Disorder and Anxiety Symptoms

PubMed Central

HEPBURN, SUSAN L.; STERN, JESSICA A.; BLAKELEY-SMITH, AUDREY; KIMEL, LILA K.; REAVEN, JUDITH A.

2015-01-01

Anxiety disorders and other co-occurring psychiatric disorders significantly impact adaptive functioning for many children with autism spectrum disorder (ASD). This descriptive study examines the complexity of psychiatric comorbidity in treatment-seeking youth with ASD and anxiety symptoms. Forty-two parents of 8- to 14-year-old children with ASD and anxiety symptoms completed a structured psychiatric interview (K-SADS) and provided information about the child’s past and current psychological functioning as part of a screening process to enter an anxiety intervention program. Overall, comorbidity was very complex, with children obtaining an average of 4 psychiatric diagnoses (including anxiety disorders) on a structured clinical interview (range = 0–9). Onset and course differed by psychiatric disorder. Complexity of comorbidity did not differ significantly by age, sex, or autism severity. Despite clinical significance of the symptoms reported, few children were currently (or ever) engaged in mental health treatment or group psychosocial intervention. Although the specificity of the current sample limits the generalizability of these results, findings suggest that treatment-seeking children with ASD and anxiety often present with additional psychiatric symptoms, which supports a transdiagnostic approach to research and intervention in this area. Accurate assessment of comorbidity may provide valuable information for families and clinicians regarding individualized treatment approaches. PMID:25960821

Clinically Unsuspected Prion Disease Among Patients With Dementia Diagnoses in an Alzheimer's Disease Database.

PubMed

Maddox, Ryan A; Blase, J L; Mercaldo, N D; Harvey, A R; Schonberger, L B; Kukull, W A; Belay, E D

2015-12-01

Brain tissue analysis is necessary to confirm prion diseases. Clinically unsuspected cases may be identified through neuropathologic testing. National Alzheimer's Coordinating Center (NACC) Minimum and Neuropathologic Data Set for 1984 to 2005 were reviewed. Eligible patients had dementia, underwent autopsy, had available neuropathologic data, belonged to a currently funded Alzheimer's Disease Center (ADC), and were coded as having an Alzheimer's disease clinical diagnosis or a nonprion disease etiology. For the eligible patients with neuropathology indicating prion disease, further clinical information, collected from the reporting ADC, determined whether prion disease was considered before autopsy. Of 6000 eligible patients in the NACC database, 7 (0.12%) were clinically unsuspected but autopsy-confirmed prion disease cases. The proportion of patients with dementia with clinically unrecognized but autopsy-confirmed prion disease was small. Besides confirming clinically suspected cases, neuropathology is useful to identify unsuspected clinically atypical cases of prion disease. © The Author(s) 2015.

Applications of Electronic Health Information in Public Health: Uses, Opportunities & Barriers

PubMed Central

Tomines, Alan; Readhead, Heather; Readhead, Adam; Teutsch, Steven

2013-01-01

Electronic health information systems can reshape the practice of public health including public health surveillance, disease and injury investigation and control, decision making, quality assurance, and policy development. While these opportunities are potentially transformative, and the federal program for the Meaningful Use (MU) of electronic health records (EHRs) has included important public health components, significant barriers remain. Unlike incentives in the clinical care system, scant funding is available to public health departments to develop the necessary information infrastructure and workforce capacity to capitalize on EHRs, personal health records, or Big Data. Current EHR systems are primarily built to serve clinical systems and practice rather than being structured for public health use. In addition, there are policy issues concerning how broadly the data can be used by public health officials. As these issues are resolved and workable solutions emerge, they should yield a more efficient and effective public health system. PMID:25848571

Patient Summary and medicines reconciliation: application of the ISO/CEN EN 13606 standard in clinical practice.

PubMed

Farfán Sedano, Francisco J; Terrón Cuadrado, Marta; Castellanos Clemente, Yolanda; Serrano Balazote, Pablo; Moner Cano, David; Robles Viejo, Montserrat

2011-01-01

The comparison of the patient's current medication list with the medication being ordered when admitted to Hospital, identifying omissions, duplications, dosing errors, and potential interactions, constitutes the core process of medicines reconciliation. Access to the medication the patient is taking at home could be unfeasible as this information is frequently stored in various locations and in diverse proprietary formats. The lack of interoperability between those information systems, namely the Primary Care and the Specialized Electronic Health Records (EHRs), facilitates medication errors and endangers patient safety. Thus, the development of a Patient Summary that includes clinical data from different electronic systems will allow doctors access to relevant information enabling a safer and more efficient assistance. Such a collection of data from heterogeneous and distributed systems has been achieved in this Project through the construction of a federated view based on the ISO/CEN EN13606 Standard for architecture and communication of EHRs.

The National Institutes of Health Clinical Center Digital Imaging Network, Picture Archival and Communication System, and Radiology Information System.

PubMed

Goldszal, A F; Brown, G K; McDonald, H J; Vucich, J J; Staab, E V

2001-06-01

In this work, we describe the digital imaging network (DIN), picture archival and communication system (PACS), and radiology information system (RIS) currently being implemented at the Clinical Center, National Institutes of Health (NIH). These systems are presently in clinical operation. The DIN is a redundant meshed network designed to address gigabit density and expected high bandwidth requirements for image transfer and server aggregation. The PACS projected workload is 5.0 TB of new imaging data per year. Its architecture consists of a central, high-throughput Digital Imaging and Communications in Medicine (DICOM) data repository and distributed redundant array of inexpensive disks (RAID) servers employing fiber-channel technology for immediate delivery of imaging data. On demand distribution of images and reports to clinicians and researchers is accomplished via a clustered web server. The RIS follows a client-server model and provides tools to order exams, schedule resources, retrieve and review results, and generate management reports. The RIS-hospital information system (HIS) interfaces include admissions, discharges, and transfers (ATDs)/demographics, orders, appointment notifications, doctors update, and results.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems.

PubMed

Weininger, Sandy; Jaffe, Michael B; Goldman, Julian M

2017-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development.

The Need to Apply Medical Device Informatics in Developing Standards for Safe Interoperable Medical Systems

PubMed Central

Weininger, Sandy; Jaffe, Michael B.; Goldman, Julian M

2016-01-01

Medical device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account this systems perspective. In this article we describe the current development of medical device standards and the need for these standards to address medical device informatics. Medical device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe medical device interoperability. Five clinical examples show how medical device informatics principles, if applied in the development of medical device standards, could help facilitate the development of safe interoperable medical device systems. These examples illustrate the clinical implications of the failure to capture important signals and device attributes. We provide recommendations relating to the coordination between historically separate standards development groups; some which focus on safety and effectiveness, and others that focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that device-to-device interactions and related safety information are considered during standards development. PMID:27584685

Towards public health decision support: a systematic review of bidirectional communication approaches.

PubMed

Dixon, Brian E; Gamache, Roland E; Grannis, Shaun J

2013-05-01

To summarize the literature describing computer-based interventions aimed at improving bidirectional communication between clinical and public health. A systematic review of English articles using MEDLINE and Google Scholar. Search terms included public health, epidemiology, electronic health records, decision support, expert systems, and decision-making. Only articles that described the communication of information regarding emerging health threats from public health agencies to clinicians or provider organizations were included. Each article was independently reviewed by two authors. Ten peer-reviewed articles highlight a nascent but promising area of research and practice related to alerting clinicians about emerging threats. Current literature suggests that additional research and development in bidirectional communication infrastructure should focus on defining a coherent architecture, improving interoperability, establishing clear governance, and creating usable systems that will effectively deliver targeted, specific information to clinicians in support of patient and population decision-making. Increasingly available clinical information systems make it possible to deliver timely, relevant knowledge to frontline clinicians in support of population health. Future work should focus on developing a flexible, interoperable infrastructure for bidirectional communications capable of integrating public health knowledge into clinical systems and workflows.

Video observation in HIT development: lessons learned on benefits and challenges.

PubMed

Høstgaard, Anna Marie; Bertelsen, Pernille

2012-08-22

Experience shows that the precondition for the development of successful health information technologies is a thorough insight into clinical work practice. In contemporary clinical work practice, clinical work and health information technology are integrated, and part of the practice is tacit. When work practice becomes routine, it slips to the background of the conscious awareness and becomes difficult to recognize without the context to support recall. This means that it is difficult to capture with traditional ethnographic research methods or in usability laboratories or clinical set ups. Observation by the use of the video technique within healthcare settings has proven to be capable of providing a thorough insight into the complex clinical work practice and its context - including parts of the tacit practice. The objective of this paper is 1) to argue for the video observation technique to inform and improve health-information-technology development and 2) to share insights and lessons learned on benefits and challenges when using the video observation technique within healthcare settings. A multiple case study including nine case studies conducted by DaCHI researchers 2004-2011 using audio-visual, non-participant video observation for data collection within different healthcare settings. In HIT development, video observation is beneficial for 1) informing and improving system design 2) studying changes in work practice 3) identifying new potentials and 4) documenting current work practices. The video observation technique used within healthcare settings is superior to other ethnographic research methods when it comes to disclosing the complexity in clinical work practice. The insights gained are far more realistic compared to traditional ethnographic studies or usability studies and studies in clinical set ups. Besides, the data generated through video recordings provide a solid basis for dialog between the health care professionals involved. The most important lessons learned are that a well considered methodology and clear formulated objectives are imperative, in order to stay focused during the data rich analysis phase. Additionally, the video observation technique is primarily recommended for studies of specific clinical work practices within delimited clinical settings. Overall, the video observation technique has proven to be capable of improving our understanding of the interwoven relation between clinical work practice and HIT and to inform us about user requirements and needs for HIT, which is a precondition for the development of more successful HIT systems in the future.

A survey of UK fertility clinics' approach to surrogacy arrangements.

PubMed

Norton, Wendy; Crawshaw, Marilyn; Hudson, Nicky; Culley, Lorraine; Law, Caroline

2015-09-01

This paper draws on the findings of the first survey of surrogacy arrangements in Human Fertilisation and Embryology Authority (HFEA) licensed fertility clinics since 1998. Given the complex social, ethical and legal issues involved, surrogacy continues to raise debate worldwide and fuel calls for increased domestic provision in developed countries. However, little is known about how recent changes have affected HFEA licensed clinics. A 24-item online survey was undertaken between August and October 2013, designed to improve understanding of recent trends and current practices associated with UK-based surrogacy, and consider the implications for future policy and practice in UK and cross-border surrogacy arrangements. The response rate was 51.4%, comprising 54 clinics. Quantitative data were analysed using descriptive statistics, and open-ended qualitative responses analysed for extending understanding. Of the participating clinics, 42.6% offered surrogacy (mostly gestational surrogacy). Heterosexual couples using gestational surrogacy were the largest group currently using services followed by male same-sex couples. Most clinics reported having encountered problems with surrogacy treatments, suggesting barriers still exist to expanding the UK provision of surrogacy arrangements. It is important that professionals are well informed about the legal implications of surrogacy and that clinics have consistent and appropriate operational protocols for surrogacy arrangements. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Interleukin-21: updated review of Phase I and II clinical trials in metastatic renal cell carcinoma, metastatic melanoma and relapsed/refractory indolent non-Hodgkin's lymphoma.

PubMed

Hashmi, Mehmood H; Van Veldhuizen, Peter J

2010-05-01

In advanced renal cell cancer and malignant melanoma, the current FDA approved immune modulators, such as IL-2, are the only agents which provide a durable complete remission. These responses, however, occur in < 10% of treated patients and their applicability is limited to selected patients because of their toxicity. The identification of new immunotherapeutic agents with an improved response rate and toxicity profile would represent a significant advancement in the treatment of these malignancies. This is a comprehensive review of IL-21 including its pharmacology and current developmental status. A literature review was performed using all PubMed listed publications involving IL-21, including original research articles, reviews and abstracts. It also includes a review of current ongoing trials and information from the official product website. Recombinant IL-21 (rIL-21) is a new immune modulator currently undergoing Phase I and II testing. It is a cytokine with a four helix structure that has structural and sequence homology to IL-2 and -15, but also possesses many unique biological properties. In this review, we evaluate the development, pharmacologic properties, safety profile and current clinical efficacy of rIL-21. rIL-21 has an acceptable safety profile and encouraging single agent activity in early phase renal cell carcinoma and melanoma clinical trials.

Surgical fellowship training in Canada: What is its current status and is improvement required?

PubMed Central

Nousiainen, Markku T.; Latter, David A.; Backstein, David; Webster, Fiona; Harris, Kenneth A.

2012-01-01

This paper examines current issues concerning surgical fellowship training in Canada. Other than information from a few studies of fellowship training in North America, there are scant data on this subject in the literature. Little is known about the demographic characteristics of those who pursue fellowship training in Canada, what the experiences and expectations are of fellows and their supervisors with respect to the strengths and weaknesses of this level of training, or how this level of education fits in with Canadian undergraduate and postgraduate medical training. We summarize current knowledge about fellowship training in Canada as it pertains to demographic characteristics, finances, work hours, residency training, preparation for clinical and research work and satisfaction with training. Most information on surgical fellowship training comes from the United States. As such, we used information from American studies to supplement the Canadian data. Because a surgical fellowship experience in Canada may be different from that in the United States, we propose that Canadian surgical fellows and their supervisors should be surveyed to gain an understanding of such information. This knowledge could be used to improve surgical fellowship training in Canada. PMID:22269304

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

PubMed

Jones, W Schuyler; Krucoff, Mitchell W; Morales, Pablo; Wilgus, Rebecca W; Heath, Anne H; Williams, Mary F; Tcheng, James E; Marinac-Dabic, J Danica; Malone, Misti L; Reed, Terrie L; Fukaya, Rie; Lookstein, Robert A; Handa, Nobuhiro; Aronow, Herbert D; Bertges, Daniel J; Jaff, Michael R; Tsai, Thomas T; Smale, Joshua A; Zaugg, Margo J; Thatcher, Robert J; Cronenwett, Jack L

2018-02-01

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators. Copyright © 2017 Society for Vascular Surgery. All rights reserved.

Improving clinical models based on knowledge extracted from current datasets: a new approach.

PubMed

Mendes, D; Paredes, S; Rocha, T; Carvalho, P; Henriques, J; Morais, J

2016-08-01

The Cardiovascular Diseases (CVD) are the leading cause of death in the world, being prevention recognized to be a key intervention able to contradict this reality. In this context, although there are several models and scores currently used in clinical practice to assess the risk of a new cardiovascular event, they present some limitations. The goal of this paper is to improve the CVD risk prediction taking into account the current models as well as information extracted from real and recent datasets. This approach is based on a decision tree scheme in order to assure the clinical interpretability of the model. An innovative optimization strategy is developed in order to adjust the decision tree thresholds (rule structure is fixed) based on recent clinical datasets. A real dataset collected in the ambit of the National Registry on Acute Coronary Syndromes, Portuguese Society of Cardiology is applied to validate this work. In order to assess the performance of the new approach, the metrics sensitivity, specificity and accuracy are used. This new approach achieves sensitivity, a specificity and an accuracy values of, 80.52%, 74.19% and 77.27% respectively, which represents an improvement of about 26% in relation to the accuracy of the original score.

Clinical Relevance of Coronary Fractional Flow Reserve: Art-of-state.

PubMed

Adiputra, Yohanes; Chen, Shao-Liang

2015-05-20

The objective was to delineate the current knowledge of fractional flow reserve (FFR) in terms of definition, features, clinical applications, and pitfalls of measurement of FFR. We searched database for primary studies published in English. The database of National Library of Medicine (NLM), MEDLINE, and PubMed up to July 2014 was used to conduct a search using the keyword term "FFR". The articles about the definition, features, clinical application, and pitfalls of measurement of FFR were identified, retrieved, and reviewed. Coronary pressure-derived FFR rapidly assesses the hemodynamic significance of individual coronary artery lesions and can readily be performed in the catheterization laboratory. The use of FFR has been shown to effectively guide coronary revascularization procedures leading to improved patient outcomes. FFR is a valuable tool to determine the functional significance of coronary stenosis. It combines physiological and anatomical information, and can be followed immediately by percutaneous coronary intervention (PCI) if necessary. The technique of FFR measurement can be performed easily, rapidly, and safely in the catheterization laboratory. By systematic use of FFR in dubious stenosis and multi-vessel disease, PCI can be made an even more effective and better treatment than it is currently. The current clinical evidence for FFR should encourage cardiologists to use this tool in the catheterization laboratory.

The role of amino acid PET in the light of the new WHO classification 2016 for brain tumors.

PubMed

Suchorska, Bogdana; Albert, Nathalie L; Bauer, Elena K; Tonn, Jörg-Christian; Galldiks, Norbert

2018-04-26

Since its introduction in 2016, the revision of the World Health Organization (WHO) classification of central nervous system tumours has already changed the diagnostic and therapeutic approach in glial tumors. Blurring the lines between entities formerly labelled as "high-grade" or "low-grade", molecular markers define distinct biological subtypes with different clinical course. This new classification raises the demand for non-invasive imaging methods focussing on depicting metabolic processes. We performed a review of current literature on the use of amino acid PET (AA-PET) for obtaining diagnostic or prognostic information on glioma in the setting of the current WHO 2016 classification. So far, only a few studies have focussed on combining molecular genetic information and metabolic imaging using AA-PET. The current review summarizes the information available on "molecular grading" as well as prognostic information obtained from AA-PET and delivers an insight into a possible interrelation between metabolic imaging and glioma genetics. Within the framework of molecular characterization of gliomas, metabolic imaging using AA-PET is a promising tool for non-invasive characterisation of molecular features and to provide additional prognostic information. Further studies incorporating molecular and metabolic features are necessary to improve the explanatory power of AA-PET in glial tumors.

Validation of next generation sequencing technologies in comparison to current diagnostic gold standards for BRAF, EGFR and KRAS mutational analysis.

PubMed

McCourt, Clare M; McArt, Darragh G; Mills, Ken; Catherwood, Mark A; Maxwell, Perry; Waugh, David J; Hamilton, Peter; O'Sullivan, Joe M; Salto-Tellez, Manuel

2013-01-01

Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical diagnosis and therapeutic decision-making in oncology owing to its enhanced sensitivity in DNA mutation detection, fast-turnaround of samples in comparison to current gold standard methods and the potential to sequence a large number of cancer-driving genes at the one time. We aim to test the diagnostic accuracy of current NGS technology in the analysis of mutations that represent current standard-of-care, and its reliability to generate concomitant information on other key genes in human oncogenesis. Thirteen clinical samples (8 lung adenocarcinomas, 3 colon carcinomas and 2 malignant melanomas) already genotyped for EGFR, KRAS and BRAF mutations by current standard-of-care methods (Sanger Sequencing and q-PCR), were analysed for detection of mutations in the same three genes using two NGS platforms and an additional 43 genes with one of these platforms. The results were analysed using closed platform-specific proprietary bioinformatics software as well as open third party applications. Our results indicate that the existing format of the NGS technology performed well in detecting the clinically relevant mutations stated above but may not be reliable for a broader unsupervised analysis of the wider genome in its current design. Our study represents a diagnostically lead validation of the major strengths and weaknesses of this technology before consideration for diagnostic use.

Redesigning an intensive insulin service for patients with type 1 diabetes: a patient consultation exercise

PubMed Central

Ozcan, Seyda; Rogers, Helen; Choudhary, Pratik; Amiel, Stephanie A; Cox, Alison; Forbes, Angus

2013-01-01

Context Providing effective support for patients in using insulin effectively is essential for good diabetes care. For that support to be effective it must reflect and attend to the needs of patients. Purpose To explore the perspectives of adult type 1 diabetes patients on their current diabetes care in order to generate ideas for creating a new patient centered intensive insulin clinic. Methods A multi-method approach was used, comprising: an observational exercise of current clinical care; three focus groups (n = 17); and a survey of service users (n = 419) to test the ideas generated from the observational exercise and focus groups (rating 1 to 5 in terms of importance). The ideas generated by the multi-method approach were organized thematically and mapped onto the Chronic Care Model (CCM). Results The themes and preferences for service redesign in relation to CCM components were: health care organization, there was an interest in having enhanced systems for sharing clinical information; self-management support, patients would like more flexible and easy to access resources and more help with diabetes technology and psychosocial support; delivery system design and clinical information systems, the need for greater integration of care and better use of clinic time; productive relationships, participants would like more continuity; access to health professionals, patient involvement and care planning. The findings from the patient survey indicate high preferences for most of the areas for service enhancement identified in the focus groups and observational exercise. Clinical feedback and professional continuity (median = 5, interquartile range = 1) were the most highly rated. Conclusion The patient consultation process had generated important ideas on how the clinical team and service can improve the care provided. Key areas for service development were: a stronger emphasis of collaborative care planning; improved patient choice in the use of health technology; more resources for self-management support; and a more explicit format for the process of care in the clinic. PMID:23776329

Glycemic Control in a Clinic-Based Sample of Diabetics in M'Bour Senegal

ERIC Educational Resources Information Center

BeLue, Rhonda; Ndiaye, Khadidiatou; NDao, Fatou; Ba, Fatou Niass Niang; Diaw, Mor

2016-01-01

Background: Sub-Saharan Africa (SSA) including Senegal is faced with a significant and increasing burden of type 2 diabetes. However, little information is available about diabetes management among Senegalese diabetics. Purpose: The current study aims to describe the level of glycemic control among a convenience sample of diabetics who receive…

Incorporating Computer-Aided Language Sample Analysis into Clinical Practice

ERIC Educational Resources Information Center

Price, Lisa Hammett; Hendricks, Sean; Cook, Colleen

2010-01-01

Purpose: During the evaluation of language abilities, the needs of the child are best served when multiple types and sources of data are included in the evaluation process. Current educational policies and practice guidelines further dictate the use of authentic assessment data to inform diagnosis and treatment planning. Language sampling and…

Functional Analysis in Public Schools: A Summary of 90 Functional Analyses

ERIC Educational Resources Information Center

Mueller, Michael M.; Nkosi, Ajamu; Hine, Jeffrey F.

2011-01-01

Several review and epidemiological studies have been conducted over recent years to inform behavior analysts of functional analysis outcomes. None to date have closely examined demographic and clinical data for functional analyses conducted exclusively in public school settings. The current paper presents a data-based summary of 90 functional…

Seroepidemiology of Sarcocystis neurona and Neospora hughesi infections in domestic donkeys (Equus asinus) in Durango, Mexico

USDA-ARS?s Scientific Manuscript database

The protozoans Sarcocystis neurona and Neospora spp. cause clinical disease in horses. There is currently no information regarding S. neurona and N. hughesi infections in donkeys in Mexico. Here, we determined the presence of antibodies against S. neurona and N. hughesi in donkeys in the northern Me...

A Parent Training Program for Increasing the Visual Development of School-Aged Children.

ERIC Educational Resources Information Center

Dikowski, Timothy J.

This practicum provided training for 50 parents of children receiving clinic services for visual processing disorders and provided information on visual disorders to the children's teachers. The 8-month program involved 13 parent training sessions. These sessions focused on such topics as: current research findings on vision; identification of…

What Do We Teach Psychiatric Residents about Suicide? A National Survey of Chief Residents

ERIC Educational Resources Information Center

Melton, Bengi B.; Coverdale, John H.

2009-01-01

Objective: Because of the clinical significance of patient suicide for trainees and current limited information on this essential educational subject, the authors sought to determine what topics involving the care of suicidal patients were taught to residents in psychiatry training programs. Methods: Chief residents of psychiatry training programs…

Seizure reporting technologies for epilepsy treatment: A review of clinical information needs and supporting technologies.

PubMed

Bidwell, Jonathan; Khuwatsamrit, Thanin; Askew, Brittain; Ehrenberg, Joshua Andrew; Helmers, Sandra

2015-11-01

This review surveys current seizure detection and classification technologies as they relate to aiding clinical decision-making during epilepsy treatment. Interviews and data collected from neurologists and a literature review highlighted a strong need for better distinguishing between patients exhibiting generalized and partial seizure types as well as achieving more accurate seizure counts. This information is critical for enabling neurologists to select the correct class of antiepileptic drugs (AED) for their patients and evaluating AED efficiency during long-term treatment. In our questionnaire, 100% of neurologists reported they would like to have video from patients prior to selecting an AED during an initial consultation. Presently, only 30% have access to video. In our technology review we identified that only a subset of available technologies surpassed patient self-reporting performance due to high false positive rates. Inertial seizure detection devices coupled with video capture for recording seizures at night could stand to address collecting seizure counts that are more accurate than current patient self-reporting during day and night time use. Copyright © 2015. Published by Elsevier Ltd.

The Telemetric and Holter ECG Warehouse Initiative (THEW): a Data Repository for the Design, Implementation and Validation of ECG-related Technologies

PubMed Central

Couderc, Jean-Philippe

2011-01-01

We present an initiative supported by the National Heart Lung, and Blood Institute and the Food and Drug Administration for the development of a repository containing continuous electrocardiographic information to be shared with the worldwide scientific community. We believe that sharing data reinforces open scientific inquiry. It encourages diversity of analysis and opinion while promoting new research and facilitating the education of new researchers. In this paper, we present the resources available in this initiative for the scientific community. We describe the set of ECG signals currently hosted and we briefly discuss the associated clinical information (medical history. Disease and study-specific endpoints) and software tools we propose. Currently, the repository contains more than 250GB of data from eight clinical studies including healthy individuals and cardiac patients. This data is available for the development, implementation and validation of technologies related to body-surface ECGs. To conclude, the Telemetric and Holter ECG Warehouse (THEW) is an initiative developed to benefit the scientific community and to advance the field of quantitative electrocardiography and cardiac safety. PMID:21097349

Knowledge Representation and Communication: Imparting Current State Information Flow to CPR Stakeholders

PubMed Central

de la Cruz, Norberto B.; Spiece, Leslie J.

2000-01-01

Understanding and communicating the who, what, where, when, why, and how of the clinics and services for which the computerized patient record (CPR) will be built is an integral part of the implementation process. Formal methodologies have been developed to diagram information flow -- flow charts, state-transition diagram (STDs), data flow diagrams (DFDs). For documentation of the processes at our ambulatory CPR pilot site, flowcharting was selected as the preferred method based upon its versatility and understandability.

Automated delineation of radiotherapy volumes: are we going in the right direction?

PubMed Central

Whitfield, G A; Price, P; Price, G J; Moore, C J

2013-01-01

ABSTRACT. Rapid and accurate delineation of target volumes and multiple organs at risk, within the enduring International Commission on Radiation Units and Measurement framework, is now hugely important in radiotherapy, owing to the rapid proliferation of intensity-modulated radiotherapy and the advent of four-dimensional image-guided adaption. Nevertheless, delineation is still generally clinically performed with little if any machine assistance, even though it is both time-consuming and prone to interobserver variation. Currently available segmentation tools include those based on image greyscale interrogation, statistical shape modelling and body atlas-based methods. However, all too often these are not able to match the accuracy of the expert clinician, which remains the universally acknowledged gold standard. In this article we suggest that current methods are fundamentally limited by their lack of ability to incorporate essential human clinical decision-making into the underlying models. Hybrid techniques that utilise prior knowledge, make sophisticated use of greyscale information and allow clinical expertise to be integrated are needed. This may require a change in focus from automated segmentation to machine-assisted delineation. Similarly, new metrics of image quality reflecting fitness for purpose would be extremely valuable. We conclude that methods need to be developed to take account of the clinician's expertise and honed visual processing capabilities as much as the underlying, clinically meaningful information content of the image data being interrogated. We illustrate our observations and suggestions through our own experiences with two software tools developed as part of research council-funded projects. PMID:23239689

Are electronic medical records helpful for care coordination? Experiences of physician practices.

PubMed

O'Malley, Ann S; Grossman, Joy M; Cohen, Genna R; Kemper, Nicole M; Pham, Hoangmai H

2010-03-01

Policies promoting widespread adoption of electronic medical records (EMRs) are premised on the hope that they can improve the coordination of care. Yet little is known about whether and how physician practices use current EMRs to facilitate coordination. We examine whether and how practices use commercial EMRs to support coordination tasks and identify work-around practices have created to address new coordination challenges. Semi-structured telephone interviews in 12 randomly selected communities. Sixty respondents, including 52 physicians or staff from 26 practices with commercial ambulatory care EMRs in place for at least 2 years, chief medical officers at four EMR vendors, and four national thought leaders. Six major themes emerged: (1) EMRs facilitate within-office care coordination, chiefly by providing access to data during patient encounters and through electronic messaging; (2) EMRs are less able to support coordination between clinicians and settings, in part due to their design and a lack of standardization of key data elements required for information exchange; (3) managing information overflow from EMRs is a challenge for clinicians; (4) clinicians believe current EMRs cannot adequately capture the medical decision-making process and future care plans to support coordination; (5) realizing EMRs' potential for facilitating coordination requires evolution of practice operational processes; (6) current fee-for-service reimbursement encourages EMR use for documentation of billable events (office visits, procedures) and not of care coordination (which is not a billable activity). There is a gap between policy-makers' expectation of, and clinical practitioners' experience with, current electronic medical records' ability to support coordination of care. Policymakers could expand current health information technology policies to support assessment of how well the technology facilitates tasks necessary for coordination. By reforming payment policy to include care coordination, policymakers could encourage the evolution of EMR technology to include capabilities that support coordination, for example, allowing for inter-practice data exchange and multi-provider clinical decision support.

Computer network for improving quality and efficiency of children's primary health care

NASA Astrophysics Data System (ADS)

Deutsch, Larry

1995-10-01

Health care is at its best when both the practitioner and patient are well-informed. In many central urban and remote rural areas, however, health care is characterized by a lack of continuity and coordination among providers. In these areas, a local information infrastructure and a patient-centered system of primary care are missing. Decision-making and ability to follow through is hampered, with limited involvement of patients in planning care and insufficient aggregate data for cost analysis, outcome research, community health planning, and other purposes. A Children's Health Network has been designed to extend current information technology to these underserved areas. Our approach to improving quality of individual care and controlling costs emphasizes use of computerized clinical information networks for better decision making and continuity, and secondarily through data aggregation for financial, research, and public health functions. This is in distinction to information systems centered on billing and administrative needs and to cost-control efforts which rely on fiscal and managerial ('gatekeeper') mechanisms. A uniform data base among sites serving the same population will answer several clinical and public health needs.

Mapping public policy on genetics.

PubMed

Weisfeld, N E

2002-06-01

The mapping of the human genome and related advances in genetics are stimulating the development of public policies on genetics. Certain notions that currently prevail in public policy development overall--including the importance of protecting privacy of information, an interest in cost-effectiveness, and the power of the anecdote--will help determine the future of public policy on genetics. Information areas affected include discrimination by insurers and employers, confidentiality, genetic databanks, genetic testing in law enforcement, and court-ordered genetic testing in civil cases. Service issues address clinical standards, insurance benefits, allocation of resources, and screening of populations at risk. Supply issues encompass funding of research and clinical positions. Likely government actions include, among others: (1) Requiring individual consent for the disclosure of personal information, except when such consent would impose inordinate costs; (2) licensing genetic databases; (3) allowing courts to use personal information in cases where a refusal to use such information would offend the public; (4) mandating health insurers to pay for cost-effective genetic services; (5) funding pharmaceutical research to develop tailored products to prevent or treat diseases; and (6) funding training programs.