Science.gov

Sample records for additional clinical information

  1. 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,...

  2. 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,...

  3. 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,...

  4. 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...

  5. Uniform Additivity in Classical and Quantum Information

    NASA Astrophysics Data System (ADS)

    Cross, Andrew; Li, Ke; Smith, Graeme

    2017-01-01

    Information theory quantifies the optimal rates of resource interconversions, usually in terms of entropies. However, nonadditivity often makes evaluating entropic formulas intractable. In a few auspicious cases, additivity allows a full characterization of optimal rates. We study uniform additivity of formulas, which is easily evaluated and captures all known additive quantum formulas. Our complete characterization of uniform additivity exposes an intriguing new additive quantity and identifies a remarkable coincidence—the classical and quantum uniformly additive functions with one auxiliary variable are identical.

  6. 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...

  7. 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...

  8. 12 CFR 1010.116 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 8 2013-01-01 2013-01-01 false Additional information. 1010.116 Section 1010.116 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION LAND REGISTRATION (REGULATION J) Reporting Requirements § 1010.116 Additional information. (a) Property Owners' Association. (1) Will there be a property owners' association for...

  9. 12 CFR 1010.116 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 8 2014-01-01 2014-01-01 false Additional information. 1010.116 Section 1010.116 Banks and Banking BUREAU OF CONSUMER FINANCIAL PROTECTION LAND REGISTRATION (REGULATION J) Reporting Requirements § 1010.116 Additional information. (a) Property Owners' Association. (1) Will there be a property owners' association for...

  10. 24 CFR 1710.116 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Additional information. 1710.116 Section 1710.116 Housing and Urban Development Regulations Relating to Housing and Urban Development... URBAN DEVELOPMENT (INTERSTATE LAND SALES REGISTRATION PROGRAM) LAND REGISTRATION Reporting...

  11. 24 CFR 1710.216 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Additional information. 1710.216 Section 1710.216 Housing and Urban Development Regulations Relating to Housing and Urban Development... URBAN DEVELOPMENT (INTERSTATE LAND SALES REGISTRATION PROGRAM) LAND REGISTRATION Reporting...

  12. 18 CFR 5.21 - Additional information.

    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. 5.21 Section 5.21 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS §...

  13. 18 CFR 5.21 - Additional information.

    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. 5.21 Section 5.21 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS §...

  14. 18 CFR 5.21 - Additional information.

    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. 5.21 Section 5.21 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS §...

  15. 18 CFR 5.21 - Additional information.

    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. 5.21 Section 5.21 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS §...

  16. 18 CFR 5.21 - Additional information.

    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. 5.21 Section 5.21 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT INTEGRATED LICENSE APPLICATION PROCESS §...

  17. 24 CFR 1710.116 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 5 2013-04-01 2013-04-01 false Additional information. 1710.116 Section 1710.116 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued) OFFICE OF ASSISTANT SECRETARY FOR HOUSING-FEDERAL HOUSING COMMISSIONER, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (INTERSTATE LAND...

  18. 27 CFR 41.197 - Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., § 41.197 was revised, effective Aug. 26, 2013 through Aug. 26, 2016. ... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Additional information. 41.197 Section 41.197 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE...

  19. 18 CFR 33.10 - Additional information.

    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. 33.10 Section 33.10 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE FEDERAL POWER ACT APPLICATIONS UNDER FEDERAL POWER ACT SECTION...

  20. BPI-ANCA Provides Additional Clinical Information to Anti-Pseudomonas Serology: Results from a Cohort of 117 Swedish Cystic Fibrosis Patients.

    PubMed

    Lindberg, Ulrika; Carlsson, Malin; Hellmark, Thomas; Segelmark, Mårten

    2015-01-01

    Patients with cystic fibrosis (CF) colonized with Pseudomonas aeruginosa (P. aeruginosa) have worse prognosis compared with patients who are not. BPI-ANCA is an anti-neutrophil cytoplasmic antibody against BPI (bactericidal/permeability increasing protein) correlating with P. aeruginosa colonization and adverse long time prognosis. Whether it provides additional information as compared to standard anti-P. aeruginosa serology tests is not known. 117 nontransplanted CF patients at the CF centre in Lund, Sweden, were followed prospectively for ten years. Bacterial colonisation was classified according to the Leeds criteria. IgA BPI-ANCA was compared with assays for antibodies against alkaline protease (AP), Elastase (ELA), and Exotoxin A (ExoA). Lung function and patient outcome, alive, lung transplanted, or dead, were registered. BPI-ANCA showed the highest correlation with lung function impairment with an r-value of 0.44. Forty-eight of the 117 patients were chronically colonized with P. aeruginosa. Twenty of these patients experienced an adverse outcome. Receiver operator curve (ROC) analysis revealed that this could be predicted by BPI-ANCA (AUC = 0.77), (p = 0.002) to a better degree compared with serology tests. BPI-ANCA correlates better with lung function impairment and long time prognosis than anti-P. aeruginosa serology and has similar ability to identify patients with chronic P. aeruginosa.

  1. [Information about phosphorus additives and nutritional counseling].

    PubMed

    Kido, Shinsuke; Nomura, Kengo; Sasaki, Shohei; Shiozaki, Yuji; Segawa, Hiroko; Tatsumi, Sawako

    2012-10-01

    Hyperphosphatemia is a common disorder in patients with chronic kidney disease (CKD) , and may result in hyperparathyroidism and renal osteodystrophy. Hyperphosphatemia also may contribute to deterioration vascular calcification and increase mortality. Hence, correction and prevention of hyperphosphatemia is a main component of the management of CKD. This goal is usually approached both by administering phosphorus binders and by restricting dietary phosphorus (P) intake. Dietary intake of phosphorus (P) is derived largely from foods with high protein content or food additives and is an important determinant of P balance in patient with CKD. Food additives (PO4) can dramatically increase the amount of P consumed in the daily diet, especially because P is more readily absorbed in its inorganic form. In addition, information about the P content and type in prepared foods is often unavailable or misleading. Therefore, during dietary counseling of patients with CKD, we recommended that they consider both the absolute dietary P content and the P-to-protein ratio of foods and meals including food additives.

  2. 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.

  3. 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.

  4. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Service (BSS) in Appendix 30 of the ITU Radio Regulations (RR) and associated feeder-link plans in Appendix 30A of the ITU RR, if the system has technical characteristics differing from those specified in... provide the Commission with the information required by Appendix 4 of the ITU RR for advance...

  5. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES SATELLITE COMMUNICATIONS... Administrations. (c) In the Direct Broadcast Satellite service, applicants and licensees shall also provide the Commission with all information it requires in order to modify the Appendix 30 Broadcasting-Satellite...

  6. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES SATELLITE COMMUNICATIONS... Administrations. (c) In the Direct Broadcast Satellite service, applicants and licensees shall also provide the Commission with all information it requires in order to modify the Appendix 30 Broadcasting-Satellite...

  7. 47 CFR 25.111 - Additional information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON CARRIER SERVICES SATELLITE COMMUNICATIONS... Administrations. (c) In the Direct Broadcast Satellite service, applicants and licensees shall also provide the Commission with all information it requires in order to modify the Appendix 30 Broadcasting-Satellite...

  8. Informed consent in clinical research.

    PubMed

    Pick, Andrew; Berry, Shelley; Gilbert, Kayleigh; McCaul, James

    Since increasing numbers of patients are asked to take part in clinical trials, nurses need to be aware of the principles of valid, informed consent. This article explores consent, which aims to protect the rights, safety and wellbeing of patients. In particular, the history of consent in research and the elements involved in obtaining informed consent from potential participants in research studies are discussed.

  9. 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...

  10. 78 FR 75568 - Notice of Request for Additional Information

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-12

    ... From the Federal Register Online via the Government Publishing Office FEDERAL MARITIME COMMISSION Notice of Request for Additional Information The Commission gives notice that it has formally requested that the parties to the below listed agreement provide additional information pursuant to 46 U.S.C. 40304(d). This action prevents the...

  11. Public information about clinical trials and research.

    PubMed

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  12. 29 CFR 502.44 - Additional information, if required.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ENFORCEMENT OF CONTRACTUAL OBLIGATIONS FOR TEMPORARY ALIEN AGRICULTURAL WORKERS ADMITTED UNDER SECTION 218 OF... Administrative Law Judge's Decision § 502.44 Additional information, if required. Where the ARB has determined...

  13. 29 CFR 502.44 - Additional information, if required.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... ENFORCEMENT OF CONTRACTUAL OBLIGATIONS FOR TEMPORARY ALIEN AGRICULTURAL WORKERS ADMITTED UNDER SECTION 218 OF... Administrative Law Judge's Decision § 502.44 Additional information, if required. Where the ARB has determined...

  14. 29 CFR 502.44 - Additional information, if required.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ENFORCEMENT OF CONTRACTUAL OBLIGATIONS FOR TEMPORARY ALIEN AGRICULTURAL WORKERS ADMITTED UNDER SECTION 218 OF... Administrative Law Judge's Decision § 502.44 Additional information, if required. Where the ARB has determined...

  15. 29 CFR 502.44 - Additional information, if required.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... ENFORCEMENT OF CONTRACTUAL OBLIGATIONS FOR TEMPORARY ALIEN AGRICULTURAL WORKERS ADMITTED UNDER SECTION 218 OF... Administrative Law Judge's Decision § 502.44 Additional information, if required. Where the ARB has determined...

  16. 29 CFR 502.44 - Additional information, if required.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... ENFORCEMENT OF CONTRACTUAL OBLIGATIONS FOR TEMPORARY ALIEN AGRICULTURAL WORKERS ADMITTED UNDER SECTION 218 OF... Administrative Law Judge's Decision § 502.44 Additional information, if required. Where the ARB has determined...

  17. 21 CFR 71.4 - Samples; additional information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Samples; additional information. 71.4 Section 71.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR... samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic...

  18. 21 CFR 71.4 - Samples; additional information.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Samples; additional information. 71.4 Section 71.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR... samples of the color additive, articles used as components thereof, or of the food, drug, or cosmetic...

  19. 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...

  20. 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 §...

  1. 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...

  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. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 21 CFR 207.31 - Additional drug listing information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 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. 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...

  9. 29 CFR 2570.39 - Opportunities to submit additional information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 9 2010-07-01 2010-07-01 false Opportunities to submit additional information. 2570.39 Section 2570.39 Labor Regulations Relating to Labor (Continued) EMPLOYEE BENEFITS SECURITY ADMINISTRATION, DEPARTMENT OF LABOR ADMINISTRATION AND ENFORCEMENT UNDER THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF...

  10. 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 Section 2570.39 Labor Regulations Relating to Labor (Continued) EMPLOYEE BENEFITS SECURITY ADMINISTRATION, DEPARTMENT OF LABOR ADMINISTRATION AND ENFORCEMENT UNDER THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF...

  11. 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 Section 2570.39 Labor Regulations Relating to Labor (Continued) EMPLOYEE BENEFITS SECURITY ADMINISTRATION, DEPARTMENT OF LABOR ADMINISTRATION AND ENFORCEMENT UNDER THE EMPLOYEE RETIREMENT INCOME SECURITY ACT OF...

  12. 43 CFR 3922.30 - Application-Additional information.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Application-Additional information. 3922.30 Section 3922.30 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) OIL SHALE LEASING...

  13. 43 CFR 3922.30 - Application-Additional information.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Application-Additional information. 3922.30 Section 3922.30 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR RANGE MANAGEMENT (4000) OIL SHALE LEASING...

  14. 43 CFR 3922.30 - Application-Additional information.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Application-Additional information. 3922.30 Section 3922.30 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) OIL SHALE LEASING...

  15. 43 CFR 3922.30 - Application-Additional information.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Application-Additional information. 3922.30 Section 3922.30 Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR MINERALS MANAGEMENT (3000) OIL SHALE LEASING...

  16. 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...

  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. Informed consent for clinical photography.

    PubMed

    Johns, Martin K

    2002-06-01

    The question of (informed) consent to medical photography has long been a vexed one. This paper briefly considers key landmarks in the debate, and examines in detail the evolution of the Addenbrooke's NHS Trust policy Photography and Video Recordings of Patients: Confidentiality and Consent, Copyright and Storage. The impact of the 1998 Data Protection Act, the Department of Health's Model Policy on Consent, and the implications of wider access to digital photography are discussed together with their integration into the Addenbrooke's policy.

  19. 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

  20. Framework for a clinical information system.

    PubMed

    Van De Velde, R; Lansiers, R; Antonissen, G

    2002-01-01

    The design and implementation of Clinical Information System architecture is presented. This architecture has been developed and implemented based on components following a strong underlying conceptual and technological model. Common Object Request Broker and n-tier technology featuring centralised and departmental clinical information systems as the back-end store for all clinical data are used. Servers located in the "middle" tier apply the clinical (business) model and application rules. The main characteristics are the focus on modelling and reuse of both data and business logic. Scalability as well as adaptability to constantly changing requirements via component driven computing are the main reasons for that approach.

  1. Integration of Surgery Management and Clinical Information Systems

    PubMed Central

    Clayton, Paul D.; Delaplaine, Kathy H.; Jensen, Ronald D.; Bird, Bruce; Evans, R. Scott; Cannon, Clawson Y.

    1987-01-01

    We describe a computer-based management system used in the Surgery deaprtment at LSD Hospital. In addition to the traditional management functions which are found in systems developed by others, our system was designed to collect and display clinical information about the surgical patient as part of a larger comprehensive clinical information system. The information derived from the surgery sub-system is integrated with information from other sources in the hospital for use in automated medical decision - making as well as departmental management.

  2. [Informed consent in clinical practice: persistent doubts].

    PubMed

    Kottow, Miguel

    2016-11-01

    Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics’ effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics’ insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.

  3. Framework for a clinical information system.

    PubMed

    Van de Velde, R

    2000-01-01

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

  4. How to retrieve additional information from the multiplicity distributions

    NASA Astrophysics Data System (ADS)

    Wilk, Grzegorz; Włodarczyk, Zbigniew

    2017-01-01

    Multiplicity distributions (MDs) P(N) measured in multiparticle production processes are most frequently described by the negative binomial distribution (NBD). However, with increasing collision energy some systematic discrepancies have become more and more apparent. They are usually attributed to the possible multi-source structure of the production process and described using a multi-NBD form of the MD. We investigate the possibility of keeping a single NBD but with its parameters depending on the multiplicity N. This is done by modifying the widely known clan model of particle production leading to the NBD form of P(N). This is then confronted with the approach based on the so-called cascade-stochastic formalism which is based on different types of recurrence relations defining P(N). We demonstrate that a combination of both approaches allows the retrieval of additional valuable information from the MDs, namely the oscillatory behavior of the counting statistics apparently visible in the high energy data.

  5. 31 CFR 26.5 - Upgrades and additional environmental information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., such environmental information from the MDB (e.g., environmental chapters from project feasibility studies or environmental data sheets) which contains this environmental analysis. The MDB Office...

  6. 76 FR 34639 - Notice of Proposed Additional Information Collection: Advisory Committee and Research and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-14

    ... Notice of Proposed Additional Information Collection: Advisory Committee and Research and Promotion... approved information collection of the Advisory Committee and Research and Promotion Background Information... . SUPPLEMENTARY INFORMATION: Title: Advisory Committee and Research and Promotion Background Information....

  7. 10 CFR 1.3 - Sources of additional information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... fall within an exemption to the Act's openness requirement and the Commission also has determined that... availability of NRC records under the Freedom of Information Act and Privacy Act of 1974 may be obtained...

  8. Successful Implementation of Clinical Information Technology

    PubMed Central

    Hill, V.; Bruner, K.; Maciaz, G.; Saucedo, L.; Catzoela, L.; Ramirez, R.; Jacobs, W.J.; Nguyen, P.; Patel, L.; Webster, S.L.

    2015-01-01

    Summary Objectives To identify and describe the most critical strategic and operational contributors to the successful implementation of clinical information technologies, as deployed within a moderate sized system of U.S. community hospitals. Background and Setting CHRISTUS Health is a multi-state system comprised of more than 350 services and 60 hospitals with over 9 000 physicians. The Santa Rosa region of CHRISTUS Health, located in greater San Antonio, Texas is comprised of three adult community hospital facilities and one Children’s hospital each with bed capacities of 142–180. Computerized Patient Order Entry (CPOE) was first implemented in 2012 within a complex market environment. The Santa Rosa region has 2 417 credentialed physicians and 263 mid-level allied health professionals. Methods This report focuses on the seven most valuable strategies deployed by the Health Informatics team in a large four hospital CHRISTUS region to achieve strong CPOE adoption and critical success lessons learned. The findings are placed within the context of the literature describing best practices in health information technology implementation. Results While the elements described involved discrete de novo process generation to support implementation and operations, collectively they represent the creation of a new customer-centric service culture in our Health Informatics team, which has served as a foundation for ensuring strong clinical information technology adoption beyond CPOE. Conclusion The seven success factors described are not limited in their value to and impact on CPOE adoption, but generalize to – and can advance success in – varied other clinical information technology implementations across diverse hospitals. A number of these factors are supported by reports in the literature of other institutions’ successful implementations of CPOE and other clinical information technologies, and while not prescriptive to other settings, may be adapted to yield

  9. 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.

  10. 77 FR 39573 - Additional Identifying Information Associated With Persons Whose Property and Interests in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-03

    ... Office of Foreign Assets Control Additional Identifying Information Associated With Persons Whose... Treasury's Office of Foreign Assets Control (``OFAC'') is publishing additional indentifying information... on June 1, 2012. FOR FURTHER INFORMATION CONTACT: Assistant Director, Sanctions...

  11. Clinical information systems market - an insider's view.

    PubMed

    Manjoney, Richard

    2004-12-01

    Clinical information systems that provide electronic charting and documentation have been commercially available for over 15 years. These systems provide varying degrees of automation to flowsheets, forms, notes, worklists, care plans, and medication administration records. Although there are many benefits that an electronic system brings, such as accessibility, legibility, process adherence, and data mining, the market has been slow to adopt these systems. A variety of historical factors can explain the lack of widespread system implementations. Survey data of CEOs/CIOs from the Healthcare Information and Management Systems Society (HIMSS) shows promising data that clinically oriented applications will receive high prioritization in near term planning. Will this prioritization materialize in actual implementations? Market drivers appear to be in place to predict an increase in sales and implementations.

  12. The clinical information system implementation evaluation scale.

    PubMed

    Gugerty, Brian; Maranda, Michael; Rook, Dona

    2006-01-01

    Measurement instruments to assess user satisfaction with Clinical Information Systems (CIS) and with the implementation of CIS are needed as part of multi-faceted evaluation of CIS. Seven years of experience in developing measurement instruments to assess staff satisfaction with CIS preceded the development effort that created the Clinical Information System Evaluation Scale (CISIES). The scale was developed using precursors of the CISIES and it was guided by an expert panel. Following its construction the 37-item measurement instrument was piloted as part of the assessment of a Critical Care Clinical Information System implementation at a medical center in Florida, USA. Results indicated satisfaction with the implementation, although not strong, at the time of administration. The results of the CISIES administration were used by informaticians at the research site to plan and execute an intervention to improve satisfaction with the implementation. Re-administration of the CISIES at the site to evaluate the success of this intervention is planned. The CISIES was found to be a useful instrument, easy to administer, acceptable to respondents, easy to score and understandable by non-researcher at the study site. Early indications are that it will be useful in the formative and summative evaluation of CIS implementations.

  13. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Hotline (800-426-4791). (b) Ending in the report due by July 1, 2001, a system which detects arsenic at... system that detects arsenic above 0.005 mg/L and up to and including 0.010 mg/L: (1) Must include in its report a short informational statement about arsenic, using language such as: While your drinking...

  14. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Hotline (800-426-4791). (b) Ending in the report due by July 1, 2001, a system which detects arsenic at... system that detects arsenic above 0.005 mg/L and up to and including 0.010 mg/L: (1) Must include in its report a short informational statement about arsenic, using language such as: While your drinking...

  15. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... consultation with the Primacy Agency. (c) A system which detects nitrate at levels above 5 mg/l, but below the MCL: (1) Must include a short informational statement about the impacts of nitrate on children using language such as: Nitrate in drinking water at levels above 10 ppm is a health risk for infants of...

  16. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... consultation with the Primacy Agency. (c) A system which detects nitrate at levels above 5 mg/l, but below the MCL: (1) Must include a short informational statement about the impacts of nitrate on children using language such as: Nitrate in drinking water at levels above 10 ppm is a health risk for infants of...

  17. 40 CFR 141.154 - Required additional health information.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... consultation with the Primacy Agency. (c) A system which detects nitrate at levels above 5 mg/l, but below the MCL: (1) Must include a short informational statement about the impacts of nitrate on children using language such as: Nitrate in drinking water at levels above 10 ppm is a health risk for infants of...

  18. 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

  19. 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).

  20. 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.

  1. SNP Markers as Additional Information to Resolve Complex Kinship Cases

    PubMed Central

    Pontes, M. Lurdes; Fondevila, Manuel; Laréu, Maria Victoria; Medeiros, Rui

    2015-01-01

    Summary Background DNA profiling with sets of highly polymorphic autosomal short tandem repeat (STR) markers has been applied in various aspects of human identification in forensic casework for nearly 20 years. However, in some cases of complex kinship investigation, the information provided by the conventionally used STR markers is not enough, often resulting in low likelihood ratio (LR) calculations. In these cases, it becomes necessary to increment the number of loci under analysis to reach adequate LRs. Recently, it has been proposed that single nucleotide polymorphisms (SNPs) could be used as a supportive tool to STR typing, eventually even replacing the methods/markers now employed. Methods In this work, we describe the results obtained in 7 revised complex paternity cases when applying a battery of STRs, as well as 52 human identification SNPs (SNPforID 52plex identification panel) using a SNaPshot methodology followed by capillary electrophoresis. Results Our results show that the analysis of SNPs, as complement to STR typing in forensic casework applications, would at least increase by a factor of 4 total PI values and correspondent Essen-Möller's W value. Conclusions We demonstrated that SNP genotyping could be a key complement to STR information in challenging casework of disputed paternity, such as close relative individualization or complex pedigrees subject to endogamous relations. PMID:26733770

  2. HPV vaccine cross-protection: Highlights on additional clinical benefit.

    PubMed

    De Vincenzo, Rosa; Ricci, Caterina; Conte, Carmine; Scambia, Giovanni

    2013-09-01

    Prophylactic human papillomavirus (HPV) vaccines are administered in vaccination programs, targeted at young adolescent girls before sexual exposure, and in catch-up programs for young women in some countries. All the data indicate that HPV-virus-like particles (VLPs) effectively prevent papillomavirus infections with a high level of antibodies and safety. Since non-vaccine HPV types are responsible for about 30% of cervical cancers, cross-protection would potentially enhance primary cervical cancer prevention efforts. High levels of specific neutralizing antibodies can be generated after immunization with HPV VLPs. Immunity to HPV is type-specific. However, if we consider the phylogenetic tree including the different HPV types, we realize that a certain degree of cross-protection is possible, due to the high homology of some viral types with vaccine ones. The assessment of cross-protective properties of HPV vaccines is an extremely important matter, which has also increased public health implications and could add further value to their preventive potential. The impact of cross-protection is mostly represented by a reduction of cervical intraepithelial neoplasia CIN2-3 more than what expected. In this article we review the mechanisms and the effectiveness of Bivalent (HPV-16/-18) and Quadrivalent (HPV-6/-11/-16/-18) HPV vaccine cross-protection, focusing on the critical aspects and the potential biases in clinical trials, in order to understand how cross-protection could impact on clinical outcomes and on the new perspectives in post-vaccine era.

  3. Additional branches of celiac trunk and its clinical significance.

    PubMed

    Nayak, S R; Prabhu, Latha V; Krishnamurthy, A; Ganesh Kumar, C; Ramanathan, Lakshmi A; Acharya, Abhijith; Prasad Sinha, Abhishek

    2008-01-01

    The anatomical variations of the abdominal arteries are important due to its clinical significance. Various types of vascular anomalies are frequently found in human abdominal viscera, during cadaveric dissection and diagnostic radiological imaging. The present report describes a variation in the celiac trunk as found during routine dissection in a 59-year-old male cadaver. The celiac trunk (CT) was unusually lengthy and took origin from the left antero-lateral surface of the abdominal aorta. Altogether, there were five branches, including three classic branches of CT. The left phrenic artery (LPA) was the first branch of the CT. The remaining four branches were left gastric artery (LGA), splenic artery (SA), common hepatic artery (CHA) and gastroduodenal artery (GDA). There was an arterial loop between the posterior branches of the superior pancreatico-duodenal artery (SPDA), arising from the GDA, and the posterior branch of the inferior pancreatico-duodenal artery (IPDA), arising from the superior mesenteric artery (SMA). The arterial loop formed by the above arteries, supplied the head of the pancreas and duodeno-jejunal flexure. The embryological and clinical significance of above variations has been described.

  4. 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:...

  5. 30 CFR 75.1200-1 - Additional information on mine map.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Additional information on mine map. 75.1200-1... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Maps § 75.1200-1 Additional information on mine map. Additional information required to be shown on mine maps under § 75.1200...

  6. 30 CFR 75.1200-1 - Additional information on mine map.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Additional information on mine map. 75.1200-1... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Maps § 75.1200-1 Additional information on mine map. Additional information required to be shown on mine maps under § 75.1200...

  7. Longitudinal analysis of new information types in clinical notes.

    PubMed

    Zhang, Rui; Pakhomov, Serguei; Melton, Genevieve B

    2014-01-01

    It is increasingly recognized that redundant information in clinical notes within electronic health record (EHR) systems is ubiquitous, significant, and may negatively impact the secondary use of these notes for research and patient care. We investigated several automated methods to identify redundant versus relevant new information in clinical reports. These methods may provide a valuable approach to extract clinically pertinent information and further improve the accuracy of clinical information extraction systems. In this study, we used UMLS semantic types to extract several types of new information, including problems, medications, and laboratory information. Automatically identified new information highly correlated with manual reference standard annotations. Methods to identify different types of new information can potentially help to build up more robust information extraction systems for clinical researchers as well as aid clinicians and researchers in navigating clinical notes more effectively and quickly identify information pertaining to changes in health states.

  8. Integrated Medical Information Technology System (IMITS): Information and Clinical Technologies for the Advancement of Healthcare

    DTIC Science & Technology

    2010-08-31

    Communications in Medicine ( DICOM ) standard interfaces allow communication between the DRDWA and various PACS vendors throughout the Air Force. This...Final Report: FY05 IMITS: Information and Clinical Technologies for the Advancement of Healthcare Page 15  DICOM standardization ensures...interoperability with all existing DICOM capable imaging repositories and future additions to the Air Force medical imaging initiative. The Air Force maintains a

  9. 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.

  10. Creating temporal abstractions in three clinical information systems.

    PubMed Central

    Kahn, M. G.; Marrs, K. A.

    1995-01-01

    Modern clinical information system developers recognize the need to associate temporal information with clinical data. However, specific clinical systems capture different temporal features using a variety of data modeling techniques. Two commonly used methods to represent temporal information are point-based events and interval-based durations. We recently implemented a rule-based expert system for drug dose monitoring on three clinical information systems. The expert system requires both static drug dosing information (drug name, amount, route, frequency) and temporal dosing information (duration of therapy, renewals, restarts). Our design goal was to use the same expert system code on all three information systems by defining a common database schema to hide differences in the original systems' data models. Although we have been successful in mapping clinical data from these three source systems into a unified temporal data representation, we describe how differences in handling time within the three clinical systems made this goal difficult to achieve. PMID:8563309

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... prospective traffic base; (3) System-wide plans to maintain equipment and rights-of-way at current or improved... 49 Transportation 4 2014-10-01 2014-10-01 false Additional information for Applicants not having a... Financial Assistance § 260.25 Additional information for Applicants not having a credit rating....

  12. 49 CFR 260.25 - Additional information for Applicants not having a credit rating.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... prospective traffic base; (3) System-wide plans to maintain equipment and rights-of-way at current or improved... 49 Transportation 4 2013-10-01 2013-10-01 false Additional information for Applicants not having a... Financial Assistance § 260.25 Additional information for Applicants not having a credit rating....

  13. 16 CFR 2.20 - Petitions for review of requests for additional information or documentary material.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... additional information or documentary material. 2.20 Section 2.20 Commercial Practices FEDERAL TRADE... material, or recommend such modification to the responsible Assistant Director of the Bureau of Competition... investigation. A request for additional information or documentary material may be modified only in...

  14. 47 CFR 25.111 - Additional information and ITU cost recovery.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 2 2014-10-01 2014-10-01 false Additional information and ITU cost recovery....111 Additional information and ITU cost recovery. (a) The Commission may request from any party at any... interference caused by radio stations authorized by other Administrations is guaranteed unless ITU...

  15. 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...

  16. 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

  17. 33 CFR 148.107 - What additional information may be required?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... What additional information may be required? (a) The Commandant (CG-5), in coordination with MARAD, may... analysis, explanation, or other information he or she deems necessary. (b) The Commandant (CG-5) may... (CG-5) may set a deadline for receiving the information. (1) If the applicant states that the...

  18. 33 CFR 148.107 - What additional information may be required?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... What additional information may be required? (a) The Commandant (CG-5), in coordination with MARAD, may... analysis, explanation, or other information he or she deems necessary. (b) The Commandant (CG-5) may... (CG-5) may set a deadline for receiving the information. (1) If the applicant states that the...

  19. 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...

  20. 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,…

  1. 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.

  2. Defense Health Care: Additional Information Needed about Mental Health Provider Staffing Needs

    DTIC Science & Technology

    2015-01-01

    DEFENSE HEALTH CARE Additional Information Needed about Mental Health Provider Staffing Needs Report to the...REPORT TYPE 3. DATES COVERED 00-00-2015 to 00-00-2015 4. TITLE AND SUBTITLE Defense Health Care: Additional Information Needed about Mental ...Z39-18 Page i GAO-15-184 DOD Mental Health Staffing Letter 1 Background 4 DOD and the Military Services Have Increased the

  3. 78 FR 52803 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Additional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-26

    ... OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any... collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1218-0237....

  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.

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

    PubMed Central

    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. PMID:26304986

  6. Sufficient trial size to inform clinical practice

    PubMed Central

    Manski, Charles F.; Tetenov, Aleksey

    2016-01-01

    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

  7. Mobile Access to Clinical Information at the Point of Care

    PubMed Central

    Mncube-Barnes, Fatima M.; Lee, Ben; Esuruoso, Olumuyiwa; Gona, Phil N.; Daphnis, Stephane

    2016-01-01

    Objectives Using library subscriptions and accessible on handheld devices, this study sought to promote authoritative health information apps, and evidence-based point-of-care resources. Methods Three cohorts of internal medicine residents were issued iPads at the beginning of their second year, and were trained to skillfully access resources from the digital library. Pre- and post-intervention surveys were respectively administered at the beginning of the second year and end of the third year of training. The residents' computer experience and computer knowledge was assessed. Additionally, before and after formal introduction to iPads, perceptions on the use of computers to access clinical information were assessed. Survey responses were compared using two sample methods and summarized through descriptive statistics. Results Sixty-eight residents completed the pre-survey questionnaires and 45 completed the post-surveys. There were significant improvements in the residents' level of computer experience, and familiarity with medical apps. Furthermore, there was increased knowledge obtained in accessing clinical information through electronic medical records. Residents positively perceived the potential effects of computers and electronic medical records in medicine. Conclusion Study findings suggested that health science libraries can be instrumental in providing search skills to health professionals, especially residents in training. Participants showed appreciation of iPads and library support that facilitated successful completion of their related tasks. Replicating this study with a larger sample derived from multiple sites is recommended for future studies. Participation of mid-level healthcare professionals, such as Physician Assistants and Nurse Practitioners is suggested. PMID:28210418

  8. "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.

  9. Design, methodology, and baseline data of the Personalized Addition Lenses Clinical Trial (PACT)

    PubMed Central

    Yu, Xinping; Zhang, Binjun; Bao, Jinhua; Zhang, Junxiao; Wu, Ge; Xu, Jinling; Zheng, Jingwei; Drobe, Björn; Chen, Hao

    2017-01-01

    Abstract Background: The aim of this study was to describe the design, methods, and baseline characteristics of children enrolled in the Personalized Addition lenses Clinical Trial (PACT). PACT aims to test the myopia control efficacy of progressive addition lenses (PALs) with personalized addition values compared with standard (+2.00 D) addition PALs and single vision lenses (SVLs). Methods: PACT is a randomized, controlled, double-masked clinical trial. Two hundred eleven myopic Chinese children (7–12 years) were enrolled and randomized into 1 of the 3 following groups: personalized addition PALs; +2.00 addition PALs; and SVLs. Personalized addition values were determined based on the highest addition that satisfied Sheard criterion. Axial length and other biometric data were also recorded. Results: At baseline, no differences were found between the right and left eyes for any of the main parameters. The enrolled children were 9.7 ± 1.1 years’ old with cycloplegic autorefraction (right eye [OD]: −2.36 ± 0.64 D), near phoria (1.0 ± 5.0 prism diopter esophoria), lag of accommodation (1.40 ± 0.50 D) and axial length (OD: 24.58 ± 0.74 mm). The personalized addition values ranged from +0.75 to +3.00 (average ± SD: 2.19 ± 0.73 D). Conclusion: PACT is a clinical trial evaluating whether myopia progression in children can be slowed by wearing personalized addition PALs compared with fixed addition PALs and SVLs as measured by cycloplegic autorefraction and axial length. Baseline data were comparable with those of previous myopia control studies in children. Subjects will be followed up every 6 months for 2 years. PMID:28296722

  10. 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

  11. Extracting medication information from clinical text

    PubMed Central

    Solti, Imre; Cadag, Eithon

    2010-01-01

    The Third i2b2 Workshop on Natural Language Processing Challenges for Clinical Records focused on the identification of medications, their dosages, modes (routes) of administration, frequencies, durations, and reasons for administration in discharge summaries. This challenge is referred to as the medication challenge. For the medication challenge, i2b2 released detailed annotation guidelines along with a set of annotated discharge summaries. Twenty teams representing 23 organizations and nine countries participated in the medication challenge. The teams produced rule-based, machine learning, and hybrid systems targeted to the task. Although rule-based systems dominated the top 10, the best performing system was a hybrid. Of all medication-related fields, durations and reasons were the most difficult for all systems to detect. While medications themselves were identified with better than 0.75 F-measure by all of the top 10 systems, the best F-measure for durations and reasons were 0.525 and 0.459, respectively. State-of-the-art natural language processing systems go a long way toward extracting medication names, dosages, modes, and frequencies. However, they are limited in recognizing duration and reason fields and would benefit from future research. PMID:20819854

  12. 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.

  13. 24 CFR 1710.200 - Instructions for Statement of Record, Additional Information and Documentation.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 5 2014-04-01 2014-04-01 false Instructions for Statement of Record, Additional Information and Documentation. 1710.200 Section 1710.200 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued) OFFICE OF ASSISTANT SECRETARY FOR...

  14. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Contents of application; additional technical information. 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;...

  15. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Contents of application; additional technical information. 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;...

  16. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Contents of application; additional technical information. 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;...

  17. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Contents of application; additional technical information. 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;...

  18. 10 CFR 52.158 - Contents of application; additional technical information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Contents of application; additional technical information. 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;...

  19. 16 CFR 803.20 - Requests for additional information or documentary material.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Requests for additional information or documentary material. 803.20 Section 803.20 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENTS AND INTERPRETATIONS UNDER THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF 1976...

  20. 16 CFR 803.20 - Requests for additional information or documentary material.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Requests for additional information or documentary material. 803.20 Section 803.20 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENTS AND INTERPRETATIONS UNDER THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF 1976...

  1. 16 CFR 803.20 - Requests for additional information or documentary material.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Requests for additional information or documentary material. 803.20 Section 803.20 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENTS AND INTERPRETATIONS UNDER THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF 1976...

  2. 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 1 2013-01-01 2013-01-01 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. 16 CFR 803.21 - Additional information shall be supplied within reasonable time.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 1 2012-01-01 2012-01-01 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...

  6. 16 CFR 803.21 - Additional information shall be supplied within reasonable time.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 1 2014-01-01 2014-01-01 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...

  7. 16 CFR 803.20 - Requests for additional information or documentary material.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Requests for additional information or documentary material. 803.20 Section 803.20 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENTS AND INTERPRETATIONS UNDER THE HART-SCOTT-RODINO ANTITRUST IMPROVEMENTS ACT OF 1976...

  8. 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... reserve existing transmission capacity needed for native load growth and network transmission...

  9. 18 CFR 33.3 - Additional information requirements for applications involving horizontal 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... reserve existing transmission capacity needed for native load growth and network transmission...

  10. 18 CFR 33.3 - Additional information requirements for applications involving horizontal 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... and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE... reserve existing transmission capacity needed for native load growth and network transmission...

  11. 40 CFR Table 42 to Subpart Uuu of... - Additional Information for Initial Notification of Compliance Status

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 13 2012-07-01 2012-07-01 false Additional Information for Initial Notification of Compliance Status 42 Table 42 to Subpart UUU of Part 63 Protection of Environment ENVIRONMENTAL... applicable emission limit and the continuous opacity or that the emission monitoring system meets...

  12. 17 CFR 229.1118 - (Item 1118) Reports and additional information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false (Item 1118) Reports and additional information. 229.1118 Section 229.1118 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION STANDARD INSTRUCTIONS FOR FILING FORMS UNDER SECURITIES ACT OF 1933, SECURITIES EXCHANGE ACT...

  13. 17 CFR 229.1118 - (Item 1118) Reports and additional information.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 17 Commodity and Securities Exchanges 2 2013-04-01 2013-04-01 false (Item 1118) Reports and additional information. 229.1118 Section 229.1118 Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION STANDARD INSTRUCTIONS FOR FILING FORMS UNDER SECURITIES ACT OF 1933, SECURITIES EXCHANGE ACT...

  14. 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,...

  15. 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...

  16. 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...

  17. 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...

  18. 30 CFR 250.418 - What additional information must I submit with my APD?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., 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 I submit with my APD? You must include the following with the APD: (a) Rated capacities of the drilling...

  19. 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 I submit with my APD? You must include the following with the APD: (a) Rated capacities of the drilling...

  20. 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 I submit with my APD? You must include the following with the APD: (a) Rated capacities of the drilling...

  1. 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 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...

  3. 38 CFR 61.15 - Obtaining additional information and awarding capital grants.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false 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 § 61.15...

  4. 38 CFR 61.15 - Obtaining additional information and awarding capital grants.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false 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 § 61.15...

  5. 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...

  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... and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER THE... entities that provides inputs to electricity products and one or more merging entities that...

  7. 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... entities that provides inputs to electricity products and one or more merging entities that...

  8. 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... entities that provides inputs to electricity products and one or more merging entities that...

  9. Targeting and Structuring Information Resource Use: A Path toward Informed Clinical Decisions

    ERIC Educational Resources Information Center

    Mangrulkar, Rajesh S.

    2004-01-01

    A core skill for all physicians to master is that of information manager. Despite a rapidly expanding set of electronic and print-based information resources, clinicians continue to answer their clinical queries predominantly through informal or formal consultation. Even as new tools are brought to market, the majority of them present information…

  10. Quantitative assessment of the benefits of specific information technologies applied to clinical studies in developing countries.

    PubMed

    Avilés, William; Ortega, Oscar; Kuan, Guillermina; Coloma, Josefina; Harris, Eva

    2008-02-01

    Clinical studies and trials require accessibility of large amounts of high-quality information in a timely manner, often daily. The integrated application of information technologies can greatly improve quality control as well as facilitate compliance with established standards such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). We have customized and implemented a number of information technologies, such as personal data assistants (PDAs), geographic information system (GIS), and barcode and fingerprint scanning, to streamline a pediatric dengue cohort study in Managua, Nicaragua. Quantitative data was obtained to assess the actual contribution of each technology in relation to processing time, accuracy, real-time access to data, savings in consumable materials, and time to proficiency in training sessions. In addition to specific advantages, these information technologies benefited not only the study itself but numerous routine clinical and laboratory processes in the health center and laboratories of the Nicaraguan Ministry of Health.

  11. 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.

  12. Economic advantage of pharmacogenomics - clinical trials with genetic information.

    PubMed

    Ohashi, Wataru; Mizushima, Hiroshi; Tanaka, Hiroshi

    2008-01-01

    The purpose of this study is to clarify the benefit and loss for the pharmaceutical companies when they adopt introducing pharmacogenomics in their clinical trials (in the following description, clinical trials by using pharmacogenomics is called "pgx clinical trial"), that is, when they use genetic information in their clinical trials. Particularly, the benefit for the pharmaceutical companies in terms of following two points is analyzed. 1. Development cost of new drug and period of clinical trial can be reduced because a clinical trial needs less subjects, 2. The new drug can be placed on the market earlier because the development period can be shortened. A survey conducted by Japan Pharmaceutical Manufacturers Association revealed that the pharmaceutical companies in Japan are interested in "pgx clinical trial". Specifically, 95% of the member companies (n=19) of the Association replied that the establishment of a guideline for pgx clinical trial by regulatory authorities are highly desirable. However, 65% of them (n=13) also replied that pgx clinical trial is difficult for the time being. It can be concluded that the pharmaceutical companies are positive about pgx clinical trial, but they cannot take a step towards it for several reasons: some of them may be worried their sales for non-responders will be reduced, poor understanding of pgx among the concerned parties, and not matured methodology of pgx clinical trial. This study shows that the advantage of pgx clinical trial outweighs its disadvantage. The sales may decrease because the drug is not used for non-responders, however, the number of subjects necessary for a clinical trial can be reduced, study period can be shortened and the drug can be marketed earlier. Furthermore, adverse events (AE) and adverse drug reactions (ADR) during the clinical trial and post-marketing phase can be markedly reduced. This represents a great benefit for the patients, pharmaceutical companies and the society as a whole.

  13. 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

  14. Integrating clinical information in National Biobank of Korea.

    PubMed

    Kim, Hangchan; Yi, Byoung-Kee; Kim, Il Kon; Kwak, Yun Sik

    2011-08-01

    The National Biobank of Korea (NBK) is a government supported project that aims at consolidating various human-originated biomedical resources collected by individual hospitals nation-wide and integrating them with their donors' clinical information which researchers can take advantage of. In this paper, we present our experiences in developing the Clinical Information Integration System (CIIS) for NBK. The system automatically extracts clinical data from hospital information systems as much as possible to avoid errors from manual entry by human errors. It maintains the independence of individual hospitals by employing a two-layer approach, one of which takes care of all hospital-specific aspects. Interoperability is achieved by adopting HL7 v2.x messaging between the biobank and hospitals. We report the current status of the biobank and system deployments. We finally identify limitations and discuss how to improve them.

  15. Enhanced information retrieval from narrative German-language clinical text documents using automated document classification.

    PubMed

    Spat, Stephan; Cadonna, Bruno; Rakovac, Ivo; Gütl, Christian; Leitner, Hubert; Stark, Günther; Beck, Peter

    2008-01-01

    The amount of narrative clinical text documents stored in Electronic Patient Records (EPR) of Hospital Information Systems is increasing. Physicians spend a lot of time finding relevant patient-related information for medical decision making in these clinical text documents. Thus, efficient and topical retrieval of relevant patient-related information is an important task in an EPR system. This paper describes the prototype of a medical information retrieval system (MIRS) for clinical text documents. The open-source information retrieval framework Apache Lucene has been used to implement the prototype of the MIRS. Additionally, a multi-label classification system based on the open-source data mining framework WEKA generates metadata from the clinical text document set. The metadata is used for influencing the rank order of documents retrieved by physicians. Combining information retrieval and automated document classification offers an enhanced approach to let physicians and in the near future patients define their information needs for information stored in an EPR. The system has been designed as a J2EE Web-application. First findings are based on a sample of 18,000 unstructured, clinical text documents written in German.

  16. Mutations in RIT1 cause Noonan syndrome – additional functional evidence and expanding the clinical phenotype

    PubMed Central

    Koenighofer, Martin; Hung, Christina Y.; McCauley, Jacob L.; Dallman, Julia; Back, Emma J.; Mihalek, Ivana; Gripp, Karen W.; Sol-Church, Katia; Rusconi, Paolo; Zhang, Zhaiyi; Shi, Geng-Xian; Andres, Douglas A.; Bodamer, Olaf A.

    2015-01-01

    RASopathies are a clinically heterogeneous group of conditions caused by mutations in one of sixteen proteins in the RAS-MAPK pathway. Recently, mutations in RIT1 were identified as a novel cause for Noonan syndrome. Here we provide additional functional evidence for a causal role of RIT1 mutations and expand the associated phenotypic spectrum. We identified two de novo missense variants p.Met90Ile and, p.Ala57Gly. Both variants resulted in increased MEK-ERK signaling compared to wild-type, underscoring gain-of-function as the primary functional mechanism. Introduction of p.Met90Ile and p.Ala57Gly into zebrafish embryos reproduced not only aspects of the human phenotype but also revealed abnormalities of eye development, emphasizing the importance of RIT1 for spatial and temporal organization of the growing organism. In addition, we observed severe lymphedema of the lower extremity and genitalia in one patient. We provide additional evidence for a causal relationship between pathogenic mutations in RIT1, increased RAS-MAPK/MEK-ERK signaling and the clinical phenotype. The mutant RIT1 protein may possess reduced GTPase activity or a diminished ability to interact with cellular GTPase activating proteins, however the precise mechanism remains unknown. The phenotypic spectrum is likely to expand and includes lymphedema of the lower extremities in addition to nuchal hygroma. PMID:25959749

  17. Web-based multimedia information retrieval for clinical application research

    NASA Astrophysics Data System (ADS)

    Cao, Xinhua; Hoo, Kent S., Jr.; Zhang, Hong; Ching, Wan; Zhang, Ming; Wong, Stephen T. C.

    2001-08-01

    We described a web-based data warehousing method for retrieving and analyzing neurological multimedia information. The web-based method supports convenient access, effective search and retrieval of clinical textual and image data, and on-line analysis. To improve the flexibility and efficiency of multimedia information query and analysis, a three-tier, multimedia data warehouse for epilepsy research has been built. The data warehouse integrates clinical multimedia data related to epilepsy from disparate sources and archives them into a well-defined data model.

  18. 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

  19. Informed consent for paediatric clinical trials in Europe

    PubMed Central

    Lepola, Pirkko; Needham, Allison; Mendum, Jo; Sallabank, Peter; Neubauer, David; de Wildt, Saskia

    2016-01-01

    Objective Paediatric clinical trials are often conducted as multinational trials. Informed consent or assent is part of the ethics committee approval for clinical trials. The consent requirements vary between countries due to national laws and regulations, which are not harmonised in Europe. These discrepancies can present challenges for paediatric clinical trials. The aim of this study was to assemble these consent and assent requirements across the European Economic Area. The collated national requirements have not been publicly available before, despite a real need for this data. Methods National consent and assent requirements for paediatric clinical trials were analysed and collated for 25 European Union Member States and 2 European Free Trade Association countries until the end of 2014. The data were retrieved from existing databases and through communication with the competent authorities and selected ethics committees. Results from a literature search for international or national guidelines, declarations and conventions and academic societies' publications served as comparison material. Results Consent and assent requirements are heterogeneous across these countries. We compiled our findings in ‘The Informed Consent and Assent Tool Kit’, a table including 27 national consent and assent requirements listed by individual country. Conclusions Wide variation in paediatric consents and assents presents challenges for multinational paediatric trials in Europe. The toolkit is available for all those involved in paediatric clinical trials and ethics committees, providing a new platform for proactive feedback on informed consent requirements, and may finally lead to a needed harmonisation process, including uniform standards accepted across Europe. PMID:27226526

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

    PubMed Central

    AUCLAIR, URSULA; EPSTEIN, CYNTHIA; MITTELMAN, MARY

    2009-01-01

    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

  1. [Rad-Esito: new informational additions in the integration of content of hospital discharge cards for acute patients].

    PubMed

    Rini, F; Piscioneri, C; Consolante, C; Fara, G M

    2009-01-01

    Since the January 2008 the tracking of additional information about hospital discharge card's content has been activated in Latium. The new data, noticed by RAD-Esito card, regard the hospitalizations for acute myocardial infarction, femoral neck fracture and coronary artery bypass surgery. This study's objective has been to evaluate the quality of the data collected with the new card, at the end of the 1st semester of experimentation, concerning two institutes of care of Latium, the Casilino Polyclinic (ASL Rome B) and the Anzio-Nettuno hospital (Assembled Hospitals, ASL Rome H). Furthermore, any significant correlation's existence between a few variables for acute myocardial infarction and femoral fracture with the mortality rate and the average hospitalization period has been statistically verified. This study's preliminary results show how the integration of the hospital informative flow with the new clinical variables will be able to allow the promotion of the quality in the coding of the diagnosis and procedures, according to the current international innovations. This additional information will also be able to support the regional appropriateness and outcome of the treatments evaluation programs.

  2. 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

  3. 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.

  4. Evaluation of popular drug information resources on clinically useful and actionable pharmacogenomic information*†

    PubMed Central

    Chang, Jennifer S.; Pham, Duyen-Anh; Dang, Maithao T.; Lu, Yiting; VanOsdol, Sheri

    2016-01-01

    Background Pharmacogenomics is the study of how genes affect a person's response to drugs. This descriptive study assessed whether popular drug information resources provide clinically useful pharmacogenomic (PGx) information. Methods Four resources (package inserts, Lexicomp, Micromedex 2.0, and Epocrates) were evaluated for information about twenty-seven drugs. Results There was wide variability of PGx information. Whereas Lexicomp included relevant PGx biomarker information for all 27 drugs, Epocrates did in less than 50% of the drugs. None of the resources had monographs that fully incorporated Clinical Pharmacogenomics Implementation Consortium (CPIC) recommendations in more than 30% of the drugs. Conclusion Lexicomp appears to be most useful PGx drug information resource, but none of the resources are sufficient. PMID:26807054

  5. Timing is everything. Time-oriented clinical information systems.

    PubMed Central

    Shahar, Y; Combi, C

    1998-01-01

    Time is important in clinical information systems. Representing, maintaining, querying, and reasoning about time-oriented clinical data is a major theoretical and practical research area in medical informatics. In this nonexhaustive overview, we present a brief synopsis of research efforts in designing and developing time-oriented information systems in medicine. These efforts can be viewed from either an application point of view, distinguishing between different clinical tasks (such as diagnosis versus therapy) and clinical areas (such as infectious diseases versus oncology), or a methodological point of view, distinguishing between different theoretical approaches. We also explore the two primary methodological and theoretical paths research has taken in the past decade: temporal reasoning and temporal data maintenance. Both of these research areas include efforts to model time, temporal entities, and temporal queries. Collaboration between the two areas is possible, through tasks such as the abstraction of raw time-oriented clinical data into higher-level meaningful clinical concepts and the management of different levels of temporal granularity. Such collaboration could provide a common ground and useful areas for future research and development. We conclude with our view of future research directions. PMID:9499744

  6. Aspects of vulnerable patients and informed consent in clinical trials

    PubMed Central

    Kuthning, Maria; Hundt, Ferdinand

    2013-01-01

    Scope: To discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint. Methods: Scientific literature search via PubMed, Medline, Google. Results: Voluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual’s freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor’s assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding. Conclusion: Discovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials. PMID:23346043

  7. [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

  8. 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.

  9. 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.

  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. 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.

  12. 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

  13. [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.

  14. 41 CFR 102-79.111 - Where may Executive agencies find additional information on Integrated Workplace concepts?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... agencies find additional information on Integrated Workplace concepts? 102-79.111 Section 102-79.111 Public... Space Integrated Workplace § 102-79.111 Where may Executive agencies find additional information on Integrated Workplace concepts? The GSA Office of Governmentwide Policy provides additional guidance in...

  15. 41 CFR 102-79.111 - Where may Executive agencies find additional information on Integrated Workplace concepts?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... agencies find additional information on Integrated Workplace concepts? 102-79.111 Section 102-79.111 Public... Space Integrated Workplace § 102-79.111 Where may Executive agencies find additional information on Integrated Workplace concepts? The GSA Office of Governmentwide Policy provides additional guidance in...

  16. 41 CFR 102-79.111 - Where may Executive agencies find additional information on Integrated Workplace concepts?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... agencies find additional information on Integrated Workplace concepts? 102-79.111 Section 102-79.111 Public... Space Integrated Workplace § 102-79.111 Where may Executive agencies find additional information on Integrated Workplace concepts? The GSA Office of Governmentwide Policy provides additional guidance in...

  17. 41 CFR 102-79.111 - Where may Executive agencies find additional information on Integrated Workplace concepts?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... agencies find additional information on Integrated Workplace concepts? 102-79.111 Section 102-79.111 Public... Space Integrated Workplace § 102-79.111 Where may Executive agencies find additional information on Integrated Workplace concepts? The GSA Office of Governmentwide Policy provides additional guidance in...

  18. 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.

  19. 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.

  20. 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.

  1. Prepositioned Stocks: Additional Information and a Consistent Definition Would Make DOD’s Annual Report More Useful

    DTIC Science & Technology

    2015-06-01

    PREPOSITIONED STOCKS Additional Information and a Consistent Definition Would Make DOD’s Annual Report More Useful...COVERED 00-00-2015 to 00-00-2015 4. TITLE AND SUBTITLE Prepositioned Stocks: Additional Information and a Consistent Definition Would Make DOD’s...STOCKS Additional Information and a Consistent Definition Would Make DOD’s Annual Report More Useful Why GAO Did This Study DOD prepositions stocks

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

    PubMed Central

    Choquet, R.

    2015-01-01

    Summary Objectives To select and summarize key constributions to current research and to select best papers published in 2014 in the field of Clinical Research Informatics (CRI). Method A bibliographic search using a combination of MeSH and free terms search over PubMed on Clinical Research Informatics (CRI) was performed followed by a double-blind literature review. Results The review process yielded four papers, illustrating various aspects of current research efforts done in the area of CRI. The first paper exemplifies the process of developping a domain ontology for integrating structured, unstructured, and signal data into a coherent structure for patient care as well as clinical research. In the second paper, the authors analysed in five sites’ hospital information system environments in Germany the possibility of implementing a patient recruitment process and provided recommendations for the development of dedicated patient recruitment modules. The third paper describes the IMI EHR4CR project which developed an instance of a platform, providing communication, security and semantic interoperability services to the eleven participating hospitals and ten pharmaceutical companies located in seven European countries. The last paper describes the relation between health status severity and the availability of data in EHR systems. They demonstrate that it introduces a biasis in patient selection for clinical research. Conclusions Distributed research networks are growing in importance for clinical research and population health surveillance and current research demonstartes that different projects and initiatives could be well placed to deliver international scale solutions to enable the reuse of hospital EHR data to support clinical research studies. Selected articles demonstrate the potential of formal representation of multimodal and multi-level data in supporting data interoperability across clinical research and care domains. With the development of

  3. Addressing electronic clinical information in the construction of quality measures.

    PubMed

    Bailey, L Charles; Mistry, Kamila B; Tinoco, Aldo; Earls, Marian; Rallins, Marjorie C; Hanley, Kendra; Christensen, Keri; Jones, Meredith; Woods, Donna

    2014-01-01

    Electronic health records (EHR) and registries play a central role in health care and provide access to detailed clinical information at the individual, institutional, and population level. Use of these data for clinical quality/performance improvement and cost management has been a focus of policy initiatives over the past decade. The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA)-mandated Pediatric Quality Measurement Program supports development and testing of quality measures for children on the basis of electronic clinical information, including de novo measures and respecification of existing measures designed for other data sources. Drawing on the experience of Centers of Excellence, we review both structural and pragmatic considerations in e-measurement. The presence of primary observations in EHR-derived data make it possible to measure outcomes in ways that are difficult with administrative data alone. However, relevant information may be located in narrative text, making it difficult to interpret. EHR systems are collecting more discrete data, but the structure, semantics, and adoption of data elements vary across vendors and sites. EHR systems also differ in ability to incorporate pediatric concepts such as variable dosing and growth percentiles. This variability complicates quality measurement, as do limitations in established measure formats, such as the Quality Data Model, to e-measurement. Addressing these challenges will require investment by vendors, researchers, and clinicians alike in developing better pediatric content for standard terminologies and data models, encouraging wider adoption of technical standards that support reliable quality measurement, better harmonizing data collection with clinical work flow in EHRs, and better understanding the behavior and potential of e-measures.

  4. A hybrid system for temporal information extraction from clinical text

    PubMed Central

    Tang, Buzhou; Wu, Yonghui; Jiang, Min; Chen, Yukun; Denny, Joshua C; Xu, Hua

    2013-01-01

    Objective To develop a comprehensive temporal information extraction system that can identify events, temporal expressions, and their temporal relations in clinical text. This project was part of the 2012 i2b2 clinical natural language processing (NLP) challenge on temporal information extraction. Materials and methods The 2012 i2b2 NLP challenge organizers manually annotated 310 clinic notes according to a defined annotation guideline: a training set of 190 notes and a test set of 120 notes. All participating systems were developed on the training set and evaluated on the test set. Our system consists of three modules: event extraction, temporal expression extraction, and temporal relation (also called Temporal Link, or ‘TLink’) extraction. The TLink extraction module contains three individual classifiers for TLinks: (1) between events and section times, (2) within a sentence, and (3) across different sentences. The performance of our system was evaluated using scripts provided by the i2b2 organizers. Primary measures were micro-averaged Precision, Recall, and F-measure. Results Our system was among the top ranked. It achieved F-measures of 0.8659 for temporal expression extraction (ranked fourth), 0.6278 for end-to-end TLink track (ranked first), and 0.6932 for TLink-only track (ranked first) in the challenge. We subsequently investigated different strategies for TLink extraction, and were able to marginally improve performance with an F-measure of 0.6943 for TLink-only track. PMID:23571849

  5. 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.

  6. Outcomes assessment of clinical information system implementation: a practical guide.

    PubMed

    Nahm, Eun-Shim; Vaydia, Vinay; Ho, Danny; Scharf, Barbara; Seagull, Jake

    2007-01-01

    Healthcare information systems (HIS) play a vital role in quality of care and the organization's daily operations. Consequently, increasing numbers of clinicians have been involved in HIS implementation, particularly for clinical information systems (CIS). Implementation of these systems is a major organizational investment, and its outcomes must be assessed. The purpose of this article is to provide clinicians and frontline informaticians with a practical guide to assess these outcomes, focusing on outcome variables, assessment methods, and timing of assessment. Based on in-depth literature reviews and their empirical experiences, the authors identified 3 frequently used outcomes: user satisfaction, clinical outcomes, and financial impact. These outcomes have been assessed employing various methods, including randomized controlled trials, pre- and post-test studies, time and motion studies, surveys, and user testing. The timing for outcomes assessments varied depending on several factors, such as learning curves or patients conditions. In conclusion, outcomes assessment is essential for the success of healthcare information technology, and the CIS implementation team members must be prepared to conduct and/or facilitate these studies.

  7. 77 FR 31068 - Additional Identifying Information Associated With Persons Whose Property and Interests in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... Information Technology AGENCY: Office of Foreign Assets Control, Treasury. ACTION: Notice. SUMMARY: The... Technology,'' whose property and interests in property are blocked. FOR FURTHER INFORMATION CONTACT... Information Technology,'' (the ``Order'') pursuant to, inter alia, the International Emergency Economic...

  8. [Evaluation of the clinical practice of Informed Consent in clinical trials].

    PubMed

    Gost, J; Silvestre, C; Ezpeleta, P; Astier, P; Díaz de Rada, O; Artázcoz, M T

    2003-01-01

    On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT) the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160) of the CTs approved by the Ethical Committee of Clinical Research (CEIC) of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.

  9. [The Use of Informed Consent in Clinical Nursing Practice].

    PubMed

    Cheng, Chun-Ting; Lin, Chiu-Chu

    2017-02-01

    Obtaining informed consent and ensuring patient autonomy are critical to implementing a patient-centered model of healthcare. Informed consent is a complex process of communication that includes three elements: disclosure, competence in making decisions, and voluntariness. However, individual patient factors, doctor-patient interaction, and cultural issues are known to influence the process of obtaining informed consent. Individual patient factors include the ability of patients to understand and determine their intent; doctor-patient interaction includes communication skills; and cultural issues include the expectations of patients with regard to family involvement in medical decision-making and in decision-making motives. After assessing the relevant influencing factors, healthcare providers typically provide patients with comprehensive information on the benefits and risks of treatment as well as related alternatives. Moreover, healthcare providers typically provide patients with audio/video, Internet, and written information with illustrations based on individual patient needs. In addition to the above, we suggest that healthcare providers proactively adopt the perspective of patients in order to better encourage patients to address questions, to engage with patients in more productive discussions, and to take the initiative to explain and clarify patients' questions in order to minimize anxiety. This approach will help ensure that patients are adequately informed and free from coercion so that they make appropriate healthcare-related decisions. However, even under this optimal situation, healthcare providers must emphasize the needs of their patients and respect their decisions.

  10. 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

  11. Use of altered informed consent in pragmatic clinical research.

    PubMed

    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

    2015-10-01

    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 institutional review boards 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.

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

    PubMed Central

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

    2012-01-01

    We are currently in an era of rapidly expanding knowledge about the genetic landscape and architectural blueprints of various cancers. These discoveries have led to a new taxonomy of malignant diseases based upon clinically relevant molecular alterations in addition to histology or tissue of origin. The new molecularly based classification holds the promise of rational rather than empiric approaches for the treatment of cancer patients. However, the accelerated pace of discovery and the expanding number of targeted anti-cancer therapies present a significant challenge for healthcare practitioners to remain informed and up-to-date on how to apply cutting-edge discoveries into daily clinical practice. In this Perspective, we use lung cancer as a paradigm to discuss challenges related to translating genomic information into the clinic, and we present one approach we took at Vanderbilt-Ingram Cancer Center to address these challenges. PMID:23019146

  13. Evaluation of a Computerized Clinical Information System (Micromedex).

    PubMed

    Lundsgaarde, H P; Moreshead, G E

    1991-01-01

    This paper summarizes data collected as part of a project designed to identify and assess the technical and organizational problems associated with the implementation and evaluation of a Computerized Clinical Information System (CCIS), Micromedex, in three U.S. Department of Veterans Affairs Medical Centers (VAMCs). The study began in 1987 as a national effort to implement decision support technologies in the Veterans Administration Decentralized Hospital Computer Program (DHCP). The specific objectives of this project were to (1) examine one particular decision support technology, (2) identify the technical and organizational barriers to the implementation of a CCIS in the VA host environment, (3) assess the possible benefits of this system to VA clinicians in terms of therapeutic decision making, and (4) develop new methods for identifying the clinical utility of a computer program designed to provide clinicians with a new information tool. The project was conducted intermittently over a three-year period at three VA medical centers chosen as implementation and evaluation test sites for Micromedex. Findings from the Kansas City Medical Center in Missouri are presented to illustrate some of the technical problems associated with the implementation of a commercial database program in the DHCP host environment, the organizational factors influencing clinical use of the system, and the methods used to evaluate its use. Data from 4581 provider encounters with the CCIS are summarized. Usage statistics are presented to illustrate the methodological possibilities for assessing the "benefits and burdens" of a computerized information system by using an automated collection of user demographics and program audit trails that allow evaluators to monitor user interactions with different segments of the database.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-13

    ...) Moderate Category: For a food additive petition without complex chemistry, manufacturing, efficacy, or...) Complex Category: For a food additive petition with complex chemistry, manufacturing, efficacy, and/or... investigational food additive file without complex chemistry, manufacturing, efficacy, or safety issues,...

  16. 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

  17. 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.

  18. 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

  19. 75 FR 78950 - Availability of Additional Information for the Proposed Rulemaking for Colorado's Attainment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

    ... provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or... contact information unless you provide it in the body of your comment. If you send an e-mail comment... information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read...

  20. 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.

  1. 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

  2. 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

  3. Additional information is not ignored: New evidence for information integration and inhibition in take-the-best decisions.

    PubMed

    Dummel, Sebastian; Rummel, Jan; Voss, Andreas

    2016-01-01

    Ignoring information when making a decision is at the heart of the take-the-best (TTB) strategy, according to which decision makers only consider information about the most valid cue (TTB-relevant) and ignore less valid cues (TTB-irrelevant). Results of four experiments, however, show that participants do not ignore information when cues are easily available (Experiments 1a, 1b, and 3) or when task instructions emphasize decision accuracy (Experiment 2). In all four experiments we found that the consistency between the TTB-relevant cue and a supposedly TTB-irrelevant cue systematically affected decision times and confidence ratings of even those participants whose choices were consistently driven by only the TTB-relevant cue. In Experiments 1a and 1b, we also found that these participants were more likely to ignore information when cues had to be acquired sequentially, suggesting that whether or not participants ignore information depends on information availability. Experiment 2 further showed that different task instructions (emphasizing decision accuracy vs. speed) affect whether or not participants ignore information. Finally, Experiment 3 addressed the question of how participants process information that, according to TTB, is considered irrelevant for their choices. We find first evidence that participants who consistently make choices in line with TTB inhibit information about a TTB-irrelevant cue when this information conflicts with their decisions. Findings are considered and discussed in relation to current models of decision making.

  4. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) REGISTRATION OF FUELS AND FUEL ADDITIVES Additive... application for registration submitted by the manufacturer of a designated fuel additive shall include the..., percentage by weight, and method of analysis of each element in the additive are required provided,...

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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...

  10. Information sheets and informed consent forms for clinical study participants: towards standardised recommendations?

    PubMed

    Chassany, Olivier; Bernard-Harlaut, Micheline; Guy, Gilles; Billon, Nathalie

    2009-01-01

    Subjects taking part in biomedical research must be provided with legible and intelligible information enabling them to freely give their informed consent. At present, sponsors tend to provide many different types of information, not all of which is directly connected with or indeed really informative about studies for those taking part.As a result of this observation, a round table was convened during the Clinical Pharmacology meetings to deliberate on the creation of a charter concerning the drafting of information documents for biomedical research participants as well as a code of good practice for the preparation of such documents.Recommendations were made based on the efforts of the various working groups concerned, such as the French National Conference of Ethics Committees (CNCP), users' representatives, patients associations and the French industrial and institutional sponsors association (CPI), together with proposals contained in the literature.The deliberations of the round table may be subsumed under the following 3 categories and 14 points: 1) Format: design, drafting rules, layout, table of contents, glossary. 2) CONTENT: introductory page, description of the study, risks, benefits. 3) Regulatory aspects: legal aspects, CNIL message (data protection), financial aspects, conflict of interests, model and varied signatures. This document should help make research in France more attractive and it was decided after the Clinical Pharmacology meeting to submit the charter and related documents for approval by the various actors involved: DGS (Direction Générale de la Santé), Afssaps (Agence Française de Sécurité Sanitaire des Produits de Santé), CNCP, CPI and LEEM (Les entreprises du médicament). Once the charter has been validated, it will be made available to Sponsors and Ethics Committees in order to ensure greater uniformity and legibility regarding information given to study subjects.

  11. Using clinical information to make individualized prognostic predictions in people at ultra high risk for psychosis.

    PubMed

    Mechelli, Andrea; Lin, Ashleigh; Wood, Stephen; McGorry, Patrick; Amminger, Paul; Tognin, Stefania; McGuire, Philip; Young, Jonathan; Nelson, Barnaby; Yung, Alison

    2016-12-04

    Recent studies have reported an association between psychopathology and subsequent clinical and functional outcomes in people at ultra-high risk (UHR) for psychosis. This has led to the suggestion that psychopathological information could be used to make prognostic predictions in this population. However, because the current literature is based on inferences at group level, the translational value of the findings for everyday clinical practice is unclear. Here we examined whether psychopathological information could be used to make individualized predictions about clinical and functional outcomes in people at UHR. Participants included 416 people at UHR followed prospectively at the Personal Assessment and Crisis Evaluation (PACE) Clinic in Melbourne, Australia. The data were analysed using Support Vector Machine (SVM), a supervised machine learning technique that allows inferences at the individual level. SVM predicted transition to psychosis with a specificity of 60.6%, a sensitivity of 68.6% and an accuracy of 64.6% (p<0.001). In addition, SVM predicted functioning with a specificity of 62.5%, a sensitivity of 62.5% and an accuracy of 62.5% (p=0.008). Prediction of transition was driven by disorder of thought content, attenuated positive symptoms and functioning, whereas functioning was best predicted by attention disturbances, anhedonia-asociality and disorder of thought content. These results indicate that psychopathological information allows individualized prognostic predictions with statistically significant accuracy. However, this level of accuracy may not be sufficient for clinical translation in real-world clinical practice. Accuracy might be improved by combining psychopathological information with other types of data using a multivariate machine learning framework.

  12. Implementation of an advanced clinical and administrative hospital information system.

    PubMed

    Vegoda, P R; Dyro, J F

    1986-01-01

    Over the last six years since University Hospital opened, the University Hospital Information System (UHIS) has continued to evolve to what is today an advanced administrative and clinical information system. At University Hospital UHIS is the way of conducting business. A wide range of patient care applications are operational including Patient Registration, ADT for Inpatient/Outpatient/Emergency Room visits, Advanced Order Entry/Result Reporting, Medical Records, Lab Automated Data Acquisition/Quality Control, Pharmacy, Radiology, Dietary, Respiratory Therapy, ECG, EEG, Cardiology, Physical/Occupational Therapy and Nursing. These systems and numerous financial systems have been installed in a highly tuned, efficient computer system. All applications are real-time, on-line, and data base oriented. Each system is provided with multiple data security levels, forward file recovery, and dynamic transaction backout of in-flight tasks. Sensitive medical information is safeguarded by job function passwords, identification codes, need-to-know master screens and terminal keylocks. University Hospital has an IBM 3083 CPU with five 3380 disk drives, four dual density tape drives, and a 3705 network controller. The network of 300 terminals and 100 printers is connected to the computer center by an RF broadband cable. The software is configured around the IBM/MVS operating system using CICS as the telecommunication monitor, IMS as the data base management system and PCS/ADS as the application enabling tool. The most extensive clinical system added to UHIS is the Physiological Monitoring/Patient Data Management System with serves 92 critical care beds. In keeping with the Hospital's philosophy of integrated computing, the PMS/PDMS with its network of minicomputers was linked to the UHIS system. In a pilot program, remote access to UHIS through the IBM personal computer has been implemented in several physician offices in the local community, further extending the communications

  13. 36 CFR 1290.2 - Scope of additional records and information.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... describe the agency's: (1) Records policies and schedules; (2) Filing systems and organization; (3) Storage... Act; and (6) Reclassification to a higher level, transfer, destruction, or other information...

  14. Physician clinical information technology and health care disparities.

    PubMed

    Ketcham, Jonathan D; Lutfey, Karen E; Gerstenberger, Eric; Link, Carol L; McKinlay, John B

    2009-12-01

    The authors develop a conceptual framework regarding how information technology (IT) can alter within-physician disparities, and they empirically test some of its implications in the context of coronary heart disease. Using a random experiment on 256 primary care physicians, the authors analyze the relationships between three IT functions (feedback and two types of clinical decision support) and five process-of-care measures. Endogeneity is addressed by eliminating unobserved patient characteristics with vignettes and by proxying for omitted physician characteristics. The results indicate that IT has no effects on physicians' diagnostic certainty and treatment of vignette patients overall. The authors find that treatment and certainty differ by patient age, gender, and race. Consistent with the framework, IT's effects on these disparities are complex. Feedback eliminated the gender disparities, but the relationships differed for other IT functions and process measures. Current policies to reduce disparities and increase IT adoption may be in discord.

  15. Biomedical device interfacing to clinical information systems: a primer.

    PubMed

    Moorman, Bridget

    2008-01-01

    I am pleased that we get to take advantage of Bridget Moorman's background, experience, and perspective in this installment of IT World. One of the most nerve-racking tasks we run into these days is getting disparate medical devices to talk to each other over a network. This is especially so if the device you're trying to communicate with doesn't support network connectivity. Bridget shares her experience here not only with a great high-level view of network interfacing, but also with references to dig into all the grim details. She shows us a lot of facets to consider when assembling such a network. You've got to convert to hit the ramp then translate and aggregate before gaining access to the clinical information system cloud. If that doesn't make sense, read on! -Jeff Kabachinski, IT World columnist.

  16. 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...

  17. 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...

  18. 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...

  19. 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.

  20. 14 CFR 121.317 - Passenger information requirements, smoking prohibitions, and additional seat belt requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... prohibitions, and additional seat belt requirements. 121.317 Section 121.317 Aeronautics and Space FEDERAL... prohibitions, and additional seat belt requirements. (a) Except as provided in paragraph (l) of this section... paragraph (l) of this section, the “Fasten Seat Belt” sign shall be turned on during any movement on...

  1. 14 CFR 121.317 - Passenger information requirements, smoking prohibitions, and additional seat belt requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... prohibitions, and additional seat belt requirements. 121.317 Section 121.317 Aeronautics and Space FEDERAL... prohibitions, and additional seat belt requirements. (a) Except as provided in paragraph (l) of this section... paragraph (l) of this section, the “Fasten Seat Belt” sign shall be turned on during any movement on...

  2. 36 CFR 1290.2 - Scope of additional records and information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... PRESIDENT JOHN F. KENNEDY ASSASSINATION RECORDS COLLECTION ACT OF 1992 (JFK ACT) § 1290.2 Scope of... Act; and (6) Reclassification to a higher level, transfer, destruction, or other information...

  3. 21 CFR 803.12 - Where and how do I submit reports and additional information?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.12 Where and how do... information required under this part to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville,...

  4. 21 CFR 803.12 - Where and how do I submit reports and additional information?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE REPORTING General Provisions § 803.12 Where and how do... information required under this part to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville,...

  5. Navigating Longitudinal Clinical Notes with an Automated Method for Detecting New Information

    PubMed Central

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

    2015-01-01

    Automated methods to detect new information in clinical notes may be valuable for navigating and using information in these documents for patient care. Statistical language models were evaluated as a means to quantify new information over longitudinal clinical notes for a given patient. The new information proportion (NIP) in target notes decreased logarithmically with increasing numbers of previous notes to create the language model. For a given patient, the amount of new information had cyclic patterns. Higher NIP scores correlated with notes having more new information often with clinically significant events, and lower NIP scores indicated notes with less new information. Our analysis also revealed “copying and pasting” to be widely used in generating clinical notes by copying information from the most recent historical clinical notes forward. These methods can potentially aid clinicians in finding notes with more clinically relevant new information and in reviewing notes more purposefully which may increase the efficiency of clinicians in delivering patient care. PMID:23920658

  6. Internet access and online cancer information seeking among Latino immigrants from safety net clinics.

    PubMed

    Selsky, Claire; Luta, George; Noone, Anne-Michelle; Huerta, Elmer E; Mandelblatt, Jeanne S

    2013-01-01

    Internet use is widespread, but little is known about Internet use for cancer information among Latinos, especially those who rely on safety net clinics. The authors investigated access to and intended use of the Internet for cancer information among low income, immigrant Latinos predominately from Central and South America. A cross-sectional study of 1,273 Latinos 21 years and older attending safety net clinics or health fairs was conducted from June 2007 to November 2008. The authors used logistic regression models to evaluate associations of age, acculturation, psychosocial factors and other covariates with Internet access and intended use of the Internet for cancer information among those with access. Of the sample, 44% reported Internet access. Higher information self-efficacy and greater trust in the Internet were independently associated with Internet access (p = .05 and p < .001, respectively). Among those with access, 53.8% reported they intended to seek cancer help online if they needed information. Those with younger age and higher acculturation, education and self-efficacy had higher odds of intended Internet use for cancer information, considering covariates. In addition, those with high (vs. low) perceived risk of cancer (OR = 1.76; 95% CI [1.14, 2.73]; p = .01) and higher levels of trust in online health information (OR = 1.47 per one-point increase; 95% [CI 1.19, 1.82]; p = .0004) were more likely to intend to seek cancer information online. These findings that Internet access is fairly high in the immigrant Latino population and that the Internet is a trusted source of cancer information suggest that the Internet may be a channel for cancer control interventions.

  7. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... has been abandoned and they no longer represent a trade secret or confidential commercial or financial... studies and tests of a color additive on animals and humans and all studies and tests on a color...

  8. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... has been abandoned and they no longer represent a trade secret or confidential commercial or financial... studies and tests of a color additive on animals and humans and all studies and tests on a color...

  9. 21 CFR 71.15 - Confidentiality of data and information in color additive petitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... established in § 20.61 of this chapter. (6) All records showing the Food and Drug Administration's testing of... studies and tests of a color additive on animals and humans and all studies and tests on a color...

  10. 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.

  11. 21 CFR 803.12 - Where and how do I submit reports and additional information?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... information? 803.12 Section 803.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... health emergency, this can be brought to FDA's attention by contacting the FDA Office of Emergency Operations (HFA-615), Office of Crisis Management, Office of the Commissioner, at 301-443-1240, followed...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... lavatory a sign or placard that reads: “Federal law provides for a penalty of up to $2,000 for tampering..., no person may operate an airplane unless it is equipped with passenger information signs that meet... signs must be constructed so that the crewmembers can turn them on and off. (b) Except as provided...

  13. 49 CFR 40.331 - To what additional parties must employers and service agents release information?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Confidentiality and... information about that employee's drug or alcohol tests to an identified person, you must provide the... for this part and DOT agency drug and alcohol program functions. (2) All written, printed,...

  14. 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,…

  15. 13 CFR 126.403 - May SBA require additional information from a HUBZone SBC?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... information from a HUBZone SBC? 126.403 Section 126.403 Business Credit and Assistance SMALL BUSINESS... HUBZone SBC? (a) At the discretion of the D/HUB, SBA has the right to require that a HUBZone SBC submit... adverse inference from the failure of a HUBZone SBC to cooperate with a program examination or...

  16. 29 CFR 2590.702-1 - Additional requirements prohibiting discrimination based on genetic information.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... diabetes. A begins to experience excessive sweating, thirst, and fatigue. A's physician examines A and... adult onset diabetes mellitus (Type 2 diabetes). (ii) Conclusion. In this Example 1, A has been... involved. The diagnosis is not based principally on genetic information. Thus, Type 2 diabetes...

  17. 45 CFR 146.122 - Additional requirements prohibiting discrimination based on genetic information.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... diabetes. A begins to experience excessive sweating, thirst, and fatigue. A's physician examines A and... adult onset diabetes mellitus (Type 2 diabetes). (ii) Conclusion. In this Example 1, A has been... involved. The diagnosis is not based principally on genetic information. Thus, Type 2 diabetes...

  18. 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... the circumstances associated with the loss of large areas of the plant due to explosions or fire...

  19. 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... the circumstances associated with the loss of large areas of the plant due to explosions or fire...

  20. 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... the circumstances associated with the loss of large areas of the plant due to explosions or fire...

  1. 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... the circumstances associated with the loss of large areas of the plant due to explosions or fire...

  2. 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... the circumstances associated with the loss of large areas of the plant due to explosions or fire...

  3. 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…

  4. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... will be accepted in lieu thereof; (2) In the case of an additive for engine oil, only the name..., that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided... any 1975 or subsequent model year vehicle or engine, or that the manufacturer has obtained a...

  5. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... will be accepted in lieu thereof; (2) In the case of an additive for engine oil, only the name..., that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided... any 1975 or subsequent model year vehicle or engine, or that the manufacturer has obtained a...

  6. 40 CFR 79.21 - Information and assurances to be provided by the additive manufacturer.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... will be accepted in lieu thereof; (2) In the case of an additive for engine oil, only the name..., that a percentage figure combining the percentages of carbon, hydrogen, and/or oxygen may be provided... any 1975 or subsequent model year vehicle or engine, or that the manufacturer has obtained a...

  7. 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...

  8. Evaluation of ICU nurses' use of the clinical information system in Taiwan.

    PubMed

    Huang, Hsin; Lee, Ting-Ting

    2011-04-01

    With the fast development of computer software and hardware, technology application is ubiquitous, and many healthcare services have integrated a clinical information system into daily practice. With today's information technology, everyone should possess basic computer competency to meet on-the-job demands and especially to use an information system in healthcare. Thus, the purpose of this study was to explore Taiwanese nurses' computer competency, the interface usability, and any change in the nurses' practice pattern as a result of the technology use. The current study adopted a descriptive research design, recruiting 114 nurses in medical and surgical ICUs to survey their technology use. Additionally, a total of 6780 observation values were obtained by a work sampling method to investigate the applicability of the information system. The results indicated that nurses with a higher education can use more computer applications and had better computer competency than other nurses. Additionally, computer competency was related to interface usability, and interface usability in the surgical ICU was rated higher than those in the medical ICU. Finally, the nursing practice patterns observed were related to the technology use. The results could serve as a reference for information technology usage evaluation in nursing.

  9. A comparison of teaching strategies for integrating information technology into clinical nursing education.

    PubMed

    Elfrink, V L; Davis, L S; Fitzwater, E; Castleman, J; Burley, J; Gorney-Moreno, M J; Sullivan, J; Nichols, B; Hall, D; Queen, K; Johnson, S; Martin, A

    2000-01-01

    As health care becomes more information-intensive and diverse, there is a need to integrate information technology (IT) into clinical education. Little is known, however, about how to design instructional strategies for integrating information technology into clinical nursing education. This article outlines the instructional strategies used by faculty in five nursing programs who taught students to use a point-of-care information technology system. The article also reports students' computer acceptance and summarizes IT clinical teaching recommendations.

  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. 77 FR 38634 - Request for Information: Collection and Use of Patient Work Information in the Clinical Setting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-28

    ... Patient Work Information in the Clinical Setting: Electronic Health Records AGENCY: The National Institute... the inclusion of work information in the electronic health record (EHR). NIOSH requests input on these... Occupational Information in Electronic Health Records'' written by the Institute of Medicine (IOM) Committee...

  12. 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…

  13. 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...

  14. A clinical comparative study of Cadiax Compact II and intraoral records using wax and addition silicone.

    PubMed

    Torabi, Kianoosh; Pour, Sasan Rasaei; Ahangari, Ahmad Hassan; Ghodsi, Safoura

    2014-01-01

    Evaluation of mandibular movements is necessary to form the occlusal anatomical contour, analyze the temporomandibular joint status, and evaluate the patient's occlusion. This clinical study was conducted to compare the mandibular recording device Cadiax Compact II with routine intraoral records for measuring condylar inclinations. The results showed that the differences between Cadiax and intraoral records were statistically significant for all measurements. Cadiax measurements had a stronger correlation with silicone records. The quantities of recorded Bennett angles were lower and the values of sagittal condylar inclination were higher with Cadiax than with routine intraoral records.

  15. 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.

  16. 77 FR 50548 - Agency Information Collection: (PACT Clinical Innovation Study: Engaging Caregivers in the Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... AFFAIRS Agency Information Collection: (PACT Clinical Innovation Study: Engaging Caregivers in the Care of... being requested for information needed to improve dementia care for patients and care givers. DATES... No. 2900--New (VA Form 10-0537). SUPPLEMENTARY INFORMATION: Title: PACT Clinical Innovation...

  17. 24 CFR 903.9 - May HUD request additional information in the Annual Plan of a troubled PHA?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false May HUD request additional information in the Annual Plan of a troubled PHA? 903.9 Section 903.9 Housing and Urban Development REGULATIONS RELATING TO HOUSING AND URBAN DEVELOPMENT (CONTINUED) OFFICE OF ASSISTANT SECRETARY FOR PUBLIC...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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 Contracts and Property Management Federal Property Management Regulations System (Continued)...

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

    PubMed

    Marchenko, Irina I

    2016-08-23

    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.

  4. 76 FR 80377 - Notice of Submission of Proposed Information Collection to OMB Additional On-Site Data Collection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-23

    ... of Submission of Proposed Information Collection to OMB Additional On-Site Data Collection for the... HCV programs. The proposed data collection will take place through site visits to up to 30 PHAs and... the PHA. The results of the site visits will be used to identify PHAs to participate in a...

  5. 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

    2016-07-04

    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.

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

    PubMed Central

    Sharma, Rajhans; Kenfack, Cyril; Shin, Dongwon; Voltz, Karine; Stote, Roland H.; Zaporozhets, Olga A.; Botta, Maurizio; Tor, Yitzhak; Mély, Yves

    2016-01-01

    Thienoguanosine (thG) is an isomorphic nucleoside analogue acting as a faithful fluorescent substitute of G, with respectable quantum yield in oligonucleotides. Photophysical analysis of thG 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. PMID:27273741

  7. 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.

  8. The challenges of using epidemiology to inform clinical practice

    PubMed Central

    Kessler, Ronald C.

    2007-01-01

    This paper discusses challenges and prospects for increasing the clinical relevance of psychiatric epidemiological research. The discussion begins with a review of the structural determinants of the fact that current psychiatric epidemiological research has less clinical relevance that epidemiological research in other areas of medicine. The discussion then turns to ways in which the focus of psychiatric epidemiological research might be changed to increase its clinical relevance. A review is then presented of recent innovations in community psychiatric epidemiological research that were designed to increase clinical relevance. An argument is then made that the full clinical value of psychiatric epidemiology will only be realized when community epidemiology becomes better integrated with clinical epidemiology and the latter takes on a more prominent role than it currently has in psychiatric research. Existing initiatives to realize an integration of community psychiatric epidemiology with clinical epidemiology are then reviewed. Finally, an agenda is proposed for an expansion of clinical psychiatric epidemiology to include a focus on both naturalistic and quasi-experimental studies of illness course and treatment response in diverse clinical samples. PMID:17896231

  9. 77 FR 56846 - Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-14

    .... FDA bases the burden on an Agency analysis of premarket submissions with clinical trials similar to... Collection; Comment Request; Clinical Laboratory Improvement Amendments of 1988 Waiver Applications AGENCY... the notice. This notice solicits comments on collections of information associated with...

  10. An Internet compendium of analytical methods and spectroscopic information for monomers and additives used in food packaging plastics.

    PubMed

    Gilbert, J; Simoneau, C; Cote, D; Boenke, A

    2000-10-01

    An internet website (http:¿cpf.jrc.it/smt/) has been produced as a means of dissemination of methods of analysis and supporting spectroscopic information on monomers and additives used for food contact materials (principally packaging). The site which is aimed primarily at assisting food control laboratories in the European Union contains analytical information on monomers, starting substances and additives used in the manufacture of plastics materials. A searchable index is provided giving PM and CAS numbers for each of 255 substances. For each substance a data sheet gives regulatory information, chemical structures, physico-chemical information and background information on the use of the substance in particular plastics, and the food packaging applications. For monomers and starting substances (155 compounds) the infra-red and mass spectra are provided, and for additives (100 compounds); additionally proton NMR are available for about 50% of the entries. Where analytical methods have been developed for determining these substances as residual amounts in plastics or as trace amounts in food simulants these methods are also on the website. All information is provided in portable document file (PDF) format which means that high quality copies can be readily printed, using freely available Adobe Acrobat Reader software. The website will in future be maintained and up-dated by the European Commission's Joint Research Centre (JRC) as new substances are authorized for use by the European Commission (DG-ENTR formerly DGIII). Where analytical laboratories (food control or other) require reference substances these can be obtained free-of-charge from a reference collection housed at the JRC and maintained in conjunction with this website compendium.

  11. Additional diverse findings expand the clinical presentation of DOCK8 deficiency.

    PubMed

    Sanal, Ozden; Jing, Huie; Ozgur, Tuba; Ayvaz, Deniz; Strauss-Albee, Dara M; Ersoy-Evans, Sibel; Tezcan, Ilhan; Turkkani, Gulten; Matthews, Helen F; Haliloglu, Goknur; Yuce, Aysel; Yalcin, Bilgehan; Gokoz, Ozay; Oguz, Kader K; Su, Helen C

    2012-08-01

    We describe seven Turkish children with DOCK8 deficiency who have not been previously reported. Three patients presented with typical features of recurrent or severe cutaneous viral infections, atopic dermatitis, and recurrent respiratory or gastrointestinal tract infections. However, four patients presented with other features. Patient 1-1 featured sclerosing cholangitis and colitis; patient 2-1, granulomatous soft tissue lesion and central nervous system involvement, with primary central nervous system lymphoma found on follow-up; patient 3-1, a fatal metastatic leiomyosarcoma; and patient 4-2 showed no other symptoms initially besides atopic dermatitis. Similar to other previously reported Turkish patients, but in contrast to patients of non-Turkish ethnicity, the patients' lymphopenia was primarily restricted to CD4(+) T cells. Patients had homozygous mutations in DOCK8 that altered splicing, introduced premature terminations, destabilized protein, or involved large deletions within the gene. Genotyping of remaining family members showed that DOCK8 deficiency is a fully penetrant, autosomal recessive disease. In our patients, bone marrow transplantation resulted in rapid improvement followed by disappearance of viral skin lesions, including lesions resembling epidermodysplasia verruciformis, atopic dermatitis, and recurrent infections. Particularly for patients who feature unusual clinical manifestations, immunological testing, in conjunction with genetic testing, can prove invaluable in diagnosing DOCK8 deficiency and providing potentially curative treatment.

  12. 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

  13. Additional safeguards for children in clinical investigations of food and drug administration-regulated products. Final rule.

    PubMed

    2013-02-26

    The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.

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

    PubMed

    Goldacre, Ben; Gray, Jonathan

    2016-04-08

    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.

  15. 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

  16. 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

  17. 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

  18. 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.

  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. Clinical effectiveness of leucoreduced, pooled donor platelet concentrates, stored in plasma or additive solution with and without pathogen reduction.

    PubMed

    Kerkhoffs, Jean-Louis H; van Putten, Wim L J; Novotny, Viera M J; Te Boekhorst, Peter A W; Schipperus, Martin R; Zwaginga, Jaap Jan; van Pampus, Lizzy C M; de Greef, Georgine E; Luten, Marleen; Huijgens, Peter C; Brand, Anneke; van Rhenen, Dick J

    2010-07-01

    Pathogen reduction (PR) of platelet products increases costs and available clinical studies are equivocal with respect to clinical and haemostatic effectiveness. We conducted a multicentre, open-label, randomized, non-inferiority trial comparing the clinical effectiveness of buffy-coat derived leukoreduced platelet concentrates (PC) stored for up to 7 d in plasma with platelets stored in platelet additive solution III (PASIII) without and with treatment with amotosalen-HCl/ultraviolet-A (UVA) photochemical pathogen reduction (PR-PASIII). Primary endpoint of the study was 1-h corrected count increment (CCI). Secondary endpoints were 24-h CCI, bleeding, transfusion requirement of red cells and PC, platelet transfusion interval and adverse transfusion reactions. Compared to plasma-PC, in the intention to treat analysis of 278 evaluable patients the mean difference for the 1-h CCI of PR-PASIII-PC and PASIII-PC was -31% (P < 0.0001) and -9% (P = n.s.), respectively. Twenty-seven patients (32%) had bleeding events in the PR-PASIII arm, as compared to 19 (19%) in the plasma arm and 14 (15%) in the PASIII arm (P = 0.034). Despite the potential advantages of pathogen (and leucocyte) inactivation of amotosalen-HCl/UVA-treated platelet products, their clinical efficacy is inferior to platelets stored in plasma, warranting a critical reappraisal of employing this technique for clinical use.

  1. 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

  2. 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.

  3. 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.

  4. Supra-additive contribution of shape and surface information to individual face discrimination as revealed by fast periodic visual stimulation.

    PubMed

    Dzhelyova, Milena; Rossion, Bruno

    2014-12-24

    Face perception depends on two main sources of information--shape and surface cues. Behavioral studies suggest that both of them contribute roughly equally to discrimination of individual faces, with only a small advantage provided by their combination. However, it is difficult to quantify the respective contribution of each source of information to the visual representation of individual faces with explicit behavioral measures. To address this issue, facial morphs were created that varied in shape only, surface only, or both. Electrocephalogram (EEG) were recorded from 10 participants during visual stimulation at a fast periodic rate, in which the same face was presented four times consecutively and the fifth face (the oddball) varied along one of the morphed dimensions. Individual face discrimination was indexed by the periodic EEG response at the oddball rate (e.g., 5.88 Hz/5 = 1.18 Hz). While shape information was discriminated mainly at right occipitotemporal electrode sites, surface information was coded more bilaterally and provided a larger response overall. Most importantly, shape and surface changes alone were associated with much weaker responses than when both sources of information were combined in the stimulus, revealing a supra-additive effect. These observations suggest that the two kinds of information combine nonlinearly to provide a full individual face representation, face identity being more than the sum of the contribution of shape and surface cues.

  5. 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

  6. 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…

  7. [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.

  8. Information and research needs of acute-care clinical nurses.

    PubMed

    Spath, M; Buttlar, L

    1996-01-01

    The majority of nurses surveyed used the library on a regular but limited basis to obtain information needed in caring for or making decisions about their patients. A minority indicated that the libraries in their own institutions totally met their information needs. In fact, only 4% depended on the library to stay abreast of new information and developments in the field. Many of the nurses had their own journal subscriptions, which could account in part for the limited use of libraries and the popularity of the professional journal as the key information source. This finding correlates with the research of Binger and Huntsman, who found that 95% of staff development educators relied on professional journal literature to keep up with current information in the field, and only 45% regularly monitored indexing-and-abstracting services. The present study also revealed that nurses seek information from colleagues more than from any other source, supporting the findings of Corcoran-Perry and Graves. Further research is necessary to clarify why nurses use libraries on a limited basis. It appears, as Bunyan and Lutz contend, that a more aggressive approach to marketing the library to nurses is needed. Further research should include an assessment of how the library can meet the information needs of nurses for both research and patient care. Options to be considered include offering library orientation sessions for new staff nurses, providing current-awareness services by circulating photocopied table-of-contents pages, sending out reviews of new monographs, inviting nurses to submit search requests on a topic, scheduling seminars and workshops that teach CD-ROM and online search strategies, and providing information about electronic databases covering topics related to nursing. Information on databases may be particularly important in light of the present study's finding that databases available in CD-ROM format are consulted very little. Nursing education programs should

  9. Website Use and Effects of Online Information About Tobacco Additives Among the Dutch General Population: A Randomized Controlled Trial

    PubMed Central

    Crutzen, Rik; Kienhuis, Anne S; Talhout, Reinskje; de Vries, Hein

    2017-01-01

    Background As a legal obligation, the Dutch government publishes online information about tobacco additives to make sure that it is publicly available. Little is known about the influence this website (”tabakinfo”) has on visitors and how the website is evaluated by them. Objective This study assesses how visitors use the website and its effect on their knowledge, risk perception, attitude, and smoking behavior. The study will also assess how the website is evaluated by visitors using a sample of the Dutch general population, including smokers and nonsmokers. Methods A randomized controlled trial was conducted, recruiting participants from an online panel. At baseline, participants (N=672) were asked to fill out an online questionnaire about tobacco additives. Next, participants were randomly allocated to either one of two experimental groups and invited to visit the website providing information about tobacco additives (either with or without a database containing product-specific information) or to a control group that had no access to the website. After 3 months, follow-up measurements took place. Results At follow-up (n=492), no statistically significant differences were found for knowledge, risk perception, attitude, or smoking behavior between the intervention and control groups. Website visits were positively related to younger participants (B=–0.07, 95% CI –0.12 to –0.01; t11=–2.43, P=.02) and having a low risk perception toward tobacco additives (B=–0.32, 95% CI –0.63 to –0.02; t11=–2.07, P=.04). In comparison, having a lower education (B=–0.67, 95% CI –1.14 to –0.17; t11=–2.65, P=.01) was a significant predictor for making less use of the website. Furthermore, the website was evaluated less positively by smokers compared to nonsmokers (t324=–3.55, P<.001), and males compared to females (t324=–2.21, P=.02). Conclusions The website did not change perceptions of tobacco additives or smoking behavior. Further research is

  10. Extracting clinical information to support medical decision based on standards.

    PubMed

    Gomoi, Valentin; Vida, Mihaela; Stoicu-Tivadar, Lăcrămioara; Stoicu-Tivadar, Vasile

    2011-01-01

    The paper presents a method connecting medical databases to a medical decision system, and describes a service created to extract the necessary information that is transferred based on standards. The medical decision can be improved based on many inputs from different medical locations. The developed solution is described for a concrete case concerning the management for chronic pelvic pain, based on the information retrieved from diverse healthcare databases.

  11. 77 FR 6808 - Proposed Collection; Comment Request: Information Program on Clinical Trials; Maintaining a...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-09

    ... as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act... and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and... certain applicable clinical trials of drugs and devices and the submission of results information...

  12. 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

  13. 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

  14. Informed Consent: Ethical Issues and Future Challenges in Clinical Education.

    ERIC Educational Resources Information Center

    Angaran, David M.

    1989-01-01

    A look at pharmaceutical care needs in the future is the basis for discussion of the educational needs of clinical pharmacists. Issues discussed include the appropriate degree (bachelor's vs. doctoral), costs of instruction, faculty/student ratios, the pharmacy practice faculty as role models, and computer-assisted instruction. (MSE)

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

    MedlinePlus

    ... Nothing is without risks, including illness itself. A study may not benefit you personally at the time of the clinical trial. You may have to stop taking your current medications, even if they are working. It is very important that you understand potential ...

  16. [A community electronic prescription system connecting physicians, pharmacists, and patients, and utilization of clinical information].

    PubMed

    Iihara, Naomi; Kirino, Yutaka

    2014-01-01

    We tested a community electronic prescription system (K-CHOPS/PPISS) that we developed in Kagawa, Japan, which connects the prescribing physicians, pharmacists at community pharmacies, and patients through a community data center server. Physicians can send prescriptions, diagnoses, and laboratory data to the datacenter. Pharmacists in community pharmacies can access their patients' information through the datacenter and can return corrected prescriptions and reports containing guidance and adverse events to the hospital or clinic where the prescription was issued. Patients can then see their dispensed medications on their PCs, cellular phones, and smart phones. Additionally, patients can input medication-taking records, allergy and adverse drug reactions (ADR), any over-the-counter drug and supplements that they take, and their physical condition through the devices. The system enables pharmacists to appropriately advise and monitor ADR based on patient clinical data and enables physicians to accurately know the medications handed to patients and advisories issued by the pharmacists. Further, physicians and pharmacists can see the patients' condition which they entered on their devices if the patients agree. These would be helpful for avoiding ADR. The information accumulated in the data center can be potentially utilized for evaluation of the effectiveness and ADR of medications and for development of innovative medication. Discussion of the pros and cons for such utilization is needed.

  17. Content Validity of Patient-Reported Outcomes Measurement Information System (PROMIS) Items in the Context of HIV Clinical Care

    PubMed Central

    Edwards, Todd C.; Fredericksen, Rob J.; Crane, Heidi M.; Crane, Paul K.; Kitahata, Mari M.; Matthews, William C.; Mayer, Kenneth H.; Morales, Leo S.; Mugavero, Michael J.; Solorio, Rosa; Yang, Frances M.; Patrick, Donald L.

    2015-01-01

    Purpose To assess content validity and patient and provider prioritization of Patient Reported Outcomes Measurement Information System (PROMIS) Depression, Anxiety, Fatigue, and Alcohol Use items in the context of clinical care for people living with HIV (PLWH), and to develop and assess new items as needed. Methods We conducted concept elicitation interviews (n=161), item pool matching, prioritization focus groups (n=227 participants), and cognitive interviews (n=48) with English-speaking (~75%) and Spanish-speaking (~25%) PLWH from clinical sites in Seattle, San Diego, Birmingham, and Boston. For each domain we also conducted item review and prioritization with two HIV provider panels of 3 to 8 members each. Results Among items most highly prioritized by PLWH and providers were those that included information regarding personal impacts of the concept being assessed, in addition to severity level. Items that addressed impact were considered most actionable for clinical care. We developed additional items addressing this. For depression we developed items related to suicide and other forms of self-harm, and for all domains we developed items addressing impacts PLWH and/or providers indicated were particularly relevant to clinical care. Across the 4 domains, 16 new items were retained for further psychometric testing. Conclusion PLWH and providers had priorities for what they believed providers should know to provide optimal care for PLWH. Incorporation of these priorities into clinical assessments used in clinical care of PLWH may facilitate patient-centered care. PMID:26245710

  18. Informed consent and the history of inclusion of women in clinical research.

    PubMed

    Stevens, Patricia E; Pletsch, Pamela K

    2002-12-01

    The purposes of this paper are to (a) discuss the troubled history of informed consent for research on women and its ramifications for women's participation in clinical trials; (b) interrogate current informed consent practices as to their accountability and justice in the treatment of women; and (c) recommend to nurse researchers and clinical nurses ways of improving the practice of informed consent in research with women.

  19. Individuals with post-stroke hemiparesis are able to use additional sensory information to reduce postural sway.

    PubMed

    Cunha, B P; Alouche, S R; Araujo, I M G; Freitas, S M S F

    2012-03-28

    The present study aimed to investigate whether stroke survivals are able to use the additional somatosensory information provided by the light touch to reduce their postural sway during the upright stance. Eight individuals, naturally right-handed pre-stroke, and eight healthy age-matched adults stood as quiet as possible on a force plate during 35s. Participants performed two trials for each visual condition (eyes open and closed) and somatosensory condition (with and without the right or left index fingertip touching an instrumented rigid and fixed bar). When participants touched the bar, they were asked to apply less than 1N of vertical force. The postural sway was assessed by the center of pressure (COP) displacement area, mean amplitude and velocity. In addition, the mean and standard deviation of the force vertically applied on the bar during the trials with touch were assessed. The averaged values of COP area, amplitude and velocity were greater for stroke individuals compared to healthy adults during all visual and somatosensory conditions. For both groups, the values of all variables increased when participants stood with eyes closed and reduced when they touched the bar regardless of the side of the touch. Overall, the results suggested that, as healthy individuals, persons with post-stroke hemiparesis are able to use the additional somatosensory information provided by the light touch to reduce the postural sway.

  20. 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.…

  1. Integrating clinical and biological information in a shanghai biobank: an introduction to the sample repository and information sharing platform project.

    PubMed

    Cui, Wenbin; Zheng, Peiyong; Yang, Jiahong; Zhao, Rong; Gao, Jiechun; Yu, Guangjun

    2015-02-01

    Biobanks are important resources and central tools for translational medicine, which brings scientific research outcomes to clinical practice. The key purpose of biobanking in translational medicine and other medical research is to provide biological samples that are integrated with clinical information. In 2008, the Shanghai Municipal Government launched the "Shanghai Tissue Bank" in an effort to promote research in translational medicine. Now a sharing service platform has been constructed to integrate clinical practice and biological information that can be used in diverse medical and pharmaceutical research studies. The platform collects two kinds of data: sample data and clinical data. The sample data are obtained from the hospital biobank management system, and mainly include the donors' age, gender, marital status, sample source, sample type, collection time, deposit time, and storage method. The clinical data are collected from the "Hospital-Link" system (a medical information sharing system that connects 23 tertiary hospitals in Shanghai). The main contents include donors' corresponding medication information, test reports, inspection reports, and hospital information. As of the end of September 2014, the project has a collection of 16,020 donors and 148,282 samples, which were obtained from 12 medical institutions, and automatically acquired donors' corresponding clinical data from the "Hospital-Link" system for 6830 occurrences. This project will contribute to scientific research at medical institutions in Shanghai, and will also support the development of the biopharmaceutical industry. In this article, we will describe the significance, the construction phases, the application prospects, and benefits of the sample repository and information sharing service platform.

  2. 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

  3. A System Architecture for Sharing De-Identified, Research-Ready Brain Scans and Health Information Across Clinical Imaging Centers

    PubMed Central

    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.

    2015-01-01

    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

  4. Neuroinflammation - using big data to inform clinical practice.

    PubMed

    Dendrou, Calliope A; McVean, Gil; Fugger, Lars

    2016-12-01

    Neuroinflammation is emerging as a central process in many neurological conditions, either as a causative factor or as a secondary response to nervous system insult. Understanding the causes and consequences of neuroinflammation could, therefore, provide insight that is needed to improve therapeutic interventions across many diseases. However, the complexity of the pathways involved necessitates the use of high-throughput approaches to extensively interrogate the process, and appropriate strategies to translate the data generated into clinical benefit. Use of 'big data' aims to generate, integrate and analyse large, heterogeneous datasets to provide in-depth insights into complex processes, and has the potential to unravel the complexities of neuroinflammation. Limitations in data analysis approaches currently prevent the full potential of big data being reached, but some aspects of big data are already yielding results. The implementation of 'omics' analyses in particular is becoming routine practice in biomedical research, and neuroimaging is producing large sets of complex data. In this Review, we evaluate the impact of the drive to collect and analyse big data on our understanding of neuroinflammation in disease. We describe the breadth of big data that are leading to an evolution in our understanding of this field, exemplify how these data are beginning to be of use in a clinical setting, and consider possible future directions.

  5. The influence of different growth hormone addition protocols to poor ovarian responders on clinical outcomes in controlled ovary stimulation cycles

    PubMed Central

    Li, Xue-Li; Wang, Li; Lv, Fang; Huang, Xia-Man; Wang, Li-Ping; Pan, Yu; Zhang, Xiao-Mei

    2017-01-01

    Abstract Background: Growth hormone (GH) is used as an adjuvant therapy in in vitro fertilization and embryo transfer (IVF-ET) for poor ovarian responders, but findings for its effects on outcomes of IVF have been conflicting. The aim of the study was to compare IVF-ET outcomes among women with poor ovarian responders, and find which subgroup can benefit from the GH addition. Methods: We searched the databases, using the terms “growth hormone,” “GH,” “IVF,” “in vitro fertilization.” Randomized controlled trials (RCT) were included if they assessed pregnancy rate, live birth rate, collected oocytes, fertilization rate, and implantation rate. Extracted the data from the corresponding articles, Mantel–Haenszel random-effects model, or fixed-effects model was used. Eleven studies were included. Results: Clinical pregnancy rate (RR 1.65, 95% CI 1.23–2.22), live birth rate (RR1.73, 1.25–2.40), collected oocytes number (SMD 1.09, 95% CI 0.54–1.64), MII oocytes number (SMD 1.48, 0.84–2.13), and E2 on human chorionic gonadotropin (HCG) day (SMD 1.03, 0.18–1.89) were significantly increased in the GH group. The cancelled cycles rate (RR 0.65, 0.45–0.94) and the dose of gonadotropin (Gn) (SMD –0.83, –1.47, –0.19) were significantly lower in patients who received GH. Subgroup analysis indicated that the GH addition with Gn significantly increased the clinical pregnancy rate (RR 1.76, 1.25–2.48) and the live birth rate (RR 1.91, 1.29–2.83). Conclusion: The GH addition can significantly improve the clinical pregnancy rate and live birth rate. Furthermore, the GH addition time and collocation of medications may affect the pregnancy outcome. PMID:28328856

  6. Robust meta-analytic-predictive priors in clinical trials with historical control information.

    PubMed

    Schmidli, Heinz; Gsteiger, Sandro; Roychoudhury, Satrajit; O'Hagan, Anthony; Spiegelhalter, David; Neuenschwander, Beat

    2014-12-01

    Historical information is always relevant for clinical trial design. Additionally, if incorporated in the analysis of a new trial, historical data allow to reduce the number of subjects. This decreases costs and trial duration, facilitates recruitment, and may be more ethical. Yet, under prior-data conflict, a too optimistic use of historical data may be inappropriate. We address this challenge by deriving a Bayesian meta-analytic-predictive prior from historical data, which is then combined with the new data. This prospective approach is equivalent to a meta-analytic-combined analysis of historical and new data if parameters are exchangeable across trials. The prospective Bayesian version requires a good approximation of the meta-analytic-predictive prior, which is not available analytically. We propose two- or three-component mixtures of standard priors, which allow for good approximations and, for the one-parameter exponential family, straightforward posterior calculations. Moreover, since one of the mixture components is usually vague, mixture priors will often be heavy-tailed and therefore robust. Further robustness and a more rapid reaction to prior-data conflicts can be achieved by adding an extra weakly-informative mixture component. Use of historical prior information is particularly attractive for adaptive trials, as the randomization ratio can then be changed in case of prior-data conflict. Both frequentist operating characteristics and posterior summaries for various data scenarios show that these designs have desirable properties. We illustrate the methodology for a phase II proof-of-concept trial with historical controls from four studies. Robust meta-analytic-predictive priors alleviate prior-data conflicts ' they should encourage better and more frequent use of historical data in clinical trials.

  7. Personalised Medicine Possible With Real-Time Integration of Genomic and Clinical Data To Inform Clinical Decision-Making.

    PubMed

    Martin-Sanchez, Fernando; Turner, Maureen; Johnstone, Alice; Heffer, Leon; Rafael, Naomi; Bakker, Tim; Thorne, Natalie; Macciocca, Ivan; Gaff, Clara

    2015-01-01

    Despite widespread use of genomic sequencing in research, there are gaps in our understanding of the performance and provision of genomic sequencing in clinical practice. The Melbourne Genomics Health Alliance (the Alliance), has been established to determine the feasibility, performance and impact of using genomic sequencing as a diagnostic tool. The Alliance has partnered with BioGrid Australia to enable the linkage of genomic sequencing, clinical treatment and outcome data for this project. This integrated dataset of genetic, clinical and patient sourced information will be used by the Alliance to evaluate the potential diagnostic value of genomic sequencing in routine clinical practice. This project will allow the Alliance to provide recommendations to facilitate the integration of genomic sequencing into clinical practice to enable personalised disease treatment.

  8. Early experiences in evolving an enterprise-wide information model for laboratory and clinical observations.

    PubMed

    Chen, Elizabeth S; Zhou, Li; Kashyap, Vipul; Schaeffer, Molly; Dykes, Patricia C; Goldberg, Howard S

    2008-11-06

    As Electronic Healthcare Records become more prevalent, there is an increasing need to ensure unambiguous data capture, interpretation, and exchange within and across heterogeneous applications. To address this need, a common, uniform, and comprehensive approach for representing clinical information is essential. At Partners HealthCare System, we are investigating the development and implementation of enterprise-wide information models to specify the representation of clinical information to support semantic interoperability. This paper summarizes our early experiences in: (1) defining a process for information model development, (2) reviewing and comparing existing healthcare information models, (3) identifying requirements for representation of laboratory and clinical observations, and (4) exploring linkages to existing terminology and data standards. These initial findings provide insight to the various challenges ahead and guidance on next steps for adoption of information models at our organization.

  9. Enhancing CBT for Chronic Insomnia: A Randomised Clinical Trial of Additive Components of Mindfulness or Cognitive Therapy.

    PubMed

    Wong, Mei Yin; Ree, Melissa J; Lee, Christopher W

    2016-09-01

    Although cognitive behavioural therapy (CBT) for insomnia has resulted in significant reductions in symptoms, most patients are not classified as good sleepers after treatment. The present study investigated whether additional sessions of cognitive therapy (CT) or mindfulness-based therapy (MBT) could enhance CBT in 64 participants with primary insomnia. All participants were given four sessions of standard CBT as previous research had identified this number of sessions as an optimal balance between therapist guidance and patient independence. Participants were then allocated to further active treatment (four sessions of CT or MBT) or a no further treatment control. The additional treatments resulted in significant improvements beyond CBT on self-report and objective measures of sleep and were well tolerated as evidenced by no dropouts from either treatment. The effect sizes for each of these additional treatments were large and clinically significant. The mean scores on the primary outcome measure, the Insomnia Severity Index, were 5.74 for CT and 6.69 for MBT, which are within the good-sleeper range. Treatment effects were maintained at follow-up. There were no significant differences between CT and MBT on any outcome measure. These results provide encouraging data on how to enhance CBT for treatment of insomnia. Copyright © 2015 John Wiley & Sons, Ltd.

  10. 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.

  11. 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.

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

    PubMed Central

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

    2016-01-01

    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. PMID:23981394

  13. Automatic detection of protected health information from clinic narratives.

    PubMed

    Yang, Hui; Garibaldi, Jonathan M

    2015-12-01

    This paper presents a natural language processing (NLP) system that was designed to participate in the 2014 i2b2 de-identification challenge. The challenge task aims to identify and classify seven main Protected Health Information (PHI) categories and 25 associated sub-categories. A hybrid model was proposed which combines machine learning techniques with keyword-based and rule-based approaches to deal with the complexity inherent in PHI categories. Our proposed approaches exploit a rich set of linguistic features, both syntactic and word surface-oriented, which are further enriched by task-specific features and regular expression template patterns to characterize the semantics of various PHI categories. Our system achieved promising accuracy on the challenge test data with an overall micro-averaged F-measure of 93.6%, which was the winner of this de-identification challenge.

  14. 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

  15. Stability of stored methacholine chloride solutions: clinically useful information.

    PubMed

    Pratter, M R; Woodman, T F; Irwin, R S; Johnson, B

    1982-10-01

    Methacholine inhalation challenge (MIC) has been shown to be an extremely useful diagnostic test. Because a decrease in the time and expense involved in the preparation of methacholine chloride solutions might encourage more laboratories to perform MIC, we assessed the stability of several different concentrations of methacholine chloride in solution over a period of 4 months. We used and compared 2 different assay techniques: a high pressure liquid chromatography assay and a colorimetric assay. Comparable results were obtained by both assays and demonstrated that methacholine solutions stored either at room temperature or at 4 degrees C showed no significant decomposition over a period of 4 months. From our results, we conclude that: (1) methacholine chloride solutions are much more stable than stated in the Merck Manual, (2) the original data of MacDonald and coworkers on the stability of methacholine chloride solution are accurate, (3) our high pressure liquid chromatography method is an accurate and highly specific technique for measuring methacholine chloride solutions. The major clinical implication of our results is that the time and cost necessary to prepare methacholine chloride solutions is much less than previously thought. This should encourage a more widespread use of this important diagnostic technique for the demonstration of bronchial hyperreactivity.

  16. The role of effective communication in achieving informed consent for clinical trials.

    PubMed

    Pick, Andrew; Gilbert, Kayleigh; McCaul, James

    2014-11-11

    Informed consent is fundamental to the protection of the rights, safety and wellbeing of patients in clinical research. For consent to be valid, patients must first be given all the information they need about the proposed research to be able to decide whether they would like to take part. This material should be presented in a way that is easy for them to understand. This article explores the importance of communication in clinical research, and how more effective communication with patients during the informed consent process can ensure they are fully informed.

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

    NASA Astrophysics Data System (ADS)

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

    2016-04-01

    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.

  18. 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

  19. Written Informed Consent: Closing the Door to Clinical Research. and Another Look at Informed Consent.

    ERIC Educational Resources Information Center

    Noble, Mary Anne; Oberst, Marilyn T.

    1985-01-01

    Two viewpoints on written informed consent are presented: Written informed consent should not be required unless research goes beyond the bounds of normal practice and poses danger or discomfort to the patient; and the principles of autonomy and individual rights must be applied at least as stringently to research as to practice. (CT)

  20. Where is information quality lost at clinical level? A mixed-method study on information systems and data quality in three urban Kenyan ANC clinics.

    PubMed

    Hahn, Daniel; Wanjala, Pepela; Marx, Michael

    2013-01-01

    Background Well-working health information systems are considered vital with the quality of health data ranked of highest importance for decision making at patient care and policy levels. In particular, health facilities play an important role, since they are not only the entry point for the national health information system but also use health data (and primarily) for patient care. Design A multiple case study was carried out between March and August 2012 at the antenatal care (ANC) clinics of two private and one public Kenyan hospital to describe clinical information systems and assess the quality of information. The following methods were developed and employed in an iterative process: workplace walkthroughs, structured and in-depth interviews with staff members, and a quantitative assessment of data quality (completeness and accurate transmission of clinical information and reports in ANC). Views of staff and management on the quality of employed information systems, data quality, and influencing factors were captured qualitatively. Results Staff rated the quality of information higher in the private hospitals employing computers than in the public hospital which relies on paper forms. Several potential threats to data quality were reported. Limitations in data quality were common at all study sites including wrong test results, missing registers, and inconsistencies in reports. Feedback was seldom on content or quality of reports and usage of data beyond individual patient care was low. Conclusions We argue that the limited data quality has to be seen in the broader perspective of the information systems in which it is produced and used. The combination of different methods has proven to be useful for this. To improve the effectiveness and capabilities of these systems, combined measures are needed which include technical and organizational aspects (e.g. regular feedback to health workers) and individual skills and motivation.

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

    PubMed

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

    2015-12-02

    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.

  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. Semantic Web Technology for Mapping and Applying Clinical Functional Assessment Information

    DTIC Science & Technology

    2015-05-01

    Award Number: W81XWH-13-2-0010 TITLE: Semantic Web Technology for Mapping and Applying Clinical Functional Assessment Information PRINCIPAL...SUBTITLE Semantic Web Technology for Mapping and Applying Clinical 5a. CONTRACT NUMBER W81XWH-13-2-0010 Functional Assessment Information 5b. GRANT...International Classification of Functioning, Disability, and Health (ICF). We developed the mechanisms to generate programmatically data-acquisition Web forms

  4. A user-editable web-based platform to streamline clinical information flow.

    PubMed

    Finkelstein, Mark; Siddiqui, Ammar; Pak, Theodore; Hu, Kevin; Ciccariello, Chloe; Knabben, Vinicius; Chiang, David; Thomas, David C; Meah, Yasmin S

    2015-01-01

    Frequent turnover of staff in medical clinics creates challenges in the maintenance of clinical protocols, workflows, and information management. Care coordination between providers in such a setting can be complex; disruptions in communication may lead to poorer health outcomes and patient satisfaction. Furthermore, protocols change frequently in response to new guidelines, which demands rapid updates to maintain compliance. To address these challenges, we developed an intuitive, end-user editable web-based knowledge management system optimized for use on mobile devices. The resulting system served as a point of care information storage and retrieval tool that providers can reference quickly for operational tasks. Since launch, the platform has allowed our clinic to consolidate knowledge banks, standardize staff training, and streamline information flow during clinic, and is now used extensively by clinic staff. During a one-year period, 175 new pages have been created and 1686 edits have been submitted by users. We posit that a mobile platform for clinical information flow management has significant potential to improve information maintenance and facilitate transfer of up-to-date clinical protocols to new personnel.

  5. 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

    ... Collection (Prevalence and Clinical course of Depression Among patients with Heart Failure); Comment Request... information needed to identify the patterns of depression in heart failure patients. DATES: Written comments...: Prevalence and Clinical Course of Depression Among Patients with Heart Failure, VA HSR&D, Nursing...

  6. Issues in the design of a clinical microbiology database within an integrated hospital information system.

    PubMed Central

    Nussbaum, B. E.

    1991-01-01

    The LASTWORD hospital information system contains a clinical microbiology database which permits both review of patient reports and retrospective data searches using clinical and/or demographic criteria. The elements supporting this database are dictionary tables of coded phrases, a general purpose query language (Tandem ENFORM), an HL7 interface to a laboratory computer system, and long-term data storage of demographic, microbiology and other clinical data in a relational database. PMID:1807616

  7. Investigating Longitudinal Tobacco Use Information from Social History and Clinical Notes in the Electronic Health Record.

    PubMed

    Wang, Yan; Chen, Elizabeth S; Pakhomov, Serguei; Lindemann, Elizabeth; Melton, Genevieve B

    2016-01-01

    The electronic health record (EHR) provides an opportunity for improved use of clinical documentation including leveraging tobacco use information by clinicians and researchers. In this study, we investigated the content, consistency, and completeness of tobacco use data from structured and unstructured sources in the EHR. A natural language process (NLP) pipeline was utilized to extract details about tobacco use from clinical notes and free-text tobacco use comments within the social history module of an EHR system. We analyzed the consistency of tobacco use information within clinical notes, comments, and available structured fields for tobacco use. Our results indicate that structured fields for tobacco use alone may not be able to provide complete tobacco use information. While there was better consistency for some elements (e.g., status and type), inconsistencies were found particularly for temporal information. Further work is needed to improve tobacco use information integration from different parts of the EHR.

  8. Investigating Longitudinal Tobacco Use Information from Social History and Clinical Notes in the Electronic Health Record

    PubMed Central

    Wang, Yan; Chen, Elizabeth S.; Pakhomov, Serguei; Lindemann, Elizabeth; Melton, Genevieve B.

    2016-01-01

    The electronic health record (EHR) provides an opportunity for improved use of clinical documentation including leveraging tobacco use information by clinicians and researchers. In this study, we investigated the content, consistency, and completeness of tobacco use data from structured and unstructured sources in the EHR. A natural language process (NLP) pipeline was utilized to extract details about tobacco use from clinical notes and free-text tobacco use comments within the social history module of an EHR system. We analyzed the consistency of tobacco use information within clinical notes, comments, and available structured fields for tobacco use. Our results indicate that structured fields for tobacco use alone may not be able to provide complete tobacco use information. While there was better consistency for some elements (e.g., status and type), inconsistencies were found particularly for temporal information. Further work is needed to improve tobacco use information integration from different parts of the EHR. PMID:28269918

  9. Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

    PubMed Central

    Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

    2015-01-01

    Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of

  10. Respiratory clinical guidelines inform ward-based nurses’ clinical skills and knowledge required for evidence-based care

    PubMed Central

    Johnson, Alisha M.

    2016-01-01

    Respiratory clinical guidelines provide clinicians with evidence-based guidance for practice. Clinical guidelines also provide an opportunity to identify the knowledge and technical and non-technical skills required by respiratory ward-based registered nurses. The aim of this review was to use a systematic process to establish the core technical and non-technical skills and knowledge identified in evidence-based clinical guidelines that enable the care of hospitalised adult respiratory patients. 17 guidelines were identified in our systematic review. The quality assessment demonstrated variability in these guidelines. Common core knowledge and technical and non-technical skills were identified. These include pathophysiology, understanding of physiological measurements and monitoring, education, counselling, and ward and patient management. The knowledge and skills extracted from respiratory clinical guidelines may inform a curriculum for ward-based respiratory nursing to ensure optimal care of adult patients. PMID:28210299

  11. Respiratory clinical guidelines inform ward-based nurses' clinical skills and knowledge required for evidence-based care.

    PubMed

    Johnson, Alisha M; Smith, Sheree M S

    2016-09-01

    Respiratory clinical guidelines provide clinicians with evidence-based guidance for practice. Clinical guidelines also provide an opportunity to identify the knowledge and technical and non-technical skills required by respiratory ward-based registered nurses. The aim of this review was to use a systematic process to establish the core technical and non-technical skills and knowledge identified in evidence-based clinical guidelines that enable the care of hospitalised adult respiratory patients. 17 guidelines were identified in our systematic review. The quality assessment demonstrated variability in these guidelines. Common core knowledge and technical and non-technical skills were identified. These include pathophysiology, understanding of physiological measurements and monitoring, education, counselling, and ward and patient management. The knowledge and skills extracted from respiratory clinical guidelines may inform a curriculum for ward-based respiratory nursing to ensure optimal care of adult patients.

  12. Development of clinical ontology for mood disorder with combination of psychomedical information.

    PubMed

    Haghighi, Mojgan; Koeda, Michihiko; Takai, Takako; Tanaka, Hiroshi

    2009-03-01

    We have developed a new educational/clinical ontology named the "Haghighi-Koeda Mood Disorder Ontology", which involves both medical and psychological approaches for mood disorders in order to promote the exchange of information between psychiatrists and psychologists. Data was gathered from more than 5000 articles published in journals and websites specialized in life science. We evaluated and selected articles which were related to 4 main categories of mood disorders. Using Protege 3.4 beta, information related to mood disorders was classified by class/subclass tree in an ontological structure. Then we developed a web-based interface system on the internet enabling the implementation of the ontology. In addition, we have designed an online scale for automated diagnosis of mood disorder. For evaluating experiments, we compare this ontology with "Decisionbase" of which content deals with mood disorders. Evaluation was in accordance with our selected criteria via the AHP (Analysis of Hierarchical Processing) method. The results demonstrated the noteworthy superiority of our ontology. We believe that combining knowledge of medical science with that in psychological fields is a key to improving the quality of diagnosis and promoting appropriate treaTMent in all psychiatric disorders.

  13. Barriers and benefits associated with nurses information seeking related to patient education needs on clinical nursing units.

    PubMed

    Jones, Josette; Schilling, Katherine; Pesut, Daniel

    2011-01-01

    . In many cases, nurses commented on specific characteristics or features of favorite information resources. Favorite sites included a variety or reputable health care organizations that displayed context in text, audio, and/or video. In addition such sites were described as easy-to read and provided content related to patient-focused information or specific content such as toll free telephone contact numbers.Information searching is the interaction between and among information users and computer-based information systems. Information seeking is becoming an important part of the knowledge work of nurses. Information seeking and searching intersects with the field of human computer interaction (HCI), which focuses on all aspects of human, and computer interactions. Users of an information system are understood as "actors" in situations, with a set of skills and shared practices based on work experiences with others. Designing better tools and developing information searching strategies that support, extend, and transform practices, begins by asking: Who are the users? What are the tasks? What is the interplay between the technology and the organization of the task? This study contributes fundamental data and information about the rationales nurses use in information seeking tasks. In addition it provides empirical evidences regarding barriers and benefits of information seeking in the context of patient education needs in inpatient clinical settings.

  14. Influence of submission form characteristics on clinical information received in biopsy accession.

    PubMed

    Brannick, Erin M; Zhang, Jianying; Zhang, Xiaoli; Stromberg, Paul C

    2012-11-01

    Clinical information supplied to diagnostic laboratories through biopsy submission forms is crucial to accurate, timely diagnosis and to clinicopathologic correlation between microscopic findings and the clinical condition of the patient. The current study attempts to quantify the prevalence of deficient and inadequate submissions in veterinary biopsy service and to determine whether form characteristics, such as the open or closed nature of the form and the presence of specific prompts, influence reporting of essential case information. The hypotheses of this study are, first, that deficient and inadequate biopsy submissions do occur in veterinary medicine and, second, that open-type biopsy submission forms elicit quantitatively and qualitatively more complete case information overall, and in specific content areas, compared to closed-type biopsy submission forms. Three percent of submissions reviewed were information deficient, devoid of information beyond patient signalment, and more than 88% of forms supplied inadequate clinical information in at least 1 key content area. Both form type and specific prompts significantly influenced reporting of important clinical information. This study demonstrates the need and lays the foundation for informational completeness research in veterinary medicine.

  15. 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…

  16. 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…

  17. 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)...

  18. 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)...

  19. 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)...

  20. 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)...

  1. Informed Consent in cross-cultural perspective: clinical research in the Tibetan Autonomous Region, PRC.

    PubMed

    Adams, Vincanne; Miller, Suellen; Craig, Sienna; Sonam; Nyima; Droyoung; Le, Phuoc V; Varner, Micheal

    2007-12-01

    Procedures of Informed Consent are considered a high priority for international biomedical research. However, informed consent protocols are not necessarily transferable across cultural, national or ethnic groups. Recent debates identify the need for balancing ethical universals with practical and local conditions and paying attention to questions of cultural competence when it comes to the Informed Consent process for clinical biomedical research. This article reports on the results of a two-year effort to establish a culturally appropriate Informed Consent process for biomedical research in the Tibet Autonomous Region in the People's Republic of China. A team of Tibetan and American researchers, physicians, health professionals and medical anthropologists conducted the research. The Informed Consent was specifically for undertaking a triple-blind, double placebo-controlled randomized clinical trial of a Tibetan medicine compared with Misoprostol for reducing postpartum blood loss. The findings suggest greater need for flexibility and cooperation in establishing Informed Consent protocols across cultures and nations.

  2. Automated information extraction of key trial design elements from clinical trial publications.

    PubMed

    de Bruijn, Berry; Carini, Simona; Kiritchenko, Svetlana; Martin, Joel; Sim, Ida

    2008-11-06

    Clinical trials are one of the most valuable sources of scientific evidence for improving the practice of medicine. The Trial Bank project aims to improve structured access to trial findings by including formalized trial information into a knowledge base. Manually extracting trial information from published articles is costly, but automated information extraction techniques can assist. The current study highlights a single architecture to extract a wide array of information elements from full-text publications of randomized clinical trials (RCTs). This architecture combines a text classifier with a weak regular expression matcher. We tested this two-stage architecture on 88 RCT reports from 5 leading medical journals, extracting 23 elements of key trial information such as eligibility rules, sample size, intervention, and outcome names. Results prove this to be a promising avenue to help critical appraisers, systematic reviewers, and curators quickly identify key information elements in published RCT articles.

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

    PubMed

    Wright, Adam; Sittig, Dean F

    2008-12-01

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

  4. Internet as clinical information system: application development using the World Wide Web.

    PubMed Central

    Cimino, J J; Socratous, S A; Clayton, P D

    1995-01-01

    Clinical computing application development at Columbia-Presbyterian Medical Center has been limited by the lack of a flexible programming environment that supports multiple client user platforms. The World Wide Web offers a potential solution, with its multifunction servers, multiplatform clients, and use of standard protocols for displaying information. The authors are now using the Web, coupled with their own local clinical data server and vocabulary server, to carry out rapid prototype development of clinical information systems. They have developed one such prototype system that can be run on most popular computing platforms from anywhere on the Internet. The Web paradigm allows easy integration of clinical information with other local and Internet-based information sources. The Web also simplifies many aspects of application design; for example, it includes facilities for the use of encryption to meet the authors' security and confidentiality requirements. The prototype currently runs on only the Web server in the Department of Medical Informatics at Columbia University, but it could be run on other Web servers that access the authors' clinical data and vocabulary servers. It could also be adapted to access clinical information from other systems with similar server capabilities. This approach may be adaptable for use in developing institution-independent standards for data and application sharing. PMID:7496876

  5. 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

  6. What do patients search for when seeking clinical trial information online?

    PubMed

    Patel, Chintan O; Garg, Vivek; Khan, Sharib A

    2010-11-13

    The Internet has become a common source for consumers to seek health information across a wide range of topics including searching for clinical trials. However, not much is known about what consumers search for in relation to clinical trials and how they formulate their search queries. In this study, we use log file data from TrialX.com, a consumer-centric website that provides clinical trial information to ascertain patterns in consumer queries. We analyzed semantic patterns in the queries by mapping query keywords to the UMLS Semantic Types and performed a manual evaluation of user paths. We found that the queries can be grouped into combinations of information needs related to condition, location and treatment. The results also suggested that the consumers using longer search queries with multiple Semantic Types are more likely to take action to participate in clinical trials. The study provides early insights that can be used to inform changes in website content and information display to improve clinical trials information seeking.

  7. Ubiquitous information for ubiquitous computing: expressing clinical data sets with openEHR archetypes.

    PubMed

    Garde, Sebastian; Hovenga, Evelyn; Buck, Jasmin; Knaup, Petra

    2006-01-01

    Ubiquitous computing requires ubiquitous access to information and knowledge. With the release of openEHR Version 1.0 there is a common model available to solve some of the problems related to accessing information and knowledge by improving semantic interoperability between clinical systems. Considerable work has been undertaken by various bodies to standardise Clinical Data Sets. Notwithstanding their value, several problems remain unsolved with Clinical Data Sets without the use of a common model underpinning them. This paper outlines these problems like incompatible basic data types and overlapping and incompatible definitions of clinical content. A solution to this based on openEHR archetypes is motivated and an approach to transform existing Clinical Data Sets into archetypes is presented. To avoid significant overlaps and unnecessary effort during archetype development, archetype development needs to be coordinated nationwide and beyond and also across the various health professions in a formalized process.

  8. Clinical reasoning in canine spinal disease: what combination of clinical information is useful?

    PubMed

    Cardy, T J A; De Decker, S; Kenny, P J; Volk, H A

    2015-08-15

    Spinal disease in dogs is commonly encountered in veterinary practice. Numerous diseases may cause similar clinical signs and presenting histories. The study objective was to use statistical models to identify combinations of discrete parameters from the patient signalment, history and neurological examination that could suggest the most likely diagnoses with statistical significance. A retrospective study of 500 dogs referred to the Queen Mother Hospital for Animals before June 2012 for the investigation of spinal disease was performed. Details regarding signalment, history, physical and neurological examinations, neuroanatomical localisation and imaging data were obtained. Univariate analyses of variables (breed, age, weight, onset, deterioration, pain, asymmetry, neuroanatomical localisation) were performed, and variables were retained in a multivariate logistic regression model if P<0.05. Leading diagnoses were intervertebral disc extrusion (IVDE, n=149), intervertebral disc protrusion (n=149), ischaemic myelopathy (IM, n=48) and neoplasms (n=44). Multivariate logistic regression characterised IM and acute non-compressive nucleus pulposus extrusions as the only peracute onset, non-progressive, non-painful and asymmetrical T3-L3 myelopathies. IVDE was most commonly characterised as acute onset, often deteriorating, painful and largely symmetrical T3-L3 myelopathy. This study suggests that most spinal diseases cause distinctive combinations of presenting clinical parameters (signalment, onset, deterioration, pain, asymmetry, neuroanatomical localisation). Taking particular account of these parameters may aid decision making in a clinical setting.

  9. A clinical laboratory information systems survey. A challenge for the decade.

    PubMed

    Elevitch, F; Treling, C; Spackman, K; Weilert, M; Aller, R; Skinner, M; Pasia, O

    1993-01-01

    In 1990, the College of American Pathologists Informatics Committee surveyed 14,785 laboratorians for their experiences with a clinical laboratory information system. A 16.25% response rate was achieved, representing 2402 questionnaires that were analyzed. Despite the perceived satisfaction of the clinical laboratory information system users with more expensive systems, no economy of scale was demonstrated with increasing system cost through either laboratory staff reduction or increased number of specimens per day. The strongest predictors of system satisfaction were (1) vendor success measured by number of installations and (2) a selection process that involved the pathologist/laboratory director and included a formal request for proposal. The need for integration of clinical laboratory information systems with hospital information systems, as well as the universal adoption of standard productivity terminology, including work load units, was evident.

  10. 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

  11. 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

  12. 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.

  13. On the additional information content of hyperspectral remote sensing data for estimating ecosystem carbon dioxde and energy exchange

    NASA Astrophysics Data System (ADS)

    Wohlfahrt, Georg; Hammerle, Albin; Tomelleri, Enrico

    2015-04-01

    Radiation reflected back from an ecosystem carries a spectral signature resulting from the interaction of radiation with the vegetation canopy and the underlying soil and thus allows drawing conclusions about the structure and functioning of an ecosystem. When this information is linked to a model of the leaf CO2 exchange, the ecosystem-scale CO2 exchange can be simulated. A well-known and very simplistic example for this approach is the light-use efficiency (LUE) model proposed by Monteith which links the flux of absorbed photosynthetically active radiation times a LUE parameter, both of which may be estimated based on remote sensing data, to predict the ecosystem gross photosynthesis. Here we explore the ability of a more elaborate approach by using near-surface remote sensing of hyperspectral reflected radiation, eddy covariance CO2 and energy flux measurements and a coupled radiative transfer and soil-vegetation-atmosphere-transfer (SVAT) model. Our main objective is to understand to what degree the joint assimilation of hyperspectral reflected radiation and eddy covariance flux measurements into the model helps to better constrain model parameters. To this end we use the SCOPE model, a combination of the well-known PROSAIL model and a SVAT model, and the Bayesian inversion algorithm DREAM. In order to explicitly link reflectance in the visible light and the leaf CO2 exchange, a novel parameterisation of the maximum carboxylation capacity parameter (Vcmax) on the leaf a+b chlorophyll content parameter of PROSAIL is introduced. Results are discussed with respect to the additional information content the hyperspectral data yield for simulating canopy photosynthesis.

  14. Adiponectin Provides Additional Information to Conventional Cardiovascular Risk Factors for Assessing the Risk of Atherosclerosis in Both Genders

    PubMed Central

    Yoon, Jin-Ha; Kim, Sung-Kyung; Choi, Ho-June; Choi, Soo-In; Cha, So-Youn; Koh, Sang-Baek

    2013-01-01

    Background This study evaluated the relation between adiponectin and atherosclerosis in both genders, and investigated whether adiponectin provides useful additional information for assessing the risk of atherosclerosis. Methods We measured serum adiponectin levels and other cardiovascular risk factors in 1033 subjects (454 men, 579 women) from the Korean Genomic Rural Cohort study. Carotid intima–media-thickness (CIMT) was used as measure of atherosclerosis. Odds ratios (ORs) with 95% confidence intervals (95% CI) were calculated using multiple logistic regression, and receiver operating characteristic curves (ROC), the category-free net reclassification improvement (NRI) and integrated discrimination improvement (IDI) were calculated. Results After adjustment for conventional cardiovascular risk factors, such as age, waist circumference, smoking history, low-density and high-density lipoprotein cholesterol, triglycerides, systolic blood pressure and insulin resistance, the ORs (95%CI) of the third tertile adiponectin group were 0.42 (0.25–0.72) in men and 0.47 (0.29–0.75) in women. The area under the curve (AUC) on the ROC analysis increased significantly by 0.025 in men and 0.022 in women when adiponectin was added to the logistic model of conventional cardiovascular risk factors (AUC in men: 0.655 to 0.680, p = 0.038; AUC in women: 0.654 to 0.676, p = 0.041). The NRI was 0.32 (95%CI: 0.13–0.50, p<0.001), and the IDI was 0.03 (95%CI: 0.01–0.04, p<0.001) for men. For women, the category-free NRI was 0.18 (95%CI: 0.02–0.34, p = 0.031) and the IDI was 0.003 (95%CI: −0.002–0.008, p = 0.189). Conclusion Adiponectin and atherosclerosis were significantly related in both genders, and these relationships were independent of conventional cardiovascular risk factors. Furthermore, adiponectin provided additional information to conventional cardiovascular risk factors regarding the risk of atherosclerosis. PMID:24116054

  15. 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

  16. 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.

  17. 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.

  18. The prevention of diabetic foot ulceration: how biomechanical research informs clinical practice

    PubMed Central

    DiLiberto, Frank E.; Baumhauer, Judith F.; Nawoczenski, Deborah A.

    2016-01-01

    ABSTRACT Background Implementation of interprofessional clinical guidelines for the prevention of neuropathic diabetic foot ulceration has demonstrated positive effects regarding ulceration and amputation rates. Current foot care recommendations are primarily based on research regarding the prevention of ulcer recurrence and focused on reducing the magnitude of plantar stress (pressure overload). Yet, foot ulceration remains to be a prevalent and debilitating consequence of Diabetes Mellitus. There is limited evidence targeting the prevention of first-time ulceration, and there is a need to consider additional factors of plantar stress to supplement current guidelines. Objectives The first purpose of this article is to discuss the biomechanical theory underpinning diabetic foot ulcerations and illustrate how plantar tissue underloading may precede overloading and breakdown. The second purpose of this commentary is to discuss how advances in biomechanical foot modeling can inform clinical practice in the prevention of first-time ulceration. Discussion Research demonstrates that progressive weight-bearing activity programs to address the frequency of plantar stress and avoid underloading do not increase ulceration risk. Multi-segment foot modeling studies indicate that dynamic foot function of the midfoot and forefoot is compromised in people with diabetes. Emerging research demonstrates that implementation of foot-specific exercises may positively influence dynamic foot function and improve plantar stress in people with diabetes. Conclusion Continued work is needed to determine how to best design and integrate activity recommendations and foot-specific exercise programs into the current interprofessional paradigm for the prevention of first-time ulceration in people with Diabetes Mellitus. PMID:27849290

  19. Clinical utility of the informant AD8 as a dementia case finding instrument in primary healthcare.

    PubMed

    Chan, Qun Lin; Xu, Xin; Shaik, Muhammad Amin; Chong, Steven Shih Tsze; Hui, Richard Jor Yeong; Chen, Christopher Li-Hsian; Dong, YanHong

    2016-01-01

    The informant AD8 has excellent discriminant ability for dementia case finding in tertiary healthcare settings. However, its clinical utility for dementia case finding at the forefront of dementia management, primary healthcare, is unknown. Therefore, we recruited participants from two primary healthcare centers in Singapore and measured their performance on the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), and a local formal neuropsychological battery, in addition to the AD8. Logistic regression was conducted to examine the associations between demographic factors and dementia. Area under the receiver operating characteristics (ROC) curve analysis was used to establish the optimal cut-off points for dementia case finding. Of the 309 participants recruited, 243 (78.7%) had CDR = 0, 22 (7.1%) CDR = 0.5, and 44 (14.2%) CDR ≥1. Age was strongly associated with dementia, and the optimal age for dementia case finding in primary healthcare settings was ≥75 years. In this age group, the AD8 has excellent dementia case finding capability and was superior to the MMSE and equivalent to the MoCA [AD8 AUC (95% CI): 0.95 (0.91-0.99), cut-off: ≥3, sensitivity: 0.90, specificity: 0.88, PPV: 0.79 and NPV: 0.94; MMSE AUC (95% CI): 0.87 (0.79-0.94), p = 0.04; MoCA AUC (95% CI): 0.88 (0.82-0.95), p = 0.06]. In conclusion, the AD8 is well suited for dementia case finding in primary healthcare settings.

  20. 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.

  1. Identifying logical clinical context clusters in nursing orders for the purpose of information retrieval.

    PubMed

    Collins, Sarah; Bakken, Suzanne; Cimino, James J; Currie, Leanne M

    2008-11-06

    Nurses information needs relate to nursing orders and nursing orders have many contexts including body systems, safety practices and other clinical categories. When searching for information related to orders one search term might retrieve documents related to multiple orders. We clustered nursing orders into sets that are related by the same logical clinical context. We then generated clusters and their search terms from a data set of 636 orders obtained from a CIS/CPOE system at an academic medical center. We refined those cluster search terms by searching an electronic nursing procedure manual to retrieve resources that could answer one of six generic nursing questions. Sixty-three cluster search terms were identified. The search terms for 100 (16%) of the orders were validated in a second hospitals electronic nursing procedure manual; precision was 32.5%.. Our process of identifying cluster search terms may be a useful method to obtain clinically relevant information resources.

  2. 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.

  3. SANDS: An Architecture for Clinical Decision Support in a National Health Information Network

    PubMed Central

    Wright, Adam; Sittig, Dean F.

    2007-01-01

    A new architecture for clinical decision support called SANDS (Service-oriented Architecture for NHIN Decision Support) is introduced and its performance evaluated. The architecture provides a method for performing clinical decision support across a network, as in a health information exchange. Using the prototype we demonstrated that, first, a number of useful types of decision support can be carried out using our architecture; and, second, that the architecture exhibits desirable reliability and performance characteristics. PMID:18693950

  4. A clinical research information system: an example of prospective observational study in oncology.

    PubMed

    Leskosek, Branimir L

    2008-11-06

    The paper presents a web-based clinical research information system (RIS) used by physicians and pharmacists at Institute of Oncology, Ljubljana and its geographically remote partners to collect research clinical data for observational study. The RIS development was focused mainly on: formal electronic data collection with on-line data validation, computer data preparation for uniform analyses, user friendliness, security issues, low establishment and maintenance costs.

  5. The promise of simultaneous transformation of practice and research with the use of clinical information systems.

    PubMed

    Lang, Norma M

    2008-01-01

    The author builds a case that the design and use of intelligent information systems in real-time practice holds the promise of simultaneously transforming practice and research. Requirements include the identification of actionable knowledge that can be embedded in clinical decision support and electronic documentation systems, the creation of clinical data repositories, and a data warehouse from which analyses can be conducted across multiple settings. An innovative project, the Knowledge-Based Nursing Initiative, is briefly described as illustrative of these requirements.

  6. [The added value of information summaries supporting clinical decisions at the point-of-care.

    PubMed

    Banzi, Rita; González-Lorenzo, Marien; Kwag, Koren Hyogene; Bonovas, Stefanos; Moja, Lorenzo

    2016-11-01

    Evidence-based healthcare requires the integration of the best research evidence with clinical expertise and patients' values. International publishers are developing evidence-based information services and resources designed to overcome the difficulties in retrieving, assessing and updating medical information as well as to facilitate a rapid access to valid clinical knowledge. Point-of-care information summaries are defined as web-based medical compendia that are specifically designed to deliver pre-digested, rapidly accessible, comprehensive, and periodically updated information to health care providers. Their validity must be assessed against marketing claims that they are evidence-based. We periodically evaluate the content development processes of several international point-of-care information summaries. The number of these products has increased along with their quality. The last analysis done in 2014 identified 26 products and found that three of them (Best Practice, Dynamed e Uptodate) scored the highest across all evaluated dimensions (volume, quality of the editorial process and evidence-based methodology). Point-of-care information summaries as stand-alone products or integrated with other systems, are gaining ground to support clinical decisions. The choice of one product over another depends both on the properties of the service and the preference of users. However, even the most innovative information system must rely on transparent and valid contents. Individuals and institutions should regularly assess the value of point-of-care summaries as their quality changes rapidly over time.

  7. 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.

  8. 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.

  9. 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.

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

    PubMed

    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.

  11. 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.

  12. Health information technology: integration of clinical workflow into meaningful use of electronic health records.

    PubMed

    Bowens, Felicia M; Frye, Patricia A; Jones, Warren A

    2010-10-01

    This article examines the role that clinical workflow plays in successful implementation and meaningful use of electronic health record (EHR) technology in ambulatory care. The benefits and barriers of implementing EHRs in ambulatory care settings are discussed. The researchers conclude that widespread adoption and meaningful use of EHR technology rely on the successful integration of health information technology (HIT) into clinical workflow. Without successful integration of HIT into clinical workflow, clinicians in today's ambulatory care settings will continue to resist adoption and implementation of EHR technology.

  13. 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.

  14. 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.

  15. Nurses’ Numeracy and Graphical Literacy: Informing Studies of Clinical Decision Support Interfaces

    PubMed Central

    Lopez, Karen Dunn; Wilkie, Diana J.; Yao, Yingwei; Sousa, Vanessa; Febretti, Alessandro; Stifter, Janet; Johnson, Andrew; Keenan, Gail M.

    2015-01-01

    We present findings of a comparative study of numeracy and graph literacy in a representative group of 60 practicing nurses. The paper focuses on a fundamental concern related to the effectiveness of numeric information displayed in various features in the electronic health record during clinical workflow. Our findings suggest the need to consider numeracy and graph literacy when presenting numerical information as well as the potential for tailoring numeric display types to individual’s cognitive strengths. PMID:26323050

  16. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.

    PubMed

    2017-01-01

    Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients

  17. Semantic interoperability between clinical and public health information systems for improving public health services.

    PubMed

    Lopez, Diego M; Blobel, Bernd G M E

    2007-01-01

    Improving public health services requires comprehensively integrating all services including medical, social, community, and public health ones. Therefore, developing integrated health information services has to start considering business process, rules and information semantics of involved domains. The paper proposes a business and information architecture for the specification of a future-proof national integrated system, concretely the requirements for semantic integration between public health surveillance and clinical information systems. The architecture is a semantically interoperable approach because it describes business process, rules and information semantics based on national policy documents and expressed in a standard language such us the Unified Modeling Language UML. Having the enterprise and information models formalized, semantically interoperable Health IT components/services development is supported.

  18. 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

  19. Barriers and Facilitators for the Implementation of an Online Clinical Health Community in Addition to Usual Fertility Care: A Cross-Sectional Study

    PubMed Central

    Faber, Marjan J; den Boogert, Anne G; Cohlen, Ben J; van der Linden, Paul JQ; Kremer, Jan AM; Nelen, Willianne LDM

    2013-01-01

    Background Online health communities are becoming more popular in health care. Patients and professionals can communicate with one another online, patients can find peer support, and professionals can use it as an additional information channel to their patients. However, the implementation of online health communities into daily practice is challenging. These challenges relate to the fact that patients need to be activated to (1) become a member (ie, subscription) and (2) participate actively within the community before any effect can be expected. Therefore, we aimed at answering 2 research questions: (1) what factors are associated with subscription to an online health community, and (2) which are associated with becoming an active participant within an online health community. Objective To identify barriers and facilitators as perceived by patients for the implementation of an online health community. Methods We performed a cross-sectional study. Three Dutch fertility clinics (2 IVF-licensed) offered their patients a secure online clinical health community through which clinicians can provide online information and patients can ask questions to the medical team or share experiences and find support from peers. We randomly selected and invited 278 men and women suffering from infertility and attending 1 of the participating clinics. Participants filled out a questionnaire about their background characteristics and current use of the online community. Possible barriers and facilitators were divided into 2 parts: (1) those for subscription to the community, and (2) those for active participation in the community. We performed 2 multivariate logistic regression analyses to calculate determinants for both subscription and active participation. Results Subscription appeared to be associated with patients’ background characteristics (eg, gender, treatment phase), intervention-related facilitators (odds ratio [OR] 2.45, 95% CI 1.14-5.27), and patient-related barriers

  20. 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

    ... collection projects, the National Institute Heart, Lung, and Blood Institute (NHBLI), the National Institutes... Heart, Lung, and Blood Institute, NIH, 6701 Rockledge Drive, Room 8102, MSC 7940, Bethesda, MD, or call... Informed Consent for Pediatric Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute...

  1. The need for clinical decision support integrated with the electronic health record for the clinical application of whole genome sequencing information.

    PubMed

    Welch, Brandon M; Kawamoto, Kensaku

    2013-12-18

    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.

  2. Clinical Computer Systems Survey (CLICS): learning about health information technology (HIT) in its context of use.

    PubMed

    Lichtner, Valentina; Cornford, Tony; Klecun, Ela

    2013-01-01

    Successful health information technology (HIT) implementations need to be informed on the context of use and on users' attitudes. To this end, we developed the CLinical Computer Systems Survey (CLICS) instrument. CLICS reflects a socio-technical view of HIT adoption, and is designed to encompass all members of the clinical team. We used the survey in a large English hospital as part of its internal evaluation of the implementation of an electronic patient record system (EPR). The survey revealed extent and type of use of the EPR; how it related to and integrated with other existing systems; and people's views on its use, usability and emergent safety issues. Significantly, participants really appreciated 'being asked'. They also reminded us of the wider range of administrative roles engaged with EPR. This observation reveals pertinent questions as to our understanding of the boundaries between administrative tasks and clinical medicine - what we propose as the field of 'administrative medicine'.

  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. Community-Based Health Education Programs Designed to Improve Clinical Measures Are Unlikely to Reduce Short-Term Costs or Utilization Without Additional Features Targeting These Outcomes.

    PubMed

    Burton, Joe; Eggleston, Barry; Brenner, Jeffrey; Truchil, Aaron; Zulkiewicz, Brittany A; Lewis, Megan A

    2016-06-07

    Stakeholders often expect programs for persons with chronic conditions to "bend the cost curve." This study assessed whether a diabetes self-management education (DSME) program offered as part of a multicomponent initiative could affect emergency department (ED) visits, hospital stays, and the associated costs for an underserved population in addition to the clinical indicators that DSME programs attempt to improve. The program was implemented in Camden, New Jersey, by the Camden Coalition of Healthcare Providers to address disparities in diabetes care. Data used are from medical records and from patient-level information about hospital services from Camden's hospitals. Using multivariate regression models to control for individual characteristics, changes in utilization over time and changes relative to 2 comparison groups were assessed. No reductions in ED visits, inpatient stays, or costs for participants were found over time or relative to the comparison groups. High utilization rates and costs for diabetes are associated with longer term disease progression and its sequelae; thus, DSME or peer support may not affect these in the near term. Some clinical indicators improved among participants, and these might lead to fewer costly adverse health events in the future. DSME deployed at the community level, without explicit segmentation and targeting of high health care utilizers or without components designed to affect costs and utilization, should not be expected to reduce short-term medical needs for participating individuals or care-seeking behaviors such that utilization is reduced. Stakeholders must include financial outcomes in a program's design if those outcomes are to improve. (Population Health Management 20XX;XX:XXX-XXX).

  5. The Electronic Healthcare Record for Clinical Research (EHR4CR) information model and terminology.

    PubMed

    Ouagne, David; Hussain, Sajjad; Sadou, Eric; Jaulent, Marie-Christine; Daniel, Christel

    2012-01-01

    A major barrier to repurposing routinely collected data for clinical research is the heterogeneity of healthcare information systems. Electronic Healthcare Record for Clinical Research (EHR4CR) is a European platform designed to improve the efficiency of conducting clinical trials. In this paper, we propose an initial architecture of the EHR4CR Semantic Interoperability Framework. We used a model-driven engineering approach to build a reference HL7-based multidimensional model bound to a set of reference clinical terminologies acting as a global as view model. We then conducted an evaluation of its expressiveness for patient eligibility. The EHR4CR information model consists in one fact table dedicated to clinical statement and 4 dimensions. The EHR4CR terminology integrates reference terminologies used in patient care (e.g LOINC, ICD-10, SNOMED CT, etc). We used the Object Constraint Language (OCL) to represent patterns of eligibility criteria as constraints on the EHR4CR model to be further transformed in SQL statements executed on different clinical data warehouses.

  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, 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)...

  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, 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)...

  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, 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)...

  10. 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, 2012 CFR

    2012-07-01

    ... 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)...

  11. 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

  12. 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

  13. PD-atricians: Leveraging Physicians and Participatory Design to Develop Novel Clinical Information Tools

    PubMed Central

    Pollack, Ari H; Miller, Andrew; Mishra, Sonali R.; Pratt, Wanda

    2016-01-01

    Participatory design, a method by which system users and stakeholders meaningfully contribute to the development of a new process or technology, has great potential to revolutionize healthcare technology, yet has seen limited adoption. We conducted a design session with eleven physicians working to create a novel clinical information tool utilizing participatory design methods. During the two-hour session, the physicians quickly engaged in the process and generated a large quantity of information, informing the design of a future tool. By utilizing facilitators experienced in design methodology, with detailed domain expertise, and well integrated into the healthcare organization, the participatory design session engaged a group of users who are often disenfranchised with existing processes as well as health information technology in general. We provide insight into why participatory design works with clinicians and provide guiding principles for how to implement these methods in healthcare organizations interested in advancing health information technology. PMID:28269900

  14. Steps towards single source--collecting data about quality of life within clinical information systems.

    PubMed

    Fritz, Fleur; Ständer, Sonja; Breil, Bernhard; Dugas, Martin

    2010-01-01

    Information about the quality of life from patients being treated in routine medical care is important for the attending physician. This data is also needed in research for example to evaluate the therapy and the course of the disease respectively. Especially skin diseases often negatively affect the quality of life. Therefore we aimed to design a concept to collect such data during treatment and use it for both medical care and research in the setting of dermatology. We performed a workflow analysis and implemented a designated form using the tools of the local clinical information system. Quality of life data is now collected within the clinical information system during treatment and is used for discharge letters, progress overviews as well as research about the treatment and course of disease. This concept which contributes to the single source approach was feasible within dermatology and is ready to be expanded into other domains.

  15. USING FORMATIVE RESEARCH TO DEVELOP A CONTEXT-SPECIFIC APPROACH TO INFORMED CONSENT FOR CLINICAL TRIALS

    PubMed Central

    Corneli, Amy L.; Bentley, Margaret E.; Sorenson, James R.; Henderson, Gail E.; van der Horst, Charles; Moses, Agnes; Nkhoma, Jacqueline; Tenthani, Lyson; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J.

    2009-01-01

    Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research. PMID:19385837

  16. 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.

  17. A Prediction Algorithm for Drug Response in Patients with Mesial Temporal Lobe Epilepsy Based on Clinical and Genetic Information

    PubMed Central

    Carvalho, Benilton S.; Bilevicius, Elizabeth; Alvim, Marina K. M.; Lopes-Cendes, Iscia

    2017-01-01

    Mesial temporal lobe epilepsy is the most common form of adult epilepsy in surgical series. Currently, the only characteristic used to predict poor response to clinical treatment in this syndrome is the presence of hippocampal sclerosis. Single nucleotide polymorphisms (SNPs) located in genes encoding drug transporter and metabolism proteins could influence response to therapy. Therefore, we aimed to evaluate whether combining information from clinical variables as well as SNPs in candidate genes could improve the accuracy of predicting response to drug therapy in patients with mesial temporal lobe epilepsy. For this, we divided 237 patients into two groups: 75 responsive and 162 refractory to antiepileptic drug therapy. We genotyped 119 SNPs in ABCB1, ABCC2, CYP1A1, CYP1A2, CYP1B1, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4, and CYP3A5 genes. We used 98 additional SNPs to evaluate population stratification. We assessed a first scenario using only clinical variables and a second one including SNP information. The random forests algorithm combined with leave-one-out cross-validation was used to identify the best predictive model in each scenario and compared their accuracies using the area under the curve statistic. Additionally, we built a variable importance plot to present the set of most relevant predictors on the best model. The selected best model included the presence of hippocampal sclerosis and 56 SNPs. Furthermore, including SNPs in the model improved accuracy from 0.4568 to 0.8177. Our findings suggest that adding genetic information provided by SNPs, located on drug transport and metabolism genes, can improve the accuracy for predicting which patients with mesial temporal lobe epilepsy are likely to be refractory to drug treatment, making it possible to identify patients who may benefit from epilepsy surgery sooner. PMID:28052106

  18. Taming Big Data: An Information Extraction Strategy for Large Clinical Text Corpora.

    PubMed

    Gundlapalli, Adi V; Divita, Guy; Carter, Marjorie E; Redd, Andrew; Samore, Matthew H; Gupta, Kalpana; Trautner, Barbara

    2015-01-01

    Concepts of interest for clinical and research purposes are not uniformly distributed in clinical text available in electronic medical records. The purpose of our study was to identify filtering techniques to select 'high yield' documents for increased efficacy and throughput. Using two large corpora of clinical text, we demonstrate the identification of 'high yield' document sets in two unrelated domains: homelessness and indwelling urinary catheters. For homelessness, the high yield set includes homeless program and social work notes. For urinary catheters, concepts were more prevalent in notes from hospitalized patients; nursing notes accounted for a majority of the high yield set. This filtering will enable customization and refining of information extraction pipelines to facilitate extraction of relevant concepts for clinical decision support and other uses.

  19. [Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

    PubMed

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-12-01

    Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

  20. Fact Sheets and Additional information Regarding the 2012 Particulate Matter (PM) National Ambient Air Quality Standards (NAAQS)

    EPA Pesticide Factsheets

    Find tools for particulate matter, maps of nonattainment areas, an overview of the proposal, and information on designations, monitoring and permitting requirements and a presentation on the 2012 PM NAAQS revision.

  1. Information given to cancer patients on diagnosis, prognosis and treatment: the clinical oncologist's perspective.

    PubMed

    Belvedere, Ornella; Minisini, Alessandro; Ramello, Monica; Sobrero, Alberto; Grossi, Francesco

    2004-08-01

    The extent of information to cancer patients is, in general, culture-dependent. Information mainly refers to three aspects, namely diagnosis (Dx), prognosis (Px) and treatment (Rx), but the relative contribution of each domain to the information given overall is not available. To address this issue, we e-mailed a questionnaire to 9893 members of the American Society of Clinical Oncology (ASCO) asking whether they agree that information about Dx, Px and Rx contribute differently to the information given to the cancer patient overall and, if so, to what extent, both in the adjuvant and advanced settings. 857 questionnaires were evaluable. There was no statistically significant difference between the contribution of these 3 domains in the adjuvant setting (33%, 34% and 33%, respectively). In subgroup analysis, medical oncologists and haematologists attributed a significantly higher contribution of Px information compared with other specialists (P < 0.05). In the advanced setting, respondents estimated a higher contribution of Px (41%) to patient information overall compared with Dx and Rx (28% and 31%, respectively; P < 0.05). This finding was more pronounced in North America than in Europe (P < 0.0001), and in Germanic-language than in Romance-language countries (P = 0.005). In conclusion, information on Dx, Px and Rx are believed to contribute differently to the information delivered to cancer patients overall, depending on the stage of disease, the cultural environment and the specialty of the physician.

  2. 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

  3. 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

  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. 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

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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

  11. Finding the evidence: resources and skills for locating information on clinical effectiveness.

    PubMed

    Bidwell, S R

    2004-12-01

    Limited time and lack of knowledge about where and how to search for information often present barriers to practitioners who want to locate current best evidence for treating their patients. There is as yet no single place they can go to get an answer to all their questions. High quality clinical studies are difficult to filter out from the mass of information on large databases, and secondary resources of evaluated information are dispersed over hundreds of Internet sites worldwide. This overview presents a practical guide for the busy practitioner who searches only occasionally and needs to maximise the time spent. Major collections of secondary resources are identified and their individual features described briefly. Following this, several services using PubMed are outlined that automatically apply filters for studies with high quality research design. Further sources of information and assistance are listed for those who wish to learn more.

  12. Processing time of addition or withdrawal of single or combined balance-stabilizing haptic and visual information

    PubMed Central

    Honeine, Jean-Louis; Crisafulli, Oscar; Sozzi, Stefania

    2015-01-01

    We investigated the integration time of haptic and visual input and their interaction during stance stabilization. Eleven subjects performed four tandem-stance conditions (60 trials each). Vision, touch, and both vision and touch were added and withdrawn. Furthermore, vision was replaced with touch and vice versa. Body sway, tibialis anterior, and peroneus longus activity were measured. Following addition or withdrawal of vision or touch, an integration time period elapsed before the earliest changes in sway were observed. Thereafter, sway varied exponentially to a new steady-state while reweighting occurred. Latencies of sway changes on sensory addition ranged from 0.6 to 1.5 s across subjects, consistently longer for touch than vision, and were regularly preceded by changes in muscle activity. Addition of vision and touch simultaneously shortened the latencies with respect to vision or touch separately, suggesting cooperation between sensory modalities. Latencies following withdrawal of vision or touch or both simultaneously were shorter than following addition. When vision was replaced with touch or vice versa, adding one modality did not interfere with the effect of withdrawal of the other, suggesting that integration of withdrawal and addition were performed in parallel. The time course of the reweighting process to reach the new steady-state was also shorter on withdrawal than addition. The effects of different sensory inputs on posture stabilization illustrate the operation of a time-consuming, possibly supraspinal process that integrates and fuses modalities for accurate balance control. This study also shows the facilitatory interaction of visual and haptic inputs in integration and reweighting of stance-stabilizing inputs. PMID:26334013

  13. 33 CFR 148.108 - What if a Federal or State agency or other interested party requests additional information?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... must state briefly why the information is needed. (c) The Commandant (CG-5) must receive the request... decision on whether or not to approve the license application. (d) The Commandant (CG-5) will consider... the application process. (e) The Commandant (CG-5) may discuss the recommendation with...

  14. 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

    ... must state briefly why the information is needed. (c) The Commandant (CG-5) must receive the request... decision on whether or not to approve the license application. (d) The Commandant (CG-5) will consider... the application process. (e) The Commandant (CG-5) may discuss the recommendation with...

  15. 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

  16. Extraction of left ventricular ejection fraction information from various types of clinical reports.

    PubMed

    Kim, Youngjun; Garvin, Jennifer H; Goldstein, Mary K; Hwang, Tammy S; Redd, Andrew; Bolton, Dan; Heidenreich, Paul A; Meystre, Stéphane M

    2017-03-01

    Efforts to improve the treatment of congestive heart failure, a common and serious medical condition, include the use of quality measures to assess guideline-concordant care. The goal of this study is to identify left ventricular ejection fraction (LVEF) information from various types of clinical notes, and to then use this information for heart failure quality measurement. We analyzed the annotation differences between a new corpus of clinical notes from the Echocardiography, Radiology, and Text Integrated Utility package and other corpora annotated for natural language processing (NLP) research in the Department of Veterans Affairs. These reports contain varying degrees of structure. To examine whether existing LVEF extraction modules we developed in prior research improve the accuracy of LVEF information extraction from the new corpus, we created two sequence-tagging NLP modules trained with a new data set, with or without predictions from the existing LVEF extraction modules. We also conducted a set of experiments to examine the impact of training data size on information extraction accuracy. We found that less training data is needed when reports are highly structured, and that combining predictions from existing LVEF extraction modules improves information extraction when reports have less structured formats and a rich set of vocabulary.

  17. Residential accessibility to information technology retailers and self reported computer use among patients attending community clinics

    PubMed Central

    Robinson, Paul; Shaheen, Madga; Smith, James; Ryan, Daniel; Baker, Richard

    2009-01-01

    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. PMID:20351914

  18. 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

  19. Patterns of usage for a Web-based clinical information system.

    PubMed

    Chen, Elizabeth S; Cimino, James J

    2004-01-01

    Understanding how clinicians are using clinical information systems to assist with their everyday tasks is valuable to the system design and development process. Developers of such systems are interested in monitoring usage in order to make enhancements. System log files are rich resources for gaining knowledge about how the system is being used. We have analyzed the log files of our Web-based clinical information system (WebCIS) to obtain various usage statistics including which WebCIS features are frequently being used. We have also identified usage patterns, which convey how the user is traversing the system. We present our method and these results as well as describe how the results can be used to customize menus, shortcut lists, and patient reports in WebCIS and similar systems.

  20. 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

  1. Developing a Manually Annotated Clinical Document Corpus to Identify Phenotypic Information for Inflammatory Bowel Disease

    PubMed Central

    South, Brett R; Shen, Shuying; Jones, Makoto; Garvin, Jennifer; Samore, Matthew H; Chapman, Wendy W; Gundlapalli, Adi V

    2009-01-01

    Background Natural Language Processing (NLP) systems can be used for specific Information Extraction (IE) tasks such as extracting phenotypic data from the electronic medical record (EMR). These data are useful for translational research and are often found only in free text clinical notes. A key required step for IE is the manual annotation of clinical corpora and the creation of a reference standard for (1) training and validation tasks and (2) to focus and clarify NLP system requirements. These tasks are time consuming, expensive, and require considerable effort on the part of human reviewers. Methods Using a set of clinical documents from the VA EMR for a particular use case of interest we identify specific challenges and present several opportunities for annotation tasks. We demonstrate specific methods using an open source annotation tool, a customized annotation schema, and a corpus of clinical documents for patients known to have a diagnosis of Inflammatory Bowel Disease (IBD). We report clinician annotator agreement at the document, concept, and concept attribute level. We estimate concept yield in terms of annotated concepts within specific note sections and document types. Results Annotator agreement at the document level for documents that contained concepts of interest for IBD using estimated Kappa statistic (95% CI) was very high at 0.87 (0.82, 0.93). At the concept level, F-measure ranged from 0.61 to 0.83. However, agreement varied greatly at the specific concept attribute level. For this particular use case (IBD), clinical documents producing the highest concept yield per document included GI clinic notes and primary care notes. Within the various types of notes, the highest concept yield was in sections representing patient assessment and history of presenting illness. Ancillary service documents and family history and plan note sections produced the lowest concept yield. Conclusions Challenges include defining and building appropriate annotation

  2. Developing a manually annotated clinical document corpus to identify phenotypic information for inflammatory bowel disease

    PubMed Central

    South, Brett R; Shen, Shuying; Jones, Makoto; Garvin, Jennifer; Samore, Matthew H; Chapman, Wendy W; Gundlapalli, Adi V

    2009-01-01

    Background Natural Language Processing (NLP) systems can be used for specific Information Extraction (IE) tasks such as extracting phenotypic data from the electronic medical record (EMR). These data are useful for translational research and are often found only in free text clinical notes. A key required step for IE is the manual annotation of clinical corpora and the creation of a reference standard for (1) training and validation tasks and (2) to focus and clarify NLP system requirements. These tasks are time consuming, expensive, and require considerable effort on the part of human reviewers. Methods Using a set of clinical documents from the VA EMR for a particular use case of interest we identify specific challenges and present several opportunities for annotation tasks. We demonstrate specific methods using an open source annotation tool, a customized annotation schema, and a corpus of clinical documents for patients known to have a diagnosis of Inflammatory Bowel Disease (IBD). We report clinician annotator agreement at the document, concept, and concept attribute level. We estimate concept yield in terms of annotated concepts within specific note sections and document types. Results Annotator agreement at the document level for documents that contained concepts of interest for IBD using estimated Kappa statistic (95% CI) was very high at 0.87 (0.82, 0.93). At the concept level, F-measure ranged from 0.61 to 0.83. However, agreement varied greatly at the specific concept attribute level. For this particular use case (IBD), clinical documents producing the highest concept yield per document included GI clinic notes and primary care notes. Within the various types of notes, the highest concept yield was in sections representing patient assessment and history of presenting illness. Ancillary service documents and family history and plan note sections produced the lowest concept yield. Conclusion Challenges include defining and building appropriate annotation

  3. Do Online Information Retrieval Systems Help Experienced Clinicians Answer Clinical Questions?

    PubMed Central

    Westbrook, Johanna I.; Coiera, Enrico W.; Gosling, A. Sophie

    2005-01-01

    Objective: To assess the impact of clinicians' use of an online information retrieval system on their performance in answering clinical questions. Design: Pre-/post-intervention experimental design. Measurements: In a computer laboratory, 75 clinicians (26 hospital-based doctors, 18 family practitioners, and 31 clinical nurse consultants) provided 600 answers to eight clinical scenarios before and after the use of an online information retrieval system. We examined the proportion of correct answers pre- and post-intervention, direction of change in answers, and differences between professional groups. Results: System use resulted in a 21% improvement in clinicians' answers, from 29% (95% confidence interval [CI] 25.4–32.6) correct pre- to 50% (95% CI 46.0–54.0) post-system use. In 33% (95% CI 29.1–36.9) answers were changed from incorrect to correct. In 21% (95% CI 17.1–23.9) correct pre-test answers were supported by evidence found using the system, and in 7% (95% CI 4.9–9.1) correct pre-test answers were changed incorrectly. For 40% (35.4–43.6) of scenarios, incorrect pre-test answers were not rectified following system use. Despite significant differences in professional groups' pre-test scores [family practitioners: 41% (95% CI 33.0–49.0), hospital doctors: 35% (95% CI 28.5–41.2), and clinical nurse consultants: 17% (95% CI 12.3–21.7; χ2 = 29.0, df = 2, p < 0.01)], there was no difference in post-test scores. (χ2 = 2.6, df = 2, p = 0.73). Conclusions: The use of an online information retrieval system was associated with a significant improvement in the quality of answers provided by clinicians to typical clinical problems. In a small proportion of cases, use of the system produced errors. While there was variation in the performance of clinical groups when answering questions unaided, performance did not differ significantly following system use. Online information retrieval systems can be an effective tool in improving the accuracy of

  4. 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…

  5. 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

  6. Information Warehouse – A Comprehensive Informatics Platform for Business, Clinical, and Research Applications

    PubMed Central

    Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S.

    2010-01-01

    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. PMID:21347019

  7. 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.

  8. Creating ISO/EN 13606 archetypes based on clinical information needs.

    PubMed

    Rinner, Christoph; Kohler, Michael; Hübner-Bloder, Gudrun; Saboor, Samrend; Ammenwerth, Elske; Duftschmid, Georg

    2011-01-01

    Archetypes model individual EHR contents and build the basis of the dual-model approach used in the ISO/EN 13606 EHR architecture. We present an approach to create archetypes using an iterative development process. It includes automated generation of electronic case report forms from archetypes. We evaluated our approach by developing 128 archetypes which represent 446 clinical information items from the diabetes domain.

  9. [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.

  10. 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

  11. 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.

  12. GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

    PubMed Central

    Nair, Satish Chandrasekhar; Ibrahim, Halah

    2015-01-01

    Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF) compliance with Good Clinical Practice (GCP) guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had significantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants' rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was significantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, significantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE. PMID:25878956

  13. Parent-Adolescent Cross-Informant Agreement in Clinically Referred Samples: Findings From Seven Societies.

    PubMed

    Rescorla, Leslie A; Ewing, Grace; Ivanova, Masha Y; Aebi, Marcel; Bilenberg, Niels; Dieleman, Gwen C; Döpfner, Manfred; Kajokiene, Ilona; Leung, Patrick W L; Plück, Julia; Steinhausen, Hans-Christoph; Winkler Metzke, Christa; Zukauskiene, Rita; Verhulst, Frank C

    2017-01-01

    To conduct international comparisons of parent-adolescent cross-informant agreement in clinical samples, we analyzed ratings on the Child Behavior Checklist (CBCL) and Youth Self-Report (YSR) for 6,762 clinically referred adolescents ages 11-18 from 7 societies (M = 14.5 years, SD = 2.0 years; 51% boys). Using CBCL and YSR data, we asked the following questions: (a) Do parents report more problems for their adolescent children than the adolescents report about themselves? (b) How do cross-informant correlations (rs) for scale scores differ by problem type and by society? (c) How well do parents and adolescents, on average, agree regarding which problems they rate as low, medium, or high? (d) How does within-dyad item agreement vary within and between societies? (e) How do societies vary in dichotomous cross-informant agreement with respect to the deviance status of the adolescents? CBCL and YSR scores were quite similar, with small and inconsistent informant effects across societies. Cross-informant rs averaged .47 across scales and societies. On average, parents and adolescents agreed well regarding which problem items received low, medium, or high ratings (M r = .87). Mean within-dyad item agreement was moderate across all societies, but dyadic agreement varied widely within every society. In most societies, adolescent noncorroboration of parent-reported deviance was more common than parental noncorroboration of adolescent-reported deviance. Overall, somewhat better parent-adolescent agreement and more consistency in agreement patterns across diverse societies were found in these seven clinical samples than in population samples studied using the same methods.

  14. [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.

  15. Utilizing Focus Groups with Potential Participants and Their Parents: An Approach to Inform Study Design in a Large Clinical Trial

    PubMed Central

    Kadimpati, Sandeep; McCormick, Jennifer B; Chiu, Yichen; Parker, Ashley B.; Iftikhar, Aliya Z.; Flick, Randall P.; Warner, David O.

    2014-01-01

    Background In the recent literature, there has been some evidence that exposure of children to anesthetic procedures during the first two years of life may impair cognitive function and learning in later life. We planned a clinical study to quantify this risk, a study involving testing 1,000 children for neurodevelopmental deficits. As a part of this planning, we conducted focus groups involving potential participants and their parents to elicit information regarding three issues: communications with the community and potential participants, recruitment and consent processes, and the return of neurodevelopmental testing results. Methods Three focus groups were conducted with the parents of potential participants and one focus group was conducted with an 18-19 year old group; each group consisted of 6-10 participants. The moderated discussions had questions about recruitment, consenting issues, and expectations from the study about return of both overall trial findings and individual research test results. Results The focus group data gave us an insight on potential participants’ views on recruitment, consenting, communications about the study, and expectations about return of both overall trial findings and individual research test results. The concerns expressed were largely addressable. In addition, the concern we had about some parents enrolling their children in the study solely for the sake of getting their child's cognitive function results was dispelled. Conclusions We found that the individuals participating in our focus groups were generally enthusiastic about the large clinical study and could see the value in answering the study question. The data from the focus groups were used to inform changes to the recruitment and consent process. Focus group input was also instrumental in affirming the study design regarding return of results. Our experience suggests that the approach we used may serve as a model for other investigators to help inform the various

  16. Addition of prednisolone and heparin in patients with failed IVF/ICSI cycles: a preliminary report of a clinical trial.

    PubMed

    Siristatidis, Charalampos; Chrelias, Charalampos; Creatsa, Maria; Varounis, Christos; Vrachnis, Nikos; Iliodromiti, Zoe; Kassanos, Demetrios

    2013-09-01

    Through a non-randomized clinical trial, we examined the theoretical benefit of the coadministration of low molecular weight heparin (LMWH) and prednisolone on pregnancy outcomes in women with previously failed IVF/ICSI cycles. Fifteen women constituted the study group, and were compared with 19 women receiving LMWH alone and another 18 women with no drugs. Our finding that the combination of the two drugs produced positive differences in terms of embryo quality, pregnancy and live birth rates points to the necessity for adequately powered randomized trials.

  17. Access patterns of a clinic-based health information web site for international travelers.

    PubMed

    Licciardone, John C

    2002-01-01

    A large national telephone survey conducted in 2000 by the Pew Internet & American Life Project estimated that 52 million American adults used the Internet to acquire health information. Based on population estimates, these users comprised 25% of all adults. The growth of online health information coupled with increasing Internet access has led to the emergence of consumer informatics as an outbranching from traditional medical informatics. The ease of international communications afforded by the Internet holds great promise for consumers in the realm of travel medicine. For example, an early study found that a Web site hosted by an international travel medicine clinic was accessed by client computers in more than 100 countries. Nevertheless, relatively little research has been conducted on consumer informatics in travel medicine. An important aspect of consumer informatics involves studying consumers' needs for health information. The purpose of this study was to perform a descriptive analysis of overall use and content-specific access patterns for health information provided on a clinic-based Web site for international travelers.

  18. 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.

  19. Caregivers’ Participation in the Oncology Clinic Visit Mediates the Relationship between Their Information Competence and Their Need Fulfillment and Clinic Visit Satisfaction

    PubMed Central

    DuBenske, Lori L.; Chih, Ming-Yuan; Gustafson, David H.; Dinauer, Susan; Cleary, James F

    2010-01-01

    Objective Caregivers maintain critical roles in cancer patient care. Understanding cancer-related information effects both caregiver involvement and ability to have needs met. This study examines the mediating role caregiver’s clinic visit involvement has on the relationships between caregiver’s information competence and their need fulfillment and clinic visit satisfaction. Methods Secondary analysis of 112 advanced lung, breast, and prostate cancer caregivers participating in a large clinical trial. Caregiver information competence was assessed at pretest. Involvement, need fulfillment, and visit satisfaction were assessed immediately following the clinic appointment. Results Involvement correlated with information competence (r=.21,p<.05), need fulfillment (r=.48,p<.001), and satisfaction (r=.35,p<.001). The correlation between information competence and need fulfillment (r=.26,p<.01) decreased when controlling for involvement (r=.19,p=.049), demonstrating mediation, and accounted for 24.4% of the variance in need fulfillment. The correlation between information competence and satisfaction (r=.21,p=.04), decreased and was non-significant when controlling for involvement (r=.15,p=.11), demonstrating mediation, and accounted for 13% of variance in visit satisfaction. Conclusion Caregiver’s clinic visit involvement mediates the relationships between their information competence and their need fulfillment and visit satisfaction. Practice Implications Efforts to improve the caregiving experience, and potentially patient outcomes, should focus on system-wide approaches to facilitating caregivers’ involvement and assertiveness in clinical encounters. PMID:20880656

  20. Providing additional information about the benefits of statins in a leaflet for patients with coronary heart disease: a qualitative study of the impact on attitudes and beliefs

    PubMed Central

    Dickinson, Rebecca; Raynor, David K; MacDonald, Jan

    2016-01-01

    Objective To explore the impact of providing additional information about the potential benefits of simvastatin in a patient leaflet on attitudes and beliefs. Design Interview-based study using a generic qualitative approach and framework analysis. Participants 21 participants receiving a prescription for simvastatin were recruited from a general practitioner practice (from a total of 120). 8 participants were women; the age range was 55–92. Intervention Participants were provided with leaflets showing one of 3 types of additional benefit information: (1) textual statement, (2) number needed to treat (NNT) or (3) natural frequency. Semistructured interviews explored patient's attitudes and beliefs. Results A descriptive narrative of preferences for format suggested patients prefer textual as opposed to numerical benefit information. Significant barriers to the acceptance of numerical benefit information included difficulty in understanding the numbers. Patients overestimated the benefits of statins and expressed surprise at the numerical information. Conclusions Textual information was preferred but numerical information, in particular in the form of a natural frequency, may help patients make judgements about their medicines. NNTs were found to be very difficult to understand. This raises the prospect that some patients might reject medicines because of disappointment with the perceived low benefits of their medicines. The self-reported impact on behaviour appeared minimal with reports of intentions to ‘do what the doctor tells me’. Further research is needed to explore the impact of such statements on people who are yet to be prescribed a statin. PMID:27913558

  1. Enhancing clinical and management discourse in ICT (information and communication technology) implementation.

    PubMed

    Waring, Teresa; Wainwright, David

    2002-01-01

    Modern NHS organisations are seen to be increasingly reliant, in terms of achieving improvements and service targets, on the efficient provision of information to enable clinical, administrative and managerial decision making A key barrier to effective ICT introduction in NHS trust hospitals has been identified as the complex social, organisational and political issues endemic within the organisation, preventing true discourse amongst key stakeholders. This paper describes how the adaptation of critical social theoretical thinking may be used to develop an innovative approach to participative process and information flow modeling. This approach is used within a hospital trust to investigate its potential as a precursor to ICT procurement and development. Empirical results of the research are described with suggestions for a more informed approach to ICT introduction, leading to a re-examination of issues concerning: historical context, emancipatory practice and the role of the systems analyst.

  2. 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.

  3. 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.

  4. Improve Quality of Life - additional criteria for health and social care information technology acceptance in an ageing world.

    PubMed

    Monteiro, Jorge

    2012-01-01

    Reversing the rising cost of health and social systems is needed in ageing developed and developing countries. A new model of ageing is advocated by the World Health Organization. This new model asks for more personal health accountability and a more integrated approach on care and preventive cure. Information systems and technologies can play an important role in supporting the changes needed in order to have better and more sustainable health and social care systems. Using value and results for patients as criteria by which systems are accepted by users and by organizations can contribute to a value based competition in health and social care systems. The unified theory of acceptance and use of technology is presented, and the pertinence of adding an extension to the theory in order capture Quality of Life improvements expectations is explored.

  5. Separate information required for nuclear and subnuclear localization: additional complexity in localizing an enzyme shared by mitochondria and nuclei.

    PubMed Central

    Rose, A M; Joyce, P B; Hopper, A K; Martin, N C

    1992-01-01

    The TRM1 gene of Saccharomyces cerevisiae codes for a tRNA modification enzyme, N2,N2-dimethylguanosine-specific tRNA methyltransferase (m2(2)Gtase), shared by mitochondria and nuclei. Immunofluorescent staining at the nuclear periphery demonstrates that m2(2)Gtase localizes at or near the nuclear membrane. In determining sequences necessary for targeting the enzyme to nuclei and mitochondria, we found that information required to deliver the enzyme to the nucleus is not sufficient for its correct subnuclear localization. We also determined that mislocalizing the enzyme from the nucleus to the cytoplasm does not destroy its biological function. This change in location was caused by altering a sequence similar to other known nuclear targeting signals (KKSKKKRC), suggesting that shared enzymes are likely to use the same import pathway as proteins that localize only to the nucleus. As with other well-characterized mitochondrial proteins, the mitochondrial import of the shared methyltransferase depends on amino-terminal amino acids, and removal of the first 48 amino acids prevents its import into mitochondria. While this truncated protein is still imported into nuclei, the immunofluorescent staining is uniform throughout rather than at the nuclear periphery, a staining pattern identical to that described for a fusion protein consisting of the first 213 amino acids of m2(2)Gtase in frame with beta-galactosidase. As both of these proteins together contain the entire m2(2)Gtase coding region, the information necessary for association with the nuclear periphery must be more complex than the short linear sequence necessary for nuclear localization. Images PMID:1448094

  6. [Clinical characteristics research of shenmai injection treating tumor based on hospital information system in real world].

    PubMed

    Hu, Yuan-Chun; Xie, Yan-Ming; Yang, Wei; Wang, Yong-Yan; Wang, Lian-Xin; Tang, Hao; Zhuang, Yan

    2014-09-01

    The study was to research the clinical characteristics of Shenmai injection treating tumor based on hospital information system, including the characteristics of the age, the sex, the dosage, the course of the treatment and the combination drugs. The data of tumor patients injected with Shenmai injection was analyzed. The information was collected from the hospital information system (HIS) in twenty hospitals of grade III-A. The method of frequencies and association rules was used in this reaearch. The patients over 45 years old were up to 3 338, about 79.36% of the whole. The ratio of male and female was 1.73: 1. The hospitalization day between 15 and 28 was most. The complications of the hypertension and coronary heart disease happened most. The support was 5.939% and 5.099% respectively. Fifty-five patients had the traditional Chinese medicine (TCM) syndrome of Qi-Yin deficiency, about 14.78% of the whole. There were 8 491 patients treated with the single dose of 81 to 100 mL, about 48.70% of the whole. The main combination drugs were dexamethasone, tropisetron and maxolon. The confidence was 44.63%, 31.22% and 20.53% respectively. The information from HIS showed that tumor patients used Shenmai injection were most quinquagenarian with smooth condition. The dose of the Shenmai injection sometimes was higher than that of the drug use instructions in clinical. Shenmai injection was most often combined with glucocorticoid, antemetic and nutritional support medicine when treating tumor in clinical.

  7. 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

  8. 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

  9. An information entropy model on clinical assessment of patients based on the holographic field of meridian

    NASA Astrophysics Data System (ADS)

    Wu, Jingjing; Wu, Xinming; Li, Pengfei; Li, Nan; Mao, Xiaomei; Chai, Lihe

    2017-04-01

    Meridian system is not only the basis of traditional Chinese medicine (TCM) method (e.g. acupuncture, massage), but also the core of TCM's basic theory. This paper has introduced a new informational perspective to understand the reality and the holographic field of meridian. Based on maximum information entropy principle (MIEP), a dynamic equation for the holographic field has been deduced, which reflects the evolutionary characteristics of meridian. By using self-organizing artificial neural network as algorithm, the evolutionary dynamic equation of the holographic field can be resolved to assess properties of meridians and clinically diagnose the health characteristics of patients. Finally, through some cases from clinical patients (e.g. a 30-year-old male patient, an apoplectic patient, an epilepsy patient), we use this model to assess the evolutionary properties of meridians. It is proved that this model not only has significant implications in revealing the essence of meridian in TCM, but also may play a guiding role in clinical assessment of patients based on the holographic field of meridians.

  10. 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

  11. Informed conditioning on clinical covariates increases power in case-control association studies.

    PubMed

    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 χ(2) test statistics and a

  12. Extracting subject demographic information from abstracts of randomized clinical trial reports.

    PubMed

    Xu, Rong; Garten, Yael; Supekar, Kaustubh S; Das, Amar K; Altman, Russ B; Garber, Alan M

    2007-01-01

    In order to make more informed healthcare decisions, consumers need information systems that deliver accurate and reliable information about their illnesses and potential treatments. Reports of randomized clinical trials (RCTs) provide reliable medical evidence about the efficacy of treatments. Current methods to access, search for, and retrieve RCTs are keyword-based, time-consuming, and suffer from poor precision. Personalized semantic search and medical evidence summarization aim to solve this problem. The performance of these approaches may improve if they have access to study subject descriptors (e.g. age, gender, and ethnicity), trial sizes, and diseases/symptoms studied. We have developed a novel method to automatically extract such subject demographic information from RCT abstracts. We used text classification augmented with a Hidden Markov Model to identify sentences containing subject demographics, and subsequently these sentences were parsed using Natural Language Processing techniques to extract relevant information. Our results show accuracy levels of 82.5%, 92.5%, and 92.0% for extraction of subject descriptors, trial sizes, and diseases/symptoms descriptors respectively.

  13. Performance of informative priors skeptical of large treatment effects in clinical trials: A simulation study.

    PubMed

    Pedroza, Claudia; Han, Weilu; Truong, Van Thi Thanh; Green, Charles; Tyson, Jon E

    2015-12-13

    One of the main advantages of Bayesian analyses of clinical trials is their ability to formally incorporate skepticism about large treatment effects through the use of informative priors. We conducted a simulation study to assess the performance of informative normal, Student-t, and beta distributions in estimating relative risk (RR) or odds ratio (OR) for binary outcomes. Simulation scenarios varied the prior standard deviation (SD; level of skepticism of large treatment effects), outcome rate in the control group, true treatment effect, and sample size. We compared the priors with regards to bias, mean squared error (MSE), and coverage of 95% credible intervals. Simulation results show that the prior SD influenced the posterior to a greater degree than the particular distributional form of the prior. For RR, priors with a 95% interval of 0.50-2.0 performed well in terms of bias, MSE, and coverage under most scenarios. For OR, priors with a wider 95% interval of 0.23-4.35 had good performance. We recommend the use of informative priors that exclude implausibly large treatment effects in analyses of clinical trials, particularly for major outcomes such as mortality.

  14. 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.

  15. 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.

  16. 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.

  17. 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…

  18. 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

  19. Adapting a Hospital Information System to Data Collection for Clinical Research

    PubMed Central

    Foy, John L.; Palestine, Alan G.; Nealon, Regina C.; Vincent, William D.; Nussenblatt, Robert B.; Lewis, Thomas L.

    1985-01-01

    A hospital-wide medical information system (MIS) has been adapted to serve as a specialized data collection vehicle for an outpatient clinical trial. The system provides structured data collection, automatic encoding of data elements (and some values), and entry of both fixed- and variable-length data. Collected items are automatically passed to a general-purpose computing facility for storage, manipulation, and analysis. Protocol data is entered directly by physicians and nurses at the time of patient contact, using MIS terminals and procedures already familiar to them by virtue of routine use for patient care. Protocol data is improved in accuracy, completeness, and timeliness, at very low marginal cost.

  20. Transaction Processing Using Remote Procedure Calls (RPC) for a Heterogeneous Distributed Clinical Information System

    PubMed Central

    Tolchin, Stephen G.; Bergan, Eric S.; Arseniev, Marina; Kuzmak, Peter; Nordquist, Roger; Siegel, Dennis

    1986-01-01

    The Johns Hopkins Hospital is developing a distributed clinical information system that integrates functionally several UNIX, IBM MVS/CICS and MUMPS computer systems. Distributed applications development is accomplished by interprocess communications across Ethernet using remote procedure calls. The remote procedure call (RPC) protocol provides a standard approach to the development of distributed applications using the metaphor of a subroutine call. The Sun Microsystems RPC and XDR (external data representation) protocols have been implemented in these environments. The systems, the distributed model, RPC implementations and applications examples are discussed.

  1. 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.

  2. Transformational Impact of Health Information Technology on the Clinical Practice of Child and Adolescent Psychiatry.

    PubMed

    Peters, Todd E

    2017-01-01

    Compared with other medical specialties, psychiatrists have been slower adopters of health information technology (IT) practices, such as electronic health records (EHRs). This delay in implementation could compromise patient safety and impede integration into accountable care organizations and multidisciplinary treatment settings. This article focuses on optimizing use of EHRs for clinical practice, leveraging health IT to improve quality of care, and focusing on the potential for future growth in health IT in child and adolescent psychiatric practice. Aligning with other medical fields and focusing on transparency of mental health treatment will help psychiatrists reach parity with other medical specialties.

  3. 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

    2008-11-06

    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).

  4. California's digital divide: clinical information systems for the haves and have-nots.

    PubMed

    Miller, Robert H; D'Amato, Katherine; Oliva, Nancy; West, Christopher E; Adelson, Joel W

    2009-01-01

    Strong barriers prevent the financing of clinical information systems (CIS) in health care delivery system organizations in market segments serving disadvantaged patients. These segments include community health centers, public hospitals, unaffiliated rural hospitals, and some Medicaid-oriented solo and small-group medical practices. Policy interventions such as loans, grants, pay-for-performance and other reimbursement changes, and support services assistance will help lower these barriers. Without intervention, progress will be slow and worsen health care disparities between the advantaged and disadvantaged populations.

  5. C-Reactive Protein in Stable Cystic Fibrosis: An Additional Indicator of Clinical Disease Activity and Risk of Future Pulmonary Exacerbations

    PubMed Central

    Matouk, Elias; Nguyen, Dao; Benedetti, Andrea; Bernier, Joanie; Gruber, James; Landry, Jennifer; Rousseau, Simon; Ahlgren, Heather G; Lands, Larry C; Wojewodka, Gabriella; Radzioch, Danuta

    2016-01-01

    Introduction In stable adult cystic fibrosis (CF) patients, we assessed the role of baseline high sensitivity C-reactive protein (hs-CRP) on CF clinical variables and frequency of intravenous (IV) treated pulmonary exacerbations (PExs) 1-year post-baseline. Methods We recruited 51 clinically stable CF patients from our Adult CF Center. We incorporated collected parameters into Matouk CF clinical score and CF questionnaire-revised quality of life score (QOL). We used the clinical minus complications subscores as a clinical disease activity score (CDAS). We dichotomized our patients according to the cohort median baseline hs-CRP of 5.2 mg/L. Results Patients in the high hs-CRP group (≥ 5.2 mg/L) demonstrated worse CDAS (r=0.67, p=0.0001) and QOL scores (r=0.57, p=0.0017) at a given FEV1% predicted. In both hs-CRP groups, prior-year IV-treated PExs and baseline CDASs were significant predictors of future IV-treated PExs. Interestingly, the association between baseline CDAS and future PExs frequency was more robust in the high compared to the low hs-CRP group (r=−0.88, p<0.0001, r=−0.48, p=0.017, respectively) with a steeper regression slope (p=0.001). In addition, a significant interaction was demonstrated between elevated baseline hs-CRP levels and CDASs for the prediction of increased risk of future PExs (p=0.02). This interaction provided an additional indicator of clinical disease activity and added another dimension to the prior year PExs frequency phenotype to identify patients at increased risk for future PExs. Conclusion Stable CF patients with elevated baseline hs-CRP (≥ 5.2 mg/L) demonstrated worse clinical disease activity and QOL scores at a given level of disease severity (FEV1% predicted). Elevated baseline hs-CRP values combined with clinical disease activity scores are associated with increased risk for future IV-treated PExs even in those with mild clinical disease activity scores. PMID:28066689

  6. Additional Targeted Biopsy in Clinically Suspected Prostate Cancer: Prospective Randomized Comparison between Contrast-Enhanced Ultrasound and Sonoelastography Guidance.

    PubMed

    Koh, Jieun; Jung, Dae Chul; Oh, Young Taik; Yoo, Moon Gyu; Noh, Songmi; Han, Kyung Hwa; Rha, Koon-Ho; Choi, Young Deuk; Hong, Sung Joon

    2015-11-01

    Our aim was to improve the detection of prostate cancer by evaluating whether contrast-enhanced ultrasound (CEUS) or sonoelastography (SE) is more helpful in guiding targeted biopsy (TB) performed before systematic biopsy (SB). A total of 52 patients suspected of having prostate cancer were prospectively included and randomly assigned to either the CEUS or SE group. Different, independent radiologists performed TB and twelve-core SB. Within each group, cancer detection rates based on core number were compared between SB and TB. We evaluated the effect of TB on core-based cancer detection rates between the CEUS and SE groups. Cancer detection was higher in overall TB cores 16.4% (28/171) than SB cores 11.4% (71/624) in both groups. In the SE group, TB cores revealed higher cancer detection than did SB cores from 4.49% (14/312) to 12.86% (9/70) (p = 0.01). Compared with CEUS, SE may improve detection rates when considering additional TB guidance methods.

  7. Supporting work practices, improving patient flow and monitoring performance using a clinical information management system.

    PubMed

    Poulos, Christopher J; Gazibarich, Boris M; Eagar, Kathy

    2007-04-01

    Providing information technology solutions to clinicians to support their work practices benefits clinicians, administrators and patients. We present our 8-year experience with an inexpensive information management system which provides clinical and business process support for clinicians and bed managers. The system has been used by an area rehabilitation and aged care service to manage inpatient consultations and patient flow across nine hospitals. Performance monitoring of the time from referral to consultation, the number, type and outcome of consultations, and the time taken to access a rehabilitation or subacute bed is also provided. Read-only access to the system for clinicians and bed managers outside the rehabilitation and aged care service allows greater transparency.

  8. Voice Capture of Medical Residents' Clinical Information Needs During an Inpatient Rotation

    PubMed Central

    Chase, Herbert S.; Kaufman, David R.; Johnson, Stephen B.; Mendonca, Eneida A.

    2009-01-01

    Objective To identify some of the challenges that medical residents face in addressing their information needs in an inpatient setting, by examining how voice capture in natural language of clinical questions fits into workflow, and by characterizing the focus, format, and semantic content and complexity of their questions. Design Internal medicine residents captured information needs on a digital recorder while on a hospital inpatient service and then participated in semi-structured interviews. Measurements Interviews were analyzed to identify emergent themes. Recorded questions were analyzed for focus (diagnosis, treatment, or epidemiology) and format, either foreground (specific knowledge relating to an individual patient) or background (general knowledge about a condition). Semantic concepts and types were identified using MetaMap (UMLS - Unified Medical Language System) and manually. Results Voice recording of questions appeared to unmask residents' latent information needs. Although residents were able to record questions during workflow, there was a delay from the time questions materialized to when they were recorded. Question focus was distributed among diagnosis (32%), treatment (40%), and epidemiology (28%), and the majority of questions were background (69%). Questions were semantically complex; foreground and background questions averaged 12.6 (SD 6.0) and 9.1 (SD 6.0) UMLS concepts, respectively. MetaMap failed to recognize concepts when residents used acronyms or abbreviations or omitted key terms. Conclusions We found that it is feasible for residents to capture their clinical questions in natural language during workflow and that recording questions may prompt awareness of previously unrecognized information needs. However, the semantic complexity of typical questions and mapping failures due to residents' use of acronyms and abbreviations present challenges to machine-based extraction of semantic content. PMID:19261939

  9. Information technology, health care, and the future: what are the implications for the clinical laboratory?

    PubMed

    Lincoln, T L; Essin, D

    1992-01-01

    As new information systems are offered for the clinical laboratory, advanced applications and improvements in computer hardware continue to dominate marketing presentations and fascinate the decision maker. However, the most important issue for all of our clinical information systems is not the speed of the hardware, the reliability of the systems software, or the ability of applications to carry out routine tasks in some novel or elegant manner. Rather, it is "coping"--the ability of a system to manage new issues that arise as information requirements change over time and to manage all the unexpected events that occur in the course of regular work but that do not follow the usual sequence of procedures. The need for new processing conventions to cope with unexpected situations without creating new problems is not unique to health care. The need is present wherever the real world intrudes directly and significantly into critical operations. Moreover, the pressure to adjust to changing external circumstances continues to grow as the rate of change in our information-based society increases. The lack of general coping procedures, although long ignored, has become such a pervasive handicap that marked improvements in this type of flexibility will be introduced over this decade. New software designs that deal with coping issues are already beginning to appear and to bear fruit. When purchasing any new laboratory computer system today, software that demonstrates an effective coping flexibility should be given more weight than fascinating innovations in hardware or software that are the favorites of vendor marketers. It is now possible to test for such flexibility on a site-specific basis.

  10. Two intelligent order viewers for chronic condition patients on clinical information system.

    PubMed

    Toyoda, Shuichi; Niki, Noboru; Nishitani, Hiromu

    2008-01-01

    The computerization of patient data is proceeding and the amount of patient records has greatly increased. However, physicians have limited time to review and process patient records. In order to use these records effectively, medical institutions need to access the information in a variety of forms. This paper comparatively describes two intelligent viewers that are SAKURA-Viewer and FUJI-Viewer. These viewers reorganize order-related data. SAKURA-Viewer is based on a concept hierarchy method and focuses the view of consolidated information. This viewer represents order history from two viewpoints simultaneously to eliminate semantic redundancies. FUJI-Viewer is based on two-dimensional mapping method and focuses the flow of periodic information. This viewer represents differences between the plan history and the order history to manage a long-term test order history and test plan history concurrently. These viewers also support data entry methods that input order-related data efficiently and accurately. This interface reduces the workload of the medical stuff. These intelligent viewers are incorporated into a clinical information system.

  11. [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).

  12. 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

  13. Informed consent for clinical research involving patients with chest disease in the United States.

    PubMed

    Luce, John M

    2009-04-01

    The concept of informed consent was applied to clinical research in the United States after research abuses were documented in Nazi Germany and this country. The concept is imbedded in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Federal regulations governing clinical research require both the consent of subjects and peer review of research proposals by institutional review boards (IRBs). Subpart A of the Code of Federal Regulations contains basic provisions for the protection of research subjects and requirements for informed consent by subjects or their surrogates; surrogate consent may or may not be allowed under state law. Other subparts contain further protections for subjects with diminished capacity, such as children, that limit the kind of research in which they can participate. Whether these protections should be extended to decisionally impaired adults, including those who are critically ill, remains to be determined. Consent can be deferred or waived for emergency research only rarely in the United States, in contrast to other countries.

  14. [Terms of informed consent for users of dental clinics in Brazil: legal and ethical issues].

    PubMed

    Sales-Peres, Sílvia Helena de Carvalho; Sales-Peres, Arsênio; Eleutério, Adriana Silveira de Lima; de Oliveira, José Luiz Góes; Gigliotti, Mariana Pracucio

    2011-01-01

    The consent of patient before the beginning of any procedure has to be a respected condition, without any exception. It is necessary the patients to be aware of their health status, their specific needs, the intention of each treatment, the alternatives plans (including no treatment), to know their prognostic, risks, consequences, limitations, and to be aware of their responsibilities and those of your dentist, resulting in the success of the treatment. The Informed Consent (TCLE) aims to fortify and to clarify the position of the patient, being established the rights and duties of both parts - patient and professional. The integral knowledge of the treatment will minimize the anxiety of the patient and treatment complications, and promote greater quality of dental services and improve the satisfaction of both dentist and patient. However, there are few articles in Brazil about this, but there are some ethics problems involving dental clinics regarding this document of information for the patient. Therefore, the aim of this work is to carry through a critical revision on the subject demonstrating the importance of the TCLE in the Brazilian dental clinics.

  15. 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.

  16. 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.

  17. 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

  18. Using the e-Chasqui, web-based information system, to determine laboratory guidelines and data available to clinical staff.

    PubMed

    Blaya, Joaquin A; Yagui, Martin; Contreras, Carmen C; Palma, Betty; Shin, Sonya S; Yale, Gloria; Suarez, Carmen; Fraser, Hamish S F

    2008-11-06

    13% of all drug susceptibility tests (DSTs) performed at a public laboratory in Peru were duplicate. To determine reasons for duplicate requests an online survey was implemented in the e-Chasqui laboratory information system. Results showed that 59.6% of tests were ordered because clinical staff was unaware of ordering guidelines or of a previous result. This shows a benefit of using a web-based system and the lack of laboratory information available to clinical staff in Peru.

  19. 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

  20. 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

  1. Assessment of Innovative Emergency Department Information Displays in a Clinical Simulation Center

    PubMed Central

    McGeorge, Nicolette; Hegde, Sudeep; Berg, Rebecca L.; Guarrera-Schick, Theresa K.; LaVergne, David T.; Casucci, Sabrina N.; Hettinger, A. Zachary; Clark, Lindsey N.; Lin, Li; Fairbanks, Rollin J.; Benda, Natalie C.; Sun, Longsheng; Wears, Robert L.; Perry, Shawna; Bisantz, Ann

    2016-01-01

    The objective of this work was to assess the functional utility of new display concepts for an emergency department information system created using cognitive systems engineering methods, by comparing them to similar displays currently in use. The display concepts were compared to standard displays in a clinical simulation study during which nurse-physician teams performed simulated emergency department tasks. Questionnaires were used to assess the cognitive support provided by the displays, participants’ level of situation awareness, and participants’ workload during the simulated tasks. Participants rated the new displays significantly higher than the control displays in terms of cognitive support. There was no significant difference in workload scores between the display conditions. There was no main effect of display type on situation awareness, but there was a significant interaction; participants using the new displays showed improved situation awareness from the middle to the end of the session. This study demonstrates that cognitive systems engineering methods can be used to create innovative displays that better support emergency medicine tasks, without increasing workload, compared to more standard displays. These methods provide a means to develop emergency department information systems—and more broadly, health information technology—that better support the cognitive needs of healthcare providers. PMID:27974881

  2. [Ethical dilemma in research: informed consent in clinical studies on persons with dementia].

    PubMed

    Sinoff, Gary

    2012-09-01

    With the world's population aging, there is an increase in the number of demented elderly. It is vital to study this phenomenon in epidemiological and clinical studies, particularly the effects on the increasing numbers of demented elderly. Researchers need to understand the factors predicting the general decline in the demented elderly. However, before any research is undertaken, it is necessary to obtain approval from the Local Internal Review Board. This committee is responsible to maintain accepted national and international ethical standards. The basis for recruitment to a study is the signature on the informed consent form, where the patient is required to understand the study, internalize the study's aim, to consider all options and finally, to express an opinion. Potential elderly participants need to have their judgment evaluated before signing the form. In cases where the subject is incapable, some countries, including Israel, require that there be a legal guardianship. This is a long and complicated process that causes researchers not to recruit demented patients into a study which may actually be beneficial to all. Some countries allow a proxy to sign informed consent forms to permit the demented subject to participate in the study. Often the threshold may depend on the invasiveness of the intervention. The problem of proxies to sign informed consent form troubles researchers worldwide. This article addresses the history and development of ethics in research, and raises the issue to promote an official policy for proxy consent signing.

  3. 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).

  4. Patients’ perceived purpose of clinical informed consent: Mill’s individual autonomy model is preferred

    PubMed Central

    2014-01-01

    Background Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes. Methods We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”. Results Respondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure

  5. Developing a Controlled Vocabulary for the Columbia-Presbyterian Medical Center Outpatient Clinical Information System

    PubMed Central

    Clark, Anthony S.; Shea, Steven

    1990-01-01

    This paper describes the development of a Controlled Vocabulary for medication and problem/diagnostic lists in an ambulatory patient care information system within the institution's overall IAIMS framework. This Controlled Vocabulary is used in a spell-checking filter for uploading existing free text data and for on-line entry of new data by physicians. The Controlled Vocabulary consists of a reference file, keyed by code, and an inverted word index file to access it. It is currently loaded with an in-house produced set of medication codes and SNOMED Level 1 Disease codes supplemented by additional user entries.

  6. Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants

    PubMed Central

    Cortés-Puch, Irene; Wesley, Robert A.; Carome, Michael A.; Danner, Robert L.; Wolfe, Sidney M.; Natanson, Charles

    2016-01-01

    Objective The adequacy of informed consent in the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) has been questioned. SUPPORT investigators and publishing editors, heads of government study funding agencies, and many ethicists have argued that informed consent was adequate because the two oxygen saturation target ranges studied fell within a range commonly recommended in guidelines. We sought to determine whether each oxygen target as studied in SUPPORT and four similar randomized controlled trials (RCTs) was consistent with usual care. Design/Participants/Setting PubMed, EMBASE, Web of Science, and Scopus were searched for English articles back to 1990 providing information on usual care oxygen management in extremely premature infants. Data were extracted on intended and achieved oxygen saturation levels as determined by pulse oximetry. Twenty-two SUPPORT consent forms were examined for statements about oxygen interventions. Results While the high oxygen saturation target range (91 to 95%) was consistent with usual care, the low range (85 to 89%) was not used outside of the SUPPORT trial according to surveys and clinical studies of usual care. During usual care, similar lower limits (< 88%) were universally paired with higher upper limits (≥ 92%) and providers skewed achieved oxygen saturations toward the upper-end of these intended ranges. Blinded targeting of a low narrow range resulted in significantly lower achieved oxygen saturations and a doubling of time spent below the lower limit of the intended range compared to usual care practices. The SUPPORT consent forms suggested that the low oxygen saturation arm was a widely practiced subset of usual care. Conclusions SUPPORT does not exemplify comparative effectiveness research studying practices or therapies in common use. Descriptions of major differences between the interventions studied and commonly practiced usual care, as well as potential risks associated with these

  7. The case for randomized controlled trials to assess the impact of clinical information systems

    PubMed Central

    Wyatt, Jeremy C

    2011-01-01

    There is a persistent view of a significant minority in the medical informatics community that the randomized controlled trial (RCT) has a limited role to play in evaluating clinical information systems. A common reason voiced by skeptics is that these systems are fundamentally different from drug interventions, so the RCT is irrelevant. There is an urgent need to promote the use of RCTs, given the shift to evidence-based policy and the need to demonstrate cost-effectiveness of these systems. The authors suggest returning to first principles and argue that what is required is clarity about how to match methods to evaluation questions. The authors address common concerns about RCTs, and the extent to which they are fallacious, and also discuss the challenges of conducting RCTs in informatics and alternative study designs when randomized trials are infeasible. While neither a perfect nor universal evaluation method, RCTs form an important part of an evaluator's toolkit. PMID:21270132

  8. CytoAccess, a relational laboratory information management system for a clinical cytogenetics laboratory.

    PubMed

    Xiang, Bixia; Li, Peining; Hemingway, Susan S; Qumsiyeh, Mazin

    2006-01-01

    We developed a CytoAccess laboratory management system based on the widely used Microsoft Access software to facilitate data processing, result reporting, and quality management for a full-service cytogenetics laboratory. The CytoAccess system consists of four functional modules. The data entry module is for logging in patient information. The result entry module is used to generate chromosome, fluorescent in situ hybridization (FISH), and array comparative genomic hybridization (aCGH) reports. The administrative module enables periodic monitoring of quality control and quality improvement (QA/QI) parameters and produces billing forms. The maintenance module allows users to update clinical demographics, report templates, code tables, and to refresh data links. We have integrated into this system over 15,000 chromosome and FISH results from prenatal, postnatal, and cancer cases for the past six years. This system is cost-effective, user-friendly, flexible in updating, and potentially adaptable for data mining.

  9. [The Medical Information Systems Project clinical coding and surgeons: why should surgeons code and how?].

    PubMed

    Bensadoun, H

    2001-02-01

    The clinical coding system recently instituted in France, the PMSI (Projet de Médicalisation du Système d'Information), has become an unavoidable element in funding allocations for short-term private and public hospitalization centers. Surgeons must take into serious consideration this controversial medicoeconomic instrument. Coding is a dire time-consuming task but, like the hospitalization or surgery report, is an essential part of the discharge procedure. Coding can in the long run be used to establish pricing by pathology. Surgeons should learn the rules and the logic behind this coding system: which, not being based on a medical rationale, may be somewhat difficult to understand. Choosing the right main diagnosis and the comobidity Items is crucial. Quality homogeneous coding is essential if one expects the health authorities to make good use of the system. Our medical societies have a role to play in promoting and harmonizing the coding technique.

  10. Pharmacogenetics Informed Decision Making in Adolescent Psychiatric Treatment: A Clinical Case Report

    PubMed Central

    Smith, Teri; Sharp, Susan; Manzardo, Ann M.; Butler, Merlin G.

    2015-01-01

    Advances made in genetic testing and tools applied to pharmacogenetics are increasingly being used to inform clinicians in fields such as oncology, hematology, diabetes (endocrinology), cardiology and expanding into psychiatry by examining the influences of genetics on drug efficacy and metabolism. We present a clinical case example of an adolescent male with anxiety, attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder who did not tolerate numerous medications and dosages over several years in attempts to manage his symptoms. Pharmacogenetics testing was performed and DNA results on this individual elucidated the potential pitfalls in medication use because of specific pharmacodynamic and pharmacokinetic differences specifically involving polymorphisms of genes in the cytochrome p450 enzyme system. Future studies and reports are needed to further illustrate and determine the type of individualized medicine approach required to treat individuals based on their specific gene patterns. Growing evidence supports this biological approach for standard of care in psychiatry. PMID:25710722

  11. Healthcare information systems: data mining methods in the creation of a clinical recommender system

    NASA Astrophysics Data System (ADS)

    Duan, L.; Street, W. N.; Xu, E.

    2011-05-01

    Recommender systems have been extensively studied to present items, such as movies, music and books that are likely of interest to the user. Researchers have indicated that integrated medical information systems are becoming an essential part of the modern healthcare systems. Such systems have evolved to an integrated enterprise-wide system. In particular, such systems are considered as a type of enterprise information systems or ERP system addressing healthcare industry sector needs. As part of efforts, nursing care plan recommender systems can provide clinical decision support, nursing education, clinical quality control, and serve as a complement to existing practice guidelines. We propose to use correlations among nursing diagnoses, outcomes and interventions to create a recommender system for constructing nursing care plans. In the current study, we used nursing diagnosis data to develop the methodology. Our system utilises a prefix-tree structure common in itemset mining to construct a ranked list of suggested care plan items based on previously-entered items. Unlike common commercial systems, our system makes sequential recommendations based on user interaction, modifying a ranked list of suggested items at each step in care plan construction. We rank items based on traditional association-rule measures such as support and confidence, as well as a novel measure that anticipates which selections might improve the quality of future rankings. Since the multi-step nature of our recommendations presents problems for traditional evaluation measures, we also present a new evaluation method based on average ranking position and use it to test the effectiveness of different recommendation strategies.

  12. Informal caregivers' hopes and expectations of a referral to a memory clinic.

    PubMed

    Morgan, Debra G; Walls-Ingram, Sheena; Cammer, Allison; O'Connell, Megan E; Crossley, Margaret; Dal Bello-Haas, Vanina; Forbes, Dorothy; Innes, Anthea; Kirk, Andrew; Stewart, Norma

    2014-02-01

    Although only 20-50% of individuals with dementia are diagnosed, early diagnosis enables patients and families to access interventions and services, and plan for the future. The current study explored the experiences of rural family caregivers in the period leading up to a diagnostic assessment at a Canadian memory clinic, their hopes and expectations of the assessment, and their experiences in the six months following diagnosis. Using a longitudinal, retrospective and prospective qualitative research design, caregivers of 30 patients referred to the clinic were interviewed during the diagnostic assessment process and again six months after the diagnosis. Most caregivers reported first noticing symptoms two years prior to diagnosis. The pre-diagnostic interviews revealed a prevalent 'need to know' among caregivers that drove the help-seeking process. Caregivers hoped that the diagnosis would have the benefits of 'naming it,' 'accessing treatment,' 'knowing what to expect,' and 'receiving guidance.' When asked six months later about the impact of the diagnosis, the main theme was 'acceptance and moving forward.' Caregivers reported that the diagnosis provided 'relief,' 'validation,' and 'improved access to services.' These findings can inform care practices of primary health care providers who represent the first point of contact regarding expectations and experiences of dementia-related diagnoses.

  13. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 3: Design considerations.

    PubMed

    Ball, Greg; Silverman, Michael H

    2011-09-01

    Ongoing safety monitoring of clinical trials of investigational treatments must operate at levels that range from the minute and detailed - namely, mathematical treatment of trial data - to the philosophical and societal - namely, ethical concerns for individuals and populations. Between those two poles lies a realm of environmental and pragmatic considerations that reflect the goals, biases, risk-tolerance, and constraints of study sponsors and organizers. These factors, while more difficult to quantify or, at times, to justify, also have a meaningful impact on the approach to safety monitoring and the resulting actions and outcomes. This paper considers the influence and interaction of two such factors, study design and statistical framework, on continuous safety monitoring procedures. Group sequential designs have been generally preferred for clinical trials over continuous sequential designs because of practical considerations. The group means and greater time for deliberation when using a group sequential procedure, as opposed to a continuous sequential procedure, can improve the quality of the analyses with minimal loss in sensitivity. However, undertaking any sequential analysis within a frequentist framework provokes considerable theoretical and practical difficulties. Continuous monitoring with a likelihood based method, on the other hand, has the advantages that all available information, including new data, can be used; sample sizes need not be fixed; and decisions can be made at any time without statistical penalty, irrespective of trial design. Such responsive statistical rules are needed to provide guidance to the human beings charged with trial monitoring.

  14. Recruit--An Ontology Based Information Retrieval System for Clinical Trials Recruitment.

    PubMed

    Patrão, Diogo F C; Oleynik, Michel; Massicano, Felipe; Morassi Sasso, Ariane

    2015-01-01

    Clinical trials are studies designed to assess whether a new intervention is better than the current alternatives. However, most of them fail to recruit participants on schedule. It is hard to use Electronic Health Record (EHR) data to find eligible patients, therefore studies rely on manual assessment, which is time consuming, inefficient and requires specialized training. In this work we describe the design and development of an information retrieval system with the objective of finding eligible patients for cancer trials. The Recruit system has been in use at A. C. Camargo Cancer Center since August/2014 and contains data from more than 500,000 patients and 9 databases. It uses ontologies to integrate data from several sources and represent medical knowledge, which helps enhance results. One can search both in structured data and inside free text reports. The preliminary quality assessments shows excellent recall rates. Recruit proved to be an useful tool for researchers and its modular design could be applied to other clinical conditions and hospitals.

  15. Can the FDA improve oversight of foreign clinical trials?: Closing the information gap and moving towards a globalized regulatory scheme.

    PubMed

    Ourso, André

    2012-01-01

    Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. This article examines the FDA's oversight of foreign clinical trials and the agency's limitations regulating these trials. In addition to looking at steps the FDA is taking to address these limitations, the article examines other potential regulatory and cooperative actions that can be taken to effectively monitor foreign clinical trials and to ensure data integrity and patient safety.

  16. Continuous safety monitoring for randomized controlled clinical trials with blinded treatment information. Part 2: Statistical considerations.

    PubMed

    Ball, Greg; Piller, Linda B

    2011-09-01

    If the primary objective of a trial is to learn about the ability of a new treatment to help future patients without sacrificing the safe and effective treatment of the current patients, then a Bayesian design with frequent assessments of the accumulating data should be considered. Unfortunately, Bayesian analyses typically do not have standard approaches, and because of the subjectivity of prior probabilities and the possibility for introducing bias, statisticians have developed other methods for statistical inference that only depend on deductive probabilities. However, these frequentist probabilities are just theories about how certain relative frequencies will develop over time. They have no real meaning in a single experiment. Designed to work well in the long run, p-values become hard to explain for individual experiments. Fortunately, the controversy surrounding Bayes' theorem comes, not from the representation of evidence, but from the use of probabilities to measure belief. A prior distribution is not necessary. The likelihood function contains all of the information in a trial relevant for making inferences about the parameters. Monitoring clinical trials is a dynamic process which requires flexibility to respond to unforeseen developments. Likelihood ratios allow the data to speak for themselves, without regard for the probability of observing weak or misleading evidence, and decisions to stop, or continue, a trial can be made at any time, with all of the available information. A likelihood based method is needed.

  17. Enhancement of CLAIM (clinical accounting information) for a localized Chinese version.

    PubMed

    Guo, Jinqiu; Takada, Akira; Niu, Tie; He, Miao; Tanaka, Koji; Sato, Junzo; Suzuki, Muneou; Takahashi, Kiwamu; Daimon, Hiroyuki; Suzuki, Toshiaki; Nakashima, Yusei; Araki, Kenji; Yoshihara, Hiroyuki

    2005-10-01

    CLinical Accounting InforMation (CLAIM) is a standard for the exchange of data between patient accounting systems and electronic medical record (EMR) systems. It uses eXtensible Markup Language (XML) as a meta-language and was developed in Japan. CLAIM is subordinate to the Medical Markup Language (MML) standard, which allows the exchange of medical data between different medical institutions. It has inherited the basic structure of MML 2.x and the current version, version 2.1, contains two modules and nine data definition tables. In China, no data exchange standard yet exists that links EMR systems to accounting systems. Taking advantage of CLAIM's flexibility, we created a localized Chinese version based on CLAIM 2.1. Since Chinese receipt systems differ from those of Japan, some information such as prescription formats, etc. are also different from those in Japan. Two CLAIM modules were re-engineered and six data definition tables were either added or redefined. The Chinese version of CLAIM takes local needs into account, and consequently it is now possible to transfer data between the patient accounting systems and EMR systems of Chinese medical institutions effectively.

  18. Approaches to informed consent for hypothesis-testing and hypothesis-generating clinical genomics research

    PubMed Central

    2012-01-01

    Background Massively-parallel sequencing (MPS) technologies create challenges for informed consent of research participants given the enormous scale of the data and the wide range of potential results. Discussion We propose that the consent process in these studies be based on whether they use MPS to test a hypothesis or to generate hypotheses. To demonstrate the differences in these approaches to informed consent, we describe the consent processes for two MPS studies. The purpose of our hypothesis-testing study is to elucidate the etiology of rare phenotypes using MPS. The purpose of our hypothesis-generating study is to test the feasibility of using MPS to generate clinical hypotheses, and to approach the return of results as an experimental manipulation. Issues to consider in both designs include: volume and nature of the potential results, primary versus secondary results, return of individual results, duty to warn, length of interaction, target population, and privacy and confidentiality. Summary The categorization of MPS studies as hypothesis-testing versus hypothesis-generating can help to clarify the issue of so-called incidental or secondary results for the consent process, and aid the communication of the research goals to study participants. PMID:23046515

  19. Budget goal commitment, clinical managers' use of budget information and performance.

    PubMed

    Macinati, Manuela S; Rizzo, Marco G

    2014-08-01

    Despite the importance placed on accounting as a means to influence performance in public healthcare, there is still a lot to be learned about the role of management accounting in clinical managers' work behavior and their link with organizational performance. The article aims at analyzing the motivational role of budgetary participation and the intervening role of individuals' mental states and behaviors in influencing the relationship between budgetary participation and performance. According to the goal-setting theory, SEM technique was used to test the relationships among variables. The data were collected by a survey conducted in an Italian hospital. The results show that: (i) budgetary participation does not directly influence the use of budget information, but the latter is encouraged by the level of budget goal commitment which, as a result, is influenced by the positive motivational consequences of participative budgeting; (ii) budget goal commitment does not directly influence performance, but the relationship is mediated by the use of budget information. This study contributes to health policy and management accounting literature and has significant policy implications. Mainly, the findings prove that the introduction of business-like techniques in the healthcare sector can improve performance if attitudinal and behavioral variables are adequately stimulated.

  20. Relation between information and advice provision to male GUM clinic attendees and sexual orientation and ethnic group

    PubMed Central

    Hope, V.; MacArthur, C.; Mullis, D.; Radcliffe, K.

    2000-01-01

    Objectives: To examine whether the provision of advice and information to male genitourinary medicine (GUM) clinic attendees was related to their reasons for attendance, ethnicity, or sexual orientation. Method: Cross sectional survey of men attending a large city centre GUM clinic. Data were collected using an anonymous subject completed questionnaire. Results: Of the 302 men recruited, 72% described themselves as white and 85% reported only female sexual partners. Information and advice provision were generally found to reflect reason for attendance—for example, those attending with a concern about "an STD or urinary problem" were more likely to report advice and information on NSU/chlamydia, herpes, gonorrhoea, or syphilis than those attending without such concerns. For those attending with a concern about HIV less than half (42%) reported receiving advice and information about HIV. The reasons for attendance were found to vary with ethnicity (black men were more likely to attend for a "check up," and less likely to attend about HIV or with genital warts than white men) and sexual orientation (those with male partners were more likely to attend about HIV or hepatitis B than those with only female partners); there were corresponding variations in the provision of advice and information. Conclusions: The clinic was generally providing advice and information appropriate to the reasons for attendance and this reflected variations in such needs with ethnicity and sexual orientation. The provision of advice and information about HIV could be more comprehensive. Key Words: advice; male GUM clinic attendees; sexual orientation; ethnic group PMID:10961198