Science.gov

Sample records for additional clinical information

  1. Clinical effects of sulphite additives.

    PubMed

    Vally, H; Misso, N L A; Madan, V

    2009-11-01

    Sulphites are widely used as preservative and antioxidant additives in the food and pharmaceutical industries. Topical, oral or parenteral exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however, exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. While contact sensitivity to sulphite additives in topical medications is increasingly being recognized, skin reactions also occur after ingestion of or parenteral exposure to sulphites. Most studies report a 3-10% prevalence of sulphite sensitivity among asthmatic subjects following ingestion of these additives. However, the severity of these reactions varies, and steroid-dependent asthmatics, those with marked airway hyperresponsiveness, and children with chronic asthma, appear to be at greater risk. In addition to episodic and acute symptoms, sulphites may also contribute to chronic skin and respiratory symptoms. To date, the mechanisms underlying sulphite sensitivity remain unclear, although a number of potential mechanisms have been proposed. Physicians should be aware of the range of clinical manifestations of sulphite sensitivity, as well as the potential sources of exposure. Minor modifications to diet or behaviour lead to excellent clinical outcomes for sulphite-sensitive individuals.

  2. Integrated clinical information system.

    PubMed

    Brousseau, G

    1995-01-01

    contains personalized profiles: questionnaires based on the predetermined choices of the information most relevant to the specific user. The SIDOCI clinical dictionary also includes the hospital's suggested or mandatory interventions, clinical guidelines, and protocols. These clinical guidelines are customized at the hospital, service, and professional levels. Common interventions have been regrouped so that health professionals may apply the appropriate diagnostic, therapeutic, educational, or other intervention plans. The clinical dictionary also serves as a teaching and continuing education tool. The patient profile is a permanent record containing information on allergies, blood type, primary and secondary diagnoses, ongoing treatments, and prior hospitalizations. The problem list dealing with the current hospitalization includes symptoms, signs, and diagnoses. This standard clinical record facilitates communication between the services and provides a quick overview of the patient's history should emergency treatment be required. This health information system integrates Requests and Results, Progress Notes, and Analysis of the results. In addition, functions inherent to a patient's clinical cycle such as Administrative Management of episodes, Adaptation to physical and professional structures of the hospital, Messages between health professionals, and Electronic signature constitute the basis of SIDOCI. The most exciting aspect of this research project is its social impact: a more efficient health care system will improve the lives of all citizens. Moreover this applied research project involves the information industry and directly calls for the input of users such as doctors, nurses and hospital support staff.

  3. Integrated clinical information system.

    PubMed

    Brousseau, G

    1995-01-01

    contains personalized profiles: questionnaires based on the predetermined choices of the information most relevant to the specific user. The SIDOCI clinical dictionary also includes the hospital's suggested or mandatory interventions, clinical guidelines, and protocols. These clinical guidelines are customized at the hospital, service, and professional levels. Common interventions have been regrouped so that health professionals may apply the appropriate diagnostic, therapeutic, educational, or other intervention plans. The clinical dictionary also serves as a teaching and continuing education tool. The patient profile is a permanent record containing information on allergies, blood type, primary and secondary diagnoses, ongoing treatments, and prior hospitalizations. The problem list dealing with the current hospitalization includes symptoms, signs, and diagnoses. This standard clinical record facilitates communication between the services and provides a quick overview of the patient's history should emergency treatment be required. This health information system integrates Requests and Results, Progress Notes, and Analysis of the results. In addition, functions inherent to a patient's clinical cycle such as Administrative Management of episodes, Adaptation to physical and professional structures of the hospital, Messages between health professionals, and Electronic signature constitute the basis of SIDOCI. The most exciting aspect of this research project is its social impact: a more efficient health care system will improve the lives of all citizens. Moreover this applied research project involves the information industry and directly calls for the input of users such as doctors, nurses and hospital support staff. PMID:8591228

  4. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest,...

  5. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest,...

  6. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE Content Requirements § 1102.16 Additional... in the Database any additional information it determines to be in the public interest,...

  7. Clinical writing: additional ethical and practical issues.

    PubMed

    Woodhouse, Susan S

    2012-03-01

    The recommendations by Sieck (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice, Psychotherapy, 49, pp. 3-11.) are a helpful starting point for considering the ethical issues involved in the decision to seek or not to seek informed consent from clients before writing about them. Sieck makes a compelling case for the idea that there are circumstances in which the most ethical choice would be to engage in clinical writing about a client without seeking informed consent, but instead disguising the client's identity. The present response raises a number of questions not considered in the article by Sieck. First, how should one disguise a case? Moreover, how should one assess whether the disguise is sufficient to preserve confidentiality while not distorting the clinical material to the point that the material is no longer useful to the field? Second, how can we estimate the likelihood of clients reading clinical writing, particularly in the age of the Internet? Given that psychologist-authored blogs that include reference to clinical material are beginning to emerge, it is crucial that we engage in a much deeper dialogue about the ethics of clinical writing. Third, how does the presentation of clinical material influence public perceptions of psychotherapy and confidentiality? If these public perceptions, in turn, could influence the likelihood of seeking psychotherapy, might these attitudes be important to consider in ethical thinking about clinical writing? Finally, where do we draw the line between clinical writing and single case study research (which requires informed consent)?

  8. 17 CFR 230.408 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Additional information. 230... RULES AND REGULATIONS, SECURITIES ACT OF 1933 General Requirements § 230.408 Additional information. (a) In addition to the information expressly required to be included in a registration statement,...

  9. 17 CFR 230.408 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 2 2013-04-01 2013-04-01 false Additional information. 230... RULES AND REGULATIONS, SECURITIES ACT OF 1933 General Requirements § 230.408 Additional information. (a) In addition to the information expressly required to be included in a registration statement,...

  10. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 2 2013-10-01 2013-10-01 false Additional information. 25.111 Section 25.111... Applications and Licenses General Application Filing Requirements § 25.111 Additional information. (a) The Commission may request from any party at any time additional information concerning any application, or...

  11. 10 CFR 810.14 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Additional information. 810.14 Section 810.14 Energy DEPARTMENT OF ENERGY ASSISTANCE TO FOREIGN ATOMIC ENERGY ACTIVITIES § 810.14 Additional information. The... activity to submit additional information....

  12. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 2 2012-10-01 2012-10-01 false Additional information. 25.111 Section 25.111... Applications and Licenses General Application Filing Requirements § 25.111 Additional information. (a) The Commission may request from any party at any time additional information concerning any application, or...

  13. 10 CFR 725.13 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 4 2013-01-01 2013-01-01 false Additional information. 725.13 Section 725.13 Energy DEPARTMENT OF ENERGY PERMITS FOR ACCESS TO RESTRICTED DATA Applications § 725.13 Additional information. The... and before the termination of the permit, require additional information in order to enable the...

  14. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 2 2011-10-01 2011-10-01 false Additional information. 25.111 Section 25.111... Applications and Licenses General Application Filing Requirements § 25.111 Additional information. (a) The Commission may request from any party at any time additional information concerning any application, or...

  15. Clinical writing: additional ethical and practical issues.

    PubMed

    Woodhouse, Susan S

    2012-03-01

    The recommendations by Sieck (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice, Psychotherapy, 49, pp. 3-11.) are a helpful starting point for considering the ethical issues involved in the decision to seek or not to seek informed consent from clients before writing about them. Sieck makes a compelling case for the idea that there are circumstances in which the most ethical choice would be to engage in clinical writing about a client without seeking informed consent, but instead disguising the client's identity. The present response raises a number of questions not considered in the article by Sieck. First, how should one disguise a case? Moreover, how should one assess whether the disguise is sufficient to preserve confidentiality while not distorting the clinical material to the point that the material is no longer useful to the field? Second, how can we estimate the likelihood of clients reading clinical writing, particularly in the age of the Internet? Given that psychologist-authored blogs that include reference to clinical material are beginning to emerge, it is crucial that we engage in a much deeper dialogue about the ethics of clinical writing. Third, how does the presentation of clinical material influence public perceptions of psychotherapy and confidentiality? If these public perceptions, in turn, could influence the likelihood of seeking psychotherapy, might these attitudes be important to consider in ethical thinking about clinical writing? Finally, where do we draw the line between clinical writing and single case study research (which requires informed consent)? PMID:22369079

  16. 28 CFR 80.7 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Additional information. 80.7 Section 80.7... § 80.7 Additional information. If an issuer's or domestic concern's submission does not contain all of the information required by § 80.6, the Department of Justice may request whatever...

  17. 28 CFR 80.7 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Additional information. 80.7 Section 80.7... § 80.7 Additional information. If an issuer's or domestic concern's submission does not contain all of the information required by § 80.6, the Department of Justice may request whatever...

  18. 16 CFR 1102.16 - Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... PUBLICLY AVAILABLE CONSUMER PRODUCT SAFETY INFORMATION DATABASE (Eff. Jan. 10, 2011) Content Requirements... notices, the CPSC shall include in the Database any additional information it determines to be in...

  19. Clinical Protocol Information System

    PubMed Central

    Wirtschafter, David D.; Gams, Richard; Ferguson, Carol; Blackwell, William; Boackle, Paul

    1980-01-01

    The Clinical Protocol Information System (CPIS) supports the clinical research and patient care objectives of the SouthEastern Cancer Study Group (SEG). The information system goals are to improve the evaluability of clinical trials, decrease the frequency of adverse patient events, implement drug toxicity surveillance, improve the availability of study data and demonstrate the criteria for computer networks that can impact on the general medical care of the community. Nodes in the network consist of Data General MicroNova MP-100 minicomputers that drive the interactive data dialogue and communicate with the network concentrator (another DG MicroNova) in Birmingham. Functions supported include: source data editing, care “advice,” care “audit,” care “explanation,” and treatment note printing. The complete database is updated nightly and resides on UAB's IBM 370/158-AP.

  20. 10 CFR 810.14 - Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 4 2012-01-01 2012-01-01 false Additional information. 810.14 Section 810.14 Energy DEPARTMENT OF ENERGY ASSISTANCE TO FOREIGN ATOMIC ENERGY ACTIVITIES § 810.14 Additional information. The Department of Energy may at any time require a person engaging in any generally or specifically...

  1. 10 CFR 810.14 - Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Additional information. 810.14 Section 810.14 Energy DEPARTMENT OF ENERGY ASSISTANCE TO FOREIGN ATOMIC ENERGY ACTIVITIES § 810.14 Additional information. The Department of Energy may at any time require a person engaging in any generally or specifically...

  2. 10 CFR 810.14 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Additional information. 810.14 Section 810.14 Energy DEPARTMENT OF ENERGY ASSISTANCE TO FOREIGN ATOMIC ENERGY ACTIVITIES § 810.14 Additional information. The Department of Energy may at any time require a person engaging in any generally or specifically...

  3. 10 CFR 810.14 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 4 2014-01-01 2014-01-01 false Additional information. 810.14 Section 810.14 Energy DEPARTMENT OF ENERGY ASSISTANCE TO FOREIGN ATOMIC ENERGY ACTIVITIES § 810.14 Additional information. The Department of Energy may at any time require a person engaging in any generally or specifically...

  4. 25 CFR 214.5 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 1 2013-04-01 2013-04-01 false Additional information. 214.5 Section 214.5 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF OSAGE RESERVATION LANDS, OKLAHOMA, FOR MINING, EXCEPT OIL AND GAS § 214.5 Additional information. The officer in...

  5. 25 CFR 214.5 - Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 1 2012-04-01 2011-04-01 true Additional information. 214.5 Section 214.5 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF OSAGE RESERVATION LANDS, OKLAHOMA, FOR MINING, EXCEPT OIL AND GAS § 214.5 Additional information. The officer in charge may, at...

  6. 25 CFR 214.5 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 1 2014-04-01 2014-04-01 false Additional information. 214.5 Section 214.5 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF OSAGE RESERVATION LANDS, OKLAHOMA, FOR MINING, EXCEPT OIL AND GAS § 214.5 Additional information. The officer in...

  7. 25 CFR 214.5 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Additional information. 214.5 Section 214.5 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF OSAGE RESERVATION LANDS, OKLAHOMA, FOR MINING, EXCEPT OIL AND GAS § 214.5 Additional information. The officer in...

  8. 25 CFR 214.5 - Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Additional information. 214.5 Section 214.5 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF OSAGE RESERVATION LANDS, OKLAHOMA, FOR MINING, EXCEPT OIL AND GAS § 214.5 Additional information. The officer in...

  9. 34 CFR 75.231 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Office of the Secretary, Department of Education DIRECT GRANT PROGRAMS How Grants Are Made Procedures to Make A Grant § 75.231 Additional information. After selecting an application for funding, the Secretary may require the applicant to submit additional information. (Authority: 20 U.S.C. 1221e-3 and 3474)...

  10. 34 CFR 75.231 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Office of the Secretary, Department of Education DIRECT GRANT PROGRAMS How Grants Are Made Procedures to Make A Grant § 75.231 Additional information. After selecting an application for funding, the Secretary may require the applicant to submit additional information. (Authority: 20 U.S.C. 1221e-3 and 3474)...

  11. 34 CFR 75.231 - Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Office of the Secretary, Department of Education DIRECT GRANT PROGRAMS How Grants Are Made Procedures to Make A Grant § 75.231 Additional information. After selecting an application for funding, the Secretary may require the applicant to submit additional information. (Authority: 20 U.S.C. 1221e-3 and 3474)...

  12. 34 CFR 75.231 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Office of the Secretary, Department of Education DIRECT GRANT PROGRAMS How Grants Are Made Procedures to Make A Grant § 75.231 Additional information. After selecting an application for funding, the Secretary may require the applicant to submit additional information. (Authority: 20 U.S.C. 1221e-3 and 3474)...

  13. 34 CFR 75.231 - Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Office of the Secretary, Department of Education DIRECT GRANT PROGRAMS How Grants Are Made Procedures to Make A Grant § 75.231 Additional information. After selecting an application for funding, the Secretary may require the applicant to submit additional information. (Authority: 20 U.S.C. 1221e-3 and 3474)...

  14. 42 CFR 1008.39 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Additional information. 1008.39 Section 1008.39 Public Health OFFICE OF INSPECTOR GENERAL-HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OIG AUTHORITIES ADVISORY OPINIONS BY THE OIG Submission of a Formal Request for an Advisory Opinion §...

  15. Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

    PubMed

    Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

    2014-02-01

    The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial. PMID:24480160

  16. Clinical research before informed consent.

    PubMed

    Miller, Franklin G

    2014-06-01

    Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.

  17. A Clinical Information Display System

    PubMed Central

    Blum, Bruce J.; Lenhard, Raymond E.; Braine, Hayden; Kammer, Anne

    1977-01-01

    A clinical information display system has been implemented as part of a prototype Oncology Clinical Information System for the Johns Hopkins Oncology Center. The information system has been developed to support the management of patient therapy. Capabilities in the prototype include a patient data system, a patient abstract, a tumor registry, an appointment system, a census system, and a clinical information display system. This paper describes the clinical information display component of the prototype. It has the capability of supporting up to 10,000 patient records with online data entry and editing. At the present time, the system is being used only in the Oncology Center. There are plans, however, for trial use by other departments, and the system represents a tool with a potential for more general application.

  18. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... information it requires for the Advance Publication, Coordination and Notification of frequency assignments..., with respect to individual administrations, by successfully completing coordination agreements. Any... terms and conditions as required to effect coordination of the frequency assignments with...

  19. 17 CFR 240.12b-20 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Additional information. 240... Securities Exchange Act of 1934 General Requirements As to Contents § 240.12b-20 Additional information. In addition to the information expressly required to be included in a statement or report, there shall...

  20. 17 CFR 270.8b-20 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 17 Commodity and Securities Exchanges 3 2010-04-01 2010-04-01 false Additional information. 270.8b...) RULES AND REGULATIONS, INVESTMENT COMPANY ACT OF 1940 § 270.8b-20 Additional information. In addition to the information expressly required to be included in a registration statement or report, there...

  1. 29 CFR 2570.39 - Opportunities to submit additional information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 9 2011-07-01 2011-07-01 false Opportunities to submit additional information. 2570.39... Prohibited Transaction Exemption Applications § 2570.39 Opportunities to submit additional information. (a) An applicant may notify the Department of its intent to submit additional information supporting...

  2. 43 CFR 3430.4-2 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Additional information. 3430.4-2 Section... Leases § 3430.4-2 Additional information. (a) If the applicant for a preference right lease has submitted timely, some, but not all of the information required in § 3430.4-1 of this title, the authorized...

  3. 34 CFR 303.212 - Additional information and assurances.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... system as required by section 427(b) of GEPA; and (b) Other information and assurances as the Secretary... 34 Education 2 2012-07-01 2012-07-01 false Additional information and assurances. 303.212 Section... Additional information and assurances. Each application must contain— (a) A description of the steps...

  4. 34 CFR 303.212 - Additional information and assurances.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... system as required by section 427(b) of GEPA; and (b) Other information and assurances as the Secretary... 34 Education 2 2014-07-01 2013-07-01 true Additional information and assurances. 303.212 Section... Additional information and assurances. Each application must contain— (a) A description of the steps...

  5. 29 CFR 2570.39 - Opportunities to submit additional information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 9 2012-07-01 2012-07-01 false Opportunities to submit additional information. 2570.39... Processing of Prohibited Transaction Exemption Applications § 2570.39 Opportunities to submit additional information. (a) An applicant may notify the Department of its intent to submit additional...

  6. 29 CFR 2570.39 - Opportunities to submit additional information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 9 2014-07-01 2014-07-01 false Opportunities to submit additional information. 2570.39... Processing of Prohibited Transaction Exemption Applications § 2570.39 Opportunities to submit additional information. (a) An applicant may notify the Department of its intent to submit additional...

  7. 29 CFR 2570.39 - Opportunities to submit additional information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 9 2013-07-01 2013-07-01 false Opportunities to submit additional information. 2570.39... Processing of Prohibited Transaction Exemption Applications § 2570.39 Opportunities to submit additional information. (a) An applicant may notify the Department of its intent to submit additional...

  8. DETAIL OF PLAQUE WITH ADDITIONAL DESIGN AND CONSTRUCTION INFORMATION, SOUTHEAST ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    DETAIL OF PLAQUE WITH ADDITIONAL DESIGN AND CONSTRUCTION INFORMATION, SOUTHEAST ABUTMENT - Connecticut Avenue Bridge, Spans Rock Creek & Potomac Parkway at Connecticut Avenue, Washington, District of Columbia, DC

  9. 19 CFR 111.60 - Request for additional information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Request for additional information. 111.60 Section 111.60 Customs Duties U.S. CUSTOMS AND BORDER PROTECTION, DEPARTMENT OF HOMELAND SECURITY; DEPARTMENT... particular language of the proposed statement of charges as to which additional information is needed. If...

  10. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 24 2013-07-01 2013-07-01 false Required additional health information... Required additional health information. (a) All reports must prominently display the following language... from their health care providers. EPA/CDC guidelines on appropriate means to lessen the risk...

  11. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 23 2014-07-01 2014-07-01 false Required additional health information... Required additional health information. (a) All reports must prominently display the following language... from their health care providers. EPA/CDC guidelines on appropriate means to lessen the risk...

  12. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 23 2011-07-01 2011-07-01 false Required additional health information... Required additional health information. (a) All reports must prominently display the following language... from their health care providers. EPA/CDC guidelines on appropriate means to lessen the risk...

  13. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Required additional health information... Required additional health information. (a) All reports must prominently display the following language... from their health care providers. EPA/CDC guidelines on appropriate means to lessen the risk...

  14. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 24 2012-07-01 2012-07-01 false Required additional health information... Required additional health information. (a) All reports must prominently display the following language... from their health care providers. EPA/CDC guidelines on appropriate means to lessen the risk...

  15. 10 CFR 71.39 - Requirement for additional information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Requirement for additional information. 71.39 Section 71.39 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL Application for Package Approval § 71.39 Requirement for additional information. The...

  16. A Public Opinion Survey on Correctional Education: Does Additional Information on Efficacy Lead to Additional Support?

    ERIC Educational Resources Information Center

    Waterland, Keri Lynn

    2009-01-01

    Though much research has been done on the efficacy of correctional education on reducing recidivism rates for prison inmates, there is little research on the effect that information about the efficacy of correctional education has on public opinion. This study examined whether providing additional information regarding the efficacy of correctional…

  17. 21 CFR 807.26 - Additional listing information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... FDA electronic device registration and listing system. Electronic submissions of such information must...) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Procedures for Device Establishments § 807.26 Additional listing information. (a) Each owner...

  18. 21 CFR 807.26 - Additional listing information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... FDA electronic device registration and listing system. Electronic submissions of such information must...) MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Procedures for Device Establishments § 807.26 Additional listing information. (a) Each owner...

  19. Value Addition in Information Technology and Literacy: An Empirical Investigation

    ERIC Educational Resources Information Center

    Sanghera, Kamaljeet K.

    2009-01-01

    The purpose of the research is to analyze the value addition in students' information communication and technology (ICT) literacy level and confidence in using technology after completing a general education information technology course at a four-year university. An online survey was created to examine students' perceptions. The findings revealed…

  20. 28 CFR 4.4 - Supporting affidavit; additional information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... EMPLOYEE RETIREMENT INCOME SECURITY ACT OF 1974 § 4.4 Supporting affidavit; additional information. (a... together with any other person and the amount and source of all income during the immediately preceding five calendar years plus income to date of application. (12) Any other information which the...

  1. Can metabolomics in addition to genomics add to prognostic and predictive information in breast cancer?

    PubMed

    Howell, Anthony

    2010-11-16

    Genomic data from breast cancers provide additional prognostic and predictive information that is beginning to be used for patient management. The question arises whether additional information derived from other 'omic' approaches such as metabolomics can provide additional information. In an article published this month in BMC Cancer, Borgan et al. add metabolomic information to genomic measures in breast tumours and demonstrate, for the first time, that it may be possible to further define subgroups of patients which could be of value clinically. See research article: http://www.biomedcentral.com/1471-2407/10/628.

  2. 25 CFR 215.17 - Additional information required.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 1 2013-04-01 2013-04-01 false Additional information required. 215.17 Section 215.17 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEAD AND ZINC MINING... interested in lead and zinc mining leases, or land under the jurisdiction of the Quapaw Indian Agency,...

  3. 25 CFR 227.7 - Additional information from applicant.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 25 Indians 1 2012-04-01 2011-04-01 true Additional information from applicant. 227.7 Section 227.7 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF CERTAIN LANDS IN WIND RIVER INDIAN RESERVATION, WYOMING, FOR OIL AND GAS MINING How to Acquire Leases §...

  4. 25 CFR 227.7 - Additional information from applicant.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 25 Indians 1 2011-04-01 2011-04-01 false Additional information from applicant. 227.7 Section 227.7 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF CERTAIN LANDS IN WIND RIVER INDIAN RESERVATION, WYOMING, FOR OIL AND GAS MINING How to Acquire...

  5. 25 CFR 227.7 - Additional information from applicant.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 25 Indians 1 2010-04-01 2010-04-01 false Additional information from applicant. 227.7 Section 227.7 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF CERTAIN LANDS IN WIND RIVER INDIAN RESERVATION, WYOMING, FOR OIL AND GAS MINING How to Acquire...

  6. 46 CFR 535.606 - Requests for additional information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 9 2010-10-01 2010-10-01 false Requests for additional information. 535.606 Section 535.606 Shipping FEDERAL MARITIME COMMISSION REGULATIONS AFFECTING OCEAN SHIPPING IN FOREIGN COMMERCE OCEAN COMMON CARRIER AND MARINE TERMINAL OPERATOR AGREEMENTS SUBJECT TO THE SHIPPING ACT OF 1984...

  7. 21 CFR 207.31 - Additional drug listing information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL...

  8. 25 CFR 227.7 - Additional information from applicant.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 25 Indians 1 2013-04-01 2013-04-01 false Additional information from applicant. 227.7 Section 227.7 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF CERTAIN LANDS IN WIND RIVER INDIAN RESERVATION, WYOMING, FOR OIL AND GAS MINING How to Acquire...

  9. 25 CFR 227.7 - Additional information from applicant.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 25 Indians 1 2014-04-01 2014-04-01 false Additional information from applicant. 227.7 Section 227.7 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR ENERGY AND MINERALS LEASING OF CERTAIN LANDS IN WIND RIVER INDIAN RESERVATION, WYOMING, FOR OIL AND GAS MINING How to Acquire...

  10. 21 CFR 207.31 - Additional drug listing information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL...

  11. 21 CFR 207.31 - Additional drug listing information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL...

  12. 21 CFR 207.31 - Additional drug listing information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL...

  13. 49 CFR 235.12 - Additional required information-prints.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... OR MATERIAL MODIFICATION OF A SIGNAL SYSTEM OR RELIEF FROM THE REQUIREMENTS OF PART 236 § 235.12... application should be shown uncolored. (Approved by the Office of Management and Budget under control number... 49 Transportation 4 2010-10-01 2010-10-01 false Additional required information-prints....

  14. 38 CFR 39.3 - Decisionmakers, notifications, and additional information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Decisionmakers, notifications, and additional information. 39.3 Section 39.3 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) AID TO STATES FOR ESTABLISHMENT, EXPANSION, AND IMPROVEMENT...

  15. Information workstations in clinical pathology.

    PubMed

    Spackman, K A

    1991-03-01

    Multitasking operating systems and expanding networks now permit smooth access to remote computers, peripherals, data, and information resources. Graphic user interfaces and productivity-enhancing software packages reduce the need for training and memorization of commands. New models of desktop computers based on "data-centered" software architecture can enhance workstation usefulness even more. Pathologists need to consider how these tools might improve access to and management of information and knowledge.

  16. Findings from the Clinical Information Systems Perspective

    PubMed Central

    2015-01-01

    Summary Objective To summarize recent research and to propose a selection of best papers published in 2014 in the field of Clinical Information Systems (CIS). Method A query with search terms from the Medical Subject Headings (MeSH) catalog as well as additional free text search terms was designed to identify relevant publications in the field of clinical information systems from PubMed and Web of Science®. The retrieved articles were then categorized in a multi-pass review carried out separately by the section editors. The final selection of 15 candidate papers was then peer-reviewed by Yearbook editors and external reviewers. Based on the review results the four best papers were then selected at the best papers selection meeting with the IMIA Yearbook editorial board. Results The query was carried out in mid-January 2015, yielding a combined result set of 1525 articles which were published in 722 different journals. Among these articles two main thematic sections were identified: i) Interoperability from a syntactical and semantic point of view as well as from a long-term preservation and organizational/legal point of view and ii) secondary use of existing health data in all its shades. Here, patient safety was a major scope of application. Conclusions CIS have become mature over the last years. The focus has now moved beyond data acquisition for just supporting the local care workflows. Actual research efforts in the CIS domain comprise the breakdown of information silos, the reduction of barriers between different systems of different care providers and secondary use of accumulated health data for multiple purposes. PMID:26293854

  17. Censored data treatment using additional information in intelligent medical systems

    NASA Astrophysics Data System (ADS)

    Zenkova, Z. N.

    2015-11-01

    Statistical procedures are a very important and significant part of modern intelligent medical systems. They are used for proceeding, mining and analysis of different types of the data about patients and their diseases; help to make various decisions, regarding the diagnosis, treatment, medication or surgery, etc. In many cases the data can be censored or incomplete. It is a well-known fact that censorship considerably reduces the efficiency of statistical procedures. In this paper the author makes a brief review of the approaches which allow improvement of the procedures using additional information, and describes a modified estimation of an unknown cumulative distribution function involving additional information about a quantile which is known exactly. The additional information is used by applying a projection of a classical estimator to a set of estimators with certain properties. The Kaplan-Meier estimator is considered as an estimator of the unknown cumulative distribution function, the properties of the modified estimator are investigated for a case of a single right censorship by means of simulations.

  18. Measuring informant discrepancies in clinical child research.

    PubMed

    De Los Reyes, Andres; Kazdin, Alan E

    2004-09-01

    Discrepancies among informants' ratings of child psychopathology have important implications for diagnosis, assessment, and treatment. Typically, parents and children complete measures (e.g., self-report checklists, diagnostic instruments) to assess child dysfunction. Ratings gathered from these sources reveal relatively little agreement on the nature and extent of the child's social, emotional, and behavioral problems. This article reviews and illustrates the most frequently used methods of measuring informant discrepancies in the clinical child literature (i.e., raw difference, standardized difference, and residual difference scores) and outlines key considerations to influence their selection. The authors conclude that frequently used methods of measuring informant discrepancies are not interchangeable and recommend that future investigations examining informant discrepancies in clinical child research use the standardized difference score as their measure of informant discrepancies.

  19. Information-based monitoring of clinical trials.

    PubMed

    Tsiatis, Anastasios A

    2006-10-15

    When designing a clinical trial to compare the effect of different treatments on response, a key issue facing the statistician is to determine how large a study is necessary to detect a clinically important difference with sufficient power. This is the case whether the study will be analysed only once (single-analysis) or whether it will be monitored periodically with the possibility of early stopping (group-sequential). Standard sample size calculations are based on both the magnitude of difference that is considered clinically important as well as values for the nuisance parameters in the statistical model. For planning purposes, best guesses are made for the value of the nuisance parameters and these are used to determine the sample size. However, if these guesses are incorrect this will affect the subsequent power to detect the clinically important difference. It is argued in this paper that statistical precision is directly related to Statistical Information and that the study should continue until the requisite statistical information is obtained. This is referred to as information-based design and analysis of clinical trials. We also argue that this type of methodology is best suited with group-sequential trials which monitor the data periodically and allow for estimation of the statistical information as the study progresses. PMID:16927248

  20. Additives

    NASA Technical Reports Server (NTRS)

    Smalheer, C. V.

    1973-01-01

    The chemistry of lubricant additives is discussed to show what the additives are chemically and what functions they perform in the lubrication of various kinds of equipment. Current theories regarding the mode of action of lubricant additives are presented. The additive groups discussed include the following: (1) detergents and dispersants, (2) corrosion inhibitors, (3) antioxidants, (4) viscosity index improvers, (5) pour point depressants, and (6) antifouling agents.

  1. Clinical information systems for integrated healthcare networks.

    PubMed Central

    Teich, J. M.

    1998-01-01

    In the 1990's, a large number of hospitals and medical practices have merged to form integrated healthcare networks (IHN's). The nature of an IHN creates new demands for information management, and also imposes new constraints on information systems for the network. Important tradeoffs must be made between homogeneity and flexibility, central and distributed governance, and access and confidentiality. This paper describes key components of clinical information systems for IHN's, and examines important design decisions that affect the value of such systems. Images Figure 1 PMID:9929178

  2. 29 CFR 2570.39 - Opportunities to submit additional information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... tentative denial letter. At the same time, the applicant should indicate generally the type of information... penalty of perjury attesting to the truth and correctness of the information provided, which is dated...

  3. 21 CFR 71.4 - Samples; additional information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in... additive, or articles used as components thereof, or of the food, drug, or cosmetic in which the color... respect to the safety of the color additive or the physical or technical effect it produces. The date...

  4. 21 CFR 71.4 - Samples; additional information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic in... additive, or articles used as components thereof, or of the food, drug, or cosmetic in which the color... respect to the safety of the color additive or the physical or technical effect it produces. The date...

  5. 77 FR 67655 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-13

    ... Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions; Extension... comment in response to the notice. This notice solicits comments on food additive petitions regarding... of information technology. Food Additive Petitions and Investigational Food Additive Exemptions,...

  6. Measuring Mortality Information in Clinical Data Warehouses.

    PubMed

    Jones, Barrett; Vawdrey, David K

    2015-01-01

    The ability to track and report long-term outcomes, especially mortality, is essential for advancing clinical research. The purpose of this study was to present a framework for assessing the quality of mortality information in clinical research databases. Using the clinical data warehouse (CDW) at Columbia University Medical Center as a case study, we measured: 1) agreement in vital status between our institution's patient registration system and the U.S. Social Security Administration's Death Master File (DMF), 2) the proportion of patients marked as deceased according to the DMF records who had subsequent visits to our institution, and 3) the proportion of patients still living according to Columbia's CDW who were over 100 and 120 years of age. Of 33,295 deaths recorded in our institution's patient registration system, 13,167 (39.5%) did not exist in the DMF. Of 315,037 patients in our CDW who marked as deceased according to the DMF, 2.1% had a subsequent clinical encounter at our institution. The proportion of patients still living according to Columbia's CDW who were over 100 and 120 years of age was 43.6% and 43.1%, respectively. These measures may be useful to other clinical research investigators seeking to assess the quality of mortality data (1-4). PMID:26306284

  7. Measuring Mortality Information in Clinical Data Warehouses

    PubMed Central

    Jones, Barrett; Vawdrey, David K.

    2015-01-01

    The ability to track and report long-term outcomes, especially mortality, is essential for advancing clinical research. The purpose of this study was to present a framework for assessing the quality of mortality information in clinical research databases. Using the clinical data warehouse (CDW) at Columbia University Medical Center as a case study, we measured: 1) agreement in vital status between our institution’s patient registration system and the U.S. Social Security Administration’s Death Master File (DMF), 2) the proportion of patients marked as deceased according to the DMF records who had subsequent visits to our institution, and 3) the proportion of patients still living according to Columbia’s CDW who were over 100 and 120 years of age. Of 33,295 deaths recorded in our institution’s patient registration system, 13,167 (39.5%) did not exist in the DMF. Of 315,037 patients in our CDW who marked as deceased according to the DMF, 2.1% had a subsequent clinical encounter at our institution. The proportion of patients still living according to Columbia’s CDW who were over 100 and 120 years of age was 43.6% and 43.1%, respectively. These measures may be useful to other clinical research investigators seeking to assess the quality of mortality data (1–4). PMID:26306284

  8. Measuring Mortality Information in Clinical Data Warehouses.

    PubMed

    Jones, Barrett; Vawdrey, David K

    2015-01-01

    The ability to track and report long-term outcomes, especially mortality, is essential for advancing clinical research. The purpose of this study was to present a framework for assessing the quality of mortality information in clinical research databases. Using the clinical data warehouse (CDW) at Columbia University Medical Center as a case study, we measured: 1) agreement in vital status between our institution's patient registration system and the U.S. Social Security Administration's Death Master File (DMF), 2) the proportion of patients marked as deceased according to the DMF records who had subsequent visits to our institution, and 3) the proportion of patients still living according to Columbia's CDW who were over 100 and 120 years of age. Of 33,295 deaths recorded in our institution's patient registration system, 13,167 (39.5%) did not exist in the DMF. Of 315,037 patients in our CDW who marked as deceased according to the DMF, 2.1% had a subsequent clinical encounter at our institution. The proportion of patients still living according to Columbia's CDW who were over 100 and 120 years of age was 43.6% and 43.1%, respectively. These measures may be useful to other clinical research investigators seeking to assess the quality of mortality data (1-4).

  9. Infrastructure support for Clinical Information Systems

    SciTech Connect

    McGovern, Greg, A.

    2007-06-15

    Executive Summary: For the past 5 years, Adventist Health has been implementing a clinical information system, titled Project IntelliCare, throughout its 19 hospitals. To successfully do this, a commitment was made to ensure continuous availability of vital patient health information to the local hospitals. This commitment required a centralized data center with sufficient capacity and a backup data center to be used in case of technical software or natural disaster where interruptions could occur. The DOE grant provided financial assistance to purchase equipment to increase the capacity of an existing data center, along with purchase of more sophisticated software for the data center thus providing a reduction in time that information is unavailable to the local hospitals when hardware or software problems occur. Relative to public good, this translates into increased safety and convenience for the patients we serve because their electronic medical records are current and available a higher percentage of the time.

  10. Informal interprofessional learning: visualizing the clinical workplace.

    PubMed

    Wagter, Judith Martine; van de Bunt, Gerhard; Honing, Marina; Eckenhausen, Marina; Scherpbier, Albert

    2012-05-01

    Daily collaboration of senior doctors, residents and nurses involves a major potential for sharing knowledge between professionals. Therefore, more attention needs to be paid to informal learning to create strategies and appropriate conditions for enhancing and effectuating informal learning in the workplace. The aim of this study is to visualize and describe patterns of informal interprofessional learning relations among staff in complex care. Questionnaires with four network questions - recognized as indicators of informal learning in the clinical workplace - were handed out to intensive and medium care unit (ICU/MCU) staff members (N = 108), of which 77% were completed and returned. Data were analyzed using social network analysis and Mokken scale analysis. Densities, tie strength and reciprocity of the four networks created show MCU and ICU nurses as subgroups within the ward and reveal central but relatively one-sided relations of senior doctors with nurses and residents. Based on the analyses, we formulated a scale of intensity of informal learning relations that can be used to understand and stimulate informal interprofessional learning.

  11. 78 FR 51265 - 30-Day Notice of Proposed Information Collection: Application for Additional Visa Pages or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... Notice of Proposed Information Collection: Application for Additional Visa Pages or Miscellaneous...: Title of Information Collection: Application for Additional Visa Pages or Miscellaneous Passport... applies for the addition of visa pages to that passport, the Department must confirm the...

  12. 21 CFR 71.4 - Samples; additional information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... respect to the safety of the color additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 721(d)(1) of the act shall be moved...

  13. 21 CFR 71.4 - Samples; additional information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... respect to the safety of the color additive or the physical or technical effect it produces. The date used for computing the 90-day limit for the purposes of section 721(d)(1) of the act shall be moved...

  14. Informal sources of supervision in clinical training.

    PubMed

    Farber, Barry A; Hazanov, Valery

    2014-11-01

    Although formal, assigned supervision is a potent source of learning and guidance for psychotherapy trainees, many beginning psychotherapists use other, informal sources of supervision or consultation for advice and support. Results of an online survey of beginning trainees (N = 146) indicate that other than their formally assigned supervisor, trainees most often consult with colleagues in their program, their own psychotherapist, and their significant other; that they're most likely to seek these other sources of help when they're feeling stuck or feel they've made a clinical mistake; that they do so because they need extra reassurance and suggestions; that they feel the advice given from these sources is helpful; and that they don't especially regret sharing this information. Several case examples are used to illustrate these points. Discussing clinical material with informal sources is, apparently, a great deal more common than typically acknowledged, and as such, has implications for training programs (including discussions of ethics) and formal supervision.

  15. 34 CFR 303.212 - Additional information and assurances.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... State is taking to ensure equitable access to, and equitable participation in, the part C statewide system as required by section 427(b) of GEPA; and (b) Other information and assurances as the Secretary may reasonably require. (Approved by Office of Management and Budget under control number...

  16. Partnering industry to develop clinical information systems.

    PubMed

    Hughes, Victoria; Hamer, Susan

    2012-09-01

    Over the past six months, the nursing team from the Department of Health's Informatics Directorate has been working with colleagues in industry to promote and share learning and understanding of issues surrounding the nursing profession. Team members were asked among other things to identify key questions senior nursing colleagues and suppliers should ask one another when considering the implementation of a new system for recording clinical information and extracting pertinent data. This article aims to encourage collaborative working and understanding of the importance of senior nurse involvement in choosing and delivering the right system for staff and patients. PMID:23008903

  17. Clinical simulation: A method for development and evaluation of clinical information systems.

    PubMed

    Jensen, Sanne; Kushniruk, Andre W; Nøhr, Christian

    2015-04-01

    Use of clinical simulation in the design and evaluation of eHealth systems and applications has increased during the last decade. This paper describes a methodological approach for using clinical simulations in the design and evaluation of clinical information systems. The method is based on experiences from more than 20 clinical simulation studies conducted at the ITX-lab in the Capital Region of Denmark during the last 5 years. A ten-step approach to conducting simulations is presented in this paper. To illustrate the approach, a clinical simulation study concerning implementation of Digital Clinical Practice Guidelines in a prototype planning and coordination module is presented. In the case study potential benefits were assessed in a full-scale simulation test including 18 health care professionals. The results showed that health care professionals can benefit from such a module. Unintended consequences concerning terminology and changes in the division of responsibility amongst healthcare professionals were also identified, and questions were raised concerning future workflow across sector borders. Furthermore unexpected new possible benefits concerning improved communication, content of information in discharge letters and quality management emerged during the testing. In addition new potential groups of users were identified. The case study is used to demonstrate the potential of using the clinical simulation approach described in the paper.

  18. 78 FR 77119 - Proposed Information Collection Request; Comment Request; Regulation of Fuels and Fuel Additives...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-20

    ... AGENCY Proposed Information Collection Request; Comment Request; Regulation of Fuels and Fuel Additives: 2011 Renewable Fuel Standards-- Petition for International Aggregate Compliance Approach AGENCY... to submit an information collection request (ICR), ``Regulation of Fuels and Fuel Additives:...

  19. The economic motivations for clinical information systems.

    PubMed Central

    Clayton, P. D.; van Mulligen, E.

    1996-01-01

    For three decades (1960-1990) the primary use of computers in hospitals' in the U.S. was to ease the task of reimbursement for care rendered and to automate results reporting for high-volume, time-critical tests such as clinical laboratory procedures. Hospitals were regarded as independent organizations/revenue centers which could pass costs to third party payers. Beginning in the mid-eighties, U.S. hospitals were no longer reimbursed on a fee-for-service basis for many patients, but received a fixed payment regardless of the actual cost of treating a patient. The size of the payment depended upon the patients' type of illness (Diagnostically related group). This approach gave hospitals incentives to reduce costs, but did not foster a fully competitive environment. Now, in the mid-nineties, hospitals in the U.S. are seen as cost centers in an integrated health care delivery system. Within this environment, a longitudinal patient record is necessary to increase levels of communication between healthcare providers. While certain management functions remain hospital-centered, clinical information systems must now cover a spectrum of patient activities within the ambulatory and inpatient arena. Several of the leading healthcare providers use computer-based logic to alert care givers whenever standards of care are not being achieved. These institutions feel that such capability will be the real impetus to reduce cost and improve the quality of care. Based upon observations over four decades, it appears that economic considerations play the major role in determining which kinds of information systems are deployed in the healthcare arena. PMID:8947748

  20. 40 CFR Table 42 to Subpart Uuu of... - Additional Information for Initial Notification of Compliance Status

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 12 2010-07-01 2010-07-01 true Additional Information for Initial..., Table 42 Table 42 to Subpart UUU of Part 63—Additional Information for Initial Notification of... applies to you. For . . . You shall provide this additional information . . . 1. Identification...

  1. 16 CFR 2.20 - Petitions for review of requests for additional information or documentary material.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... or documentary material issued under 16 CFR 803.20. (b) Second request procedures—(1) Notice. Every request for additional information or documentary material issued under 16 CFR 803.20 shall inform the... additional information or documentary material. 2.20 Section 2.20 Commercial Practices FEDERAL...

  2. Transforming Clinic Environments into Information Workspaces for Patients

    PubMed Central

    Unruh, Kenton T.; Skeels, Meredith; Civan-Hartzler, Andrea; Pratt, Wanda

    2010-01-01

    Although clinic environments are a primary location for exchanging information with clinicians, patients experience these spaces as harsh environments to access, use, exchange, and manage information. In this paper, we present results from an ethnographic-inspired study of breast cancer patients actively interacting with information in clinic environments. Through observations and interviews, we observed information interactions in awkward physical positions; inefficient use of existing clinical space; separation of patients from their information and lack of support for collaborative document viewing. These factors compromised patients’ abilities to manage their information work when they experienced bursts of information exchange, lack of advance information, fragmented attention, and heightened stress in clinic environments. To overcome these challenges, we identify formative strategies to focus attention, encourage collaboration, and improve communication in clinical settings. PMID:21654895

  3. Experiences of clinical tutors with English as an additional language (EAL) students.

    PubMed

    Lu, Hongyan; Maithus, Caroline

    2012-11-01

    Clinical tutors, referred to in the international literature as clinical supervisors, facilitators, mentors or instructors, are responsible for providing and supervising workplace learning opportunities for groups of Bachelor of Nursing (BN) students. They also play a key role in assessing students. The role modeling and support provided by both clinical tutors and registered nurses (RN) or nurse preceptors helps students become familiar with the language in which nursing work is realised. As BN student cohorts in New Zealand have become more diverse in terms of cultures, ethnicities and language backgrounds, clinical tutors have to directly facilitate the development of context-specific and client-focused communication skills for students who speak English as an additional language. We undertook a study which looked at the perceptions of new nursing graduates with English as an additional language (EAL) on the development of spoken language skills for the clinical workplace. As well as interviewing graduates, we spoke to four clinical tutors in order to elicit their views on the language development of EAL students in previous cohorts. This article reports on the themes which emerged from the interviews with the tutors. These include goal setting for communication, integrating students into nursing work, making assessment less stressful, and endorsing independent learning strategies. Based on their observations and on other published research we make some suggestions about ways both clinical tutors and EAL students within their teaching groups could be supported in the development of communication skills for clinical practice.

  4. Experiences of clinical tutors with English as an additional language (EAL) students.

    PubMed

    Lu, Hongyan; Maithus, Caroline

    2012-11-01

    Clinical tutors, referred to in the international literature as clinical supervisors, facilitators, mentors or instructors, are responsible for providing and supervising workplace learning opportunities for groups of Bachelor of Nursing (BN) students. They also play a key role in assessing students. The role modeling and support provided by both clinical tutors and registered nurses (RN) or nurse preceptors helps students become familiar with the language in which nursing work is realised. As BN student cohorts in New Zealand have become more diverse in terms of cultures, ethnicities and language backgrounds, clinical tutors have to directly facilitate the development of context-specific and client-focused communication skills for students who speak English as an additional language. We undertook a study which looked at the perceptions of new nursing graduates with English as an additional language (EAL) on the development of spoken language skills for the clinical workplace. As well as interviewing graduates, we spoke to four clinical tutors in order to elicit their views on the language development of EAL students in previous cohorts. This article reports on the themes which emerged from the interviews with the tutors. These include goal setting for communication, integrating students into nursing work, making assessment less stressful, and endorsing independent learning strategies. Based on their observations and on other published research we make some suggestions about ways both clinical tutors and EAL students within their teaching groups could be supported in the development of communication skills for clinical practice. PMID:23421011

  5. The Effectiveness and Clinical Usability of a Handheld Information Appliance

    PubMed Central

    Abbott, Patricia A.

    2012-01-01

    Clinical environments are complex, stressful, and safety critical—heightening the demand for technological solutions that will help clinicians manage health information efficiently and safely. The industry has responded by creating numerous, increasingly compact and powerful health IT devices that fit in a pocket, hook to a belt, attach to eyeglasses, or wheel around on a cart. Untethering a provider from a physical “place” with compact, mobile technology while delivering the right information at the right time and at the right location are generally welcomed in clinical environments. These developments however, must be looked at ecumenically. The cognitive load of clinicians who are occupied with managing or operating several different devices during the process of a patient encounter is increased, and we know from decades of research that cognitive overload frequently leads to error. “Technology crowding,” enhanced by the plethora of mobile health IT, can actually become an additional millstone for busy clinicians. This study was designed to gain a deeper understanding of clinicians' interactions with a mobile clinical computing appliance (Motion Computing C5) designed to consolidate numerous technological functions into an all-in-one device. Features of usability and comparisons to current methods of documentation and task performance were undertaken and results are described. PMID:22548159

  6. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Confidentiality of data and information in color... and information in color additive petitions. (a) The following data and information in a color... because of the deficiencies involved: (1) All safety and functionality data and information submitted...

  7. 42 CFR 435.955 - Additional requirements regarding information released by a Federal agency.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Additional requirements regarding information... requirements regarding information released by a Federal agency. (a) Unless waived under paragraph (d) of this section, based on information received from a computerized data match in which information on...

  8. 49 CFR 260.25 - Additional information for Applicants not having a credit rating.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Additional information for Applicants not having a... Financial Assistance § 260.25 Additional information for Applicants not having a credit rating. Each application submitted by Applicants not having a recent credit rating from one or more nationally...

  9. Information Model for Reusability in Clinical Trial Documentation

    ERIC Educational Resources Information Center

    Bahl, Bhanu

    2013-01-01

    In clinical research, New Drug Application (NDA) to health agencies requires generation of a large number of documents throughout the clinical development life cycle, many of which are also submitted to public databases and external partners. Current processes to assemble the information, author, review and approve the clinical research documents,…

  10. Adoption of Clinical Information Systems in Health Services Organizations

    PubMed Central

    Austin, Charles J.; Holland, Gloria J.

    1988-01-01

    This paper presents a conceptual model of factors which influence organizational decisions to invest in the installation of clinical information systems. Using results of previous research as a framework, the relative influence of clinical, fiscal, and strategic-institutional decision structures are examined. These adoption decisions are important in health services organizations because clinical information is essential for managing demand and allocating resources, managing quality of care, and controlling costs.

  11. A clinical information consultation service at a teaching hospital.

    PubMed Central

    Tobia, R C; Kronick, D A; Harris, G D

    1983-01-01

    The library and the department of medicine at the University of Texas Health Science Center at San Antonio cooperated in a three-month pilot project to test a clinical information consultation service that provides patient care information to house staff members in the clinical setting. Evaluation indicated that users were highly satisfied with the service. Results of our pilot project seem to show that a clinical information consultation service can be an efficient and cost-effective means to provide information in a patient-care setting. PMID:6652299

  12. A clinical information consultation service at a teaching hospital.

    PubMed

    Tobia, R C; Kronick, D A; Harris, G D

    1983-10-01

    The library and the department of medicine at the University of Texas Health Science Center at San Antonio cooperated in a three-month pilot project to test a clinical information consultation service that provides patient care information to house staff members in the clinical setting. Evaluation indicated that users were highly satisfied with the service. Results of our pilot project seem to show that a clinical information consultation service can be an efficient and cost-effective means to provide information in a patient-care setting.

  13. SMARCE1, a rare cause of Coffin-Siris Syndrome: Clinical description of three additional cases.

    PubMed

    Zarate, Yuri A; Bhoj, Elizabeth; Kaylor, Julie; Li, Dong; Tsurusaki, Yoshinori; Miyake, Noriko; Matsumoto, Naomichi; Phadke, Shubha; Escobar, Luis; Irani, Afifa; Hakonarson, Hakon; Schrier Vergano, Samantha A

    2016-08-01

    Coffin-Siris syndrome (CSS, MIM 135900), is a well-described, multiple congenital anomaly syndrome characterized by coarse facial features, hypertrichosis, sparse scalp hair, and hypo/aplastic digital nails and phalanges, typically of the 5th digits. Mutations in the BAF (SWI/SNF)-complex subunits (SMARCA4, SMARCE1, SMARCB1, SMARCA2, ARID1B, and ARID1A) have been shown to cause not only CSS, but also related disorders including Nicolaides-Baraitser (MIM 601358) syndrome and ARID1B-intellectual disability syndrome (MIM 614562). At least 200 individuals with CSS have been found to have a mutation in the BAF pathway. However, to date, only three individuals with CSS have been reported to have pathogenic variants in SMARCE1. We report here three additional individuals with clinical features consistent with CSS and alterations in SMARCE1, one of which is novel. The probands all exhibited dysmorphic facial features, moderate developmental and cognitive delay, poor growth, and hypoplastic digital nails/phalanges, including digits not typically affected in the other genes associated with CSS. Two of the three probands had a variety of different organ system anomalies, including cardiac disease, genitourinary abnormalities, feeding difficulties, and vision abnormalities. The 3rd proband has not had further investigative studies. Although an increasing number of individuals are being diagnosed with disorders in the BAF pathway, SMARCE1 is the least common of these genes. This report doubles the number of probands with these mutations, and allows for better phenotypic information of this rare syndrome. © 2016 Wiley Periodicals, Inc. PMID:27264197

  14. 75 FR 77645 - Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ... Collection; Comment Request; Color Additive Certification Requests and Recordkeeping AGENCY: Food and Drug... certification of color additives manufactured for use in foods, drugs, cosmetics or medical devices in the... of information technology. Color Additive Certification Requests and Recordkeeping--21 CFR Part...

  15. [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. PMID:20799410

  16. Respiratory microbiota: addressing clinical questions, informing clinical practice.

    PubMed

    Rogers, Geraint B; Shaw, Dominick; Marsh, Robyn L; Carroll, Mary P; Serisier, David J; Bruce, Kenneth D

    2015-01-01

    Over the last decade, technological advances have revolutionised efforts to understand the role played by microbes in airways disease. With the application of ever more sophisticated techniques, the literature has become increasingly inaccessible to the non-specialist reader, potentially hampering the translation of these gains into improvements in patient care. In this article, we set out the key principles underpinning microbiota research in respiratory contexts and provide practical guidance on how best such studies can be designed, executed and interpreted. We examine how an understanding of the respiratory microbiota both challenges fundamental assumptions and provides novel clinical insights into lung disease, and we set out a number of important targets for ongoing research.

  17. Republished: Respiratory microbiota: addressing clinical questions, informing clinical practice.

    PubMed

    Rogers, Geraint B; Shaw, Dominick; Marsh, Robyn L; Carroll, Mary P; Serisier, David J; Bruce, Kenneth D

    2015-08-01

    Over the last decade, technological advances have revolutionised efforts to understand the role played by microbes in airways disease. With the application of ever more sophisticated techniques, the literature has become increasingly inaccessible to the non-specialist reader, potentially hampering the translation of these gains into improvements in patient care. In this article, we set out the key principles underpinning microbiota research in respiratory contexts and provide practical guidance on how best such studies can be designed, executed and interpreted. We examine how an understanding of the respiratory microbiota both challenges fundamental assumptions and provides novel clinical insights into lung disease, and we set out a number of important targets for ongoing research.

  18. An academic, clinical and industrial update on electrospun, additive manufactured and imprinted medical devices.

    PubMed

    Ryan, Christina N M; Fuller, Kieran P; Larrañaga, Aitor; Biggs, Manus; Bayon, Yves; Sarasua, Jose R; Pandit, Abhay; Zeugolis, Dimitrios I

    2015-01-01

    Electrospinning, additive manufacturing and imprint lithography scaffold fabrication technologies have attracted great attention in biomedicine, as they allow production of two- and three- dimensional constructs with tuneable topographical and geometrical features. In vitro data demonstrate that electrospun and imprinted substrates offer control over permanently differentiated and stem cell function. Advancements in functionalisation strategies have further enhanced the bioactivity and reparative capacity of electrospun and additive manufactured devices, as has been evidenced in several preclinical models. Despite this overwhelming success in academic setting, only a few technologies have reached the clinic and only a fraction of them have become commercially available products.

  19. Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment.

    PubMed

    Tobin, Thomas J; Tobin, Mary L

    2015-01-01

    Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions. PMID:26514264

  20. Minnesota clinics' adoption, use and exchange of electronic health information.

    PubMed

    Soderberg, Karen; Laventure, Marty

    2013-09-01

    In 2007, Minnesota passed a law requiring all health care providers in the state to implement an interoperable electronic health record (EHR) system by January 1, 2015. Since then, the Minnesota Department of Health has been monitoring progress each year by surveying hospitals, clinics and other health and health care facilities about their EHR use. This article summarizes findings from the 2013 survey of ambulatory clinics. Those results show Minnesota clinics are well on the way to achieving the state's goals for using EHRs to exchange information: 87% of clinics have adopted EHRs, 80% routinely use medication guides and alerts, and 36% exchange health information with unaffiliated settings.

  1. 30 CFR 250.418 - What additional information must I submit with my APD?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.418 What additional information must...

  2. 30 CFR 250.418 - What additional information must I submit with my APD?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.418 What additional information must...

  3. Sufficient trial size to inform clinical practice.

    PubMed

    Manski, Charles F; Tetenov, Aleksey

    2016-09-20

    Medical research has evolved conventions for choosing sample size in randomized clinical trials that rest on the theory of hypothesis testing. Bayesian statisticians have argued that trials should be designed to maximize subjective expected utility in settings of clinical interest. This perspective is compelling given a credible prior distribution on treatment response, but there is rarely consensus on what the subjective prior beliefs should be. We use Wald's frequentist statistical decision theory to study design of trials under ambiguity. We show that ε-optimal rules exist when trials have large enough sample size. An ε-optimal rule has expected welfare within ε of the welfare of the best treatment in every state of nature. Equivalently, it has maximum regret no larger than ε We consider trials that draw predetermined numbers of subjects at random within groups stratified by covariates and treatments. We report exact results for the special case of two treatments and binary outcomes. We give simple sufficient conditions on sample sizes that ensure existence of ε-optimal treatment rules when there are multiple treatments and outcomes are bounded. These conditions are obtained by application of Hoeffding large deviations inequalities to evaluate the performance of empirical success rules. PMID:27601679

  4. Clinical and histopathological evaluation of the effect of addition of immunotherapy with Mw vaccine to standard chemotherapy in borderline leprosy.

    PubMed

    Kamal, R; Natrajan, M; Katoch, K; Arora, M

    2012-01-01

    increase in the epithelioid cells population in this group. This suggests a possible immunoactivation of the macrophages especially in BB/BL immunotherapy group. Overall comparison of regression induced by chemotherapy alone with that induced by combined chemotherapy and immunotherapy shows a greater reduction in clinical parameters as well as granuloma fraction in BT cases as well as in BB/BL cases. This trial shows the potential usefulness of this approach of addition of immunotherapy to standard chemotherapy in borderline leprosy cases which leads to in faster recovery from disease reduced chances of reactions and faster granuloma clearance. Such information is expected to be useful in improving the immunotherapeutic approaches for treatinggranulomatous conditions in general and in leprosy in particular. PMID:23720894

  5. 18 CFR 33.4 - Additional information requirements for applications involving vertical competitive impacts.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Additional information requirements for applications involving vertical competitive impacts. 33.4 Section 33.4 Conservation of Power... FEDERAL POWER ACT APPLICATIONS UNDER FEDERAL POWER ACT SECTION 203 § 33.4 Additional...

  6. 18 CFR 33.4 - Additional information requirements for applications involving vertical competitive impacts.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Additional information requirements for applications involving vertical competitive impacts. 33.4 Section 33.4 Conservation of Power... FEDERAL POWER ACT APPLICATIONS UNDER FEDERAL POWER ACT SECTION 203 § 33.4 Additional...

  7. Informed consent, confidentiality, and subject rights in clinical trials.

    PubMed

    Smith-Tyler, June

    2007-05-01

    The informed consent process is designed to inform the subject of the risks, rights, and benefits of participation in a clinical research trial. Informed consent, while not always necessary, is a critical component of ethical research involving human subjects. This article includes an overview of two sets of regulations regarding informed consent found in the Code of Federal Regulations (CFR) Titles 21 and 45: 21 CFR 50 and 56, the Food and Drug Administration Regulations, and 45 CFR 46, where applicable, the Department of Health and Human Services Regulations. Also included in this discussion are the general requirements of informed consent; challenging issues regarding informed consent; determining and obtaining informed consent in research involving vulnerable subjects (e.g., children, critically ill patients); the use of genetic information; confidentiality and privacy of subject information; and compensation for injury during a research study. Examples of acceptable and unacceptable (exculpatory) informed consent language are also provided as they may pertain to commercial gain, confidentiality, and compensation for injury. The goal of this article is to provide the clinical researcher with an explanation of the legal requirements for informed consent in clinical research. The researcher faces many challenges in implementing effective informed consent beyond the federal regulations.

  8. The Information Quality Triangle: a methodology to assess clinical information quality.

    PubMed

    Choquet, Rémy; Qouiyd, Samiha; Ouagne, David; Pasche, Emilie; Daniel, Christel; Boussaïd, Omar; Jaulent, Marie-Christine

    2010-01-01

    Building qualitative clinical decision support or monitoring based on information stored in clinical information (or EHR) systems cannot be done without assessing and controlling information quality. Numerous works have introduced methods and measures to qualify and enhance data, information models and terminologies quality. This paper introduces an approach based on an Information Quality Triangle that aims at providing a generic framework to help in characterizing quality measures and methods in the context of the integration of EHR data in a clinical datawarehouse. We have successfully experimented the proposed approach at the HEGP hospital in France, as part of the DebugIT EU FP7 project.

  9. Units of Measure in Clinical Information Systems

    PubMed Central

    Schadow, Gunther; McDonald, Clement J.; Suico, Jeffrey G.; Föhring, Ulrich; Tolxdorff, Thomas

    1999-01-01

    The authors surveyed existing standard codes for units of measures, such as ISO 2955, ANSI ×3.50, and Health Level 7′s ISO+. Because these standards specify only the character representation of units, the authors developed a semantic model for units based on dimensional analysis. Through this model, conversion between units and calculations with dimensioned quantities become as simple as calculating with numbers. All atomic symbols for prefixes and units are defined in one small table. Huge permutated conversion tables are not required. This method is also simple enough to be widely implementable in today's information systems. To promote the application of the method the authors provide an open-source implementation of this method in JAVA. All existing code standards for units, however, are incomplete for practical use and require substantial changes to correct their many ambiguities. The authors therefore developed a code for units that is much more complete and free from ambiguities. PMID:10094068

  10. Couples Counseling in Alzheimer's Disease: Additional Clinical Findings from a Novel Intervention Study.

    PubMed

    Auclair, Ursula; Epstein, Cynthia; Mittelman, Mary

    2009-04-01

    This article describes the clinical findings of a study designed to assess the benefit of counseling for couples, one of whom is in the early stage of Alzheimer's disease (AD). We previously reported our findings based on the first 12 couples that enrolled in the study. Based on the treatment of 30 additional couples, we have refined our treatment strategy to include concepts of Gestalt Therapy and Transactional Analysis and identified prevalent issues of concern to this cohort. The study design has remained as described in the earlier article (Epstein et al., 2006), and has proven to be appropriate to meet the goals of this intervention as indicated by our clinical experience and feedback from the participating couples. Case vignettes demonstrate how to conduct the sessions so that the experience of each member of the dyad is validated, while acknowledging the differential impact of the disease on them. PMID:19865591

  11. Prazosin addition to fluvoxamine: A preclinical study and open clinical trial in OCD.

    PubMed

    Feenstra, Matthijs G P; Klompmakers, André; Figee, Martijn; Fluitman, Sjoerd; Vulink, Nienke; Westenberg, Herman G M; Denys, Damiaan

    2016-02-01

    The efficacy of selective serotonin reuptake inhibitors (SRIs) in psychiatric disorders may be "augmented" through the addition of atypical antipsychotic drugs. A synergistic increase in dopamine (DA) release in the prefrontal cortex has been suggested to underlie this augmentation effect, though the mechanism of action is not clear yet. We used in vivo microdialysis in rats to study DA release following the administration of combinations of fluvoxamine (10 mg/kg) and quetiapine (10 mg/kg) with various monoamine-related drugs. The results confirmed that the selective 5-HT1A antagonist WAY-100635 (0.05 mg/kg) partially blocked the fluvoxamine-quetiapine synergistic effect (maximum DA increase dropped from 325% to 214%). A novel finding is that the α1-adrenergic blocker prazosin (1 mg/kg), combined with fluvoxamine, partially mimicked the effect of augmentation (maximum DA increase 205%; area-under-the-curve 163%). As this suggested that prazosin augmentation might be tested in a clinical study, we performed an open clinical trial of prazosin 20 mg addition to SRI in therapy-resistant patients with obsessive-compulsive disorder applying for neurosurgery. A small, non-significant reduction in Yale Brown Obsessive Compulsive Scale (Y-BOCS) scores was observed in 10 patients and one patient was classified as a responder with a reduction in Y-BOCS scores of more than 25%. We suggest that future clinical studies augmenting SRIs with an α1-adrenergic blocker in less treatment resistant cases should be considered. The clinical trial "Prazosin in combination with a serotonin reuptake inhibitor for patients with Obsessive Compulsive disorder: an open label study" was registered at 24/05/2011 under trial number ISRCTN61562706: http://www.controlled-trials.com/ISRCTN61562706. PMID:26712326

  12. "The Dose Makes the Poison": Informing Consumers About the Scientific Risk Assessment of Food Additives.

    PubMed

    Bearth, Angela; Cousin, Marie-Eve; Siegrist, Michael

    2016-01-01

    Intensive risk assessment is required before the approval of food additives. During this process, based on the toxicological principle of "the dose makes the poison,ˮ maximum usage doses are assessed. However, most consumers are not aware of these efforts to ensure the safety of food additives and are therefore sceptical, even though food additives bring certain benefits to consumers. This study investigated the effect of a short video, which explains the scientific risk assessment and regulation of food additives, on consumers' perceptions and acceptance of food additives. The primary goal of this study was to inform consumers and enable them to construct their own risk-benefit assessment and make informed decisions about food additives. The secondary goal was to investigate whether people have different perceptions of food additives of artificial (i.e., aspartame) or natural origin (i.e., steviolglycoside). To attain these research goals, an online experiment was conducted on 185 Swiss consumers. Participants were randomly assigned to either the experimental group, which was shown a video about the scientific risk assessment of food additives, or the control group, which was shown a video about a topic irrelevant to the study. After watching the video, the respondents knew significantly more, expressed more positive thoughts and feelings, had less risk perception, and more acceptance than prior to watching the video. Thus, it appears that informing consumers about complex food safety topics, such as the scientific risk assessment of food additives, is possible, and using a carefully developed information video is a successful strategy for informing consumers. PMID:25951078

  13. "The Dose Makes the Poison": Informing Consumers About the Scientific Risk Assessment of Food Additives.

    PubMed

    Bearth, Angela; Cousin, Marie-Eve; Siegrist, Michael

    2016-01-01

    Intensive risk assessment is required before the approval of food additives. During this process, based on the toxicological principle of "the dose makes the poison,ˮ maximum usage doses are assessed. However, most consumers are not aware of these efforts to ensure the safety of food additives and are therefore sceptical, even though food additives bring certain benefits to consumers. This study investigated the effect of a short video, which explains the scientific risk assessment and regulation of food additives, on consumers' perceptions and acceptance of food additives. The primary goal of this study was to inform consumers and enable them to construct their own risk-benefit assessment and make informed decisions about food additives. The secondary goal was to investigate whether people have different perceptions of food additives of artificial (i.e., aspartame) or natural origin (i.e., steviolglycoside). To attain these research goals, an online experiment was conducted on 185 Swiss consumers. Participants were randomly assigned to either the experimental group, which was shown a video about the scientific risk assessment of food additives, or the control group, which was shown a video about a topic irrelevant to the study. After watching the video, the respondents knew significantly more, expressed more positive thoughts and feelings, had less risk perception, and more acceptance than prior to watching the video. Thus, it appears that informing consumers about complex food safety topics, such as the scientific risk assessment of food additives, is possible, and using a carefully developed information video is a successful strategy for informing consumers.

  14. Additional technician tasks and turnaround time in the clinical Stat laboratory

    PubMed Central

    Salinas, Maria; López-Garrigós, Maite; Flores, Emilio; Leiva-Salinas, Maria; Lillo, Rosa; Leiva-Salinas, Carlos

    2016-01-01

    Introduction Many additional tasks in the Stat laboratory (SL) increase the workload. It is necessary to control them because they can affect the service provided by the laboratory. Our aim is to calculate these tasks, study their evolution over a 10 year period, and compare turnaround times (TAT) in summer period to the rest of the year. Materials and methods Additional tasks were classified as “additional test request” and “additional sample”. We collected those incidences from the laboratory information system (LIS), and calculated their evolution over time. We also calculated the monthly TAT for troponin for Emergency department (ED) patients, as the difference between the verification and LIS registration time. A median time of 30 minutes was our indicator target. TAT results and tests workload in summer were compared to the rest of the year. Results Over a 10-year period, the technologists in the SL performed 51,385 additional tasks, a median of 475 per month. The workload was significantly higher during the summer (45,496 tests) than the rest of the year (44,555 tests) (P = 0.019). The troponin TAT did not show this variation between summer and the rest of the year, complying always with our 30 minutes indicator target. Conclusion The technicians accomplished a significant number of additional tasks, and the workload kept increasing over the period of 10 years. That did not affect the TAT results. PMID:27346970

  15. Clinical Trials Registration and Results Information Submission. Final rule.

    PubMed

    2016-09-21

    This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA. PMID:27658315

  16. The role of clinical information technology in depression care management.

    PubMed

    Kilbourne, Amy M; McGinnis, Gretchen Flanders; Belnap, Bea Herbeck; Klinkman, Michael; Thomas, Marshall

    2006-01-01

    We examine the literature on the growing application of clinical information technology in managing depression care and highlight lessons learned from Robert Wood Johnson Foundation's national program "Depression in Primary Care-Incentives Demonstrations." Several program sites are implementing depression care registries. Key issues discussed about implementing registries include using a simple yet functional format, designing registries to track multiple conditions versus depression alone (i.e., patient-centric versus disease-centric registries) and avoiding violations of patient privacy with the advent of more advanced information technologies (e.g., web-based formats). Finally, we discuss some implications of clinical information technology for health care practices and policy makers.

  17. Clinical and Management Requirements for Computerized Mental Health Information Systems

    PubMed Central

    Levinton, Paula H.; Dunning, Tessa F.E.

    1980-01-01

    Information requirements of mental health providers are sufficiently different from those of other health care managers to warrant a different approach to the development of management information systems (MIS). Advances in computer technology and increased demands for fiscal accountability have led to developing integrated mental health information systems (MHIS) that support clinical and management requirements. In a study made to define a set of generic information requirements of mental health providers that can be supported by an MHIS, it was found that basic data needs can be defined and classified in functional terms: clinical, management, and consultation/education requirements. A basic set of data to support these needs was defined: demographic, financial, clinical, programmatic, and service delivery data.

  18. Use of generalised additive models to categorise continuous variables in clinical prediction

    PubMed Central

    2013-01-01

    Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically

  19. A study of clinical and information management processes in the surgical pre-assessment clinic

    PubMed Central

    2014-01-01

    Background Establishing day-case surgery as the preferred hospital admission route for all eligible patients requires adequate preoperative assessment of patients in order to quickly distinguish those who will require minimum assessment and are suitable for day-case admission from those who will require more extensive management and will need to be admitted as inpatients. Methods As part of a study to elucidate clinical and information management processes within the patient surgical pathway in NHS Scotland, we conducted a total of 10 in-depth semi-structured interviews during 4 visits to the Dumfries & Galloway Royal Infirmary surgical pre-assessment clinic. We modelled clinical processes using process-mapping techniques and analysed interview data using qualitative methods. We used Normalisation Process Theory as a conceptual framework to interpret the factors which were identified as facilitating or hindering information elucidation tasks and communication within the multi-disciplinary team. Results The pre-assessment clinic of Dumfries & Galloway Royal Infirmary was opened in 2008 in response to clinical and workflow issues which had been identified with former patient management practices in the surgical pathway. The preoperative clinic now operates under well established processes and protocols. The use of a computerised system for managing preoperative documentation substantially transformed clinical practices and facilitates communication and information-sharing among the multi-disciplinary team. Conclusion Successful deployment and normalisation of innovative clinical and information management processes was possible because both local and national strategic priorities were synergistic and the system was developed collaboratively by the POA staff and the health-board IT team, resulting in a highly contextualised operationalisation of clinical and information management processes. Further concerted efforts from a range of stakeholders are required to fully

  20. CliniProteus: A flexible clinical trials information management system

    PubMed Central

    Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael

    2007-01-01

    Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796

  1. Clinical information systems: strategic imperatives driving IDNs forward.

    PubMed

    Schneider, M

    1999-11-01

    Reviewing the "state of the art" of clinical information systems in healthcare, one can't help but be struck by how many promises remain unfulfilled. Yes, there have been advances in electronic medical information systems in the past three decades, but in many ways, the same problems exist today that have existed all along. Implementation of clinical information systems (CIS) still requires major changes in workflow. And those core problems continue to dog the progress of integrated healthcare delivery systems, which are struggling to demonstrate value to purchasers, payers, providers, and consumers as they aggregate vertically and horizontally across the continuum. At the same time, mastering the "people" issues, those that revolve around how technology is integrated into the clinical practice of medicine, continues to be the key success factor for producing a usable solution, even with all the advances in hardware and software. PMID:10724559

  2. 38 CFR 61.15 - Capital grants-obtaining additional information and awarding capital grants.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Capital grants-obtaining additional information and awarding capital grants. 61.15 Section 61.15 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) VA HOMELESS PROVIDERS GRANT AND PER DIEM PROGRAM Capital Grants § 61.15...

  3. 16 CFR 803.21 - Additional information shall be supplied within reasonable time.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Additional information shall be supplied within reasonable time. 803.21 Section 803.21 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENTS AND INTERPRETATIONS UNDER THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF...

  4. 16 CFR 803.21 - Additional information shall be supplied within reasonable time.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Additional information shall be supplied within reasonable time. 803.21 Section 803.21 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENTS AND INTERPRETATIONS UNDER THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF...

  5. 13 CFR 126.403 - May SBA require additional information from a HUBZone SBC?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 13 Business Credit and Assistance 1 2012-01-01 2012-01-01 false May SBA require additional information from a HUBZone SBC? 126.403 Section 126.403 Business Credit and Assistance SMALL BUSINESS... adverse inference from the failure of a HUBZone SBC to cooperate with a program examination or...

  6. 13 CFR 126.403 - May SBA require additional information from a HUBZone SBC?

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 13 Business Credit and Assistance 1 2013-01-01 2013-01-01 false May SBA require additional information from a HUBZone SBC? 126.403 Section 126.403 Business Credit and Assistance SMALL BUSINESS... adverse inference from the failure of a HUBZone SBC to cooperate with a program examination or...

  7. 13 CFR 126.403 - May SBA require additional information from a HUBZone SBC?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false May SBA require additional information from a HUBZone SBC? 126.403 Section 126.403 Business Credit and Assistance SMALL BUSINESS... adverse inference from the failure of a HUBZone SBC to cooperate with a program examination or...

  8. 18 CFR 33.3 - Additional information requirements for applications involving horizontal competitive impacts.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Additional information... and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE... role that entry could play in mitigating adverse competitive effects of the transaction; (3)...

  9. 18 CFR 33.3 - Additional information requirements for applications involving horizontal competitive impacts.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Additional information... and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE... role that entry could play in mitigating adverse competitive effects of the transaction; (3)...

  10. 18 CFR 33.4 - Additional information requirements for applications involving vertical competitive impacts.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Additional information... and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE... competitive effects of the transaction. (ii) The potential for entry in the market and the role that...

  11. 18 CFR 33.4 - Additional information requirements for applications involving vertical competitive impacts.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Additional information... and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE... competitive effects of the transaction. (ii) The potential for entry in the market and the role that...

  12. 18 CFR 33.4 - Additional information requirements for applications involving vertical competitive impacts.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Additional information... and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE... competitive effects of the transaction. (ii) The potential for entry in the market and the role that...

  13. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Confidentiality of data and information in color additive petitions. 71.15 Section 71.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... established in § 20.61 of this chapter. (6) All records showing the Food and Drug Administration's testing...

  14. 76 FR 24854 - Proposed Information Collection; Comment Request; Additional Protocol Report Forms

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... International Atomic Energy Agency (IAEA) on a number of commercial nuclear and nuclear-related items, materials... for a nuclear weapons program. These forms provides the IAEA with information about additional aspects...; buildings on sites of facilities selected by the IAEA from the U.S. Eligible Facilities List;...

  15. 30 CFR 250.418 - What additional information must I submit with my APD?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false What additional information must I submit with my APD? 250.418 Section 250.418 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT, REGULATION, AND... plot if the well is to be directionally drilled; (d) A Hydrogen Sulfide Contingency Plan (see §...

  16. 30 CFR 250.418 - What additional information must I submit with my APD?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations Applying for A Permit to Drill § 250.418 What additional information must I submit with my APD? You must include the following with the APD: (a) Rated capacities of the drilling rig and...

  17. 38 CFR 39.4 - Decision makers, notifications, and additional information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Decision makers, notifications, and additional information. 39.4 Section 39.4 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) AID TO STATES FOR ESTABLISHMENT, EXPANSION, AND IMPROVEMENT,...

  18. 38 CFR 39.4 - Decision makers, notifications, and additional information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Decision makers, notifications, and additional information. 39.4 Section 39.4 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) AID FOR THE ESTABLISHMENT, EXPANSION, AND IMPROVEMENT, OR...

  19. 38 CFR 39.4 - Decision makers, notifications, and additional information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Decision makers, notifications, and additional information. 39.4 Section 39.4 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) AID FOR THE ESTABLISHMENT, EXPANSION, AND IMPROVEMENT, OR...

  20. 38 CFR 39.4 - Decision makers, notifications, and additional information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Decision makers, notifications, and additional information. 39.4 Section 39.4 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) AID FOR THE ESTABLISHMENT, EXPANSION, AND IMPROVEMENT, OR...

  1. 26 CFR 1.852-7 - Additional information required in returns of shareholders.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... shareholders. 1.852-7 Section 1.852-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY... Trusts § 1.852-7 Additional information required in returns of shareholders. Any person who fails or....852-6 requires the company to demand from its shareholders shall submit as a part of his income...

  2. Review of the Registration in the Clinical Research Information Service

    PubMed Central

    2016-01-01

    Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement. PMID:26770030

  3. Technological Feasibility of a Nursing Clinical Information System

    PubMed Central

    Jeddi, Fatemeh Rangraz; Hajbaghery, Mohsen Adib; Akbari, Hossein; Esmaili, Soheila

    2016-01-01

    Introduction A successful implementation of an information system is impossible without sufficient knowledge of available technical resources of an institute. The aim of this study was to determine technical feasibility of a nursing clinical information system (NCIS) in Mazandaran province, Iran, 2015. Methods This cross-sectional study was conducted in three steps. In the first step, a data gathering tool was developed through an unsystematic literature review. In the second step, a questionnaire was developed and validity of the tool was confirmed by receiving opinions of faculty members and calculating indices of Content Validity Index (CVI) and Content Validity Ratio (CVR). The questionnaire reliability was confirmed by calculating Cronbach’s alpha coefficient (α= 0.72). In the third step, the feasibility of implementation of NCIS was evaluated by forming a panel of IT experts (n= 30), and through a questionnaire. Data were collected by 5-point Likert scale, very low to very high (scoring 1–5). Scores of each item were calculated and score percentage was determined. Chi-square and Fisher Exact tests were used. Results Maximum possibility of implementing NCIS were in the hardware area, additional equipment (92.6%), in the area of software, financial software (99.4%), in the area of network equipment, the possibility of integration with other internal systems, (92.6%) and in the area of network security, the possibility of backup version for security purposes (97.4%). Type of employment was statistically significant according to IT experts’ opinions (p= 0.014) Conclusion Hardware and software infrastructures for implementation of NCIS were desirable. The provision of more portable computers, advanced equipment such as barcode scanner, Radio-frequency identification (RFID), some approaches for increase accessibility of the system and essential databases from other resources and also increase of network lines’ speed are necessary. PMID:27790348

  4. Defining, monitoring and combining safety information in clinical trials.

    PubMed

    Enas, G G; Goldstein, D J

    Assessment of clinical trial safety data for industry, regulatory agencies, medical practitioners and patients requires definition and measurement, monitoring, and overall analysis. Prospective 'safety' definitions and reliable measurement tools reduce inefficient data collection and improve the validity of resulting analyses. Statistical tools can help investigators monitor safety data from controlled clinical trials and help improve post-marketing surveillance. Also, when evaluating overall safety, one needs to assess all available information by combining information from many trials and other sources. Planning for this combined assessment, incorporating flexibility to assess unanticipated yet important nuances in individual trials, may be more important than the actual statistical analysis method used. A keen awareness of the future needs of consumers of this information is quite important. Some current proposals to combine safety information will be discussed.

  5. Development of a clinical data warehouse from an intensive care clinical information system.

    PubMed

    de Mul, Marleen; Alons, Peter; van der Velde, Peter; Konings, Ilse; Bakker, Jan; Hazelzet, Jan

    2012-01-01

    There are relatively few institutions that have developed clinical data warehouses, containing patient data from the point of care. Because of the various care practices, data types and definitions, and the perceived incompleteness of clinical information systems, the development of a clinical data warehouse is a challenge. In order to deal with managerial and clinical information needs, as well as educational and research aims that are important in the setting of a university hospital, Erasmus Medical Center Rotterdam, The Netherlands, developed a data warehouse incrementally. In this paper we report on the in-house development of an integral part of the data warehouse specifically for the intensive care units (ICU-DWH). It was modeled using Atos Origin Metadata Frame method. The paper describes the methodology, the development process and the content of the ICU-DWH, and discusses the need for (clinical) data warehouses in intensive care.

  6. Clinical utility of an electronic poisons information and clinical decision support tool.

    PubMed

    Watts, Martin; Fountain, John; Reith, David M; Herbison, Peter

    2003-08-01

    The objective of the study was to assess the use of a computer toxicology database/clinical decision aid by clinical practitioners. The study investigated the sources that Emergency Department (ED) personnel use to obtain toxicology information and performed a quality audit of the current database. A questionnaire survey of ED staff was used in departments with access to the New Zealand Poisons Centre Substance Database (NZSD), a toxicology CD ROM computer database. Outcome measures were reported use of alternative data sources when managing clinical toxicology presentations and the qualities of the NZSD. Computer databases are commonly used for the management of clinical toxicology cases and the toxicology computer database/clinical decision aid studied is well accepted and used in Emergency Medicine practice. The users of the NZSD assessed the usability and quality of the information of the database. PMID:12909152

  7. The wired physician: current clinical information on the Internet.

    PubMed

    Gallagher, K; McFarland, M A

    1996-07-01

    The Internet and associated World Wide Web are electronic technologies that can help physicians identify needed clinical information quickly and can put physicians in ready contact with other specialists for communication and consultation. This article outlines the kinds of resources available on the Internet and methods for connecting your personal computer to the "information superhighway." Selected Internet sites and a short bibliography of books and articles relating to the Internet are included. PMID:8772319

  8. Radiologist's clinical information review workstation interfaced with digital dictation system.

    PubMed

    McEnery, K W; Suitor, C T; Hildebrand, S; Downs, R L

    2000-05-01

    Efficient access to information systems integrated into the radiologist's interpretation workflow will result in a more informed radiologist, with an enhanced capability to render an accurate interpretation. We describe our implementation of radStation, a radiologist's clinical information review workstation that combines a digital dictation station with a clinical information display. radStation uses client software distributed to the radiologist's workstation and central server software, both running Windows NT (Microsoft, Redmond, WA). The client system has integrated digital dictation software. The bar-code microphone (Boomerang, Dictaphone Corp, Stratford, CT) also serves as a computer input device forwarding the procedure's accession number to the server software. This initiates multiple queries to available legacy databases, including the radiology information system (RIS), laboratory information system, clinic notes, hospital discharge, and operative report system. The three-tier architecture then returns the clinical results to the radStation client for display. At the conclusion of the dictation, the digital voice file is transferred to the dictation server and the client notifies the RIS to update the examination status. The system is efficient in its information retrieval, with queries displayed in about 1 second. The radStation client requires less than 5 minutes of radiologist training in its operation, given that its control interface integrates with the well-learned dictation process. The telephone-based dictation system, which this new system replaced, remains available as a back-up system in the event of an unexpected digital dictation system failure. This system is well accepted and valued by the radiologists. The system interface is quickly mastered. The system does not interrupt dictation workflow with the display of all information initiated with examination bar-coding. This system's features could become an accepted model as a standard tool

  9. CMR Quantification of Myocardial Scar Provides Additive Prognostic Information in Nonischemic Cardiomyopathy

    PubMed Central

    Neilan, Tomas G.; Coelho-Filho, Otavio R.; Danik, Stephan B.; Shah, Ravi V.; Dodson, John A.; Verdini, Daniel J.; Tokuda, Michifumi; Daly, Caroline A.; Tedrow, Usha B.; Stevenson, William G.; Jerosch-Herold, Michael; Ghoshhajra, Brian B.; Kwong, Raymond Y.

    2014-01-01

    OBJECTIVES This study sought to determine whether the extent of late gadolinium enhancement (LGE) can provide additive prognostic information in patients with a nonischemic dilated cardiomyopathy (NIDC) with an indication for implantable cardioverter-defibrillator (ICD) therapy for the primary prevention of sudden cardiac death (SCD). BACKGROUND Data suggest that the presence of LGE is a strong discriminator of events in patients with NIDC. Limited data exist on the role of LGE quantification. METHODS The extent of LGE and clinical follow-up were assessed in 162 patients with NIDC prior to ICD insertion for primary prevention of SCD. LGE extent was quantified using both the standard deviation–based (2-SD) method and the full-width half-maximum (FWHM) method. RESULTS We studied 162 patients with NIDC (65% male; mean age: 55 years; left ventricular ejection fraction [LVEF]: 26 ± 8%) and followed up for major adverse cardiac events (MACE), including cardiovascular death and appropriate ICD therapy, for a mean of 29 ± 18 months. Annual MACE rates were substantially higher in patients with LGE (24%) than in those without LGE (2%). By univariate association, the presence and the extent of LGE demonstrated the strongest associations with MACE (LGE presence, hazard ratio [HR]: 14.5 [95% confidence interval (CI): 6.1 to 32.6; p < 0.001]; LGE extent, HR: 1.15 per 1% increase in volume of LGE [95% CI: 1.12 to 1.18; p < 0.0001]). Multivariate analyses showed that LGE extent was the strongest predictor in the best overall model for MACE, and a 7-fold hazard was observed per 10% LGE extent after adjustments for patient age, sex, and LVEF (adjusted HR: 7.61; p < 0.0001). LGE quantitation by 2-SD and FWHM both demonstrated robust prognostic association, with the highest MACE rate observed in patients with LGE involving >6.1% of LV myocardium. CONCLUSIONS LGE extent may provide further risk stratification in patients with NIDC with a current indication for ICD implantation for

  10. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  11. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  12. Discussions of Cancer Clinical Trials with the National Cancer Institute’s Cancer Information Service

    PubMed Central

    BYRNE, MARGARET M.; KORNFELD, JULIE; VANDERPOOL, ROBIN; BELANGER, MARC

    2016-01-01

    Clinical trials are essential for the development of new and effective treatments for cancer; however, participation rates are low. One reason for this is lack of knowledge about clinical trials. This study assessed how often clinical trials are discussed on calls to National Cancer Institute’s Cancer Information Service (CIS). The authors quantitatively analyzed 283,094 calls to the CIS (1-800-4-CANCER) over 3 years (2006–2008). They calculated descriptive statistics and multivariate regressions to determine whether specific caller characteristics are associated with the presence of a clinical trials discussion. In addition, 2 focus groups were conducted with CIS information specialists (n = 12) to provide insight into the findings. The authors found that approximately 9.3% of CIS calls discussed clinical trials, with higher percentages for patients (12.5%) and family members (15.4%). Calls with Hispanics, Blacks, and Spanish speakers were less likely to include a conversation. For all cancers, patients who are in treatment or experiencing a recurrence were statistically significantly more likely to discuss clinical trials. CIS information specialists reported callers’ limited knowledge of clinical trials. The CIS has the unique ability to make a substantial effect in educating patients about clinical trials as an option in cancer treatment and care. PMID:22150169

  13. 75 FR 35119 - 60-Day Notice of Proposed Information Collection: Form DS-4085 Application for Additional Visa...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-21

    ... Notice of Proposed Information Collection: Form DS-4085 Application for Additional Visa Pages or... the Paperwork Reduction Act of 1995. Title of Information Collection: Application for Additional Visa... collection: The information collected on the DS-4085 is used to facilitate the issuance of additional...

  14. 26 CFR 301.6223(c)-1 - Additional information regarding partners furnished to the Internal Revenue Service.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... shown on the partnership return, the Internal Revenue Service will use additional information as... additional information at any time by filing a written statement with the Internal Revenue Service. However...) of this section. (f) Internal Revenue Service may use other information. In addition to...

  15. Legal briefing: informed consent in the clinical context.

    PubMed

    Pope, Thaddeus Mason; Hexum, Melinda

    2014-01-01

    This issue's "Legal Briefing" column covers recent legal developments involving informed consent.1 We covered this topic in previous articles in The Journal of Clinical Ethics.2 But an updated discussion is warranted. First, informed consent remains a central and critically important issue in clinical ethics. Second, there have been numerous significant legal changes over the past year. We categorize recent legal developments into the following 13 categories: (1) Medical Malpractice Liability, (2) Medical Malpractice Liability in Wisconsin, (3) Medical Malpractice Liability in Novel Situations, (4) Enforcement by Criminal Prosecutors, (5) Enforcement by State Medical Boards, (6) Enforcement through Anti-Discrimination Laws, (7) Statutorily Mandated Disclosures Related to End-of-Life Counseling, (8) Statutorily Mandated Disclosures Related to Aid in Dying, (9) Statutorily Mandated Disclosures Related to Abortion, (10) Statutorily Mandated Disclosures Related to Telemedicine, (11) Statutorily Mandated Disclosures Related to Other Interventions, (12) Statutorily Mandated Gag and Censorship Laws, (13) Informed Consent in the Research Context. PMID:24972066

  16. [Informed consent in clinical practice and medical research].

    PubMed

    Santillan-Doherty, Patricio; Cabral-Castañeda, Antonio; Soto-Ramírez, Luis

    2003-01-01

    The present paper deals with the basic aspects, influences and elements that constitute Informed Consent seeing it as a process and not only as an administrative format. Both the patient-physician relationship, as well as the research subject-investigator relationship, should be seen in the same manner, in spite of recognizing specific objectives for each one. For this reason, Informed Consent should not be different regarding both clinical as well as research activities. The patient-physician relationship presents a disbalance of power within the relationship in favor of the physician; this adds to the moral considerations that take place within both participants. Informed Consent should be defined in a broad sense as all those actions that promote a process of communication and dialogue which facilitates a person in order to make decisions with respect of an action, practice or product that have an impact on his/her body, intimacy or other vital spaces. Informed Consent has influences that originate in basic bioethical principles (autonomy, beneficience, non-maleficence, justice), professional and international declarations (Hippocratic Oath, Declaration of Helsinki), as well as legal considerations pertinent to each country. In our country legality emmanates from the General Health Law which, unfortunately, only contemplates Informed Consent as part of the relation established in clinical research. However, the Official Medican Norm on the Clinical Record establishes the conditions where Informed Consent must be obtained during clinical as well as research activities. Primary components of Informed Consent (revelation, capacity to understand and voluntariness), can be better understood when divided into several elements: information, voluntariness, risks and benefits, confidentiality, return of information, utility of the process and management of fragility. Informed Consent should be legally instrumented in an explicit written manner (administrative formats

  17. Managing medical images and clinical information: InCor's experience.

    PubMed

    Furuie, Sergio S; Rebelo, Marina S; Moreno, Ramon A; Santos, Marcelo; Bertozzo, Nivaldo; Motta, Gustavo H M B; Pires, Fabio A; Gutierrez, Marco A

    2007-01-01

    Patients usually get medical assistance in several clinics and hospitals during their lifetime, archiving vital information in a dispersed way. Clearly, a proper patient care should take into account that information in order to check for incompatibilities, avoid unnecessary exams, and get relevant clinical history. The Heart Institute (InCor) of São Paulo, Brazil, has been committed to the goal of integrating all exams and clinical information within the institution and other hospitals. Since InCor is one of the six institutes of the University of São Paulo Medical School and each institute has its own information system, exchanging information among the institutes is also a very important aspect that has been considered. In the last few years, a system for transmission, archiving, retrieval, processing, and visualization of medical images integrated with a hospital information system has been successfully created and constitutes the InCor's electronic patient record (EPR). This work describes the experience in the effort to develop a functional and comprehensive EPR, which includes laboratory exams, images (static, dynamic, and three dimensional), clinical reports, documents, and even real-time vital signals. A security policy based on a contextual role-based access control model was implemented to regulate user's access to EPR. Currently, more than 10 TB of digital imaging and communications in medicine (DICOM) images have been stored using the proposed architecture and the EPR stores daily more than 11 GB of integrated data. The proposed storage subsystem allows 6 months of visibility for rapid retrieval and more than two years for automatic retrieval using a jukebox. This paper addresses also a prototype for the integration of distributed and heterogeneous EPR.

  18. How can sharing clinical information be made to work?

    PubMed

    Neame, R; Olson, M

    1998-01-01

    There is a recognised need to share clinical information in order to improve integrity, continuity, safety and speed of delivering patient care. This remains a serious weakness in the conceptualisation of existing health information management systems. The evolution of structured (e.g., HL7) messaging standards has been driven largely from an administrative information viewpoint, as have many of the initiatives driving the development of electronic patient record (EPR) systems. Neither appears to address crucial needs for clinical data exchanges often across wide areas to meet the needs of best quality, cost-effective and low risk patient care delivery. The present reality is that clinical messaging is complex, rigid and ineffective, and the business case for its users is not compelling. Administrative and financial arrangements need to be developed which support the more widespread use of clinical data exchanges. This paper underlines the importance of web technology as a key element in the communications strategy and as an adjunct (or alternative) to more structured messaging environments. It also raises some of the fundamental structural problems, which impact the use of messaging in healthcare, and puts forward proposals as to how these may best be addressed and resolved.

  19. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  20. Addition of meloxicam to the treatment of clinical mastitis improves subsequent reproductive performance.

    PubMed

    McDougall, S; Abbeloos, E; Piepers, S; Rao, A S; Astiz, S; van Werven, T; Statham, J; Pérez-Villalobos, N

    2016-03-01

    A blinded, negative controlled, randomized intervention study was undertaken to test the hypothesis that addition of meloxicam, a nonsteroidal anti-inflammatory drug, to antimicrobial treatment of mild to moderate clinical mastitis would improve fertility and reduce the risk of removal from the herd. Cows (n=509) from 61 herds in 8 regions (sites) in 6 European countries were enrolled. Following herd-owner diagnosis of mild to moderate clinical mastitis within the first 120 d of lactation in a single gland, the rectal temperature, milk appearance, and California Mastitis Test score were assessed. Cows were randomly assigned within each site to be treated either with meloxicam or a placebo (control). All cows were additionally treated with 1 to 4 intramammary infusions of cephalexin and kanamycin at 24-h intervals. Prior to treatment and at 14 and 21 d posttreatment, milk samples were collected for bacteriology and somatic cell count. Cows were bred by artificial insemination and pregnancy status was subsequently defined. General estimating equations were used to determine the effect of treatment (meloxicam versus control) on bacteriological cure, somatic cell count, the probability of being inseminated by 21 d after the voluntary waiting period, the probability of conception to first artificial insemination, the number of artificial insemination/conception, the probability of pregnancy by 120 or 200 d postcalving, and the risk of removal by 300 d after treatment. Cox's proportional hazards models were used to test the effect of treatment on the calving to first insemination and calving to conception intervals. Groups did not differ in terms of age, clot score, California Mastitis Test score, rectal temperature, number of antimicrobial treatments given or bacteria present at the time of enrollment, but cows treated with meloxicam had greater days in milk at enrollment. Cows treated with meloxicam had a higher bacteriological cure proportion than those treated with

  1. Influence of an alloy addition on the physical and clinical behaviour of glass ionomer cement

    NASA Astrophysics Data System (ADS)

    Abour, Mohamed Abour Bashir

    These in vitro studies compared the various properties of an experimental high powder liquid content glass ionomer cement (EXPT) with those of a metal addition GIC (Hi-Dense) and disperse phase amalgam (Dispersalloy). Bi-axial, four point flexural and compressive tests were used to evaluate strength. Six groups of ten specimens were constructed for each test for each material and allowed to set in an oven at 37°C for 60 minutes. Specimens were stored in distilled water at 37°C until testing at one day, one week, one, three, six months and year. It was found that the strength of Hi-Dense increased and then maintained over extended time, whereas the strength of EXPT showed a declined at 3 months. The bond strengths of the materials to both enamel and dentine were also evaluated. Ten groups of ten teeth, five for each surface for each glass ionomer materials, were prepared. Teeth were aligned leaving the enamel and dentine surfaces exposed. The mixed material was condensed into a cylinder placed on the appropriate surface. These specimens were also stored in distilled water at 37°C. It was found that Hi-Dense had a higher bond strength to enamel that increased with time. The bond strength to dentine was maintained over the test period. The erosion rate of the materials was evaluated using the lactic acid erosion test. Three groups of six specimens for each material were constructed and tested after one hour, one day and at six months. Each specimen was subjected to an impinging jet of lactic acid solution. The erosion rate was determined by weight loss and dimensional change. It was found that Hi-Dense had a high erosion resistance which was slightly better than the experimental material. The microleakage, around restorations prepared, using the glass ionomer materials, was evaluated after cyclical loading the restoration-tooth complex. It was found that there was less leakage around Hi-Dense than EXPT at both the cervical and occlusal margins. In a clinical

  2. Clinical writing about clients: is informed consent sufficient?

    PubMed

    Barnett, Jeffrey E

    2012-03-01

    The use of client information in clinical writings or presentations may be very helpful in advancing the knowledge base of the profession. Yet, the very act of asking a client for permission to use their treatment information in this way may be detrimental to the therapeutic alliance and treatment process. As such, great care must be taken in how such issues are considered and acted upon. Sieck's article (2011, Obtaining clinical writing informed consent versus using client disguise and recommendations for practice. Psychotherapy, 49, pp. 3-11.) on the use of informed consent for obtaining permission to use a client's treatment information for professional writing and presentations is examined and discussed. The nature and role of the informed consent process is accentuated; psychotherapist needs and goals and client vulnerabilities are each addressed in the context of the relevant sections of the APA Ethics Code and each psychotherapist's obligation to act only in ways consistent with each client's best interests. Recommendations for a thoughtful consideration of these issues are presented, consistent with Sieck's proposed decision-making process for use in these situations.

  3. Clinical information systems: cornerstone for an efficient hospital management.

    PubMed

    Lovis, Christian

    2011-01-01

    The university hospitals of Geneva are the largest consortium of public hospitals in Switzerland. This organization is born in 1995, after a political decision to merge the seven public and teaching hospitals of the Canton of Geneva. From an information technologies perspective, it took several years to reach a true unified vision of the complete organization. The clinical information system is deployed in all sites covering in- and outpatient cares. It is seen as the cornerstone of information management and flow in the organization, for direct patient care and decision support, but also for the management to drive, improve and leverage the activities, for better efficiency, quality and safety of care, but also to drive processes. As the system has become more important for the organization, it has required progressive changes in its governance. The high importance of interoperability and use of formal representation has become a major challenge in order to be able to reuse clinical information for real-time care and management activities, and for secondary usage such as billing, resource management, strategic planning and clinical research. This paper proposes a short overview of the tools allowing to leverage the management for physicians, nurses, human resources and hospital governance.

  4. Ontology patterns-based transformation of clinical information.

    PubMed

    Legaz-García, María del Carmen; Martínez-Costa, Catalina; Miñarro-Giménez, José Antonio; Fernández-Breis, Jesualdo Tomás; Schulz, Stefan; Menárguez-Tortosa, Marcos

    2014-01-01

    The semantic interoperability of clinical information requires methods able to transform heterogeneous data sources from both technological and structural perspectives, into representations that facilitate the sharing of meaning. The SemanticHealthNet (SHN) project proposes using semantic content patterns for representing clinical information based on a model of meaning, preventing users from a deep knowledge on ontology and description logics formalism. In this work we propose a flexible transformation method that uses semantic content patterns to guide the mapping between the source data and a target domain ontology. As use case we show how one of the semantic content patterns proposed in SHN can be used to transform heterogeneous data about medication administration.

  5. Clinical effect of additional electroacupuncture on thoracolumbar intervertebral disc herniation in 80 paraplegic dogs.

    PubMed

    Han, Hyun-Jung; Yoon, Hun-Young; Kim, Joon-Young; Jang, Ha-Young; Lee, Bora; Choi, Seok Hwa; Jeong, Soon-Wuk

    2010-01-01

    The clinical efficacy of electroacupuncture and acupuncture in combination with medication for the treatment of thoracolumbar intervertebral disc herniation was investigated in paraplegic dogs with intact deep pain perception. To evaluate the additional effect of electroacupuncture, dogs treated with conventional medicines alone were compared to dogs treated with electroacupuncture and acupuncture and conventional medicine. Medical records of 80 dogs were reviewed for this investigation and classified into two groups undergoing different treatment methods: (1) treatment with conventional medicine alone (Group C, n = 37) and (2) treatment with conventional medicine combined with electroacupuncture and acupuncture (Group CE, n = 43). Prednisone was the conventional medicine and electroacupuncture was applied at GV07 and GV02-1 at 0.5-2.5 mV, mixed Hz of 2 and 15 Hz for 25-30 min. Acupuncture was performed locally at urinary bladder meridian points near the lesion, and bilaterally distantly at GB30, GB34, and ST36. Treatment efficacy was evaluated by post-operative neurologic function, ambulation, relapse, complication, and urinary function. Ambulation recovery was more prevalent in Group CE than Group C (p = 0.01) and recovery of ambulation and back pain relief time was shorter in Group CE compared to Group C (p = 0.011 and 0.001, respectively). Relapse rate was significantly lower in Group CE (p = 0.031). The results suggest that a combination of electroacupuncture and acupuncture with conventional medicine is more effective than conventional medicine alone in recovering ambulation, relieving back pain, and decreasing relapse. Electroacupuncture and acupuncture is thus a reasonable option for the treatment of intervertebral disc herniation in paraplegic dogs with intact deep pain perception. PMID:21061457

  6. ADDITIONAL DEMOGRAPHIC AND CLINICAL EVIDENCES ON THE RELEVANCE OF THE SYSTEMIC THERAPY IN ALCOHOL DEPENDENCE.

    PubMed

    Alexinschi, Ovidiu; Chirita, Roxana; Manuela, Padurariu; Ciobica, Alin; Dobrin, Romeo; Petrariu, F D; Timofte, Daniel; Chirita, Vasile

    2015-01-01

    The modern treatment for alcohol dependence is still problematic, in many cases with the costs exceeding benefits. In these conditions a new management approach was developed lately, known as the systemic therapy. In this way, the crystallization and practical transposition of this new treatment approach is represented by the Clubs of Alcoholics in Treatment. These clubs are in fact a form of psycho-social intervention consisting of multi-family communities in order to maintain long-term abstinence from alcohol and to change their lifestyle and behavior. Thus, in the present paper we were interested in understanding the demographics of this systemic theory and how these aspects are influencing the final results of the therapy, as well as studying/confirming how relevant is this systemic approach on the management of alcohol dependence. Our results presented in this report bring additional evidences for the superiority of the systemic, multi-family approach of alcohol-related problems, as complemented to the standard medicinal therapy. Moreover, the data collected from patients in this study might suggest that patients with a higher educational level and therefore better capacity of understanding the information, with family support, and also with a better occupational insertion, have accepted to follow The Clubs of Alcoholics in Treatment program, with a subsequently better evolution. PMID:26793858

  7. [Study on Information Extraction of Clinic Expert Information from Hospital Portals].

    PubMed

    Zhang, Yuanpeng; Dong, Jiancheng; Qian, Danmin; Geng, Xingyun; Wu, Huiqun; Wang, Li

    2015-12-01

    Clinic expert information provides important references for residents in need of hospital care. Usually, such information is hidden in the deep web and cannot be directly indexed by search engines. To extract clinic expert information from the deep web, the first challenge is to make a judgment on forms. This paper proposes a novel method based on a domain model, which is a tree structure constructed by the attributes of search interfaces. With this model, search interfaces can be classified to a domain and filled in with domain keywords. Another challenge is to extract information from the returned web pages indexed by search interfaces. To filter the noise information on a web page, a block importance model is proposed. The experiment results indicated that the domain model yielded a precision 10.83% higher than that of the rule-based method, whereas the block importance model yielded an F₁ measure 10.5% higher than that of the XPath method.

  8. [Study on Information Extraction of Clinic Expert Information from Hospital Portals].

    PubMed

    Zhang, Yuanpeng; Dong, Jiancheng; Qian, Danmin; Geng, Xingyun; Wu, Huiqun; Wang, Li

    2015-12-01

    Clinic expert information provides important references for residents in need of hospital care. Usually, such information is hidden in the deep web and cannot be directly indexed by search engines. To extract clinic expert information from the deep web, the first challenge is to make a judgment on forms. This paper proposes a novel method based on a domain model, which is a tree structure constructed by the attributes of search interfaces. With this model, search interfaces can be classified to a domain and filled in with domain keywords. Another challenge is to extract information from the returned web pages indexed by search interfaces. To filter the noise information on a web page, a block importance model is proposed. The experiment results indicated that the domain model yielded a precision 10.83% higher than that of the rule-based method, whereas the block importance model yielded an F₁ measure 10.5% higher than that of the XPath method. PMID:27079096

  9. Understanding information synthesis in oral surgery for the design of systems for clinical information technology.

    PubMed

    Suebnukarn, Siriwan; Chanakarn, Piyawadee; Phisutphatthana, Sirada; Pongpatarat, Kanchala; Wongwaithongdee, Udom; Oupadissakoon, Chanekrid

    2015-12-01

    An understanding of the processes of clinical decision-making is essential for the development of health information technology. In this study we have analysed the acquisition of information during decision-making in oral surgery, and analysed cognitive tasks using a "think-aloud" protocol. We studied the techniques of processing information that were used by novices and experts as they completed 4 oral surgical cases modelled from data obtained from electronic hospital records. We studied 2 phases of an oral surgeon's preoperative practice including the "diagnosis and planning of treatment" and "preparing for a procedure". A framework analysis approach was used to analyse the qualitative data, and a descriptive statistical analysis was made of the quantitative data. The results showed that novice surgeons used hypotheticodeductive reasoning, whereas experts recognised patterns to diagnose and manage patients. Novices provided less detail when they prepared for a procedure. Concepts regarding "signs", "importance", "decisions", and "process" occurred most often during acquisition of information by both novices and experts. Based on these results, we formulated recommendations for the design of clinical information technology that would help to improve the acquisition of clinical information required by oral surgeons at all levels of expertise in their clinical decision-making.

  10. PAT-1 safety analysis report addendum author responses to request for additional information.

    SciTech Connect

    Weiner, Ruth F.; Schmale, David T.; Kalan, Robert J.; Akin, Lili A.; Miller, David Russell; Knorovsky, Gerald Albert; Yoshimura, Richard Hiroyuki; Lopez, Carlos; Harding, David Cameron; Jones, Perry L.; Morrow, Charles W.

    2010-09-01

    The Plutonium Air Transportable Package, Model PAT-1, is certified under Title 10, Code of Federal Regulations Part 71 by the U.S. Nuclear Regulatory Commission (NRC) per Certificate of Compliance (CoC) USA/0361B(U)F-96 (currently Revision 9). The National Nuclear Security Administration (NNSA) submitted SAND Report SAND2009-5822 to NRC that documented the incorporation of plutonium (Pu) metal as a new payload for the PAT-1 package. NRC responded with a Request for Additional Information (RAI), identifying information needed in connection with its review of the application. The purpose of this SAND report is to provide the authors responses to each RAI. SAND Report SAND2010-6106 containing the proposed changes to the Addendum is provided separately.

  11. 20 CFR 30.518 - Can OWCP require the recipient of the overpayment to submit additional financial information?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... overpayment to submit additional financial information? 30.518 Section 30.518 Employees' Benefits OFFICE OF... OWCP require the recipient of the overpayment to submit additional financial information? (a) The recipient of the overpayment is responsible for providing information about income, expenses and assets...

  12. Perspectives on clinical informatics: integrating large-scale clinical, genomic, and health information for clinical care.

    PubMed

    Choi, In Young; Kim, Tae-Min; Kim, Myung Shin; Mun, Seong K; Chung, Yeun-Jun

    2013-12-01

    The advances in electronic medical records (EMRs) and bioinformatics (BI) represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO) aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population.

  13. Perspectives on Clinical Informatics: Integrating Large-Scale Clinical, Genomic, and Health Information for Clinical Care

    PubMed Central

    Choi, In Young; Kim, Tae-Min; Kim, Myung Shin; Mun, Seong K.

    2013-01-01

    The advances in electronic medical records (EMRs) and bioinformatics (BI) represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO) aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population. PMID:24465229

  14. Clinical genomics information management software linking cancer genome sequence and clinical decisions.

    PubMed

    Watt, Stuart; Jiao, Wei; Brown, Andrew M K; Petrocelli, Teresa; Tran, Ben; Zhang, Tong; McPherson, John D; Kamel-Reid, Suzanne; Bedard, Philippe L; Onetto, Nicole; Hudson, Thomas J; Dancey, Janet; Siu, Lillian L; Stein, Lincoln; Ferretti, Vincent

    2013-09-01

    Using sequencing information to guide clinical decision-making requires coordination of a diverse set of people and activities. In clinical genomics, the process typically includes sample acquisition, template preparation, genome data generation, analysis to identify and confirm variant alleles, interpretation of clinical significance, and reporting to clinicians. We describe a software application developed within a clinical genomics study, to support this entire process. The software application tracks patients, samples, genomic results, decisions and reports across the cohort, monitors progress and sends reminders, and works alongside an electronic data capture system for the trial's clinical and genomic data. It incorporates systems to read, store, analyze and consolidate sequencing results from multiple technologies, and provides a curated knowledge base of tumor mutation frequency (from the COSMIC database) annotated with clinical significance and drug sensitivity to generate reports for clinicians. By supporting the entire process, the application provides deep support for clinical decision making, enabling the generation of relevant guidance in reports for verification by an expert panel prior to forwarding to the treating physician.

  15. Mapping query terms to data and schema using content based similarity search in clinical information systems.

    PubMed

    Safari, Leila; Patrick, Jon D

    2013-01-01

    This paper reports on the issues in mapping the terms of a query to the field names of the schema of an Entity Relationship (ER) model or to the data part of the Entity Attribute Value (EAV) model using similarity based Top-K algorithm in clinical information system together with an extension of EAV mapping for medication names. In addition, the details of the mapping algorithm and the required pre-processing including NLP (Natural Language Processing) tasks to prepare resources for mapping are explained. The experimental results on an example clinical information system demonstrate more than 84 per cent of accuracy in mapping. The results will be integrated into our proposed Clinical Data Analytics Language (CliniDAL) to automate mapping process in CliniDAL.

  16. Emerging Technologies in the Built Environment: Geographic Information Science (GIS), 3D Printing, and Additive Manufacturing

    SciTech Connect

    New, Joshua Ryan

    2014-01-01

    Abstract 1: Geographic information systems emerged as a computer application in the late 1960s, led in part by projects at ORNL. The concept of a GIS has shifted through time in response to new applications and new technologies, and is now part of a much larger world of geospatial technology. This presentation discusses the relationship of GIS and estimating hourly and seasonal energy consumption profiles in the building sector at spatial scales down to the individual parcel. The method combines annual building energy simulations for city-specific prototypical buildings and commonly available geospatial data in a GIS framework. Abstract 2: This presentation focuses on 3D printing technologies and how they have rapidly evolved over the past couple of years. At a basic level, 3D printing produces physical models quickly and easily from 3D CAD, BIM (Building Information Models), and other digital data. Many AEC firms have adopted 3D printing as part of commercial building design development and project delivery. This presentation includes an overview of 3D printing, discusses its current use in building design, and talks about its future in relation to the HVAC industry. Abstract 3: This presentation discusses additive manufacturing and how it is revolutionizing the design of commercial and residential facilities. Additive manufacturing utilizes a broad range of direct manufacturing technologies, including electron beam melting, ultrasonic, extrusion, and laser metal deposition for rapid prototyping. While there is some overlap with the 3D printing talk, this presentation focuses on the materials aspect of additive manufacturing and also some of the more advanced technologies involved with rapid prototyping. These technologies include design of carbon fiber composites, lightweight metals processing, transient field processing, and more.

  17. Proteomics and Ovarian Cancer: Integrating Proteomics Information Into Clinical Care

    PubMed Central

    Hays, John L.; Kim, Geoffrey; Giuroiu, Iulia; Kohn, Elise C.

    2010-01-01

    The power of proteomics allows unparalleled opportunity to query the molecular mechanisms of a malignant cell and the tumor microenvironment in patients with ovarian cancer and other solid tumors. This information has given us insight into the perturbations of signaling pathways within tumor cells and has aided the discovery of new drug targets for the tumor and possible prognostic indicators of outcome and disease response to therapy. Proteomics analysis of serum and ascites has also given us sources with which to discover possible early markers for the presence of new disease and for the progression of established cancer throughout the course of treatment. Unfortunately, this wealth of information has yielded little to date in changing the clinical care of these patients from a diagnostic, prognostic, or treatment perspective. The rational examination and translation of proteomics data in the context of past clinical trials and the design of future clinical trials must occur before we can march forward into the future of personalized medicine. PMID:20561909

  18. Clinical decision support for perioperative information management systems.

    PubMed

    Wanderer, Jonathan P; Ehrenfeld, Jesse M

    2013-12-01

    Clinical decision support (CDS) systems are being used to optimize the increasingly complex care that our health care system delivers. These systems have become increasingly important in the delivery of perioperative care for patients undergoing cardiac, thoracic, and vascular procedures. The adoption of perioperative information management systems (PIMS) has allowed these technologies to enter the operating room and support the clinical work flow of anesthesiologists and operational processes. Constructing effective CDS systems necessitates an understanding of operative work flow and technical considerations as well as achieving integration with existing information systems. In this review, we describe published examples of CDS for PIMS, including support for cardiopulmonary bypass separation physiological alarms, β-blocker guideline adherence, enhanced revenue capture for arterial line placement, and detection of hemodynamic monitoring gaps. Although these and other areas are amenable to CDS systems, the challenges of latency and data reliability represent fundamental limitations on the potential application of these tools to specific types of clinical issues. Ultimately, we expect that CDS will remain an important tool in our efforts to optimize the quality of care delivered.

  19. Use of altered informed consent in pragmatic clinical research

    PubMed Central

    McKinney, Ross E.; Beskow, Laura M.; Ford, Daniel E.; Lantos, John D.; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J.; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-01-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to IRBs as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients’ rights and interests. PMID:26374677

  20. The effects of practice on speed of information processing using the Adjusting-Paced Serial Addition Test (Adjusting-PSAT) and the Computerized Tests of Information Processing (CTIP).

    PubMed

    Baird, B J; Tombaugh, Thomas N; Francis, M

    2007-01-01

    Three experiments were conducted to determine the effects of practice on the Adjusting-Paced Serial Addition Task (Adjusting-PSAT) (Tombaugh, 1999) and the Computerized Tests of Information Processing (CTIP) (Tombaugh & Rees, 2000). The Adjusting-PSAT is a computerized modification of the Paced Auditory Serial Addition Test (PASAT) (Gronwall, 1977) that makes the interval between digits contingent on the correctness of the response. This titration procedure permits a threshold value to be derived that represents the shortest presentation interval in which a person can process the digits to produce the correct sum. The CTIP consists of three reaction time tests that are progressively more difficult. Results showed that robust practice effects occurred with the Adjusting-PSAT, with the greatest increase in performance occurring on the first retest trial. Practice effects were equally prominent regardless of whether the first retest trial occurred 20A min, 1 week, or 3 months after the first administration. These gains were maintained for periods up to 6 months and were independent of modality of presentation (visual or auditory) and type of number list (easy or hard). In contrast to the findings with the Adjusting-PSAT, only minimal practice effects were observed with the CTIP. The major clinical implication of the study is that the high reliability coefficients for the CTIP, the lack of anxiety associated with its administration, and its insensitivity to variables such as numerical and verbal ability make the CTIP ideally suited for the serial evaluation of cognitive status. These characteristics also make the CTIP a viable alternative to the Adjusting-PSAT or PASAT for measuring speed of information processing. If the Adjusting-PSAT is administered repeatedly in clinical evaluations, a "dual baseline" or "run in" procedure should be used, with the second administration serving as the baseline measurement. PMID:17523883

  1. Finnish physicians' experiences with computer-supported patient information exchange and communication in clinical work.

    PubMed

    Viitanen, Johanna; Nieminen, Marko; Hypponen, Hannele; Laaveri, Tinja

    2011-01-01

    Several researchers share the concern of healthcare information systems failing to support communication and collaboration in clinical practices. The objective of this paper is to investigate the current state of computer-supported patient information exchange and associated communication between clinicians. We report findings from a national survey on Finnish physicians? experiences with their currently used clinical information systems with regard to patient information documentation, retrieval, management and exchange-related tasks. The questionnaire study with 3929 physicians indicated the main concern being cross-organisational patient information delivery. In addition, physicians argued computer usage increasingly steals time and attention from caring activities and even disturbs physician?nurse collaboration. Problems in information management were particularly emphasised among those physicians working in hospitals and wards. The survey findings indicated that collaborative applications and mobile or wireless solutions have not been widely adapted in Finnish healthcare and suggested an urgent need for adopting appropriate information and communication technology applications to support information exchange and communication between physicians, and physicians and nurses.

  2. Methodology of integration of a clinical data warehouse with a clinical information system: the HEGP case.

    PubMed

    Zapletal, Eric; Rodon, Nicolas; Grabar, Natalia; Degoulet, Patrice

    2010-01-01

    Clinical Data Warehouses (CDW) can complement current Clinical Information Systems (CIS) with functions that are not easily implemented by traditional operational database systems. Here, we describe the design and deployment strategy used at the Pompidou University Hospital in southwest Paris. Four realms are described: technological realm, data realm, restitution realm, and administration realm. The corresponding UML use cases and the mapping rules from the shared integrated electronic health records to the five axes of the i2b2 CDW star model are presented. Priority is given to the anonymization and security principles used for the 1.2 million patient records currently stored in the CDW. Exploitation of a CDW by clinicians and investigators can facilitate clinical research, quality evaluations and outcome studies. These indirect benefits are among the reasons for the continuous use of an integrated CIS.

  3. The impact of genetic information on policy and clinical practice.

    PubMed

    Abel, Elizabeth; Horner, Sharon D; Tyler, Diane; Innerarity, Sheryl A

    2005-02-01

    This article discusses genetics-related policy issues that have an impact on health care systems, health care providers, and their patients: privacy, mass screening, family screening, and knowledge dissemination. Access, cost, and ethical implications are important discussant points for each of these genetic-related policy issues. Embedded in the issue of privacy are concerns of insurability, confidentiality, and discrimination. The public health policy implications related to mass screening programs include efficacy of the screening tests, availability of primary and secondary interventions, access, costs, and program evaluation. Policy issues for family screening are similar to mass screening, with added concerns about privacy and availability of adequate resources, including health care providers and counselors trained in genetics. Knowledge dissemination is critical to maintaining currency of clinical information and applications of genetic technologies and treatments. As genetic information expands, the need for knowledge dissemination will increase. The importance of advanced practice nurses' involvement in these policy issues is discussed. PMID:16443953

  4. Automatic generation of computable implementation guides from clinical information models.

    PubMed

    Boscá, Diego; Maldonado, José Alberto; Moner, David; Robles, Montserrat

    2015-06-01

    Clinical information models are increasingly used to describe the contents of Electronic Health Records. Implementation guides are a common specification mechanism used to define such models. They contain, among other reference materials, all the constraints and rules that clinical information must obey. However, these implementation guides typically are oriented to human-readability, and thus cannot be processed by computers. As a consequence, they must be reinterpreted and transformed manually into an executable language such as Schematron or Object Constraint Language (OCL). This task can be difficult and error prone due to the big gap between both representations. The challenge is to develop a methodology for the specification of implementation guides in such a way that humans can read and understand easily and at the same time can be processed by computers. In this paper, we propose and describe a novel methodology that uses archetypes as basis for generation of implementation guides. We use archetypes to generate formal rules expressed in Natural Rule Language (NRL) and other reference materials usually included in implementation guides such as sample XML instances. We also generate Schematron rules from NRL rules to be used for the validation of data instances. We have implemented these methods in LinkEHR, an archetype editing platform, and exemplify our approach by generating NRL rules and implementation guides from EN ISO 13606, openEHR, and HL7 CDA archetypes. PMID:25910958

  5. Technological innovations in the development of cardiovascular clinical information systems.

    PubMed

    Hsieh, Nan-Chen; Chang, Chung-Yi; Lee, Kuo-Chen; Chen, Jeen-Chen; Chan, Chien-Hui

    2012-04-01

    Recent studies have shown that computerized clinical case management and decision support systems can be used to assist surgeons in the diagnosis of disease, optimize surgical operation, aid in drug therapy and decrease the cost of medical treatment. Therefore, medical informatics has become an extensive field of research and many of these approaches have demonstrated potential value for improving medical quality. The aim of this study was to develop a web-based cardiovascular clinical information system (CIS) based on innovative techniques, such as electronic medical records, electronic registries and automatic feature surveillance schemes, to provide effective tools and support for clinical care, decision-making, biomedical research and training activities. The CIS developed for this study contained monitoring, surveillance and model construction functions. The monitoring layer function provided a visual user interface. At the surveillance and model construction layers, we explored the application of model construction and intelligent prognosis to aid in making preoperative and postoperative predictions. With the use of the CIS, surgeons can provide reasonable conclusions and explanations in uncertain environments.

  6. Making the case for a clinical information system: the chief information officer view.

    PubMed

    Cotter, Carole M

    2007-03-01

    Adequate decision support for clinicians and other caregivers requires accessible and reliable patient information. Powerful societal and economic forces are moving us toward an integrated, patient-centered health care information system that will allow caregivers to exchange up-to-date patient health information quickly and easily. These forces include patient safety, potential health care cost savings, empowerment of consumers (and their subsequent demands for quality), new federal policies, and growing regional health care initiatives. Underspending on health care information technologies has gone on for many years; and the creation and implementation of a comprehensive clinical information system will entail many difficulties, particularly in regard to patients' privacy and control of their information, standardization of electronic health records, cost of adopting information technology, unbalanced financial incentives, and the varying levels of preparation across caregivers. There will also be potential effects on the physician-patient relationship. Ultimately, an integrated system will require a concerted transformation of the health care industry that is akin to what the banking industry has accomplished with electronic automation. Critical care units provide a good starting point for how information system technologies can be used and electronic patient information collected, although the robust systems designed for intensive care units are not always used to their potential. PMID:17371748

  7. Making the case for a clinical information system: the chief information officer view.

    PubMed

    Cotter, Carole M

    2007-03-01

    Adequate decision support for clinicians and other caregivers requires accessible and reliable patient information. Powerful societal and economic forces are moving us toward an integrated, patient-centered health care information system that will allow caregivers to exchange up-to-date patient health information quickly and easily. These forces include patient safety, potential health care cost savings, empowerment of consumers (and their subsequent demands for quality), new federal policies, and growing regional health care initiatives. Underspending on health care information technologies has gone on for many years; and the creation and implementation of a comprehensive clinical information system will entail many difficulties, particularly in regard to patients' privacy and control of their information, standardization of electronic health records, cost of adopting information technology, unbalanced financial incentives, and the varying levels of preparation across caregivers. There will also be potential effects on the physician-patient relationship. Ultimately, an integrated system will require a concerted transformation of the health care industry that is akin to what the banking industry has accomplished with electronic automation. Critical care units provide a good starting point for how information system technologies can be used and electronic patient information collected, although the robust systems designed for intensive care units are not always used to their potential.

  8. Dolphin project--cooperative regional clinical system centered on clinical information center.

    PubMed

    Takada, Akira; Guo, s Jinqiu; Tanaka, Koji; Sato, Junzo; Suzuki, Muneou; Suenaga, Takatoshi; Kikuchi, Ken; Araki, Kenji; Yoshihara, Hiroyuki

    2005-08-01

    In 2001, a system was created to improve patient service, improve the quality of medical care, and achieve efficient medical care. A Data Center was established to accumulate and manage clinical information in the regions and share clinical information safely and appropriately. The system has already been in operation for 3 years. Even though a patient may have been examined at multiple hospitals, his medical record information will be integrated at the Center. This ensures medical care continuity and enables the patient to view his own medical records at home. Its usefulness in obtaining informed consent has been demonstrated as well. XML instances established in the MML standards (MML (Medical Markup Language): http.//www.medxml.net/E_mml30/mmlv3_E_index.htm Accessed July 2004; Jpn. J. Med. Informatics (JJMI) 17(3):203-207, 1997; J. Med. Syst. 24(3):195-211, 2000; J. Med. Syst. 27(4):357-366, 2003; J. Med. Syst. 28(6):523-533, 2004) are used for Electronic Medical Record System data exchange between the Data Center and each medical institution. The openness provided by XML makes it possible to connect diverse electronic medical records to the Center. As of the year 2004, over 10 types of electronic medical records have an MML interface, enabling connection to the Center.

  9. A Leader in Clinical Trials, Medical Data, & Electronic Health Information | NIH MedlinePlus the Magazine

    MedlinePlus

    ... Hill Photo courtesy of Bachrach A Leader in Clinical Trials, Medical Data, & Electronic Health Information This year marks ... has provided the latest, most complete information about clinical trials in the United States and abroad. It is ...

  10. 76 FR 63355 - Proposed Information Collection (Prevalence and Clinical course of Depression Among patients with...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-12

    ... AFFAIRS Proposed Information Collection (Prevalence and Clinical course of Depression Among patients with... depression in heart failure patients. DATES: Written comments and recommendations on the proposed collection... information technology. Title: Prevalence and Clinical Course of Depression Among Patients with Heart...

  11. Systematics of the family Plectopylidae in Vietnam with additional information on Chinese taxa (Gastropoda, Pulmonata, Stylommatophora)

    PubMed Central

    Páll-Gergely, Barna; Hunyadi, András; Ablett, Jonathan; Lương, Hào Văn; Fred Naggs; Asami, Takahiro

    2015-01-01

    Abstract Vietnamese species from the family Plectopylidae are revised based on the type specimens of all known taxa, more than 600 historical non-type museum lots, and almost 200 newly-collected samples. Altogether more than 7000 specimens were investigated. The revision has revealed that species diversity of the Vietnamese Plectopylidae was previously overestimated. Overall, thirteen species names (anterides Gude, 1909, bavayi Gude, 1901, congesta Gude, 1898, fallax Gude, 1909, gouldingi Gude, 1909, hirsuta Möllendorff, 1901, jovia Mabille, 1887, moellendorffi Gude, 1901, persimilis Gude, 1901, pilsbryana Gude, 1901, soror Gude, 1908, tenuis Gude, 1901, verecunda Gude, 1909) were synonymised with other species. In addition to these, Gudeodiscus hemmeni sp. n. and Gudeodiscus messageri raheemi ssp. n. are described from north-western Vietnam. Sixteen species and two subspecies are recognized from Vietnam. The reproductive anatomy of eight taxa is described. Based on anatomical information, Halongella gen. n. is erected to include Plectopylis schlumbergeri and Plectopylis fruhstorferi. Additionally, the genus Gudeodiscus is subdivided into two subgenera (Gudeodiscus and Veludiscus subgen. n.) on the basis of the morphology of the reproductive anatomy and the radula. The Chinese Gudeodiscus phlyarius werneri Páll-Gergely, 2013 is moved to synonymy of Gudeodiscus phlyarius. A spermatophore was found in the organ situated next to the gametolytic sac in one specimen. This suggests that this organ in the Plectopylidae is a diverticulum. Statistically significant evidence is presented for the presence of calcareous hook-like granules inside the penis being associated with the absence of embryos in the uterus in four genera. This suggests that these probably play a role in mating periods before disappearing when embryos develop. Sicradiscus mansuyi is reported from China for the first time. PMID:25632253

  12. The aspartame story: a model for the clinical testing of a food additive.

    PubMed

    Stegink, L D

    1987-07-01

    Toxicology is based on the premise that all compounds are toxic at some dose. Thus, it is not surprising that very large doses of aspartame (or its components--aspartate, phenylalanine, and methanol) produce deleterious effects in sensitive animal species. The critical question is whether aspartame ingestion is potentially harmful to humans at normal use and potential abuse levels. This paper reviews clinical studies testing the effects of various doses of aspartame upon blood levels of aspartate, phenylalanine, and methanol. These studies demonstrate that blood levels of these compounds are well below levels associated with adverse effects in sensitive animal species.

  13. Lateralization of High-Frequency Clicks Based on Interaural Time: Additivity of Information across Frequency

    NASA Astrophysics Data System (ADS)

    Wenzel, Elizabeth Marie

    Lateralization performance based on interaural differences of time (IDTs) was measured for trains of Gaussian clicks which varied in spectral content. In the first experiment, thresholds ((DELTA)IDTs) were measured as a function of the number of clicks in the train (n = 1 to 32), the interclick interval (ICI = 2.5 or 5 ms), and the spectral content (1 vs. 2 or 4 carriers). Subjects' performance was compared to perfect statistical summation which predicts slopes of -.50 when log-(DELTA)IDT vs. long -n is plotted. The results showed that increasing the spectral content of the clicks decreased the intercepts of the log -log functions (decreased thresholds) while having little effect on their slopes. Shortening the ICIs caused the slopes of the functions to decrease in absolute value. To estimate the bandwidth of frequency-interaction in lateralization, d's were measured for clicks with constant IDTs (n = 1) with a fixed carrier (FF = 4000, 5200, 6000 or 7200 Hz), both alone and combined with a second click whose carrier (F) varied from 3500 to 8500 Hz. Performance in combined conditions was compared to independent summation of the information carried by the two frequency-bands. Performance improved as the separation between F and FF increased until the level predicted by independence was reached. The final experiment investigated the interaction of frequency content with IDT. d's were measured as a function of the IDT in clicks with carriers of 5200, 6000 or 7200 Hz, both alone and combined with a 4000-Hz click with a fixed IDT. Performance in combined conditions was again compared to independent additivity. The improvement with frequency was explained by an increase in the number of samples of the IDT reaching the binaural centers due to spread of excitation along the basilar membrane. Less than independent summation was explained by correlation between overlapping bands which reduced the amount of information exciting independent channels. The data also suggest that

  14. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with the requirement of Section 3506... information on the proposed project, contact: Ms. Victoria Pemberton, Clinical Trials Specialist, National... Informed Consent for Pediatric Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute...

  15. Assessing clinical outcomes of patients with acute calculous cholecystitis in addition to the Tokyo grading: a retrospective study.

    PubMed

    Cheng, Wei-Chun; Chiu, Yen-Cheng; Chuang, Chiao-Hsiung; Chen, Chiung-Yu

    2014-09-01

    The management of acute cholecystitis is still based on clinical expertise. This study aims to investigate whether the outcome of acute cholecystitis can be related to the severity criteria of the Tokyo guidelines and additional clinical comorbidities. A total of 103 patients with acute cholecystitis were retrospectively enrolled and their medical records were reviewed. They were all classified according to therapeutic modality, including early cholecystectomy and antibiotic treatment with or without percutaneous cholecystostomy. The impact of the Tokyo guidelines and the presence of comorbidities on clinical outcome were assessed by univariate and multivariate regression analyses. According to Tokyo severity grading, 48 patients were Grade I, 31 patients were Grade II, and 24 patients were Grade III. The Grade III patients had a longer hospital stay than Grade II and Grade I patients (15.2 days, 9.2 days, and 7.3 days, respectively, p < 0.05). According to multivariate analysis, patients with Grade III Tokyo severity, higher Charlson's Comorbidity Score, and encountering complications had a longer hospital stay. Based on treatment modality, surgeons selected the patients with less severity and fewer comorbidities for cholecystectomy, and these patients had a shorter hospital stay. In addition to the grading of the Tokyo guidelines, comorbidities had an additional impact on clinical outcomes and should be an important consideration when making therapeutic decisions.

  16. Information-seeking behavior and use of information resources by clinical research coordinators

    PubMed Central

    Wessel, Charles B.; Tannery, Nancy H.; Epstein, Barbara A.

    2006-01-01

    Purpose: The study sought to understand the literature searching experiences and skills of clinical research coordinators at a large academic medical center. Setting/Participants/Resources: The Health Sciences Library System, University of Pittsburgh, conducted a survey of clinical research coordinators at the University of Pittsburgh and the University of Pittsburgh Medical Center to solicit their perceived use and knowledge of the library's electronic resources. Brief Description: The University of Pittsburgh Institutional Review Board (IRB) is a “high volume IRB” that monitors human subject research at both the University of Pittsburgh and the University of Pittsburgh Medical Center. More than 3,500 human research studies and clinical trials are active at any given time. Many studies entail more than minimal risk to human subjects, with the majority evaluating or including a drug or medical device. Clinical research coordinators are involved in most of these studies or trials. Their roles and responsibilities focus on managing many aspects of the study or clinical trial. As a first step in understanding the literature searching experiences and skills of these research coordinators, baseline data were gathered from this group in November 2004. Results/Outcome: The data from this survey indicate that clinical research coordinators are a population who would benefit from training by academic medical center librarians in how to use electronic library resources and services. Evaluation Method: A Web-based survey solicited participants' information (gender, education, job title) and role in the IRB process (job responsibilities, number studies they manage). The majority of the survey questions focused on the use of specific electronic library resources, the type of information wanted, and the types of problems encountered. PMID:16404469

  17. Analyzing Statistical Mediation with Multiple Informants: A New Approach with an Application in Clinical Psychology.

    PubMed

    Papa, Lesther A; Litson, Kaylee; Lockhart, Ginger; Chassin, Laurie; Geiser, Christian

    2015-01-01

    Testing mediation models is critical for identifying potential variables that need to be targeted to effectively change one or more outcome variables. In addition, it is now common practice for clinicians to use multiple informant (MI) data in studies of statistical mediation. By coupling the use of MI data with statistical mediation analysis, clinical researchers can combine the benefits of both techniques. Integrating the information from MIs into a statistical mediation model creates various methodological and practical challenges. The authors review prior methodological approaches to MI mediation analysis in clinical research and propose a new latent variable approach that overcomes some limitations of prior approaches. An application of the new approach to mother, father, and child reports of impulsivity, frustration tolerance, and externalizing problems (N = 454) is presented. The results showed that frustration tolerance mediated the relationship between impulsivity and externalizing problems. The new approach allows for a more comprehensive and effective use of MI data when testing mediation models. PMID:26617536

  18. Using Language Models to Identify Relevant New Information in Inpatient Clinical Notes

    PubMed Central

    Zhang, Rui; Pakhomov, Serguei V.; Lee, Janet T.; Melton, Genevieve B.

    2014-01-01

    Redundant information in clinical notes within electronic health record (EHR) systems is ubiquitous and may negatively impact the use of these notes by clinicians, and, potentially, the efficiency of patient care delivery. Automated methods to identify redundant versus relevant new information may provide a valuable tool for clinicians to better synthesize patient information and navigate to clinically important details. In this study, we investigated the use of language models for identification of new information in inpatient notes, and evaluated our methods using expert-derived reference standards. The best method achieved precision of 0.743, recall of 0.832 and F1-measure of 0.784. The average proportion of redundant information was similar between inpatient and outpatient progress notes (76.6% (SD=17.3%) and 76.7% (SD=14.0%), respectively). Advanced practice providers tended to have higher rates of redundancy in their notes compared to physicians. Future investigation includes the addition of semantic components and visualization of new information. PMID:25954438

  19. Automated Extraction of Substance Use Information from Clinical Texts

    PubMed Central

    Wang, Yan; Chen, Elizabeth S.; Pakhomov, Serguei; Arsoniadis, Elliot; Carter, Elizabeth W.; Lindemann, Elizabeth; Sarkar, Indra Neil; Melton, Genevieve B.

    2015-01-01

    Within clinical discourse, social history (SH) includes important information about substance use (alcohol, drug, and nicotine use) as key risk factors for disease, disability, and mortality. In this study, we developed and evaluated a natural language processing (NLP) system for automated detection of substance use statements and extraction of substance use attributes (e.g., temporal and status) based on Stanford Typed Dependencies. The developed NLP system leveraged linguistic resources and domain knowledge from a multi-site social history study, Propbank and the MiPACQ corpus. The system attained F-scores of 89.8, 84.6 and 89.4 respectively for alcohol, drug, and nicotine use statement detection, as well as average F-scores of 82.1, 90.3, 80.8, 88.7, 96.6, and 74.5 respectively for extraction of attributes. Our results suggest that NLP systems can achieve good performance when augmented with linguistic resources and domain knowledge when applied to a wide breadth of substance use free text clinical notes. PMID:26958312

  20. Harmonization of Clinical Laboratory Information – Current and Future Strategies

    PubMed Central

    2016-01-01

    According to a patient-centered viewpoint, the meaning of harmonization in the context of laboratory medicine is that the information should be comparable irrespective of the measurement procedure used and where and/or when a measurement is made. Harmonization represents a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of an accurate and actionable laboratory information. Although the initial focus has to a large extent been to harmonize and standardize analytical processes and methods, the scope of harmonization goes beyond to include all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits, as well as tests and test profiles request and criteria for interpretation. Two major progresses have been made in the area of harmonization in laboratory medicine: first, the awareness that harmonization should take into consideration not only the analytical phase but all steps of the TTP, thus dealing with the request, the sample, the measurement, and the report. Second, as the processes required to achieve harmonization are complicated, a systematic approach is needed. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has played a fundamental and successful role in the development of standardized and harmonized assays, and now it should continue to work in the field through the collaboration and cooperation with many other stakeholders.

  1. Harmonization of Clinical Laboratory Information - Current and Future Strategies.

    PubMed

    Plebani, Mario

    2016-02-01

    According to a patient-centered viewpoint, the meaning of harmonization in the context of laboratory medicine is that the information should be comparable irrespective of the measurement procedure used and where and/or when a measurement is made. Harmonization represents a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of an accurate and actionable laboratory information. Although the initial focus has to a large extent been to harmonize and standardize analytical processes and methods, the scope of harmonization goes beyond to include all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits, as well as tests and test profiles request and criteria for interpretation. Two major progresses have been made in the area of harmonization in laboratory medicine: first, the awareness that harmonization should take into consideration not only the analytical phase but all steps of the TTP, thus dealing with the request, the sample, the measurement, and the report. Second, as the processes required to achieve harmonization are complicated, a systematic approach is needed. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has played a fundamental and successful role in the development of standardized and harmonized assays, and now it should continue to work in the field through the collaboration and cooperation with many other stakeholders. PMID:27683502

  2. A digital process for additive manufacturing of occlusal splints: a clinical pilot study

    PubMed Central

    Salmi, Mika; Paloheimo, Kaija-Stiina; Tuomi, Jukka; Ingman, Tuula; Mäkitie, Antti

    2013-01-01

    The aim of this study was to develop and evaluate a digital process for manufacturing of occlusal splints. An alginate impression was taken from the upper and lower jaws of a patient with temporomandibular disorder owing to cross bite and wear of the teeth, and then digitized using a table laser scanner. The scanned model was repaired using the 3Data Expert software, and a splint was designed with the Viscam RP software. A splint was manufactured from a biocompatible liquid photopolymer by stereolithography. The system employed in the process was SLA 350. The splint was worn nightly for six months. The patient adapted to the splint well and found it comfortable to use. The splint relieved tension in the patient's bite muscles. No sign of tooth wear or significant splint wear was detected after six months of testing. Modern digital technology enables us to manufacture clinically functional occlusal splints, which might reduce costs, dental technician working time and chair-side time. Maximum-dimensional errors of approximately 1 mm were found at thin walls and sharp corners of the splint when compared with the digital model. PMID:23614943

  3. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... fuel additive will be sold, offered for sale, or introduced into commerce, and the fuel additive manufacturer's recommended range of concentration and purpose-in-use for each such type of fuel. (e) Such other... (e) of this section as provided in § 79.5(b). (g) Assurances that the additive manufacturer will...

  4. Exploring the structure and organization of information within nursing clinical handovers.

    PubMed

    Johnson, Maree; Jefferies, Diana; Nicholls, Daniel

    2012-10-01

    Clinical handover is the primary source of patient information for nurses; however, inadequate information transfer compromises patient safety. We investigated the content and organization of information conveyed at 81 handovers. A structure that captures and presents the information transferred at handover emerged: identification of the patient and clinical risks, clinical history/presentation, clinical status, care plan and outcomes/goals of care (ICCCO). This approach covers essential information while allowing for prioritization of information when required. Further research into the impact of ICCCO on patient safety is in progress.

  5. Can Vitamin D Supplementation in Addition to Asthma Controllers Improve Clinical Outcomes in Patients With Asthma?

    PubMed Central

    Luo, Jian; Liu, Dan; Liu, Chun-Tao

    2015-01-01

    Abstract Effects of vitamin D on acute exacerbation, lung function, and fraction of exhaled nitric oxide (FeNO) in patients with asthma are controversial. We aim to further evaluate the roles of vitamin D supplementation in addition to asthma controllers in asthmatics. From 1946 to July 2015, we searched the PubMed, Embase, Medline, Cochrane Central Register of Controlled Trials, and ISI Web of Science using “Vitamin D,” “Vit D,” or “VitD” and “asthma,” and manually reviewed the references listed in the identified articles. Randomized controlled trials which reported rate of asthma exacerbations and adverse events, forced expiratory volume in 1 s (FEV1, % of predicted value), FeNO, asthma control test (ACT), and serum 25-hydroxyvitamin D levels were eligible. We conducted the heterogeneities test and sensitivity analysis of the enrolled studies, and random-effects or fixed-effects model was applied to calculate risk ratio (RR) and mean difference for dichotomous and continuous data, respectively. Cochrane systematic review software Review Manager (RevMan) was used to test the hypothesis by Mann–Whitney U test, which were displayed in Forest plots. Seven trials with a total of 903 patients with asthma were pooled in our final studies. Except for asthma exacerbations (I2 = 81%, χ2 = 10.28, P = 0.006), we did not find statistical heterogeneity in outcome measures. The pooled RR of asthma exacerbation was 0.66 (95% confidence interval: 0.32–1.37), but without significant difference (z = 1.12, P = 0.26), neither was in FEV1 (z = 0.30, P = 0.77), FeNO (z = 0.28, P = 0.78), or ACT (z = 0.92, P = 0.36), although serum 25-hydroxyvitamin D was significantly increased (z = 6.16, P < 0.001). Vitamin D supplementation in addition to asthma controllers cannot decrease asthma exacerbation and FeNO, nor improve lung function and asthma symptoms, although it can be safely applied to increase serum 25

  6. 41 CFR 102-75.140 - In addition to the title report, and all necessary environmental information and certifications...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 102-75.140 Public Contracts and Property Management Federal Property Management Regulations System... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false In addition to the title report, and all necessary environmental information and certifications, what information must...

  7. 41 CFR 102-79.111 - Where may Executive agencies find additional information on Integrated Workplace concepts?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Where may Executive agencies find additional information on Integrated Workplace concepts? 102-79.111 Section 102-79.111 Public... Integrated Workplace concepts? The GSA Office of Governmentwide Policy provides additional guidance in...

  8. Information mining over heterogeneous and high-dimensional time-series data in clinical trials databases.

    PubMed

    Altiparmak, Fatih; Ferhatosmanoglu, Hakan; Erdal, Selnur; Trost, Donald C

    2006-04-01

    An effective analysis of clinical trials data involves analyzing different types of data such as heterogeneous and high dimensional time series data. The current time series analysis methods generally assume that the series at hand have sufficient length to apply statistical techniques to them. Other ideal case assumptions are that data are collected in equal length intervals, and while comparing time series, the lengths are usually expected to be equal to each other. However, these assumptions are not valid for many real data sets, especially for the clinical trials data sets. An addition, the data sources are different from each other, the data are heterogeneous, and the sensitivity of the experiments varies by the source. Approaches for mining time series data need to be revisited, keeping the wide range of requirements in mind. In this paper, we propose a novel approach for information mining that involves two major steps: applying a data mining algorithm over homogeneous subsets of data, and identifying common or distinct patterns over the information gathered in the first step. Our approach is implemented specifically for heterogeneous and high dimensional time series clinical trials data. Using this framework, we propose a new way of utilizing frequent itemset mining, as well as clustering and declustering techniques with novel distance metrics for measuring similarity between time series data. By clustering the data, we find groups of analytes (substances in blood) that are most strongly correlated. Most of these relationships already known are verified by the clinical panels, and, in addition, we identify novel groups that need further biomedical analysis. A slight modification to our algorithm results an effective declustering of high dimensional time series data, which is then used for "feature selection." Using industry-sponsored clinical trials data sets, we are able to identify a small set of analytes that effectively models the state of normal health.

  9. Does the anti-prothrombin antibodies measurement provide additional information in patients with thrombosis?

    PubMed

    Bardin, Nathalie; Alessi, Marie Christine; Dignat-George, Francoise; Vague, Irene Juhan; Sampol, Jose; Harlé, Jean Robert; Sanmarco, Marielle

    2007-01-01

    The aim of this study is to get new insight into the relevance of IgG anti-prothrombin antibodies in patients with thrombosis and to determine whether human prothrombin alone (aPT) or complexed to phosphatidylserine (aPS/PT) should be preferentially used for measuring these antibodies by enzyme-linked immunosorbent assay (ELISA). To this end, prevalence of anti-prothrombin antibodies, their characteristics in terms of avidity and heterogeneity, and their relationship with anti-beta2 glycoprotein I antibodies (abeta2GPI) were studied in 152 patients with thrombosis. Patients were divided into two groups according to the presence or absence of antiphospholipid antibodies (aPL), called aPL+ or aPL-, respectively. In the aPL- group (n=90), the prevalence of anti-prothrombin antibodies was substantial (10%) but not significantly different from that of control (5%). In the aPL+ group (n=62), lupus anticoagulant (LA) or anticardiolipin antibodies (aCL) positive, 61% were positive for anti-prothrombin antibodies with no statistical difference between aPT and aPS/PT prevalence (42% vs. 55%, respectively). In the whole thrombotic population, 19% were only aPT and 34% only aPS/PT suggesting the presence of different antibodies. Absorption experiments confirmed the heterogeneity of aPT and aPS/PT. No difference in their avidity was demonstrated. From the aPL+ group, 60 were LA positive. Among them, 18% were negative for abeta2GPI and anti-prothrombin antibodies showing that the detection of these antibodies could not substitute for LA determination. In conclusion, our data show that the screening of the different anti-prothrombin antibodies is not warranted in the aPL+ group since these antibodies do not provide additional information compared to aCL, LA and/or abeta2GPI measurement. Nevertheless, the substantial prevalence of anti-prothrombin antibodies in the aPL- group should be further explored in a large prospective study. PMID:17678713

  10. Modeling the acceptance of clinical information systems among hospital medical staff: an extended TAM model.

    PubMed

    Melas, Christos D; Zampetakis, Leonidas A; Dimopoulou, Anastasia; Moustakis, Vassilis

    2011-08-01

    Recent empirical research has utilized the Technology Acceptance Model (TAM) to advance the understanding of doctors' and nurses' technology acceptance in the workplace. However, the majority of the reported studies are either qualitative in nature or use small convenience samples of medical staff. Additionally, in very few studies moderators are either used or assessed despite their importance in TAM based research. The present study focuses on the application of TAM in order to explain the intention to use clinical information systems, in a random sample of 604 medical staff (534 physicians) working in 14 hospitals in Greece. We introduce physicians' specialty as a moderator in TAM and test medical staff's information and communication technology (ICT) knowledge and ICT feature demands, as external variables. The results show that TAM predicts a substantial proportion of the intention to use clinical information systems. Findings make a contribution to the literature by replicating, explaining and advancing the TAM, whereas theory is benefited by the addition of external variables and medical specialty as a moderator. Recommendations for further research are discussed.

  11. 14 CFR 121.317 - Passenger information requirements, smoking prohibitions, and additional seat belt requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Passenger information requirements, smoking... OPERATIONS Instrument and Equipment Requirements § 121.317 Passenger information requirements, smoking... command. (c) No person may operate an airplane on a flight on which smoking is prohibited by part 252...

  12. 14 CFR 121.317 - Passenger information requirements, smoking prohibitions, and additional seat belt requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Passenger information requirements, smoking... OPERATIONS Instrument and Equipment Requirements § 121.317 Passenger information requirements, smoking... command. (c) No person may operate an airplane on a flight on which smoking is prohibited by part 252...

  13. 14 CFR 121.317 - Passenger information requirements, smoking prohibitions, and additional seat belt requirements.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Passenger information requirements, smoking... OPERATIONS Instrument and Equipment Requirements § 121.317 Passenger information requirements, smoking... command. (c) No person may operate an airplane on a flight on which smoking is prohibited by part 252...

  14. 14 CFR 121.317 - Passenger information requirements, smoking prohibitions, and additional seat belt requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Passenger information requirements, smoking... OPERATIONS Instrument and Equipment Requirements § 121.317 Passenger information requirements, smoking... command. (c) No person may operate an airplane on a flight on which smoking is prohibited by part 252...

  15. 14 CFR 121.317 - Passenger information requirements, smoking prohibitions, and additional seat belt requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Passenger information requirements, smoking... OPERATIONS Instrument and Equipment Requirements § 121.317 Passenger information requirements, smoking... command. (c) No person may operate an airplane on a flight on which smoking is prohibited by part 252...

  16. 77 FR 6808 - Proposed Collection; Comment Request: Information Program on Clinical Trials; Maintaining a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

    ... on Clinical Trials; Maintaining a Registry and Results Databank Summary: In compliance with the... Program on Clinical Trials: Maintaining a Registry and Results Databank. Type of Information Collection... Information Collection: The National Institutes of Health operates ClinicalTrials.gov , which was...

  17. Automated Methods to Extract Patient New Information from Clinical Notes in Electronic Health Record Systems

    ERIC Educational Resources Information Center

    Zhang, Rui

    2013-01-01

    The widespread adoption of Electronic Health Record (EHR) has resulted in rapid text proliferation within clinical care. Clinicians' use of copying and pasting functions in EHR systems further compounds this by creating a large amount of redundant clinical information in clinical documents. A mixture of redundant information (especially outdated…

  18. 76 FR 78740 - Agency Information Collection (Prevalence and Clinical Course of Depression Among Patients With...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... AFFAIRS Agency Information Collection (Prevalence and Clinical Course of Depression Among Patients With... Control No. 2900- 0719.'' SUPPLEMENTARY INFORMATION: Titles: Prevalence and Clinical Course of Depression.... Abstracts: The data collected will be used to evaluate the prevalence of clinical depression and...

  19. A risk assessment of two interorganizational clinical information systems.

    PubMed

    Sicotte, Claude; Paré, Guy; Moreault, Marie-Pierre; Paccioni, André

    2006-01-01

    A risk analysis framework was used to examine the implementation barriers that may hamper the successful implementation of interorganizational clinical information systems (ICIS). In terms of study design, an extensive literature review was first performed in order to elaborate a comprehensive model of project risk factors. To test the applicability of the model, we next conducted a longitudinal multiple-case study of two large-scale ICIS demonstration projects carried out in Quebec, Canada. Variations in the levels of several risk dimensions measured throughout the duration of the projects were analyzed to determine their impact on successful implementation. The analysis shows that the proposed framework, composed of five risk dimensions, was very robust, and suitable for conducting a thorough risk analysis. The results also show that there are links between the quality of the risk management and the level of project outcomes. To be successful, it is important that the implementation efforts be distributed proportionally according to the importance of each of the risk factors. Furthermore, because the risks evolve dynamically, there is a need for high responsiveness to emerging implementation problems. Thus, implementation success lies in the ability of the project management team to be aware of and to manage several risk threats simultaneously and coherently since they evolve dynamically through time and interact with one another. PMID:16799130

  20. A Risk Assessment of Two Interorganizational Clinical Information Systems

    PubMed Central

    Sicotte, Claude; Paré, Guy; Moreault, Marie-Pierre; Paccioni, André

    2006-01-01

    A risk analysis framework was used to examine the implementation barriers that may hamper the successful implementation of interorganizational clinical information systems (ICIS). In terms of study design, an extensive literature review was first performed in order to elaborate a comprehensive model of project risk factors. To test the applicability of the model, we next conducted a longitudinal multiple-case study of two large-scale ICIS demonstration projects carried out in Quebec, Canada. Variations in the levels of several risk dimensions measured throughout the duration of the projects were analyzed to determine their impact on successful implementation. The analysis shows that the proposed framework, composed of five risk dimensions, was very robust, and suitable for conducting a thorough risk analysis. The results also show that there are links between the quality of the risk management and the level of project outcomes. To be successful, it is important that the implementation efforts be distributed proportionally according to the importance of each of the risk factors. Furthermore, because the risks evolve dynamically, there is a need for high responsiveness to emerging implementation problems. Thus, implementation success lies in the ability of the project management team to be aware of and to manage several risk threats simultaneously and coherently since they evolve dynamically through time and interact with one another. PMID:16799130

  1. 78 FR 27936 - Request for Extension and Revision of a Currently Approved Information Collection With Additional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-13

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF AGRICULTURE Agricultural Marketing Service Request for Extension and Revision of a Currently Approved Information... of Fresh and Processed Fruits, Vegetables and Other Products AGENCY: Agricultural Marketing...

  2. Clinical simulation and workflow by use of two clinical information systems, the electronic health record and digital dictation.

    PubMed

    Koldby, Sven; Schou Jensen, Iben

    2013-01-01

    Clinical information systems do not always support clinician workflows. An increasing number of unintended clinical incidents might be related to implementation of clinical information systems and to a new registration praxis of unintended clinical incidents. Evidence of performing clinical simulations before implementation of new clinical information systems provides the basis for use of this method. The intention has been to evaluate patient safety issues, functionality, workflow, and usefulness of a new solution before implementation in the hospitals. Use of a solution which integrates digital dictation and the EHR (electronic health record) were simulated in realistic and controlled clinical environments. Useful information dealing with workflow and patient safety were obtained. The clinical simulation demonstrated that the EHR locks during use of the integration of digital dictation, thus making it impossible to use the EHR or connected applications during digital dictation. The results of the simulations showed that the tested and evaluated solution does not support the clinical workflow. Conducting the simulations enabled us to improve the solution before implementation, but further development is necessary before implementation of the solution.

  3. SU-D-BRD-04: A Logical Organizational Approach to Clinical Information Management

    SciTech Connect

    Shao, W; Kupelian, P; Wang, J; Low, D; Ruan, D

    2014-06-01

    Purpose: To develop a clinical information management system (CIMS) that collects, organizes physician inputs logically and supports analysis functionality. Methods: In a conventional electronic medical record system (EMR), the document manager component stores data in a pool of standalone .docx or .pdf files. The lack of a content-based logical organization makes cross-checking, reference or automatic inheritance of information challenging. We have developed an information-oriented clinical record system that addresses this shortcoming. In CIMS, a parent library predefines a set of available questions along with the data types of their expected answers. The creation of a questionnaire template is achieved by selecting questions from this parent library to form a virtual group. Instances of the same data field in different documents are linked by their question identifier. This design allows for flexible data sharing and inheritance among various forms using a longitudinal lineage of data indexed according to the modification time stamps of the documents. CIMS is designed with a web portal to facilitate querying, data entry and modification, aggregate report generation, and data adjudication. The current implementation addresses diagnostic data, medical history, vital signs, and various quantities in consult note and treatment summaries. Results: CIMS is currently storing treatment summary information of over 1,000 patients who have received treatment at UCLA Radiation Oncology between March 1, 2013 and January 31, 2014. We are in the process of incorporating a DICOM-RT dosimetry parser and patient reporting applications into CIMS, as well as continuing to define document templates to support additional forms. Conclusion: We are able to devise an alternative storage paradigm which results in an improvement in the accuracy and organizational structure of clinical information.

  4. Image engine: an integrated multimedia clinical information system.

    PubMed

    Lowe, H J; Buchanan, B G; Cooper, G F; Kaplan, B; Vries, J K

    1995-01-01

    Image Engine is a microcomputer-based system for the integration, storage, retrieval, and sharing of digitized clinical images. The system seeks to address the problem of integrating a wide range of clinically important images with the text-based electronic patient record. Rather than create a single, integrated database system for all clinical data, we are developing a separate image database system that creates real-time, dynamic links to other network-based clinical databases. To the user, this system will present an integrated multimedia representation of the patient record, providing access to both the image and text-based data required for effective clinical decision making. PMID:8591216

  5. Image engine: an integrated multimedia clinical information system.

    PubMed

    Lowe, H J; Buchanan, B G; Cooper, G F; Kaplan, B; Vries, J K

    1995-01-01

    Image Engine is a microcomputer-based system for the integration, storage, retrieval, and sharing of digitized clinical images. The system seeks to address the problem of integrating a wide range of clinically important images with the text-based electronic patient record. Rather than create a single, integrated database system for all clinical data, we are developing a separate image database system that creates real-time, dynamic links to other network-based clinical databases. To the user, this system will present an integrated multimedia representation of the patient record, providing access to both the image and text-based data required for effective clinical decision making.

  6. Twenty-five additional cases of trisomy 9 mosaic: Birth information, medical conditions, and developmental status.

    PubMed

    Bruns, Deborah A; Campbell, Emily

    2015-05-01

    Limited literature exists on children and adults diagnosed with the mosaic form of trisomy 9. Data from the Tracking Rare Incidence Syndromes (TRIS) project has provided physical characteristics and medical conditions for 14 individuals. This article provides TRIS Survey results of 25 additional cases at two data points (birth and survey completion) as well as developmental status. Results confirmed a number of phenotypic features and medical conditions. In addition, a number of cardiac anomalies were reported along with feeding and respiratory difficulties in the immediate postnatal period. In addition, developmental status data indicated a range in functioning level up to skills in the 36 and 48-month range. Strengths were also noted across the sample in language and communication, fine motor and social-emotional development. Implications for professionals caring for children with this genetic condition are offered. PMID:25755087

  7. Testing 1...2...3...: Additional Files Available for Test Information Online.

    ERIC Educational Resources Information Center

    Fabiano, Emily

    1984-01-01

    Reviews databases providing information on published, standardized and unpublished, non-standardized test instruments: Educational Testing Service File, Mental Measurements Yearbook Database, Dissertation Abstracts Online, ERIC, and Psychological Abstracts. Search strategies, search examples, and a summary chart of searchable fields for test…

  8. 17 CFR 229.1118 - (Item 1118) Reports and additional information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... transaction documents. Describe the reports or other documents provided to security holders required under the... Commission maintains an Internet site that contains reports, proxy and information statements, and other... electronically filed with, or furnished to, the Commission. (2) Disclose whether other reports to...

  9. 75 FR 68608 - Information Collection; Request for Authorization of Additional Classification and Rate, Standard...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-08

    ...(c), and 5.15 (records to be kept by employers under the Fair Labor Standards Act (FLSA), 29 CFR 516... . SUPPLEMENTARY INFORMATION: A. Purpose This regulation prescribes labor standards for federally financed and assisted construction contracts subject to the Davis-Bacon and Related Acts (DBRA), as well as...

  10. 49 CFR 260.25 - Additional information for Applicants not having a credit rating.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... corresponding to those used in this section, the following information: (a) A narrative statement detailing...; and (f) A narrative description of Applicant's management team, including: (1) Rail experience of top... narrative description of Applicant's workforce and the historical rate of employee turnover....

  11. 49 CFR 260.25 - Additional information for Applicants not having a credit rating.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... corresponding to those used in this section, the following information: (a) A narrative statement detailing...; and (f) A narrative description of Applicant's management team, including: (1) Rail experience of top... narrative description of Applicant's workforce and the historical rate of employee turnover....

  12. Software for Information Storage and Retrieval Tested, Evaluated and Compared: Part VI--Various Additional Programs.

    ERIC Educational Resources Information Center

    Sieverts, Eric G.; And Others

    1993-01-01

    Reports on tests evaluating nine microcomputer software packages designed for information storage and retrieval: BRS-Search, dtSearch, InfoBank, Micro-OPC, Q&A, STN-PFS, Strix, TINman, and ZYindex. Tables and narrative evaluations detail results related to security, hardware, user features, search capability, indexing, input, maintenance of files,…

  13. 78 FR 22937 - 60-Day Notice of Proposed Information Collection: Application for Additional Visa Pages or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 60-Day... Passport Services ACTION: Notice of request for public comment. SUMMARY: The Department of State is seeking Office of Management and ] Budget (OMB) approval for the information collection described below....

  14. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... shall be made that any such ingredient list is incomplete. (5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption... information as defined in § 20.61 of this chapter: (1) Manufacturing methods or processes, including...

  15. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... shall be made that any such ingredient list is incomplete. (5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption... information as defined in § 20.61 of this chapter: (1) Manufacturing methods or processes, including...

  16. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... shall be made that any such ingredient list is incomplete. (5) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within the exemption... information as defined in § 20.61 of this chapter: (1) Manufacturing methods or processes, including...

  17. Informed consent procedure for clinical trials in emergency settings: the Polish perspective.

    PubMed

    Iwanowski, Piotr S

    2007-09-01

    Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients' to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants' consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant's consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. PMID:18210227

  18. 77 FR 58911 - Additional Identifying Information for One (1) Individual Designated Pursuant to Executive Order...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-24

    ... Threaten to Disrupt the Middle East Peace Process'' (the ``Order''). DATES: The addition by the Director of... sanctions on persons who threaten to disrupt the Middle East peace process. The President identified in the... Middle East peace ] process; or (2) assist in, sponsor, or provide financial, material, or...

  19. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., percentage by weight, and method of analysis of each element in the additive are required provided, however, that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided unless the breakdown into percentages for these individual elements is already known to the...

  20. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., percentage by weight, and method of analysis of each element in the additive are required provided, however, that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided unless the breakdown into percentages for these individual elements is already known to the...

  1. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., percentage by weight, and method of analysis of each element in the additive are required provided, however, that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided unless the breakdown into percentages for these individual elements is already known to the...

  2. Facing Facts: Can the Face-Name Mnemonic Strategy Accommodate Additional Factual Information?

    ERIC Educational Resources Information Center

    Carney, Russell N.; Levin, Joel R.

    2012-01-01

    In 3 experiments, undergraduates used their own best method (control) or an "imposed" face-name mnemonic strategy to associate 18 caricatured faces, names, and additional facts. On all immediate tests (prompted by the faces), and on the delayed tests of Experiments 2a and 2b combined, mnemonic students statistically outperformed control students…

  3. 75 FR 62404 - Agency Information Collection Activities; Proposed Collection; Comment Request; Additional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-08

    ...-counter (OTC) drugs as generally recognized as safe and effective and not misbranded. DATES: Submit either... additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded (2002 TEA final rule). The regulations in Sec. 330.14 state that OTC drug...

  4. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... environmental report, either in accordance with 10 CFR 51.50(c) if a limited work authorization under 10 CFR...

  5. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... 52.158 Section 52.158 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Manufacturing Licenses § 52.158 Contents of application; additional... environmental report as required by 10 CFR 51.54. (2) If the manufacturing license application references...

  6. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... environmental report, either in accordance with 10 CFR 51.50(c) if a limited work authorization under 10 CFR...

  7. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... environmental report, either in accordance with 10 CFR 51.50(c) if a limited work authorization under 10 CFR...

  8. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... environmental report, either in accordance with 10 CFR 51.50(c) if a limited work authorization under 10 CFR...

  9. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... 52.158 Section 52.158 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Manufacturing Licenses § 52.158 Contents of application; additional... environmental report as required by 10 CFR 51.54. (2) If the manufacturing license application references...

  10. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... 52.158 Section 52.158 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Manufacturing Licenses § 52.158 Contents of application; additional... environmental report as required by 10 CFR 51.54. (2) If the manufacturing license application references...

  11. 10 CFR 52.80 - Contents of applications; additional technical information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 52.80 Section 52.80 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Combined Licenses § 52.80 Contents of applications; additional technical... environmental report, either in accordance with 10 CFR 51.50(c) if a limited work authorization under 10 CFR...

  12. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... 52.158 Section 52.158 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSES, CERTIFICATIONS, AND APPROVALS FOR NUCLEAR POWER PLANTS Manufacturing Licenses § 52.158 Contents of application; additional... environmental report as required by 10 CFR 51.54. (2) If the manufacturing license application references...

  13. Towards knowledge-based systems in clinical practice: development of an integrated clinical information and knowledge management support system.

    PubMed

    Kalogeropoulos, Dimitris A; Carson, Ewart R; Collinson, Paul O

    2003-09-01

    Given that clinicians presented with identical clinical information will act in different ways, there is a need to introduce into routine clinical practice methods and tools to support the scientific homogeneity and accountability of healthcare decisions and actions. The benefits expected from such action include an overall reduction in cost, improved quality of care, patient and public opinion satisfaction. Computer-based medical data processing has yielded methods and tools for managing the task away from the hospital management level and closer to the desired disease and patient management level. To this end, advanced applications of information and disease process modelling technologies have already demonstrated an ability to significantly augment clinical decision making as a by-product. The wide-spread acceptance of evidence-based medicine as the basis of cost-conscious and concurrently quality-wise accountable clinical practice suffices as evidence supporting this claim. Electronic libraries are one-step towards an online status of this key health-care delivery quality control environment. Nonetheless, to date, the underlying information and knowledge management technologies have failed to be integrated into any form of pragmatic or marketable online and real-time clinical decision making tool. One of the main obstacles that needs to be overcome is the development of systems that treat both information and knowledge as clinical objects with same modelling requirements. This paper describes the development of such a system in the form of an intelligent clinical information management system: a system which at the most fundamental level of clinical decision support facilitates both the organised acquisition of clinical information and knowledge and provides a test-bed for the development and evaluation of knowledge-based decision support functions.

  14. OpenTrials: towards a collaborative open database of all available information on all clinical trials.

    PubMed

    Goldacre, Ben; Gray, Jonathan

    2016-01-01

    OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data. PMID:27056367

  15. Impact and user satisfaction of a clinical information portal embedded in an electronic health record.

    PubMed

    Tannery, Nancy H; Epstein, Barbara A; Wessel, Charles B; Yarger, Frances; LaDue, John; Klem, Mary Lou

    2011-01-01

    In 2008, a clinical information tool was developed and embedded in the electronic health record system of an academic medical center. In 2009, the initial information tool, Clinical-e, was superseded by a portal called Clinical Focus, with a single search box enabling a federated search of selected online information resources. To measure the usefulness and impact of Clinical Focus, a survey was used to gather feedback about users' experience with this clinical resource. The survey determined what type of clinicians were using this tool and assessed user satisfaction and perceived impact on patient care decision making. Initial survey results suggest the majority of respondents found Clinical Focus easy to navigate, the content easy to read, and the retrieved information relevant and complete. The majority would recommend Clinical Focus to their colleagues. Results indicate that this tool is a promising area for future development.

  16. Impact and user satisfaction of a clinical information portal embedded in an electronic health record.

    PubMed

    Tannery, Nancy H; Epstein, Barbara A; Wessel, Charles B; Yarger, Frances; LaDue, John; Klem, Mary Lou

    2011-01-01

    In 2008, a clinical information tool was developed and embedded in the electronic health record system of an academic medical center. In 2009, the initial information tool, Clinical-e, was superseded by a portal called Clinical Focus, with a single search box enabling a federated search of selected online information resources. To measure the usefulness and impact of Clinical Focus, a survey was used to gather feedback about users' experience with this clinical resource. The survey determined what type of clinicians were using this tool and assessed user satisfaction and perceived impact on patient care decision making. Initial survey results suggest the majority of respondents found Clinical Focus easy to navigate, the content easy to read, and the retrieved information relevant and complete. The majority would recommend Clinical Focus to their colleagues. Results indicate that this tool is a promising area for future development. PMID:22016670

  17. Impact and User Satisfaction of a Clinical Information Portal Embedded in an Electronic Health Record

    PubMed Central

    Tannery, Nancy H; Epstein, Barbara A; Wessel, Charles B; Yarger, Frances; LaDue, John; Klem, Mary Lou

    2011-01-01

    In 2008, a clinical information tool was developed and embedded in the electronic health record system of an academic medical center. In 2009, the initial information tool, Clinical-e, was superseded by a portal called Clinical Focus, with a single search box enabling a federated search of selected online information resources. To measure the usefulness and impact of Clinical Focus, a survey was used to gather feedback about users' experience with this clinical resource. The survey determined what type of clinicians were using this tool and assessed user satisfaction and perceived impact on patient care decision making. Initial survey results suggest the majority of respondents found Clinical Focus easy to navigate, the content easy to read, and the retrieved information relevant and complete. The majority would recommend Clinical Focus to their colleagues. Results indicate that this tool is a promising area for future development. PMID:22016670

  18. A Study of the Effectiveness of Information Design Principles Applied to Clinical Research Questionnaires.

    ERIC Educational Resources Information Center

    Zimmerman, Beverly B.; Schultz, Jessica R.

    2000-01-01

    Investigates the effectiveness of information design principles and feedback-based usability testing in developing clinical questionnaires. Finds that a form developed using information design principles collected significantly more data than did a control form. (SR)

  19. CliniWeb: managing clinical information on the World Wide Web.

    PubMed Central

    Hersh, W R; Brown, K E; Donohoe, L C; Campbell, E M; Horacek, A E

    1996-01-01

    The World Wide Web is a powerful new way to deliver on-line clinical information, but several problems limit its value to health care professionals: content is highly distributed and difficult to find, clinical information is not separated from non-clinical information, and the current Web technology is unable to support some advanced retrieval capabilities. A system called CliniWeb has been developed to address these problems. CliniWeb is an index to clinical information on the World Wide Web, providing a browsing and searching interface to clinical content at the level of the health care student or provider. Its database contains a list of clinical information resources on the Web that are indexed by terms from the Medical Subject Headings disease tree and retrieved with the assistance of SAPHIRE. Limitations of the processes used to build the database are discussed, together with directions for future research. PMID:8816350

  20. National-scale clinical information exchange in the United Kingdom: lessons for the United States

    PubMed Central

    Detmer, Don E; Wyatt, Jeremy C; Buchan, Iain E

    2010-01-01

    Over the last four decades, the UK has made large investments in healthcare information technology. The authors conducted interviews and reviewed published and unpublished documents to describe national-scale clinical information exchange in England, how it was achieved, and the problems experienced that the USA might avoid. Clinical information exchange in the UK was accomplished by establishing a foundation of policy, infrastructure, and systems of care, by creating and acquiring clinical computing applications and with strong use of financial and clinical incentives. Many software and hardware vendors played a part in this effort; they participated in a national framework created by the NHS in which standards for exchange are specified and their applications designed to make clinical information exchange part of normal practice. Great potential exists for cost reduction, increased safety, and greater patient involvement as a result of clinical information exchange. PMID:21134976

  1. Clinical Trials: Information and Options for People with Mood Disorders

    MedlinePlus

    ... events Visit the podcast archive Mood Disorders Depression Bipolar Disorder Anxiety Screening Center Co-occurring Illnesses/Disorders Related ... for Your Patients Information about Depression Information about Bipolar Disorder Wellness Tools DBSA Support Groups Active Research Studies ...

  2. Informed consent for whole-genome sequencing studies in the clinical setting. Proposed recommendations on essential content and process

    PubMed Central

    Ayuso, Carmen; Millán, José M; Mancheño, Marta; Dal-Ré, Rafael

    2013-01-01

    The development of new massive sequencing techniques has now made it possible to significantly reduce the time and costs of whole-genome sequencing (WGS). Although WGS will soon become a routine testing tool, new ethical issues have surfaced. In light of these concerns, a systematic review of papers published by expert authors on IC or specific ethical issues related to IC for WGS analysis in the clinical setting has been conducted using the Pubmed, Embase and Cochrane Library databases. Additionally, a search was conducted for international ethical guidelines for genetic studies published by scientific societies and ethical boards. Based on these documents, a minimum set of information to be provided to patients in the IC form was determined. Fourteen and seven documents from the database search and from scientific societies, respectively, were selected. A very high level of consistency between them was found regarding the recommended IC form content. Pre-test counselling and general information common to all genetic tests should be included in the IC form for WGS for diagnostic purposes, but additional information addressing specific issues on WGS are proposed, such as a plan for the ethical, clinically oriented return of incidental findings. Moreover, storage of additional information for future use should also be agreed upon with the patient in advance. Recommendations for WGS studies in the clinical setting concerning both the elements of information and the process of obtaining the IC as well as how to handle the results obtained are proposed. PMID:23321621

  3. Multimodal Neuroimaging-Informed Clinical Applications in Neuropsychiatric Disorders

    PubMed Central

    O’Halloran, Rafael; Kopell, Brian H.; Sprooten, Emma; Goodman, Wayne K.; Frangou, Sophia

    2016-01-01

    Recent advances in neuroimaging data acquisition and analysis hold the promise to enhance the ability to make diagnostic and prognostic predictions and perform treatment planning in neuropsychiatric disorders. Prior research using a variety of types of neuroimaging techniques has confirmed that neuropsychiatric disorders are associated with dysfunction in anatomical and functional brain circuits. We first discuss current challenges associated with the identification of reliable neuroimaging markers for diagnosis and prognosis in mood disorders and for neurosurgical treatment planning for deep brain stimulation (DBS). We then present data on the use of neuroimaging for the diagnosis and prognosis of mood disorders and for DBS treatment planning. We demonstrate how multivariate analyses of functional activation and connectivity parameters can be used to differentiate patients with bipolar disorder from those with major depressive disorder and non-affective psychosis. We also present data on connectivity parameters that mediate acute treatment response in affective and non-affective psychosis. We then focus on precision mapping of functional connectivity in native space. We describe the benefits of integrating anatomical fiber reconstruction with brain functional parameters and cortical surface measures to derive anatomically informed connectivity metrics within the morphological context of each individual brain. We discuss how this approach may be particularly promising in psychiatry, given the clinical and etiological heterogeneity of the disorders, and particularly in treatment response prediction and planning. Precision mapping of connectivity is essential for DBS. In DBS, treatment electrodes are inserted into positions near key gray matter nodes within the circuits considered relevant to disease expression. However, targeting white matter tracts that underpin connectivity within these circuits may increase treatment efficacy and tolerability therefore relevant

  4. Multimodal Neuroimaging-Informed Clinical Applications in Neuropsychiatric Disorders.

    PubMed

    O'Halloran, Rafael; Kopell, Brian H; Sprooten, Emma; Goodman, Wayne K; Frangou, Sophia

    2016-01-01

    Recent advances in neuroimaging data acquisition and analysis hold the promise to enhance the ability to make diagnostic and prognostic predictions and perform treatment planning in neuropsychiatric disorders. Prior research using a variety of types of neuroimaging techniques has confirmed that neuropsychiatric disorders are associated with dysfunction in anatomical and functional brain circuits. We first discuss current challenges associated with the identification of reliable neuroimaging markers for diagnosis and prognosis in mood disorders and for neurosurgical treatment planning for deep brain stimulation (DBS). We then present data on the use of neuroimaging for the diagnosis and prognosis of mood disorders and for DBS treatment planning. We demonstrate how multivariate analyses of functional activation and connectivity parameters can be used to differentiate patients with bipolar disorder from those with major depressive disorder and non-affective psychosis. We also present data on connectivity parameters that mediate acute treatment response in affective and non-affective psychosis. We then focus on precision mapping of functional connectivity in native space. We describe the benefits of integrating anatomical fiber reconstruction with brain functional parameters and cortical surface measures to derive anatomically informed connectivity metrics within the morphological context of each individual brain. We discuss how this approach may be particularly promising in psychiatry, given the clinical and etiological heterogeneity of the disorders, and particularly in treatment response prediction and planning. Precision mapping of connectivity is essential for DBS. In DBS, treatment electrodes are inserted into positions near key gray matter nodes within the circuits considered relevant to disease expression. However, targeting white matter tracts that underpin connectivity within these circuits may increase treatment efficacy and tolerability therefore relevant

  5. Isosemantic rendering of clinical information using formal ontologies and RDF.

    PubMed

    Martínez-Costa, Catalina; Bosca, Diego; Legaz-García, Mari Carmen; Tao, Cui; Fernández Breis, Jesualdo Tomás; Schulz, Stefan; Chute, Christopher G

    2013-01-01

    The generation of a semantic clinical infostructure requires linking ontologies, clinical models and terminologies [1]. Here we describe an approach that would permit data coming from different sources and represented in different standards to be queried in a homogeneous and integrated way. Our assumption is that data providers should be able to agree and share the meaning of the data they want to exchange and to exploit. We will describe how Clinical Element Model (CEM) and OpenEHR datasets can be jointly exploited in Semantic Web environments.

  6. Isosemantic rendering of clinical information using formal ontologies and RDF.

    PubMed

    Martínez-Costa, Catalina; Bosca, Diego; Legaz-García, Mari Carmen; Tao, Cui; Fernández Breis, Jesualdo Tomás; Schulz, Stefan; Chute, Christopher G

    2013-01-01

    The generation of a semantic clinical infostructure requires linking ontologies, clinical models and terminologies [1]. Here we describe an approach that would permit data coming from different sources and represented in different standards to be queried in a homogeneous and integrated way. Our assumption is that data providers should be able to agree and share the meaning of the data they want to exchange and to exploit. We will describe how Clinical Element Model (CEM) and OpenEHR datasets can be jointly exploited in Semantic Web environments. PMID:23920859

  7. 50 CFR 23.25 - What additional information is required on a non-Party CITES document?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 50 Wildlife and Fisheries 9 2014-10-01 2014-10-01 false What additional information is required on a non-Party CITES document? 23.25 Section 23.25 Wildlife and Fisheries UNITED STATES FISH AND..., BARTER, EXPORTATION, AND IMPORTATION OF WILDLIFE AND PLANTS (CONTINUED) CONVENTION ON INTERNATIONAL...

  8. 50 CFR 23.25 - What additional information is required on a non-Party CITES document?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 50 Wildlife and Fisheries 6 2010-10-01 2010-10-01 false What additional information is required on a non-Party CITES document? 23.25 Section 23.25 Wildlife and Fisheries UNITED STATES FISH AND..., BARTER, EXPORTATION, AND IMPORTATION OF WILDLIFE AND PLANTS (CONTINUED) CONVENTION ON INTERNATIONAL...

  9. 12 CFR 516.220 - If OTS requests additional information to complete my application, how will it process my...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... complete my application, how will it process my application? 516.220 Section 516.220 Banks and Banking... Standard Treatment § 516.220 If OTS requests additional information to complete my application, how will it... your response. OTS will notify you that it has extended the period before the end of the initial...

  10. 12 CFR 116.220 - If the OCC requests additional information to complete my application, how will it process my...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... complete my application, how will it process my application? 116.220 Section 116.220 Banks and Banking... Treatment § 116.220 If the OCC requests additional information to complete my application, how will it... that it has extended the period before the end of the initial 15-day period and will briefly...

  11. 12 CFR 516.220 - If OTS requests additional information to complete my application, how will it process my...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... complete my application, how will it process my application? 516.220 Section 516.220 Banks and Banking... Standard Treatment § 516.220 If OTS requests additional information to complete my application, how will it... your response. OTS will notify you that it has extended the period before the end of the initial...

  12. 12 CFR 390.128 - If the FDIC requests additional information to complete my application, how will it process my...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... complete my application, how will it process my application? 390.128 Section 390.128 Banks and Banking... additional information to complete my application, how will it process my application? (a) You may use the... will notify you that it has extended the period before the end of the initial 15-day period and...

  13. Inclusion of Additional Plant Species and Trait Information in Dynamic Vegetation Modeling of Arctic Tundra and Boreal Forest Ecosystem

    NASA Astrophysics Data System (ADS)

    Euskirchen, E. S.; Patil, V.; Roach, J.; Griffith, B.; McGuire, A. D.

    2015-12-01

    Dynamic vegetation models (DVMs) have been developed to model the ecophysiological characteristics of plant functional types in terrestrial ecosystems. They have frequently been used to answer questions pertaining to processes such as disturbance, plant succession, and community composition under historical and future climate scenarios. While DVMs have proved useful in these types of applications, it has often been questioned if additional detail, such as including plant dynamics at the species-level and/or including species-specific traits would make these models more accurate and/or broadly applicable. A sub-question associated with this issue is, 'How many species, or what degree of functional diversity, should we incorporate to sustain ecosystem function in modeled ecosystems?' Here, we focus on how the inclusion of additional plant species and trait information may strengthen dynamic vegetation modeling in applications pertaining to: (1) forage for caribou in northern Alaska, (2) above- and belowground carbon storage in the boreal forest and lake margin wetlands of interior Alaska, and (3) arctic tundra and boreal forest leaf phenology. While the inclusion of additional information generally proved valuable in these three applications, this additional detail depends on field data that may not always be available and may also result in increased computational complexity. Therefore, it is important to assess these possible limitations against the perceived need for additional plant species and trait information in the development and application of dynamic vegetation models.

  14. Tautomers of a Fluorescent G Surrogate and Their Distinct Photophysics Provide Additional Information Channels.

    PubMed

    Sholokh, Marianna; Improta, Roberto; Mori, Mattia; Sharma, Rajhans; Kenfack, Cyril; Shin, Dongwon; Voltz, Karine; Stote, Roland H; Zaporozhets, Olga A; Botta, Maurizio; Tor, Yitzhak; Mély, Yves

    2016-07-01

    Thienoguanosine ((th) G) is an isomorphic nucleoside analogue acting as a faithful fluorescent substitute of G, with respectable quantum yield in oligonucleotides. Photophysical analysis of (th) G reveals the existence of two ground-state tautomers with significantly shifted absorption and emission wavelengths, and high quantum yield in buffer. Using (TD)-DFT calculations, the tautomers were identified as the H1 and H3 keto-amino tautomers. When incorporated into the loop of (-)PBS, the (-)DNA copy of the HIV-1 primer binding site, both tautomers are observed and show differential sensitivity to protein binding. The red-shifted H1 tautomer is strongly favored in matched (-)/(+)PBS duplexes, while the relative emission of the H3 tautomer can be used to detect single nucleotide polymorphisms. These tautomers and their distinct environmental sensitivity provide unprecedented information channels for analyzing G residues in oligonucleotides and their complexes.

  15. Extracting additional risk managers information from a risk assessment of Listeria monocytogenes in deli meats.

    PubMed

    Pérez-Rodríguez, F; van Asselt, E D; Garcia-Gimeno, R M; Zurera, G; Zwietering, M H

    2007-05-01

    The risk assessment study of Listeria monocytogenes in ready-to-eat foods conducted by the U.S. Food and Drug Administration is an example of an extensive quantitative microbiological risk assessment that could be used by risk analysts and other scientists to obtain information and by managers and stakeholders to make decisions on food safety management. The present study was conducted to investigate how detailed sensitivity analysis can be used by assessors to extract more information on risk factors and how results can be communicated to managers and stakeholders in an understandable way. The extended sensitivity analysis revealed that the extremes at the right side of the dose distribution (at consumption, 9 to 11.5 log CFU per serving) were responsible for most of the cases of listeriosis simulated. For concentration at retail, values below the detection limit of 0.04 CFU/g and the often used limit for L. monocytogenes of 100 CFU/g (also at retail) were associated with a high number of annual cases of listeriosis (about 29 and 82%, respectively). This association can be explained by growth of L. monocytogenes at both average and extreme values of temperature and time, indicating that a wide distribution can lead to high risk levels. Another finding is the importance of the maximal population density (i.e., the maximum concentration of L. monocytogenes assumed at a certain temperature) for accurately estimating the risk of infection by opportunistic pathogens such as L. monocytogenes. According to the obtained results, mainly concentrations corresponding to the highest maximal population densities caused risk in the simulation. However, sensitivity analysis applied to the uncertainty parameters revealed that prevalence at retail was the most important source of uncertainty in the model.

  16. Perception Gaps and the Adoption of Information Technology in the Clinical Healthcare Environment

    ERIC Educational Resources Information Center

    Hare, Karen

    2008-01-01

    Implementation of information systems has lagged in many areas of clinical healthcare for a variety of reasons. Economics, data complexity and resistance are among the often quoted roadblocks. Research suggests that physicians play a major part in the adoption, use and diffusion of information technology (IT) in clinical settings. There are also…

  17. [Construction and thinking of data element standard directory of traditional Chinese medicine clinical pharmacy information].

    PubMed

    Wang, Xiao-Xia; Jin, Zhong-Zheng; Guo, Gui-Ming; Zhai, Hua-Qiang; Jin, Shi-Yuan

    2014-05-01

    The aim of this study was to develop the data element standard directory of traditional Chinese medicine (TCM) clinical pharmacy information, to provide application standards and models of TCM clinical pharmacy for the electronic medical record (EMR). The developed line of work is as follows: initially establish research through four forms: literature analysis, questionnaires, discussion groups, expert advice. The research range from the Chinese herbal medicine research, herbal origin, harvesting, processing, identification of traits, physical and chemical identification, modern research, character, taste, Indications, clinical application, processing, dispensing medicine, Chinese medicine specifications, usage, dosage, caution, efficacy indications to small packaging applications, drug research, management and other related issues, including traditional Chinese medicine theory, application and hospital management information; according to the general and part 16 content of the national "Health Information Data Element Standards", and the basic method of extracting data element to study and develop the data element of TCM clinical pharmacy information from the defining content. Correspondingly propose the ideas and methods of construction of the "Data Element Standard Directory of TCM Clinical Pharmacy Information", sort out medicine clinical information data element standard catalog, divided into basic categories, clinical application class, management class three parts, and set norms and standards of identifying data elements, definitions, allowable value of traditional Chinese medicine clinical information, and discuss the sources and standards of information collection, leaving the interface, standardized and scientific terminology, docking with the existing standards, maintenance and management program and oter issues.

  18. 77 FR 22578 - Submission for OMB Review; Comment Request; Information Program on Clinical Trials: Maintaining a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-16

    ... Program on Clinical Trials: Maintaining a Registry and Results Databank SUMMARY: Under the provisions of... control number. Proposed Collection: Title: Information Program on Clinical Trials: Maintaining a Registry... Collection: The National Institutes of Health operates ClinicalTrials.gov , which was established as...

  19. 78 FR 13067 - Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... Collection; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug... contained in FDA's regulations on foreign clinical studies not conducted under an investigational new drug... appropriate, and other forms of information technology. Foreign Clinical Studies Not Conducted Under an...

  20. Diabetes Information Technology: Designing Informatics Systems to Catalyze Change in Clinical Care

    PubMed Central

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

    2008-01-01

    Current computerized reminder and decision support systems intended to improve diabetes care have had a limited effect on clinical outcomes. Increasing pressures on health care networks to meet standards of diabetes care have created an environment where information technology systems for diabetes management are often created under duress, appended to existing clinical systems, and poorly integrated into the existing workflow. After defining the components of diabetes disease management, the authors present an eight-step conceptual framework to guide the development of more effective diabetes information technology systems for translating clinical information into clinical action. PMID:19885355

  1. Roogle: an information retrieval engine for clinical data warehouse.

    PubMed

    Cuggia, Marc; Garcelon, Nicolas; Campillo-Gimenez, Boris; Bernicot, Thomas; Laurent, Jean-François; Garin, Etienne; Happe, André; Duvauferrier, Régis

    2011-01-01

    High amount of relevant information is contained in reports stored in the electronic patient records and associated metadata. R-oogle is a project aiming at developing information retrieval engines adapted to these reports and designed for clinicians. The system consists in a data warehouse (full-text reports and structured data) imported from two different hospital information systems. Information retrieval is performed using metadata-based semantic and full-text search methods (as Google). Applications may be biomarkers identification in a translational approach, search of specific cases, and constitution of cohorts, professional practice evaluation, and quality control assessment.

  2. Drug Signature-based Finding of Additional Clinical Use of LC28-0126 for Neutrophilic Bronchial Asthma

    PubMed Central

    Shin, Eunji; Lee, Yong Chul; Kim, So Ri; Kim, Soon Ha; Park, Joonghoon

    2015-01-01

    In recent decades, global pharmaceutical companies have suffered from an R&D innovation gap between the increased cost of a new drug’s development and the decreased number of approvals. Drug repositioning offers another opportunity to fill the gap because the approved drugs have a known safety profile for human use, allowing for a reduction of the overall cost of drug development by eliminating rigorous safety assessment. In this study, we compared the transcriptional profile of LC28-0126, an investigational drug for acute myocardial infarction (MI) at clinical trial, obtained from healthy male subjects with molecular activity profiles in the Connectivity Map. We identified dyphilline, an FDA-approved drug for bronchial asthma, as a top ranked connection with LC28-0126. Subsequently, we demonstrated that LC28-0126 effectively ameliorates the pathophysiology of neutrophilic bronchial asthma in OVALPS-OVA mice accompanied with a reduction of inflammatory cell counts in the bronchoalveolar lavage fluid (BALF), inhibition of the release of proinflammatory cytokines, relief of airway hyperactivity, and improvement of histopathological changes in the lung. Taken together, we suggest that LC28-0126 could be a potential therapeutic for bronchial asthma. In addition, this study demonstrated the potential general utility of computational drug repositioning using clinical profiles of the investigational drug. PMID:26626943

  3. A clinical information system strategic planning model for integrated healthcare delivery networks.

    PubMed

    Snyder-Halpern, R; Chervany, N L

    2000-12-01

    As healthcare organizations are transformed into consolidated healthcare delivery networks, their success is increasingly dependent on the integration and effectiveness of their clinical information systems (CIS). Greater financial investments are being made in CIS products and services to support processes related to clinical care oversight, direct care delivery, and ancillary clinical services. To make good investment decisions, these enterprises must engage in a comprehensive strategic planning process that tightly links their healthcare delivery network clinical strategy, CIS strategic vision, and specific CIS investments. The authors illustrate the linkages among these three strategic planning stages through the application of a clinical information system strategic planning model to a case example.

  4. Implementing a Web-based clinical information system using EMR middle layer services.

    PubMed Central

    Kittredge, R. L.; Estey, G.; Pappas, J. J.; Barnett, G. O.

    1996-01-01

    The Clinical Summary is a Web-based application for accessing the clinical database at the Massachusetts General Hospital. The application has been developed to give physicians in our health care community access to clinical information for patients they refer to our hospital. "Middle layer" services, written previously for the hospital's clinical workstation, supply much of the application's functionality. Employment of reusable services together with a Web-based front end has afforded a rapid and inexpensive means for developing a new clinical information system. This paper discusses the system's design, function, and methods of implementation. PMID:8947742

  5. Metadata registry and management system based on ISO 11179 for cancer clinical trials information system

    PubMed Central

    Park, Yu Rang; Kim*, Ju Han

    2006-01-01

    Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers. PMID:17238675

  6. Implications of the concept of minimal risk in research on informed choice in clinical practice.

    PubMed

    Wada, Kyoko; Nisker, Jeff

    2015-10-01

    The concept of a minimal risk threshold in research, beneath which exception to informed consent and ethics review processes may occur, has been codified for over 30 years in many national research regulations and by the Council for International Organizations of Medical Sciences. Although minimal risk in research constitutes one of the criteria for allowing waiver of informed consent or modification to the consent process and a large body of literature exists, discussion of a minimal risk threshold in clinical practice has not occurred. One reason for lack of discussion may be that implicit consent is accepted for a wide range of routine clinical practices. Extending the role of minimal risk in research to clinical practice might assist clinicians in identifying circumstances for which implicit consent is indeed sufficient and circumstances in which it is not. Further, concepts from minimal risk in research might assist clinicians regarding when information provision in health promotion is required. We begin by reviewing concepts in both minimal risk in research and informed choice in clinical practice. We then explore how a clinical minimal risk concept may clarify recommendations for information provision in clinical practice and support the patient's informed choice regarding therapeutic and diagnostic procedures and also health promotion. Given that clinical practice involves a broad scope of health information, professional practice guidelines on information provision based on the application of the minimal risk threshold in research could be developed to guide clinicians in what information must be provided to their patients.

  7. Information Technology for Clinical, Translational and Comparative Effectiveness Research

    PubMed Central

    Choquet, R.

    2014-01-01

    Summary Objectives To select and summarize key contributions to current research in the field of Clinical Research Informatics (CRI). Method: A bibliographic search using a combination of MeSH and free terms search over PubMed was performed followed by a blinded review. Results The review process resulted in the selection of four papers illustrating various aspects of current research efforts in the area of CRI. The first paper tackles the challenge of extracting accurate phenotypes from Electronic Healthcare Records (EHRs). Privacy protection within shared de-identified, patient-level research databases is the focus of the second selected paper. Two other papers exemplify the growing role of formal representation of clinical data - in metadata repositories - and knowledge – in ontologies - for supporting the process of reusing data for clinical research. Conclusions The selected articles demonstrate how concrete platforms are currently achieving interoperability across clinical research and care domains and have reached the evaluation phase. When EHRs linked to genetic data have the potential to shift the research focus from research driven patient recruitment to phenotyping in large population, a key issue is to lower patient re-identification risks for biomedical research databases. Current research illustrates the potential of knowledge engineering to support, in the coming years, the scientific lifecycle of clinical research. PMID:25123747

  8. Development of a clinical information tool for the electronic medical record: a case study*

    PubMed Central

    Epstein, Barbara A; Wessel, Charles B; Yarger, Frances; LaDue, John; Fiorillo, Anthony B

    2010-01-01

    Question: What is the process of developing a clinical information tool to be embedded in the electronic health record of a very large and diverse academic medical center? Setting: The development took place at the University of Pittsburgh Health Sciences Library System. Method: The clinical information tool developed is a search box with subject tabs to provide quick access to designated full-text information resources. Each subject tab offers a federated search of a different pool of resources. Search results are organized “on the fly” into meaningful categories using clustering technology and are directly accessible from the results page. Results: After more than a year of discussion and planning, a clinical information tool was embedded in the academic medical center's electronic health record. Conclusion: The library successfully developed a clinical information tool, called Clinical-e, for use at the point of care. Future development will refine the tool and evaluate its impact and effectiveness. PMID:20648256

  9. Understanding the dynamics of information technology implementation: a study of clinical information systems.

    PubMed

    Paré, G; Elam, J J

    1995-01-01

    Health care institutions are considering a variety of emerging information technologies (ITs) in the hope of increasing efficiency, reducing costs, re-engineering work processes, and improving quality of care. The recent, rapid advances made in the use of innovative ITs in the health care field can present a plethora of problems to the administrative staff. Perhaps the most pressing of these concerns is the ability of today's hospitals to effectively create and utilize computer-based information systems. IT implementation has long been of great interest for information systems researchers. This branch of information system study seeks to identify those factors that are integral to optimizing the usage of IT. For example, researchers have advised practitioners that managerial support, high quality system design, commitment to advancing with the field, and extensive project planning are all key elements of successful system. In sum, previous research has produced a set of managerial proscriptions which, taken as a whole, constitute the "ideal" way to implement an IT system. Yet despite these normative principles and proscriptions, many health care institutions continue to find their attempts to make use of IT fraught with difficulty. Therefore, the objective of this study is to broaden and edify our understanding of IT implementation. More specifically, we seek to dispel the myth of the "ideal" system setup by exploring some of the alternative systems in use. We wish to investigate how and why the components of these alternative systems interact to produce utilization success (or failure). The study investigates the establishment and subsequent use of three clinical information systems (CIS) in a large tertiary care teaching hospital. The first case study is that of the hospital-wide implementation of a computer system that allows physicians to sign their medical records electronically. The second case examines the use of an electronic patient chart used to support

  10. [Development of information system at Sestre Milosrdnice Clinical Hospital].

    PubMed

    Plasaj, Tomislav

    2005-01-01

    Information Systems (IS) in healthcare are complex with a heterogeneous structure. They support decision making in healthcare and therefore must be integrated, consistent, reliable, secure and simple for use and maintenance. Data entry is strongly controlled, data are coded and ready for inventory printing or scientific analysis. Efforts in developing the Integrated Hospital Information System (IHIS) at Sestre Milosrdnice University Hospital, Zagreb (Croatia) from a Hospital Information System (HIS) are presented. From the very beginning, the Information System was developed without planning, only to satisfy the current needs and to stay within financial possibilities. Today, many hospital departments have their own Information Subsystems and one or two servers. All local area networks and offline computers are connected to optical ring and through the farm of servers (firewall, www, e-mail, DNS-Domain Name System) to the Internet. We need a long time to achieve the current degree of development of IS. However, today we can obviously recognize a few layers of information applications just like business application, medicine application, scientific application, education application, telemedicine and Internet application. Very powerful information technology and very fast progress in communications leads to digital or paperless hospital. PMID:16095194

  11. Developing Clinical Information Needs and Systems. Final Grant Report.

    ERIC Educational Resources Information Center

    Noback, Richardson K.; Byrd, Gary D.

    This report represents the extended research following an initial three-year grant reported on in 1975. Goals were: (1) to enact, observe, and assess the results of a program in which medical librarians become integral members of multi-disciplinary patient care and educational teams; and (2) to test the ability of these Clinical Medical Librarians…

  12. A system architecture for sharing de-identified, research-ready brain scans and health information across clinical imaging centers.

    PubMed

    Chervenak, Ann L; van Erp, Theo G M; Kesselman, Carl; D'Arcy, Mike; Sobell, Janet; Keator, David; Dahm, Lisa; Murry, Jim; Law, Meng; Hasso, Anton; Ames, Joseph; Macciardi, Fabio; Potkin, Steven G

    2012-01-01

    Progress in our understanding of brain disorders increasingly relies on the costly collection of large standardized brain magnetic resonance imaging (MRI) data sets. Moreover, the clinical interpretation of brain scans benefits from compare and contrast analyses of scans from patients with similar, and sometimes rare, demographic, diagnostic, and treatment status. A solution to both needs is to acquire standardized, research-ready clinical brain scans and to build the information technology infrastructure to share such scans, along with other pertinent information, across hospitals. This paper describes the design, deployment, and operation of a federated imaging system that captures and shares standardized, de-identified clinical brain images in a federation across multiple institutions. In addition to describing innovative aspects of the system architecture and our initial testing of the deployed infrastructure, we also describe the Standardized Imaging Protocol (SIP) developed for the project and our interactions with the Institutional Review Board (IRB) regarding handling patient data in the federated environment. PMID:22941984

  13. A new species of Neparholaspis (Acari: Parholaspididae) from Russia, with additional information on Neparholaspis evansi Krantz, 1960.

    PubMed

    Marchenko, Irina I

    2016-01-01

    Neparholaspis dubatolovi sp. nov. is described and illustrated from adult females and males collected from litter and moss in montane forest in north-eastern Sikhote-Alin Ridge in the Far East of Russia. Additional morphological information and illustrations of Neparholaspis evansi Krantz, 1960 are provided, based on examination of a paratype. A key to the world species of Neparholaspis is provided. PMID:27615851

  14. MedTime: a temporal information extraction system for clinical narratives.

    PubMed

    Lin, Yu-Kai; Chen, Hsinchun; Brown, Randall A

    2013-12-01

    Temporal information extraction from clinical narratives is of critical importance to many clinical applications. We participated in the EVENT/TIMEX3 track of the 2012 i2b2 clinical temporal relations challenge, and presented our temporal information extraction system, MedTime. MedTime comprises a cascade of rule-based and machine-learning pattern recognition procedures. It achieved a micro-averaged f-measure of 0.88 in both the recognitions of clinical events and temporal expressions. We proposed and evaluated three time normalization strategies to normalize relative time expressions in clinical texts. The accuracy was 0.68 in normalizing temporal expressions of dates, times, durations, and frequencies. This study demonstrates and evaluates the integration of rule-based and machine-learning-based approaches for high performance temporal information extraction from clinical narratives.

  15. Clinical Decision Support for Whole Genome Sequence Information Leveraging a Service-Oriented Architecture: a Prototype

    PubMed Central

    Welch, Brandon M.; Rodriguez-Loya, Salvador; Eilbeck, Karen; Kawamoto, Kensaku

    2014-01-01

    Whole genome sequence (WGS) information could soon be routinely available to clinicians to support the personalized care of their patients. At such time, clinical decision support (CDS) integrated into the clinical workflow will likely be necessary to support genome-guided clinical care. Nevertheless, developing CDS capabilities for WGS information presents many unique challenges that need to be overcome for such approaches to be effective. In this manuscript, we describe the development of a prototype CDS system that is capable of providing genome-guided CDS at the point of care and within the clinical workflow. To demonstrate the functionality of this prototype, we implemented a clinical scenario of a hypothetical patient at high risk for Lynch Syndrome based on his genomic information. We demonstrate that this system can effectively use service-oriented architecture principles and standards-based components to deliver point of care CDS for WGS information in real-time. PMID:25954430

  16. Information-seeking behavior of nursing students and clinical nurses: implications for health sciences librarians*

    PubMed Central

    Dee, Cheryl; Stanley, Ellen E.

    2005-01-01

    Objectives: This research was conducted to provide new insights on clinical nurses' and nursing students' current use of health resources and libraries and deterrents to their retrieval of electronic clinical information, exploring implications from these findings for health sciences librarians. Methods: Questionnaires, interviews, and observations were used to collect data from twenty-five nursing students and twenty-five clinical nurses. Results: Nursing students and clinical nurses were most likely to rely on colleagues and books for medical information, while other resources they frequently cited included personal digital assistants, electronic journals and books, and drug representatives. Significantly more nursing students than clinical nurses used online databases, including CINAHL and PubMed, to locate health information, and nursing students were more likely than clinical nurses to report performing a database search at least one to five times a week. Conclusions and Recommendations: Nursing students made more use of all available resources and were better trained than clinical nurses, but both groups lacked database-searching skills. Participants were eager for more patient care information, more database training, and better computer skills; therefore, health sciences librarians have the opportunity to meet the nurses' information needs and improve nurses' clinical information-seeking behavior. PMID:15858624

  17. Does an additional structured information program during the intensive care unit stay reduce anxiety in ICU patients?: a multicenter randomized controlled trial

    PubMed Central

    2014-01-01

    Background Communication and information in order to reduce anxiety in the intensive care unit (ICU) has been described as area needing improvement. Therefore, the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients. Methods Multicenter, two-armed, non-blinded, parallel-group randomized controlled trial in hospitals in the cities of Marburg, Halle, and Stuttgart (Germany). The trial was performed in cardiac surgery, general surgery, and internal medicine ICUs. Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study (intervention group, n = 104; control group, n = 107). The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts: (1) A more standardized part about predefined ICU specific aspects – mainly procedural, sensory and coping information, and (2) an individualized part about fears and questions of the patient. The control group received a non-specific episodic conversation of similar length additional to standard care. Both conversations took place at the beginning of the ICU stay and lasted 10–15 minutes. Study nurses administered both interventions. The primary outcome ICU-related anxiety (CINT-Score, 0–100 pts., higher scores indicate higher anxiety) was assessed after admission to a regular ward. Results The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 (SD 14.4) compared to 20.8 (SD 14.7) and a mean difference of −0.2 (CI 95% -4.5 to 4.1). Conclusions A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration. Reduction of anxiety in ICU patients will probably require more continuous

  18. Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes

    PubMed Central

    Cook, Andrea J.; Wellman, Robert D.; Cherkin, Daniel C.; Kahn, Janet R.; Sherman, Karen J.

    2015-01-01

    Background Context This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of non-pharmacological treatments. Purpose To determine the optimal dose of massage for neck pain. Study Design/Setting Two-phase randomized trial for persons with chronic non-specific neck pain. Primary randomization to one of 5 groups receiving 4 weeks of massage (30 minutes 2×/ or 3×/week or 60 minutes 1×, 2×, or 3×/week). Booster randomization of participants to receive an additional 6 massages, 60 minute 1×/week, or no additional massage. Patient Sample 179 participants from Group Health and the general population of Seattle, WA USA recruited between June 2010 and August 2011. Outcome Measures Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0–10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as >5 point decrease in dysfunction and > 30% decrease in pain from baseline. Methods Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations. Secondary analyses for the continuous outcomes used linear generalized estimating equations. This study was funded the National Center for Complementary and Alternative Medicine, NIH, USA (R01 AT004411). The funders had no role in the interpretation or reporting of results. Results There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: RR=1.56(1.08–2.25), P=0.018; pain: RR=1.25(0.98–1.61); P=0.077), but those were non-significant at 26 weeks (dysfunction: RR=1.22(0.85–1.74); pain: RR=1.09(0.82–1.43)). Subgroup analysis by primary and booster treatments found the booster dose only

  19. 75 FR 34142 - Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Clinical Efficacy Information in Professional Labeling and Direct-to... on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act...

  20. CISweb: Dynamically Generated Reference for a Clinical Information System

    PubMed Central

    Banken, J; Lober, WB; Love, E; Gossett, A; Lowry, D

    2001-01-01

    We devised a method of producing dynamically generated reference material based on flexible templates. Our open source system allows modification of an entire website through a user-friendly interface to a database. This model has multiple other applications in developing informational /educational websites.

  1. Another Fine MeSH: Clinical Medicine Meets Information Science.

    ERIC Educational Resources Information Center

    O'Rourke, Alan; Booth, Andrew; Ford, Nigel

    1999-01-01

    Discusses evidence-based medicine (EBM) and the need for systematic use of databases like MEDLINE with more sophisticated search strategies to optimize the retrieval of relevant papers. Describes an empirical study of hospital libraries that examined requests for information and search strategies using both structured and unstructured forms.…

  2. [Adoption of information and communication technologies in the dialysis clinics of Bahia State].

    PubMed

    Mota, Fábio Batista; Ferreira Júnior, Hamilton de Moura

    2010-06-01

    The aim of this article is to investigate the adoption and use of information and communication technologies within private dialysis clinics in Bahia State. A case study was developed with companies by applying, to clinics' managerial teams, a research questionnaire adapted from RedeSist and from PINTEC. The sample included 20 companies, listed by CNES of the Ministry of Health, and obtained a positive usage rate data of 60%. The collected quantitative information was analyzed by interviewees' answer frequency distribution. Conclusion indicates that the adoption of information and communication technologies by the clinics is not directly related to their access to these technologies but to the under usage of their economical potential.

  3. CRC Clinical Trials Management System (CTMS): An Integrated Information Management Solution for Collaborative Clinical Research

    PubMed Central

    Payne, Philip R.O.; Greaves, Andrew W.; Kipps, Thomas J.

    2003-01-01

    The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC) consists of 9 geographically distributed sites conducting a program of research including both basic science and clinical components. To enable the CRC’s clinical research efforts, a system providing for real-time collaboration was required. CTMS provides such functionality, and demonstrates that the use of novel data modeling, web-application platforms, and management strategies provides for the deployment of an extensible, cost effective solution in such an environment. PMID:14728471

  4. Obtaining clinical writing informed consent versus using client disguise and recommendations for practice.

    PubMed

    Sieck, Barbara C

    2012-03-01

    Clinical writing about psychotherapy clients has long been a part of didactic texts and research articles because it allows new treatments and interventions to be presented in an effective and memorable way. The main ways that clinicians write about their clients include obtaining informed consent, using client disguise, or creating case composites. Although many clinicians use a combination of all three approaches, this article specifically addresses the implications of using clinical writing informed consent. The present article begins with a brief history of clinical writing and an examination of the relevant standards in the current APA Ethics Code and the Health Insurance Portability and Accountability Act; this is followed by a discussion of the benefits of engaging in the clinical writing informed consent process. Subsequently, the limitations of using clinical writing informed consent are explored, including the potentially negative impact on the therapeutic alliance and the client's progress. The article concludes that clinicians should be cautious when deciding to engage in clinical writing informed consent. Recommendations in the form of a checklist are provided to help clinicians identify when it is most appropriate to use client disguise or case composites, and how to do so, as well as when it is appropriate to engage in clinical writing informed consent. Future directions are considered.

  5. An automated tuberculosis screening strategy combining X-ray-based computer-aided detection and clinical information

    PubMed Central

    Melendez, Jaime; Sánchez, Clara I.; Philipsen, Rick H. H. M.; Maduskar, Pragnya; Dawson, Rodney; Theron, Grant; Dheda, Keertan; van Ginneken, Bram

    2016-01-01

    Lack of human resources and radiological interpretation expertise impair tuberculosis (TB) screening programmes in TB-endemic countries. Computer-aided detection (CAD) constitutes a viable alternative for chest radiograph (CXR) reading. However, no automated techniques that exploit the additional clinical information typically available during screening exist. To address this issue and optimally exploit this information, a machine learning-based combination framework is introduced. We have evaluated this framework on a database containing 392 patient records from suspected TB subjects prospectively recruited in Cape Town, South Africa. Each record comprised a CAD score, automatically computed from a CXR, and 12 clinical features. Comparisons with strategies relying on either CAD scores or clinical information alone were performed. Our results indicate that the combination framework outperforms the individual strategies in terms of the area under the receiving operating characteristic curve (0.84 versus 0.78 and 0.72), specificity at 95% sensitivity (49% versus 24% and 31%) and negative predictive value (98% versus 95% and 96%). Thus, it is believed that combining CAD and clinical information to estimate the risk of active disease is a promising tool for TB screening. PMID:27126741

  6. Detailed Clinical Models: Representing Knowledge, Data and Semantics in Healthcare Information Technology

    PubMed Central

    2014-01-01

    Objectives 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. Methods 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. Results 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. Conclusions 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. PMID:25152829

  7. 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.

  8. The impact of extracellular matrix on the chemoresistance of solid tumors--experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy.

    PubMed

    Baumgartner, G; Gomar-Höss, C; Sakr, L; Ulsperger, E; Wogritsch, C

    1998-09-11

    Chemoresistance is of outstanding importance for the limited results of chemotherapy in solid tumors. Chemoresistance of multicellular tumor tissues is more pronounced than that of single cells in vivo and in vitro. The enzyme hyaluronidase is able to loosen the cell-cell contact and the interstitial connective tissue and as such, in a number of preclinical and clinical trials, was shown to enhance the efficacy of cytostatic agents. Although proven to be very effective as additive to local chemotherapy, the systemic efficacy is not documented as well. We present a randomized trial done in high-grade astrocytomas with combined chemotherapy and radiation therapy with and without hyaluronidase. After very promising pilot results with systemic hyaluronidase in various tumor entities and also astrocytomas, this randomized study failed to show synergy to chemotherapy and radiation therapy in high-grade astrocytomas concerning survival. The promising preclinical data and the rather well documented activity in therapeutic use as additive to local chemotherapy seem to be an adequate motive to further elucidate the complex manner in which hyaluronidase is active in the interstitial tumor matrix and to obtain more information concerning the optimal route of application, the optimal dosage and the spectrum of tumor entities where it is synergistic with cytostatic chemotherapy and perhaps even radiation therapy.

  9. Selecting clinical diagnoses: logical strategies informed by experience.

    PubMed

    Stanley, Donald Edward; Campos, Daniel G

    2016-08-01

    This article describes reasoning strategies used by clinicians in different diagnostic circumstances and how these modes of inquiry may allow further insight into the evaluation and treatment of patients. Specifically, it aims to make explicit the implicit logical considerations that guide a variety of strategies in the diagnostic process, as exemplified in specific clinical cases. It focuses, in particular, in strategies that clinicians use to move from a large set of possible diagnoses initially suggested by abductive inferences - the process of hypothesis generation that creates a diagnostic space - to a narrower set or even to a single 'best' diagnosis, where the criteria to determine what is 'best' may differ according to different strategies. Experienced clinicians should have a diversified kit of strategies - for example, Bayesian probability or inference to a lovely explanation - to select from among previously generated hypotheses, rather than rely on any one approach every time.

  10. Using biological markers to inform a clinically meaningful treatment response.

    PubMed

    Yehuda, Rachel; Bierer, Linda M; Pratchett, Laura C; Pelcovitz, Michelle

    2010-10-01

    Combat veterans with posttraumatic stress disorder (PTSD) demonstrate less robust improvement following treatments than do civilians with PTSD. This paper discusses a theoretical model for evaluating treatment response based on the extent of change in biological markers of symptom severity or resilience between treatment initiation and termination. Such analysis permits a determination of biological change associated with the liberal criteria commonly used to determine treatment response in combat PTSD, and a comparison of this to the biological change associated with clinical response determined according to the conservative definition more appropriate to civilian PTSD. Interim data supporting the utility of this approach is presented based on preliminary analyses from our work in progress. We propose that future studies consider the unique consequences of combat trauma and develop treatments that incorporate the complex nature of the exposure and response characteristic of a veteran population. PMID:20955338

  11. Optimizing perioperative decision making: improved information for clinical workflow planning.

    PubMed

    Doebbeling, Bradley N; Burton, Matthew M; Wiebke, Eric A; Miller, Spencer; Baxter, Laurence; Miller, Donald; Alvarez, Jorge; Pekny, Joseph

    2012-01-01

    Perioperative care is complex and involves multiple interconnected subsystems. Delayed starts, prolonged cases and overtime are common. Surgical procedures account for 40-70% of hospital revenues and 30-40% of total costs. Most planning and scheduling in healthcare is done without modern planning tools, which have potential for improving access by assisting in operations planning support. We identified key planning scenarios of interest to perioperative leaders, in order to examine the feasibility of applying combinatorial optimization software solving some of those planning issues in the operative setting. Perioperative leaders desire a broad range of tools for planning and assessing alternate solutions. Our modeled solutions generated feasible solutions that varied as expected, based on resource and policy assumptions and found better utilization of scarce resources. Combinatorial optimization modeling can effectively evaluate alternatives to support key decisions for planning clinical workflow and improving care efficiency and satisfaction.

  12. Factors influencing outcomes of clinical information systems implementation: a systematic review.

    PubMed

    Gruber, Dianne; Cummings, Greta G; LeBlanc, Lisa; Smith, Donna L

    2009-01-01

    Healthcare agencies spend significant resources to acquire or develop clinical information systems. However, implementation of clinical information systems often report significant failures. A systematic review of the research literature identified processes and outcomes of clinical information system implementation and factors that influenced success or failure. Of 124 original papers, 18 met the primary inclusion criteria-clinical systems implementation, healthcare facility, and outcome measures. Data extraction elements included study characteristics, outcomes, and implementation risk factors classified according to the Expanded Systems Life Cycle. The quality of each study was also assessed. Forty-nine outcomes of clinical information system implementation were identified. No single implementation strategy proved completely effective. The findings of this synthesis direct the attention of managers and decision makers to the importance of clinical context to successful implementation of clinical information systems. The highest number of factors influencing success or failure was reported during implementation and system "go-live." End-user support or lack thereof was the important factor in both successful and failed implementations, respectively. Following the Expanded Systems Life Cycle management model instead of a traditional project management approach may contribute to greater success over time, by paying particular attention to the underrecognized maintenance phase of implementation. PMID:19411944

  13. Tantalum trabecular metal - addition of human skeletal cells to enhance bone implant interface strength and clinical application.

    PubMed

    Smith, J O; Sengers, B G; Aarvold, A; Tayton, E R; Dunlop, D G; Oreffo, R O C

    2014-04-01

    The osteo-regenerative properties of allograft have recently been enhanced by addition of autogenous human bone marrow stromal cells (HBMSCs). Limitations in the use of allograft have prompted the investigation of tantalum trabecular metal (TTM) as a potential alternative. TTM is already in widespread orthopaedic use, although in applications where there is poor initial stability, or when TTM is used in conjunction with bone grafting, initial implant loading may need to be limited. The aim of this study was to evaluate the osteo-regenerative potential of TTM with HBMSCs, in direct comparison to human allograft and autograft. HBMSCs were cultured on blocks of TTM, allograft or autograft in basal and osteogenic media. Molecular profiling, confocal and scanning electron microscopy (SEM) and biochemical assays were used to characterize cell adherence, proliferation and phenotype. Mechanical testing was used to define the tensile characteristics of the constructs. HBMSCs displayed adherence and proliferation throughout TTM, evidenced by immunocytochemistry and SEM, with significant cellular ingrowth and matrix production through TTM. In contrast to cells cultured with allograft, cell proliferation assays showed significantly higher activity with TTM (p < 0.001), although molecular profiling confirmed no significant difference in expression of osteogenic genes. In contrast to acellular constructs, mechanical testing of cell-TTM constructs showed enhanced tensile characteristics, which compared favourably to cell-allograft constructs. These studies demonstrated the ability of TTM to support HBMSC growth and osteogenic differentiation comparable to allograft. Thus, TTM represents an alternative to allograft for osteo-regenerative strategies, extending its clinical applications as a substitute for allograft.

  14. The deployment of information technology in clinical laboratories and its impact on professional roles.

    PubMed

    Friedman, B A; Mitchell, W

    1992-01-01

    New information technology is deployed in hospital clinical laboratories to increase both the quality and efficiency of laboratory operations. Although total laboratory expenses may rise as a result of technology deployment, the average cost per test may decline. S-curves can be used to illustrate the effects of new information technology--such as a laboratory information system (LIS)--on the useful output and use of resources in laboratories. Major changes are now occurring as a result of the deployment of information technology, most notably in the area of automated information management. The role of laboratory professionals must be modified in response to this new information environment. The generation of information within clinical laboratories should be considered as the beginning--not the end--of the responsibility of laboratory professionals. PMID:10116938

  15. The clinical adoption meta-model: a temporal meta-model describing the clinical adoption of health information systems.

    PubMed

    Price, Morgan; Lau, Francis

    2014-01-01

    Health information systems (HISs) hold the promise to transform health care; however, their adoption is challenged. We have developed the Clinical Adoption Meta-Model (CAMM) to help describe processes and possible challenges with clinical adoption. The CAMM, developed through an action research study to evaluate a provincial HIS, is a temporal model with four dimensions: availability, use, behaviour changes, and outcome changes. Seven CAMM archetypes are described, illustrating classic trajectories of adoption of HISs over time. Each archetype includes an example from the literature. The CAMM and its archetypes can support HIS implementers, evaluators, learners, and researchers. PMID:24884588

  16. A CIS (Clinical Information System) Quality Evaluation Tool for Nursing Care Services

    ERIC Educational Resources Information Center

    Lee, Seon Ah

    2010-01-01

    The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…

  17. 77 FR 50547 - Agency Information Collection: Emergency Submission for OMB Review (PACT: Clinical Innovation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... Study--Helping Veterans Manage Chronic Pain); Comment Request AGENCY: Veterans Health Administration... emergency clearance is being requested for information needed to assess the effectiveness of pain care...).'' SUPPLEMENTARY INFORMATION: Titles: Clinical Innovation Study--Helping Veterans Manage Chronic Pain. a. Pain...

  18. Factors Influencing Electronic Clinical Information Exchange in Small Medical Group Practices

    ERIC Educational Resources Information Center

    Kralewski, John E.; Zink, Therese; Boyle, Raymond

    2012-01-01

    Purpose: The purpose of this study was to identify the organizational factors that influence electronic health information exchange (HIE) by medical group practices in rural areas. Methods: A purposive sample of 8 small medical group practices in 3 experimental HIE regions were interviewed to determine the extent of clinical information exchange…

  19. An ontologically founded architecture for information systems in clinical and epidemiological research

    PubMed Central

    2011-01-01

    This paper presents an ontologically founded basic architecture for information systems, which are intended to capture, represent, and maintain metadata for various domains of clinical and epidemiological research. Clinical trials exhibit an important basis for clinical research, and the accurate specification of metadata and their documentation and application in clinical and epidemiological study projects represents a significant expense in the project preparation and has a relevant impact on the value and quality of these studies. An ontological foundation of an information system provides a semantic framework for the precise specification of those entities which are presented in this system. This semantic framework should be grounded, according to our approach, on a suitable top-level ontology. Such an ontological foundation leads to a deeper understanding of the entities of the domain under consideration, and provides a common unifying semantic basis, which supports the integration of data and the interoperability between different information systems. The intended information systems will be applied to the field of clinical and epidemiological research and will provide, depending on the application context, a variety of functionalities. In the present paper, we focus on a basic architecture which might be common to all such information systems. The research, set forth in this paper, is included in a broader framework of clinical research and continues the work of the IMISE on these topics. PMID:21995847

  20. Sharing of information by students in an objective structured clinical examination.

    PubMed

    Rutala, P J; Witzke, D B; Leko, E O; Fulginiti, J V; Taylor, P J

    1991-03-01

    Increasing numbers of medical schools are using Objective Structured Clinical Examinations (OSCEs) to evaluate students. An Objective Structured Clinical Examination employs a multiple-station format and standardized patients to document students' clinical skills. A lengthy format is necessary; testing an entire class often necessitates multiple repetitions of the same examination. This dictates a need to minimize sharing of information among students. We studied six administrations of an Objective Structured Clinical Examination designed to measure skills. Analyses were conducted to detect changes in scores over the administrations as well as over the 8.5 hours of each day of testing. An increase in either might indicate information sharing had occurred. No significant increase occurred. If information was shared, it had no significant effect on scores. Skills a student uses to approach a patient should not change even if the patient's complaints are known.

  1. Using an information warehouse to screen patients for clinical trials: a prototype.

    PubMed

    Kamal, Jyoti; Pasuparthi, Kabardhi; Rogers, Patrick; Buskirk, Jason; Mekhjian, Hagop

    2005-01-01

    Success of a clinical trial recruitment process for drug discovery and new treatments depends on screening and identifying eligible patients in a timely manner. This can be a complex and tedious process that in many instances requires a research nurse to manually track patients that may be eligible. At the Ohio State University Medical Center (OSUMC) we have developed a web-based functional prototype that uses the data stored in the Information Warehouse (IW) to screen patients that meet the eligibility criteria for clinical trials. Using this prototype, a researcher can apply a set of inclusion/exclusion criteria pertinent to a research protocol and instantly find patients that may qualify for the clinical trial without revealing their identity. A researcher has access to all detailed historical clinical information such as lab results, diagnosis codes, pathology reports and clinical notes.

  2. Information needs of health care professionals in an AIDS outpatient clinic as determined by chart review.

    PubMed Central

    Giuse, N B; Huber, J T; Giuse, D A; Brown, C W; Bankowitz, R A; Hunt, S

    1994-01-01

    OBJECTIVE: To examine the information needs of health care professionals in HIV-related clinical encounters, and to determine the suitability of existing information sources to address those needs. SETTING: HIV outpatient clinic. PARTICIPANTS: Seven health care professionals with diverse training and patient care involvement. METHODS: Based on patient charts describing 120 patient encounters, participants generated 266 clinical questions. Printed and on-line information sources were used to answer questions in two phases: using commonly available sources and using all available medical library sources. MEASUREMENTS: The questions were divided into 16 categories by subject. The number of questions answered, their categories, the information source(s) providing answers, and the time required to answer questions were recorded for each phase. RESULTS: Each participant generated an average of 3.8 clinical questions per chart. Five categories accounted for almost 75% of all questions; the treatment protocols/regimens category was most frequent (24%). A total of 245 questions (92%) were answered, requiring an average of 15 minutes per question. Most (87%) of the questions were answered via electronic sources, even though paper sources were consulted first. CONCLUSIONS: The participating professionals showed considerable information needs. A combination of on-line and paper sources was necessary to provide the answers. The study suggests that present-day information sources are not entirely satisfactory for answering clinical questions generated by examining charts of HIV-infected patients. PMID:7850563

  3. Technology-Assisted Patient Access to Clinical Information: An Evaluation Framework for Blue Button

    PubMed Central

    Nazi, Kim M; Luger, Tana M; Amante, Daniel J; Smith, Bridget M; Barker, Anna; Shimada, Stephanie L; Volkman, Julie E; Garvin, Lynn; Simon, Steven R; Houston, Thomas K

    2014-01-01

    Background Patient access to clinical information represents a means to improve the transparency and delivery of health care as well as interactions between patients and health care providers. We examine the movement toward augmenting patient access to clinical information using technology. Our analysis focuses on “Blue Button,” a tool that many health care organizations are implementing as part of their Web-based patient portals. Objective We present a framework for evaluating the effects that technology-assisted access to clinical information may have on stakeholder experiences, processes of care, and health outcomes. Methods A case study of the United States Department of Veterans Affairs' (VA) efforts to make increasing amounts of clinical information available to patients through Blue Button. Drawing on established collaborative relationships with researchers, clinicians, and operational partners who are engaged in the VA’s ongoing implementation and evaluation efforts related to Blue Button, we assessed existing evidence and organizational practices through key informant interviews, review of documents and other available materials, and an environmental scan of published literature and the websites of other health care organizations. Results Technology-assisted access to clinical information represents a significant advance for VA patients and marks a significant change for the VA as an organization. Evaluations of Blue Button should (1) consider both processes of care and outcomes, (2) clearly define constructs of focus, (3) examine influencing factors related to the patient population and clinical context, and (4) identify potential unintended consequences. Conclusions The proposed framework can serve as a roadmap to guide subsequent research and evaluation of technology-assisted patient access to clinical information. To that end, we offer a series of related recommendations. PMID:24675395

  4. Exploring the use of large clinical data to inform patients for shared decision making.

    PubMed

    Hill, Brent; Proulx, Joshua; Zeng-Treitler, Qing

    2013-01-01

    Barriers to patient participation in the shared decision making process prevent patients from fully participating in evaluating treatment options and treatment selection. Patients who use a decision aid are more informed and engaged in the shared decision making process. Patient decision aids do not use real clinical data for patient information and may not represent the data well. We designed an interface, for a shared decision making aid, that leverages clinical data to inform risk ratios and create patient stories, or vignettes, and present a visual representation of quantified treatment outcomes data. Usability testing was conducted with experts to evaluate the interface and the utility of using real clinical information that patients can explore. The experts' comments were transcribed and coded for themes. Themes were quantified and comments were interpreted for refinement and modification to the patient decision aid interface and data visualization.

  5. Distilling clinically interpretable information from data collected on next-generation wearable sensors.

    PubMed

    Haslam, Bryan; Gordhandas, Ankit; Ricciardi, Catherine; Verghese, George; Heldt, Thomas

    2011-01-01

    Medical electronic systems are generating ever larger data sets from a variety of sensors and devices. Such systems are also being packaged in wearable designs for easy and broad use. The large volume of data and the constraints of low-power, extended-duration, and wireless monitoring impose the need for on-chip processing to distill clinically relevant information from the raw data. The higher-level information, rather than the raw data, is what needs to be transmitted. We present one example of information processing for continuous, high-sampling-rate data collected from wearable and portable devices. A wearable cardiac and motion monitor designed by colleagues at MIT simultaneously records electrocardiogram (ECG) and 3-axis acceleration to onboard memory, in an ambulatory setting. The acceleration data is used to generate a continuous estimate of physical activity. Additionally, we use a Portapres continuous blood pressure monitor to concurrently record the arterial blood pressure (ABP) waveform. To help reduce noise, which is an increased challenge in ambulatory monitoring, we use both the ECG and ABP waveforms to generate a robust measure of heart rate from noisy data. We also generate an overall signal abnormality index to aid in the interpretation of the results. Two important cardiovascular quantities, namely cardiac output (CO) and total peripheral resistance (TPR), are then derived from this data over a sequence of physical activities. CO and TPR can be estimated (to within a scale factor) from heart rate, pulse pressure and mean arterial blood pressure, which in turn are directly obtained from the ECG and ABP signals. Data was collected on 10 healthy subjects. The derived quantities vary in a manner that is consistent with known physiology. Further work remains to correlate these values with the cardiac health state.

  6. A Proposed Clinical Decision Support Architecture Capable of Supporting Whole Genome Sequence Information

    PubMed Central

    Welch, Brandon M.; Rodriguez Loya, Salvador; Eilbeck, Karen; Kawamoto, Kensaku

    2014-01-01

    Whole genome sequence (WGS) information may soon be widely available to help clinicians personalize the care and treatment of patients. However, considerable barriers exist, which may hinder the effective utilization of WGS information in a routine clinical care setting. Clinical decision support (CDS) offers a potential solution to overcome such barriers and to facilitate the effective use of WGS information in the clinic. However, genomic information is complex and will require significant considerations when developing CDS capabilities. As such, this manuscript lays out a conceptual framework for a CDS architecture designed to deliver WGS-guided CDS within the clinical workflow. To handle the complexity and breadth of WGS information, the proposed CDS framework leverages service-oriented capabilities and orchestrates the interaction of several independently-managed components. These independently-managed components include the genome variant knowledge base, the genome database, the CDS knowledge base, a CDS controller and the electronic health record (EHR). A key design feature is that genome data can be stored separately from the EHR. This paper describes in detail: (1) each component of the architecture; (2) the interaction of the components; and (3) how the architecture attempts to overcome the challenges associated with WGS information. We believe that service-oriented CDS capabilities will be essential to using WGS information for personalized medicine. PMID:25411644

  7. Audit of the informed consent process as a part of a clinical research quality assurance program.

    PubMed

    Lad, Pramod M; Dahl, Rebecca

    2014-06-01

    Audits of the informed consent process are a key element of a clinical research quality assurance program. A systematic approach to such audits has not been described in the literature. In this paper we describe two components of the audit. The first is the audit of the informed consent document to verify adherence with federal regulations. The second component is comprised of the audit of the informed consent conference, with emphasis on a real time review of the appropriate communication of the key elements of the informed consent. Quality measures may include preparation of an informed consent history log, notes to accompany the informed consent, the use of an informed consent feedback tool, and the use of institutional surveys to assess comprehension of the informed consent process.

  8. 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

  9. Guidance on Evaluating Options for Representing Clinical Data within Health Information Systems.

    PubMed

    Hardiker, Nicholas R; Hynes, Brenda

    2012-01-01

    The health information system PlunketPlus is a clinical initiative of Plunket (the Royal New Zealand Plunket Society) with a goal of further improving the health outcomes for children in New Zealand. The success of PlunketPlus depends heavily on how data is represented within the system. The purpose of the study described in this paper was to use PlunketPlus as a case study to inform the development of guidance on evaluating options for representing clinical data within health information systems, with a particular focus on automating existing informational processes. It has been possible to take some of the lessons learned to inform the development of initial more generic guidance that might be applicable across a range of domains. This paper concludes with a description of how Plunket applied the guidance as part of the development of PlunketPlus.

  10. Connecting public health and clinical information systems by using a standardized methodology.

    PubMed

    Lopez, Diego M; Blobel, Bernd G M E

    2007-01-01

    To meet the challenge for efficient, high quality and sustainable care, health systems in developed and increasingly in developing countries require extended communication and cooperation between all principals involved in citizen's care. The challenge also concerns supporting information systems, which demand interoperation with public health, bioinformatics, genomics, administrative, governmental, and other sources of data. The paper describes an architecture development methodology for modeling the integration between clinical and public health information systems that harmonizes existent standardized modeling approaches and integrates HL7 domain knowledge. An integration-architecture for information sharing between public health surveillance and clinical information systems is derived demonstrating the feasibility of the proposed methodology. Predominantly, a harmonized process for analysis, design, implementation and maintenance of semantically interoperable information systems based on formal grammars is discussed in some detail.

  11. 43 CFR 3276.13 - What additional information must I give BLM in the monthly report for flash and dry steam...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... BLM in the monthly report for flash and dry steam facilities? 3276.13 Section 3276.13 Public Lands... What additional information must I give BLM in the monthly report for flash and dry steam facilities? In addition to the regular monthly report information required by § 3276.12, send to BLM: (a)...

  12. 43 CFR 3276.13 - What additional information must I give BLM in the monthly report for flash and dry steam...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... BLM in the monthly report for flash and dry steam facilities? 3276.13 Section 3276.13 Public Lands... What additional information must I give BLM in the monthly report for flash and dry steam facilities? In addition to the regular monthly report information required by § 3276.12, send to BLM: (a)...

  13. 43 CFR 3276.13 - What additional information must I give BLM in the monthly report for flash and dry steam...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... BLM in the monthly report for flash and dry steam facilities? 3276.13 Section 3276.13 Public Lands... What additional information must I give BLM in the monthly report for flash and dry steam facilities? In addition to the regular monthly report information required by § 3276.12, send to BLM: (a)...

  14. 43 CFR 3276.13 - What additional information must I give BLM in the monthly report for flash and dry steam...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... BLM in the monthly report for flash and dry steam facilities? 3276.13 Section 3276.13 Public Lands... What additional information must I give BLM in the monthly report for flash and dry steam facilities? In addition to the regular monthly report information required by § 3276.12, send to BLM: (a)...

  15. How Strong are Passwords Used to Protect Personal Health Information in Clinical Trials?

    PubMed Central

    Moreau, Katherine; Jonker, Elizabeth

    2011-01-01

    Background Findings and statements about how securely personal health information is managed in clinical research are mixed. Objective The objective of our study was to evaluate the security of practices used to transfer and share sensitive files in clinical trials. Methods Two studies were performed. First, 15 password-protected files that were transmitted by email during regulated Canadian clinical trials were obtained. Commercial password recovery tools were used on these files to try to crack their passwords. Second, interviews with 20 study coordinators were conducted to understand file-sharing practices in clinical trials for files containing personal health information. Results We were able to crack the passwords for 93% of the files (14/15). Among these, 13 files contained thousands of records with sensitive health information on trial participants. The passwords tended to be relatively weak, using common names of locations, animals, car brands, and obvious numeric sequences. Patient information is commonly shared by email in the context of query resolution. Files containing personal health information are shared by email and, by posting them on shared drives with common passwords, to facilitate collaboration. Conclusion If files containing sensitive patient information must be transferred by email, mechanisms to encrypt them and to ensure that password strength is high are necessary. More sophisticated collaboration tools are required to allow file sharing without password sharing. We provide recommendations to implement these practices. PMID:21317106

  16. An Automated Medical Information Management System (OpScan-MIMS) in a Clinical Setting

    PubMed Central

    Margolis, S.; Baker, T.G.; Ritchey, M.G.; Alterescu, S.; Friedman, C.

    1981-01-01

    This paper describes an automated medical information management system within a clinic setting. The system includes an optically scanned data entry system (OpScan), a generalized, interactive retrieval and storage software system(Medical Information Management System, MIMS) and the use of time-sharing. The system has the advantages of minimal hardware purchase and maintenance, rapid data entry and retrieval, user-created programs, no need for user knowledge of computer language or technology and is cost effective. The OpScan-MIMS system has been operational for approximately 16 months in a sexually transmitted disease clinic. The system's application to medical audit, quality assurance, clinic management and clinical training are demonstrated.

  17. Biomedical data mining in clinical routine: expanding the impact of hospital information systems.

    PubMed

    Müller, Marcel; Markó, Kornel; Daumke, Philipp; Paetzold, Jan; Roesner, Arnold; Klar, Rüdiger

    2007-01-01

    In this paper we want to describe how the promising technology of biomedical data mining can improve the use of hospital information systems: a large set of unstructured, narrative clinical data from a dermatological university hospital like discharge letters or other dermatological reports were processed through a morpho-semantic text retrieval engine ("MorphoSaurus") and integrated with other clinical data using a web-based interface and brought into daily clinical routine. The user evaluation showed a very high user acceptance - this system seems to meet the clinicians' requirements for a vertical data mining in the electronic patient records. What emerges is the need for integration of biomedical data mining into hospital information systems for clinical, scientific, educational and economic reasons.

  18. WebCIS: large scale deployment of a Web-based clinical information system.

    PubMed

    Hripcsak, G; Cimino, J J; Sengupta, S

    1999-01-01

    WebCIS is a Web-based clinical information system. It sits atop the existing Columbia University clinical information system architecture, which includes a clinical repository, the Medical Entities Dictionary, an HL7 interface engine, and an Arden Syntax based clinical event monitor. WebCIS security features include authentication with secure tokens, authorization maintained in an LDAP server, SSL encryption, permanent audit logs, and application time outs. WebCIS is currently used by 810 physicians at the Columbia-Presbyterian center of New York Presbyterian Healthcare to review and enter data into the electronic medical record. Current deployment challenges include maintaining adequate database performance despite complex queries, replacing large numbers of computers that cannot run modern Web browsers, and training users that have never logged onto the Web. Although the raised expectations and higher goals have increased deployment costs, the end result is a far more functional, far more available system. PMID:10566471

  19. Key informants' perspectives of implementing chromosomal microarrays into clinical practice in Australia.

    PubMed

    Turbitt, Erin; Halliday, Jane L; Metcalfe, Sylvia A

    2013-08-01

    High-resolution genomic tests have the potential to revolutionize healthcare by vastly improving mutation detection. The use of chromosomal microarray (CMA) represents one of the earliest examples of these new genomic tests being introduced and disseminated in the clinic. While CMA has clear advantages over traditional karyotyping in terms of mutation detection, little research has investigated the process by which CMA was implemented in clinical settings. Fifteen key informants, six clinicians, and nine laboratory scientists from four Australian states were interviewed about their experiences during and in the time since CMA was adopted for clinical use. Participants discussed challenges such as result interpretation and communication. Strengths were also highlighted, including the collaborative approaches of some centers. Clinical experiences and opinions can inform larger studies with a range of stakeholders, including patients. The historical perspectives from this retrospective study can be helpful in guiding the implementation of future genomic technologies such as whole exome/genome sequencing.

  20. Information needs of clinical teams: analysis of questions received by the Clinical Informatics Consult Service

    PubMed Central

    Jerome, Rebecca N.; Giuse, Nunzia B.; Wilder Gish, Kimbra; Sathe, Nila A.; Dietrich, Mary S.

    2001-01-01

    Objectives: To examine the types of questions received by Clinical Informatics Consult Service (CICS) librarians from clinicians on rounds and to analyze the number of clearly differentiated viewpoints provided in response. Design: Questions were retrieved from an internal database, the CICS Knowledge Base, and analyzed for redundancy by subject analysis. The unique questions were classified into ten categories by subject. Treatment-related questions were analyzed for the number of viewpoints represented in the librarian's response. Results: The CICS Knowledge Base contained 476 unique questions and 71 redundant questions. Among the unique queries, the top two categories accounted for 67%: treatment (36%) and disease description (31%). Within the treatment-related subset, 138 questions (59%) required representation of more than one viewpoint in the librarian's response. Discussion: Questions generated by clinicians frequently require comprehensive, critical appraisal of the medical literature, a need that can be filled by librarians trained in such techniques. This study demonstrates that many questions require representation of more than one viewpoint to answer completely. Moreover, the redundancy rate underscores the need for resources like the CICS Knowledge Base. By critically analyzing the medical literature, CICS librarians are providing a time-saving and valuable service for clinicians and charting new territory for librarians. PMID:11337949

  1. The development and evaluation of a nursing information system for caring clinical in-patient.

    PubMed

    Fang, Yu-Wen; Li, Chih-Ping; Wang, Mei-Hua

    2015-01-01

    The research aimed to develop a nursing information system in order to simplify the admission procedure for caring clinical in-patient, enhance the efficiency of medical information documentation. Therefore, by correctly delivering patients’ health records, and providing continues care, patient safety and care quality would be effectively improved. The study method was to apply Spiral Model development system to compose a nursing information team. By using strategies of data collection, working environment observation, applying use-case modeling, and conferences of Joint Application Design (JAD) to complete the system requirement analysis and design. The Admission Care Management Information System (ACMIS) mainly included: (1) Admission nursing management information system. (2) Inter-shift meeting information management system. (3) The linkage of drug management system and physical examination record system. The framework contained qualitative and quantitative components that provided both formative and summative elements of the evaluation. System evaluation was to apply information success model, and developed questionnaire of consisting nurses’ acceptance and satisfaction. The results of questionnaires were users’ satisfaction, the perceived self-involvement, age and information quality were positively to personal and organizational effectiveness. According to the results of this study, the Admission Care Management Information System was practical to simplifying clinic working procedure and effective in communicating and documenting admission medical information. PMID:26578276

  2. The development and evaluation of a nursing information system for caring clinical in-patient.

    PubMed

    Fang, Yu-Wen; Li, Chih-Ping; Wang, Mei-Hua

    2015-01-01

    The research aimed to develop a nursing information system in order to simplify the admission procedure for caring clinical in-patient, enhance the efficiency of medical information documentation. Therefore, by correctly delivering patients’ health records, and providing continues care, patient safety and care quality would be effectively improved. The study method was to apply Spiral Model development system to compose a nursing information team. By using strategies of data collection, working environment observation, applying use-case modeling, and conferences of Joint Application Design (JAD) to complete the system requirement analysis and design. The Admission Care Management Information System (ACMIS) mainly included: (1) Admission nursing management information system. (2) Inter-shift meeting information management system. (3) The linkage of drug management system and physical examination record system. The framework contained qualitative and quantitative components that provided both formative and summative elements of the evaluation. System evaluation was to apply information success model, and developed questionnaire of consisting nurses’ acceptance and satisfaction. The results of questionnaires were users’ satisfaction, the perceived self-involvement, age and information quality were positively to personal and organizational effectiveness. According to the results of this study, the Admission Care Management Information System was practical to simplifying clinic working procedure and effective in communicating and documenting admission medical information.

  3. Beyond information retrieval and electronic health record use: competencies in clinical informatics for medical education.

    PubMed

    Hersh, William R; Gorman, Paul N; Biagioli, Frances E; Mohan, Vishnu; Gold, Jeffrey A; Mejicano, George C

    2014-01-01

    Physicians in the 21st century will increasingly interact in diverse ways with information systems, requiring competence in many aspects of clinical informatics. In recent years, many medical school curricula have added content in information retrieval (search) and basic use of the electronic health record. However, this omits the growing number of other ways that physicians are interacting with information that includes activities such as clinical decision support, quality measurement and improvement, personal health records, telemedicine, and personalized medicine. We describe a process whereby six faculty members representing different perspectives came together to define competencies in clinical informatics for a curriculum transformation process occurring at Oregon Health & Science University. From the broad competencies, we also developed specific learning objectives and milestones, an implementation schedule, and mapping to general competency domains. We present our work to encourage debate and refinement as well as facilitate evaluation in this area.

  4. ClinicalTrials.gov registration can supplement information in abstracts for systematic reviews: a comparison study

    PubMed Central

    2013-01-01

    Background The inclusion of randomized controlled trials (RCTs) reported in conference abstracts in systematic reviews is controversial, partly because study design information and risk of bias is often not fully reported in the abstract. The Association for Research in Vision and Ophthalmology (ARVO) requires trial registration of abstracts submitted for their annual conference as of 2007. Our goal was to assess the feasibility of obtaining study design information critical to systematic reviews, but not typically included in conference abstracts, from the trial registration record. Methods We reviewed all conference abstracts presented at the ARVO meetings from 2007 through 2009, and identified 496 RCTs; 154 had a single matching registration record in ClinicalTrials.gov. Two individuals independently extracted information from the abstract and the ClinicalTrials.gov record, including study design, sample size, inclusion criteria, masking, interventions, outcomes, funder, and investigator name and contact information. Discrepancies were resolved by consensus. We assessed the frequencies of reporting variables appearing in the abstract and the trial register and assessed agreement of information reported in both sources. Results We found a substantial amount of study design information in the ClinicalTrials.gov record that was unavailable in the corresponding conference abstract, including eligibility criteria associated with gender (83%; 128/154); masking or blinding of study participants (53%, 82/154), persons administering treatment (30%, 46/154), and persons measuring the outcomes (40%, 61/154)); and number of study centers (58%; 90/154). Only 34% (52/154) of abstracts explicitly described a primary outcome, but a primary outcome was included in the “Primary Outcome” field in the ClinicalTrials.gov record for 82% (126/154) of studies. One or more study interventions were reported in each abstract, but agreed exactly with those reported in Clinical

  5. The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs

    PubMed Central

    Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

    2011-01-01

    The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs. PMID:21816958

  6. The NIAID Division of AIDS enterprise information system: integrated decision support for global clinical research programs.

    PubMed

    Kagan, Jonathan M; Gupta, Nitin; Varghese, Suresh; Virkar, Hemant

    2011-12-01

    The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS) Enterprise Information System (DAIDS-ES) is a web-based system that supports NIAID in the scientific, strategic, and tactical management of its global clinical research programs for HIV/AIDS vaccines, prevention, and therapeutics. Different from most commercial clinical trials information systems, which are typically protocol-driven, the DAIDS-ES was built to exchange information with those types of systems and integrate it in ways that help scientific program directors lead the research effort and keep pace with the complex and ever-changing global HIV/AIDS pandemic. Whereas commercially available clinical trials support systems are not usually disease-focused, DAIDS-ES was specifically designed to capture and incorporate unique scientific, demographic, and logistical aspects of HIV/AIDS treatment, prevention, and vaccine research in order to provide a rich source of information to guide informed decision-making. Sharing data across its internal components and with external systems, using defined vocabularies, open standards and flexible interfaces, the DAIDS-ES enables NIAID, its global collaborators and stakeholders, access to timely, quality information about NIAID-supported clinical trials which is utilized to: (1) analyze the research portfolio, assess capacity, identify opportunities, and avoid redundancies; (2) help support study safety, quality, ethics, and regulatory compliance; (3) conduct evidence-based policy analysis and business process re-engineering for improved efficiency. This report summarizes how the DAIDS-ES was conceptualized, how it differs from typical clinical trial support systems, the rationale for key design choices, and examples of how it is being used to advance the efficiency and effectiveness of NIAID's HIV/AIDS clinical research programs.

  7. A clinical information systems strategy for a large integrated delivery network.

    PubMed Central

    Kuperman, G. J.; Spurr, C.; Flammini, S.; Bates, D.; Glaser, J.

    2000-01-01

    Integrated delivery networks (IDNs) are an emerging class of health care institutions. IDNs are formed from the affiliation of individual health care institutions and are intended to be more efficient in the current fiscal health care environment. To realize efficiencies and support their strategic visions, IDNs rely critically on excellent information technology (IT). Because of its importance to the mission of the IDN, strategic decisions about IT are made by the top leadership of the IDN. At Partners HealthCare System, a large IDN in Boston, MA, a clinical information systems strategy has been created to support the Partners clinical vision. In this paper, we discuss the Partners' structure, clinical vision, and current IT initiatives in place to address the clinical vision. The initiatives are: a clinical data repository, inpatient process support, electronic medical records, a portal strategy, referral applications, knowledge resources, support for product lines, patient computing, confidentiality, and clinical decision support. We address several of the issues encountered in trying to bring excellent information technology to a large IDN. PMID:11079921

  8. Centers Speak Up: The Clinical Context for Health Information Technology in the Ambulatory Care Setting

    PubMed Central

    Cheung, Ming; Webster, Tashonna R.; Curry, Leslie; Bradley, Elizabeth H.; Fifield, Judith; Burstin, Helen

    2008-01-01

    Background Clinicians in ambulatory care settings are increasingly called upon to use health information technology (health IT) to improve practice efficiency and performance. Successful adoption of health IT requires an understanding of how clinical tasks and workflows will be affected; yet this has not been well described. Objective To describe how health IT functions within a clinical context. Design Qualitative study, using in-depth, semi-structured interviews. Participants Executives and staff at 4 community health centers, 3 health center networks, and 1 large primary care organization. Approach Transcribed audio-recorded interviews, analyzed using the constant comparative method. Results Systematic characterization of clinical context identified 6 primary clinical domains. These included results management, intra-clinic communication, patient education and outreach, inter-clinic coordination, medication management, and provider education and feedback. We generated clinical process diagrams to characterize these domains. Participants suggested that underlying workflows for these domains must be fully operational to ensure successful deployment of health IT. Conclusions Understanding the clinical context is a necessary precursor to successful deployment of health IT. Process diagrams can serve as the basis for EHR certification, to identify challenges, to measure health IT adoption, or to develop curricular content regarding the role of health IT in clinical practice. PMID:18373132

  9. Current state of information technologies for the clinical research enterprise across academic medical centers.

    PubMed

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

    2012-06-01

    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. PMID:22686207

  10. Information systems for administration, clinical documentation and quality assurance in an Austrian disease management programme.

    PubMed

    Beck, Peter; Truskaller, Thomas; Rakovac, Ivo; Bruner, Fritz; Zanettin, Dominik; Pieber, Thomas R

    2009-01-01

    5.9% of the Austrian population is affected by diabetes mellitus. Disease Management is a structured treatment approach that is suitable for application to the diabetes mellitus area and often is supported by information technology. This article describes the information systems developed and implemented in the Austrian disease management programme for type 2 diabetes. Several workflows for administration as well as for clinical documentation have been implemented utilizing the Austrian e-Health infrastructure. De-identified clinical data is available for creating feedback reports for providers and programme evaluation.

  11. 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.

  12. Identification of potential surgical site infections leveraging an enterprise clinical information warehouse.

    PubMed

    Santangelo, Jennifer; Erdal, Selnur; Wellington, Linda; Mekhjian, Hagop; Kamal, Jyoti

    2008-11-06

    At The Ohio State University Medical Center (OSUMC), infection control practitioners (ICPs) need an accurate list of patients undergoing defined operative procedures to track surgical site infections. Using data from the OSUMC Information Warehouse (IW), we have created an automated report detailing required data. This report also displays associated surgical and pathology text or dictated reports providing additional information to the ICPs.

  13. Additional value of F-18 FDG PET/CT for initial staging in breast cancer with clinically negative axillary nodes.

    PubMed

    Jeong, Young Jin; Kang, Do-Young; Yoon, Hyun Jin; Son, Hye Joo

    2014-05-01

    The aim of this study was to evaluate the clinical impact of the preoperative ¹⁸F-FDG PET/CT in the initial workup of breast cancer with clinically negative axillary nodes. Whether the status of the clinical axillary nodal involvement can be considered a parameter for making a decision to omit the preoperative ¹⁸F-FDG PET/CT in the situation reported herein was also determined. A total of 178 patients who had newly diagnosed breast cancer and for whom the conventional diagnostic modalities showed no sign of axillary node metastasis were retrospectively enrolled in this study. All the patients underwent preoperative ¹⁸F-FDG PET/CT. The images and histologic results that were obtained were analyzed. ¹⁸F-FDG PET/CT detected primary lesions in 156 of the 178 patients, with an overall sensitivity of 87.6 %, and false negative results were obtained for 22 patients (12.4 %). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ¹⁸F-FDG PET/CT in the detection of axillary nodes were 20.8, 86.9, 37.0, 74.8, and 69.1 %, respectively. Extra-axillary node metastasis was identified in two patients (1.1 %) who had internal mammary nodes. There was no distant metastasis, but coexisting primary tumor was detected in five patients (2.8 %). In total, the therapeutic plan was changed based on ¹⁸F-FDG PET/CT in seven (3.9 %) of the 178 patients, but considering only the cases confined to breast cancer, the change occurred in only two patients (1.1 %). ¹⁸F-FDG PET/CT almost did not affect the initial staging and treatment plan in breast cancer with clinically negative axillary node. If the axillary node is clinically negative in the preoperative workup of breast cancer, then ¹⁸F-FDG PET/CT can be omitted.

  14. Impact of the information age on residency training: communication, access to public information, and clinical care.

    PubMed

    Hilty, Donald M; Belitsky, Richard; Cohen, Mitchell B; Cabaniss, Deborah L; Dickstein, Leah J; Bernstein, Carol A; Kaplan, Allan S; Scheiber, Stephen C; Crisp-Han, Holly D; Wrzosek, Marika I; Silberman, Edward K

    2015-02-01

    Access to technology in practice helps physicians manage information, communicate, and research topics; however, those in training receive almost no formal preparation for integrating web-based technologies into practice. One reason for this is that many faculty-aside from junior faculty or those in recent generations-did not grow up using Internet communication, may use it minimally, if at all, in their own practices, and may know little about its forms and varieties. This report presents a case to illustrate how these disparities may play out in the supervisory situation and makes suggestions about helping supervisors integrate technology-awareness into their teaching. PMID:25124878

  15. Impact of the information age on residency training: communication, access to public information, and clinical care.

    PubMed

    Hilty, Donald M; Belitsky, Richard; Cohen, Mitchell B; Cabaniss, Deborah L; Dickstein, Leah J; Bernstein, Carol A; Kaplan, Allan S; Scheiber, Stephen C; Crisp-Han, Holly D; Wrzosek, Marika I; Silberman, Edward K

    2015-02-01

    Access to technology in practice helps physicians manage information, communicate, and research topics; however, those in training receive almost no formal preparation for integrating web-based technologies into practice. One reason for this is that many faculty-aside from junior faculty or those in recent generations-did not grow up using Internet communication, may use it minimally, if at all, in their own practices, and may know little about its forms and varieties. This report presents a case to illustrate how these disparities may play out in the supervisory situation and makes suggestions about helping supervisors integrate technology-awareness into their teaching.

  16. Improving information availability in vascular surgical clinics. A service evaluation and improvement project.

    PubMed

    Hurst, Katherine; Kreckler, Simon; Handa, Ashok; Handa, Ashok

    2016-01-01

    This prospective service evaluation was designed to assess the availability of critical information required in vascular surgical clinics. All the data was collected via a repeated questionnaire, and the outcomes from each cycle were used to highlight where intervention was required to improve the surgical clinic experience. The first audit identified outpatient clinic deficiencies and allowed for problem analysis. Two Plan-Do-Check-Act (PDCA) cycles then were undertaken. Interventions following each cycle included consultant access to online duplex scans and secretarial access to referral letters. Results from the first cycle showed that approximately 20% of clinic appointments were missing information and only 30% of these issues were resolved during the clinic using a work around. Following the first intervention; the numbers of missing patient notes reduced to 4.3% (10.5%), and referral letters to 3.6% (4.6%). Although the numbers of missing duplex scan results increased to 6.5% (3.3%), the new system of online scan results allowed for all scans to be accessed during the clinic. Following results of a second PDCA cycle, vascular surgical secretaries were given access to 'choose and book', a database of GP referral letters. Post intervention, all missing referral letters (2%) could be accessed immediately within the clinic setting. Data driven interventions and repeated PDCA cycles can improve hospital systems for minimal cost. With an annual clinic turnaround of 2500 patients, these interventions can reduce clinic delays and potential harm caused by unavailable records for up to 500 patients a year. PMID:26893887

  17. Classification of Benign and Malignant Thyroid Nodules Using a Combined Clinical Information and Gene Expression Signatures

    PubMed Central

    Gu, Jianlei; Du, Jing; Wang, Lin; Gu, Shengli; Cheng, Juan; Yang, Jun; Lu, Hui

    2016-01-01

    Background A key challenge in thyroid carcinoma is preoperatively diagnosing malignant thyroid nodules. A novel diagnostic test that measures the expression of a 3-gene signature (DPP4, SCG5 and CA12) has demonstrated promise in thyroid carcinoma assessment. However, more reliable prediction methods combining clinical features with genomic signatures with high accuracy, good stability and low cost are needed. Methodology/Principal Findings 25 clinical information were recorded in 771 patients. Feature selection and validation were conducted using random forest. Thyroid samples and clinical data were obtained from 142 patients at two different hospitals, and expression of the 3-gene signature was measured using quantitative PCR. The predictive abilities of three models (based on the selected clinical variables, the gene expression profile, and integrated gene expression and clinical information) were compared. Seven clinical characteristics were selected based on a training set (539 patients) and tested in three test sets, yielding predictive accuracies of 82.3% (n = 232), 81.4% (n = 70), and 81.9% (n = 72). The predictive sensitivity, specificity, and accuracy were 72.3%, 80.5% and 76.8% for the model based on the gene expression signature, 66.2%, 81.8% and 74.6% for the model based on the clinical data, and 83.1%, 84.4% and 83.8% for the combined model in a 10-fold cross-validation (n = 142). Conclusions These findings reveal that the integrated model, which combines clinical data with the 3-gene signature, is superior to models based on gene expression or clinical data alone. The integrated model appears to be a reliable tool for the preoperative diagnosis of thyroid tumors. PMID:27776138

  18. 77 FR 51850 - Agency Information Collection: Emergency Submission for OMB Review (PACT: Clinical Innovation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-27

    ... Study--Helping Veterans Manage Chronic Pain); Comment Request AGENCY: Veterans Health Administration... emergency clearance is being requested for information needed to assess the effectiveness of pain care...: Clinical Innovation Study--Helping Veterans Manage Chronic Pain a. Pain Care Management Tracking Tool,...

  19. A Review of "Research-Informed Clinical Practice" in Initial Teacher Education

    ERIC Educational Resources Information Center

    Burn, Katharine; Mutton, Trevor

    2015-01-01

    This review examines the kinds of relationship between research and practice that have been envisaged in programmes designed to provide opportunities for beginning teachers to engage in "research-informed clinical practice". Although the terminology varies, scope for inclusion is defined by an intention to facilitate and deepen the…

  20. The added value of using mutational profiling in addition to cytology in diagnosing aggressive pancreaticobiliary disease: review of clinical cases at a single center

    PubMed Central

    2014-01-01

    Background This study aimed to better understand the supporting role that mutational profiling (MP) of DNA from microdissected cytology slides and supernatant specimens may play in the diagnosis of malignancy in fine-needle aspirates (FNA) and biliary brushing specimens from patients with pancreaticobiliary masses. Methods Cytology results were examined in a total of 30 patients with associated surgical (10) or clinical (20) outcomes. MP of DNA from microdissected cytology slides and from discarded supernatant fluid was analyzed in 26 patients with atypical, negative or indeterminate cytology. Results Cytology correctly diagnosed aggressive disease in 4 patients. Cytological diagnoses for the remaining 26 were as follows: 16 negative (9 false negative), 9 atypical, 1 indeterminate. MP correctly determined aggressive disease in 1 false negative cytology case and confirmed a negative cytology diagnosis in 7 of 7 cases of non-aggressive disease. Of the 9 atypical cytology cases, MP correctly diagnosed 7 as positive and 1 as negative for aggressive disease. One specimen that was indeterminate by cytology was correctly diagnosed as non-aggressive by MP. When first line malignant (positive) cytology results were combined with positive second line MP results, 12/21 cases of aggressive disease were identified, compared to 4/21 cases identified by positive cytology alone. Conclusions When first line cytology results were uncertain (atypical), questionable (negative), or not possible (non-diagnostic/indeterminate), MP provided additional information regarding the presence of aggressive disease. When used in conjunction with first line cytology, MP increased detection of aggressive disease without compromising specificity in patients that were difficult to diagnose by cytology alone. PMID:25084836

  1. The Definition of Placebo in the Informed Consent Forms of Clinical Trials

    PubMed Central

    Hernández, Astrid; Baños, Josep-E.; Llop, Cristina; Farré, Magí

    2014-01-01

    Aim Lack of knowledge concerning the nature of placebo and why it is necessary may influence the participation of patients in clinical trials. The objective of the present study is to review how placebo is described in written information for participants in clinical trials to be evaluated by a Human Research Ethics Committee. Methods All research protocols submitted for evaluation in a Spanish hospital during 2007–2013 were reviewed. The main characteristics of the studies using a placebo were collected. Three authors read each of them to determine how the term “placebo” was explained and if there was any comment on its efficacy and safety. Results Two thousand seven-hundred and forty research protocols were evaluated, of which three hundred and fifty-nine used a placebo. Pharmaceutical companies sponsored most placebo-controlled clinical trials (91.9%), and phase III studies were the commonest (59.9%). Oncology (15.0%), cardiology (14.2%), and neurology (13.1%) made the greatest contributions. A review of the informed consent forms showed that placebo was described in a similar manner in most studies: the explanation was limited to between four and eight words. Very few gave information about the risks of its use or adverse reactions from its administration. None of the studies provided details about the placebo effect. And 23 lacked any information about placebo at all. Conclusions Explanations about placebo in informed consent forms is often scarce, and information about the placebo effect and associated risks are absent. This situation may influence a full understanding of placebo by participants in clinical trials and might reduce their informed decision to participate. PMID:25423149

  2. Mapping from a clinical data warehouse to the HL7 Reference Information Model.

    PubMed

    Lyman, Jason A; Scully, Ken; Tropello, Steve; Boyd, James; Dalton, Jason; Pelletier, Sandra; Egyhazy, Csaba

    2003-01-01

    Large-scale data integration efforts to support clinical and biologic research are greatly facilitated by the adoption of standards for the representation and exchange of data. As part of a larger project to design the necessary architecture for multi-institutional sharing of disparate biomedical data, we explored the potential of the HL7 Reference Information Model (RIM) for representing the data stored in a local academic clinical data warehouse. A necessary first step in information exchange with such a warehouse is the development and utilization of tools for transforming between local data schemas and standards-based conceptual data models. We describe our initial efforts at mapping clinical concepts from a relational data warehouse to the HL7 RIM.

  3. Informed consent in clinical research; Do patients understand what they have signed?

    PubMed

    Villamañán, Elena; Ruano, Margarita; Fernández-de Uzquiano, Enma; Lavilla, Paz; González, Diana; Freire, Mercedes; Sobrino, Carmen; Herrero, Alicia

    2016-05-01

    Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.

  4. Informed consent in clinical research; Do patients understand what they have signed?

    PubMed

    Villamañán, Elena; Ruano, Margarita; Fernández-de Uzquiano, Enma; Lavilla, Paz; González, Diana; Freire, Mercedes; Sobrino, Carmen; Herrero, Alicia

    2016-01-01

    Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial. PMID:27145389

  5. Selecting a commercial clinical information system: an academic medical center's experience.

    PubMed

    Wong, E T; Abendroth, T W

    1994-01-01

    Choosing a commercial clinical information system to meet the information needs of patient care, research, education, administration, finance, and ongoing changes of the healthcare system of an academic medical center is a challenging task. For the past six months, The Milton S. Hershey Medical Center undertook this task through (i) establishing a task force, (ii) assessing end-user information needs, (iii) understanding future institutional development and strategies, (iv) conceptualizing the ideal system, (v) identifying a short list of vendors, (vi) sending RFIs to vendors, (vii) visiting vendors' headquarters, (viii) technical review, (ix) reference calls, (x) using consultation services, (xi) on-site demonstration, and (xii) visiting the vendor's clients. PMID:7950008

  6. Use of information: environmental standards, assessments of risk, prevention and clinical implications.

    PubMed

    Becklake, M R

    1985-07-22

    Information which relates morbidity or mortality to environmental conditions (exposure-response relationships) forms the basis for public health as well as for clinical action. For both types of action, the information base is the same, neither complete nor comprehensive. So, both types of action are based on hypothesis, the best available to explain the facts, but subject to review in the light of new facts. Even though the volume of information may be considerable, as in the case of asbestos, there are always gaps in knowledge to be bridged by judgement. This should be made on the basis of as complete an evaluation as possible of all the available evidence.

  7. Selecting a commercial clinical information system: an academic medical center's experience.

    PubMed

    Wong, E T; Abendroth, T W

    1994-01-01

    Choosing a commercial clinical information system to meet the information needs of patient care, research, education, administration, finance, and ongoing changes of the healthcare system of an academic medical center is a challenging task. For the past six months, The Milton S. Hershey Medical Center undertook this task through (i) establishing a task force, (ii) assessing end-user information needs, (iii) understanding future institutional development and strategies, (iv) conceptualizing the ideal system, (v) identifying a short list of vendors, (vi) sending RFIs to vendors, (vii) visiting vendors' headquarters, (viii) technical review, (ix) reference calls, (x) using consultation services, (xi) on-site demonstration, and (xii) visiting the vendor's clients.

  8. Novel Representation of Clinical Information in the ICU: Developing User Interfaces which Reduce Information Overload.

    PubMed

    Pickering, B W; Herasevich, V; Ahmed, A; Gajic, O

    2010-01-01

    The introduction of electronic medical records (EMR) and computerized physician order entry (CPOE) into the intensive care unit (ICU) is transforming the way health care providers currently work. The challenge facing developers of EMR's is to create products which add value to systems of health care delivery. As EMR's become more prevalent, the potential impact they have on the quality and safety, both negative and positive, will be amplified. In this paper we outline the key barriers to effective use of EMR and describe the methodology, using a worked example of the output. AWARE (Ambient Warning and Response Evaluation), is a physician led, electronic-environment enhancement program in an academic, tertiary care institution's ICU. The development process is focused on reducing information overload, improving efficiency and eliminating medical error in the ICU.

  9. Comparing and using assessments of the value of information to clinical decision-making.

    PubMed Central

    Urquhart, C J; Hepworth, J B

    1996-01-01

    This paper discusses the Value project, which assessed the value to clinical decision-making of information supplied by National Health Service (NHS) library and information services. The project not only showed how health libraries in the United Kingdom help clinicians in decision-making but also provided quality assurance guidelines for these libraries to help make their information services more effective. The paper reviews methods and results used in previous studies of the value of health libraries, noting that methodological differences appear to affect the results. The paper also discusses aspects of user involvement, categories of clinical decision-making, the value of information to present and future clinical decisions, and the combination of quantitative and qualitative assessments of value, as applied to the Value project and the studies reviewed. The Value project also demonstrated that the value placed on information depends in part on the career stage of the physician. The paper outlines the structure of the quality assurance tool kit, which is based on the findings and methods used in the Value project. PMID:8913550

  10. The educational and supportive needs of informal caregivers working at Refentse Clinic, Hammanskraal.

    PubMed

    Richter, M S; Peu, D

    2004-03-01

    Informal caregivers have long been used as health care providers. It is also not uncommon in present days, to see such practice in the community. This practice of caring normally occurs within the context of the family. The purpose of the study is to explore and describe the educational and supportive needs of informal caregivers. This will assist in planning and establishing health education programmes and a supportive network, for the informal caregivers at Refentse clinic, at Hammanskraal. A qualitative, explorative and descriptive design was followed, to collect the data. Participants in this study were informal caregivers, who were involved in Refentse clinic and resided in Stinkwater village. The method of choice, to gather data, was focus groups. An unstructured interview with a schedule was followed. Tesch's method was used, to analyse the data. The results indicated that the informal caregivers' educational needs were mostly concentrated on health promotion and disease prevention activities. Their needs concerning support, mainly concentrated around support from government, the community, the University and the Primary Health Care clinic, in the area where they are serving. Personal needs focussed on recognition and respect.

  11. Lollipops in the Clinic: Information Dense Mutation Plots for Precision Medicine

    PubMed Central

    Brouwer, Cory

    2016-01-01

    Introduction Concise visualization is critical to present large amounts of information in a minimal space that can be interpreted quickly. Clinical applications in precision medicine present an important use case due to the time dependent nature of the interpretations, although visualization is increasingly necessary across the life sciences. In this paper we describe the Lollipops software for the presentation of panel or exome sequencing results. Source code and binaries are freely available at https://github.com/pbnjay/lollipops. Although other software and web resources exist to produce lollipop diagrams, these packages are less suited to clinical applications. The demands of precision medicine require the ability to easily fit into a workflow and incorporate external information without manual intervention. Results The Lollipops software provides a simple command line interface that only requires an official gene symbol and mutation list making it easily scriptable. External information is integrated using the publicly available Uniprot and Pfam resources. Heuristics are used to select the most informative components and condense them for a concise plot. The output is a flexible Scalable Vector Graphic (SVG) diagram that can be displayed in a web page or graphic illustration tool. Conclusion The Lollipops software creates information-dense, publication-quality mutation plots for automated pipelines and high-throughput workflows in precision medicine. The automatic data integration enables clinical data security, and visualization heuristics concisely present knowledge with minimal user configuration. PMID:27490490

  12. The Readability of Information and Consent Forms in Clinical Research in France

    PubMed Central

    Ménoni, Véronique; Lucas, Noël; Leforestier, Jean François; Dimet, Jérôme; Doz, François; Chatellier, Gilles; Tréluyer, Jean-Marc; Chappuy, Hélène

    2010-01-01

    Background Quantitative tools have been developed to evaluate the readability of written documents and have been used in several studies to evaluate information and consent forms. These studies all showed that such documents had a low level of readability. Our objective is to evaluate the readability of Information and Consent Forms (ICFs) used in clinical research. Methods and Findings Clinical research protocols were collected from four public clinical research centers in France. Readability was evaluated based on three criteria: the presence of an illustration, the length of the text and its Flesch score. Potential effects of protocol characteristics on the length and readability of the ICFs were determined. Medical and statutory parts of the ICF form were analyzed separately. The readability of these documents was compared with that of everyday contracts, press articles, literary extracts and political speeches. We included 209 protocols and the corresponding 275 ICFs. The median length was 1304 words. Their Flesch readability scores were low (median: 24), and only about half that of selected press articles. ICF s for industrially sponsored and randomized protocols were the longest and had the highest readability scores. More than half (52%) of the text in ICFs concerned medical information, and this information was statistically (p<0.05) more readable (Flesch: 28) than statutory information (Flesch: 21). Conclusion Regardless of the field of research, the ICFs for protocols included had poor readability scores. However, a prospective analysis of this test in French should be carried out before it is put into general use. PMID:20485505

  13. Construction of a Drug Safety Assurance Information System Based on Clinical Genotyping

    PubMed Central

    Springer, John A.; Iannotti, Nicholas V.; Sprague, Jon E.; Kane, Michael D.

    2012-01-01

    To capitalize on the vast potential of patient genetic information to aid in assuring drug safety, a substantial effort is needed in both the training of healthcare professionals and the operational enablement of clinical environments. Our research aims to satisfy these needs through the development of a drug safety assurance information system (GeneScription) based on clinical genotyping that utilizes patient-specific genetic information to predict and prevent adverse drug responses. In this paper, we present the motivations for this work, the algorithms at the heart of GeneScription, and a discussion of our system and its uses. We also describe our efforts to validate GeneScription through its evaluation by practicing pharmacists and pharmacy professors and its repeated use in training pharmacists. The positive assessment of the GeneScription software tool by these domain experts provides strong validation of the importance, accuracy, and effectiveness of GeneScription. PMID:25969745

  14. Clinical, information and business process modeling to promote development of safe and flexible software.

    PubMed

    Liaw, Siaw-Teng; Deveny, Elizabeth; Morrison, Iain; Lewis, Bryn

    2006-09-01

    Using a factorial vignette survey and modeling methodology, we developed clinical and information models - incorporating evidence base, key concepts, relevant terms, decision-making and workflow needed to practice safely and effectively - to guide the development of an integrated rule-based knowledge module to support prescribing decisions in asthma. We identified workflows, decision-making factors, factor use, and clinician information requirements. The Unified Modeling Language (UML) and public domain software and knowledge engineering tools (e.g. Protégé) were used, with the Australian GP Data Model as the starting point for expressing information needs. A Web Services service-oriented architecture approach was adopted within which to express functional needs, and clinical processes and workflows were expressed in the Business Process Execution Language (BPEL). This formal analysis and modeling methodology to define and capture the process and logic of prescribing best practice in a reference implementation is fundamental to tackling deficiencies in prescribing decision support software.

  15. Text de-identification for privacy protection: a study of its impact on clinical text information content.

    PubMed

    Meystre, Stéphane M; Ferrández, Óscar; Friedlin, F Jeffrey; South, Brett R; Shen, Shuying; Samore, Matthew H

    2014-08-01

    As more and more electronic clinical information is becoming easier to access for secondary uses such as clinical research, approaches that enable faster and more collaborative research while protecting patient privacy and confidentiality are becoming more important. Clinical text de-identification offers such advantages but is typically a tedious manual process. Automated Natural Language Processing (NLP) methods can alleviate this process, but their impact on subsequent uses of the automatically de-identified clinical narratives has only barely been investigated. In the context of a larger project to develop and investigate automated text de-identification for Veterans Health Administration (VHA) clinical notes, we studied the impact of automated text de-identification on clinical information in a stepwise manner. Our approach started with a high-level assessment of clinical notes informativeness and formatting, and ended with a detailed study of the overlap of select clinical information types and Protected Health Information (PHI). To investigate the informativeness (i.e., document type information, select clinical data types, and interpretation or conclusion) of VHA clinical notes, we used five different existing text de-identification systems. The informativeness was only minimally altered by these systems while formatting was only modified by one system. To examine the impact of de-identification on clinical information extraction, we compared counts of SNOMED-CT concepts found by an open source information extraction application in the original (i.e., not de-identified) version of a corpus of VHA clinical notes, and in the same corpus after de-identification. Only about 1.2-3% less SNOMED-CT concepts were found in de-identified versions of our corpus, and many of these concepts were PHI that was erroneously identified as clinical information. To study this impact in more details and assess how generalizable our findings were, we examined the overlap between

  16. Clinical Evaluation of Functional Vision of +1.5 Diopters near Addition, Aspheric, Rotational Asymmetric Multifocal Intraocular Lens

    PubMed Central

    Khoramnia, Rahmin; Attia, Mary Safwat; Koss, Michael Janusz; Linz, Katharina; Auffarth, Gerd Uwe

    2016-01-01

    Purpose To evaluate postoperative outcomes and visual performance in intermediate distance after implantation of a +1.5 diopters (D) addition, aspheric, rotational asymmetric multifocal intraocular lens (MIOL). Methods Patients underwent bilateral cataract surgery with implantation of an aspheric, asymmetric MIOL with +1.5 D near addition. A complete ophthalmological examination was performed preoperatively and 3 months postoperatively. The main outcome measures were monocular and binocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity (UIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UNVA) and distance corrected keratometry, and manifest refraction. The Salzburg Reading Desk was used to analyze unilateral and bilateral functional vision with uncorrected and corrected reading acuity, reading distance, reading speed, and the smallest log-scaled print size that could be read effectively at near and intermediate distances. Results The study comprised 60 eyes of 30 patients (mean age, 68.30 ± 9.26 years; range, 34 to 80 years). There was significant improvement in UDVA and CDVA. Mean UIVA was 0.01 ± 0.09 logarithm of the minimum angle of resolution (logMAR) and mean DCIVA was -0.02 ± 0.11 logMAR. In Salzburg Reading Desk analysis for UIVA, the mean subjective intermediate distance was 67.58 ± 8.59 cm with mean UIVA of -0.02 ± 0.09 logMAR and mean word count of 96.38 ± 28.32 words/min. Conclusions The new aspheric, asymmetric, +1.5 D near addition MIOL offers good results for distance visual function in combination with good performance for intermediate distances and functional results for near distance. PMID:27729759

  17. Potential impact of advanced clinical information technology on cancer care in 2015.

    PubMed

    Sittig, Dean F

    2006-08-01

    New clinical information technologies now sporadically available will soon be in routine clinical use, bringing many changes to all phases of the cancer care continuum. For example, new technologies such as: (1) The next generation Internet; (2) Real-time clinical decision support systems; (3) Off-line, population-based systems; (4) Large, integrated, individual patient-level phenotypic and genotypic databases with intelligent data mining capabilities; (5) Wireless, invasive and non-invasive physiologic monitoring devices; (6) Natural Language Processing (NLP) systems; and (7) Mathematical models of complex biological systems all have the potential to impact significantly the provision of cancer care throughout its continuum. While new information management and communication techniques and technologies will reduce many of the inefficiencies and inaccuracies of our present systems, there will be an equal, and potentially far more dangerous, set of unintended consequences. Informatics investigators, cancer specialists, and health system administrators must focus on the study of what is working and what is not, as well as, on development and testing of the new clinical information management and communication technologies, if we are to be ready for the future. PMID:16783609

  18. Potential impact of advanced clinical information technology on healthcare in 2015.

    PubMed

    Sittig, Dean F

    2004-01-01

    Clinical information technologies now sporadically available will soon be in routine clinical use, bringing many changes to healthcare. For example, 1) The next generation Internet; 2) Real-time clinical decision support systems; 3) Off-line, population-based systems; 4) Large, integrated, individual patient-level phenotypic and genotypic databases with intelligent data mining capabilities; 5) Wireless, invasive and non-invasive physiologic monitoring devices; 6) Natural Language Processing (NLP) systems; and 7) Mathematical models of complex biological systems have the potential to impact significantly the future healthcare delivery system. While new information management and communication techniques and technologies will reduce many of the inefficiencies and inaccuracies of our present systems, there will be an equal, and potentially far more dangerous, set of unintended consequences. Informatics investigators and health system administrators must focus on the study of what is working and what is not, as well as, on development and testing of the new clinical information management and communication technologies, if we are to be ready for the future. PMID:15361041

  19. Reporting Device Observations for semantic interoperability of surgical devices and clinical information systems.

    PubMed

    Andersen, Björn; Ulrich, Hannes; Rehmann, Daniel; Kock, Ann-Kristin; Wrage, Jan-Hinrich; Ingenerf, Josef

    2015-08-01

    Service-oriented medical device architectures make the progress from interdisciplinary research projects to international standardisation: A new set of IEEE 11073 proposals shall pave the way to industry acceptance. This expected availability of device observations in a standardised representation enables secondary usage if interoperability with clinical information systems can be achieved. The Device Observation Reporter (DOR) described in this work is a gateway that connects these realms. After a user chooses a selection of signals from different devices in the digital operating room, the DOR records these semantically described values for a specified duration. Upon completion, the signals descriptions and values are transformed to Health Level Seven version 2 messages and sent to a hospital information system/electronic health record system within the clinical IT network. The successful integration of device data for documentation and usage in clinical information systems can further leverage the novel device communication standard proposals. Complementing these, an Integrating the Healthcare Enterprise profile will aid commercial implementers in achieving interoperability. Their solutions could incorporate clinical knowledge to autonomously select signal combinations and generate reports of diagnostic and interventional procedures, thus saving time and effort for surgical documentation.

  20. Leveraging a clinical research information system to assist biospecimen data and workflow management: a hybrid approach

    PubMed Central

    2011-01-01

    Background Large multi-center clinical studies often involve the collection and analysis of biological samples. It is necessary to ensure timely, complete and accurate recording of analytical results and associated phenotypic and clinical information. The TRIBE-AKI Consortium http://www.yale.edu/tribeaki supports a network of multiple related studies and sample biorepository, thus allowing researchers to take advantage of a larger specimen collection than they might have at an individual institution. Description We describe a biospecimen data management system (BDMS) that supports TRIBE-AKI and is intended for multi-center collaborative clinical studies that involve shipment of biospecimens between sites. This system works in conjunction with a clinical research information system (CRIS) that stores the clinical data associated with the biospecimens, along with other patient-related parameters. Inter-operation between the two systems is mediated by an interactively invoked suite of Web Services, as well as by batch code. We discuss various challenges involved in integration. Conclusions Our experience indicates that an approach that emphasizes inter-operability is reasonably optimal in allowing each system to be utilized for the tasks for which it is best suited. PMID:21884570

  1. Care episode retrieval: distributional semantic models for information retrieval in the clinical domain

    PubMed Central

    2015-01-01

    Patients' health related information is stored in electronic health records (EHRs) by health service providers. These records include sequential documentation of care episodes in the form of clinical notes. EHRs are used throughout the health care sector by professionals, administrators and patients, primarily for clinical purposes, but also for secondary purposes such as decision support and research. The vast amounts of information in EHR systems complicate information management and increase the risk of information overload. Therefore, clinicians and researchers need new tools to manage the information stored in the EHRs. A common use case is, given a - possibly unfinished - care episode, to retrieve the most similar care episodes among the records. This paper presents several methods for information retrieval, focusing on care episode retrieval, based on textual similarity, where similarity is measured through domain-specific modelling of the distributional semantics of words. Models include variants of random indexing and the semantic neural network model word2vec. Two novel methods are introduced that utilize the ICD-10 codes attached to care episodes to better induce domain-specificity in the semantic model. We report on experimental evaluation of care episode retrieval that circumvents the lack of human judgements regarding episode relevance. Results suggest that several of the methods proposed outperform a state-of-the art search engine (Lucene) on the retrieval task. PMID:26099735

  2. How Can Psychological Science Inform Research About Genetic Counseling for Clinical Genomic Sequencing?

    PubMed Central

    Rini, Christine; Bernhardt, Barbara A.; Roberts, J. Scott; Christensen, Kurt D.; Evans, James P.; Brothers, Kyle B.; Roche, Myra I.; Berg, Jonathan S.; Henderson, Gail E.

    2016-01-01

    Next generation genomic sequencing technologies (including whole genome or whole exome sequencing) are being increasingly applied to clinical care. Yet, the breadth and complexity of sequencing information raise questions about how best to communicate and return sequencing information to patients and families in ways that facilitate comprehension and optimal health decisions. Obtaining answers to such questions will require multidisciplinary research. In this paper, we focus on how psychological science research can address questions related to clinical genomic sequencing by explaining emotional, cognitive, and behavioral processes in response to different types of genomic sequencing information (e.g., diagnostic results and incidental findings). We highlight examples of psychological science that can be applied to genetic counseling research to inform the following questions: (1) What factors influence patients' and providers' informational needs for developing an accurate understanding of what genomic sequencing results do and do not mean?; (2) How and by whom should genomic sequencing results be communicated to patients and their family members?; and (3) How do patients and their families respond to uncertainties related to genomic information? PMID:25488723

  3. Development of patient centric virtual organizations (PCVOs) in clinical environment for patient information management.

    PubMed

    Mohyuddin; Gray, W A; Bailey, Hazel; Jones, Wendy; Morrey, David

    2007-01-01

    A novel Virtual Organization framework which incorporates wireless technology support is presented in the research work. The Virtual Organization is designed for a clinical environment to provide better patient information management and enhanced collaborative working of multidisciplinary care teams. The analysis studies the current clinical practices and looks at the general patient information resource structure currently in use for patient care. Based on this problem analysis and current requirements of the multi-disciplinary care team members, we propose a generic and sustainable Patient Centric Virtual Organization (PCVO) framework to complement the functionality of the existing infrastructure by incorporating wireless technologies support for improved patient information provision at the point of care. The preliminary results of the study identify and classify the specific point of care tasks suited to appropriate information resources needed by the care team members. This paper concentrates on the patient information management aspects brought in by incorporating wireless technologies at the point of care using patient information resources in a decentralized and distributed computing environment. This applied research is carried out in the secondary and tertiary care sector in the cancer domain. For the analysis and results of the pilot project, we have used a case study of a local NHS Cancer Hospital.

  4. Care episode retrieval: distributional semantic models for information retrieval in the clinical domain.

    PubMed

    Moen, Hans; Ginter, Filip; Marsi, Erwin; Peltonen, Laura-Maria; Salakoski, Tapio; Salanterä, Sanna

    2015-01-01

    Patients' health related information is stored in electronic health records (EHRs) by health service providers. These records include sequential documentation of care episodes in the form of clinical notes. EHRs are used throughout the health care sector by professionals, administrators and patients, primarily for clinical purposes, but also for secondary purposes such as decision support and research. The vast amounts of information in EHR systems complicate information management and increase the risk of information overload. Therefore, clinicians and researchers need new tools to manage the information stored in the EHRs. A common use case is, given a--possibly unfinished--care episode, to retrieve the most similar care episodes among the records. This paper presents several methods for information retrieval, focusing on care episode retrieval, based on textual similarity, where similarity is measured through domain-specific modelling of the distributional semantics of words. Models include variants of random indexing and the semantic neural network model word2vec. Two novel methods are introduced that utilize the ICD-10 codes attached to care episodes to better induce domain-specificity in the semantic model. We report on experimental evaluation of care episode retrieval that circumvents the lack of human judgements regarding episode relevance. Results suggest that several of the methods proposed outperform a state-of-the art search engine (Lucene) on the retrieval task.

  5. Organophosphate and carbamate pesticide poisoning: the usefulness of a computerized clinical information system.

    PubMed

    Lerman, Y; Hirshberg, A; Shteger, Z

    1984-01-01

    Organophosphate (OP) and carbamate poisoning are still a worldwide health problem causing numerous fatalities in humans. Physicians who have no clinical toxicological experience with these compounds may have difficulties in promptly identifying the etiologic agent and managing the acute phase of the poisoning. We describe the potential use of a computerized medical information system that includes clinical data on 236 cases of OP and carbamate poisoning, and may improve the management of such poisoning. The methods of constructing the system, the first results of using the system, and the medical institutions that can benefit from such systems are discussed.

  6. 36 CFR 1281.12 - What information must be provided to NARA for its report to Congress on a change or addition to a...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... provided to NARA for its report to Congress on a change or addition to a Presidential library facility... ADMINISTRATION NARA FACILITIES PRESIDENTIAL LIBRARY FACILITIES § 1281.12 What information must be provided to NARA for its report to Congress on a change or addition to a Presidential library facility? (a)...

  7. 36 CFR 1281.12 - What information must be provided to NARA for its report to Congress on a change or addition to a...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... provided to NARA for its report to Congress on a change or addition to a Presidential library facility... ADMINISTRATION NARA FACILITIES PRESIDENTIAL LIBRARY FACILITIES § 1281.12 What information must be provided to NARA for its report to Congress on a change or addition to a Presidential library facility? (a)...

  8. 36 CFR 1281.12 - What information must be provided to NARA for its report to Congress on a change or addition to a...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... provided to NARA for its report to Congress on a change or addition to a Presidential library facility... ADMINISTRATION NARA FACILITIES PRESIDENTIAL LIBRARY FACILITIES § 1281.12 What information must be provided to NARA for its report to Congress on a change or addition to a Presidential library facility? (a)...

  9. 36 CFR 1281.12 - What information must be provided to NARA for its report to Congress on a change or addition to a...

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... provided to NARA for its report to Congress on a change or addition to a Presidential library facility... ADMINISTRATION NARA FACILITIES PRESIDENTIAL LIBRARY FACILITIES § 1281.12 What information must be provided to NARA for its report to Congress on a change or addition to a Presidential library facility? (a)...

  10. Readability of informed consent forms in clinical trials conducted in a skin research center.

    PubMed

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch-Kincaid reading ease score, Flesch-Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23-14.09) using the Flesch-Kincaid formula and 14.64 ± 1.22 (12.67-18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11(th) grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  11. Readability of informed consent forms in clinical trials conducted in a skin research center

    PubMed Central

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  12. 76 FR 64366 - Notice of Proposed Information Collection for Public Comment: Additional On-Site Data Collection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... Collection for the Housing Choice Voucher Program Administrative Fee Study AGENCY: Office of the Policy... lists the following information: Title of Proposal: Housing Choice Voucher Program Administrative...

  13. Benchmarking Clinical Speech Recognition and Information Extraction: New Data, Methods, and Evaluations

    PubMed Central

    Zhou, Liyuan; Hanlen, Leif; Ferraro, Gabriela

    2015-01-01

    Background Over a tenth of preventable adverse events in health care are caused by failures in information flow. These failures are tangible in clinical handover; regardless of good verbal handover, from two-thirds to all of this information is lost after 3-5 shifts if notes are taken by hand, or not at all. Speech recognition and information extraction provide a way to fill out a handover form for clinical proofing and sign-off. Objective The objective of the study was to provide a recorded spoken handover, annotated verbatim transcriptions, and evaluations to support research in spoken and written natural language processing for filling out a clinical handover form. This dataset is based on synthetic patient profiles, thereby avoiding ethical and legal restrictions, while maintaining efficacy for research in speech-to-text conversion and information extraction, based on realistic clinical scenarios. We also introduce a Web app to demonstrate the system design and workflow. Methods We experiment with Dragon Medical 11.0 for speech recognition and CRF++ for information extraction. To compute features for information extraction, we also apply CoreNLP, MetaMap, and Ontoserver. Our evaluation uses cross-validation techniques to measure processing correctness. Results The data provided were a simulation of nursing handover, as recorded using a mobile device, built from simulated patient records and handover scripts, spoken by an Australian registered nurse. Speech recognition recognized 5276 of 7277 words in our 100 test documents correctly. We considered 50 mutually exclusive categories in information extraction and achieved the F1 (ie, the harmonic mean of Precision and Recall) of 0.86 in the category for irrelevant text and the macro-averaged F1 of 0.70 over the remaining 35 nonempty categories of the form in our 101 test documents. Conclusions The significance of this study hinges on opening our data, together with the related performance benchmarks and some

  14. Evaluating the Quality of Website Information of Private-Practice Clinics Offering Cell Therapies in Japan

    PubMed Central

    Nakayama, Takeo; Hatta, Taichi; Takahashi, Naomi; Fujita, Misao

    2016-01-01

    Background Although the safety and effectiveness of stem cell therapies are yet to be proven, recent studies show that such therapies are being advertised with some questionable marketing techniques to effect positive portrayal of the therapies on the webpages of private-practice clinics to sell their therapies worldwide. In such context, those clinics communicate directly with consumers (patients and their family members) via the clinics’ websites. Meanwhile, the Health Science Council at the Ministry of Health, Labour, and Welfare (MHLW) in Japan has pointed out noncompliance of some local clinics with the provisions concerning medical advertising in the Medical Care Act in the past. However, locally little is known about the current status of those clinics including the quality of their webpage information disseminated. Objective To evaluate the quality of website information of private-practice clinics offering cell therapies in Japan. Methods Twenty-four websites with 77 treatments from the Google search were identified for evaluation. The following three exploratory analyses were performed: first in order to ascertain web-based portrayal of private-practice clinics offering cell therapies, a descriptive analysis was conducted using a coding frame; second we evaluated the quality of the target website information from the viewpoint of the level of consideration taken for patients and their family members, using 10 quality criteria (“the Minimum Standard”) from the e-Health Code of Ethics 2.0; third we counted and coded expressions that matched set categories for “name-dropping” and “personalized medicine” in the information posted on these websites. Results Analysis on the treatments (N=77) revealed 126 indications (multiple response): the top three indications were “cancer,” “skin-rejuvenation/antiaging/anti–skin aging,” and “breast augmentation/buttock augmentation.” As for the portrayal of treatment risks and benefits, 78% (60

  15. Clinics and home-based care organisations: an interface between theformal and informal health sectors.

    PubMed

    Boros, Adam Kenneth

    2010-12-01

    The article outlines the findings of a study designed to explore the working relationship between home-based caregivers and clinic nurses at locations in two informal settlements in Johannesburg, South Africa. By considering the views and experiences of both sponsored and unsponsored caregivers, the research focused on how degrees of informality affect this relationship. The nurse/caregiver relationship represents a primary interface between the formal and informal health sectors and is an important part of the country's primary healthcare system. Despite the attention given to linking home-based care (HBC) with the formal health system, very little research has examined the functionality of this link at the ground level. Through a number of qualitative, semi-structured interviews with nurses, home-based caregivers, and staff from the Department of Health, information was collected to better understand what systems are in place to facilitate the relationship between clinics and HBC organisations, and whether these systems are helping to create the desired results. Do the formal and informal health sectors complement and strengthen or do they distract and damage each other? By examining the influence of degrees of informality, the research also lends insight into how this distinction plays a role in healthcare provision. For instance, how does state support impact the link between the formal and informal health sectors and the ultimate quality of care? And what steps can be taken to improve the health system in this regard, as a whole? The findings point to a number of problems and challenges with integrating HBC into the formal health sector. Degrees of informality are found to have a profound impact on the work of home-based caregivers in some respects, but a surprising lack of impact in others. These issues need to be confronted in order to improve the existing system and, ultimately, health outcomes in South Africa. PMID:25875880

  16. Case two: A Kantian approach to the morality of blood substitute clinical trials without informed consent.

    PubMed

    Fields, Keota

    2008-01-01

    Clinical trials in a number of countries are now underway to evaluate experimental, non-human blood substitute. One scenario calls for the blood substitute to be available on board emergency vehicles. This allows first responders the opportunity to provide transfusion support at an accident site and on the way to the hospital. However, many of the patients who would most benefit from the use of this material may be unconscious and unable to comprehend or sign an informed consent. One possible solution would be to eliminate the need for informed consent. PMID:18507310

  17. A Rule-Based Expert System as an Integrated Resource in an Outpatient Clinic Information System

    PubMed Central

    Wilton, Richard

    1990-01-01

    A rule-based expert system can be integrated in a useful way into a microcomputer-based clinical information system by using symmetric data-communication methods and intuitive user-interface design. To users of the computer system, the expert system appears as one of several distributed information resources, among which are database management systems and a gateway to a mainframe computing system. Transparent access to the expert system is based on the use of both commercial and public-domain data-communication standards.

  18. Residential accessibility to information technology retailers and self reported computer use among patients attending community clinics.

    PubMed

    Robinson, Paul; Shaheen, Madga; Smith, James; Ryan, Daniel; Baker, Richard

    2009-11-14

    The actual mechanisms that maintain the individual disparities in home computer use and internet access that are collectively termed "the digital divide" remain unclear. We hypothesized that geographic accessibility to IT retailers would independently influence community clinic patients self reported use of computers at home thus limiting their ability to access health related information via the internet. To test this we obtained information on the locations of IT retailers in Los Angeles County, California and generated accessibility scores for the patient's home residence. Geographic measures of accessibility to IT retailers independently predicted clinic patient's self reported use of computers at home, and this effect was driven by low income individuals. Our results indicate that the causes of the digital divide are influenced by less commonly considered factors such as local IT retailer availability.

  19. A Systematic Approach to Find a Professional Audiology Clinic: Patient-Based Information.

    PubMed

    Kim, Gungu; Kim, Gibbeum; Na, Wondo; Han, Woojae

    2016-09-01

    This brief communication introduced a systematic way to find a professional audiology clinic developed for patients and professionals by the American Academy of Audiology, American Speech-Language-Hearing Association, and Healthy Hearing. Patients can access each organization's website to find professionals and/or clinics based on criteria such as location, hours, special areas, types of service, reviews and rating by previous patients, and kinds of insurance accepted. Such a system may protect the patients from information overload, guarantee accurate information, and help them find themselves professional audiologists who can assist them. We expect professional organizations to adopt this system as soon as possible and link hearing-impaired patients with professional audiologists in Korea. PMID:27626086

  20. A Systematic Approach to Find a Professional Audiology Clinic: Patient-Based Information

    PubMed Central

    Kim, Gungu; Kim, Gibbeum; Na, Wondo

    2016-01-01

    This brief communication introduced a systematic way to find a professional audiology clinic developed for patients and professionals by the American Academy of Audiology, American Speech-Language-Hearing Association, and Healthy Hearing. Patients can access each organization's website to find professionals and/or clinics based on criteria such as location, hours, special areas, types of service, reviews and rating by previous patients, and kinds of insurance accepted. Such a system may protect the patients from information overload, guarantee accurate information, and help them find themselves professional audiologists who can assist them. We expect professional organizations to adopt this system as soon as possible and link hearing-impaired patients with professional audiologists in Korea.

  1. A Systematic Approach to Find a Professional Audiology Clinic: Patient-Based Information.

    PubMed

    Kim, Gungu; Kim, Gibbeum; Na, Wondo; Han, Woojae

    2016-09-01

    This brief communication introduced a systematic way to find a professional audiology clinic developed for patients and professionals by the American Academy of Audiology, American Speech-Language-Hearing Association, and Healthy Hearing. Patients can access each organization's website to find professionals and/or clinics based on criteria such as location, hours, special areas, types of service, reviews and rating by previous patients, and kinds of insurance accepted. Such a system may protect the patients from information overload, guarantee accurate information, and help them find themselves professional audiologists who can assist them. We expect professional organizations to adopt this system as soon as possible and link hearing-impaired patients with professional audiologists in Korea.

  2. A Systematic Approach to Find a Professional Audiology Clinic: Patient-Based Information

    PubMed Central

    Kim, Gungu; Kim, Gibbeum; Na, Wondo

    2016-01-01

    This brief communication introduced a systematic way to find a professional audiology clinic developed for patients and professionals by the American Academy of Audiology, American Speech-Language-Hearing Association, and Healthy Hearing. Patients can access each organization's website to find professionals and/or clinics based on criteria such as location, hours, special areas, types of service, reviews and rating by previous patients, and kinds of insurance accepted. Such a system may protect the patients from information overload, guarantee accurate information, and help them find themselves professional audiologists who can assist them. We expect professional organizations to adopt this system as soon as possible and link hearing-impaired patients with professional audiologists in Korea. PMID:27626086

  3. Information warehouse - a comprehensive informatics platform for business, clinical, and research applications.

    PubMed

    Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S

    2010-11-13

    Since its inception in 1997, the IW (Information Warehouse) at the Ohio State University Medical Center (OSUMC) has gradually transformed itself from a single purpose business decision support system to a comprehensive informatics platform supporting basic, clinical, and translational research. The IW today is the combination of four integrated components: a clinical data repository containing over a million patients; a research data repository housing various research specific data; an application development platform for building business and research enabling applications; a business intelligence environment assisting in reporting in all function areas. The IW is structured and encoded using standard terminologies such as SNOMED-CT, ICD, and CPT. The IW is an important component of OSUMC's Clinical and Translational Science Award (CTSA) informatics program.

  4. A knowledge discovery and reuse pipeline for information extraction in clinical notes

    PubMed Central

    Nguyen, Dung H M; Wang, Yefeng; Li, Min

    2011-01-01

    Objective Information extraction and classification of clinical data are current challenges in natural language processing. This paper presents a cascaded method to deal with three different extractions and classifications in clinical data: concept annotation, assertion classification and relation classification. Materials and Methods A pipeline system was developed for clinical natural language processing that includes a proofreading process, with gold-standard reflexive validation and correction. The information extraction system is a combination of a machine learning approach and a rule-based approach. The outputs of this system are used for evaluation in all three tiers of the fourth i2b2/VA shared-task and workshop challenge. Results Overall concept classification attained an F-score of 83.3% against a baseline of 77.0%, the optimal F-score for assertions about the concepts was 92.4% and relation classifier attained 72.6% for relationships between clinical concepts against a baseline of 71.0%. Micro-average results for the challenge test set were 81.79%, 91.90% and 70.18%, respectively. Discussion The challenge in the multi-task test requires a distribution of time and work load for each individual task so that the overall performance evaluation on all three tasks would be more informative rather than treating each task assessment as independent. The simplicity of the model developed in this work should be contrasted with the very large feature space of other participants in the challenge who only achieved slightly better performance. There is a need to charge a penalty against the complexity of a model as defined in message minimalisation theory when comparing results. Conclusion A complete pipeline system for constructing language processing models that can be used to process multiple practical detection tasks of language structures of clinical records is presented. PMID:21737844

  5. Protecting the privacy of patient information in clinical networks: regulatory effectiveness analysis.

    PubMed

    Brannigan, V M

    1992-12-17

    Patient privacy is one of the major issues in the development of modern clinical information system networks. Such networks will have to demonstrate an appropriate concern for privacy as a precondition of operation. Regulatory effectiveness analysis is a novel technique for measuring compliance with a technological regulatory system. By examining the public policies, legal structures, and technical tools involved in the regulatory system, it is possible to discover discontinuities that may result in noncompliance with the regulatory system.

  6. [Perinatal Information System. Incorporation latency and impact on perinatal clinical registry].

    PubMed

    Simini, F; Fernández, A; Sosa, C; Díaz Rossello, J L

    2001-10-01

    The Perinatal Information System (SIP) is a clinical record, local management and quality assurance software standard in Latin America and the Caribbean. The time to implement SIP in a Maternity Hospital is evaluated as well as the effect of statistics on perinatal health indicators in subsequent years. In the sample of 20 Maternity Hospitals (5 Countries, 40% Private and 60% Public) 85% had a reliable information system by the third year of use of SIP. 15% of hospitals still had problems at that time that were already clear during the second year, a time corrective measures can still be taken. The evaluation of the impact of yearly reports shows that 58% of recommendations were fulfilled, specially those regarding the complete filling-in of clinical records (62%) and to a lesser extent variables that reflect clinical practices and organization of services (52%). The conclusion is that Maternity Hospitals in Latin America and the Caribbean have the capacity to adopt a complex tool of computerized clinical records for quality assurance of perinatal care and monitoring of health indicators.

  7. [Perinatal Information System. Incorporation latency and impact on perinatal clinical registry].

    PubMed

    Simini, F; Fernández, A; Sosa, C; Díaz Rossello, J L

    2001-10-01

    The Perinatal Information System (SIP) is a clinical record, local management and quality assurance software standard in Latin America and the Caribbean. The time to implement SIP in a Maternity Hospital is evaluated as well as the effect of statistics on perinatal health indicators in subsequent years. In the sample of 20 Maternity Hospitals (5 Countries, 40% Private and 60% Public) 85% had a reliable information system by the third year of use of SIP. 15% of hospitals still had problems at that time that were already clear during the second year, a time corrective measures can still be taken. The evaluation of the impact of yearly reports shows that 58% of recommendations were fulfilled, specially those regarding the complete filling-in of clinical records (62%) and to a lesser extent variables that reflect clinical practices and organization of services (52%). The conclusion is that Maternity Hospitals in Latin America and the Caribbean have the capacity to adopt a complex tool of computerized clinical records for quality assurance of perinatal care and monitoring of health indicators. PMID:11816526

  8. How to extract clinically useful information from large amount of dialysis related stored data.

    PubMed

    Vito, Domenico; Casagrande, Giustina; Bianchi, Camilla; Costantino, Maria L

    2015-01-01

    The basic storage infrastructure used to gather data from the technological evolution also in the healthcare field was leading to the storing into public or private repository of even higher quantities of data related to patients and their pathological evolution. Big data techniques are spreading also in medical research. By these techniques is possible extract information from complex heterogeneous sources, realizing longitudinal studies focused to correlate the patient status with biometric parameters. In our work we develop a common data infrastructure involving 4 clinical dialysis centers between Lombardy and Switzerland. The common platform has been build to store large amount of clinical data related to 716 dialysis session of 70 patient. The platform is made up by a combination of a MySQL(®) database (Dialysis Database) and a MATLAB-based mining library (Dialysis MATlib). A statistical analysis of these data has been performed on the data gathered. These analyses led to the development of two clinical indexes, representing an example of transformation of big data into clinical information. PMID:26737858

  9. Ubiquitous Diabetes Management System via Interactive Communication Based on Information Technologies: Clinical Effects and Perspectives

    PubMed Central

    Cho, Jae-Hyoung; Kim, Hun-Sung; Han, Jae-Hoon; Lee, Jin-Hee; Oh, Jeong-Ah; Choi, Yoon-Hee

    2010-01-01

    New diabetes management systems based on interactive communication have been introduced recently, accompanying rapid advances in information technology; these systems are referred to as "ubiquitous diabetes management systems." In such ubiquitous systems, patients and medical teams can communicate via Internet or telecommunications, with patients uploading their glucose data and personal information, and medical teams sending optimal feedback. Clinical evidence from both long-term and short-term trials has been reported by some researchers. Such systems appear to be effective not only in reducing the levels of HbA1c but also in stabilizing glucose control. However, most notably, evidence for the cost-effectiveness of such a system should be demonstrated before it can be propagated out to the general population in actual clinical practice. To establish a cost-effective model, various types of clinical decision supporting software designed to reduce the labor time of physicians must first be developed. A number of sensors and devices for monitoring patients' data are expected to be available in the near future; thus, methods for automatic interconnections between devices and web charts were also developed. Further investigations to demonstrate the clinical outcomes of such a system should be conducted, hopefully leading to a new paradigm of diabetes management. PMID:21076573

  10. How Missing Information in Diagnosis Can Lead to Disparities in the Clinical Encounter

    PubMed Central

    Alegría, Margarita; Nakash, Ora; Lapatin, Sheri; Oddo, Vanessa; Gao, Shan; Lin, Julia; Normand, Sharon-Lise

    2009-01-01

    Previous studies have documented diagnostic bias and noted that its reduction could eliminate misdiagnosis and improve mental health service delivery. Few studies have investigated clinicians' methods of obtaining and using information during the initial clinical encounter. We describe a study examining contributions to clinician bias during diagnostic assessment of ethnic/racial minority patients. A total of 129 mental health intakes were videotaped, involving 47 mental health clinicians from 8 primarily safety-net clinics. Videos were coded by another clinician using an information checklist, blind to the diagnoses provided by the original clinician. We found high levels of concordance between clinicians for substance-related disorders, low levels for depressive disorders, and anxiety disorders except panic. Most clinicians rely on patients' mention of depression, anxiety, or substance use to identify disorders, without assessing specific criteria. With limited diagnostic information, clinicians can optimize the clinical intake time to establish rapport with patients. We found Latino ethnicity to be a modifying factor of the association between symptom reports and likelihood of a depression diagnosis. Differential discussion of symptom areas, depending on patient ethnicity, may lead to differential diagnosis and increased likelihood of diagnostic bias. PMID:18843234

  11. 33 CFR 148.108 - What if a Federal or State agency or other interested party requests additional information?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... impact statement or environmental assessment. MARAD will consider the request before making a final... time and effort required by the applicant in gathering the information will result in an undue delay...

  12. No effect of additional screw fixation of a cementless, all-polyethylene press-fit socket on migration, wear, and clinical outcome.

    PubMed

    Minten, Michiel J M; Heesterbeek, Petra J C; Spruit, Maarten

    2016-08-01

    Background and purpose - Additional screw fixation of the all-polyethylene press-fit RM cup (Mathys) has no additional value for migration, in the first 2 years after surgery. However, the medium-term and long-term effects of screw fixation remain unclear. We therefore evaluated the influence of screw fixation on migration, wear, and clinical outcome at 6.5 years using radiostereometric analysis (RSA). Patients and methods - This study involved prolonged follow-up from a previous randomized controlled trial (RCT). We analyzed RSA radiographs taken at baseline and at 1-, 2-, and 6.5-year follow-up. Cup migration and wear were assessed using model-based RSA software. Wear was calculated as translation of the femoral head model in relation to the cup model. Total translation, rotation, and wear were calculated mathematically from results of the orthogonal components. Results - 27 patients (15 with screw fixation and 12 without) were available for follow-up at 6.5 (5.6-7.2) years. Total translation (0.50 mm vs. 0.56 mm) and rotation (1.01 degrees vs. 1.33 degrees) of the cup was low, and was not significantly different between the 2 groups. Wear increased over time, and was similar between the 2 groups (0.58 mm vs. 0.53 mm). Wear rate (0.08 mm/year vs. 0.09 mm/year) and clinical outcomes were also similar. Interpretation - Our results indicate that additional screw fixation of all-polyethylene press-fit RM cups has no additional value regarding medium-term migration and clinical outcome. The wear rate was low in both groups. PMID:27299418

  13. [The clinical informativeness of detection of antibodies to citrullinated proteins under rheumatoid arthritis].

    PubMed

    Cherkasova, M V; Novikov, A A; Alexndrova, E N; Karateev, D E; Popkova, T V; Luchikhina, E L; Avdeeva, A S; Nasonov, E L

    2015-02-01

    .8) and antibodies to modified citrullinated vimentin (ratio of likelihood of positive and negative results of test was correspondingly 4.4 and 0.2; area under ROC curve 0.9) surpassed the same in analysis of IgM rheumatoid factor (ratio of likelihood of positive results--3.2, ratio of likelihood of negative results--0.4, area under ROC curve--0.8). The weak positive correlation relationship was established between concentration of antibodies to cyclic citrillinatedpeptide/antibodies to modified citrullinated vimentin in blood serum and indicators of clinical laboratory activity of rheumatoid arthritis (ESR, CRP DAS 28, (r-0.2. p < 0.05). The high positive levels of antibodies to modified citrullinated vimentin associated with expressed destructive affection of joints (p < 0.02). The antibodies to cyclic citrullinated peptide are the most highly specific and clinically informative laboratory diagnostic marker of rheumatoid arthritis. The detection of antibodies to modified citrullinated vimentin is an important additional serological test to diagnose rheumatoid arthritis in IgM rheumatoid factor-negative and/or antibodies to cyclic citrullinated peptide-negative patients and to forecast severe destructive affection of joints under the given disease. The joint study of IgM rheumatoid factor, antibodies to cyclic citrullinated peptide and antibodies to modified citrullinated vimentin under rheumatoid arthritis has higher diagnostic sensitivity as compared with isolated antibodies to citrullinated proteins.

  14. Information Resources in Clinical Medicine: Family Practice, Pediatrics, Obstetrics and Gynecology, General Surgery, Internal Medicine.

    ERIC Educational Resources Information Center

    Schwank, Jean; Allen, Joyce

    Designed for beginning health science librarians, this continuing education course syllabus presents a guide to information resources for answering physicians' questions about patient care. Sources from standard core lists, such as the Alfred Brandon list, are highlighted and described, along with additional titles. General resources covered…

  15. Clinical information system services and capabilities desired for scalable, standards-based, service-oriented decision support: consensus assessment of the Health Level 7 clinical decision support Work Group.

    PubMed

    Kawamoto, Kensaku; Jacobs, Jason; Welch, Brandon M; Huser, Vojtech; Paterno, Marilyn D; Del Fiol, Guilherme; Shields, David; Strasberg, Howard R; Haug, Peter J; Liu, Zhijing; Jenders, Robert A; Rowed, David W; Chertcoff, Daryl; Fehre, Karsten; Adlassnig, Klaus-Peter; Curtis, A Clayton

    2012-01-01

    A standards-based, service-oriented architecture for clinical decision support (CDS) has the potential to significantly enhance CDS scalability and robustness. To enable such a CDS architecture, the Health Level 7 CDS Work Group reviewed the literature, hosted multi-stakeholder discussions, and consulted domain experts to identify and prioritize the services and capabilities required from clinical information systems (CISs) to enable service-oriented CDS. In addition, relevant available standards were identified. Through this process, ten CIS services and eight CIS capabilities were identified as being important for enabling scalable, service-oriented CDS. In particular, through a survey of 46 domain experts, five services and capabilities were identified as being especially critical: 1) the use of standard information models and terminologies; 2) the ability to leverage a Decision Support Service (DSS); 3) support for a clinical data query service; 4) support for an event subscription and notification service; and 5) support for a user communication service.

  16. Clinical Information System Services and Capabilities Desired for Scalable, Standards-Based, Service-oriented Decision Support: Consensus Assessment of the Health Level 7 Clinical Decision Support Work Group

    PubMed Central

    Kawamoto, Kensaku; Jacobs, Jason; Welch, Brandon M.; Huser, Vojtech; Paterno, Marilyn D.; Del Fiol, Guilherme; Shields, David; Strasberg, Howard R.; Haug, Peter J.; Liu, Zhijing; Jenders, Robert A.; Rowed, David W.; Chertcoff, Daryl; Fehre, Karsten; Adlassnig, Klaus-Peter; Curtis, A. Clayton

    2012-01-01

    A standards-based, service-oriented architecture for clinical decision support (CDS) has the potential to significantly enhance CDS scalability and robustness. To enable such a CDS architecture, the Health Level 7 CDS Work Group reviewed the literature, hosted multi-stakeholder discussions, and consulted domain experts to identify and prioritize the services and capabilities required from clinical information systems (CISs) to enable service-oriented CDS. In addition, relevant available standards were identified. Through this process, ten CIS services and eight CIS capabilities were identified as being important for enabling scalable, service-oriented CDS. In particular, through a survey of 46 domain experts, five services and capabilities were identified as being especially critical: 1) the use of standard information models and terminologies; 2) the ability to leverage a Decision Support Service (DSS); 3) support for a clinical data query service; 4) support for an event subscription and notification service; and 5) support for a user communication service. PMID:23304315

  17. Understanding managerial behaviour during initial steps of a clinical information system adoption

    PubMed Central

    2011-01-01

    Background While the study of the information technology (IT) implementation process and its outcomes has received considerable attention, the examination of pre-adoption and pre-implementation stages of configurable IT uptake appear largely under-investigated. This paper explores managerial behaviour during the periods prior the effective implementation of a clinical information system (CIS) by two Canadian university multi-hospital centers. Methods Adopting a structurationist theoretical stance and a case study research design, the processes by which CIS managers' patterns of discourse contribute to the configuration of the new technology in their respective organizational contexts were longitudinally examined over 33 months. Results Although managers seemed to be aware of the risks and organizational impact of the adoption of a new clinical information system, their decisions and actions over the periods examined appeared rather to be driven by financial constraints and power struggles between different groups involved in the process. Furthermore, they largely emphasized technological aspects of the implementation, with organizational dimensions being put aside. In view of these results, the notion of 'rhetorical ambivalence' is proposed. Results are further discussed in relation to the significance of initial decisions and actions for the subsequent implementation phases of the technology being configured. Conclusions Theoretical and empirically grounded, the paper contributes to the underdeveloped body of literature on information system pre-implementation processes by revealing the crucial role played by managers during the initial phases of a CIS adoption. PMID:21682885

  18. Comprehensive temporal information detection from clinical text: medical events, time, and TLINK identification

    PubMed Central

    Sohn, Sunghwan; Wagholikar, Kavishwar B; Li, Dingcheng; Jonnalagadda, Siddhartha R; Tao, Cui; Komandur Elayavilli, Ravikumar; Liu, Hongfang

    2013-01-01

    Background Temporal information detection systems have been developed by the Mayo Clinic for the 2012 i2b2 Natural Language Processing Challenge. Objective To construct automated systems for EVENT/TIMEX3 extraction and temporal link (TLINK) identification from clinical text. Materials and methods The i2b2 organizers provided 190 annotated discharge summaries as the training set and 120 discharge summaries as the test set. Our Event system used a conditional random field classifier with a variety of features including lexical information, natural language elements, and medical ontology. The TIMEX3 system employed a rule-based method using regular expression pattern match and systematic reasoning to determine normalized values. The TLINK system employed both rule-based reasoning and machine learning. All three systems were built in an Apache Unstructured Information Management Architecture framework. Results Our TIMEX3 system performed the best (F-measure of 0.900, value accuracy 0.731) among the challenge teams. The Event system produced an F-measure of 0.870, and the TLINK system an F-measure of 0.537. Conclusions Our TIMEX3 system demonstrated good capability of regular expression rules to extract and normalize time information. Event and TLINK machine learning systems required well-defined feature sets to perform well. We could also leverage expert knowledge as part of the machine learning features to further improve TLINK identification performance. PMID:23558168

  19. Formalize clinical processes into electronic health information systems: Modelling a screening service for diabetic retinopathy.

    PubMed

    Eguzkiza, Aitor; Trigo, Jesús Daniel; Martínez-Espronceda, Miguel; Serrano, Luis; Andonegui, José

    2015-08-01

    Most healthcare services use information and communication technologies to reduce and redistribute the workload associated with follow-up of chronic conditions. However, the lack of normalization of the information handled in and exchanged between such services hinders the scalability and extendibility. The use of medical standards for modelling and exchanging information, especially dual-model based approaches, can enhance the features of screening services. Hence, the approach of this paper is twofold. First, this article presents a generic methodology to model patient-centered clinical processes. Second, a proof of concept of the proposed methodology was conducted within the diabetic retinopathy (DR) screening service of the Health Service of Navarre (Spain) in compliance with a specific dual-model norm (openEHR). As a result, a set of elements required for deploying a model-driven DR screening service has been established, namely: clinical concepts, archetypes, termsets, templates, guideline definition rules, and user interface definitions. This model fosters reusability, because those elements are available to be downloaded and integrated in any healthcare service, and interoperability, since from then on such services can share information seamlessly.

  20. Formalize clinical processes into electronic health information systems: Modelling a screening service for diabetic retinopathy.

    PubMed

    Eguzkiza, Aitor; Trigo, Jesús Daniel; Martínez-Espronceda, Miguel; Serrano, Luis; Andonegui, José

    2015-08-01

    Most healthcare services use information and communication technologies to reduce and redistribute the workload associated with follow-up of chronic conditions. However, the lack of normalization of the information handled in and exchanged between such services hinders the scalability and extendibility. The use of medical standards for modelling and exchanging information, especially dual-model based approaches, can enhance the features of screening services. Hence, the approach of this paper is twofold. First, this article presents a generic methodology to model patient-centered clinical processes. Second, a proof of concept of the proposed methodology was conducted within the diabetic retinopathy (DR) screening service of the Health Service of Navarre (Spain) in compliance with a specific dual-model norm (openEHR). As a result, a set of elements required for deploying a model-driven DR screening service has been established, namely: clinical concepts, archetypes, termsets, templates, guideline definition rules, and user interface definitions. This model fosters reusability, because those elements are available to be downloaded and integrated in any healthcare service, and interoperability, since from then on such services can share information seamlessly. PMID:26049092

  1. Does kinematics add meaningful information to clinical assessment in post-stroke upper limb rehabilitation? A case report

    PubMed Central

    Bigoni, Matteo; Baudo, Silvia; Cimolin, Veronica; Cau, Nicola; Galli, Manuela; Pianta, Lucia; Tacchini, Elena; Capodaglio, Paolo; Mauro, Alessandro

    2016-01-01

    [Purpose] The aims of this case study were to: (a) quantify the impairment and activity restriction of the upper limb in a hemiparetic patient; (b) quantitatively evaluate rehabilitation program effectiveness; and (c) discuss whether more clinically meaningful information can be gained with the use of kinematic analysis in addition to clinical assessment. The rehabilitation program consisted of the combined use of different traditional physiotherapy techniques, occupational therapy sessions, and the so-called task-oriented approach. [Subject and Methods] Subject was a one hemiplegic patient. The patient was assessed at the beginning and after 1 month of daily rehabilitation using the Medical Research Council scale, Nine Hole Peg Test, Motor Evaluation Scale for Upper Extremity in Stroke Patients, and Hand Grip Dynamometer test as well as a kinematic analysis using an optoelectronic system. [Results] After treatment, significant improvements were evident in terms of total movement duration, movement completion velocity, and some smoothness parameters. [Conclusion] Our case report showed that the integration of clinical assessment with kinematic evaluation appears to be useful for quantitatively assessing performance changes.

  2. Does kinematics add meaningful information to clinical assessment in post-stroke upper limb rehabilitation? A case report.

    PubMed

    Bigoni, Matteo; Baudo, Silvia; Cimolin, Veronica; Cau, Nicola; Galli, Manuela; Pianta, Lucia; Tacchini, Elena; Capodaglio, Paolo; Mauro, Alessandro

    2016-08-01

    [Purpose] The aims of this case study were to: (a) quantify the impairment and activity restriction of the upper limb in a hemiparetic patient; (b) quantitatively evaluate rehabilitation program effectiveness; and (c) discuss whether more clinically meaningful information can be gained with the use of kinematic analysis in addition to clinical assessment. The rehabilitation program consisted of the combined use of different traditional physiotherapy techniques, occupational therapy sessions, and the so-called task-oriented approach. [Subject and Methods] Subject was a one hemiplegic patient. The patient was assessed at the beginning and after 1 month of daily rehabilitation using the Medical Research Council scale, Nine Hole Peg Test, Motor Evaluation Scale for Upper Extremity in Stroke Patients, and Hand Grip Dynamometer test as well as a kinematic analysis using an optoelectronic system. [Results] After treatment, significant improvements were evident in terms of total movement duration, movement completion velocity, and some smoothness parameters. [Conclusion] Our case report showed that the integration of clinical assessment with kinematic evaluation appears to be useful for quantitatively assessing performance changes. PMID:27630445

  3. Does kinematics add meaningful information to clinical assessment in post-stroke upper limb rehabilitation? A case report

    PubMed Central

    Bigoni, Matteo; Baudo, Silvia; Cimolin, Veronica; Cau, Nicola; Galli, Manuela; Pianta, Lucia; Tacchini, Elena; Capodaglio, Paolo; Mauro, Alessandro

    2016-01-01

    [Purpose] The aims of this case study were to: (a) quantify the impairment and activity restriction of the upper limb in a hemiparetic patient; (b) quantitatively evaluate rehabilitation program effectiveness; and (c) discuss whether more clinically meaningful information can be gained with the use of kinematic analysis in addition to clinical assessment. The rehabilitation program consisted of the combined use of different traditional physiotherapy techniques, occupational therapy sessions, and the so-called task-oriented approach. [Subject and Methods] Subject was a one hemiplegic patient. The patient was assessed at the beginning and after 1 month of daily rehabilitation using the Medical Research Council scale, Nine Hole Peg Test, Motor Evaluation Scale for Upper Extremity in Stroke Patients, and Hand Grip Dynamometer test as well as a kinematic analysis using an optoelectronic system. [Results] After treatment, significant improvements were evident in terms of total movement duration, movement completion velocity, and some smoothness parameters. [Conclusion] Our case report showed that the integration of clinical assessment with kinematic evaluation appears to be useful for quantitatively assessing performance changes. PMID:27630445

  4. Clinic expert information extraction based on domain model and block importance model.

    PubMed

    Zhang, Yuanpeng; Wang, Li; Qian, Danmin; Geng, Xingyun; Yao, Dengfu; Dong, Jiancheng

    2015-11-01

    To extract expert clinic information from the Deep Web, there are two challenges to face. The first one is to make a judgment on forms. A novel method based on a domain model, which is a tree structure constructed by the attributes of query interfaces is proposed. With this model, query interfaces can be classified to a domain and filled in with domain keywords. Another challenge is to extract information from response Web pages indexed by query interfaces. To filter the noisy information on a Web page, a block importance model is proposed, both content and spatial features are taken into account in this model. The experimental results indicate that the domain model yields a precision 4.89% higher than that of the rule-based method, whereas the block importance model yields an F1 measure 10.5% higher than that of the XPath method. PMID:26231612

  5. Data extraction and archiving for nursing research using a bedside clinical information system.

    PubMed

    Saville, J; Goodwin, L; Bryars, D

    1997-01-01

    Institution wide use of an intensive care bedside information system creates the opportunity to make available vast amounts of clinical data to support research and quality improvement activities. Acting on this opportunity has required the development of several innovative approaches to transform this raw data into usable information. The process described herein uses commercially available software and hardware tools to extract on a daily basis, process and archive data for 7 intensive care units. Once this procedure is complete, attention is turned to using individual and combinations of data elements to build a higher level of information that more directly relates to the kinds of inquiries that help to address questions of outcome, and care quality.

  6. A Study to Determine if Addition of Palatal Petechiae to Centor Criteria Adds More Significance to Clinical Diagnosis of Acute Strep Pharyngitis in Children.

    PubMed

    Nibhanipudi, Kumara V

    2016-01-01

    Objective. A study to determine if addition of palatal petechiae to Centor criteria adds more value for clinical diagnosis of acute strep pharyngitis in children. Hypothesis. In children, Centor Criteria does not cover all the symptoms and signs of acute strep pharyngitis. We hypothesize that addition of palatal petechiae to Centor Criteria will increase the possibility of clinical diagnosis of group A streptococcal pharyngitis in children. Methods. One hundred patients with a complaint of sore throat were enrolled in the study. All the patients were examined clinically using the Centor Criteria. They were also examined for other signs and symptoms like petechial lesions over the palate, abdominal pain, and skin rash. All the patients were given rapid strep tests, and throat cultures were sent. No antibiotics were given until culture results were obtained. Results. The sample size was 100 patients. All 100 had fever, sore throat, and erythema of tonsils. Twenty of the 100 patients had tonsillar exudates, 85/100 had tender anterior cervical lymph nodes, and 86/100 had no cough. In total, 9 out of the 100 patients had positive throat cultures. We observed that petechiae over the palate, a very significant sign, is not included in the Centor Criteria. Palatal petechiae were present in 8 out of the 100 patients. Six out of these 8 with palatal petechiae had positive throat culture for strep (75%). Only 7 out of 20 with exudates had positive strep culture. Sixteen out of the 100 patients had rapid strep test positive. Those 84/100 who had negative rapid strep also had negative throat culture. Statistics. We used Fisher's exact test, comparing throat culture positive and negative versus presence of exudates and palatal hemorrhages with positive and negative throat cultures and the resultant P value <.0001. Conclusion. Our study concludes that addition of petechiae over the palate to Centor Criteria will increase the possibility of diagnosing acute group A streptococcal

  7. A Study to Determine if Addition of Palatal Petechiae to Centor Criteria Adds More Significance to Clinical Diagnosis of Acute Strep Pharyngitis in Children

    PubMed Central

    Nibhanipudi, Kumara V.

    2016-01-01

    Objective. A study to determine if addition of palatal petechiae to Centor criteria adds more value for clinical diagnosis of acute strep pharyngitis in children. Hypothesis. In children, Centor Criteria does not cover all the symptoms and signs of acute strep pharyngitis. We hypothesize that addition of palatal petechiae to Centor Criteria will increase the possibility of clinical diagnosis of group A streptococcal pharyngitis in children. Methods. One hundred patients with a complaint of sore throat were enrolled in the study. All the patients were examined clinically using the Centor Criteria. They were also examined for other signs and symptoms like petechial lesions over the palate, abdominal pain, and skin rash. All the patients were given rapid strep tests, and throat cultures were sent. No antibiotics were given until culture results were obtained. Results. The sample size was 100 patients. All 100 had fever, sore throat, and erythema of tonsils. Twenty of the 100 patients had tonsillar exudates, 85/100 had tender anterior cervical lymph nodes, and 86/100 had no cough. In total, 9 out of the 100 patients had positive throat cultures. We observed that petechiae over the palate, a very significant sign, is not included in the Centor Criteria. Palatal petechiae were present in 8 out of the 100 patients. Six out of these 8 with palatal petechiae had positive throat culture for strep (75%). Only 7 out of 20 with exudates had positive strep culture. Sixteen out of the 100 patients had rapid strep test positive. Those 84/100 who had negative rapid strep also had negative throat culture. Statistics. We used Fisher’s exact test, comparing throat culture positive and negative versus presence of exudates and palatal hemorrhages with positive and negative throat cultures and the resultant P value <.0001. Conclusion. Our study concludes that addition of petechiae over the palate to Centor Criteria will increase the possibility of diagnosing acute group A streptococcal

  8. 45 CFR 1351.19 - What additional information should an applicant or grantee have about a Runaway and Homeless...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Homeless Youth Program grants. These include: (1) The provisions of 45 CFR part 74 pertaining to the Administration of Grants; (2) The provisions of 45 CFR part 16, Departmental Grants Appeal Process, and the provisions of Informal Grant Appeal Procedures (Indirect Costs) in volume 45 CFR part 75; (3) The...

  9. 45 CFR 1351.19 - What additional information should an applicant or grantee have about a Runaway and Homeless...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Homeless Youth Program grants. These include: (1) The provisions of 45 CFR part 74 pertaining to the Administration of Grants; (2) The provisions of 45 CFR part 16, Departmental Grants Appeal Process, and the provisions of Informal Grant Appeal Procedures (Indirect Costs) in volume 45 CFR part 75; (3) The...

  10. 45 CFR 1351.19 - What additional information should an applicant or grantee have about a Runaway and Homeless...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Homeless Youth Program grants. These include: (1) The provisions of 45 CFR part 74 pertaining to the Administration of Grants; (2) The provisions of 45 CFR part 16, Departmental Grants Appeal Process, and the provisions of Informal Grant Appeal Procedures (Indirect Costs) in volume 45 CFR part 75; (3) The...

  11. 45 CFR 1351.19 - What additional information should an applicant or grantee have about a Runaway and Homeless...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Homeless Youth Program grants. These include: (1) The provisions of 45 CFR part 74 pertaining to the Administration of Grants; (2) The provisions of 45 CFR part 16, Departmental Grants Appeal Process, and the provisions of Informal Grant Appeal Procedures (Indirect Costs) in volume 45 CFR part 75; (3) The...

  12. 36 CFR 1290.4 - Types of materials included in scope of assassination record and additional records and information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION JFK ASSASSINATION RECORDS... COLLECTION ACT OF 1992 (JFK ACT) § 1290.4 Types of materials included in scope of assassination record and... information includes, for purposes of interpreting and implementing the JFK Act: (a) Papers, maps, and...

  13. 36 CFR 1290.4 - Types of materials included in scope of assassination record and additional records and information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION JFK ASSASSINATION RECORDS... COLLECTION ACT OF 1992 (JFK ACT) § 1290.4 Types of materials included in scope of assassination record and... information includes, for purposes of interpreting and implementing the JFK Act: (a) Papers, maps, and...

  14. 36 CFR 1290.4 - Types of materials included in scope of assassination record and additional records and information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION JFK ASSASSINATION RECORDS... COLLECTION ACT OF 1992 (JFK ACT) § 1290.4 Types of materials included in scope of assassination record and... information includes, for purposes of interpreting and implementing the JFK Act: (a) Papers, maps, and...

  15. 36 CFR 1290.4 - Types of materials included in scope of assassination record and additional records and information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION JFK ASSASSINATION RECORDS... COLLECTION ACT OF 1992 (JFK ACT) § 1290.4 Types of materials included in scope of assassination record and... information includes, for purposes of interpreting and implementing the JFK Act: (a) Papers, maps, and...

  16. 36 CFR 1290.4 - Types of materials included in scope of assassination record and additional records and information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., Forests, and Public Property NATIONAL ARCHIVES AND RECORDS ADMINISTRATION JFK ASSASSINATION RECORDS... COLLECTION ACT OF 1992 (JFK ACT) § 1290.4 Types of materials included in scope of assassination record and... information includes, for purposes of interpreting and implementing the JFK Act: (a) Papers, maps, and...

  17. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.

    PubMed

    Lentz, Jennifer; Kennett, Michele; Perlmutter, Jane; Forrest, Annemarie

    2016-07-01

    Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Broad consensus among sponsors, research staff, study participants, and advocates indicate that the current process could be improved to enhance participants' understanding of study-related information and meet the needs of individuals. The Clinical Trials Transformation Initiative (CTTI) convened a project to identify problems in the current process and to formulate recommendations for improvement. A literature review, expert interviews, and multi-stakeholder meeting were conducted to identify barriers and develop solutions for a more effective informed consent process. Four key topics were the foundation of the recommendations: 1) defining an effective informed consent process, 2) training research staff, 3) improving the informed consent document, and 4) exploring the use of electronic consent. The ideal informed consent process involves an ongoing, interactive conversation between the participant and knowledgeable, responsive research staff who were trained in best practices. The informed consent process should be supported by a tiered informed consent document that provides critically relevant information to aid in the decision to participate in a study. Adoption of the CTTI informed consent recommendations should lead to a more participant-centric informed consent process. Participant involvement better meets the needs of participants and benefits the clinical trial enterprise by promoting a research culture that encourages informed participation in clinical studies.

  18. Space Takes Time: Concentration Dependent Output Codes from Primary Olfactory Networks Rapidly Provide Additional Information at Defined Discrimination Thresholds.

    PubMed

    Daly, Kevin C; Bradley, Samual; Chapman, Phillip D; Staudacher, Erich M; Tiede, Regina; Schachtner, Joachim

    2015-01-01

    As odor concentration increases, primary olfactory network representations expand in spatial distribution, temporal complexity and duration. However, the direct relationship between concentration dependent odor representations and the psychophysical thresholds of detection and discrimination is poorly understood. This relationship is absolutely critical as thresholds signify transition points whereby representations become meaningful to the organism. Here, we matched stimulus protocols for psychophysical assays and intracellular recordings of antennal lobe (AL) projection neurons (PNs) in the moth Manduca sexta to directly compare psychophysical thresholds and the output representations they elicit. We first behaviorally identified odor detection and discrimination thresholds across an odor dilution series for a panel of structurally similar odors. We then characterized spatiotemporal spiking patterns across a population of individually filled and identified AL PNs in response to those odors at concentrations below, at, and above identified thresholds. Using spatial and spatiotemporal based analyses we observed that each stimulus produced unique representations, even at sub-threshold concentrations. Mean response latency did not decrease and the percent glomerular activation did not increase with concentration until undiluted odor. Furthermore, correlations between spatial patterns for odor decreased, but only significantly with undiluted odor. Using time-integrated Euclidean distance (ED) measures, we determined that added spatiotemporal information was present at the discrimination but not detection threshold. This added information was evidenced by an increase in integrated distance between the sub-detection and discrimination threshold concentrations (of the same odor) that was not present in comparison of the sub-detection and detection threshold. After consideration of delays for information to reach the AL we find that it takes ~120-140 ms for the AL to

  19. Space Takes Time: Concentration Dependent Output Codes from Primary Olfactory Networks Rapidly Provide Additional Information at Defined Discrimination Thresholds

    PubMed Central

    Daly, Kevin C.; Bradley, Samual; Chapman, Phillip D.; Staudacher, Erich M.; Tiede, Regina; Schachtner, Joachim

    2016-01-01

    As odor concentration increases, primary olfactory network representations expand in spatial distribution, temporal complexity and duration. However, the direct relationship between concentration dependent odor representations and the psychophysical thresholds of detection and discrimination is poorly understood. This relationship is absolutely critical as thresholds signify transition points whereby representations become meaningful to the organism. Here, we matched stimulus protocols for psychophysical assays and intracellular recordings of antennal lobe (AL) projection neurons (PNs) in the moth Manduca sexta to directly compare psychophysical thresholds and the output representations they elicit. We first behaviorally identified odor detection and discrimination thresholds across an odor dilution series for a panel of structurally similar odors. We then characterized spatiotemporal spiking patterns across a population of individually filled and identified AL PNs in response to those odors at concentrations below, at, and above identified thresholds. Using spatial and spatiotemporal based analyses we observed that each stimulus produced unique representations, even at sub-threshold concentrations. Mean response latency did not decrease and the percent glomerular activation did not increase with concentration until undiluted odor. Furthermore, correlations between spatial patterns for odor decreased, but only significantly with undiluted odor. Using time-integrated Euclidean distance (ED) measures, we determined that added spatiotemporal information was present at the discrimination but not detection threshold. This added information was evidenced by an increase in integrated distance between the sub-detection and discrimination threshold concentrations (of the same odor) that was not present in comparison of the sub-detection and detection threshold. After consideration of delays for information to reach the AL we find that it takes ~120–140 ms for the AL to

  20. Supporting Clinical Cognition: A Human-Centered Approach to a Novel ICU Information Visualization Dashboard

    PubMed Central

    Faiola, Anthony; Srinivas, Preethi; Duke, Jon

    2015-01-01

    Advances in intensive care unit bedside displays/interfaces and electronic medical record (EMR) technology have not adequately addressed the topic of visual clarity of patient data/information to further reduce cognitive load during clinical decision-making. We responded to these challenges with a human-centered approach to designing and testing a decision-support tool: MIVA 2.0 (Medical Information Visualization Assistant, v.2). Envisioned as an EMR visualization dashboard to support rapid analysis of real-time clinical data-trends, our primary goal originated from a clinical requirement to reduce cognitive overload. In the study, a convenience sample of 12 participants were recruited, in which quantitative and qualitative measures were used to compare MIVA 2.0 with ICU paper medical-charts, using time-on-task, post-test questionnaires, and interviews. Findings demonstrated a significant difference in speed and accuracy with the use of MIVA 2.0. Qualitative outcomes concurred, with participants acknowledging the potential impact of MIVA 2.0 for reducing cognitive load and enabling more accurate and quicker decision-making. PMID:26958190

  1. An integrated data-warehouse-concept for clinical and biological information.

    PubMed

    Brammen, Dominik; Katzer, Christian; Röhrig, Rainer; Weismüller, Katja; Maier, Michael; Hossain, Hamid; Menges, Thilo; Hempelmann, Gunter; Chakraborty, Trinad

    2005-01-01

    The development of medical research networks within the framework of translational research has fostered interest in the integration of clinical and biological research data in a common database. The building of one single database integrating clinical data and biological research data requires a concept which enables scientists to retrieve information and to connect known facts to new findings. Clinical parameters are collected by a Patient Data Management System and viewed in a database which also includes genomic data. This database is designed as an Entity Attribute Value model, which implicates the development of a data warehouse concept. For the realization of this project, various requirements have to be taken into account which has to be fulfilled sufficiently in order to align with international standards. Data security and protection of data privacy are most important parts of the data warehouse concept. It has to be clear how patient pseudonymization has to be carried out in order to be within the scope of data security law. To be able to evaluate the data stored in a database consisting of clinical data collected by a Patient Data Management System and genomic research data easily, a data warehouse concept based on an Entity Attribute Value datamodel has been developed.

  2. Correlates of depression and burden for informal caregivers of patients in a geriatrics referral clinic.

    PubMed

    Drinka, T J; Smith, J C; Drinka, P J

    1987-06-01

    Caregiver burden has been associated with patient dementia. In this study we tested the hypothesis that caregiver burden and depression are related to patient cognitive impairment. We analyzed records of 127 elderly male patients from a Veterans hospital geriatrics referral clinic. The patients and their informal caregivers had been referred to the clinic because the complexity and multiplicity of their problems were beyond the treatment capability of other clinics. There was a high prevalence of dementia (73%) and depression (69%) in these patients according to Diagnostic and Statistical Manual (DSM-III) criteria. Quantitative measures of patient dementia and dependency in activities of daily living were not statistically associated with measures of caregiver depression or burden. In contrast, measures of patient depression were significantly correlated with measures of caregiver depression and burden. We hypothesize that caregivers of chronically ill, elderly men cope better with physical and cognitive incapacity than with affective symptoms. Because caregiver support is the most important factor in maintaining a disabled elder in the community, we suggest evaluating patients and caregivers for depression as part of standard practice in geriatric clinical settings. PMID:3553288

  3. Informed Practice: Students' Clinical Experiences in the Undergraduate Phase of an Accelerated Physician Assistant Program.

    PubMed

    Dereczyk, Amy; DeWitt, Rachel

    2016-06-01

    This qualitative study explored the clinical experiences of students in an accelerated physician assistant (PA) program. The participants were either certified nursing assistants (CNAs) or emergency medical technicians-basic (EMTs-B). The study was designed to elicit (1) how the participants perceived their older patients and (2) how the participants' experiences might affect their own future communications, bedside manner, and clinical preparedness as PAs. This study used a focus group to explore students' clinical experiences before the graduate phase of their accelerated PA program. Five female and 2 male PA students (N = 7) participated in the study. All participants were 23 years old and worked as either a CNA or an EMT-B. Results fell into 2 basic themes: informing practice and forming relationships. Regarding the first theme, participants felt that their experience as entry-level health care providers allowed them to improve their communication skills and bedside manner and to provide greater comfort to patients. Regarding the second theme, participants gained appreciation for older people and began to recognize the knowledge deficits and learning needs of their patients. The results suggested that a student's clinical experience as a CNA or an EMT-B before entering a PA program has a positive effect on the student's personal and professional development. The participants acquired greater appreciation and respect for older patients and members of the health care team. PMID:27123599

  4. The Need for Clinical Decision Support Integrated with the Electronic Health Record for the Clinical Application of Whole Genome Sequencing Information

    PubMed Central

    Welch, Brandon M.; Kawamoto, Kensaku

    2013-01-01

    Whole genome sequencing (WGS) is rapidly approaching widespread clinical application. Technology advancements over the past decade, since the first human genome was decoded, have made it feasible to use WGS for clinical care. Future advancements will likely drive down the price to the point wherein WGS is routinely available for care. However, were this to happen today, most of the genetic information available to guide clinical care would go unused due to the complexity of genetics, limited physician proficiency in genetics, and lack of genetics professionals in the clinical workforce. Furthermore, these limitations are unlikely to change in the future. As such, the use of clinical decision support (CDS) to guide genome-guided clinical decision-making is imperative. In this manuscript, we describe the barriers to widespread clinical application of WGS information, describe how CDS can be an important tool for overcoming these barriers, and provide clinical examples of how genome-enabled CDS can be used in the clinical setting. PMID:25411643

  5. Using comparative clinical information to understand practice patterns and affect organizational change.

    PubMed

    Adams, S W; Schultz, S; Elias, A; Jordon, T; Duke, J; Lieber, A

    1991-01-01

    The University Hospital Consortium is collecting clinical, administrative and financial data from its members to develop a Clinical Information Network. The value of this collective data lies in how comparative information about peer hospitals and physicians in the same specialty can be used to influence practice. The raw data from each hospital is analyzed, classified, normalized and stored in a data repository which is easily accessible. This data becomes information when it is presented in a variety of ways, and is supported by a knowledge-base of health care rules. The "drilling down" technique to progressive levels of detail serves the needs of all levels in the organization--executives, managers, and analysts. The system combines the power of a mainframe for the data repository with the ease of use of a PC-based workstation. With an open-ended approach, the users can ask a variety of questions of the data, as well as perform statistical analysis, create graphical presentations and generate explanations of the analysis techniques. PMID:1807758

  6. Identifying adverse drug event information in clinical notes with distributional semantic representations of context.

    PubMed

    Henriksson, Aron; Kvist, Maria; Dalianis, Hercules; Duneld, Martin

    2015-10-01

    For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce.

  7. Identifying adverse drug event information in clinical notes with distributional semantic representations of context.

    PubMed

    Henriksson, Aron; Kvist, Maria; Dalianis, Hercules; Duneld, Martin

    2015-10-01

    For the purpose of post-marketing drug safety surveillance, which has traditionally relied on the voluntary reporting of individual cases of adverse drug events (ADEs), other sources of information are now being explored, including electronic health records (EHRs), which give us access to enormous amounts of longitudinal observations of the treatment of patients and their drug use. Adverse drug events, which can be encoded in EHRs with certain diagnosis codes, are, however, heavily underreported. It is therefore important to develop capabilities to process, by means of computational methods, the more unstructured EHR data in the form of clinical notes, where clinicians may describe and reason around suspected ADEs. In this study, we report on the creation of an annotated corpus of Swedish health records for the purpose of learning to identify information pertaining to ADEs present in clinical notes. To this end, three key tasks are tackled: recognizing relevant named entities (disorders, symptoms, drugs), labeling attributes of the recognized entities (negation, speculation, temporality), and relationships between them (indication, adverse drug event). For each of the three tasks, leveraging models of distributional semantics - i.e., unsupervised methods that exploit co-occurrence information to model, typically in vector space, the meaning of words - and, in particular, combinations of such models, is shown to improve the predictive performance. The ability to make use of such unsupervised methods is critical when faced with large amounts of sparse and high-dimensional data, especially in domains where annotated resources are scarce. PMID:26291578

  8. How Qualitative Research Informs Clinical and Policy Decision Making in Transplantation: A Review.

    PubMed

    Tong, Allison; Morton, Rachael L; Webster, Angela C

    2016-09-01

    Patient-centered care is no longer just a buzzword. It is now widely touted as a cornerstone in delivering quality care across all fields of medicine. However, patient-centered strategies and interventions necessitate evidence about patients' decision-making processes, values, priorities, and needs. Qualitative research is particularly well suited to understanding the experience and perspective of patients, donors, clinicians, and policy makers on a wide range of transplantation-related topics including organ donation and allocation, adherence to prescribed therapy, pretransplant and posttransplant care, implementation of clinical guidelines, and doctor-patient communication. In transplantation, evidence derived from qualitative research has been integrated into strategies for shared decision-making, patient educational resources, process evaluations of trials, clinical guidelines, and policies. The aim of this article is to outline key concepts and methods used in qualitative research, guide the appraisal of qualitative studies, and assist clinicians to understand how qualitative research may inform their practice and policy. PMID:27479165

  9. What is culturally informed psychiatry? Cultural understanding and withdrawal in the clinical encounter

    PubMed Central

    Leseth, Anne Birgitte

    2015-01-01

    What is culturally informed psychiatry? What does it mean, and why is it important? These questions are discussed with a focus on the cultural aspects of the clinical encounter. The DSM-5 Outline for Cultural Formulation was developed as a method of assessing the cultural factors affecting the clinical encounter. It calls for the assessment of the cultural features of the relationship between the patient and the clinician; however, there is a lack of debate about what this means in practice. Clinicians run the risk of withdrawal rather than cultural understanding when facing patients with different cultural backgrounds. Using ethnographic material from anthropological fieldwork, I suggest that the encounter with cultural differences could be a useful point of departure for the clinician to develop cultural understanding. It is argued that recognising the experiences of differences is crucial in strengthening transcultural communication and preventing misdiagnosis in the clinician–patient encounter. PMID:26755952

  10. Principles of cardiovascular magnetic resonance feature tracking and echocardiographic speckle tracking for informed clinical use.

    PubMed

    Pedrizzetti, Gianni; Claus, Piet; Kilner, Philip J; Nagel, Eike

    2016-01-01

    Tissue tracking technology of routinely acquired cardiovascular magnetic resonance (CMR) cine acquisitions has increased the apparent ease and availability of non-invasive assessments of myocardial deformation in clinical research and practice. Its widespread availability thanks to the fact that this technology can in principle be applied on images that are part of every CMR or echocardiographic protocol. However, the two modalities are based on very different methods of image acquisition and reconstruction, each with their respective strengths and limitations. The image tracking methods applied are not necessarily directly comparable between the modalities, or with those based on dedicated CMR acquisitions for strain measurement such as tagging or displacement encoding. Here we describe the principles underlying the image tracking methods for CMR and echocardiography, and the translation of the resulting tracking estimates into parameters suited to describe myocardial mechanics. Technical limitations are presented with the objective of suggesting potential solutions that may allow informed and appropriate use in clinical applications. PMID:27561421

  11. How Qualitative Research Informs Clinical and Policy Decision Making in Transplantation: A Review.

    PubMed

    Tong, Allison; Morton, Rachael L; Webster, Angela C

    2016-09-01

    Patient-centered care is no longer just a buzzword. It is now widely touted as a cornerstone in delivering quality care across all fields of medicine. However, patient-centered strategies and interventions necessitate evidence about patients' decision-making processes, values, priorities, and needs. Qualitative research is particularly well suited to understanding the experience and perspective of patients, donors, clinicians, and policy makers on a wide range of transplantation-related topics including organ donation and allocation, adherence to prescribed therapy, pretransplant and posttransplant care, implementation of clinical guidelines, and doctor-patient communication. In transplantation, evidence derived from qualitative research has been integrated into strategies for shared decision-making, patient educational resources, process evaluations of trials, clinical guidelines, and policies. The aim of this article is to outline key concepts and methods used in qualitative research, guide the appraisal of qualitative studies, and assist clinicians to understand how qualitative research may inform their practice and policy.

  12. Event Detection: A Clinical Notification Service on a Health Information Exchange Platform

    PubMed Central

    Moore, Thomas; Shapiro, Jason S.; Doles, Luke; Calman, Neil; Camhi, Eli; Check, Thomas; Onyile, Arit; Kuperman, Gilad

    2012-01-01

    Notifying ambulatory providers when their patients visit the hospital is a simple concept but potentially a powerful tool for improving care coordination. A health information exchange (HIE) can provide automatic notifications to its members by building services on top of their existing infrastructure. NYCLIX, Inc., a functioning HIE in New York City, has developed a system that detects hospital admissions, discharges and emergency department visits and notifies their providers. The system has been in use since November 2010. Out of 63,305 patients enrolled 6,913 (11%) had one or more events in the study period and on average there were 238 events per day. While event notifications have a clinical value, their use also involves non-clinical care coordination; new workflows should be designed to incorporate a broader care team in their use. This paper describes the user requirements for the notification system, system design, current status, lessons learned and future directions. PMID:23304336

  13. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds.

    PubMed

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne; Haase, Lone; Lundquist, Rasmus

    2011-12-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients' blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm(2) (median 2.3 cm(2)) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm(2) (range = 0-9.6cm(2)). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.

  14. Additional hemodynamic measurements with an esophageal Doppler monitor: a preliminary report of compliance, force, kinetic energy, and afterload in the clinical setting.

    PubMed

    Atlas, Glen; Brealey, David; Dhar, Sunil; Dikta, Gerhard; Singer, Meryvn

    2012-12-01

    The esophageal Doppler monitor (EDM) is a minimally-invasive hemodynamic device which evaluates both cardiac output (CO), and fluid status, by estimating stroke volume (SV) and calculating heart rate (HR). The measurement of these parameters is based upon a continuous and accurate approximation of distal thoracic aortic blood flow. Furthermore, the peak velocity (PV) and mean acceleration (MA), of aortic blood flow at this anatomic location, are also determined by the EDM. The purpose of this preliminary report is to examine additional clinical hemodynamic calculations of: compliance (C), kinetic energy (KE), force (F), and afterload (TSVR(i)). These data were derived using both velocity-based measurements, provided by the EDM, as well as other contemporaneous physiologic parameters. Data were obtained from anesthetized patients undergoing surgery or who were in a critical care unit. A graphical inspection of these measurements is presented and discussed with respect to each patient's clinical situation. When normalized to each of their initial values, F and KE both consistently demonstrated more discriminative power than either PV or MA. The EDM offers additional applications for hemodynamic monitoring. Further research regarding the accuracy, utility, and limitations of these parameters is therefore indicated.

  15. Additional evidence that rosacea pathogenesis may involve demodex: new information from the topical efficacy of ivermectin and praziquantel.

    PubMed

    Abokwidir, Manal; Fleischer, Alan B

    2015-09-01

    Additional evidence that Demodex folliculorum may contribute to the pathogenesis of papulopustular rosacea are new studies of two topical antiparasitic agents. Ivermectin and praziquantel have recently been shown to be effective in decreasing the severity of papulopustular rosacea. These two agents significantly differ in molecular structure, but yield similar antiparasitic mechanisms of action. Higher numbers of Demodex mites are found in the skin of patients with rosacea than in people with normal skin. If Demodex play a role in pathogenesis, then hypersensitivity to the mites, their flora, or their products could explain the observed efficacy of antidemodectic therapy. PMID:26437294

  16. Performance of online drug information databases as clinical decision support tools in infectious disease medication management.

    PubMed

    Polen, Hyla H; Zapantis, Antonia; Clauson, Kevin A; Clauson, Kevin Alan; Jebrock, Jennifer; Paris, Mark

    2008-01-01

    Infectious disease (ID) medication management is complex and clinical decision support tools (CDSTs) can provide valuable assistance. This study evaluated scope and completeness of ID drug information found in online databases by evaluating their ability to answer 147 question/answer pairs. Scope scores produced highest rankings (%) for: Micromedex (82.3), Lexi-Comp/American Hospital Formulary Service (81.0), and Medscape Drug Reference (81.0); lowest includes: Epocrates Online Premium (47.0), Johns Hopkins ABX Guide (45.6), and PEPID PDC (40.8). PMID:18999059

  17. [The analytical reliability of clinical laboratory information and role of the standards in its support].

    PubMed

    Men'shikov, V V

    2012-12-01

    The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

  18. A rapid usability assessment methodology to support the choice of clinical information systems: a case study.

    PubMed

    Beuscart-Zéphir, M C; Watbled, L; Carpentier, A M; Degroisse, M; Alao, O

    2002-01-01

    We present here an adapted methodology integrating usability engineering and early evaluation procedures to support the choice of a Clinical Information System in the context of a standard Call for Tender. We illustrate the application of this methodology with a case study. We integrated a standard 'contextual task and activity analysis' into the choice process and then drew up usability recommendations for the choice of an application. We organized a one-week on-site exhibition and test for each candidate company. During the test sessions, we performed a rapid usability assessment. The final choice of the application is strongly and positively influenced by the results of the usability assessment. PMID:12463784

  19. Columbia-Presbyterian Medical Center Integrated Academic Information Management System (IAIMS) Outpatient Clinical Information System Implemented in a Faculty General Medicine Practice

    PubMed Central

    Shea, Steven; Clark, Anthony S.; Clayton, Paul D.

    1990-01-01

    We describe a clinical information system for hospital-based ambulatory care implemented in the context of the institution's IAIMS Phase III effort. Key features of this application are physician data entry to maintain summary clinical profiles that include medication lists, problem lists, and preventive care, and integration with other components of the Clinical Information System at the levels of the database, the user interface, and data sharing. A goal of this application is to provide coded data as a substrate for computer-based decision support.

  20. EPA evaluation of the SYNERGY-1 fuel additive under Section 511 of the Motor Vehicle Information and Cost Savings Act. Technical report

    SciTech Connect

    Syria, S.L.

    1981-06-01

    This document announces the conclusions of the EPA evaluation of the 'SYNERGY-1' device under provisions of Section 511 of the Motor Vehicle Information and Cost Savings Act. This additive is intended to improve fuel economy and exhaust emission levels of two and four cycle gasoline fueled engines.

  1. Radiology image perception and observer performance: How does expertise and clinical information alter interpretation? Stroke detection explored through eye-tracking

    NASA Astrophysics Data System (ADS)

    Cooper, Lindsey; Gale, Alastair; Darker, Iain; Toms, Andoni; Saada, Janak

    2009-02-01

    Historically, radiology research has been dominated by chest and breast screening. Few studies have examined complex interpretative tasks such as the reading of multidimensional brain CT or MRI scans. Additionally, no studies at the time of writing have explored the interpretation of stroke images; from novices through to experienced practitioners using eye movement analysis. Finally, there appears a lack of evidence on the clinical effects of radiology reports and their influence on image appraisal and clinical diagnosis. A computer-based, eye-tracking study was designed to assess diagnostic accuracy and interpretation in stroke CT and MR imagery. Eight predetermined clinical cases, five images per case, were presented to participants (novices, trainee, and radiologists; n=8). The presence or absence of abnormalities was rated on a five-point Likert scale and their locations reported. Half cases of the cases were accompanied by clinical information; half were not, to assess the impact of information on observer performance. Results highlight differences in visual search patterns amongst novice, trainee and expert observers; the most marked differences occurred between novice readers and experts. Experts spent more time in challenging areas of interest (AOI) than novices and trainee, and were more confident unless a lesion was large and obvious. The time to first AOI fixation differed by size, shape and clarity of lesion. 'Time to lesion' dropped significantly when recognition appeared to occur between slices. The influence of clinical information was minimal.

  2. Informal Reading-Thinking Inventory: An Informal Reading Inventory (IRI) with Options for Assessing Additional Elements of Higher-Order Literacy.

    ERIC Educational Resources Information Center

    Manzo, Anthony V.; And Others

    Focusing on better assessing the thinking, or meaning-making, aspects of reading that are emphasized in current views of the reading process, this book presents the Informal Reading-Thinking Inventory (IR-TI) which offers options to enhance assessment beyond assessing students' listening level, oral reading of words, and basic comprehension. The…

  3. Rates of provision of clinical information in the skin biopsy requisition form and corresponding encounter visit note

    PubMed Central

    Olson, Meredith A.; Lohse, Christine M.; Comfere, Nneka I.

    2016-01-01

    Background: The skin biopsy requisition form (RF) serves as a key communication tool for transfer of relevant information related to skin biopsy between clinicians and pathologists. Clinical information in the skin biopsy RF is frequently missing or incomplete. Objective: To determine the rates of provision of critical clinical information necessary for histopathologic interpretation in the skin biopsy RF and encounter visit note (EVN). Methods: A retrospective review of 300 RFs and corresponding EVNs from May 1 to 7, 2012, in a tertiary care dermatology practice. Results: Age (100%), lesion location (100%), and clinical impression (93%) were the most commonly supplied elements in the RF and EVN. Clinical elements that were commonly not provided in the RF but present in the EVN included sampling method – partial versus complete (46%), duration of lesion (54%), morphology of lesion (97%), clinical symptoms (63%), clinical photos (63%), previous clinical (97%), and dermatopathologic diagnoses (82%). Limitations: Retrospective study design. Conclusions: These data suggest that while missing critical clinical information in the RF is often present in the EVN, some information is still not present in either source.

  4. Nurses' Information Seeking Behavior for Clinical Practice: A Case Study in a Developing Country.

    PubMed

    Sarbaz, Masoumeh; Kimiafar, Khalil; Sheikhtaheri, Abbas; Taherzadeh, Zhila; Eslami, Saeid

    2016-01-01

    We used a valid questionnaire to survey Iranian nurses' seeking information behavior and their confidence on different information sources. The frequently used sources were Internet" and "personal experiences" (54.8% and 48.2% respectively). "English medical journals" (61.9%) and "English textbooks" (41.3%) were the least frequently used sources. Nurses felt high confidence in sources such as "International instructions/guidelines" (58.6%) and "English medical textbooks" (50.4%). The main reasons for selecting sources were easy accessibility, being up to date and reliability. Google, Pubmed and Up to Date were the most used electronic sources. In addition, there were differences in terms of using some of these resources and nurse' age and gender. In developing information sources for nurses, factors such as reliability level, availability, and updatedness of resources should be more emphasized.

  5. Nurses' Information Seeking Behavior for Clinical Practice: A Case Study in a Developing Country.

    PubMed

    Sarbaz, Masoumeh; Kimiafar, Khalil; Sheikhtaheri, Abbas; Taherzadeh, Zhila; Eslami, Saeid

    2016-01-01

    We used a valid questionnaire to survey Iranian nurses' seeking information behavior and their confidence on different information sources. The frequently used sources were Internet" and "personal experiences" (54.8% and 48.2% respectively). "English medical journals" (61.9%) and "English textbooks" (41.3%) were the least frequently used sources. Nurses felt high confidence in sources such as "International instructions/guidelines" (58.6%) and "English medical textbooks" (50.4%). The main reasons for selecting sources were easy accessibility, being up to date and reliability. Google, Pubmed and Up to Date were the most used electronic sources. In addition, there were differences in terms of using some of these resources and nurse' age and gender. In developing information sources for nurses, factors such as reliability level, availability, and updatedness of resources should be more emphasized. PMID:27332155

  6. Information Seeking Behaviour of Parents of Paediatric Patients for Clinical Decision Making: The Central Role of Information Literacy in a Participatory Setting

    ERIC Educational Resources Information Center

    Kostagiolas, Petros; Martzoukou, Konstantina; Georgantzi, Georgia; Niakas, Dimitris

    2013-01-01

    Introduction: This study investigated the information seeking behaviour and needs of parents of paediatric patients and their motives for seeking Internet-based information. Method: A questionnaire survey of 121 parents was conducted in a paediatric clinic of a Greek university hospital. Analysis: The data were analysed using SPSS; descriptive…

  7. Improving documentation of clinical care within a clinical information network: an essential initial step in efforts to understand and improve care in Kenyan hospitals

    PubMed Central

    Tuti, Timothy; Bitok, Michael; Malla, Lucas; Paton, Chris; Muinga, Naomi; Gathara, David; Gachau, Susan; Mbevi, George; Nyachiro, Wycliffe; Ogero, Morris; Julius, Thomas; Irimu, Grace; English, Mike

    2016-01-01

    In many low income countries health information systems are poorly equipped to provide detailed information on hospital care and outcomes. Information is thus rarely used to support practice improvement. We describe efforts to tackle this challenge and to foster learning concerning collection and use of information. This could improve hospital services in Kenya. We are developing a Clinical Information Network, a collaboration spanning 14 hospitals, policy makers and researchers with the goal of improving information available on the quality of inpatient paediatric care across common childhood illnesses in Kenya. Standardised data from hospitals’ paediatric wards are collected using non-commercial and open source tools. We have implemented procedures for promoting data quality which are performed prior to a process of semi-automated analysis and routine report generation for hospitals in the network. In the first phase of the Clinical Information Network, we collected data on over 65 000 admission episodes. Despite clinicians’ initial unfamiliarity with routine performance reporting, we found that, as an initial focus, both engaging with each hospital and providing them information helped improve the quality of data and therefore reports. The process has involved mutual learning and building of trust in the data and should provide the basis for collaborative efforts to improve care, to understand patient outcome, and to evaluate interventions through shared learning. We have found that hospitals are willing to support the development of a clinically focused but geographically dispersed Clinical Information Network in a low-income setting. Such networks show considerable promise as platforms for collaborative efforts to improve care, to provide better information for decision making, and to enable locally relevant research. PMID:27398232

  8. [From library to clinical decision support systems: access of general practitioner to quality information].

    PubMed

    Fauquert, B

    2012-09-01

    Since 2003, the following tools have been implemented in Belgium for improving the access of general practioners to the EBM literature: the Digital Library for Health and the evidence-linker of the CEBAM, the portal EBMPracticeNet.be and the multidimensional electronic clinical decision support EBMeDS. The aim of this article is to show the progress achieved in the information dissemination toward the belgian general practioners, particularly the access from the electronic health record. From the literature published these last years, the opportunities cited by the users are for using EBM and the strong willingness for using these literature access in the future; the limits are the medical data coding, the irrelevance of the search results, the alerts fatigue induced by EBMeDS. The achievements done and planned for the new EBMPracticeNet guidelines portal and the EBMeDS system are explained in the aim of informing belgian healthcare professionals. These projects are claiming for lauching a participatory process in the production and dissemination of EBM information. The discussion is focused on the belgian healthcare system advantages, the solutions for a reasonable implementation of these projects and for increasing the place of an evidence-based information in the healthcare decision process. Finally the input of these projects to the continuing medical education and to the healthcare quality are discussed, in a context of multifactorial interaction healthcare design (complexity design).

  9. “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

  10. Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision.

    PubMed

    Gillies, Kate; Entwistle, Vikki A

    2012-12-01

    Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about 'voluntariness', underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge.

  11. Timing invitations to participate in clinical research: preliminary versus informed consent.

    PubMed

    Iltis, Ana Smith

    2005-02-01

    This article addresses the impact of the potential conflict between the roles of physicians who are both clinicians and researchers on the recruitment of persons into research trials. It has been proposed (1) that a physician breaches inter-role confidentiality when he or she uses information gathered in his or her clinical role to inform patients about trials for which they may be eligible and (2) that clinician-researchers should adopt a model of preliminary consent to be approached about research prior to commencing a clinical relationship. This article argues that even if we grant the legitimacy of inter-role confidentiality (which is open to question), there are circumstances in which other obligations physicians bear override the obligation of inter-role confidentiality. Moreover, it is argued that the practice of preliminary consent is morally suspect and that such consent cannot be deemed valid. The article concludes with a series of recommendations of ways in which the legitimate concern regarding the conflicting roles of clinician-researchers can be addressed in the recruitment stage of research.

  12. Use of national clinical databases for informing and for evaluating health care policies.

    PubMed

    Black, Nick; Tan, Stefanie

    2013-02-01

    Policy-makers and analysts could make use of national clinical databases either to inform or to evaluate meso-level (organisation and delivery of health care) and macro-level (national) policies. Reviewing the use of 15 of the best established databases in England, we identify and describe four published examples of each use. These show that policy-makers can either make use of the data itself or of research based on the database. For evaluating policies, the major advantages are the huge sample sizes available, the generalisability of the data, its immediate availability and historic information. The principal methodological challenges involve the need for risk adjustment and time-series analysis. Given their usefulness in the policy arena, there are several reasons why national clinical databases have not been used more, some due to a lack of 'push' by their custodians and some to the lack of 'pull' by policy-makers. Greater exploitation of these valuable resources would be facilitated by policy-makers' and custodians' increased awareness, minimisation of legal restrictions on data use, improvements in the quality of databases and a library of examples of applications to policy.

  13. Using circulating tumor cells to inform on prostate cancer biology and clinical utility

    PubMed Central

    Li, Jing; Gregory, Simon G.; Garcia-Blanco, Mariano A.; Armstrong, Andrew J.

    2016-01-01

    Substantial advances in the molecular biology of prostate cancer have led to the approval of multiple new systemic agents to treat men with metastatic castration-resistant prostate cancer (mCRPC). These treatments encompass androgen receptor directed therapies, immunotherapies, bone targeting radiopharmaceuticals and cytotoxic chemotherapies. There is, however, great heterogeneity in the degree of patient benefit with these agents, thus fueling the need to develop predictive biomarkers that are able to rationally guide therapy. Circulating tumor cells (CTCs) have the potential to provide an assessment of tumor-specific biomarkers through a non-invasive, repeatable “liquid biopsy” of a patient’s cancer at a given point in time. CTCs have been extensively studied in men with mCRPC, where CTC enumeration using the Cellsearch® method has been validated and FDA approved to be used in conjunction with other clinical parameters as a prognostic biomarker in metastatic prostate cancer. In addition to enumeration, more sophisticated molecular profiling of CTCs is now feasible and may provide more clinical utility as it may reflect tumor evolution within an individual particularly under the pressure of systemic therapies. Here, we review technologies used to detect and characterize CTCs, and the potential biological and clinical utility of CTC molecular profiling in men with metastatic prostate cancer. PMID:26079252

  14. An approach to 'dynamic--DDD (defined daily dose) monitoring' to reduce adverse clinical outcomes and increase patient safety: information repositories and event triggers in clinical practice.

    PubMed

    Eryilmaz, Esat N

    2011-01-01

    The goal of every effort and actions/interventions in almost all healthcare settings throughout the world's health systems -primary care, inpatient, outpatient encounters, diagnostic and therapeutic interventions, peri-operative settings- is and has been to achieve a well defined outcome (a kind of improvement in health status of the patient under consideration, an observable and significant change(s) in selected set(s) of clinical parameters confirmed by laboratory results and pathology findings, improvements in clinical outcomes). Clinical inefficiencies, in this context, should be addressed very systematically and scientifically. This is achieved through a continuously monitoring approach to adverse drug events based on information repositories and evidence-based rule sets. For monitoring drug-related outcomes and clinical outcomes in general, the concept of DDD (Defined Daily Dose) compliance is explained in this article to eliminate and avoid adverse clinical outcomes.

  15. Use of IDEF modeling to develop an information management system for drug and alcohol outpatient treatment clinics

    NASA Astrophysics Data System (ADS)

    Hoffman, Kenneth J.

    1995-10-01

    Few information systems create a standardized clinical patient record in which there are discrete and concise observations of patient problems and their resolution. Clinical notes usually are narratives which don't support an aggregate and systematic outcome analysis. Many programs collect information on diagnosis and coded procedures but are not focused on patient problems. Integrated definition (IDEF) methodology has been accepted by the Department of Defense as part of the Corporate Information Management Initiative and serves as the foundation that establishes a need for automation. We used IDEF modeling to describe present and idealized patient care activities. A logical IDEF data model was created to support those activities. The modeling process allows for accurate cost estimates based upon performed activities, efficient collection of relevant information, and outputs which allow real- time assessments of process and outcomes. This model forms the foundation for a prototype automated clinical information system (ACIS).

  16. Informed Conditioning on Clinical Covariates Increases Power in Case-Control Association Studies

    PubMed Central

    Zaitlen, Noah; Lindström, Sara; Pasaniuc, Bogdan; Cornelis, Marilyn; Genovese, Giulio; Pollack, Samuela; Barton, Anne; Bickeböller, Heike; Bowden, Donald W.; Eyre, Steve; Freedman, Barry I.; Friedman, David J.; Field, John K.; Groop, Leif; Haugen, Aage; Heinrich, Joachim; Henderson, Brian E.; Hicks, Pamela J.; Hocking, Lynne J.; Kolonel, Laurence N.; Landi, Maria Teresa; Langefeld, Carl D.; Le Marchand, Loic; Meister, Michael; Morgan, Ann W.; Raji, Olaide Y.; Risch, Angela; Rosenberger, Albert; Scherf, David; Steer, Sophia; Walshaw, Martin; Waters, Kevin M.; Wilson, Anthony G.; Wordsworth, Paul; Zienolddiny, Shanbeh; Tchetgen, Eric Tchetgen; Haiman, Christopher; Hunter, David J.; Plenge, Robert M.; Worthington, Jane; Christiani, David C.; Schaumberg, Debra A.; Chasman, Daniel I.; Altshuler, David; Voight, Benjamin; Kraft, Peter; Patterson, Nick; Price, Alkes L.

    2012-01-01

    Genetic case-control association studies often include data on clinical covariates, such as body mass index (BMI), smoking status, or age, that may modify the underlying genetic risk of case or control samples. For example, in type 2 diabetes, odds ratios for established variants estimated from low–BMI cases are larger than those estimated from high–BMI cases. An unanswered question is how to use this information to maximize statistical power in case-control studies that ascertain individuals on the basis of phenotype (case-control ascertainment) or phenotype and clinical covariates (case-control-covariate ascertainment). While current approaches improve power in studies with random ascertainment, they often lose power under case-control ascertainment and fail to capture available power increases under case-control-covariate ascertainment. We show that an informed conditioning approach, based on the liability threshold model with parameters informed by external epidemiological information, fully accounts for disease prevalence and non-random ascertainment of phenotype as well as covariates and provides a substantial increase in power while maintaining a properly controlled false-positive rate. Our method outperforms standard case-control association tests with or without covariates, tests of gene x covariate interaction, and previously proposed tests for dealing with covariates in ascertained data, with especially large improvements in the case of case-control-covariate ascertainment. We investigate empirical case-control studies of type 2 diabetes, prostate cancer, lung cancer, breast cancer, rheumatoid arthritis, age-related macular degeneration, and end-stage kidney disease over a total of 89,726 samples. In these datasets, informed conditioning outperforms logistic regression for 115 of the 157 known associated variants investigated (P-value = 1×10−9). The improvement varied across diseases with a 16% median increase in χ2 test statistics and a

  17. Pediatric Brain Tumors: Innovative Genomic Information Is Transforming the Diagnostic and Clinical Landscape.

    PubMed

    Gajjar, Amar; Bowers, Daniel C; Karajannis, Matthias A; Leary, Sarah; Witt, Hendrik; Gottardo, Nicholas G

    2015-09-20

    Pediatric neuro-oncology has undergone an exciting and dramatic transformation during the past 5 years. This article summarizes data from collaborative group and institutional trials that have advanced the science of pediatric brain tumors and survival of patients with these tumors. Advanced genomic analysis of the entire spectrum of pediatric brain tumors has heralded an era in which stakeholders in the pediatric neuro-oncology community are being challenged to reconsider their current research and diagnostic and treatment strategies. The incorporation of this new information into the next-generation treatment protocols will unleash new challenges. This review succinctly summarizes the key advances in our understanding of the common pediatric brain tumors (ie, medulloblastoma, low- and high-grade gliomas, diffuse intrinsic pontine glioma, and ependymoma) and some selected rare tumors (ie, atypical teratoid/rhabdoid tumor and CNS primitive neuroectodermal tumor). The potential impact of this new information on future clinical protocols also is discussed. Cutting-edge genomics technologies and the information gained from such studies are facilitating the identification of molecularly defined subgroups within patients with particular pediatric brain tumors. The number of evaluable patients in each subgroup is small, particularly in the subgroups of rare diseases. Therefore, international collaboration will be crucial to draw meaningful conclusions about novel approaches to treating pediatric brain tumors.

  18. Clinical information systems end user satisfaction: the expectations and needs congruencies effects.

    PubMed

    Karimi, Faezeh; Poo, Danny C C; Tan, Yung Ming

    2015-02-01

    Prior research on information systems (IS) shows that users' attitudes and continuance intentions are associated with their satisfaction with information systems. As such, the increasing amount of investments in clinical information systems (CIS) signifies the importance of understanding CIS end users' (i.e., clinicians) satisfaction. In this study, we develop a conceptual framework to identify the cognitive determinants of clinicians' satisfaction formation. The disconfirmation paradigm serves as the core of the framework. The expectations and needs congruency models are the two models of this paradigm, and perceived performance is the basis of the comparisons in the models. The needs and expectations associated with the models are also specified. The survey methodology is adopted in this study to empirically validate the proposed research model. The survey is conducted at a public hospital and results in 112 and 203 valid responses (56% and 98% response rates) from doctors and nurses respectively. The partial least squares (PLS) method is used to analyze the data. The results of the study show that perceived CIS performance is the most influential factor on clinicians' (i.e., doctors and nurses) satisfaction. Doctors' expectations congruency is the next significant determinant of their satisfaction. Contrary to most previous findings, nurses' expectations and expectations congruency do not show a significant effect on their satisfaction. However, the needs congruency is found to significantly affect nurses' satisfaction. PMID:25542853

  19. Pediatric Brain Tumors: Innovative Genomic Information Is Transforming the Diagnostic and Clinical Landscape.

    PubMed

    Gajjar, Amar; Bowers, Daniel C; Karajannis, Matthias A; Leary, Sarah; Witt, Hendrik; Gottardo, Nicholas G

    2015-09-20

    Pediatric neuro-oncology has undergone an exciting and dramatic transformation during the past 5 years. This article summarizes data from collaborative group and institutional trials that have advanced the science of pediatric brain tumors and survival of patients with these tumors. Advanced genomic analysis of the entire spectrum of pediatric brain tumors has heralded an era in which stakeholders in the pediatric neuro-oncology community are being challenged to reconsider their current research and diagnostic and treatment strategies. The incorporation of this new information into the next-generation treatment protocols will unleash new challenges. This review succinctly summarizes the key advances in our understanding of the common pediatric brain tumors (ie, medulloblastoma, low- and high-grade gliomas, diffuse intrinsic pontine glioma, and ependymoma) and some selected rare tumors (ie, atypical teratoid/rhabdoid tumor and CNS primitive neuroectodermal tumor). The potential impact of this new information on future clinical protocols also is discussed. Cutting-edge genomics technologies and the information gained from such studies are facilitating the identification of molecularly defined subgroups within patients with particular pediatric brain tumors. The number of evaluable patients in each subgroup is small, particularly in the subgroups of rare diseases. Therefore, international collaboration will be crucial to draw meaningful conclusions about novel approaches to treating pediatric brain tumors. PMID:26304884

  20. Clinical information systems end user satisfaction: the expectations and needs congruencies effects.

    PubMed

    Karimi, Faezeh; Poo, Danny C C; Tan, Yung Ming

    2015-02-01

    Prior research on information systems (IS) shows that users' attitudes and continuance intentions are associated with their satisfaction with information systems. As such, the increasing amount of investments in clinical information systems (CIS) signifies the importance of understanding CIS end users' (i.e., clinicians) satisfaction. In this study, we develop a conceptual framework to identify the cognitive determinants of clinicians' satisfaction formation. The disconfirmation paradigm serves as the core of the framework. The expectations and needs congruency models are the two models of this paradigm, and perceived performance is the basis of the comparisons in the models. The needs and expectations associated with the models are also specified. The survey methodology is adopted in this study to empirically validate the proposed research model. The survey is conducted at a public hospital and results in 112 and 203 valid responses (56% and 98% response rates) from doctors and nurses respectively. The partial least squares (PLS) method is used to analyze the data. The results of the study show that perceived CIS performance is the most influential factor on clinicians' (i.e., doctors and nurses) satisfaction. Doctors' expectations congruency is the next significant determinant of their satisfaction. Contrary to most previous findings, nurses' expectations and expectations congruency do not show a significant effect on their satisfaction. However, the needs congruency is found to significantly affect nurses' satisfaction.